BTS BTSWEMG2 Wireless EMG sensor for EMG system User Manual ERTMJ 00998 04 TMJOINT ENG v 3 0 0

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Document Description	ERTMJ-00998-04 TMJOINT User Manual ENG v.3.0.0
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BTS TMJOINT
user manual
english
version 3.0.0
Document Number : ERTMJ-00998-04
Published: January 2013
Copyright © 2010 - 2013 BTS SpA. All Rights Reserved.
BTS TMJOINT
contents
contents							
icons, symbols and acronyms					
radio regulation							
disposal (WEEE)						
intended use 							
regulatory label							
receiving unit regulatory label				
EMG wireless probes regulatory label			
charger regulatory label					
warnings
copyright
introduction 							
general description 					
case contents						
system components						
receiving unit						
wireless EMG probes					
charger							
installation							
user PC minimum configuration 				
connections						
description of the software on the user PC			
software installation					
hardware installation					
first software use						
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patient setup							
POC4 protocol						
POC6 protocol						
guide to the use of BTS DCA					
initial screen 						
menu bar						
tool bar							
probes status bar						
patient list and research filter				
patient, session and trial information			
trial viewing and report generation area			
main features of the BTS DCA software				
new patient		
new session						
edit pathology						
new trial		
data acquisition						
edit patient						
edit session		
delete patient			
delete session						
delete trial						
more features of the BTS DCA software				
database and data folder					
managing files in the recycle bin				
guide to of the data report reading				
INT tab							
EXT tab						
POC tab						
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contents
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contents
BTS TMJOINT
ISTO tab						
MAST tab						
INFO tab						
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appendix A – technical specifications 				
wireless probes						
receiving unit						
appendix B – environmental specifications			
appendix C – power supply and switch off		
appendix D – battery						
appendix E – troubleshooting guide				
warning – invalid trigger mode 			
appendix F – declaration of conformity				
appendix G– bibliography					
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icons, symbols and acronyms
Symbol in the instructions for the function.
The icon represents the information which requires special attention.
Symbol in the instructions for the function.
This icon makes reference to a more detailed discussion of the subject in
hand.
Symbol on the equipment:
The data appearing next to the manufacturer’s symbol refer to the place of
manufacture of the equipment itself.
Symbol on the equipment:
The “FCC” simbol refers to the Federal Communication Commission of
the USA. The 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:
The figure 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:
The 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 Notified Body. The CE mark certifies that
the product conforms to the standards applicable in the member states of
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icons, symbols and acronyms
BTS TMJOINT
the European Union (see Declaration of Conformity).
Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies
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).
The 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 Coefficent
MVC Maximum Voluntary Contraction
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radio regulation
Radio equipment identification:
- EMG probes:
FCC ID: YQH-BTSWEMG2
IC: 9188A-BTSWEMG2
- receiving 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.
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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. This
equipment belongs to Category 8 (medical equipment) and is classified in
the Business-to-Business sector.
The symbol of the crossed out rubbish bin
indicates that the equipment must not be
disposed of in normal domestic waste.
The regulations for disposal may differ between
individual countries in the EU. In cases of doubt,
refer to the respective sales outlet.
This 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
This equipment is an instrument for the EMG surface analysis, classified
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 qualified
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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BTS TMJOINT
regulatory label
Receiving Unit Regulatory label
EMG Wireless Probes Regulatory label
Label on the probes:
Probe ID
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regulatory label
BTS TMJOINT
Label not on actual probes due to size constraints:
Charger Regulatory label
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warnings
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 qualified and authorized personnel, according to
the laws in force in the nation it is in use. The EMG probes are classified as
ETSI EN 300 440 “Receiver category 3” according to Directive R&TTE
99/5/EEC.
The 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.
The uses of the device for other purposes and with methodologies different
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.
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warnings
BTS TMJOINT
- 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.
- The use of any components different from the original ones
declines the conformity of the device.
- The 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.
The 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.
The information contained in this manual is subject to change
without notice and does not constitute product specifications or
any obligation on the part of BTS S.p.A.
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copyright
The software of the system described in this manual is supplied with the
“licence to use” contract. The 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 specified, 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.
This publication contains reserved information which is the
property of BTS S.p.A.
The 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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BTS TMJOINT
introduction
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
differential influence of the occlusal function through indices validated
and published in scientific 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. This method allows the elimination of problems of the
wrong positioning of the electrodes, of the difference of impedance of
the patient’s skin, of the differences of muscular tropism, etc. making it
accurate and repeatable.
The results are shown via a special graphic interface that is easy to
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understand for both the physician and patient.
The specialized software BTS Dental Contact Analyzer, provide, indeed,
the automatic indices calculation, plotted in a table form, with pie charts
and histograms.
BTS TMJOINT is a modular and scalable solution, structured on various
levels of analysis.
The first level, called POC4, includes 4 capture probes and the analysis
protocol. Through a quick 5 second clenching test, the activities of the
masseter and anterior temporal muscles, right and left, provide, as an
immediate result, a POC percentage overlapping coefficient (an index
of the symmetric distribution of the muscular activity determined by
the occlusion) and a TORS torque coefficient (to estimate the possible
presence of mandibular torque), which makes it possible to establish the
role of occlusion on muscular balance.
A third index, called IMPACT, allows to evaluate the muscular work,
providing information about the occlusal vertical dimension.
The second level, called POC6, adds to the previous 2 capture probes for
calculating the indices related to the sternocleidomastoid muscle, right and
left. The effects of the teeth touching, on the neck muscles are evaluated.
The third level, called MASTICATION, analyses the neuromuscular
coordination during mastication. The masticatory frequency, the Lissajous
curve, and indices of muscle symmetry are calculated.
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Case contents
• Receiving Unit
• Probes Kit available in 2 versions:
• POC4: include 4 wireless probes*
• POC6: include 6 wireless probes*
*(identificative labels available in 4 different colors)
• Probes Charger (AC adapter included)
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introduction
introduction
BTS TMJOINT
• Set of disposable electrodes
• USB extension cable
• User manual
You will receive the instructions for use for other possible optional
components not mentioned in this manual.
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system components
BTS TMJOINT system consists of two parts: the receiving unit and the
wireless EMG probes.
Receiving unit
The receiving unit, connected to the PC trough USB, allows the WiFi
reception of the EMG signal acquired by the wireless probes
WiFi transmission
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BTS TMJOINT
system components
Wireless EMG Probes
BTS FREEEMG 300 utilises miniaturized probes with active electrodes
weighing less than 13 grams.
The special design ensures maximum space-saving and comfort for the
patient who is free to move around without obstacles.
The probes can be hooked on directly to the pre-gelled electrodes without
requiring additional fixing with plasters or double-sided tape.
This together with the total absence of cables enables a much faster patient
preparation, drastically reducing the time of each session.
Each probe consists of a mother electrode and a satellite electrode, each
fitted with a clip. The two parts, connected via a flexible cable, may be
positioned as needed by the user at adjustable distance (electrodes with
variable geometry).
All probes are also equipped with a solid state memory buffer, to prevent
data loss for problems due to the WiFi network or due to exceeding the
useful operating range.
mother electrode
LED
satellite electrode
mother electrode clip
satellite electrode clip
flexible cable
probe ID
Each probe is fitted with a LED indicating its state.
The probes can be in one of a number of different states:
• Charge: steady blue LED.
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system components
During the recharging phase the steady blue LED is on.
This phase occurs when the probes are connected to the charger
turned on, and the charge level is less than 90%.
When the charge level reaches 90% the led turns OFF.
Since, by connecting a probe to the charger on, it enters in “Deep
Sleep” mode, even while charging the probe will be completely
passive and does not respond to any commands.
• Active-Scanning: white LED which cyclically lights for a few
seconds.
In this mode the probe is searching for the receiving unit.
At intervals of about 1 minutes it carries out a scan of the
frequencies of few seconds. During the scan the white LED
flashes quickly.
• Active-Connected: white LED which flashes slowly.
When the probe and the receiving unit establish a connection,
the white LED begins to pulse slowly: the probe is waiting for
commands.
If the connection is interrupted, the probe returns to “ActiveScanning” mode and attempts to re-establish the connection
with the receiving unit.
• Active-Capturing: white LED which lights and goes out at
regular intervals.
During acquisition the white LED flashes at regular intervals of
approximately one second. At the conclusion of the acquisition,
the probe returns to the “Active-Connected” condition.
If during the acquisition, connection to the receiver unit is lost,
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the probe continues to acquire, storing the data locally for one
minute and at the same time scans the assigned channel trying
to reconnect to the receiving unit.
If after one minute the scan is unsuccessful, the probe returns
to the “Active-Scanning” condition interrupting the storage of
data.
• Completely discharged or in “Deep Sleep” mode: LED is off.
If the probe is completely discharged the LED does not display
any flashing cycle and is off.
The same happens when it is in “Deep Sleep” mode (except
during the recharging phase in witch the led is steady blue).
The probes in “Deep Sleep” mode do not perform any
scan cycle, but are turned off. Is therefore guaranteed
energy savings.
To put the probe in “Deep Sleep” mode it is necessary to connect
them to the Charger switched on, or to put them in contact
with a magnet for half a second.
Before the next use is necessary to reactivate the probes,
putting them in contact with a magnet.
The probes are charged by a dedicated charger to which the probes are
connected via their respective clips.
For more info about the probes charge sse the paragraph “Charger”
of this chapter.
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system components
Charger
The Charger, included with the product, charges the BTS TMJOINT
probes.
The Charger can simultaneously charge all the EMG probes of the system
(6 maximum) and includes a lodging to store the receiver when not in use
for acquisition.
The EMG probes are connected to the charger using the same clips that
normally collect the EMG signal.
For correct connection simply follow the outline of the probes
shown on the base of the Charger.
At any rate, poles connected incorrectly will not recharge.
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BTS TMJOINT
In any case, the Charger comes with an output short circuit
protection system also in case of reversed recharging poles.
To recharge connect all the probes that you would like to charge to the
Charger (follow the instructions described above) and connect the AC/
DC adaptor to the mains and turn on the switch located on the rear panel.
When the Charger is properly connected to the mains and has been turned
on, the status LED “Power” will show a steady GREEN light.
The charging status of the probes is indicated by the status LED of the
probes (see § “Wireless Probes”).
Note that inserting the EMG probes into the Charger when it is
on, these come in “Deep Sleep” mode.
It is necessary to reactivate the probes, prior to use them, using a
magnet.
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installation
User PC minimum configuration
Operating system		
Windows 7
Processor			
Intel Dual Core
RAM				
2 GB
Video resolution			
1280x800
Disk space			
100 MB for the application,
not including storage for acquired data
USB				
2.0
Connections
The wireless probes transmit in real-time the acquired data to the receiver
connected via USB to the Workstation.
Connect the receiver to the WS using the USB connector.
If the morphology of the WS does not allow direct connection of
the receiver, use the USB extension cable.
Also verify that the probes are fully charged and ready for use.
It is required that the probes are disconnected from the charger to
be recognized and activated by the system.
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BTS TMJOINT
Description of the software on the user PC
BTS TMJOINT is provided with BTS DENTAL CONTACT ANALYZER
- DCA, the specialized software for the automatic calculation of indices
correlated to the occlusal contact and to the possible neuromuscular
alterations induced by it.
The software allows managing the patient database, organized with a tree
root with sessions, trials and subject data, esplorable through different
database queries.
The provided data are translated in graphical form for an easier
interpretation and plotted in a table form, with pie charts and histograms.
It is possible to create report of single trial or to compare two trials such as
a pre and a post treatment.
All the reports, once created, can be saved and reloaded in a second time.
Software installation
BTS DENTAL CONTACT ANALYZER software is usually pre-installed
and configured.
However, if it is necessary to perform again the installation just follow the
instructions below.
Once entered in the CD player of the computer dedicated, the BTS CD
software containing the installation files, launch the .exe file “POCAnalyzerX.X.XX.X.msi” and follow the instructions provided by the application.
It will appear the following screen:
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installation
After have accepted the installation terms and chosen the Typical
installation, click always on “Next” key, until the procedure end.
Then perform a double click on the “CDM20814_Setup.exe” file and wait
for the window that has just opened, to close.
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installation
BTS TMJOINT
Check that on the PC are installed the following two elements:
• “Microsoft.NET Framework 3.5” (for Windows XP) or
“Microsoft.NET Framework 4” (for the next versions);
• “PDF Creator 1.2.1” (disable the research for possible
updates)
In case they are not already on your PC please download
them from the Internet (they are free) and install them.
Hardware installation
After have performed all the steps above, it will be necessary to configure
the port for the USB receiver.
To set the characteristics of the receiver the system requires the
receiver to be connected to the PC via a USB port.
Then, clicking the mouse right button on “My Computer”, select
“Properties”, choose “Hardware” and then enter the “Device Manager”:
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installation
Once inside the Device Manager menu, select “Ports (COM & LPT)” and
click the right button on the item below “USB Serial Port (COMx)” and
select “Properties”.
Entering the port properties window it will be displayed the following:
In which you must select “Port Settings”.
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Set in the drop box menu related to the “Bits per second”, the value
115200 and then click “Advanced”.
In the window that opens, you must set the value of “Latency Timer
(msec)” equal to 1msec, and then click “OK”, returning to the previous
screen. Also in the “Port Settings” window click on “OK” then close the
windows remained still open.
During the setting operations of the COM port, take note of the
port number that the PC automatically associates to the device,
because you will need it at the software first start..
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installation
First software use
Continuing to keep the USB receiver into the USB input, double-click
the icon on your desktop “Dental Contact Analyzer” to run the software.
On the first start it will be asked to choose the preferred language for the
interface software; once selected you must click on OK.
When the procedure will be completed, the software will start showing the
following window:
On the first start you should check that the correct COM port is set by
selecting the “Laboratory” voice from the tool bar and click “ Set EMG
Device”.
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Clicking on the device settings, a new window will open.
Select the correct COM port number among the voices in the drop box
menu “Port”.
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installation
If the chosen port is the one corresponding to the USB receiver
and if it is set correctly, the fields below will activate showing the
“MAC Address” of the probes associated with the receiver you are
using.
If all of these operations are successful, clicking on “Update” the window
will close and you can start using the software.
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patient setup
POC4 Protocol
The POC 4 protocol provides the acquisition of 4 muscles: the masseter
and the temporalis anterior bundle for both face sides.
Temporalis Anterior
Masseter
Each probe is numbered and for this protocol we will use the probes from
1 to 4.
It is mandatory to follow this sequence:
• probe n. 1 – right anterior temporalis;
• probe n. 2 – left anterior temporalis;
• probe n. 3 – right masseter;
• probe n. 4 – left masseter.
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patient setup
For the RIGHT temporalis anterior bundle, touch the muscle during the
maximum clenching and find the major axis of the zygomatic process of
the frontal bone; the electrode should be applied along a line parallel to
this axis that runs through a couple of centimeters posterior to the process
and above the temporal process of the zygomatic bone.
Repeat the procedure also with the LEFT temporalis anterior bundle,
trying to maintain a symmetry of positioning.
For the RIGHT masseter, position yourself behind the patient when
possible and touch the muscle during the maximum clenching, finding
its venter.
The electrode should be applied along the line that connects the external
canthus of the eye with the mandibular angle.
Repeat the procedure also with the LEFT masseter, trying to maintain a
symmetry of positioning.
It is recommended to apply in advance the probes on the pregelled through the special clips, in order to avoid exerting pressure
directly on the subject face.
Before proceeding with the acquisition, verify that the chair’s
back is in vertical position. We ask to the subject to stay relaxed
with your legs uncrossed, hands resting on his knees and looking
forward.
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patient setup
POC6 Protocol
The POC 4 protocol provides the acquisition of 6 muscles: will be acquired
also the sternocleidomastoid muscles, in addition to the masseters and the
temporalis anterior bundles analyzed in the POC 4 protocol.
Temporalis Anterior
Masseter
Sternocleidomastoid
We will use the probes from 1 to 6 following this sequence:
• probe n. 1 – right anterior temporalis;
• probe n. 2 – left anterior temporalis;
• probe n. 3 – right masseter;
• probe n. 4 – left masseter.
• probe n. 5 - right sternocleidomastoid;
• probe n. 6 - left sternocleidomastoid.
For the probes positioning on the masseters and temporal muscles, refers
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patient setup
to the instructions in the previous paragraph.
To find the RIGHT sternocleidomastoid, asks the subject to rotate, as
much as possible, the head to the left; the electrodes will be positioned on
the muscle so identified.
Repeat the procedure also with the LEFT sternocleidomastoid, trying to
maintain a symmetry of positioning.
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guide to the use of BTS DCA
Initial screen
To launch the software DCA doubleclicking on the relative icon.
Once loaded the software the following windows will be loaded:
The windows includes the following main areas:
• the menu bar
• the tool bar
• the probe status bar
• the list of patients in the database provided with a search filter
• the information related to the patient, session or trial selected from
the list
• the area which manages the trial viewing and the report generation.
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guide to the use of BTS DCA
Menu bar
The menu bar contains:
• The “Database” menu which manages all the operations associated
with the patient database;
• The “Laboratory” menu from which to configure the EMG devices
to use;
• The “Options” menu which allows setting the software languages and
the chart property;
• The “Help” menu which supplies the software version number.
The following functions can be accessed from the “Database” pop-down
menu:
• “New Patient” to add a new patient to the Database.
• “New Session” to add a session to the patient already inserted in
the Database.
• “New Trial” to capture or import trials to an existing session.
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BTS TMJOINT
• “Edit Patient” to modify the information about a patient.
• “Edit Session” to modify the information associated with a
session.
• “Remove Patient” to eliminate the selected from the database. A
confirmation is requested.
• “Remove Session” to eliminate the selected session. A
confirmation is requested;
• “Remove Trial” to eliminate the selected trial. A confirmation is
requested.
From the database menu by selecting the voice “Database & Data folder”
it is also possible to select an other Database or create a new one, modify
the data folder path and select an application to read reports in PDF
format.
The second menu of the menu bar is the “Laboratory” menu:
From this menu the voice “Set Emg Device” may be accessed:
BTS TMJOINT use an Embedded EMG device, for this reason
be sure that this option is selected.
The BTS Dental Contact Analyzer software can interface itself
also with the BTS FREEEMG systems for the data acquisition.
Anyway the procedure of use of DCA with these other devices is
not described in this manual.
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The following windows will be displayed:
This window is divided in two areas:
• the “Device” area containing the information related to the Port
and to the RF Channel for the data transmission;
• the “Sensors” area containing the information related to the 4 or
6 probes (depending on the version installed) and in particular for
each probes is indicated:
- the MAC Address containing the probe identificative code
printed on the clip of the same probe.
- the number indicated on the probe label
- the identificative color of the probe label
- the name of the muscle associated to that probe.
All these value can be modified by the user.
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If any change has been done, click on “Update” to make the changes
effective, while clicking on “Cancel” the values previously saved won’t be
changed.
The next menu is the “Options” one:
From this menu the following functions may be accessed:
• “Language selection” to choose between Italian and English.
Select this command to call up the window in the figure:
Click on “Save” and restart the programme to make the changes
effective, or close this windows to come back to the previous
screen.
• “Chart properties” to set the visualization parameters of the
graphs of the acquired EMG signals and in particular the abscissa
unit of measure and the text, background and line color and the
line tight.
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From this menu voice the following windows may be accessed:
Click on “Save and Exit” to make the changes effective, or close
this windows to come back to the previous screen.
The last voice is the “Help” menu:
From this menu may be selected the voice “About” that supplies the
software version number:
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To close this windows and come back to the previous screen, just click on
the top right hand corner cross.
Tool bar
The tool bar provides rapid access to the most used functions:
• “New Patient” to insert a new patient in the Database.
• “New Session” to add a session to a patient already in the
Database.
• “New Trial” to manage the acquisition or import of a trial in an
existing session.
• “Edit Patient” to correct details about a patient.
• “Edit Session” to modify the information associated with a
session.
• “Remove Trial” to eliminate the selected trial. A confirmation is
required before proceeding with the operation.
The deleted trial is moved to the recycle bin.
• “Exit” to leave the programme.
Probes status bar
The probes stratus bar, located in the top right hand area of the main
screen, allows knowing immediately at any time the connection status of
the 4 or 6 supplied probes.
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The LED can appear:
- blinking GREEN if the probe is active;
- blinking RED if the probe is not active;
- GRAY if the probe is not enabled.
It is also possible to know the active probes battery status by clicking on
the button marked by the symbol “>>”:
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Patient list and research filter
On the left side of the screen there is the area to manage the patients
inserted in the database.
At the software startup, it appears empty:
By opening the drop box menu marked with the red ellipse, a list of all the
patients inserted in the Database will appear.
Each patient is identified by a surname, first name and if available among
the patient data, by his or her internal code.
The patients are ordered, according to the alphanumeric characters,
respect the field indicated in the drop box menu “Search for”, in the
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example “Surname”.
It is possible to search for the patient via “Surname” or “Internal Code”.
When the number of patient included in the database is high, it is possible
to use a search filter to restrict the number of patients displayed in the
drop box menu.
To do that, select the search criteria to be used between the two voice of
the drop box menu “Search for” (“Surname” and “Internal Code”) and
type in the underlying white box the letters or the numbers to be used as
filter (i.e. if you are looking for the patient “JOHN SMITH” you have to
select the “Surname” search criteria and type the letters “S”, “M”...).
Once selected a patient from the list, it will be loaded in the underlying
area, and all his sessions and trials will be available for the elaboration
organized in tree structure.
Click the “+” symbol to expand the patient node and access the list of the
sessions for that patient. Expanding the session node obtains the list of
the trials for that session.
If a patient or a session doesn’t have the “+” symbol it doesn’t contain any
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data.
To compact the list and hide the trials or the sessions click the “-” symbol.
When the node is selected, the node icon is substituted by an azure arrow.
In this way the patient, the session, or the selected trial, can always be
identified..
Besides the name of the patient there is an ID number that is a code
assigned automatically by the software to the patient and cannot be
changed. It identify all the data related to this patient saved in the PC.
If the file is not physically present in the current data folder, the icon
alongside the node is cancelled with a cross
The information continues to be present in the database, but it is
not possible to use them.
When a node is selected to which data is no longer associated, the arrow
appears within a prohibited symbol.
The icon of a full recycle bin at the bottom on the right indicates that
there are data (patients, sessions or trials) which have been deleted but can
be recovered.
To recover them double click the full recycle bin symbol to access the
deleted files.
The empty recycle bin symbol indicates that there are no files which can
be recovered.
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Patient, session and trial information
In the bottom left hand corner area of the main screen there are the
information of the selected patient, session and trial.
There are two main panels:
- the first one contains the information related to the patient that are:
• “Name”
• “Surname”
• “Birthdate”
Click the “More patient information” button to open a table which
records all the information related to that patient: :
To close the table click the “Close patient information” button.
- The second one contains information related to the trial and in particular:
• “Acquisition date”;
• “Trial notes (max 255)”.
This last field can be updated by editing the notes field and clicking the
“Save” icon.
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It is also possible to visualize the information of the session that contains
the selected trial by clicking on “Session information”.
“Close session information” close the panel.
Trial viewing and report generation area
The trial viewing and report generation area is made of the following
panels:
- “Patient reports”: consists of a drop box menu containing all the saved
report of the selected patient.
After selecting a report from the drop box menu the “Open” button
became active.
By clicking the “Open” button the application for the PDF reading will
be loaded and the selected report will be visualized.
- “Trial to process”: this panel contains all the trials among whom selected
the trials for the report generation.
To insert a trial in the “Trial to process” panel is enough a double-click
on the trial from the tree of the selected patient and it will be added
immediately to the trial list.
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To proceed with the report generation, it is necessary to identify the type
of trial by using the 8 button at the left of the panel:
The software will automatically assign a typology among “COT”, “CLE”,
“ROT”, “MASTDX”, “MASTSX”, to each trial loaded. The “POST”
label will be assigned to the second trial of the same type loaded, while
all other trials of this typology loaded after won’t be labeled.
If the type that you are trying to assign to a trial is not compatible with
it a warning massage will be displayed.
For example:
Before to proceed with the report generation verify that the type
assigned to each trial is correct, otherwise modify it by selecting
the trial from the list and clicking on the right button.
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To facilitate the procedure of classification, when one trial is selected the
“Acquisition date” and any “Trial notes” are displayed on the right side
of the panel:
To remove a label from a trial in the list, select it and click on “CLEAR”.
To remove all the trial from the panel “Trial to process” is enough to click
on the recycled bin icon.
Once the trial labeling procedure has been properly executed it is possible
to create the report by clicking the “REPORT” button:
The report could be created only if:
• at least one “COT” type trial and one “CLE” trial have been
loaded;
• a “MASTDX” and/or “MASTSX” type trial have been
loaded.
If at least one of these two condition is not verified a warning
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massage will be displayed. For example:
When a PRE-POSt report must be created it is possible to use
two different trials of cotton type labeled as “COT” and “COT
POST”(typically when we need to compare trials acquired in
different days), or to use just on “COT” type trial that will be
used to normalize both the “CLE” trial and the “CLE POST”
trial (typically when we need to compare trials acquired the
same day, without modify the position of the electrodes, such as
clench test executed with and without bite).
Only the trials witch have been marked with a color correspondent
to one of the 8 trial typologies, among all the trial present in the
list “Trial to processed” will be used to construct the report.
If all the operation have been executed correctly the window for the
report management will be displayed. From that window it is possible to
select all the element to be inserted in the report. There will be also the
button to open the print preview, to launch the print or to save the report
in the database to recall it in a second time.
The windows is divided in two area:
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• the main area shows, organized in TABS, the graphs, the tables and
the info that can be inserted in the report.
• the button bar contains the “Print preview”, “Print” and “Save Report”
buttons, the field “report PDF name” in witch is visualized the report
name automatically assigned by the software (this name can be
modified by the user before to click on “Save Report”), finally there
is the “Exit” button to come back to the main screen of the software.
- “Preview of selected trial”: in this panel in shown a preview of the Trial
selected in the panel “Trial to process”.
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The scale of the y-axis can be modified selecting the maximum value to
be visualized among the value of the drop box menu “(+-mV)” placed at
the right of the panel.
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New patient
Select “New Patient” from the menu and tool bar to open the window
below:
To insert a new patient simply fill in the fields and click “Add Patient”.
The fields marked with an * are mandatory.
Click on “Cancel” to come back to the previous screen.
Any inserted data will be lost.
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New session
Select “New Session” from the menu and tool bar to open the window
below:
To create a new session simply fill in the fields and click “Create Session”.
In particular it is required to:
• give a name to the session to be created.
This field is mandatory.
To proceed with the creation of the session the session
name must been inserted otherwise the following
warning message will be displayed:
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• select the pathology among the voices available in the drop box
menu (automatically the first voice of the list respect the alphabetic
order will be proposed).
the list of pathologies is completed entirely by the user.
To add, eliminate or modify a pathology from the list
click the
icon, to access the “Edit pathology” window.
At the first use of the software the pathology list will be
empty.
It is necessary to insert at least one pathology to proceed
with the session creation.
• insert any Note about the session (field not mandatory).
• indicate any previous treatment of the patient.
For both these fields there are 255 characters available.
• modify the session date (if different from the date of the actual
day proposed as default).
To delete the session creation and come back to the previous screen click
on the button “Cancel”.
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Edit Pathology
From the “New Session” window, click the symbol
pathology list.
to open the
In the central panel all the pathology already inserted in the database are
listed in alphabetic order.
To add a new pathology write the name of the pathology in the field
“Insert new pathology to add” and click the blue arrow to add the
pathology to the list.
To change a pathology:
• Select the pathology from the list. The name is shown in the field
“Modify the selected pathology”.
• Modify the name of the pathology
• Click the icon alongside to apply the change to the list.
To delete a pathology:
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• Select the pathology to be deleted
• Click on the recycle bin icon
• Confirm the deletion of the trial by clicking “Yes”.
To exit from the window “Edit pathology” click on “Close”.
New Trial
Select “New Trial” from the menu and tool bar to open the following
window:
To create a new trial it is possible to make an acquisition or to import a
trial acquired in the past.
In any case it is necessary to select a “Type” among the voices proposed in
the drop box menu for the trial to be created.
Fill the fields relative to “Trial to acquire” if you want to proceed with an
acquisition, or fill the fields relative to “Import TDF file” if instead you
want to import a trial acquired in the past.
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7 typologies of test are allowed:
• COT4: requires the use of 4 probes placed on the temporal
and masseter muscles. To the subject it is required to perform a
clenching of 5 seconds with two cotton roll interplaced between
the two arches, one for each side.
• CLE4: requires the use of 4 probes placed on the temporal and
masseter muscles. To the subject it is required to perform a
clenching of 5 seconds.
• COT6: requires the use of 6 probes placed on the temporal,
masseter and sternocleidomastoid muscles. To the subject it is
required to perform a clenching of 5 seconds with two cotton roll
interplaced between the two arches, one for each side.
• CLE6: requires the use of 6 probes placed on the temporal,
masseter and sternocleidomastoid muscles. To the subject it is
required to perform a clenching of 5 seconds.
• ROT6: requires the use of 6 probes placed on the temporal,
masseter and sternocleidomastoid muscles. To the subject it is
required to perform a series of head rotations.
• MASTRT: requires the use of 4 probes placed on the temporal
and masseter muscles. To the subject it is required to chew for
15 seconds on the right side.
• MASTLT: requires the use of 4 probes placed on the temporal
and masseter muscles. To the subject it is required to chew for
15 seconds on the left side.
Once all the fields have been filled in, click respectively on “Acquire” to
start the process of acquisition (see next chapter), or on “Browse...” to
select the trial to be imported directly from Windows Explorer on your
PC.
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Before clicking on “Acquire”, ensure that the receiving unit is
connected to the PC via USB and check the status of the probes
from the probes status bar of the probes.
If an acquisition is launched when the receiver is not connected to
the PC, the following warning message will be displayed:
When a trial is imported the user can enter some notes that will be saved
in the database.
After selecting the test to be imported the following window will appear:
Edit the notes and click “Add note” or, if you don’t want to enter any notes
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simply close the window.
The procedure for trial acquisition or import can be repeated several times
to add more trials to the same session.
Note that the system doesn’t allows for two tests with the same
name under the same session.
Once all the required trial were acquired or imported, click “Close” to
return to the main screen.
Data acquisition
By clicking on “Acquire” from “New Trial” the following screen will be
displayed:
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On the top bar is shown the six probes status:
Information displayed are referred in sequence to probes number 1, 2, 3,
4, 5, and 6 starting from left going to right.
For each probe there are a status LED and an identification label.
The status LED beside each channel can be:
- GREEN: if the probe is active;
- RED: if the probe is not active;
- GREY: if the probe is not allowed for the system.
The identification label is linked to the muscle is acquired with that specific
probe:
- R_TEM for the right temporal muscle,
- L_TEM for the left temporal muscle,
- R_MAS for the right masseter muscle,
- L_MAS for the left masseter muscle,
- R_SCMCL for the right sternocleidomastoid long head muscle,
- L_SCMCL for the left sternocleidomastoid long head muscle.
In case of inactive probes, the label is usually Ch1, Ch2, Ch3, Ch4, Ch5,
Ch6.
On the central area of the screen the real-time oscilloscope will show the
signals coming from the probes. There will be displayed 4 or 6 channels
depending on the protocol chosen:
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The oscilloscope allows to verify the correct probes positioning before
starting the real acquisition and to verify the proper movement execution
required to the patient.
For a better signals visualization it is possible to modify the axis scales
clicking on the drop down menu on the bottom:
To start the acquisition all probes required in the selected trial’s
protocol have to be active. Before proceeding with the next steps
verify that all the LED corresponding to the probes required by
the Protocol are green.
When everything is ready, click on “Record” to start recording the trial.
In clenching trials, with or without cotton rolls, and in chewing
tests it is better to start the acquisition just after the patient has
already start to perform the movement required from the protocol.
When the acquisition starts, the “Timer” on the right top of the screen
starts.
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The clenching trials CLE4, COT4, CLE6 and COT6 stop automatically
after 5 seconds, while chewing trials MASTRT and MASTLT stop after
15 seconds.
By the way it is possible to interrupt before the record clicking on “Stop”.
The acquisition of the rotation trial ROT6 has to be interrupted manually
clicking on “Stop” when the subject executed all the movements required.
At the end of the trial data will be automatically downloaded, when this
will be complete a signals acquired preview will be shown.
It is possible to modify the visualization range to zoom in the signal to
evaluate that the trial has been performed properly before save it.
For clenching trials, (COT and CLE) at the end of each acquisition, it is
possible to visualize a preview of the pie chart related to the RMS mean
value clicking on the correct button:
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If more than one acquisition of clenching trials has been performed,
besides the pie chart of the current trial, there will be also displaied pie
charts of the previous ones (up to two) to allow the verification of the data
repeatability:
If the acquisition is good it is possible to save the trial clicking on “Save”.
A window will appear to add, if necessary, notes related to the trial:
After edited the notes, click on “Add note” while if notes are not required
just close the window.
Once this operation is done the “New Trial” window will appear again.
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If the trial just acquired is not good enough to be saved, it is possible to
proceed with a new acquisition. To do that click on “View” to restart the
real-time oscilloscope and repeat the recording procedure.
Data just acquired are not going to be recovered, for that reason
a window will ask a confirmation about choosing not to save the
last acquisition:
Finally, to exit from the acquisition and go back to the “New Trial” section,
click on “Exit”.
If the last trial has not been saved, the following screen will appear:
Clicking on “Yes” data will be stored, clicking on “No” the acquisition
window will be closed and last trial data will be canceled, finally clicking
on “Cancel” you go back to the acquisition screen.
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Edit patient
Select “Edit patient” from the menu and tool bar to open the following
window:
Note that to do this a patient must be selected in the database,
otherwise the following warning message will appear:
The “Edit patient” window will show all the selected patient data previously
entered. It is possible to modify them or add new ones.
When all changes have been made ​​click on “Update patient” to save the
new data in the database.
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Se l’operazione è andata a buon fine comparirà la seguente finestra:
Finally, to exit without making any changes to the data click on “Cancel”.
Any change made will be lost.
Edit session
Select “Edit Session” from the menu and tool bar to open the following
window:
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Note that to do this a patient must be selected in the database,
otherwise the following warning message will appear:
The “Edit Session” window will show all the selected patient data previously
entered.
It is possible to modify them or add new ones.
When all changes have been made ​​click on “Update Session” to save the
new data in the database.
To exit without making any changes to the data click on “Cancel”.
Any change made will be lost.
Delete patient
To remove a patient from the database, select it and choose “Delete
Patient” from the menu bar.
This operation will move the selected patient in the recycled bin together
with all sessions and trials related to him.
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A conform to the cancellation will be asked:
Note that to do this operation a patient must be selected in the
database, otherwise the following warning message will appear:
Delete session
To remove a session from the database, select it and choose “Delete Session”
from the menu bar.
This operation will move the selected session in the recycled bin together
with all the trials related to him.
A conform to the cancellation will be asked:
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Note that to do this operation a session must be selected in the
database, otherwise the following warning message will appear:
Delete trial
To remove a trial from the database, select it and choose “Delete Trial”
from the menu bar.
This operation will move the selected trial in the recycled bin.
A conform to the cancellation will be asked:
Note that to do this operation a trial must be selected in the
database, otherwise the following warning message will appear:
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Database and data folder
From the menu bar select the “Database” option, and then the “Database
& Data folder” function to open the window below:
The field “Current database” shows the path of the database actually
selected. It is possible to lad an other database or to create a new empty
one.
To create an empty database, click the icon “Create an empty database”:
a new window in witch enter the name of the new database will appear.
Click “Save” to create a new database. The “Current Database” field will
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be updated accordingly.
To work with a different database to the default one:
• Click the icon “Change current database”
• Browse the folders and select the database desired.
• Click “open” to change the database. The “Database” field will
be updated.
If you wish to use the new database as a reference, tick the option “Set
current database as default”.
If this is not done, the setting will be lost when the BTS Dental
Contact Analyzer is closed, and the default database will be loaded
at the next launch of the program.
To change the data folder:
• Click the “Change current data folder” icon.
• Select or create the new folder.
A sub-folder will be created automatically in which the files will be saved.
The name of the subfolder is shown in brackets under “Current data
folder”.
In the figure the subfolder is “DataPOCAnalyzer”.
This folder is changed automatically when the current database is changed.
Also in this case to set the new folder as the default data folder put a check
in the “Set current data folder as default”.
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If this is not done, the setting will be lost when the BTS Dental
Contact Analyzer is closed, and the data will be saved in the
default folder at the next launch of the program.
The reference My Captures folder is that which contains all the file
required by the software to work properly.
It is therefore recommended to choose a new folder only with the
consent of the technical staff of BTS.
To change this folder:
• Click the icon “Change current folder “My Captures””.
• Select the new reference folder (which will contain all the file
required by the software to work properly)
Also in this case to set the new folder as the default data folder put a check
in the “Set “My Captures” folder as default”.
If this is not done, the setting will be lost when the BTS Dental
Contact Analyzer is closed, and the old “My Captures” folder will
be used at the next launch of the program.
From this screen you can then select the application used to read the
report in PDF format.
To select the application click on “Browse...” and select the exe file you
want to use.
Please note that if no application is selected you can not see the
reports.
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To apply the changes click “Save and exit”.
Managing files in the recycle bin
If you wish to remove a patient, session or trial, the file is moved to the
recycle bin.
To access the files held in the recycle bin, double click the icon representing
the recycled bin which appears in the patient list.
The following windows will appear:
In the left side of the panel there are all the data contained in the recycled
bin organized per patient with a tree structure.
By expanding the nodes it is possible to access to sessions and trials.
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In the file tree the node labels may have three different colors:
• The black label indicates that the file (patient, session or trial)
has been removed from the database together with all the files
associated with it.
• The dark grey label and
icon indicate that the file is present
in the database, but some elements associated with it have been
removed (e.g. a session of a patient has been removed, or a trial
from a session).
• The light grey label indicates that the file has been deleted along
with the root file (e.g. a patient main file has been deleted. As a
result all of the related sessions and trials have also been removed).
Selecting a node which has been removed updates the patient, session and
trial information.
From the “Deleted data” window it is possible to carry out four different
operations:
This button recovers the selected file.
When a session is selected all the associated trials will also be
recovered. When a patient is selected all the associated sessions
and trials will also be recovered.
This button eliminates the selected file permanently.
Before eliminating the file, a confirmation will be requested.
If you eliminate a file, it cannot be recovered. Eliminating a
session also eliminates all the associated trials. Eliminating a
patient also eliminates the associated sessions and trials.
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If the button is deactivated, it means that the file is not
present in the recycle bin (the
icon alongside dark
grey text), or it may not be recovered individually. In this
case it is necessary to select the root file.
This button recovers all the files in the recycle bin. All patients,
sessions and trials will be available again in the database and the
recycle bin will be empty.
This button permanently eliminates all the files in the recycle bin.
A confirmation must be given for this operation.
Confirming the elimination means that the files will no
longer be recoverable. At the end of this operation the
recycle bin will be empty.
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The data report is automatically generated by the software DCA. The
results of the data elaborations are organized in tabs: INT, EXT, POC,
ISTO and MAST.
Moreover there is an INFO tab for the customization of the printed report.
INT tab
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The elaborated data are divided into PRE and POST sections, for the
comparison of two tests of the same acquisition session, or of tests made
in different temporal session. This is helpful in evaluating the treatment
efficacy and for the patient follow up.
The graphic shows a dental arch, which works as a 2D morphological map,
on which are superimposed icons “target” style (they will be so called in
the rest of the document), positioned in order to summarize the occlusal
condition, according to the calculated indices, whose values are given in
the table below.
• POC: percentage overlapping coefficient
It is an index of the standardized contraction symmetry within the
same muscular couple. It expresses, in percentage terms, the difference
in electrical signal generated by a muscle couple during a maximum
voluntary contraction (MVC) compared to its homologous standardized
value.
If the two homologous muscles of each pair are contracted in perfect
symmetry, thanks to a functionally balanced dental occlusion, the POC
result is expected close to 100%.
While if muscle couples show standardized values in percentage terms
different from each other, the POC turns out to be considerably less than
100%.
When the POC exceeds 83%, there is a normal muscular symmetry,
induced by the contact of the teeth, otherwise, the dental contact is
influencing the neuromuscular equilibrium of the patient.
With the 4-channel protocol, are calculated the POC of the anterior
temporal and masseter muscles, which are respectively indicated by POC
TA and POC MM, indicators of the influence of tooth contact on the
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neuromuscular balance of the stomatognathic system; with 6-channel
protocol, is calculated in addition the coefficient of overlapping
percentage of the sternocleidomastoid muscles POC SCM, indicator
of the influence of tooth contact on the cranio-cervical neuromuscular
balance.
For each POC is also indicated which is the predominant muscle and
in what percentage it contributes to the total level of asymmetry. In
particular, the letter “R” indicates that there is a prevalence of the right
muscle while the letters “L” that there is prevalence of the left one.
• POC: graphical representation
The central vertical line, dark gray, dotted, corresponds to the 100%
value and the light-gray vertical band indicates the range of normality, up
to the value 83%, both right and left of central line, in order to represent
the prevalence of right or left muscle activity.
The blue target refers to the POC index of the anterior temporal (POC
TA), while the red refers to the POC index of the masseters (POC MM).
The POC TA index corresponds to the influence of dental
contacts of the incisors, canines and first premolars.
The index POC MM corresponds to the influence of dental
contacts of the premolar and molar teeth.
Values ​​of POC out of the norms indicates a quality of contact
prevalent or lack of one side respect the controlateral.
The target is represented at a distance from the central vertical line
corresponding to the calculated value.
If the POC value is more than 83%, the target is represented within the
gray central band, while if it is lower it is represented outside the normal
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range.
So it is easy to observe the predominance of the right or left temporal in
the anterior quadrants, and the masseter, left or right, in the posterior
quadrants.
The value of the POC SCM does not affect the targets position, but only
the percentage of co-contraction of neck muscles during MVC.
• BAR: Barycenter
It provides an estimate of the occlusal barycenter position. It is obtained
by calculating the percentage overlapping coefficient between the
activities of the couple of temporal and the activities of the couple of
masseter (while the POC index compares single homologous muscle).
When the contact points tend to focus on the molars, the masseters
record a major contraction respect to the correspondent temporalis
(Posterior barycenter).
Instead, in the occlusal condition in which the barycenter moves in the
anterior-lateral areas, that means until the first-second premolar, the
temporalis express major contraction forces (Anterior barycenter). In
this case there is a bilateral overload of the joints that, with the passing of
time, can lead to pathological conditions.
For the BAR index if the position of the barycenter is mainly anterior,
there will be the letter “A”, will also be indicated in what percentage the
anterior temporal muscles contribute to move the barycenter upwards.
Vice versa there will be the letter “P” and will also be indicated in what
percentage the masseter muscles contribute to move backwards the
barycenter.
• BAR: graphical representation
The normal value of the BAR index is > 90%.
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The two horizontal dark gray lines with dots, superimposed to dental
arch, represent the BAR value equal to 100%, while the gray bands
represent the normal range up to 90%.
The two targets will be translated at a distance from the relative horizontal
line of a value corresponding to the BAR index calculated, upwards
or downwards following the prevalence of the BAR index (anterior or
posterior), according to the occlusal condition.
The value and the direction of the vertical displacement of the two target
points are then exactly the same.
The BAR value in the normal population always expresses a
prevalence of differential activities of the couple of masseter
muscles compared to that of temporal.
This condition is reversed in the second skeletal class in which
the temporal muscles always express a differential electrical
activity greater than the masseter’s one.
• TORS: torsion
It provides an estimate of the rotation attitude of the mandible in the
horizontal plane when it is in occlusion with the superior maxilla. Is
obtained from the comparison of the torque moment of the right
temporal and the left masseter couple (by convention rightward torque)
with the torque moment of the left temporal with the right masseter
couple (by convention leftward torque).
When this index is >90%, torque moments do not occur on the mandible.
On the contrary, if this index is outside of the normal ranges that means
below 90%, the muscles tend to twist the lower jaw to the right or left
depending on whether one or the other muscular couple prevalence, due
to the presence of occlusal fulcrums.
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There will be the letter “R” when there is mainly a torsion to the right,
while the letters “L” when the torsion is mainly to the left. It will be
also reported in what percentage the dominant couple contributes to the
creation of torque.
• TORS: graphical representation
The resulting action of the temporalis muscle, added to the resulting
strength of the contralateral masseter, generates a pair of forces with a
moment which tends to laterodeviate the jaw in the direction of the
resultant of the anterior temporal.
If the right is greater, the target will be not only circular, but it will report
an arrow to the right.
Similarly, the arrow will be leftward if the coefficient calculated for the
couple anterior temporal-right masseter is greater.
We must not think that there is a real torsion of the mandible
because we are under static conditions. Any clinical condition,
which can be likened to pre-contact and then to tooth contact
sliding, is therefore already occurred. The TORS index expresses
a condition clinically worse because detectable only using
instruments, that is the presence of fulcrums.
The muscles continue to activate and inhibited themselves in
the pursuit of stability. Clinically this corresponds to a contact
mainly in the antero lateral area of the dental arch or to a
contact qualitatively insufficient in the latero posterior sectors.
It is generally associated also with temporomandibular joint
problems. If associated with values ​​of IMPACT lower than
normal, it may indicate the presence of both, pain and protective
mechanism to nociceptive stimulus.
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• NOTE
In the “Notes” field it is possible to add a text description that the
clinicians want to include in the printable report as a comment of the
represented data in the INT tab.
• “Add to report” checkbox
If the check is in the box, the INT tab content will be included in the
printed report, otherwise it will be ignored.
“EXT” tab
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In this tab are represented the ulterior calculated indices, reporting for an
easier reading also the values of the coefficients already seen in the previous
tab.
The referring indices are TA%, MM%, SCM%, ATTIV, TORQUE,
POCm, ASIM, CL and IMP.
• TA%, MM%, SCM%
These indexes represent in percentage the standardized average value of
the activity respectively of the anterior temporal muscles, masseters and
sternocleidomastoids left and right.
The graphical representation includes a 3D model, for a male or female,
according to the patient for whom the report relates.
The status bars represent the level of electrical intensity, measured in the
muscle near which are represented.
Depending on the protocol used (4 or 6 channels), 4 or 6 bars are
displayed corresponding to the anterior temporal muscles, masseters and
sternocleidomastoids.
The muscle that expresses the greater amplitude value of the electric
potential, percentualized, is represented with a full bar and becomes the
reference scale for the bars graphical representation of the other muscles,
which will be compared to.
In the example shown in the figure the right TA% is 83.57% and is
the highest value of the 4. Then the bar will be represented “full” and
the others will be represented in proportion according to the calculated
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values: left TA% = 57.92%, right MM = 45.62%, left MM = 38.67%.
The bars can be green if the width value is greater than 83%, yellow if
the amplitude is less than 83%, but above 75%, red if the width value is
less than 75%.
Similar interpretation for the SCM muscle, shown in the figure below as
an example.
The SCM POC is calculated only when using the POC6 protocol.
• ATTIV: activation
It’s a parameter similar to the BAR, but computed on the average value of
maximum contraction and compared to zero, instead of 100%.
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Provides an estimate of the occlusal barycenter position.
It is very useful for an immediate interpretation of the biomechanics
levers induced by the contact of the teeth.
When the contact points tend to focus on the molars, the masseters
record a greater contraction than the corresponding temporalis and so
the index takes a positive value.
In the occlusal condition in which the barycenter moves in the anteriorlateral areas, that means until the first-second premolar, the temporalis
express greater contraction forces and the index becomes negative.
Normally this index is always positive except in the second
skeletal class in which the index is usually negative.
For the resolution of TMJ (temporomandibular joint) acute pain
problems it must be find a condition biomechanically favorable
to the discharge of the forces burden on the TMJ that leads to a
positivization of this index.
• TORQUE: mandibular torque
It’s a parameter similar to the TORS, but compared to zero, instead of
100%.
The resultant force of the action of the temporalis muscle, added to the
resultant force of the controlateral masseter, generates a force couple. The
moment of this couple tends to laterodeviate the jaw in the direction
of the resultant of the anterior temporal: if the right is greater, the
torque values will be negative; while it will be positive it the left TA is
predominant.
• POCm : medium percentage overlapping coefficient
It is simply the medium between the TA POC and the MM POC. It
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represents the global POC. Also in this case the normality range is on
≥83% values.
• ASIM: asymmetry
This index allows you to compare the activity of the muscles of the right
side with the muscles of the left side.
A positive value indicates a greater activation of the right side, while a
negative value indicates a greater activation of the left side. The normal
range is between -10 and 10.
• CL: Cervical Load
This index is calculated only when using the protocol POC6,
which includes the performance of a test of maximum rotation
of the head to the right and left, in addition to the trials of
clenching with and without cotton roll (thus with maximum
intercuspation).
Gives the percentage of co-contraction of SCM muscle during clenching:
a cervical load of 0% indicates an absence of recruitment, while a value of
100% indicates that the recruitment is maximum.
The normal values ​​occurs at CL ≤ 15%.
Excessive values ​​of CL indicate an excessive recruitment of neck
muscles during the MVC, which may favor the persistence of
clinical conditions for neck ache, especially in clencher patients.
• IMP: Impact
this index indicates the muscle work, represented geometrically by the
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area under the curve of the electrical activity of muscles examined in the
time.
The normal range of the index are in the range 100% ± 15%.
Higher values indicated that the subject ​should be considered a
strong clencher.
Values ​​lower than normal may express a condition of
proprioceptive inhibition acute with presence of pain during
MVC, or chronic with presence of a nociceptive protective
reflex.
If the POC, TORS and BAR indexes are normal the IMP index
is related to the vertical dimension.
In this case there are indications on the possibility of raising
(index higher than normal) or reducing (index lower than
normal) the vertical dimension, compatibly with the aesthetic
condition of the patient.
• Outcome
It is possible to add some notes to the report. Write them in this box to
put them in the printed report.
• “Add to report” Checkbox
If the check is in the box, the contents of the EXTtab will be included in
the printed report, otherwise it will be ignored.
POC tab
In this tab the average activity of the four muscles Masseter right and left
and Temporal right and left, are represented by pie charts.
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The first and second columns show the average activity of 4 muscles in
microvolts, relative to clenching trials performed respectively with and
without cottons. The third column, instead, shows the percentage value
of the average activity of the 4 muscles as the ratio between the values​​
obtained from the clenching trial without cotton and those with cotton.
In order to evaluate the occlusal state you must refer to this third
column.
The dark blue sector represents the left temporal muscle activity while the
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light blue sector the one of the right, the red sector represents the activity
of the left masseter muscle, while the yellow of the one of right.
With a good neuromuscular balance, corresponding to the
absence of malocclusion, the colors will be equally distributed in
the 4 quadrants.
If you are analyzing two sessions (PRE, POST), the graphs for the second
session can be visualized on a second row.
ISTO tab
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The tab “ISTO” provides an alternate view of the main indices calculated:
Masseter POC, Temporal POC, Sternocleidomastoid POC (where
provided 6 channels), TORS and BAR.
In the graphs of the POC the activities associated to homologous muscles
are represented as histograms.
The activity of the right side (identified by white color) is compared with
the activity of the left side (identified by red color): for each bar will be
colored the data of the dominant muscle activity, while the contralateral
muscle will be represented in gray.
The values ​​for each bar are calculated considering the average value of
muscle activity of the clenching trial normalized with respect to the
clenching trial execute with cottons in an interval of 25 ms.
When the white is prevalent there is an activity of the muscle of the right
side more pronounced, while when is the red to prevail, the left side is
dominant.
Is then given information on a possible asymmetry of muscle.
Regarding the TORS index any torsion attitudes rightward are represented
with the color white, while those leftward with the color red.
Finally regarding the BAR index the white color indicates that the
barycenter is moved anteriorly, while the red color, posteriorly.
If you are analyzing two sessions (PRE, POST), the graphs for the second
session can be viewed by clicking on “Next”.
The “Previous” button allows returning to the charts of the first session.
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MAST tab
The chewing protocol is composed of two separate trials, of 15 seconds
each, in which the patient must chew a chewing gum holding it, for the
entire duration of the test, on one side only.
Produces, as a result, a graph about the coordination of masticatory muscles
TA and MM: while, therefore, with the POC and the evaluation of the
clenching, we evaluate the neuromuscular balance (Static condition), with
the mastication protocol we evaluate the neuromuscular coordination
(Dynamic condition), by analyzing the repeatability of the muscular
patterns.
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The ideal situation, corresponding to a good level of chewing coordination,
is when the two ellipses of confidence are equidistant from the origin and
present reduced dimensions.
In addition to the graphical representation, some numerical indexes are
calculated, for left and right side of chewing:
• Frequency (bps)
It is the number of masticatory acts per second.
• ModMed
It is the distance from the center of the graph and the center of the ellipse
of representation.
• TA Impact (uV)
It is an index of the work done by the anterior temporal muscles during
the test.
• MM Impact (uV)
It is an index of the work done by the masseter muscles during the test.
• SMI: Index of chewing symmetry.
It is a unique index, not differentiated by side. The ideal is a value of
about 50%.
Dental contact analyzer allows processing also a single test: in this case will
be represented a single ellipse for the side “measured”. The index SMI, in
this case, will not be calculated.
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INFO tab
This tab allows you to enter data to customize the report and upload your
own logo if desired.
To do this, complete the fields of interest and click on “Browse” to select
the image of your logo directly from your PC or put a check next to
“None” if you do not want to use this option.
Once you have completed entering the info you need to click on “Modify
Info” to ensure that data is stored and included in the report. At first use,
the fields are empty.
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Saving the data they will be automatically loaded at the next opening.
It is possible to make further changes to the saved data.
To save these changes it is necessary to click on “Modify info”. The
following windows will appear:
Clicking on “Yes” to report information will be updated and will no longer
be possible to recover previous data.
If the operation has been successful you will see the following screen:
If you do not want to save the changes click on “Upload Info” to reload
the last save.
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appendix A
technical specifications
Wireless Probes
Geometry: 			
Electrodes: 			
Separation: 			
Autonomy: 			
Battery: 			
Dimensions: 			
Weight: 			
Frequency used: 			
Input impedance: 		
CMMR: 			
Resolution: 			
Acquisition frequency:		
Sensitivity: 			
Measure accuracy*:		
variable
standard with clip connection
min: 16mm - max: 66mm
5h of use
some days stand-by
rechargeable, lithium ion
17x36x8mm mother electrode
diameter 17 x 8mm satellite electrode
<9g battery included
ISM band
2.4GHz (standard IEEE802.15.4)
>10 GOhm
>110 dB @ 50-60Hz
16bit
up to 4KHz
1μV
± 2%
Receiving Unit
Connection: 			
Dimensions: 			
Weight: 			
Frequency used: 			
USB
82x44x22,5mm
80 gr
ISM band
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2.4GHz (standard IEEE802.15.4)
* The system is calibrated at the factory. No further calibration is required
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appendix B
environmental specifications
Operating Temperature
Min
-20°
Max
+45°
Operating Humidity
50%
80%
0°
+40°
50%
80%
0m
2000m
Storage and Transport
Temperature
Storage and Transport
Humidity
Altitude
Note
Relative,
non-condensing
Relative,
non-condensing
Degrees of protection provided by the dangerous enclosures of water and
dust (IEC 60529): IPX0.
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appendix C
power supply and switch off
The receiving unit is powered by the USB port.
To switch off the system the following operation must be done:
- Exit from the DCA application
- Unplug the receiving unit from the USB port.
- Put the probes in Stand-By placing them on the “Charger”.
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appendix D
battery
BTS TMJOINT probes are internally powered.
The Probe battery replacement can be done only by BTS qualified
personnel.
The probes are sealed to avoid the access to the internal circuit
components.
Batteries are equipped with battery protection circuit to:
-over-voltage, threshold 4.3V
-under-voltage, threshold 2.8V
- short-circuits
The specific characteristic of the Wireless probes equipped with the battery
are:
Quantity: 		
1 per each EMG probe
Technology: 		
lithium polymer (Li-Poly)
Removable: 		
NO, BTS technical service is required
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appendix E
troubleshooting guide
Warning – Invalid trigger mode
During the hardware installation, the USB port dedicated to the receiver,
is configured.
May happen that these port settings went lost.
This event may occur for example when another USB device is connected
to the PC and the PC assigns to it the same port previously assigned to the
receiver, returning the port setting to
​​ the default configuration.
In these cases it may occur that by launching an acquisition the following
warning message may appear:
In this case to proceed immediately with the acquisition, it is necessary
to restart the application, however the same problem will recur in later
acquisitions.
To resolve this problem you must repeat the USB port configuration
procedure described in the “Hardware Installation” paragraph of the
“Installation” chapter.
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appendix F
declaration of conformity
DECLARATION OF CONFORMITY
BTS SpA
Via della Croce Rossa 11, 35129 Padova (PD)
– Italy
Tel. +39 049 981 5500
Fax +39 049 792 9260
declare under our sole responsibility that the product(s):
name / description:
model:
S/N:
Electromyographic system / device for the functional analysis of dental occlusion.
TMJOINT
SN
satisfies the essential requirements of the Medical Devices Directive 93/42/EC (and its amendments inluding
2007/47/CE), and therefore carries the CE marking of the European Union. The conformity assessment procedure is
according to the article 11 of the directive (Annex II.3 full quality assurance) and the article 12 it is not applicable.
In accordance with Annex IX of the 93/42/EC directive it is classified as follow:
CLASS “IIa” (rule 10)
In accordance with IEC 60601-1 is also classified as follow:
Class: internally powered device
Applied part type: BF
The product conforms to the following standards:
EN ISO 14971
Medical Devices - Application of risk management to medical devices.
IEC 60601-1
Medical Electrical Equipment - Part 1: General Requirements for basic safety and
essential performance.
IEC 60601-1-2
Medical Electrical Equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: electromagnetic compatibility Requirements and tests.
IEC 60601-1-6
Medical Electrical Equipment - Part 1-6: General Requirements for basic safety and
essential performance - collateral Standard: Usability
EN 62304
Medical device software - Software life-cycle processes
ETSI EN 301 489-3 Electromagnetic compatibility and Radio spectrum Matters (ERM) – Electromagnetic
Compatibility (EMC) – standard for radio equipment and services – Part 3: Specific
conditions for Short-Range Devices (SRD) operating on frequencies between 9 KHz and
40 GHz.
ETSI EN 301 440-2 Electromagnetic compatibility and Radio spectrum Matters (ERM) – Short Range Devices
(SRD) – Radio equipment to be used in the 1 GHz to 40 GHz frequency range – Part 2:
Harmonized EN covering essential requirements of Article 3(2) of the R&TTE Directive.
This compliance is valid ONLY for the equipment identified when used in a manner consistent
with the intent of the referenced documents and according to the product’s usage manual.
Notified Body : TÜV Product Service GmbH, Zertifizierstelle, Ridierstrasse 65, 80339 München – Germany, Identification N. 0123.
EC certificate N. G1 12 10 65301 003 valid until January, 16 2018.
Padova, Date
Bruno Ros
CEO
BTS S.p.A.
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appendix
appendix G
bibliography
1. Ferrario VF, Sforza C, D’Addona A, Miani A Jr.
Reproducibility of Electromyographic measures: a statistical analysis.
J Oral Rehabil. 1991 Nov;18(6):513-21. PubMed PMID: 1845607.
2. Ferrario VF, Sforza C, Miani A Jr, D’Addona A, Barbini E.
Electromyographic activity of human masticatory muscles in normal
young people.
Statistical evaluation of reference values for clinical applications.
J Oral Rehabil. 1993
3. Ferrario VF, Sforza C.
Biomechanical model of the human mandible in unilateral clench:
distribution of temporomandibular joint reaction forces between
working and balancing sides.
J Prosthet Dent. 1994 Aug;72(2):169-76. PubMed PMID: 7932264.
4. Ferrario VF, Sforza C.
Coordinated electromyographic activity of the human masseter and
temporalis anterior muscles during mastication.
Eur J Oral Sci. 1996 Oct-Dec;104(5-6):511-7. PubMed PMID:
9021318.
5. Ferrario VF, Sforza C, Serrao G.
The influence of crossbite on the coordinated electromyographic
activity of human masticatory muscles during mastication.
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J Oral Rehabil. 1999 Jul;26(7):575-81. PubMed PMID: 10445477.
6. Ferrario VF, Sforza C, Serrao G, Colombo A, Schmitz JH.
The effects of a single intercuspal interference on electromyographic
characteristics of human masticatory muscles during maximal
voluntary teeth clenching.
Cranio. 1999 Jul;17(3):184-8. PMID: 10650405.
7. Ferrario VF, Sforza C, Colombo A, Ciusa V.
An electromyographic investigation of masticatory muscles symmetry
in normo-occlusion subjects.
J Oral Rehabil. 2000 Jan;27(1):33-40. PubMed PMID: 10632841.
8. Ferrario VF, Sforza C, Serrao G, Fragnito N, Grassi G.
The influence of different jaw positions on the endurance and
electromyographic pattern of the biceps brachii muscle in young
adults with different occlusal characteristics.
J Oral Rehabil. 2001 Aug;28(8):732-9. PubMed PMID: 11556954.
9. Ferrario VF, Marciandi PV, Tartaglia GM, Dellavia C, Sforza C.
Neuromuscular evaluation of post-orthodontic stability: an
experimental protocol.
Int J Adult Orthodon Orthognath Surg. 2002;17(4):307-13. PMID:
12596694.
10. Ferrario VF, Serrao G, Dellavia C, Caruso E, Sforza C.
Relationship between the number of occlusal contacts and masticatory
muscle activity in healthy young adults.
Cranio. 2002 Apr;20(2):91-8. PubMed PMID: 12002835.
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11. Ferrario VF, Sforza C, Tartaglia GM, Dellavia C.
Immediate effect of a stabilization splint on masticatory muscle
activity in temporomandibular disorder patients.
J Oral Rehabil. 2002 Sep;29(9):810-5. PubMed PMID: 12366533.
12. Ferrario VF, Sforza C, Dellavia C, Tartaglia GM.
Evidence of an influence of asymmetrical occlusal interferences on the
activity of the sternocleidomastoid muscle.
J Oral Rehabil. 2003 Jan;30(1):34-40. PubMed PMID: 12485381.
13. Ferrario VF, Tartaglia GM, Maglione M, Simion M, Sforza C.
Neuromuscular coordination of masticatory muscles in subjects with
two types of implant-supported prostheses.
Clin Oral Implants Res. 2004 Apr;15(2):219-25. PubMed PMID:
15008934.
14. Ferrario VF, Sforza C, Zanotti G, Tartaglia GM.
Maximal bite forces in healthy young adults as predicted by surface
electromyography.
J Dent. 2004 Aug;32(6):451-7. PubMed PMID: 15240063.
15. Ferrario VF, Tartaglia GM, Galletta A, Grassi GP, Sforza C.
The influence of occlusion on jaw and neck muscle activity: a surface
EMG study in healthy young adults.
J Oral Rehabil. 2006 May;33(5):341-8. PubMed PMID: 16629892.
16. Ferrario VF, Tartaglia GM, Luraghi FE, Sforza C.
The use of surface electromyography as a tool in differentiating
temporomandibular disorders from neck disorders.
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Man Ther. 2007 Nov;12(4):372-9. Epub 2006 Sep 14. PubMed PMID:
16973402.
17. Sforza C, Zanotti G, Mantovani E, Ferrario VF.
Fatigue in the masseter and temporalis muscles at constant load.
Cranio. 2007 Jan;25(1):30-6. PubMed PMID: 17304915.
18. Dellavia C, Romeo E, Ghisolfi M, Chiapasco M, Sforza C, Ferrario VF.
Electromyographic evaluation of implant-supported prostheses in
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Clin Oral Implants Res. 2007 Jun;18(3):388-95. Epub 2007 Feb 13.
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19. Ries LG, Alves MC, Bérzin F.
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20. Tartaglia GM, Moreira Rodrigues da Silva MA, Bottini S, Sforza C,
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Masticatory muscle activity during maximum voluntary clench in
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Man Ther. 2008 Oct;13(5):434-40. Epub 2007 Jul 20. PubMed PMID:
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21. Tartaglia GM, Testori T, Pallavera A, Marelli B, Sforza C.
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23. De Felício CM, Sidequersky FV, Tartaglia GM, Sforza C.
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muscoli masticatori in pazienti disfunzionali
Immediate effects of an occlusal splint of stabilization on the
masticatory muscles activity in disfunctional patients
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Immediate effect of an elastomeric oral appliance on the neuromuscular
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26. Botelho AL, Silva BC, Gentil FH, Sforza C, da Silva MA.
Immediate effect of the resilient splint evaluated using surface
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electromyography in patients with TMD.
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27. Rodrigues-Bigaton D, Berni KC, Almeida AF, Silva MT.
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29. Botelho AL, Gentil FH, Sforza C, da Silva MA.
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30. Tartaglia GM, Lodetti G, Paiva G, De Felicio CM, Sforza C.
Surface electromyographic assessment of patients with long lasting
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J Electromyogr Kinesiol. 2011 Aug;21(4):659-64. Epub 2011 Apr 3.
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31. Sforza C, Rosati R, De Menezes M, Musto F, Toma M.
EMG analysis of trapezius and masticatory muscles: experimental
protocol and data reproducibility.
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J Oral Rehabil. 2011 Sep;38(9):648-54. doi: 10.1111/j.13652842.2011.02208.x. Epub 2011 Feb 18. PMID: 21332571.
32. De Felício CM, Ferreira CL, Medeiros AP, Rodrigues Da Silva MA,
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Electromyographic indices, orofacial myofunctional status and
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J Electromyogr Kinesiol. 2012 Apr;22(2):266-72. Epub 2011 Dec 27.
PubMed PMID: 22206640.
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EXIF Metadata provided by EXIF.tools