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

BTS SpA Wireless EMG sensor for EMG system ERTMJ 00998 04 TMJOINT ENG v 3 0 0

ERTMJ-00998-04 TMJOINT User Manual ENG v.3.0.0

version 3.0.0

user manual

english

BTS TMJOINT

Document Number : ERTMJ-00998-04

Published: January 2013

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contents 1

icons, symbols and acronyms 5

radio regulation 9

disposal (WEEE) 10

intended use 11

regulatory label 12

receiving unit regulatory label 12

EMG wireless probes regulatory label 12

charger regulatory label 13

warnings 14

introduction 18

general description 18

case contents 20

system components 22

receiving unit 22

wireless EMG probes 23

charger 26

installation 28

user PC minimum conguration 28

connections 28

description of the software on the user PC 29

software installation 29

hardware installation 31

rst software use 34

contents

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contents

patient setup 37

POC4 protocol 37

POC6 protocol 39

guide to the use of BTS DCA 41

initial screen 41

menu bar 42

tool bar 47

probes status bar 47

patient list and research lter 49

patient, session and trial information 52

trial viewing and report generation area 53

main features of the BTS DCA software 59

new patient 59

new session 59

edit pathology 62

new trial 63

data acquisition 66

edit patient 72

edit session 73

delete patient 74

delete session 75

delete trial 76

more features of the BTS DCA software 77

database and data folder 77

managing les in the recycle bin 80

guide to of the data report reading 83

INT tab 83

EXT tab 89

POC tab 94

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contents

ISTO tab 96

MAST tab 98

INFO tab 100

appendix A – technical specications 103

wireless probes 103

receiving unit 103

appendix B – environmental specications 105

appendix C – power supply and switch o 106

appendix D – battery 107

appendix E – troubleshooting guide 108

warning – invalid trigger mode 108

appendix F – declaration of conformity 109

appendix G– bibliography 110

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icons, symbols and acronyms

Symbol in the instructions for the function.

e icon represents the information which requires special attention.

Symbol in the instructions for the function.

is icon makes reference to a more detailed discussion of the subject in

hand.

Symbol on the equipment:

e data appearing next to the manufacturer’s symbol refer to the place of

manufacture of the equipment itself.

Symbol on the equipment:

e “FCC” simbol refers to the Federal Communication Commission of

the USA. e device complies with the relevant regulations put forth by

the FCC as long as it is operated according to the instructions contained

in this manual and to all national and local regulations.

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icons, symbols and acronyms

Symbol on the equipment:

e gure in the square indicates the insulation class and the part types

used. In accordance with Standard ISO 60601-1, the equipment has an

internal power supply and the parts used are type BF.

Symbol on the equipment:

Attention, read the information in the users’ manual carefully before using

the equipment.

Symbol on the equipment:

e double square indicates that the product is a medical device of II

Class (In accordance with the law EN 60601-1).

Symbol on the equipment:

CE mark with the code of the Notied Body. e CE mark certies that

the product conforms to the standards applicable in the member states of

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icons, symbols and acronyms

the European Union (see Declaration of Conformity).

Symbol on the equipment:

CE mark with the code of the Notied Body. e CE mark certies

that the product conforms to the Directive 99/05/EEC - R&TTE and

obtained the Expert Opinion by IMQ.

Symbol on the equipment and in the users’ instructions:

Symbol for the separate disposal of electrical and electronic equipment, in

accordance with Directive 2002/96/CE (WEEE).

e equipment belongs to Group 8 (medical equipment).

In force in the nations of the European Union, Norway and Switzerland.

Rx only

Symbol for prescription only. U.S. Federal law restricts this device to sale

by or on the order of a physician or properly licensed practitioner.

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icons, symbols and acronyms

REF

Symbol on the equipment:

Symbol located next to the model number (ref.to catalogue).

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 Coecent

MVC Maximum Voluntary Contraction

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radio regulation

Radio equipment identication:

- EMG probes:

FCC ID: YQH-BTSWEMG2

IC: 9188A-BTSWEMG2

- receiving Unit contains:

FCC ID: TFB-MATRIXLP

IC: 5969A-MATRIXLP

is device complies with part 15 of the FCC Rules. Operation

is subject to the following two conditions: (1) is device may

not cause harmful interference, and (2) this device must accept

any interference received, including interference that may cause

undesired operation.

Modications not expressly approved by BTS SpA could void the

user’s authority to operate the equipment under FCC rules.

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disposal (WEEE)

In disposing of the equipment observe the legal prescriptions.

In accordance with Directive 2002/96/CE (WEEE) all equipment supplied

after 13/08/2005 may not be disposed of in general domestic waste. is

equipment belongs to Category 8 (medical equipment) and is classied in

the Business-to-Business sector.

e symbol of the crossed out rubbish bin

indicates that the equipment must not be

disposed of in normal domestic waste.

e regulations for disposal may dier between

individual countries in the EU. In cases of doubt,

refer to the respective sales outlet.

is is a battery-powered equipment.

See Appendix D for information about the batteries used. Operate

and dispose of this equipment according to the instructions set in

the “warnings” section.

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intended use

is equipment is an instrument for the EMG surface analysis, classied

as medical equipment in accordance with European Directive 93/42/CE

(and its amendments).

BTS TMJOINT must always be used only for this purpose, by qualied

persons, in an environment suitable for the execution of EMG analyses

and respecting the prevailing regulations in the countries in which it is

being utilised.

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regulatory label

Probe ID

Receiving Unit Regulatory label

EMG Wireless Probes Regulatory label

Label on the probes:

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regulatory label

Label not on actual probes due to size constraints:

Charger Regulatory label

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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 qualied and authorized personnel, according to

the laws in force in the nation it is in use. e EMG probes are classied as

ETSI EN 300 440 “Receiver category 3” according to Directive R&TTE

99/5/EEC.

e results of the acquisitions must be assessed by people legally authorised

by national law, who possess the suitable necessary knowledge of anatomy

and muscular function.

e uses of the device for other purposes and with methodologies dierent

from of those indicated in this manual are not to be considered congruent

with the precise use of the device.

- Use the product according to the usage that it has been intended.

- Avoid connecting the probes to the charger with inverted polarity

with respect to that shown on the cover of the recharger - this

could cause irreparable damage to them.

- To not wet or dip in water the parts that make up the system.

warnings

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warnings

- Apply the probes only on undamaged skin.

- Only use CE branded probes and hypoallergenic double-sided

tape, compatible with the usage on undamaged skin for brief

periods of time.

- Periodically verify the integrity of the system and of its components.

- In case the device accidentally falls, tear of the probes or other

accidents always address authorized technical support.

- Do not undertake any kind of internal maintenance of the device:

in case of need always address to authorized technical support.

- e use of any components dierent from the original ones

declines the conformity of the device.

- e instrument must be used in a medical environment, since it

has a high level of sensitivity (measured voltage levels of between

1 microvolt and 6 millivolt).

- In addition to the users’ instructions, the prescriptions regarding

accident prevention and technical regulations regarding

occupational safety must also be complied with.

e appertaining national regulations and standards of the country

of use, with regards prevention of accidents and environment, are

an extension of the users’ instructions.

- TMJOINT is a device that is able to function CONTINUOUSLY,

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warnings

this is of course limited by the battery duration and by the

memory available for the acquisition data storing.

- the device uses lithium ion battery. For the battery replacement

and disposal please contact the technical support. At any rate,

ensure that device component (i.e. probes, receiving unit,...)

integrity is never compromised.

e information contained in this manual is subject to change

without notice and does not constitute product specications or

any obligation on the part of BTS S.p.A.

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e software of the system described in this manual is supplied with the

“licence to use” contract. e software may be used or copied only as

stipulated under the terms of this contract.

No part of this manual may be copied or transmitted in any form or

means, electronic or mechanical, including photocopying, without prior

written permission from BTS S.p.A.

Unless otherwise specied, any reference to companies, names, data and

addresses used in the reproduction of the screens and the examples are

purely incidental, and has the sole purpose of illustrating the use of the

BTS product. All trademarks are registered by the respective owners.

is publication contains reserved information which is the

property of BTS S.p.A.

e recipient acknowledges that the illustrations and information

supplied in this manual shall not be made available to third parties

without explicit written agreement by BTS S.p.A.

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General description

BTS TMJOINT is the solution for the functional analysis of dental

occlusion. Functional information is provided on the neuromuscular

alterations induced by occlusal contact.

BTS TMJOINT integrates the latest wireless technology available today.

Based on wireless technology, this solution includes a set of EMG probes

with active electrodes, the only one of its kind in the world due to its

light weight (weighing less than 9 grams), compact size and data capturing

accuracy, a USB receiving unit and the dedicated software BTS Dental

Contact Analyzer.

BTS TMJOINT uses surface electromyographic analysis to measure the

dierential inuence of the occlusal function through indices validated

and published in scientic literature.

Special feature of this system is the standardization of the electromyographic

signal that is provided by the comparison between two test of clenching,

done with and without the interposition of cotton rolls between the

dental arches. is method allows the elimination of problems of the

wrong positioning of the electrodes, of the dierence of impedance of

the patient’s skin, of the dierences of muscular tropism, etc. making it

accurate and repeatable.

e results are shown via a special graphic interface that is easy to

introduction

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introduction

understand for both the physician and patient.

e 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.

e rst level, called POC4, includes 4 capture probes and the analysis

protocol. rough 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 coecient (an index

of the symmetric distribution of the muscular activity determined by

the occlusion) and a TORS torque coecient (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.

e second level, called POC6, adds to the previous 2 capture probes for

calculating the indices related to the sternocleidomastoid muscle, right and

left. e eects of the teeth touching, on the neck muscles are evaluated.

e third level, called MASTICATION, analyses the neuromuscular

coordination during mastication. e masticatory frequency, the Lissajous

curve, and indices of muscle symmetry are calculated.

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introduction

Case contents

• Receiving Unit

• Probes Kit available in 2 versions:

• POC4: include 4 wireless probes*

• POC6: include 6 wireless probes*

*(identicative labels available in 4 dierent colors)

• Probes Charger (AC adapter included)

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introduction

• 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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BTS TMJOINT system consists of two parts: the receiving unit and the

wireless EMG probes.

Receiving unit

e receiving unit, connected to the PC trough USB, allows the WiFi

reception of the EMG signal acquired by the wireless probes

WiFi transmission

system components

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system components

Wireless EMG Probes

BTS FREEEMG 300 utilises miniaturized probes with active electrodes

weighing less than 13 grams.

e special design ensures maximum space-saving and comfort for the

patient who is free to move around without obstacles.

e probes can be hooked on directly to the pre-gelled electrodes without

requiring additional xing with plasters or double-sided tape.

is 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

tted with a clip. e two parts, connected via a exible 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 buer, to prevent

data loss for problems due to the WiFi network or due to exceeding the

useful operating range.

Each probe is tted with a LED indicating its state.

e probes can be in one of a number of dierent states:

• Charge: steady blue LED.

mother electrode

LED

satellite electrode

mother electrode clip

satellite electrode clip

exible cable

probe ID

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system components

During the recharging phase the steady blue LED is on.

is 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

ashes quickly.

• Active-Connected: white LED which ashes 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 “Active-

Scanning” 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 ashes 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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system components

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 o.

If the probe is completely discharged the LED does not display

any ashing cycle and is o.

e same happens when it is in “Deep Sleep” mode (except

during the recharging phase in witch the led is steady blue).

e probes in “Deep Sleep” mode do not perform any

scan cycle, but are turned o. 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.

e 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

e Charger, included with the product, charges the BTS TMJOINT

probes.

e 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.

e 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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system components

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.

e 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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User PC minimum conguration

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

e 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.

installation

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installation

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.

e software allows managing the patient database, organized with a tree

root with sessions, trials and subject data, esplorable through dierent

database queries.

e 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 congured.

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 les, launch the .exe le “POCAnalyzer-

X.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.

en perform a double click on the “CDM20814_Setup.exe” le and wait

for the window that has just opened, to close.

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installation

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 congure

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.

en, 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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installation

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 rst 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 rst 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 rst 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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installation

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 elds 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

e POC 4 protocol provides the acquisition of 4 muscles: the masseter

and the temporalis anterior bundle for both face sides.

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.

Temporalis Anterior

Masseter

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patient setup

For the RIGHT temporalis anterior bundle, touch the muscle during the

maximum clenching and nd 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, nding

its venter.

e 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 pre-

gelled 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

e 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.

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

Temporalis Anterior

Masseter

Sternocleidomastoid

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patient setup

to the instructions in the previous paragraph.

To nd 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 identied.

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:

e 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 lter

• 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 congure the EMG devices

to use;

• e “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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guide to the use of BTS DCA

• “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

conrmation is requested.

• “Remove Session” to eliminate the selected session. A

conrmation is requested;

• “Remove Trial” to eliminate the selected trial. A conrmation 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.

e 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.

e 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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e following windows will be displayed:

is 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 identicative code

printed on the clip of the same probe.

- the number indicated on the probe label

- the identicative color of the probe label

- the name of the muscle associated to that probe.

All these value can be modied 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.

e 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 gure:

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 conrmation is

required before proceeding with the operation.

The deleted trial is moved to the recycle bin.

• “Exit” to leave the programme.

Probes status bar

e 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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e 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 lter

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 identied by a surname, rst 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 eld 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 lter 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

lter (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

identied..

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 le 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 les.

The empty recycle bin symbol indicates that there are no les 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.

ere are two main panels:

- the rst 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 eld can be updated by editing the notes eld 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

e 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:

e software will automatically assign a typology among “COT”, “CLE”,

“ROT”, “MASTDX”, “MASTSX”, to each trial loaded. e “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 classication, 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:

e 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 veried 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 dierent trials of cotton type labeled as “COT” and “COT

POST”(typically when we need to compare trials acquired in

dierent 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. ere 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.

e 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 eld “report PDF name” in witch is visualized the report

name automatically assigned by the software (this name can be

modied by the user before to click on “Save Report”), nally 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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e scale of the y-axis can be modied 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 ll in the elds and click “Add Patient”.

The elds 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 ll in the elds and click “Create Session”.

In particular it is required to:

• give a name to the session to be created.

This eld 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 rst 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 rst 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 (eld not mandatory).

• indicate any previous treatment of the patient.

For both these elds there are 255 characters available.

• modify the session date (if dierent 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 to open the

pathology list.

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 eld

“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 eld

“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

• Conrm 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 elds relative to “Trial to acquire” if you want to proceed with an

acquisition, or ll the elds relative to “Import TDF le” 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 elds have been lled 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.

e 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 identication label.

e 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.

e identication label is linked to the muscle is acquired with that specic

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. ere will be displayed 4 or 6 channels

depending on the protocol chosen:

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e 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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e 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”.

e 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 verication 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 conrmation 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, nally 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:

e “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 ne comparirà la seguente nestra:

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:

e “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.

is 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.

is 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.

is 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:

e eld “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” eld 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” eld 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 les will be saved.

The name of the subfolder is shown in brackets under “Current data

folder”.

In the gure 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 le

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 le

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 le 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 les in the recycle bin

If you wish to remove a patient, session or trial, the le is moved to the

recycle bin.

To access the les held in the recycle bin, double click the icon representing

the recycled bin which appears in the patient list.

e 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 le tree the node labels may have three different colors:

• The black label indicates that the le (patient, session or trial)

has been removed from the database together with all the les

associated with it.

• The dark grey label and icon indicate that the le 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 le has been deleted along

with the root le (e.g. a patient main le 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 le.

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 le permanently.

Before eliminating the le, a conrmation will be requested.

If you eliminate a le, 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 le 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 le.

This button recovers all the les 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 les in the recycle bin.

A conrmation must be given for this operation.

Conrming the elimination means that the les will no

longer be recoverable. At the end of this operation the

recycle bin will be empty.

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e data report is automatically generated by the software DCA. e

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

guide to the report data reading

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e 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 dierent temporal session. is is helpful in evaluating the treatment

ecacy and for the patient follow up.

e 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 coecient

It is an index of the standardized contraction symmetry within the

same muscular couple. It expresses, in percentage terms, the dierence

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

dierent 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

inuencing 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 inuence of tooth contact on the

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neuromuscular balance of the stomatognathic system; with 6-channel

protocol, is calculated in addition the coecient of overlapping

percentage of the sternocleidomastoid muscles POC SCM, indicator

of the inuence 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

e 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.

e 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).

e POC TA index corresponds to the inuence of dental

contacts of the incisors, canines and rst premolars.

e index POC MM corresponds to the inuence 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.

e 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.

e value of the POC SCM does not aect 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 coecient 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 rst-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

e normal value of the BAR index is > 90%.

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e 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%.

e 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.

e value and the direction of the vertical displacement of the two target

points are then exactly the same.

e BAR value in the normal population always expresses a

prevalence of dierential activities of the couple of masseter

muscles compared to that of temporal.

is condition is reversed in the second skeletal class in which

the temporal muscles always express a dierential 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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ere 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

e 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 coecient 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. e TORS index expresses

a condition clinically worse because detectable only using

instruments, that is the presence of fulcrums.

e 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 insucient 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” eld 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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guide to the report data reading

In this tab are represented the ulterior calculated indices, reporting for an

easier reading also the values of the coecients already seen in the previous

tab.

e referring indices are TA%, MM%, SCM%, ATTIV, TORQUE,

POCm, ASIM, CL and IMP.

• TA%, MM%, SCM%

ese indexes represent in percentage the standardized average value of

the activity respectively of the anterior temporal muscles, masseters and

sternocleidomastoids left and right.

e graphical representation includes a 3D model, for a male or female,

according to the patient for whom the report relates.

e 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.

e 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 gure the right TA% is 83.57% and is

the highest value of the 4. en 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%.

e 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 gure below as

an example.

e 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 anterior-

lateral areas, that means until the rst-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 nd 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%.

e resultant force of the action of the temporalis muscle, added to the

resultant force of the controlateral masseter, generates a force couple. e

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 coecient

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

is 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. e normal

range is between -10 and 10.

• CL: Cervical Load

is 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.

e 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.

e 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

reex.

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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e rst and second columns show the average activity of 4 muscles in

microvolts, relative to clenching trials performed respectively with and

without cottons. e 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.

e 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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e 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.

e activity of the right side (identied by white color) is compared with

the activity of the left side (identied 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.

e 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”.

e “Previous” button allows returning to the charts of the rst session.

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MAST tab

e 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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e ideal situation, corresponding to a good level of chewing coordination,

is when the two ellipses of condence 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 dierentiated by side. e 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”. e index SMI, in

this case, will not be calculated.

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guide to the report data reading

INFO tab

is tab allows you to enter data to customize the report and upload your

own logo if desired.

To do this, complete the elds 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 rst use,

the elds 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”. e

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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Wireless Probes

Geometry: variable

Electrodes: standard with clip connection

Separation: min: 16mm - max: 66mm

Autonomy: 5h of use

some days stand-by

Battery: rechargeable, lithium ion

Dimensions: 17x36x8mm mother electrode

diameter 17 x 8mm satellite electrode

Weight: <9g battery included

Frequency used: ISM band

2.4GHz (standard IEEE802.15.4)

Input impedance: >10 GOhm

CMMR: >110 dB @ 50-60Hz

Resolution: 16bit

Acquisition frequency: up to 4KHz

Sensitivity: 1μV

Measure accuracy*: ± 2%

Receiving Unit

Connection: USB

Dimensions: 82x44x22,5mm

Weight: 80 gr

Frequency used: ISM band

appendix A

technical specications

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appendix

2.4GHz (standard IEEE802.15.4)

* e system is calibrated at the factory. No further calibration is required

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appendix B

environmental specications

Min Max Note

Operating Temperature -20° +45°

Operating Humidity 50% 80% Relative,

non-condensing

Storage and Transport

Temperature 0° +40°

Storage and Transport

Humidity 50% 80% Relative,

non-condensing

Altitude 0m 2000m

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 o

e receiving unit is powered by the USB port.

To switch o 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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BTS TMJOINT probes are internally powered.

e Probe battery replacement can be done only by BTS qualied

personnel.

e 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

e specic 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

appendix D

battery

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appendix E

troubleshooting guide

Warning – Invalid trigger mode

During the hardware installation, the USB port dedicated to the receiver,

is congured.

May happen that these port settings went lost.

is 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 conguration.

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 conguration

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: Electromyographic system / device for the functional analysis of dental occlusion.

model: TMJOINT

S/N: 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 – Germa-

ny, 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

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.

e inuence of crossbite on the coordinated electromyographic

activity of human masticatory muscles during mastication.

appendix G

bibliography

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appendix

J Oral Rehabil. 1999 Jul;26(7):575-81. PubMed PMID: 10445477.

6. Ferrario VF, Sforza C, Serrao G, Colombo A, Schmitz JH.

e eects 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.

e inuence of dierent jaw positions on the endurance and

electromyographic pattern of the biceps brachii muscle in young

adults with dierent 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.

112

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11. Ferrario VF, Sforza C, Tartaglia GM, Dellavia C.

Immediate eect 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 inuence 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.

e inuence 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 dierentiating

temporomandibular disorders from neck disorders.

113

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Man er. 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, Ghisol M, Chiapasco M, Sforza C, Ferrario VF.

Electromyographic evaluation of implant-supported prostheses in

hemimandibulectomy-reconstructed patients.

Clin Oral Implants Res. 2007 Jun;18(3):388-95. Epub 2007 Feb 13.

PMID: 17298492.

19. Ries LG, Alves MC, Bérzin F.

Asymmetric activation of temporalis, masseter, and sternocleidomastoid

muscles in temporomandibular disorder patients.

Cranio. 2008 Jan;26(1):59-64. PMID: 18290526.

20. Tartaglia GM, Moreira Rodrigues da Silva MA, Bottini S, Sforza C,

Ferrario VF.

Masticatory muscle activity during maximum voluntary clench in

dierent research diagnostic criteria for temporomandibular disorders

(RDC/TMD) groups.

Man er. 2008 Oct;13(5):434-40. Epub 2007 Jul 20. PubMed PMID:

17643338.

21. Tartaglia GM, Testori T, Pallavera A, Marelli B, Sforza C.

Electromyographic analysis of masticatory and neck muscles in

subjects with natural dentition, teeth-supported and implant-

114

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supported prostheses.

Clin Oral Implants Res. 2008 Oct;19(10):1081-8. PubMed PMID:

18828826.

22. Ferrario VF, Sforza C, Tartaglia GM.

Commentary to Suvinen and Kemppainen (JOR 2007;34:631-44).

J Oral Rehabil. 2009 Jan;36(1):9-10. PubMed PMID: 19207367.

23. De Felício CM, Sidequersky FV, Tartaglia GM, Sforza C.

Electromyographic standardized indices in healthy Brazilian young

adults and data reproducibility.

J Oral Rehabil. 2009 Aug;36(8):577-83. Epub 2009 Jun 22. PubMed

PMID: 19548958.

24. E. Di Palma, M. Leopardi, S. Alonzi, M. Lucci, V. Parziale C. Chimenti

Eetti immediati di uno splint di stabilizzazione sull’attività dei

muscoli masticatori in pazienti disfunzionali

Immediate eects of an occlusal splint of stabilization on the

masticatory muscles activity in disfunctional patients

Ortognatodonzia Italiana vol. 16, 2-2009.

25. Sforza C, Montagna S, Rosati R, DE Menezes M.

Immediate eect of an elastomeric oral appliance on the neuromuscular

coordination of masticatory muscles: a pilot study in healthy subjects.

J Oral Rehabil. 2010 Nov;37(11):840-7. doi: 10.1111/j.1365-

2842.2010.02114.x. PubMed PMID: 20529177.

26. Botelho AL, Silva BC, Gentil FH, Sforza C, da Silva MA.

Immediate eect of the resilient splint evaluated using surface

115

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electromyography in patients with TMD.

Cranio. 2010 Oct; 28(4):266-73. PubMed PMID: 21032981.

27. Rodrigues-Bigaton D, Berni KC, Almeida AF, Silva MT.

Activity and asymmetry index of masticatory muscles in women with

and without dysfunction temporomandibular.

Electromyogr Clin Neurophysiol. 2010 Nov-Dec;50(7-8):333-8. PMID:

21284371.

28. Krechina EK, Lisovskaia VT, Pogabalo IV.

Electromyographic evaluation of functional status of temporal muscles

and mastication muscles in patients with close position of frontal teeth

in cases of dierent occlusion. [Article in Russian]

Stomatologiia (Mosk). 2010;89(3):69-71. PMID: 20559240.

29. Botelho AL, Gentil FH, Sforza C, da Silva MA.

Standardization of the electromyographic signal through the maximum

isometric voluntary contraction.

Cranio. 2011 Jan; 29(1):23-31. PubMed PMID: 21370766.

30. Tartaglia GM, Lodetti G, Paiva G, De Felicio CM, Sforza C.

Surface electromyographic assessment of patients with long lasting

temporomandibular joint disorder pain.

J Electromyogr Kinesiol. 2011 Aug;21(4):659-64. Epub 2011 Apr 3.

PubMed PMID: 21463956.

31. Sforza C, Rosati R, De Menezes M, Musto F, Toma M.

EMG analysis of trapezius and masticatory muscles: experimental

protocol and data reproducibility.

116

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J Oral Rehabil. 2011 Sep;38(9):648-54. doi: 10.1111/j.1365-

2842.2011.02208.x. Epub 2011 Feb 18. PMID: 21332571.

32. De Felício CM, Ferreira CL, Medeiros AP, Rodrigues Da Silva MA,

Tartaglia GM, Sforza C.

Electromyographic indices, orofacial myofunctional status and

temporomandibular disorders severity: A correlation study.

J Electromyogr Kinesiol. 2012 Apr;22(2):266-72. Epub 2011 Dec 27.

PubMed PMID: 22206640.

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

BTS SpA Wireless EMG sensor for EMG system ERTMJ 00998 04 TMJOINT ENG v 3 0 0

Contents

ERTMJ-00998-04 TMJOINT User Manual ENG v.3.0.0

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