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EREMB-01091-06 FREEEMG 100 RT User Manual ENG v.2.0.3 | Users Manual | 2.94 MiB | September 08 2013 | |||
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ERFNC-00782-16 FREEEMG 300 User Manual ENG v.4.0.3 | Users Manual | 4.73 MiB | September 08 2013 | |||
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ERTMJ-00998-04 TMJOINT User Manual ENG v.3.0.0 | Users Manual | 4.14 MiB | September 08 2013 | |||
1 | Test Report | September 08 2013 | ||||||
1 | Cover Letter(s) | September 08 2013 | ||||||
1 | Cover Letter(s) | September 08 2013 | ||||||
1 | External Photos | September 08 2013 | ||||||
1 | Internal Photos | September 08 2013 | ||||||
1 | ID Label/Location Info | September 08 2013 | ||||||
1 | Test Setup Photos | September 08 2013 |
1 | EREMB-01091-06 FREEEMG 100 RT User Manual ENG v.2.0.3 | Users Manual | 2.94 MiB | September 08 2013 |
user manual english version 2.0.3 Document Number : EREMB-01091-06 Published: June 2013 Copyright 2010 - 2013 BTS SpA. All Rights Reserved. receiving unit regulatory label EMG wireless probes regulatory label AUX wireless probes regulatory label BTS charger regulatory label contents icons, symbols and acronyms radio regulation disposal (WEEE) intended use regulatory label warnings copyright introduction system components installation general description case contents receiving unit wireless EMG probes wireless FSW/EGN probes (optional) on-off analysis (optional) electrogoniometers (optional) charger user PC minimum configuration connections contents 1 3 7 8 9 10 10 10 11 12 13 16 17 17 18 21 21 22 25 27 29 30 33 33 33 BTS Bioengineering 1 acquisition protocol hardware installation description of the software on the user PC BTS EMG-Analyzer configuration check contents 34 37 38 41 wireless probes receiving unit BTS internal coding appendix A technical specifications appendix B environmental specifications appendix C power supply and switch off appendix D battery appendix E troubleshooting guide warning invalid trigger mode appendix F declaration of conformity appendix G regulatory notice 47 47 47 48 49 50 51 52 52 53 54 FDA medical device reporting systemreportable events 54 adverse event report (21 CFR 803.32) 55 2 BTS Bioengineering icons, symbols and acronyms Symbol in the instructions for the function. The icon represents the information which requires special attention. Symbol in the instructions for the function. This icon makes reference to a more detailed discussion of the subject in hand. Symbol on the equipment:
The data appearing next to the manufacturers symbol refer to the place of manufacture of the equipment itself. Symbol on the equipment:
The FCC simbol refers to the Federal Communication Commission of the USA. The device complies with the relevant regulations put forth by the FCC as long as it is operated according to the instructions contained in this manual and to all national and local regulations. BTS Bioengineering 3 icons, symbols and acronyms Symbol on the equipment:
The figure in the square indicates the insulation class and the part types used. In accordance with Standard ISO 60601-1, the equipment has an internal power supply and the parts used are type BF. Symbol on the equipment:
Attention, read the information in the users manual carefully before using the equipment. Symbol on the equipment:
The double square indicates that the product is a medical device of II Class (In accordance with the law EN 60601-1). Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies that the product conforms to the standards applicable in the member states of 4 BTS Bioengineering icons, symbols and acronyms the European Union (see Declaration of Conformity). Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies that the product conforms to the Directive 99/05/EEC - R&TTE and obtained the Expert Opinion by IMQ. Symbol on the equipment and in the users instructions:
Symbol for the separate disposal of electrical and electronic equipment, in accordance with Directive 2002/96/CE (WEEE). The equipment belongs to Group 8 (medical equipment). In force in the nations of the European Union, Norway and Switzerland. Rx only Symbol for prescription only. U.S. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. BTS Bioengineering 5 icons, symbols and acronyms REF Symbol on the equipment:
Symbol located next to the model number (ref.to catalogue). SN Symbol on the equipment:
Symbol located next to the series number on the equipment. Receiving Unit Acronyms used in this manual:
RU EMG Electromyography WS Workstation 6 BTS Bioengineering radio regulation Radio equipment identification:
- EMG probes:
FCC ID: YQH-BTSWEMG2 IC: 9188A-BTSWEMG2
- FSWEGN probes:
FCC ID: YQH-BTSWAUX IC: 9188A-BTSWAUX
- Receiving Unit contains:
FCC ID: TFB-MATRIXLP IC: 5969A-MATRIXLP This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by BTS SpA could void the users authority to operate the equipment under FCC rules. BTS Bioengineering 7 disposal (WEEE) In disposing of the equipment observe the legal prescriptions. In accordance with Directive 2002/96/CE (WEEE) all equipment supplied after 13/08/2005 may not be disposed of in general domestic waste. This equipment belongs to Category 8 (medical equipment) and is classified in the Business-to-Business sector. The symbol of the crossed out rubbish bin indicates that the equipment must not be disposed of in normal domestic waste. The regulations for disposal may differ between individual countries in the EU. In cases of doubt, refer to the respective sales outlet. This is a battery-powered equipment. See Appendix D for information about the batteries used. Operate and dispose of this equipment according to the instructions set in the warnings section. 8 BTS Bioengineering intended use This equipment is an instrument for the EMG surface analysis, classified as medical equipment in accordance with European Directive 93/42/CE
(and its amendments). BTS FREEEMG 100 RT must always be used only for this purpose, by qualified persons, in an environment suitable for the execution of EMG analyses and respecting the prevailing regulations in the countries in which it is being utilized. BTS Bioengineering 9 regulatory label Receiving Unit Regulatory label EMG Wireless Probes Regulatory label Label on the probes:
Probe ID 10 BTS Bioengineering regulatory label Label not on actual probes due to size constraints:
AUX Wireless Probes Regulatory label Label on the probes:
Probe ID Label not on actual probes due to size constraints:
BTS Bioengineering 11 regulatory label BTS Charger Regulatory label 9V 3A 9V 3A 3A 12 BTS Bioengineering warnings We recommend to carry out any kind of operation keeping strictly to the security regulations contained in this manual. The safety of the instrument cannot be guaranteed if these conditions are not respected. BTS FreeEMG 100 RT is a medical device (EU Directive 93/42/CE and its amendments, including Directive 2007/47/CE) which use must be at all times be supervised by qualified and authorized personnel, according to the laws in force in the nation it is in use. The EMG probes are classified as ETSI EN 300 440 Receiver category 3 according to Directive R&TTE 99/5/EEC. The results of the acquisitions must be assessed by people legally authorised by national law, who possess the suitable necessary knowledge of anatomy and muscular function. The 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). The uses of the device for other purposes and with methodologies different from of those indicated in this manual are not to be considered congruent with the precise use of the device. During the preparation of the patient, take particular care that the systems components do not impede in any way the normal movements of the subject. Apply the probes only on undamaged skin. BTS Bioengineering 13 warnings 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. To not wet or dip in water the parts which make up the system. No modification of this equipment is allowed. Only BTS S.p.A. authorized technicians may maintain and operate servicing to the instrument. BTS S.p.A. cannot be held responsible for system safety should the instrument be opened, repairs carried out, third parties software be installed, or system components be replaced by persons other than those authorized by BTS S.p.A. Users cannot change any software configuration (including O.S. and CD writer software). In case the device accidentally falls, tear of the probes or other accidents always address authorized technical support. Use only the provided power supply unit FW7363M/09 (FRIWO) or the one provided by BTS S.p.A. for supplying the charger unit. If a different power supply unit is used, the compliance to IEC 60601-1 is not ensured. Only original cables must be used, otherwise BTS S.p.A. cannot assure the safety of the instrument. Should it be necessary to replace any part of the system, only original BTS S.p.A. parts may be used. In addition to the users instructions, the prescriptions regarding accident prevention and regarding occupational safety must also be complied with. The appertaining national regulations and standards of the country of use, with regards prevention of accidents and environment, are an extension of the users instructions. regulations technical 14 BTS Bioengineering warnings Make sure that the cables have been connected correctly. When disconnecting cables, use the connectors and not the cables themselves to unplug the connectors. Mains plug of external power supply unit is considered as disconnecting device. 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. For a safe use and adequate maintenance of rechargeable batteries strictly follow the instructions given in this manual. If rechargeable batteries are used in such a way that is not the one specified by BTS S.p.A. the shelf life, functionality and the integrity of the batteries is not ensured. ESD application to EGN probes, causes a loss of link to the device. Temporary loss of function or performance which is recoverable with operator action. BTS FREEEMG 100 RT is a device that is able to function COUNTINUOUSLY, this is of course limited by the battery duration and by the memory available for the acquisition data storing. The device uses lithium ion battery. For the battery replacement and disposal please contact the technical support. At any rate, ensure that device component (i.e.) probes, receiving unit, ) integrity is never compromised. The information contained in this manual is subject to change without notice and does not constitute product specifications or any obligation on the part of BTS S.p.A. BTS Bioengineering 15 copyright The software of the system described in this manual is supplied with the licence to use contract. The software may be used or copied only as stipulated under the terms of this contract. No part of this manual may be copied or transmitted in any form or means, electronic or mechanical, including photocopying, without prior written permission from BTS S.p.A. Unless otherwise specified, any reference to companies, names, data and addresses used in the reproduction of the screens and the examples are purely incidental, and has the sole purpose of illustrating the use of the BTS product. All trademarks are registered by the respective owners. This publication contains reserved information which is the property of BTS S.p.A. The recipient acknowledges that the illustrations and information supplied in this manual shall not be made available to third parties without explicit written agreement by BTS S.p.A. 16 BTS Bioengineering introduction General description BTS FREEEMG 100 RT allows for a functional evaluation and a real-
time visualization of the acquired signals for biofeedback and monitoring applications. That makes it an indispensable instrument in the fields of sport, rehabilitation, ergonomics, neurology and orthopaedics. With BTS FREEEMG 100 RT the patient set up in very quick: the lightweight probes are attached directly to the pre-gelled electrodes and do not require any additional fixing such as adhesive tape. Thanks to the total absence of cables the patient can move around freely. BTS FREEEMG 100 RT is supplied with EMG-Analyzer the most complete software solution for analyzing electromyographic signals and with BTS MIOFEED, an easy-to-use therapeutic solution, studied also for home applications. BTS EMG-Analyzer software includes predefined templates for evaluations in the clinical, sports, and research field: Jump, plyometrics, walking, fatigue analysis, isokinetic, etc... BTS EMG-Analyzer also has an editor for creating elaboration protocols:
thanks to an innovative object interface, that translates the biomechanical analysis language into graphical form, the user can develop quickly and effectively customized analysis protocols. BTS Bioengineering 17 introduction BTS MIOFEED software allows a real-time monitoring of muscular activations during rehabilitative or sports tests execution. The EMG signal acquired with BTS FREEEMG 100 RT are transmitted in real-time directly at the receiving unit connected to the PC and transformed in graphic form and sounds to provide a prompt audio-visual feedback to the subject. This increase of audio and visual afferences is fundamental in order to improve the contractile capacities of the muscles., also of the paretic ones. BTS FREEEMG 100 RT seamlessly integrates with BTS motion analysis systems, through the SMART (and ELITE) dedicated software. Case contents Standard components:
Receiving Unit Up to 6 wireless EMG probes (identificative labels available in 4 different colors) Magnet for EMG probes activations 18 BTS Bioengineering introduction Probes Charger (AC adapter included) Set of disposable electrodes USB extension cable User manual Optional components:
Footswitch Kit 2 FSW/EGN Wireless Probes 2 Connectors of 4 Switches 10 single Switches BTS Bioengineering 19 introduction Electrogoniometer Kit 1 FSW/EGN Wireless Probe 1 Electrogoniometer 1 Connector You will receive the instructions for use for other possible optional components not mentioned in this manual. 20 BTS Bioengineering system components BTS FREEEMG 100 RT system consists of two parts: the receiving unit and the wireless probes. Receiving unit The receiving unit, connected to the PC trough USB, allows the WiFi reception of the signal acquired by the wireless probes. The receiving unit is able to handle simultaneously 6 wireless probes with the following limitations:
up to 6 EMG probes, used for acquisition of the same number up to 2 probes for the connection of 4 switches each, used for of electromyographic signals;
the basographic acquisition;
up to 6 probes for electrogoniometers connection, used for acquisition of up to 2 angle components each;
it is not possible to acquire simultaneously FSW and EGN probes. BTS Bioengineering 21 system components All the probe combinations that respect what indicated above are possible. WiFi transmission 7 Wireless EMG Probes BTS FREEEMG 100 RT utilizes miniaturized probes with active electrodes weighing less than 13 grams. The special design ensures maximum space-saving and comfort for the patient who is free to move around without obstacles. The probes can be hooked on directly to the pre-gelled electrodes without requiring additional fixing with plasters or double-sided tape. This together with the total absence of cables enables a much faster patient preparation, drastically reducing the time of each session. Each probe consists of a mother electrode and a satellite electrode, each fitted with a clip. The two parts, connected via a flexible cable, may be positioned as needed by the user at adjustable distance (electrodes with variable geometry). 22 BTS Bioengineering system components All probes are equipped with a solid state memory buffer, to prevent data loss for problems due to the WiFi network or due to exceeding the useful operating range. 6 1 22 3 5 1 2 3 4 5 6 7 mother electrode LED satellite electrode mother electrode clip satellite electrode clip flexible cable probe ID 4 7 5 Each probe is fitted with an LED indicating its state. The probes can be in one of a number of different states:
Charge: steady blue LED. During the recharging phase the steady blue LED is on. This phase occurs when the probes are connected to the charger turned on, and the charge level is less than 90%. When the charge level reaches 90% the led turns OFF. Since, by connecting a probe to the charger on, it enters in Deep Sleep mode, even while charging the probe will be completely passive and does not respond to any commands. Active-Scanning: white LED which cyclically lights for a few seconds. In this mode the probe is searching for the receiving unit. At intervals of about 1 minutes it carries out a scan of the frequencies of few seconds. During the scan the white LED flashes quickly. BTS Bioengineering 23 system components Active-Connected: white LED which flashes slowly. When the probe and the receiving unit establish a connection, the white LED begins to pulse slowly: the probe is waiting for commands. If the connection is interrupted, the probe returns to 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 flashes at regular intervals of approximately one second. At the conclusion of the acquisition, the probe returns to the Active-Connected condition. If during the acquisition, connection to the receiver unit is lost, the probe continues to acquire, storing the data locally for one minute and at the same time scans the assigned channel trying to reconnect to the receiving unit. If after one minute the scan is unsuccessful, the probe returns to the Active-Scanning condition interrupting the storage of data. Completely discharged or in Deep Sleep mode: LED is off. If the probe is completely discharged the LED does not display any flashing cycle and is off. The same happens when it is in Deep Sleep mode (except during the recharging phase in witch the led is steady blue). The probes in Deep Sleep mode do not perform any scan cycle, but are turned off. Is therefore guaranteed energy savings. 24 BTS Bioengineering system components To put the probe in Deep Sleep mode it is necessary to connect them to the Charger switched on, or to put them in contact with a magnet for half a second. Before the next use is necessary to reactivate the probes, putting them in contact with a magnet. The probes are charged by a dedicated charger to which the probes are connected via their respective clips. For more info about the probes charge sse the paragraph Charger of this chapter. Wireless FSW/EGN Probes (optional) For collecting the on-off analysis signals coming from the Footswitch or for collecting data from the Electrogoniometers (optional system components) BTS FREEEMG 100 RT uses wireless probes which must be connected to the FSW or EGN probes using a special connector. The probe will work differently if used with one or the other probe and will receive from the same receiving unit information on its work modality during activation. BTS Bioengineering 25 system components The probe consists of a single parallelepiped-shaped block. The upper face has an ID tag characterized by a color (Green, Red, Yellow, Blue) and a letter (A, B, C, D, E or F) and a status LED. The probes can be in one of a number of different states:
Charge: steady red LED. During recharging the red LED is on, the probe is completely passive and does not respond to any command. When the battery is fully recharged or when the probe is removed from the charger, if sufficiently recharged it passes to the Active-
Scanning mode. Active-Scanning: green LED which cyclically lights for a few seconds. In this mode the probe is searching for a receiving unit. At intervals of about 3 minutes for 3 seconds its carries out a scan of the frequencies. During the scan the green LED flashes quickly. Active-Connected: Green LED which flashes slowly. When the probe and the receiving unit establish a connection, the green 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. Active-Capturing: Green LED which lights and goes out at regular intervals. 26 BTS Bioengineering system components During acquisition the green LED flashes at regular intervals of approximately one second. At the conclusion of the acquisition, the probe returns to the Active-Connected condition. If during the acquisition, connection to the receiver unit is lost, 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. Probe discharged: LED is off. If the probe is completely discharged the LED does not display any flashing cycle and is off. The two lateral faces have two connectors; the one on the ID tag side serves to charge the probe, and a cable will be connected to this to enable connection to the Charger. The one on the other side is for the probe connections (FSW or EGN). Finally, the ID identifier of the probe is on the bottom left corner of the back side. On-off analysis (optional) The Footswitches are useful in defining the contact points during the contact phases of deambulation. BTS Bioengineering 27 system components The footswitches consist of a resistive membrane, (FSR technology), of diameter 18 mm and thickness less than 0.5 mm, expressly designed for applications in the analysis of movement. The compact size of the instrument permits a maximum of flexibility in positioning on the patients foot. For applications other than gait analysis, there are available on request smaller diameter (8 mm) switch probes (applicable, for example, to the finger), and square (useful for tapping tests), 44 mm x 44 mm. BTS FREEEMG 100 RT permits up to 8 basographic zones to be measured, through 2 connectors from 4 single switches (usually right and left side) that are connected to the two FSW/EGN wireless probes. The footswitch channels are not supplementary to the 6 electromyographic channels. Moreover it is not possible to acquire simultaneously FSW and EGN. Refer to receiving unit for the possible probes combination. 28 BTS Bioengineering system components Electrogoniometers (optional) The Electrogoniometer is an easy to use device that allows the measurement of joint angle progress over time. There are primarily two types of electrogoniometers: the potentiometer and the strain gauge. BTS FREEEMG 100 RT uses the strain gauge electrogoniometer of Biometrics LTD. There are single-axle models for the neck (axial rotation) and the forearm
(prone-supination) and biaxial models for other main joints: wrist, elbow, knee, ankle, hip and back. The strain gauge electrogoniometers are made up of two sensors, connected to each other, that are fixed to the bone segments involved in the joint to value. The measure of the angle is provided by the relative angle between the axes of the two sensors and, unlike the potentiometric electrogoniometers, it doesnt depend on the linear slidings in which the two extremities can incur. Each electrogoniometer is connected to a FSW/EGN wireless probe BTS Bioengineering 29 system components using the appropriate connector. Each receiving unit can handle up to 6 electrogoniometers. The EGN channels are not supplementary to the electromyographic ones, each EGN probe replace a EMG probe. Each EGN probe allows acquiring up to two angular components. Moreover it is not possible to acquire simultaneously FSW and EGN. Refer to receiving unit for the possible probes combinations. Charger The Charger, included with the product, charges the BTS FREEEMG 100 RT probes. The Charger can simultaneously charge up to 8 EMG probes and 2 FSW/
EGN probes. More units can be connected in series for simultaneous power supply through the same AC adapter, using the cable included. 30 BTS Bioengineering system components The EMG probes are connected to the charger using the same clips that normally collect the EMG signal. Refer to the cover of the charger to identify the correct polarity. The probes cannot be recharged if the polarities are inverted. The Charger comes with an output short circuit protection system also in case of reversed recharging poles. At any rate, poles connected incorrectly will not recharge. While the FSW/EGN probes connect to the charger using the special connector as shown in the figure below:
To recharge connect all the probes that you would like to charge to the Charger (follow the instructions described above) and connect the AC/
BTS Bioengineering 31 system components DC adaptor to the mains and turn on the switch located on the rear panel. When the Charger is properly connected to the mains and has been turned on, the status LED Power will show a steady GREEN light. The charging status of the EMG probes and of the FSW/EGN probes is indicated by the respective status LED (see Wireless EMG Probes and Wireless FSW/EGN 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. 32 BTS Bioengineering installation User PC minimum configuration Operating system Processor RAM Video resolution Disk space USB Windows 7 Intel Dual Core 2 GB 1280x800 100 MB for the application, not including storage for acquired data 2.0 Connections The wireless probes transmit in real-time the acquired data to the receiver connected via USB to the Workstation. Connect the receiver to the WS using the USB connector. If the morphology of the WS does not allow direct connection of the receiver, use the USB extension cable. Also verify that the probes are fully charged and ready for use:
Note that to be recognized and activated by the system it is necessary that all the probes have been disconnected from the Charger (if switched-on) and that the EMG probes have been also reactivated using a magnet. BTS Bioengineering 33 installation Hardware installation The first step of the hardware installation procedure consist in the USB receiver driver installation. To do that enter in the CD player of the workstation, the BTS CD software containing the installation files that contains the EmbEMG-
X.X.XX.X.zip file. Extract the .zip file in the local disk C and then perform a double click on the file CDM20814_Setup.exe and wait for the window that has just opened, to close. After have performed all the steps above, it will be necessary to configure the port for the USB receiver. To set the characteristics of the receiver the system requires the receiver to be connected to the PC via a USB port. Then, clicking the mouse right button on My Computer, select Properties, choose Hardware and then enter the Device Manager:
34 BTS Bioengineering 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:
BTS Bioengineering 35 installation In which you must select the TAB Port Settings. From this TAB 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. 36 BTS Bioengineering installation Also in the Port Settings window click on OK then close the windows remained still open. During the setting operations of the COM port, take note of the port number that the PC automatically associates to the device, because you will need it at the software first start. Description of the software on the user PC BTS EMG-Analyzer is the complete and highly flexible solution for making advanced elaborations of electromyographic signals and angular measurements of body segments. Includes predefined templates for evaluations in clinics, sports, and research and an editor to develop customized elaboration protocols. BTS Bioengineering 37 installation In the following paragraph we will refer to this software, however BTS FREEEMG 100 RT is manageable also by BTS MIOFEED software and all BTS applications of SMART family dedicated to the motion analysis. For more details concerning the use of BTS FREEEMG 100 RT with other software, please refer to its specific manual. Before to proceed verify that the software BTS EMG-Analyzer has been properly installed on the user PC (please refer to its manual for the installation procedure). BTS EMG-Analyzer configuration check Keeping the receiver still inserted in the USB port, launch BTS EMG-
Analyzer double-clicking on the relative icon. If the following windows appears:
Click on OK to reach the software main screen. On the menu bar at the voice Laboratory select Set Emg Device. The following windows will open:
38 BTS Bioengineering installation Verify that the check is on EMG embedded. Select the correct Port number acting on the drop box menu, according with the port number that the PC has automatically associated to the device during the COM port setting operations (see Hardware installation). If the port number selected is the correct one the software will activate the Sensors area of the windows and all the info about the sensors associated with the USB receiver connected to the workstation will be visualized. BTS Bioengineering 39 installation Verify that all the parameters values coincide with those reported on the supplied sensors that you want to use (see Wireless EMG probes and Wireless EGN/FSW probes). During the acquisition the system will acquire always all the sensors enable in this windows. Is possible to disable the sensors that you dont need for the acquisition. Click on Update before closing the window to save the new configuration. To enable a sensor click on the white square correspondent, the check mark will appear and then fill the fields Serial, Label Code and Label Color, according with the value reported on the probes (see Wireless EMG probes and Wireless EGN/FSW probes), and select a Type between EMG and AUX. Click on Update before closing the window to save the new configuration. 40 BTS Bioengineering acquisition protocol Now we will describe a basic procedure about how to create a new protocol using BTS EMG-Analyzer software. Refer to the EMG-Analyzer manual for further details about the Protocol builder function. The procedure may be different if performed with other applications. In this case, refer to the specific manual of the software you are using. Please note that with BTS FREEEMG 100 RT it is possible to acquire up to 6 probes. Refer to Receiving unit for the details about possible probe combinations. Launch the software EMG-Analyzer. Before to proceed we suggest you to make the procedure described in the Software configuration check to be sure to have selected the EMG embedded device and to have enabled all the probes required for the acquisition. To create a new protocol, from the menu voice Laboratory of BTS EMG-Analyzer, select Create Emg Protocol . BTS Bioengineering 41 acquisition protocol The window for the creation or modification of protocols will open. If the receiver is connected to the PC and correctly set, in the first column of the protocol table there will be reported the labels of the probes connected to the receiver, and the active protocol will be displayed. If the active protocol is not consistent with the set of probes connected to the receiver the following warning message will be displayed on the bottom part of the windows:
42 BTS Bioengineering acquisition protocol To proceed with the acquisitions it is necessary to have the probes set and the selected protocol compatible. To reach this condition it is possible:
- to select a line of the protocol and modify any fields to make it consistent with the probes set,
- to select an other protocol compatible with the probes set among the ones saved in the database and displayed in the Protocol folder area of this windows, and set it as Active protocol clicking on Set Active,
- coming back to the Set Emg Device windows and modify the probes set. To create a new protocol follow this procedure:
- click on New. The fields to be filled for the protocol creation will be enabled.
- select the anatomical map containing the muscle you want to add to the protocol and click on the little yellow square that identified it;
immediately the first free row available in the protocol table will be filled with the info related to the selected muscle.
- repeat this operation for all the muscles to be acquired.
- if you want to acquire Footswitches, first of all verify that there were no EGN already selected in the protocols, otherwise the protocol wont be valid and the software wont allow saving it. Select the District anatomical map and proceed click on the right and then on the left foot by selecting the corresponding square in the BTS Bioengineering 43 acquisition protocol anatomical map:
- If you want to acquire Electrogoniometers, first of all verify that there were no FSW already selected in the protocols, otherwise the protocol wont be valid and the software wont allow saving it. Check the first free line in the protocol table, click on the Type field and select EGN among the voices available in the drop box menu. In the same way, click on the Description field and select among the drop box menu voices the angles you want to acquire with the EGN, then on the Side field to select the body side to which the data refers.
- indicate a name for the protocol specifying it on the Name box.
-it is possible to insert also a short description of the protocol using the appropriate box Description. When every signal of the protocol has been inserted, proceed saving the 44 BTS Bioengineering acquisition protocol protocol, clicking on Save. If the protocol is compatible with the probes combination allowed by the system the protocol could be saved. If the Probes setup is compatible with the protocol the following windows will be displayed:
Clicking on Yes it will be set as Active protocol and will be used in the next acquisition session. Instead if the Probes setup is not compatible with the protocol the message displayed will be:
To proceed with the acquisition it is necessary make the probes set and Active protocol consistent. In both cases clicking on NO the protocol will be saved in the Protocol Folder and will be available in the future, but the Active protocol wont be modified. BTS Bioengineering 45 Wireless Probes Geometry:
Electrodes:
Separation:
Autonomy:
Battery:
Dimensions:
Weight:
Frequency used:
Input impedance:
CMMR:
Resolution:
Acquisition frequency:
Sensitivity:
Accuratezza di misura*:
Receiving Unit Connection:
Dimensions:
Weight:
appendix A technical specifications variable standard with clip connection min: 16mm - max: 66mm 8h of use some days stand-by some months deep sleep rechargeable, lithium ion 14x41,5x24,8mm mother electrode diameter 16x12mm satellite electrode 13g battery included ISM band 2.4GHz (standard IEEE802.15.4)
>10 GOhm
>110 dB @ 50-60Hz 16bit 1KHz 1V 2%
USB 82x44x22,5mm 80 gr BTS Bioengineering 47 appendix Frequency used:
ISM band 2.4GHz (standard IEEE802.15.4)
* The system is calibrated at the factory. No further calibration is required BTS internal coding Name of device, components, parts and/or accessories as per product label FREEEMG 100 RT USB receiving unit EMG wireless probes Identifier for device (bar code, catalogue, model or part number) FREEEMG 100 RT FSW/EGN wireless probe Foot switches: Insole individual foot switches for the automatic identification of the gait events. Electrogoniometers: Sensors for the measurement of joint angles progress over the time. EMG-Analyzer: software application for EMG signal analysis Charger FRESPU12 SMAN0901 FRESPU06 48 BTS Bioengineering appendix B environmental specifications Operating Temperature Operating Humidity Storage and Transport Temperature Storage and Transport Humidity Altitude Min
-20 50%
0 50%
Note Max
+45 80% Relative, non-condensing
+40 80% Relative, non-condensing 0m 2000m Degrees of protection provided by the dangerous enclosures of water and dust (IEC 60529): IPX0. BTS Bioengineering 49 appendix C power supply and switch off The receiving unit is powered by the USB port. To switch off the system the following operation must be done:
- Exit from the application software
- Unplug the receiving unit from the USB port.
- Put the probes in Deep Sleep Mode placing them on the Charger. 50 BTS Bioengineering appendix D battery BTS FREEEMG 100 RT probes are internally powered. The Probe battery replacement can be done only by BTS qualified personnel. The probes are sealed to avoid the access to the internal circuit components. Batteries are equipped with battery protection circuit to:
-over-voltage, threshold 4.3V
-under-voltage, threshold 2.8V
- short-circuits The specific characteristic of the Wireless probes equipped with the battery are:
Quantity:
Technology:
Removable:
1 per each EMG probe lithium polymer (Li-Poly) NO, BTS technical service is required BTS Bioengineering 51 appendix E troubleshooting guide Warning Invalid trigger mode During the hardware installation, the USB port dedicated to the receiver, is configured. May happen that these port settings went lost. This event may occur for example when another USB device is connected to the PC and the PC assigns to it the same port previously assigned to the receiver, returning the port setting to the default configuration. In these cases it may occur that by launching an acquisition the following warning message may appear:
In this case to proceed immediately with the acquisition, it is necessary to restart the application, however the same problem will recur in later acquisitions. To resolve this problem you must repeat the USB port configuration procedure described in the Hardware Installation paragraph of the Installation chapter. 52 BTS Bioengineering appendix E declartion of conformity DECLARATION OF CONFORMITY Italy Fax +39 049 792 9260 BTS SpA Via della Croce Rossa 11, 35129 Padova (PD) Tel. +39 049 981 5500 name / description:
model:
S/N:
FreeEMG 100 RT SN declare under our sole responsibility that the product(s):
Electromyographic system / device for recording myoelectrical activity. 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 The product conforms to the following standards:
Applied part type: BF EN ISO 14971 IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 Medical Devices - Application of risk management to medical devices. Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance. Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility -
Requirements and tests. Medical Electrical Equipment - Part 1-6: General Requirements for basic safety and essential performance - collateral Standard: Usability Medical device software - Software life-cycle processes EN 62304 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 products usage manual. Notified Body : TV Product Service GmbH, Zertifizierstelle, Ridierstrasse 65, 80339 Mnchen 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. BTS Bioengineering 53 appendix G regulatory notice FDA Medical Device Reporting SystemReportable Events Notice to Agents: for inclusion in all BTS systems supplied to the United States of America, the master Medical Device Reporting
(MDR) file is located at BTS S.p.A. Should an adverse event occur, the following form is to be completed and forwarded within one working day to BTS S.p.A. Department of Health & Human Services, US Food and Drug Administration Medical Device Reporting SystemReportable Events Code of Federal Regulations Title 21, Volume 8 Revised as of April 1, 2006 Cite: 21CFG803.32 Under 803.1(a) device user facilities and manufacturers must report deaths and serious injuries to which a device has or may have caused or contributed. Should such an event occur, please complete the following details and forward the document in accordance with the applicable regulations and time limits to one of the following addresses:
BTS S.p.A. via della Croce Rossa 11 35129 Padova PD - Italy tel +39 049 981 5500 fax +39 049 792 9260 54 BTS Bioengineering appendix Adverse Event Report (21 CFR 803.32) Use blank pages if required. Section A. Patient Information Patient confidentiality to be maintained unless authorized otherwise in writing by User Facility. Patient name or other identifier Age at the time of the event (Years, Months), or Date of birth (MM/DD/YYYY) Gender Weight Female Male lb kg Section B. Adverse Event or Product Problem Identification of adverse event or product problem
(check all that apply) Adverse Event Product Use Error Product Problem (e.g. defects/malfunctions) Problem with Different Manufacturer of Same System BTS Bioengineering 55 appendix Outcomes attributed to the adverse event
(check all that apply) Death:
(MM/DD/YYYY) Life-threatening injury or illness Hospitalizationinitial or prolonged Required intervention to prevent permanent impairment/ damage (Devices) Disability or permanent damage:
Congenital Anomaly/Birth Defect Other Serious (Important Medical Events) Date of Event Date of this report
(MM/DD/YYYY)
(MM/DD/YYYY) Describe event, problem or product use error
(include a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event) 56 BTS Bioengineering appendix Relevant tests/laboratory data, including dates Other relevant history, including preexisting medical conditions
(e.g. allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.) Section C. Device Information Brand Name Type of Device Manufacturer name and address Model #
Catalog #
Serial #
Lot #
Expiration Date Other #
(MM/DD/YYYY) BTS Bioengineering 57 appendix Operator of the device
(delete not applicable) Date of system installation Device available for evaluation?
(Do not send to FDA) health professional patient lay user other:
(specify)
(MM/DD/YYYY) yes no Returned to BTS S.p.A. or its agents on:
Concomitant medical products and therapy dates
(do not report products that were used to treat the event)
(MM/DD/YYYY) 58 BTS Bioengineering appendix Section D. Initial Reporter Information For the reporter who initially provided information to you, or to the manufacturer or distributor:
Name Address Telephone Number E-mail Address Health Professional?
Occupation (include speciality if appropriate) Initial reporter also sent a copy of report to FDA?
Yes No Yes No BTS Bioengineering 59 appendix Section E. User Facility Information Health Professional?
User Facility Importer User Facility Number User Facility Name User Facility Address Contact Person Phone Number Date User Facility became aware of event Type of Report Date of this Report Approximate age of system Event problem Codes (refer to MED-
WATCH Medical Device Reporting Code Instructions) Report sent to FDA?
Report sent to manufacturer?
60 BTS Bioengineering
(MM/DD/YYYY) Initial Follow-up #
(MM/DD/YYYY) Yes No Yes No
(MM/DD/YYYY)
(MM/DD/YYYY) appendix Location where event occurred Manufacturer Name/Address Hospital Home Nursing Home Outpatient Treatment Facility Outpatient Diagnostic Facility Ambulatory Surgical Facility other:
(specify) BTS Bioengineering 61 BTS Bioengineering Corp. 147 Prince Street - Suite 11 11201 Brooklyn NY USA info: +1 347 204 7027 helpdesk: +1 646 575 0426 www.btsbioengineering.com info@btsbioengineering.com BTS S.p.A. viale Forlanini 40 20024 Garbagnate M.se MI Italy tel +39 02 366 490 00 fax +39 02 366 490 24
1 | ERFNC-00782-16 FREEEMG 300 User Manual ENG v.4.0.3 | Users Manual | 4.73 MiB | September 08 2013 |
G M E E E R F S T B user manual english version 4.0.3 Document Number : ERFNC-00782-16 Published: June 2013 Copyright 2010 - 2013 BTS SpA. All Rights Reserved. BTS FREEEMG contents acquisition unit regulatory label EMG wireless probes regulatory label AUX wireless probes regulatory label BTS charger regulatory label BTS docking station regulatory label contents icons, symbols and acronyms radio regulation disposal (WEEE) intended use regulatory label warnings copyright introduction system components physical description acquisition unit PDA (Personal Digital Assistant) wireless EMG probes wireless FSW/EGN probes (optional) on-off analysis (optional) electrogoniometers (optional) charger general description case contents 1 5 9 10 11 12 12 12 13 14 14 15 18 19 19 20 24 24 25 27 29 33 34 35 36 BTS Bioengineering 1 BTS FREEEMG contents docking station (optional) installation acquisition protocol fitting the patient guide to the use of onboard software BTS FREEEMG 300 updating user PC minimum configuration installation of the Wi-Fi interface description of the software on the user PC switching on BTS FREEEMG 300 first connection connection check correct data visualization check initial screen Active button selecting the work mode description of the main bars and menu protocol probes setup digital oscilloscope (gane) digital oscilloscope (cross check) footswitches Local button: holter mode Remote button: lab mode Download button Config button Exit button updating the onboard software creating a backup image 38 43 43 43 45 45 47 48 50 52 57 60 60 60 64 65 68 69 72 75 77 78 91 95 97 106 107 107 108 2 BTS Bioengineering contents BTS FREEEMG maintenance and cleaning wireless probes receiving unit BTS internal coding appendix A technical specifications appendix B environmental specifications appendix C power supply and switch off appendix D battery appendix E declaration of conformity appendix F troubleshooting guide 1708 error - Incorrect IP address or port set up 1709 error - Impossibility to connect to the unit backup restoring receiving unit hardware reset 110 113 113 113 114 116 117 118 120 121 121 122 122 124 BTS Bioengineering 3 BTS FREEEMG icons, symbols and acronyms Symbol in the instructions for the function. The icon represents the information which requires special attention. Symbol in the instructions for the function. This icon makes reference to a more detailed discussion of the subject in hand. Symbol on the equipment:
The data appearing next to the manufacturers symbol refer to the place of manufacture of the equipment itself. Symbol on the equipment:
Attention, read the information in the users manual carefully before using the equipment. BTS Bioengineering 5 BTS FREEEMG icons, symbols and acronyms Symbol on the equipment and in the users instructions. Symbol for the separate disposal of electrical and electronic equipment, in accordance with Directive 2002/96/CE (WEEE). The equipment belongs to Group 8 (medical equipment). In force in the nations of the European Union, Norway and Switzerland. Symbol on the equipment:
The figure in the square indicates the insulation class and the part types used. In accordance with Standard ISO 60601-1, the equipment has an internal power supply and the parts used are type BF. REF Symbol on the equipment:
Symbol located next to the model number (ref. to catalogue). SN Symbol on the equipment:
Symbol located next to the series number on the equipment. 6 BTS Bioengineering icons, symbols and acronyms BTS FREEEMG Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies that the product conforms to the standards applicable in the member states of the European Union (see Declaration of Conformity). Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies that the product conforms to the Directive 99/05/EEC - R&TTE and obtained the Expert Opinion by IMQ. Symbol on the equipment:
The double square indicates that the product is a medical device of II Class (In accordance with the law EN 60601-1). Symbol on the equipment:
The FCC symbol refers to the Federal Communication Commission of the USA. The device complies with the relevant regulations put forth by the FCC as long as it is operated according to the instructions contained in this manual and to all national and local regulations. BTS Bioengineering 7 BTS FREEEMG icons, symbols and acronyms Symbol on the equipment:
The symbol indicates that U.S. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Acronyms used in this manual:
AP AU EMG FSW Access Point Acquisition Unit Electromyography Footswitch PDA RU SW Personal Digital Assistant Receiving Unit Workstation 8 BTS Bioengineering BTS FREEEMG radio regulation Radio equipment identification:
- EMG probes:
FCC ID: YQH-BTSWEMG2 IC: 9188A-BTSWEMG2
- FSWEGN probes:
FCC ID: YQH-BTSWAUX IC: 9188A-BTSWAUX
- Acquisition Unit contains:
FCC ID: TFB-MATRIXLP IC: 5969A-MATRIXLP This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by BTS SpA could void the users authority to operate the equipment under FCC rules. BTS Bioengineering 9 BTS FREEEMG disposal (WEEE) In disposing of the equipment observe the legal prescriptions. In accordance with Directive 2002/96/CE (WEEE) all equipment supplied after 13/08/2005 may not be disposed of in general domestic waste. This equipment belongs to Category 8 (medical equipment) and is classified in the Business-to-Business sector. The symbol of the crossed out rubbish bin indicates that the equipment must not be disposed of in normal domestic waste. The regulations for disposal may differ between individual countries in the EU. In cases of doubt, refer to the respective sales outlet. This is a battery-powered equipment. See Appendix D for information about the batteries used. Operate and dispose of this equipment according to the instructions set in the warnings section. 10 BTS Bioengineering BTS FREEEMG intended use This equipment is an instrument for the EMG surface analysis, classified as medical equipment in accordance with European Directive 93/42/CE
(and its amendments). The BTS FREEEMG 300 must always be used only for this purpose, by qualified persons, in an environment suitable for the execution of EMG analyses and respecting the prevailing regulations in the countries in which it is being utilized. U.S. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. BTS Bioengineering 11 BTS FREEEMG regulatory label Acquisition Unit Regulatory label EMG Wireless Probes Regulatory label Label on the probes:
Probe ID 12 BTS Bioengineering regulatory label BTS FREEEMG Label not on actual probes due to size constraints:
AUX Wireless Probes Regulatory label Label on the probes:
Probe ID Label not on actual probes due to size constraints:
BTS Bioengineering 13 BTS FREEEMG regulatory label BTS Charger Regulatory label 9V 3A 9V 3A 3A BTS Docking Station Regulatory label 14 BTS Bioengineering BTS FREEEMG warnings We recommend to carry out any kind of operation keeping strictly to the security regulations contained in this manual. The safety of the instrument cannot be guaranteed if these conditions are not respected. BTS FreeEMG 300 is a medical device (EU Directive 93/42/CE and its amendments, including Directive 2007/47/CE) which use must be at all times be supervised by qualified and authorized personnel, according to the laws in force in the nation it is in use. The EMG probes are classified as ETSI EN 300 440 Receiver category 3 according to Directive R&TTE 99/5/EEC. The results of the acquisitions must be assessed by people legally authorised by national law, who possess the suitable necessary knowledge of anatomy and muscular function. The 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). The uses of the device for other purposes and with methodologies different from of those indicated in this manual are not to be considered congruent with the precise use of the device. During the preparation of the patient, take particular care that the systems components do not impede in any way the normal movements of the subject. Apply the probes only on undamaged skin. BTS Bioengineering 15 BTS FREEEMG warnings 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. To not wet or dip in water the parts that make up the system. No modification of this equipment is allowed. Only BTS S.p.A. authorized technicians may maintain and operate servicing to the instrument. BTS S.p.A. cannot be held responsible for system safety should the instrument be opened, repairs carried out, third parties software be installed, or system components be replaced by persons other than those authorized by BTS S.p.A. Users cannot change any software configuration (including O.S. and CD writer software). In case the device accidentally falls, tear of the probes or other accidents always address authorized technical support. Use only the provided power supply unit FW7363M/09 (FRIWO) or the one provided by BTS S.p.A. for supplying docking station and charger unit. If a different power supply unit is used, the compliance to IEC 60601-1 is not ensured. Only original cables must be used, otherwise BTS S.p.A. cannot assure the safety of the instrument. Should it be necessary to replace any part of the system, only original BTS S.p.A. parts may be used. In addition to the users instructions, the prescriptions regarding accident prevention and regarding occupational safety must also be complied with. The appertaining national regulations and standards of the country of use, with regards prevention of accidents and environment, are an extension of the users instructions. regulations technical 16 BTS Bioengineering warnings BTS FREEEMG Make sure that the cables have been connected correctly. When disconnecting cables, use the connectors and not the cables themselves to unplug the connectors. Mains plug of external power supply unit is considered as disconnecting device. 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. For a safe use and adequate maintenance of rechargeable batteries strictly follow the instructions given in this manual. If rechargeable batteries are used in such a way that is not the one specified by BTS S.p.A. the shelf life, functionality and the integrity of the batteries is not ensured. ESD application to EGN probes, causes a loss of link to the device. Temporary loss of function or performance which is recoverable with operator action. BTS FREEEMG 300 is a device that is able to function COUNTINUOUSLY, this is of course limited by the battery duration and by the memory available for the acquisition data storing. The device uses lithium ion battery. For the battery replacement and disposal please contact the technical support. At any rate, ensure that device component (i.e.) probes, receiving unit, ) integrity is never compromised. The information contained in this manual is subject to change without notice and does not constitute product specifications or any obligation on the part of BTS S.p.A. BTS Bioengineering 17 BTS FREEEMG copyright The software of the system described in this manual is supplied with the licence to use contract. The software may be used or copied only as stipulated under the terms of this contract. No part of this manual may be copied or transmitted in any form or means, electronic or mechanical, including photocopying, without prior written permission from BTS S.p.A. Unless otherwise specified, any reference to companies, names, data and addresses used in the reproduction of the screens and the examples are purely incidental, and has the sole purpose of illustrating the use of the BTS product. All trademarks are registered by the respective owners. This publication contains reserved information which is the property of BTS S.p.A. The recipient acknowledges that the illustrations and information supplied in this manual shall not be made available to third parties without explicit written agreement by BTS S.p.A. 18 BTS Bioengineering BTS FREEEMG introduction General description BTS FREEEMG 300 is an indispensable instrument for laboratories which are concerned with the study of muscular activity in the fields of rehabilitation, sports medicine, ergonomics, clinical research, and assessment of functional ability and muscular fatigue. BTS FREEEMG 300 makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid. BTS FREEEMG 300 can be applied in research, sports, occupational medicine, gnatology, neurology, and orthopaedics. With the software tools available, BTS FREEEMG 300 becomes an advanced diagnostic tool to evaluate neurological and orthopaedic disorders, pharmacological therapy, progression of motor deficits, use of ortheses, rehabilitative follow-up, and to optimize sports training programmes,... BTS FREEEMG 300 is applied with EMG-Analyzer the most complete software solution for analyzing electromyographic signals. It includes predefined templates for evaluations in the clinical, sports, and research field: Jump, plyometrics, walking, fatigue analysis, isokinetic, etc... BTS EMG-Analyzer also has an editor for creating elaboration protocols:
BTS Bioengineering 19 BTS FREEEMG introduction thanks to an innovative object interface, that translates the biomechanical analysis language into graphical form, the user can develop quickly and effectively customized analysis protocols. BTS FREEEMG 300 seamlessly integrates with BTS motion analysis systems, through the SMART (and ELITE) dedicated software. Case contents Standard components:
Receiving Unit Acquisition Unit HP iPAQ hx4700 Pocket PC Belts for attachment to patient Stylus (located in the Pocket PC) Pocket PC Acquisition Unit Probes Kit up to 16 wireless probes (identificative labels available in 4 different colors) 20 BTS Bioengineering introduction BTS FREEEMG Probes Chargers:
up to 2 Charger units:
each charger handles up to 8 probes and 2 FSW/
EGN. The second unit is included in the standard kit only for FREEEMG with at least 12 probes, or available as an option. The optional Docking Station version is also available Accessories USB-PDA cable AC adapter Access Point Set of disposable electrodes BTS Bioengineering 21 BTS FREEEMG introduction Manuals BTS FREEEMG 300 user manual complete of CD Optional components:
Footswitch Kit 2 FSW/EGN Wireless Probes 2 Connectors of 4 Switches 10 single Switches Fine-Wire Adaptor Fine-Wire Kit Electrogoniometer Kit fixing set for Fine-Wire adaptor set of disposal Fine-Wire electrodes with applicator 22 BTS Bioengineering introduction BTS FREEEMG 1 FSW/EGN Wireless Probe 1 Electrogoniometer 1 Connector Supplementary Receiving Unit Secure Digital You will receive the instructions for use for other possible op-
tional components not mentioned in this manual. BTS Bioengineering 23 BTS FREEEMG system components BTS FREEEMG 300 electromyograph consists of a receiving unit which utilizes a PocketPC platform and wireless probes designed and developed by BTS SpA. Physical description power button (on/off) 1 Compact Flash (CF) slot type II 2 Secure Digital (SD) slot 3 stylus pen 4 1 2 activesync connector battery door lock (in lock position to switch on BTS FREEEMG 300) 1 22 4 3 5 6 1 4 2 3 1 2 1 2 3 4 5 6 LED - WIFI (solid blue = WiFi Active) LED - charging and notification indicators
(blinking amber = charging; solid amber = full charge) VGA color display antenna service slot grip wireless probes 24 BTS Bioengineering system components BTS FREEEMG Acquisition unit The acquisition unit consists of:
a digital card a receiver card a plastic casing a guide for the PDA insertion. The digital card is connected to the palmtop, via the Compact Flash port, when this is made to slide in the proper guide. When the acquisition unit is connected to the palmtop, the card communicates, describing itself to the driver in operation and thereby allowing the system to self-configure and to carry out a self-diagnosis. In addition to serving as a Compact Flash interface the card allows control BTS Bioengineering 25 BTS FREEEMG system components of the receiver card and handles acquisition of data coming from the probes. The receiver card is comprised of 4 elements that act as coordinators of the wireless connection network with the probes, thus managing communications with the probes, both for activation and data acquisition. The acquisition unit is able to handle:
up to 16 probes, used for acquisition of the activity of the same number of electromyographic signals up to 2 probes of 4 auxiliary channels for switch connection, used for the basographic acquisition as an alternative to the EMG channels it is possible to acquire up to 8 electrogoniometers (each EGN occupies 2 analogue channels). In particular, the following probe combinations are possible:
EGN EMG FSW 0 1-2 3-4 5-6 7-8 up to 16 probes up to 12 probes up to 8 probes up to 4 probes 0 2 probes of 4 switches 2 probes of 4 switches 2 probes of 4 switches 1 probe of 4 switches 0 26 BTS Bioengineering system components BTS FREEEMG PDA (Personal Digital Assistant) HP iPAQ hx4700 Pocket PC is based on Microsoft Windows. It uses the Intel PXA270 processor and the new transflective display VGATFT, 4 with 64k colors, to provide exceptional graphics power and performance to display large dimension images at highest quality resolution. HP hx4700 is fitted with excellent expansion capacity (Compact Flash Type II and SD slot) to provide more storage space and greater function range. 64 MB of SDRAM and 128 MB of ROM memory allow a greater number of programmes and files to be stored, while the 1800 mAh lithium ion battery ensures longer uninterrupted use of the Pocket PC. BTS Bioengineering 27 BTS FREEEMG system components For further details please refer to the HP iPAQ hx4700 Pocket PC Manual included. 28 BTS Bioengineering system components BTS FREEEMG Wireless EMG Probes BTS FREEEMG 300 utilizes miniaturized probes with active electrodes weighing less than 13 grams. The special design ensures maximum space-
saving and comfort for the patient who is free to move around without obstacles. The probes can be hooked on directly to the pre-gelled electrodes without requiring additional fixing with plasters or double-sided tape. This together with the total absence of cables enables a much faster patient preparation, drastically reducing the time of each session. Each receiving unit can control up to 16 probes, for a total therefore of 16 analysable muscles in a single exam (standard configuration with one receiving unit). 6 1 22 3 5 1 2 3 4 5 6 7 mother electrode LED satellite electrode mother electrode clip satellite electrode clip flexible cable probe ID 4 7 5 Each probe consists of a mother electrode and a satellite electrode, each fitted with a clip. The two parts, connected via a flexible cable, may be positioned as needed by the user at adjustable distance (electrodes with variable geometry). In the mother electrode there are the A/D converter, the antenna and the battery. In the satellite electrode there is the Signal Conditioning
(preamplifier and filter) and is reported the probe ID. All probes are also equipped with a solid state memory buffer, to prevent data loss for problems due to the Wi-Fi network or due to exceeding the useful operating range. BTS Bioengineering 29 BTS FREEEMG system components Each probe is fitted with an LED indicating its state. The probes can be in one of a number of different states:
Charge: steady blue LED. During the recharging phase the steady blue LED is on. This phase occurs when the probes are connected to the charger turned on, and the charge level is less than 90%. When the charge level reaches 90% the led turns OFF. Since, by connecting a probe to the charger on, it enters in Deep Sleep mode, even while charging, the probe will be completely passive and does not respond to any commands. Inactive: white LED which cyclically lights with a steady light for a few seconds every 3 minutes. In the Inactive mode the probes cannot be used directly by the patient unit but are in constant standby to be activated by the activation software. When the probe is inactive, it carries out a scan of the radio frequencies: during the scan the white LED is lit continuously. Active-Scanning: white LED which cyclically lights for a few seconds. In this mode the probe is searching for the receiving unit on the channel assigned during the activation phase. At intervals of about 1 minutes it carries out a scan of the frequencies of few seconds. During the scan the white LED flashes quickly. Active-Connected: white LED which flashes slowly. When the probe and the receiving unit establish a connection, the white LED begins to pulse slowly: the probe is waiting for 30 BTS Bioengineering system components BTS FREEEMG commands. If the connection is interrupted, the probe returns to Active-Scanning mode and attempts to re-establish the connection. Active-Capturing: white LED which lights and goes out at regular intervals. During acquisition the white LED flashes at regular intervals of approximately one second. At the conclusion of the acquisition, the probe returns to the Active-Connected condition. If during the acquisition, connection to the receiver unit is lost, the probe continues to acquire, storing the data locally for one minute and at the same time scans the assigned channel trying to reconnect to the receiving unit. If after one minute the scan is unsuccessful, the probe returns to the Active-Scanning condition interrupting the storage of data. Completely discharged or in Deep Sleep mode: LED is off. If the probe is completely discharged the LED does not display any flashing cycle and is off. The same happens when it is in Deep Sleep mode (except during the recharging phase in witch the led is steady blue). The probes in Deep Sleep mode do not perform any scan cycle, but are turned off. Is therefore guaranteed energy savings. To put the probe in Deep Sleep mode it is necessary to connect them to the Charger switched on, or to put them in contact with a magnet for half a second. BTS Bioengineering 31 BTS FREEEMG system components Before the next use is necessary to reactivate the probes, putting them in contact with a magnet. After this operation they will pass to Inactive mode. The probes are charged by a dedicated charger to which the probes are connected via their respective clips. When the probes are in charge and the charger is turned on, they are in Deep Sleep mode and all the LEDs are off. it is necessary to reactivate the probes, prior to use them, using a magnet. The EMG probes can be used also to acquire the EMG signal by means of Fine-Wire electrodes. With this aim, there are available, in option, adaptors allowing for the connection with Fine-Wire electrodes. The EMG probes can be connected to them using the clips. Each adaptor can be fixed to the subject by means of proper elastics. For these applications the acquisition frequency must be set on 4 KHz (the guidelines recommend for Fine-Wire electrodes an acquisition frequency major or equal to 2 KHz). 32 BTS Bioengineering system components BTS FREEEMG Wireless FSW/EGN Probes (optional) For collecting the on-off analysis signals coming from the Footswitch or for collecting data from the Electrogoniometers (optional system components) BTS FREEEMG 300 uses wireless probes which must be connected to the FSW or EGN probes using a special connector. The probe will work differently if used with one or the other probe and will receive from the same receiving unit information on its work modality during activation. The probe consists of a single parallelepiped-shaped block. The upper face has an ID tag characterized by a color (Green, Red, Yellow, Blue) and a letter (A, B, C, D, E or F) and a status LED which operates similar to that described for the EMG probes (see previous paragraph). The two lateral faces have two connectors; the one on the ID tag side serves to charge the probe, and a cable will be connected to this to enable connection to the charger (Charger or Docking Station). The one on the other side is for the probe connections (FSW or EGN). Finally, the ID identifier of the probe is on the bottom left corner of the back side. BTS Bioengineering 33 BTS FREEEMG system components On-off analysis (optional) The footswitches are useful in defining the contact points during the contact phases of deambulation. The footswitches consist of a resistive membrane, (FSR technology), of diameter 18 mm and thickness less than 0.5 mm, expressly designed for applications in the analysis of movement. The compact size of the instrument permits a maximum of flexibility in positioning on the patients foot. For applications other than gait analysis, there are available on request smaller diameter (8 mm) switch probes (appliable, for example, to the finger), and square (useful for tapping tests), 44 mm x 44 mm. BTS FREEEMG 300 permits up to 8 basographic zones to be measured, through 2 connectors from 4 single switches (usually right and left side) that are connected to the two FSW/EGN wireless probes. footswitch channels are The electromyographic channels. supplementary to the 16 Refer to Acquisition unit for the list of probe combinations possible in case of acquisition also with EGN. 34 BTS Bioengineering system components BTS FREEEMG Electrogoniometers (optional) The electrogoniometer is an easy to use device that allows the measurement of joint angle progress over time. There are primarily two types of electrogoniometers: the potentiometer and the strain gauge. BTS FREEEMG 300 uses the strain gauge electrogoniometer of Biometrics LTD. There are single-axle models for the neck (axial rotation) and the forearm
(prone-supination) and biaxial models for other main joints: wrist, elbow, knee, ankle, hip and back. The strain gauge electrogoniometers are made up of two sensors, connected to each other, that are fixed to the bone segments involved in the joint to value. The measure of the angle is provided by the relative angle between the axes of the two sensors and, unlike the potentiometric electrogoniometers, it doesnt depend on the linear slidings in which the two extremities can incur. Each electrogoniometer is connected to a FSW/EGN wireless probe using the appropriate connector. Each receiving unit can handle up to 8 electrogoniometers. BTS Bioengineering 35 BTS FREEEMG system components The electrogoniometer channels are not supplementary to the 16 electromyographic channels, but each electrogoniometer used engages 2 EMG channels. Refer to Acquisition unit for the detailed list of probe combinations possible. Charger The Charger, included with the product, charges the FREEEMG probes. The Charger can simultaneously charge 8 EMG probes and 2 FSW/EGN probes. Two units are provided for systems with more than 12 probes. More units can be connected in series for simultaneous power supply through the same AC adapter, using the cable included. The EMG probes are connected to the charger using the same clips that normally collect the EMG signal, while the FSW/EGN probes connect to the charger using the special connector as shown in the figure below:
36 BTS Bioengineering system components BTS FREEEMG For correct connection simply follow the outline of the probes shown on the base of the Charger:
The Charger comes with an output short circuit protection system also in case of reversed recharging poles. At any rate, poles connected incorrectly will not recharge. To recharge connect all the probes that you would like to charge to the Charger (follow the instructions described above) and connect the AC/
DC adaptor to the mains and turn on the switch located on the rear panel. When the Charger is properly connected to the mains and has been turned on, the status LED Power will show a steady GREEN light. The charging status of the EMG probes and of the FSW/EGN probes is indicated by the respective status LED (see Wireless EMG Probes and Wireless FSW/EGN Probes). BTS Bioengineering 37 BTS FREEEMG system components Note that inserting the EMG probes into the Charger when it is on, these come in Deep Sleep mode. It is necessary to reactivate these probes, prior to use them, using a magnet. After this operation they will pass to Inactive mode. While, connecting the FSW/EGN probes to the Charger (connected to the mains and turned on) if they are charged less than 90% they will be automatically reset and will pass to the Inactive mode. To proceed with another acquisitions it is necessary to repeat the activation procedure. Docking Station (optional) As in alternative to the Charger an optional Docking Station is available. This unit has additional features that are described below. Each Docking Station can simultaneously charge 8 EMG probes and 2 FSW/EGN probes. Unlike the standard Charger, each Docking Station will have to be powered separately; therefore two units cannot be connected in series for contemporary power supply. 38 BTS Bioengineering system components BTS FREEEMG The EMG probes are connected to the charger using the clips for collecting the electromyographic signal, while the FSW/EGN probes connect to the charger using the special connector. For correct positioning simply follow the outline shown on the base of the Docking Station as shown in the following figure:
The Docking Station comes with an output short circuit protection system also in case of reversed recharging poles. At any rate, poles connected incorrectly will not recharge. The Docking Station also allows for recharging the receiving unit by connecting it with the relevant cable (USB/PDA cable) in the USB port located on the rear panel. It should be noted that you can use the Docking Station to recharge the PDA only when by pressing the power button the palmtop turns on. Otherwise you will need to recharge the PDA with the supplied HP by connecting it to the network. In order to go back and recharge using the Docking Station, simply charge with the power supply unit for about one minute, and then check that it is BTS Bioengineering 39 BTS FREEEMG system components sufficiently charged by unplugging it from the power supply unit and turning it off and then back on. There are two ways to recharge the probes:
using the medical power supply unit from the network using the internal battery The first method involves the connection of the Docking Station by means of the AC/DC adaptor to the mains. In this case not only the connected probes will be charged but also the internal battery of the unit itself. The second method lets you recharge the probes and/or the receiving unit when you are not at the laboratory and a mains power network is unavailable. In particular with the battery fully charged you can fully recharge all the probes and receiving unit or fully charge the probes only twice. To recharge a probe simply connect it as described in the method above. Connection to the Docking Station resets the probe if charged less than 90%, to use it again for acquisitions you must repeat the activation procedure. The Docking System is equipped with an Activate button and 3 status LEDs: Charge, Battery and Power. 40 BTS Bioengineering system components BTS FREEEMG The Activate button allows immediate activation of the FSW/EGN probes connected to the Docking Station and selected to activate in the receiving unit (see Active Button); you do not need to wait for the software cycle of the inactive state probe to be complete. By pressing the button the FSW/EGN probe will immediately scan the radio frequencies and enter immediately in communication with the receiving unit. The Charge LED gives information on the probes charging and consists of a BLUE light which signals the following:
BLUE LED breathing: indicates that the probes are charging. Two situations can be verified in this case:
Status LED of the probe on: The probe is charged less than 90%
Status LED of the probe off: The probe is more than 90% charged but still not complete. It is important to remember that the LED of the probe stays on until it is 90% charged. This function allows you to have an indication on the full charge of the probe, therefore increasing the autonomy of the probe by about 10%. BLUE LED off: indicates that all probes are fully recharged. BLUE LED fix on: indicates that the activate button has been pressed. In this case the probes are not powered by the Docking Station but by the probes battery. The Battery LED is an indicator of the state of the auxiliary battery and consists of a two-tone RED- GREEN LED, whose signals have the BTS Bioengineering 41 BTS FREEEMG system components following significance:
LED off (both the RED light and the GREEN light are off): in this case the battery is in sleep mode or has been removed from the Docking Station GREEN light of LED on: the auxiliary battery is charging. Steady RED light of LED on: the auxiliary battery is fully charged. Blinking RED light of LED on: indicates battery malfunction or a battery charging problem. The Power LED is on (GREEN light) when the switch located on the rear panel of the Docking Station is ON and it is connected to the mains or, if this is not the case, the auxiliary battery is sufficiently charged. The Docking Station has a lid, which opens automatically by means of a spring- brake mechanism, which works by pressing close to the word Push, located on the left shoulder of the unit. The probes should be put back in the Docking Station when not in use for acquisition sessions. Moreover, if left for a long period, we recommend turning of the unit by moving the switch located on the rear panel of the Docking Station to OFF. Close the lid for better protection of the probes. 42 BTS Bioengineering BTS FREEEMG installation User PC minimum configuration Operating system Processor RAM Video card Disk space USB Windows XP Microsoft.NET framework 1.1 P IV 1600 MHz 256 MB 32 MB, Open GL 100 MB for the application, not including storage for acquired data 2.0 Installation of the Wi-Fi Interface The real time data transmission between the BTS FREEEMG 300 and the Workstation occurs thanks to the Wi-Fi network. This type of connection is permitted using an Access Point supplied with the system. An AP is an Ethernet device which works with devices present in a small area. The AP, starting point of the service, operates from bridges between the wireless devices and the systems physically connected to the network with an RJ45 connector. The AP transmits the signals to the surrounding area via radio waves. All the wireless devices within the area can receive signals and communicate with the AP, and through them, with all the other devices, creating a network without cables. BTS Bioengineering 43 BTS FREEEMG installation Connecting a Workstation (PC laptop or desktop), not provided with a Wi-Fi interface, to Access Point with a normal network cable is created through the wireless connection with BTS FREEEMG 300. Receiving Unit Wireless Probes Access Point Workstation The access point included in the system is already configured with the network name (SSID) BTSFREEEMG300 with transmission on channel 6. The base configuration prepared in BTS (factory settings) uses the following IP addresses:
Access Point 192.168.1.1 BTS FREEEMG 300 192.168.1.2 Workstation assigned automatically by the Access Point You should always use the AP included even if the Workstation is equipped with a Wi-Fi interface. 44 BTS Bioengineering installation BTS FREEEMG Description of the software on the user PC BTS EMG-Analyzer is the complete and highly flexible solution for making advanced elaborations of electromyographic signals and angular measurements of body segments. Includes predefined templates for evaluations in clinics, sports, and research and an editor to develop customized elaboration protocols. For more details concerning the use of this software, please refer to its specific manual. However BTS FREEEMG 300 is manageable by all BTS applications of SMART family dedicated to the motion analysis with which is possible to acquire and process the electromyography signals in a integrate and synchronous way with the other devices connected. The SMART-Analyzer software allows to perform advanced elaborations of the EMG signals, integrating the electromyography information with the cinematic and kinetic data. It is possible to construct customized analysis protocols complete of advanced multimedial report. Switching on BTS FREEEMG 300 The patients unit consists of two main components: the PDA and the Acquisition Unit and is usually given with the two parts already connected. Anyway, to connect the Acquisition Unit to the palmtop, run the PDA along the AU guides, being particularly careful that the CF enters the BTS Bioengineering 45 BTS FREEEMG installation appropriate slot without being forced or receives any sudden impact, and avoid any excessive pressure on the palmtop screen. To avoid damaging the Compact Flash we suggest only to remove the PDA from the AU only if necessary and in any case, even if expressly requested, it is suggested not to move it completely from its place, but to let it slip just enough to disconnect it from the digital card (more or less 1 cm) event that will be signalled by an audio beep. The recharge of the battery and the transfer of data with the USB can also be done through the specific cable, without disconnecting the AU or the PDA. It is also advisable to perform a connecting/separating operation of these parts only when the device is turned off. Check the connection between PDA and AU. Switch on the BTS FREEEMG 300: check that the slot switch, located on the side of the BTS FREEEMG 300 shown in the diagram, is in the position closest to the closed lock symbol. If not, move it to this position. 46 BTS Bioengineering installation BTS FREEEMG Switch on by actuating the button on the opposite side of the BTS FREEEMG 300, as shown here:
At this point wait until the application BTS FREEEMG 300 is completely charged. On the BTS FREEEMG 300 display the following screen will be visualized:
First Connection The BTS FREEEMG 300 is supplied with the onboard PDA software preinstalled and configured. In any case for the first connection we suggest to perform some verifications. BTS Bioengineering 47 BTS FREEEMG installation Connection check The user PC communicates with the BTS FREEEMG 300 by means of Wi-Fi protocol through the Access Point (see Installation of the Wi-Fi Interface). Verify that the local net resources are laid out, like assumed in the configuration of default according to BTS, the PC user IP address must assigned automatically by the Access Point. Verify the software configuration installed on the PC. To do so, launch the program that you want to configure, i.e. EMG-
Analyzer, and on the menu bar at the voice Laboratory select Select Emg Device and verify that the check is on the voice FREEEMG. Then, again from the menu bar at the voice Laboratory, select Set Emg Device and verify that the check is on EMG device:
48 BTS Bioengineering installation BTS FREEEMG Verify that the IP address and the port are set with the following connection parameters:
IP Address:
Port:
192.168.1.2 8000 Moreover, if there is a second BTS FREEEMG 300 receiving unit available
(mind that in this case it is possible to manage up to 8 channels with each unit), select the option Activate Second Unit (only for BTS FREEEMG) and check that the IP address and the port for the second device are set up with the following connection parameters:
IP Address:
Port:
192.168.1.3 9000 If the values do not correspond change them and click on Update before closing the window. Switch-on the BTS FREEEMG 300 (see switching on BTS FREEEMG 300), wait until the application of the acquisition management is completely loaded and select the remote application clicking on Remote. If the Wi-Fi connection between the Receiving Unit and the Workstation is assigned in the correct way, after clicking on the Remote button, the connection led of the Wi-Fi net, that you can find on the front of the BTS FREEEMG 300 and that presents the Wi-Fi logo ( ), will result on
(solid blue). BTS Bioengineering 49 BTS FREEEMG installation During the start-up of the Remote mode different wireless nets can be found present in the working area. Always use the BTSFREEEMG 300 net ignoring the other nets. From the Workstation launch the BTS EMG-Analyzer application. Wait until, in the application being used, the respective LED indicating the state of the Wi-Fi connection between the receiving unit and the workstation changes from red to flashing green. Correct data visualization check During the initial connection, check the correct operation of the probes in use, and the correct display of data on the BTS FREEEMG 300. To do this, activate all the EMG probes and, if the system is also provided with footswitches, two FSW/EGN probes, enabled as FSW, to be tested all previously charged, as indicated in Active Button. When all the probes are shown to be active on the display, select the Remote mode by clicking on the Remote button. Select the default protocol and then Setup Probes from the menu and wait for all the activated probes to be acknowledged (the respective box must be green). To verify the correct functioning of the EMG probes, position a pair of electrodes (see Fitting the Patient) and connect Probe 1. Next, select Gains from the menu and check the progress of the EMG1 signal. Repeat the procedure connecting the other probes one at a time. After checking the electromyograph channels, if the system is also 50 BTS Bioengineering installation BTS FREEEMG provided with footswitches, attach the connectors with the 4 switches already inserted to the 2 corresponding FSW/EGN probes. After selecting from the menu the item Footswitch (as shown later in Guide to using the software on the BTS FREEEMG 300), check each contact is functioning correctly by pressing firmly each switch and observing the corresponding red LED light on the display of the BTS FREEEMG 300
(see Footswitch). If your system has one or more electrogoniometers, repeat the probe activation procedures deactivating all the EMG probes and enabling as EGN a number of FSW/EGN probes equal to the number of electrogoniometers included (maximum 8), refer to Active Button. When all the probes required are active go back to Remote mode by clicking on the Remote button. From the Workstation prepare an acquisition protocol that entails the use of a number of EGN equal to those provided with your system and transfer it on the receiving unit (see Create a new protocol). Selection the newly transferred protocol, select Probes setup on the menu and assign each channel to an EGN probe, checking that they are all recognized (the respective box must be green)
(see Probes Setup). Finally, connect each electrogoniometer to a connector and then to a FSW/EGN probe. Select Gains from the menu and check the related signal to the EGN channel that is testing. Repeat the procedure for each electrogoniometer provided. BTS Bioengineering 51 BTS FREEEMG acquisition protocol Now we will describe a basic procedure about how to create a new protocol using BTS EMG-Analyzer software. Refer to the EMG-Analyzer manual for further details about the Protocol Builder function. The procedure may be different if performed with other applications. In this case, refer to the specific manual of the software you are using. Please note that with BTS FREEEMG 300 it is possible to acquire:
- up to 16 analog channels: electromyographic signals - EMG (each EMG employs 1 analog channel), up to 16 electrogoniometer signals - EGN (each EGN employs 2 analog channels)
- 8 on-off analysis areas - FSW. Refer to Acquisition unit for the detailed list of possible probe combinations. Launch the software EMG-Analyzer and wait for the led of communication with the receiving unit to be green. Put BTS FREEEMG 300 in Lab Modality by clicking from the main page on the Remote button; if two receiving units are being used, make sure that both of them have the Remove Mode activated. 52 BTS Bioengineering acquisition protocol BTS FREEEMG To create a new protocol, from the menu voice Laboratory of EMG-
Analyzer, select Create Emg Protocol . A window will open, which allows to create or modify protocols. To create a new protocol follow this procedure:
- Click on New. The fields to be filled for the protocol creation will be enabled:
BTS Bioengineering 53 BTS FREEEMG acquisition protocol
-select the anatomical map containing the muscle you want to add to the protocol and click on the little yellow square that identified it; immediately the first free row available in the protocol table will be filled with the info related to the selected muscle.
- repeat this operation for all the muscles to be acquired.
-If you want to acquire Footswitches, select the District anatomical map and proceed insert the 8 contact point in the protocol by selecting the corresponding square in the anatomical map:
-Finally, if you want to acquire electrogoniometers check the first free line in the protocol table, click on the Type field and select EGN among the voices available in the drop box menu:
54 BTS Bioengineering acquisition protocol BTS FREEEMG In the same way, click on the Description field and select among the drop box menu voices the angle you want to acquire with the EGN, then on the Side field to select the body side to which the data refers.
- indicate a name for the protocol specifying it on the Name box
-it is possible to insert also a short description of the protocol using the appropriate box Description When every signal of the protocol is inserted, proceed saving the protocol, following these instructions:
- make sure that the BTS FREEEMG 300 is in the Lab Modality
- click on Save and Transfer: the protocol will be both saved on the PC and transferred on to the BTS FREEEMG 300. If two receiving units are being used, it is necessary to wait for the protocol to be transferred to both units. At the end of the transfer, the protocol will be visible in both, but in each unit will be displayed only the respective signals from the channels they are BTS Bioengineering 55 BTS FREEEMG acquisition protocol connected to. Note that If you are working with two receiving units the first 8 channels and the FSW will always be assigned to the first unit, while the other, starting from the 9Th to the 16th, will be loaded on the second unit. For example, if a protocol with 10 EMG channels and the footswitches has been created, the protocol on the first unit will register 8 EMG channels and the FSWs, while the protocol on the second unit will register only 2 EMG channels. 56 BTS Bioengineering acquisition protocol BTS FREEEMG fitting the patient Here some guidelines to follow for a correct application of the probes. Carefully prepare the skin of the subject in the area of the muscle in which the pre-gelled electrodes will be positioned. Note that the condition of the skin where the electrodes are applied influences the quality of the acquired signal. Therefore you should pay careful attention to this phase in preparing the subject. Attach the probes, previously activated (see Active Button), to the electrodes using the appropriate clips. Find the position in which to place the electrode on each muscle that you want to analyze and apply the probe in the direction of muscle fibers through the pre-gelled already applied to the probe, trying to keep the two electrodes as close as possible (tangent to each other). Thanks to the special hardware architecture of the probes and the much reduced weight, normally no extra fixing is required. If the analysis protocol being used requires it, proceed to the positioning of the footswitches to the respective contact areas. When FSWs are used, these are fixed to the skin of the subject used tape BTS Bioengineering 57 BTS FREEEMG acquisition protocol or hyper-allergenic bi-adhesive tape. Never apply the tape on the black membrane of the sensor, removing the tape could cause the detachment of the membrane making the switch unusable. After positioning the sensors, connect them by means of the appropriate connector to the corresponding preactivated probe. Finally, attach the probe and the switch box with the hypo-allergenic adhesive tape close to the same switches (i.e. close to the ankle when the sensor have been placed on the foot sole) at all times taking care to leave the patient the greatest degree of freedom of movement. Finally, If the analysis protocol being used requires it, proceed to the positioning of the Electrogoniometers. Each EGN should be positioned straddling the joint with the two stiff ends positioned on the sagittal plane, parallel to the axes of the two body segments that make up the joint under investigation, securing them to the patients skin using the plaster or hypoallergenic double-sided tape. After positioning the sensors, connect them by means of the appropriate connector to the corresponding preactivated probe. 58 BTS Bioengineering acquisition protocol BTS FREEEMG Finally, attach the probe and the switch box with the hypo-allergenic adhesive tape close to the sensor on the side where the connection cable comes out. Throughout the dressing procedure of the patient or at the end of it you can use the receiving unit to check, using the oscilloscope of the Gains function of the RU, the correct placement of the electrodes and control that the acquisition gain of the EMG channels is properly set. Its possible also to compare two channels at a time using the Cross check function (see Guide to the use of the onboard software). After making all the checks, it is possible to proceed with the acquisition session. BTS Bioengineering 59 BTS FREEEMG guide to the use of onboard software Initial screen At the start-up of the BTS FREEEMG 300 you see the initial screen comprised of six buttons: Local, Remote, Download, Config, Activate and Exit. In the lower right hand corner of the main screen there is the version num-
ber of the software installed on board. Active button The Active button allows only those probes to be activated which are to be used during the acquisition and to assign each of these to a specific channel. Click on this button to call up the following display:
60 BTS Bioengineering guide to the use of onboard software BTS FREEEMG The probes are divided by type: EMG, up to 16 probes for collecting electromyographic signals, FSW, up to 8 probes for collecting basographic signals (up to 2 can be selected at the same time), and EGN, up to 8 probes for collecting signals from the electrogoniometers. A number (or letter) and the color corresponding to the ID tag of the probe is shown next to each probe. By clicking on Options and then Show probe ID you can pass from viewing by label to that for viewing by ProbeID identification code, the code shown on the clip of each probe and vice versa:
BTS Bioengineering 61 BTS FREEEMG guide to the use of onboard software To activate, select the probe that you would like to use for the acquisition by enabling the check mark in the appropriate box:
It is important to remember that only certain probe configurations can be activated (for the detailed list of possible configurations, see acquisition unit). This procedure will be guided by the software disabling, upon reaching a configuration limit, all the checkboxes that can no longer be selected, furthermore, in the notification area at the bottom, any time the maximum configuration for a type of probe
(EMG, EGN, or FSW) is reached, a warning message will appear as shown in the following figure:
62 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Before proceeding to activation, connect the probes to the Charger (or to the Docking Station) included, use two units if required. This operation resets the probes, deactivating any probes already active, except for those probes that are more than 90% charged (in case of Charger to reset these probes you must wait for the battery level to below the threshold of 90%). It is advisable to connect all the probes and not just those used during acquisition to ensure that you reset any previously activated probes, which will not be used. An already active probe can be reused and does not require reactivation. In this case it must be selected in the activation program, but do not connect it to the Charger or Docking Station so it doesnt reset. It is in any case necessary that the probes are sufficiently charged for the activation to succeed. Click Start to initiate the probe activation procedure. Now we would like to distinguish between operations to perform based on if you use the Charger or Docking Station:
- Charger procedures:
The probes will be activated only when removed from the Charger. Remove the probes, therefore, from the charger, and wait for the BTS FREEEMG 300 to activate all the selected probes. BTS Bioengineering 63 BTS FREEEMG guide to the use of onboard software To facilitate the activation and to verify that all the required probes are active, we suggest detaching the probes from the charger one at a time.
- Docking Station procedures:
Click on the Docking Station Activate button. Immediately all the probes selected in the activation probe will be automatically activated and all the other probes will be reset, regardless of the charge level. When a probe has been recognized and activated, it will be highlight by a green rectangle, as shown in the following figure:
When all the selected EMG, EGN and FSW probes are indicated as activated, click Stop to terminate the activation procedure. Finally, click Exit to return to the initial screen. Selecting the work mode The first two buttons (Red and Yellow) allows the user to select the desired 64 BTS Bioengineering guide to the use of onboard software BTS FREEEMG working mode: button Local Holter mode, button Remote Lab mode. Local Acquisition
(Holter Mode) Remote Acquisition
(Lab Mode) Clicking on the button for the desired mode, you can enter the software of relative management. In particular by clicking on the Local and Remote buttons you will see the following screens:
Description of the main bars and menu All of the BTS FREEEMG 300 pages have a button bar on the right and a status bar at the top. Button Bar BTS Bioengineering 65 BTS FREEEMG guide to the use of onboard software The side arrows (Toggles) can be used to change the active field. The up and down buttons make it possible to:
change the value in the active field navigate around the main menu The menu button opens the main menu Status Bar The status bar displays:
active page the condition of the 4 transmitters indicated with A, B, C, D. One transmitter can serve more than one probe. When a probe is transmitting the LED of its corresponding transmitter turns steady green The status of the FSWs (steady green LED if at least 1 FSW probe is active and recognized by the system) battery level Main Menu Clicking on the menu button of the buttons bar you enter the main menu. There are two menus: one for the Holter mode and one for the Lab mode. The two are different for the items: Database and PlayBack which exist only in the Holter mode. 66 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Lab Mode Menu Holter Mode Menu The main menu allows you to:
- explore the functions of the BTS FREEEMG 300. To enter a page select the corresponding icon by clicking with the stylus on the desired function or by using the Up and Down Buttons.
- lock up the palm by clicking with the stylus on the icon Lock. Accomplishing this function will result in the following screen:
To unlock the palm, clik on the Unlock button, this will BTS Bioengineering 67 BTS FREEEMG guide to the use of onboard software immediately move to another position. To complete this procedure it is necessary to press it again before it goes back to the original position.
- close the application by clicking on the Exit button. The following describes the menu functions starting from the ones that you can find both in the Holter Mode and in the Lab Mode that have the same characteristics. Protocol This item allows the user to select a protocol from the ones previously created by the user (see Acquisition protocol). In any case if a protocol hasnt yet been created it is possible to use the default protocol. Selecting a protocol is achieved by scrolling through the list on the left panel by clicking on the Up and Down buttons of the buttons bar. The protocol you select will be highlighted in blue. 68 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Probes Setup When a new protocol is defined, the user needs to associate with the items of the protocol (muscles, joints and foot areas) the channel that physically acquires the data. By clicking Probes setup from the menu you will see the following screens:
In particular we can identify two zones:
the probe-protocol association table The Probes area The table, for each signal of the acquisition protocol, previously selected in the protocol section shows:
the identifier of the assigned probe (comprised of the color and number/letter of the label), if no probe has been assigned the field is set on --
the type of probe: Surface, Footswitch, Electrogoniometer,... the state of the probe:
OK: Signal/probe properly assigned, the probe has been BTS Bioengineering 69 BTS FREEEMG guide to the use of onboard software selected in the activator and is connected to the RU. NOT CONNECTED: Signal/probe properly assigned, the probe has been selected in the activator, but does not appear to be connected to the RU.
-- : no assigned probe. NOT ACTIVATED: the probe is assigned to the protocol signal, but has not been selected in the activator. ERROR: the signal/probe has not been properly assigned as the type of probe expected by the protocol does not match the actual probe In the Probes area (rectangle at the bottom) where the selected probes in the activator are listed and the state is described. In particular, the boxes associated to channels can have different colors:
Green:
the selected probe in the activator is connected to the RU and is assigned to a protocol signal (the Status field of the protocol is OK) Grey:
the selected probe in the activator is connected to the RU but is not assigned to any protocol signal Orange:
the selected probe in the activator is not connected to the RU but is assigned to a protocol signal (the Status field of the protocol is NOT CONNECTED) White:
the selected probe in the activator is not connected to the RU and has not been assigned to any protocol signal 70 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Red:
the selected probe in the activator is connected to the RU and assigned to a protocol signal, but the type of probe expected by the protocol does not match the actual probe (the Status field of the protocol is ERROR). To make the association probe-signal:
1. use Up and Down buttons to select a signal 2. use toggle to select the Probe field 3. choose among the available ones (all the probes present in the probe area will be proposed), the probe to pair to the highlighted signal 4. use toggle to select the description (the whole row) 5. move on the next description with the arrow Down and restart from point 2 to assign the channel to the next item. Active fields (Toggle) Value range (Select) Description Probe Signals List 1, 2, ..., 15, 16, for EMG channels A.1, A.2, A.3, A.4, B.1, B.2, B.3, B.4, C.1, C.2, C.3, C.4, D.1, D.2, D.3, D.4, E.1, E.2, E.3, E.4, F.1, F.2, F.3, F.4, for EGN and FSW all available in 4 colors:
Green, Red, Blue, Yellow BTS Bioengineering 71 BTS FREEEMG guide to the use of onboard software Each Electrogoniometer generates two signals, it is important that you assign two channels of the same probe to the signals generated by the same EGN, e.g. C.1, C.2 To properly assign the basographic signals to the FSW probe channels please remember to match the 4 signals related to one probe to the protocol signals related to the physically close contact area, e.g. A.1, A.2, A,3, A.4 for the Right foot and B.1, B.2, B.3, B.4 for the Left foot. Before starting acquisition, the user needs to confirm that the Status of each protocol voice is OK. Digital Oscilloscope (gain) With BTS FREEEMG 300 the user can set up to 3 different ranges of values to see the muscular contractions better. To setting this value see Config Button. The selectable values are:
S1: 6mV;
S2: 3mV;
S3: 1,5mV. By accessing the gains page it is possible to verify that electrodes have been well positioned (no noise or motion artefacts) and that the signals are properly displayed and if they are not you can change the range of value 72 BTS Bioengineering guide to the use of onboard software BTS FREEEMG set in the configuration section. To do this, simply view via the oscilloscope the real-time muscular activity of each muscle you would like to analyze for a few seconds, asking the patient to perform several contractions. If the intensity of the muscle is very low, so that it is difficult to distinguish between when the muscle is in contraction from when it is at rest, the range needs to be reduced (the system will increase the gain correspondingly). If, on the other hand, the signal in the current amplitude tends to saturate
(meaning during the contraction there are peaks in the orange zone or beyond), it is necessary to increase the range (the system will reduce the signal gain accordingly). Keep in mind that the base range value will be the same for all signals acquired. Therefore select the value that lets you best see the channels simultaneously without saturation. If the selected range is insufficient to contain the entire signal dynamic, the acquisition data will tend to saturate during the contraction, which will appear as unnatural plateaus in measurement values at the limits of the selected range. On the other hand, if the signal is very weak, maintaining a high range is not a mistake. It is recommended, however, that the range be reduced whenever possible, in order to make better use of the digitalization of the acquisition card. BTS Bioengineering 73 BTS FREEEMG guide to the use of onboard software The gain used in the acquisition of the EMG signals is managed by the application on the basis of the range selected, the choice of range should be done with great care since it affects not only the display but also the acquisition signal (it is not a just a simple zoom!). By clicking the voice Gain from the menu you will see the following screens:
To scroll the different signals, click on the Toggle to activate the Signal active field and select the protocol item desired by actuating the Up and Down buttons. To make the signal visualization easier it is possible to use the Time active field (by selecting it with the Toggle) this allows to adjust the speed at which the signals run on the screen (this is only for display purposes, and will have no effect on the capture). It is possible to set the time value interval shown on the axes of the oscilloscope abscissas, selecting from a range of values from 1 to 10 seconds, that can be selected with the Up and Down buttons. 74 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Active fields (Toggle) Value range (Select) Signal Time Protocol signals 1 sec - 10 sec Digital Oscilloscope (cross check) The Cross Check is very useful during the patient setup phase, allows the operator to verify, prior to the actual acquisition of the signals, that the electrodes have been positioned correctly. The possibility of displaying two traces simultaneously prevents the problem of cross-talk: this phenomenon occurs as a detection of electrical activity on the trace of a muscle during a movement which should not involve the muscle in question. Cross-talk is occurring if, for example, during the movement of extension of the wrist, one observes the activity of the ulnar carpus flexor. BTS Bioengineering 75 BTS FREEEMG guide to the use of onboard software This is due to an incorrect positioning of the electrodes, as a consequence of which the channel dedicated to a certain muscle is in reality measuring the activity of another muscle. In the above example, the activity measured on the trace of the ulnar carpus flexor is not in reality being produced by that muscle, but by one deeper down or by its antagonist. To appoint the signals to visualize select the Signal 1 and then Signal 2 field with the Toggle and scroll the signal list included in the protocol using the Up and Down buttons. The current display can be enlarged or reduced via the zoom function: this does not affect in any way the data being read. The Time field can be used to vary the speed at which the signal runs on the screen (again, this has no effect on the reading, but only on the display). It is possible to fix the time intervals represented on the axis of the abscissas of the oscilloscope, choosing from a range of values from 1 to 10 seconds. Active fields (Toggle) Value range (Select) Signal 1 Signal 2 Zoom Time Protocol signals Protocol signals From 1/10 to x10 From 1 sec to 10 sec 76 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Footswitches The Footswitches page shows in real time the activation of the contact zone during the deambulation contact phase. When a zone is active, the foot is resting on it - the corresponding circle colors is red. If there isnt correspondence between the contact points indicated on the display and the movements done by the subject (for example if with the right foot in stance the areas under the left foot of the display became red) we suggest you to review the FSW channels setup selecting the menu voice Probes Setup. Usually the Footswitches are used for studying the sole of the foot during deambulation. Four points have been identified for this purpose in order to be able to distinguish the foot tread while walking. These 4 areas are:
BTS Bioengineering 77 BTS FREEEMG guide to the use of onboard software However, while preparing the protocol you can indicate the general contact areas:
Internal Contact, External Contact, Heel Contact, Toe Contact. Contact area 1, Contact area 2, Contact area 3,
... The Footswitch probes can also be used for other applications and placed on other parts of the body where you would like to record the moment of contact (for example on a finger during pointing exercises). In this case you should use a general Contact Area 1, Contact Area 2 in the protocol, and in the FSW page refer to the rectangles located under the figure showing the foot to check that the probes are properly activated. Local button: Holter Mode In this mode the RU is completely independent and its possible to acquire the data independently of the WS. Session preparation:
selecting Local you can enter the patients database on the palm. 78 BTS Bioengineering guide to the use of onboard software BTS FREEEMG List of patients already included in the database of the BTS FREEEMG 300 List of sessions for the highlighted patient List of the tests of the highlighted session To add a new patient click with the stylus on New subject button. A window will open which allows you to insert general information about the patient. To insert the patient data:
move up to the field to insert insert the value with the keypad, (each tap on the gender field will change from F to M and viceversa) press OK to insert the patient into the database BTS Bioengineering 79 BTS FREEEMG guide to the use of onboard software It is possible to modify or to delete the data of a patient already inserted. By clicking on the line of that patient, it will be underlined in light blue and the Delete and Modify buttons will appear. Clicking on Modify a window will open that allows to modify the general information of this patient. Click on Delete and immediately a window with the request to confirm the deletion will appear:
Clicking on Yes the trial will be removed from the database, with all the related sessions and trials, while if you choose No the deletion will be aborted. 80 BTS Bioengineering guide to the use of onboard software BTS FREEEMG To create a new test session click on New Session. A window will open that allows to the user to insert data linked to the session:
patient weight patient height pathology possible notes of the session Press OK to add the session of the selected patient. The default protocol is linked to the session; to change the protocol click on the Menu button and enter the Protocol item
(see Protocol). Cautious that it is not possible, rather than, to change protocol of a session when this has already got some acquisitions. To continue working with the same patient but with a different protocol it is necessary to create a new acquisition session for that patient. BTS Bioengineering 81 BTS FREEEMG guide to the use of onboard software To modify or to delete the data of a session created previously click on the correspondent line, it will be underlined in light blue and the Delete and Modify buttons will appear. Clicking on Modify a window will open that allows to modify the data related to this session:
Click on Delete and immediately a window with the request to confirm the deletion of the session and the relate trials will appear:
Clicking on Yes the session and the trials will be removed from the database, with all the related sessions and trials, while if you choose No the deletion will be aborted. 82 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Latter it is possible to delete single trials. To do that click on the correspondent line, it will be underlined in light blue and the Delete buttons will appear. Click on Delete and immediately a window with the request to confirm the deletion of the trial will appear:
Clicking on Yes the selected trial will be removed from the database, with all the related sessions and trials, while if you choose No the deletion will be aborted. Acquisition:
to proceed with the acquisition in Local mode it is necessary to have created a new session and to have selected an analysis protocol or to have selected a session already in the database. Proceed then with the operations described in the previous paragraphs:
Probes Setup, Range, Digital Oscilloscope, Footswitches. Once finished all the preliminary operations and the necessary checking it is possible to proceed with the acquisitions. To do that, select the item Capture from the Menu. BTS Bioengineering 83 BTS FREEEMG guide to the use of onboard software A screen will appear, which gives the setup for that acquisition:
For every test its possible to indicate the Start and Stop mode, the acquisition frequency and the type and notes of the test. To edit the notes click on Edit Notes, a window will open which allows you to edit the notes. Introduce the note using the keyboard and then click on OK to confirm or on Cancel to come back to the previous screen without saving the text just typed. 84 BTS Bioengineering guide to the use of onboard software BTS FREEEMG To modify the other acquisition parameters select the relative field with the Toggle and then use the Up and Down buttons. Active fields (Toggle) Value range (Select) Acq. Frequency 1KHz, 2KHz, 3KHz, 4KHz Flag MMT, Resting, Walking, Undefined, Extra If the acquisition frequency selected is 3 or 4KHz, the system can acquire 8 EMG channels maximum. If the selected protocol requires a higher number of probes a warning message will appear and the acquisition wont be allowed. By clicking on the Start button, the acquisition starts and the system automatically goes into Lock mode, showing the following:
To unlock the palm click on the Unlock button, this will immediately BTS Bioengineering 85 BTS FREEEMG guide to the use of onboard software move to another position. To complete this procedure it is necessary to press it again before it goes back to the original position. Before quitting this mode the screen with the acquiring setup reappears but the Start (or Arm) button is substituted with the Unlock and Stop buttons. The Unlock button allows to come back to the previous screen. Clicking on Stop, instead, will end the acquisition. At this point the following screen will be visualized:
86 BTS Bioengineering guide to the use of onboard software BTS FREEEMG To save data on BTS FREEEMG 300 select Store whereas to cancel the data just acquired click on Delete. In this case a confirmation for the cancellation will be asked of the user, select Yes if you want to delete the new acquired data. ClickNo button and then Store to save the test. After the storing or the cancellation of the last acquired test you are redirected to the screen containing the Start button. To continue with another acquisition click on Start and repeat the operations just described. If any other acquisition wont be executed, select Exit from the menu. Playback In the Holter mode it is possible to visualize a preview of the data acquired and saved in the database. To do that, from the menu select the voice Database and select the patient, the session and the trial that you want to visualize clicking with the stylus on the correspondent line, that will be underlined in light blue. Once the trial is selected, from the menu select the voice Playback. At the end of an acquisition session it is possible to go directly to the Playback page, without passing from the database: in this circumstance all the trials saved in the last session acquired will be loaded. In both these circumstances the following screen will appear:
BTS Bioengineering 87 BTS FREEEMG guide to the use of onboard software From the lower panel select the trial to visualize by tapping on the correspondent line. It is possible to visualize two signals at the same time. To do that select the field Signal 1 and than Signal 2 using the Toggle and scroll the list of the available signals operating on the Up and Down buttons. After that to improve the signal visualization, adjust the active fields Zoom and Time selecting them with the Toggle and changing their value with the Up and Down buttons. In particular the Zoom field allows increasing or reducing the current view area (it acts on the axis of ordinates), while the Time field allows changing the temporal value range showed on the axis of the abscissas, choosing among a range of value in between 1 and 10 seconds. This means that the selected trial will not be entirely visualized, but only bits of the length of 1, 2, 5 or 10 seconds according with the Time field. 88 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Active fields (Toggle) Value range (Select) Signal 1 Signal 2 Zoom Time
# Trial Protocol signals Protocol signals From 1 sec to 10 sec Trials of the selected session However it is possible to scroll the whole trial changing time after time the frame from where the visualization starts. To do that click with the stylus on the grey band that represents the whole trial in the point correspondent to the first frame to visualize. On the grey band at the two extremities, are indicated the beginning of the trial (that is 0:00) and the total length of it (like in the example in the figure 0:34, that means 0 minutes and 34 seconds). In the spot in which you tap, a grey rectangle will appear in which will be indicated the correspondent time of the selected first frame (like in the example in the figure 0:21). Therefore, if the Time field is set, for example, on 5sec, we are visualizing 5 seconds of trial starting from the 21st second. It is possible, if you regard it relevant, delete some trials. BTS Bioengineering 89 BTS FREEEMG guide to the use of onboard software Click on the trial, choosing it in the lower panel, that you want to delete. It will be underlined in light blue and the Delete button will appear. Click on Delete and immediately a window with the request to confirm the deletion will appear:
Clicking on Yes the trial will be removed from the database, while if you choose No the deletion will be aborted. Importing data to EMG-Analyzer The data acquired in Holter mode is saved in a local database in the BTS FREEEMG 300. To execute the elaboration and the analysis of the data, you need to import the test using the software EMG-Analyzer. To do this, proceed as described further in Download button. 90 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Remote button: Lab mode In this mode the connection between RU and WS is always available. The specific characteristics are:
sending data boxes to the WS for the visualization in the remote oscilloscope, available in the applicative software. data transfer at the end of acquisition. the duration of acquisition and the Start/Stop are controlled by the PC. Selecting Capture from the main menu the following screen appears:
This screen displays some information concerning the system:
Status: Ready mode Mode: Stand Alone Data: None To make an acquisition in Lab mode, there must be no data saved on the BTS FREEEMG 300. BTS Bioengineering 91 BTS FREEEMG guide to the use of onboard software This possibility can happen only with a loss of WiFi connection between BTS FREEEMG 300 and Workstation during the last acquisition, or if the data transfer has not gone well. In this case the screen displayed after having selected Capture from the main menu will contain instead of the Arm button, the Delete button and the Data field will be Ready. If you want, it is possible to recover the lost data saved in the RU before proceeding with the new acquisitions downloading them on the Workstation using the EMG-Analyzer software. To know the download procedure consult the manual of EMG-
Analyzer. Otherwise the data will have to be deleted and cannot be retrieved in the future. To delete the data, click on the Delete button; by doing this the system will ask you a confirmation for the deletion, select Yes if you really want to delete the data in a permanent way, otherwise click on No to come back to the previous screen. 92 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Once deleted the file, the Arm button appears again and the Data field will again become None; so its possible to proceed with the acquisition. Before arming the system it is possible to set the acquisition frequency using the Up and Down button of the button bar. Active fields (Toggle) Value range (Select) Acq. Frequency 1KHz, 2KHz, 3KHz, 4KHz If the acquisition frequency selected is 3 or 4KHz, the system can acquire 8 EMG channels maximum. If the selected protocol requires a higher number of probes a warning message will appear and the acquisition wont be allowed. To prepare the system for capture it is necessary to arm it by simply tapping the Arm button that will be replaced by the Lock and the Cancel buttons. Now it is possible to make the acquisition via remote control. BTS Bioengineering 93 BTS FREEEMG guide to the use of onboard software At this level it is not possible to change the acquisition frequency. Tapping on the Cancel button the previous screen appears, returns control to the RU. To proceed with the next acquisition, the system needs to be armed again. It is possible to lock the system by clicking on Lock directly by this window, therefore at the beginning of the acquisition the BTS FREEEMG 300 locks automatically displaying:
The acquisition starts-up through the remote control, directly by the Workstation. This display will remain on the BTS FREEEMG 300 until the acquiring session is over. Its possible to interrupt the acquisition remotely and proceed with the next ones. 94 BTS Bioengineering guide to the use of onboard software BTS FREEEMG At the end of every acquisition an automatic data download will be executed. Only at the end of the download is it possible to launch another remote acquisition. Once the acquisition session is over, unlock the BTS FREEEMG 300. In order to do so, press the Unlock button, this will immediately move to another position. To complete this procedure it is necessary to press it again before it goes back to the original position. Finally to quit from the Armed status click on the Cancel button. For the details of the remote management of the acquisition from the WS refer to the specific manual of the software meant to be used. Download Button If the Holter mode is chosen (local acquisition), the acquisitions are saved in a local database to BTS FREEEMG 300. To elaborate the acquired data with the dedicate softwares installed on the Workstation, the user needs to download them with EMG-Analyzer following these instructions:
Select from the main page the download mode clicking on the Download button BTS FREEEMG 300 keeps waiting, showing the following screen:
BTS Bioengineering 95 BTS FREEEMG guide to the use of onboard software From EMG-Analyzer, select the View Local Database item from the Laboratory menu. A window will appear that will allow you to explore and modify the active database on the BTS FREEEMG 300, and download all the files that you are interested in. For further details concerning the data download refer to the user manuals of EMG-Analyzer software. The data import takes place with a wireless connection;
if the import operation fails, you need to verify that the RU and WS are connected (see Appendix C troubleshooting guide). When the download is finished on the BTS FREEEMG 300 keep pressing the Exit button to go back to the main screen. 96 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Config button The Config button launches an application that allows the modification of some system settings. It uses five tabs to reach the different information and features:
Info:
Main screen that contains information of the installed versions. General:
General settings (i.e. language, audio settings...). Radio:
Associates the ID identifier of each EMG and FSW/EGN probe to its label identified by color and number/letter;
setting of the signal range;
setting the radio channels utilizing the probes. Database:
Database management. Maintenance:
session permitted only to BTS Technician staff, for assistance. For this reason to access this area a Password is required. To execute any changes of the parts that can type on it is possible to use the touch-screen features of the display and where necessary, activate the keyboard, clicking on the low right corner icon represented by a little keyboard. To exit this application and come back to the main screen, you must tap on the Ok button, placed in the top right corner. One tap on this button will confirm all the changes made. BTS Bioengineering 97 BTS FREEEMG guide to the use of onboard software It wont be possible to undo the changes made, apart setting again, manually the previous values. All the changes made are immediately activated, therefore, in some circumstance, it will be necessary to restart the BTSFREEEMG300 application to see these changes applied (for example when you change the language). Lets analyze now, more in depth, the four tabs that the user can modify. Info Clicking on the Config button on the main screen, it automatically selects the application screen in which the tab Info is selected:
On this page it is possible to read all the information about the versions of each installed component, hardware or software. 98 BTS Bioengineering guide to the use of onboard software BTS FREEEMG General Selecting General, the following screen will be visualized:
It is possible to set:
The language DHCP, for automatic host configuration, the IP address and Netmask, available only with the DHCP not checked, to manually assign the connection parameters and the Port Number. Quite mode: Checking this voice, the program will play without any noise (instead of what normally happens when for example you Tap on a button or activate an acquisition) Lock on Capture: Checking this voice when an acquisition starts the BTS FREEEMG 300 will be automatically locked showing the Unlock button Video off on Capture: if checked, the display automatically will switch-off at the acquisition beginning. To activate the screen again a click on one of the PocketPC button is enough The use of a Secure Digital memory card to store the temp file generated during the acquisition (check this voice only if there is a Secure Digital board in the related port). BTS Bioengineering 99 BTS FREEEMG guide to the use of onboard software Radio When Radio is selected the following page is displayed:
The EMG probes and FSW/EGN probes sections allow to associate the ID that uniquely identifies each probe manufactured by BTS S.p.A. with the probes label. The ID is shown on the clip of every EMG probe and on the back of every FSW/EGN probe. Up to 16 EMG probes and up to 8 FSW/ EGN probes can be registered. Probes that are not registered in this section will not be recognized by the Receiving Unit and therefore may not be used for acquisitions. Generally, the system is distributed to the customer with this association already made. However it could be useful if new probes are purchased or if probes are replaced due to a malfunction. 100 BTS Bioengineering guide to the use of onboard software BTS FREEEMG However when you receive the system it is advisable to check that the association has been made correctly. If a probe has been incorrectly associated to a label or the ID number does not match that on the clip the probe may not work. Instead, changing two IDs compared to the label could cause an exchange of acquisition signals as well and therefore cause false results in the Electromyographic examination. Follow the procedure below, to register a probe that has not been introduced:
Enter the ID of the probe using the keypad that can be activated on the bottom right-hand side of the page. If the string entered is not admissible or has already been entered the software will highlight it in red. Select the color of the probes label (the colors can be Red, Green, Blue, and Yellow) using the drop down menu. BTS Bioengineering 101 BTS FREEEMG guide to the use of onboard software Finally, select the number or letter shown on the probes label
(number selection from 1- 16, letter selection from A-F). If the label (identified by the color/ number or letter combination) has already been used the software will highlight the ID string in red. 102 BTS Bioengineering guide to the use of onboard software BTS FREEEMG From the Radio page two other sections may be accessed. The Signal section allows to select the Range for electromyographic signals. 3 different value are available:
6,34mV;
3,17mV;
1,62mV From the Radio Channels section the ZigBee channel with which to work can be assigned to the activator and the four transmitters. BTS Bioengineering 103 BTS FREEEMG guide to the use of onboard software It is recommended to modify this section only if absolutely necessary and eventually with referral to BTS technical support. Database Selecting Database the following screen will be visualized:
In this section it is possible to select the current database, to create new databases, to delete and rename existent databases. There are two list-boxes, the first one, Media, allows the selection of the box in which the database can be found or to insert a new one. In particular there are two possible medias: the flash memory, internal to the Pocket PC and the Secure Digital card. If the latter is not present, a message will be visualized indicating that the card is not inserted. 104 BTS Bioengineering guide to the use of onboard software BTS FREEEMG Instead the error message:
ERROR: media not initialized will be visualized if the card has been inserted but hasnt still been initialized. In this circumstance a button will appear allowing the initialization. Once selected the Media it is possible operating on the second list-box to select the database to use. Mind that if the selected Media is empty, it is necessary to create a new one. To create a new database click on New. The new database will be created with the default name TrialsDB. To change the name select it and click on Rename. To delete a database select it and click on Delete. This operation removes completely the database and all its content
(patients, sessions and trials). For this reason the system will ask a confirmation before proceeding with the deletion. Exit button The Exit button allows the closing of the application and the visualization BTS Bioengineering 105 BTS FREEEMG guide to the use of onboard software of the operative system installed on the PDA. To do that it is enough to press and hold the Exit button for few seconds. 106 BTS Bioengineering BTS FREEEMG BTS FREEEMG 300 updating Updating the onboard software To update the BTS FREEEMG 300, exit the application by selecting the entry of the Exit menu and holding down the Exit button for some seconds. Before carrying out the upgrade of the software it is recommended a backup be made of the software version currently installed. Slide the PDA out of the methacrylate guide enough to disconnect the Compact Flash. Connect the PDA via the dedicated cable to the USB port of the WS. On the WS, from Windows, run the update program, launching the BTSFREEEMG300Setup.exe file, and follow the video instructions till the update is complete. Reinsert the PDA in the AU. Restart the BTSFREEEMG300 application on the BTS FREEEMG 300: from the Start menu, click on Programs, search for the BTSFREEEMG300 icon and single click it. The main screen will appear. BTS Bioengineering 107 BTS FREEEMG BTS FREEEMG 300 updating Creating a backup image At the end of each software upgrading, it is important to remember to create a backup image. It can happen that the Pocket PC battery goes completely dead. When this happens all the BTS settings as also the BTSFREEEMG300 software will be lost. To restore the software and bring the BTS FREEEMG 300 to the standard configuration it will be enough to proceed with the restore of the last backup done (see Appendix D Troubleshooting guide). To do the backup proceed as follow:
exit from the BTSFREEEMG300 application holding the button Exit for some seconds select Start and then Programs among the installed programs, choose iPAQ Backup:
with the stylus tap on Restore Now and wait the end of the backup procedure. The Pocket PC will restart and then the BTSFREEEMG300 software will be automatically reloaded. 108 BTS Bioengineering BTS FREEEMG 300 updating BTS FREEEMG The backup procedure is now finished, therefore we suggest to rename the backup file created giving it a more meaningful name, in particular we recommend to indicate the version number of the software. To do that proceed in this way:
exit from the application select Start and then Programs among the installed programs, choose File Explorer click on the arrow that appears on the grey bar, under the title File Explorer and choose Device open the folder iPAQ File Store look for the backup file just created that will have a name like:
Backup_2007-07-15, where the date is the one during the backup time with the stylus, tap and hold for few seconds on the backup file icon till when the menu appears choose rename and type the new name (i.e. Backup_v107 supposing you have updated the software with the version 1.2.107.0). BTS Bioengineering 109 BTS FREEEMG maintenance and cleaning Periodically inspect the PDA and the slide of the receiving unit for any signs of detachment, cracks or other damage. Clean the external parts periodically with cleaning liquid approved for computers. On the PDA monitor use a microfibre cloth only, and do not use liquid detergents or solvents. Contact with the skin of the patients is achieved via the pre-gelled Ag/
AgCl electrodes, which, being single-use disposable, intrinsically guarantee a sufficiently high level of hygiene. Generally you use hypoallergenic band-aid or hypoallergenic double-
sided tape to apply the Footswitches in correspondence of the foot contact points. At the end of each work session, it is important to carefully remove every glue or gel residual from these parts and from the probes. After each use we suggest to clean the switches using a soft cloth moist with a disinfectant solution, being careful removing any glue residual left. The BTS FREEEMG 300 cannot be sterilised. 110 BTS Bioengineering BTS FREEEMG appendix A technical specifications variable standard with clip connection min: 16mm - max: 66mm 8h of use some days stand-by some months deep sleep rechargeable, lithium ion 14x41,5x24,8mm mother electrode diameter 16x12mm satellite electrode 13g battery included ISM band 2.4GHz (standard IEEE802.15.4)
>10 GOhm
>110 dB @ 50-60Hz 16bit up to 4KHz 1V 2%
Wireless Probes Geometry:
Electrodes:
Separation:
Autonomy:
Battery:
Dimensions:
Weight:
Frequency used:
Input impedance:
CMMR:
Resolution:
Acquisition frequency:
Sensitivity:
Aaccuracy of measurement*:
Receiving Unit Autonomy:
Battery:
up to 24h with rechargeable battery up to 9h with single battery rechargeable, lithium ion BTS Bioengineering 113 BTS FREEEMG appendix Dimensions:
Weight:
Frequency used:
Display:
155x106x35mm 360 grams ISM band 2.4GHz (standard IEEE802.15.4 and IEEE802.11b) 4 VGA color touch-screen
* The system is calibrated at the factory. No further calibration is required BTS internal coding Name of device, components, parts and/or accessories as per product label FREEEMG 300 Pocket PC with Stylus Acquisition unit Belts and armbands for attachment to patient 16 EMG probes FootSwitch/Electrogoniometer Wireless Probe Foot switches: Insole individual foot switches for the automatic identification of the gait events. Electrogoniometers: Sensors for the measurement of joint angles progress over the time. Identifier for device (bar code, catalogue, model or part number) FREEEMG 300 FRESPU12 114 BTS Bioengineering BTS FREEEMG Name of device, components, parts and/or accessories as per product label Fine-Wire adapter : Adapter for the Fine-Wire electrodes. Identifier for device (bar code, catalogue, model or part number) FRESPU23 O-Port expander : Digital to Analogue EMG data converter. FREALG16 EMGenius: software application to acquire, elaborate and report electromyography and footswitch signals EMG-Analyzer: software application for EMG signal analysis Docking station Charger EMGE0901 SMAN0901 FRESPU05 FRESPU06 BTS Bioengineering 115 BTS FREEEMG appendix B environmental specifications Operating Temperature Operating Humidity Storage and Transport Temperature Storage and Transport Humidity Altitude Min
-20 50%
0 50%
Note Max
+45 80% Relative, non-condensing
+40 80% Relative, non-condensing 0m 2000m Degrees of protection provided by the dangerous enclosures of water and dust (IEC 60529): IPX0. 116 BTS Bioengineering BTS FREEEMG appendix C power supply and switch off The medical power supplier TR30RAM050 provided with the system has the following functionality:
- Provide power to the Receiving Unit and recharge its battery.
-Guarantee the galvanic insulation of the Receiving Unit from the power. To switch off the system the following operation must be done:
- Stand-By of the Receiving Unit:
1) push the graphical button MENU and then select Exit to quit the 2) set the Receiving Unit state on stand-by by clicking on the switch application.
-on/off button of the PDA.
- Stand-By of the Probes:
place the probes on the Charger or Docking Station. BTS Bioengineering 117 BTS FREEEMG appendix D battery BTS FREEEMG 300 is an internally powered device: several of its components use batteries as indicated below. The Probe battery replacement can be done only by BTS qualified personnel. The probes are sealed to avoid the access to the internal circuit components. Batteries are equipped with battery protection circuit to:
-over-voltage, threshold 4.3V
-under-voltage, threshold 2.8V
- short-circuits The specific characteristic of the different components of the system equipped with the battery are:
- Receiving Unit Quantity:
Technology:
Removable:
1 per each unit lithium ion (Li-Ion) yes, by removing the PDA from the acquisition unit
- Wireless Probes Quantity:
Technology:
Removable:
1 per each EMG or FSW/EGN probe lithium polymer (Li-Poly) NO, BTS technical service is required 118 BTS Bioengineering appendix BTS FREEEMG
- Docking Station (optional) Quantity:
Technology:
Removable:
1 for each unit lithium polymer (Li-Poly) NO, BTS technical service is required BTS Bioengineering 119 BTS FREEEMG appendix E declaration of conformity DECLARATION OF CONFORMITY Italy Fax +39 049 792 9260 BTS SpA Via della Croce Rossa 11, 35129 Padova (PD) Tel. +39 049 981 5500 name / description:
model:
S/N:
FreeEMG300 SN declare under our sole responsibility that the product(s):
Electromyographic system / device for recording myoelectrical activity. 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 The product conforms to the following standards:
Applied part type: BF EN ISO 14971 IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 Medical Devices - Application of risk management to medical devices. Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance. Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility -
Requirements and tests. Medical Electrical Equipment - Part 1-6: General Requirements for basic safety and essential performance - collateral Standard: Usability Medical device software - Software life-cycle processes EN 62304 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 products usage manual. Notified Body : TV Product Service GmbH, Zertifizierstelle, Ridierstrasse 65, 80339 Mnchen 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. 120 BTS Bioengineering BTS FREEEMG appendix F troubleshooting guide 1708 Error Incorrect IP address or port set up The software uses IP address parameters and communication ports to cre-
ate network connections between the Workstation and the PDA. In the case of incorrect configuration, the correct parameter values need to be re-input. To do this, launch the software that you are going to use and then, by the menu voice Laboratory select Set Emg Device. Verify that the IP address and the port setting are correct. The values to specify are the following:
IP Address:
Port:
192.168.1.2 8000 and if a second receiving unit is available:
IP Address:
Port:
192.168.1.3 9000 If necessary, correct the values and click on Upgrade before closing the windows. BTS Bioengineering 121 BTS FREEEMG appendix 1709 Error Impossibility to connect to the unit One or more Wi-Fi network resources (Access Point, Workstation, PDA) are not available. In general, we recommend some simple checks as follows:
- Access Point Check they are correctly connected to the power supply and switched on. Try switching the AP off and then back on. Since some models are not fitted with an On/Off switch, it may be necessary to remove and reinsert the power cable. If on the rear of the model there is a selection button, verify it is on position AP
- Workstation If the Workstation is fitted with a Wi-Fi interface, check it is active and connected to BTSFREEEMG300. As the connection is through the AP, check that the LAN (local area network) is active.
- BTS FREEEMG 300 The Wi-Fi connection is active only when the BTS FREEEMG 300 is in Remote Mode or in Download Mode. From the main screen choose one of these two mode. If the connection is still not activated, also with all these settings, please contact the BTS Customer Care. Backup restoring The backup restoring procedure allows the reloading of the 122 BTS Bioengineering appendix BTS FREEEMG BTSFREEEMG300 software and the restoring of the standard configuration of the Pocket PC. This is very useful, for example, when the PDA battery goes completely dead. If this happens, when the PDA is switched on, the software BTSFREEEMG300 wont be loaded and, instead of it, a screen will appear in which the system will ask the user to execute some start-up operations. In this circumstance, before proceeding with the restoring procedure, it is necessary to complete the start-up operations required by the system that consists in the execution of some simple exercises like the stylus pointing, to execute a copy and paste, etc...(for further details refer to the PDA manual). When all these operation are finished, the windows main screen will be visualized and it will be possible to proceed with the restoring of the last backup. To restore the backup follow these instructions:
select Start and then Programs among the installed programs, choose iPAQ Backup:
click on Restore Now to restore the last backup, the PDA will restart and then the BTSFREEEMG300 software will be reloaded at this point, exit from the application to set the date and the time, to do that select the date under the voice Start. For further details about the time and date setting refer to the PDA manual. BTS Bioengineering 123 BTS FREEEMG appendix Receiving unit hardware reset In case the PDA blocks during use and does not respond to any commands, you must perform an hardware reset operation. To do that follow these instructions:
place the receiver on a plane;
grip with your right hand the PDA stilus;
using index and middle finger of your left hand push the two buttons (marked by the icons keypad and arrow) positioned at the right of the PDA display and simultaneously, with your right hand, insert the stylus in the hole on the right side of the PDA, as shown in the figure below:
the PDA will Immediately the system will be rebooted;
when software BTSFREEEMG300 wont be loaded and, instead of it, a screen will appear in which the system will ask the user to execute some start-up operations; complete the operations required that consists in the execution of some simple exercises like the stylus switch on again the 124 BTS Bioengineering appendix BTS FREEEMG pointing, to execute a copy and paste, etc...(for further details refer to the PDA manual). when all these operation are finished, wait for the windows main screen to be visualized;
finally proceed with the restoring of the last backup procedure described in the previous paragraph. BTS Bioengineering 125 BTS Bioengineering Corp. 147 Prince Street - Suite 11 11201 Brooklyn NY USA info: +1 347 204 7027 helpdesk: +1 646 575 0426 www.btsbioengineering.com info@btsbioengineering.com BTS S.p.A. viale Forlanini 40 20024 Garbagnate M.se MI Italy tel +39 02 366 490 00 fax +39 02 366 490 24
1 | ERTMJ-00998-04 TMJOINT User Manual ENG v.3.0.0 | Users Manual | 4.14 MiB | September 08 2013 |
I T N O J M T S T B user manual english version 3.0.0 Document Number : ERTMJ-00998-04 Published: January 2013 Copyright 2010 - 2013 BTS SpA. All Rights Reserved. BTS TMJOINT contents receiving unit regulatory label EMG wireless probes regulatory label charger regulatory label contents icons, symbols and acronyms radio regulation disposal (WEEE) intended use regulatory label warnings copyright introduction system components installation user PC minimum configuration connections description of the software on the user PC software installation hardware installation first software use receiving unit wireless EMG probes charger general description case contents 1 5 9 10 11 12 12 12 13 14 17 18 18 20 22 22 23 26 28 28 28 29 29 31 34 BTS Biomedical 1 BTS TMJOINT contents POC4 protocol POC6 protocol initial screen menu bar tool bar probes status bar patient list and research filter patient, session and trial information trial viewing and report generation area patient setup guide to the use of BTS DCA main features of the BTS DCA software more features of the BTS DCA software guide to of the data report reading database and data folder managing files in the recycle bin new patient new session edit pathology new trial data acquisition edit patient edit session delete patient delete session delete trial INT tab EXT tab POC tab 37 37 39 41 41 42 47 47 49 52 53 59 59 59 62 63 66 72 73 74 75 76 77 77 80 83 83 89 94 2 BTS Biomedical contents BTS TMJOINT ISTO tab MAST tab INFO tab wireless probes receiving unit appendix A technical specifications appendix B environmental specifications appendix C power supply and switch off appendix D battery appendix E troubleshooting guide warning invalid trigger mode appendix F declaration of conformity appendix G bibliography 96 98 100 103 103 103 105 106 107 108 108 109 110 BTS Biomedical 3 BTS TMJOINT icons, symbols and acronyms Symbol in the instructions for the function. The icon represents the information which requires special attention. Symbol in the instructions for the function. This icon makes reference to a more detailed discussion of the subject in hand. Symbol on the equipment:
The data appearing next to the manufacturers symbol refer to the place of manufacture of the equipment itself. Symbol on the equipment:
The FCC simbol refers to the Federal Communication Commission of the USA. The device complies with the relevant regulations put forth by the FCC as long as it is operated according to the instructions contained in this manual and to all national and local regulations. BTS Biomedical 5 BTS TMJOINT icons, symbols and acronyms Symbol on the equipment:
The figure in the square indicates the insulation class and the part types used. In accordance with Standard ISO 60601-1, the equipment has an internal power supply and the parts used are type BF. Symbol on the equipment:
Attention, read the information in the users manual carefully before using the equipment. Symbol on the equipment:
The double square indicates that the product is a medical device of II Class (In accordance with the law EN 60601-1). Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies that the product conforms to the standards applicable in the member states of 6 BTS Biomedical icons, symbols and acronyms BTS TMJOINT the European Union (see Declaration of Conformity). Symbol on the equipment:
CE mark with the code of the Notified Body. The CE mark certifies that the product conforms to the Directive 99/05/EEC - R&TTE and obtained the Expert Opinion by IMQ. Symbol on the equipment and in the users instructions:
Symbol for the separate disposal of electrical and electronic equipment, in accordance with Directive 2002/96/CE (WEEE). The equipment belongs to Group 8 (medical equipment). In force in the nations of the European Union, Norway and Switzerland. Rx only Symbol for prescription only. U.S. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. BTS Biomedical 7 BTS TMJOINT icons, symbols and acronyms REF Symbol on the equipment:
Symbol located next to the model number (ref.to catalogue). SN Symbol on the equipment:
Symbol located next to the series number on the equipment. Receiving Unit Acronyms used in this manual:
RU EMG Electromyography WS Workstation DCA Dental Contact Analyzer POC Percent Overlapping Coefficent MVC Maximum Voluntary Contraction 8 BTS Biomedical BTS TMJOINT radio regulation Radio equipment identification:
- EMG probes:
FCC ID: YQH-BTSWEMG2 IC: 9188A-BTSWEMG2
- receiving Unit contains:
FCC ID: TFB-MATRIXLP IC: 5969A-MATRIXLP This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by BTS SpA could void the users authority to operate the equipment under FCC rules. BTS Biomedical 9 BTS TMJOINT disposal (WEEE) In disposing of the equipment observe the legal prescriptions. In accordance with Directive 2002/96/CE (WEEE) all equipment supplied after 13/08/2005 may not be disposed of in general domestic waste. This equipment belongs to Category 8 (medical equipment) and is classified in the Business-to-Business sector. The symbol of the crossed out rubbish bin indicates that the equipment must not be disposed of in normal domestic waste. The regulations for disposal may differ between individual countries in the EU. In cases of doubt, refer to the respective sales outlet. This is a battery-powered equipment. See Appendix D for information about the batteries used. Operate and dispose of this equipment according to the instructions set in the warnings section. 10 BTS Biomedical BTS TMJOINT intended use This equipment is an instrument for the EMG surface analysis, classified as medical equipment in accordance with European Directive 93/42/CE
(and its amendments). BTS TMJOINT must always be used only for this purpose, by qualified persons, in an environment suitable for the execution of EMG analyses and respecting the prevailing regulations in the countries in which it is being utilised. BTS Biomedical 11 BTS TMJOINT regulatory label Receiving Unit Regulatory label EMG Wireless Probes Regulatory label Label on the probes:
Probe ID 12 BTS Biomedical regulatory label BTS TMJOINT Label not on actual probes due to size constraints:
Charger Regulatory label BTS Biomedical 13 BTS TMJOINT warnings We recommend to carry out any kind of operation keeping strictly to the security regulations contained in this manual. TMJOINT is a medical device (EU Directive 93/42/CE and its amendments, including Directive 2007/47/CE) which use must be at all times be supervised by qualified and authorized personnel, according to the laws in force in the nation it is in use. The EMG probes are classified as ETSI EN 300 440 Receiver category 3 according to Directive R&TTE 99/5/EEC. The results of the acquisitions must be assessed by people legally authorised by national law, who possess the suitable necessary knowledge of anatomy and muscular function. The uses of the device for other purposes and with methodologies different from of those indicated in this manual are not to be considered congruent with the precise use of the device.
- Use the product according to the usage that it has been intended.
- Avoid connecting the probes to the charger with inverted polarity with respect to that shown on the cover of the recharger - this could cause irreparable damage to them.
- To not wet or dip in water the parts that make up the system. 14 BTS Biomedical warnings BTS TMJOINT
- Apply the probes only on undamaged skin.
- Only use CE branded probes and hypoallergenic double-sided tape, compatible with the usage on undamaged skin for brief periods of time.
- Periodically verify the integrity of the system and of its components.
- In case the device accidentally falls, tear of the probes or other accidents always address authorized technical support.
- Do not undertake any kind of internal maintenance of the device:
in case of need always address to authorized technical support.
- The use of any components different from the original ones declines the conformity of the device.
- The instrument must be used in a medical environment, since it has a high level of sensitivity (measured voltage levels of between 1 microvolt and 6 millivolt).
- In addition to the users instructions, the prescriptions regarding regarding accident prevention and occupational safety must also be complied with. regulations technical The appertaining national regulations and standards of the country of use, with regards prevention of accidents and environment, are an extension of the users instructions.
- TMJOINT is a device that is able to function CONTINUOUSLY, BTS Biomedical 15 BTS TMJOINT warnings this is of course limited by the battery duration and by the memory available for the acquisition data storing.
- the device uses lithium ion battery. For the battery replacement and disposal please contact the technical support. At any rate, ensure that device component (i.e. probes, receiving unit,...) integrity is never compromised. The information contained in this manual is subject to change without notice and does not constitute product specifications or any obligation on the part of BTS S.p.A. 16 BTS Biomedical BTS TMJOINT copyright The software of the system described in this manual is supplied with the licence to use contract. The software may be used or copied only as stipulated under the terms of this contract. No part of this manual may be copied or transmitted in any form or means, electronic or mechanical, including photocopying, without prior written permission from BTS S.p.A. Unless otherwise specified, any reference to companies, names, data and addresses used in the reproduction of the screens and the examples are purely incidental, and has the sole purpose of illustrating the use of the BTS product. All trademarks are registered by the respective owners. This publication contains reserved information which is the property of BTS S.p.A. The recipient acknowledges that the illustrations and information supplied in this manual shall not be made available to third parties without explicit written agreement by BTS S.p.A. BTS Biomedical 17 BTS TMJOINT introduction General description BTS TMJOINT is the solution for the functional analysis of dental occlusion. Functional information is provided on the neuromuscular alterations induced by occlusal contact. BTS TMJOINT integrates the latest wireless technology available today. Based on wireless technology, this solution includes a set of EMG probes with active electrodes, the only one of its kind in the world due to its light weight (weighing less than 9 grams), compact size and data capturing accuracy, a USB receiving unit and the dedicated software BTS Dental Contact Analyzer. BTS TMJOINT uses surface electromyographic analysis to measure the differential influence of the occlusal function through indices validated and published in scientific literature. Special feature of this system is the standardization of the electromyographic signal that is provided by the comparison between two test of clenching, done with and without the interposition of cotton rolls between the dental arches. This method allows the elimination of problems of the wrong positioning of the electrodes, of the difference of impedance of the patients skin, of the differences of muscular tropism, etc. making it accurate and repeatable. The results are shown via a special graphic interface that is easy to 18 BTS Biomedical introduction BTS TMJOINT understand for both the physician and patient. The specialized software BTS Dental Contact Analyzer, provide, indeed, the automatic indices calculation, plotted in a table form, with pie charts and histograms. BTS TMJOINT is a modular and scalable solution, structured on various levels of analysis. The first level, called POC4, includes 4 capture probes and the analysis protocol. Through a quick 5 second clenching test, the activities of the masseter and anterior temporal muscles, right and left, provide, as an immediate result, a POC percentage overlapping coefficient (an index of the symmetric distribution of the muscular activity determined by the occlusion) and a TORS torque coefficient (to estimate the possible presence of mandibular torque), which makes it possible to establish the role of occlusion on muscular balance. A third index, called IMPACT, allows to evaluate the muscular work, providing information about the occlusal vertical dimension. The second level, called POC6, adds to the previous 2 capture probes for calculating the indices related to the sternocleidomastoid muscle, right and left. The effects of the teeth touching, on the neck muscles are evaluated. The third level, called MASTICATION, analyses the neuromuscular coordination during mastication. The masticatory frequency, the Lissajous curve, and indices of muscle symmetry are calculated. BTS Biomedical 19 BTS TMJOINT introduction Case contents Receiving Unit Probes Kit available in 2 versions:
POC4: include 4 wireless probes*
POC6: include 6 wireless probes*
*(identificative labels available in 4 different colors) Probes Charger (AC adapter included) 20 BTS Biomedical introduction BTS TMJOINT Set of disposable electrodes USB extension cable User manual You will receive the instructions for use for other possible optional components not mentioned in this manual. BTS Biomedical 21 BTS TMJOINT system components BTS TMJOINT system consists of two parts: the receiving unit and the wireless EMG probes. Receiving unit The receiving unit, connected to the PC trough USB, allows the WiFi reception of the EMG signal acquired by the wireless probes WiFi transmission 2 4 6 8 3 5 7 22 BTS Biomedical system components BTS TMJOINT Wireless EMG Probes BTS FREEEMG 300 utilises miniaturized probes with active electrodes weighing less than 13 grams. The special design ensures maximum space-saving and comfort for the patient who is free to move around without obstacles. The probes can be hooked on directly to the pre-gelled electrodes without requiring additional fixing with plasters or double-sided tape. This together with the total absence of cables enables a much faster patient preparation, drastically reducing the time of each session. Each probe consists of a mother electrode and a satellite electrode, each fitted with a clip. The two parts, connected via a flexible cable, may be positioned as needed by the user at adjustable distance (electrodes with variable geometry). All probes are also equipped with a solid state memory buffer, to prevent data loss for problems due to the WiFi network or due to exceeding the useful operating range. 6 1 22 3 5 Each probe is fitted with a LED indicating its state. 4 7 5 1 2 3 4 5 6 7 mother electrode LED satellite electrode mother electrode clip satellite electrode clip flexible cable probe ID The probes can be in one of a number of different states:
Charge: steady blue LED. BTS Biomedical 23 BTS TMJOINT system components During the recharging phase the steady blue LED is on. This phase occurs when the probes are connected to the charger turned on, and the charge level is less than 90%. When the charge level reaches 90% the led turns OFF. Since, by connecting a probe to the charger on, it enters in Deep Sleep mode, even while charging the probe will be completely passive and does not respond to any commands. Active-Scanning: white LED which cyclically lights for a few seconds. In this mode the probe is searching for the receiving unit. At intervals of about 1 minutes it carries out a scan of the frequencies of few seconds. During the scan the white LED flashes quickly. Active-Connected: white LED which flashes slowly. When the probe and the receiving unit establish a connection, the white LED begins to pulse slowly: the probe is waiting for commands. If the connection is interrupted, the probe returns to 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 flashes at regular intervals of approximately one second. At the conclusion of the acquisition, the probe returns to the Active-Connected condition. If during the acquisition, connection to the receiver unit is lost, 24 BTS Biomedical system components BTS TMJOINT the probe continues to acquire, storing the data locally for one minute and at the same time scans the assigned channel trying to reconnect to the receiving unit. If after one minute the scan is unsuccessful, the probe returns to the Active-Scanning condition interrupting the storage of data. Completely discharged or in Deep Sleep mode: LED is off. If the probe is completely discharged the LED does not display any flashing cycle and is off. The same happens when it is in Deep Sleep mode (except during the recharging phase in witch the led is steady blue). The probes in Deep Sleep mode do not perform any scan cycle, but are turned off. Is therefore guaranteed energy savings. To put the probe in Deep Sleep mode it is necessary to connect them to the Charger switched on, or to put them in contact with a magnet for half a second. Before the next use is necessary to reactivate the probes, putting them in contact with a magnet. The probes are charged by a dedicated charger to which the probes are connected via their respective clips. For more info about the probes charge sse the paragraph Charger of this chapter. BTS Biomedical 25 BTS TMJOINT system components Charger The Charger, included with the product, charges the BTS TMJOINT probes. The Charger can simultaneously charge all the EMG probes of the system
(6 maximum) and includes a lodging to store the receiver when not in use for acquisition. The EMG probes are connected to the charger using the same clips that normally collect the EMG signal. For correct connection simply follow the outline of the probes shown on the base of the Charger. At any rate, poles connected incorrectly will not recharge. 26 BTS Biomedical system components BTS TMJOINT In any case, the Charger comes with an output short circuit protection system also in case of reversed recharging poles. To recharge connect all the probes that you would like to charge to the Charger (follow the instructions described above) and connect the AC/
DC adaptor to the mains and turn on the switch located on the rear panel. When the Charger is properly connected to the mains and has been turned on, the status LED Power will show a steady GREEN light. The charging status of the probes is indicated by the status LED of the probes (see Wireless Probes). Note that inserting the EMG probes into the Charger when it is on, these come in Deep Sleep mode. It is necessary to reactivate the probes, prior to use them, using a magnet. BTS Biomedical 27 BTS TMJOINT installation User PC minimum configuration Operating system Processor RAM Video resolution Disk space USB Windows 7 Intel Dual Core 2 GB 1280x800 100 MB for the application, not including storage for acquired data 2.0 Connections The wireless probes transmit in real-time the acquired data to the receiver connected via USB to the Workstation. Connect the receiver to the WS using the USB connector. If the morphology of the WS does not allow direct connection of the receiver, use the USB extension cable. Also verify that the probes are fully charged and ready for use. It is required that the probes are disconnected from the charger to be recognized and activated by the system. 28 BTS Biomedical installation BTS TMJOINT Description of the software on the user PC BTS TMJOINT is provided with BTS DENTAL CONTACT ANALYZER
- DCA, the specialized software for the automatic calculation of indices correlated to the occlusal contact and to the possible neuromuscular alterations induced by it. The software allows managing the patient database, organized with a tree root with sessions, trials and subject data, esplorable through different database queries. The provided data are translated in graphical form for an easier interpretation and plotted in a table form, with pie charts and histograms. It is possible to create report of single trial or to compare two trials such as a pre and a post treatment. All the reports, once created, can be saved and reloaded in a second time. Software installation BTS DENTAL CONTACT ANALYZER software is usually pre-installed and configured. However, if it is necessary to perform again the installation just follow the instructions below. Once entered in the CD player of the computer dedicated, the BTS CD software containing the installation files, launch the .exe file POCAnalyzer-
X.X.XX.X.msi and follow the instructions provided by the application. It will appear the following screen:
BTS Biomedical 29 BTS TMJOINT installation After have accepted the installation terms and chosen the Typical installation, click always on Next key, until the procedure end. Then perform a double click on the CDM20814_Setup.exe file and wait for the window that has just opened, to close. 30 BTS Biomedical installation BTS TMJOINT Check that on the PC are installed the following two elements:
Microsoft.NET Framework 3.5 (for Windows XP) or Microsoft.NET Framework 4 (for the next versions);
PDF Creator 1.2.1 (disable the research for possible updates) In case they are not already on your PC please download them from the Internet (they are free) and install them. Hardware installation After have performed all the steps above, it will be necessary to configure the port for the USB receiver. To set the characteristics of the receiver the system requires the receiver to be connected to the PC via a USB port. Then, clicking the mouse right button on My Computer, select Properties, choose Hardware and then enter the Device Manager:
BTS Biomedical 31 BTS TMJOINT 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. 32 BTS Biomedical installation BTS TMJOINT Set in the drop box menu related to the Bits per second, the value 115200 and then click Advanced. In the window that opens, you must set the value of Latency Timer
(msec) equal to 1msec, and then click OK, returning to the previous screen. Also in the Port Settings window click on OK then close the windows remained still open. During the setting operations of the COM port, take note of the port number that the PC automatically associates to the device, because you will need it at the software first start.. BTS Biomedical 33 BTS TMJOINT installation First software use Continuing to keep the USB receiver into the USB input, double-click the icon on your desktop Dental Contact Analyzer to run the software. On the first start it will be asked to choose the preferred language for the interface software; once selected you must click on OK. When the procedure will be completed, the software will start showing the following window:
On the first start you should check that the correct COM port is set by selecting the Laboratory voice from the tool bar and click Set EMG Device. 34 BTS Biomedical installation BTS TMJOINT 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. BTS Biomedical 35 BTS TMJOINT installation If the chosen port is the one corresponding to the USB receiver and if it is set correctly, the fields below will activate showing the MAC Address of the probes associated with the receiver you are using. If all of these operations are successful, clicking on Update the window will close and you can start using the software. 36 BTS Biomedical BTS TMJOINT patient setup POC4 Protocol The POC 4 protocol provides the acquisition of 4 muscles: the masseter and the temporalis anterior bundle for both face sides. Temporalis Anterior Masseter Each probe is numbered and for this protocol we will use the probes from 1 to 4. It is mandatory to follow this sequence:
probe n. 1 right anterior temporalis;
probe n. 2 left anterior temporalis;
probe n. 3 right masseter;
probe n. 4 left masseter. BTS Biomedical 37 BTS TMJOINT patient setup For the RIGHT temporalis anterior bundle, touch the muscle during the maximum clenching and find the major axis of the zygomatic process of the frontal bone; the electrode should be applied along a line parallel to this axis that runs through a couple of centimeters posterior to the process and above the temporal process of the zygomatic bone. Repeat the procedure also with the LEFT temporalis anterior bundle, trying to maintain a symmetry of positioning. For the RIGHT masseter, position yourself behind the patient when possible and touch the muscle during the maximum clenching, finding its venter. The electrode should be applied along the line that connects the external canthus of the eye with the mandibular angle. Repeat the procedure also with the LEFT masseter, trying to maintain a symmetry of positioning. It is recommended to apply in advance the probes on the 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 chairs 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. 38 BTS Biomedical patient setup BTS TMJOINT POC6 Protocol The POC 4 protocol provides the acquisition of 6 muscles: will be acquired also the sternocleidomastoid muscles, in addition to the masseters and the temporalis anterior bundles analyzed in the POC 4 protocol. Temporalis Anterior Masseter Sternocleidomastoid We will use the probes from 1 to 6 following this sequence:
probe n. 1 right anterior temporalis;
probe n. 2 left anterior temporalis;
probe n. 3 right masseter;
probe n. 4 left masseter. probe n. 5 - right sternocleidomastoid;
probe n. 6 - left sternocleidomastoid. For the probes positioning on the masseters and temporal muscles, refers BTS Biomedical 39 BTS TMJOINT patient setup to the instructions in the previous paragraph. To find the RIGHT sternocleidomastoid, asks the subject to rotate, as much as possible, the head to the left; the electrodes will be positioned on the muscle so identified. Repeat the procedure also with the LEFT sternocleidomastoid, trying to maintain a symmetry of positioning. 40 BTS Biomedical BTS TMJOINT guide to the use of BTS DCA Initial screen To launch the software DCA doubleclicking on the relative icon. Once loaded the software the following windows will be loaded:
The windows includes the following main areas:
the menu bar the tool bar the probe status bar the list of patients in the database provided with a search filter the information related to the patient, session or trial selected from the list the area which manages the trial viewing and the report generation. BTS Biomedical 41 BTS TMJOINT guide to the use of BTS DCA Menu bar The menu bar contains:
The Database menu which manages all the operations associated with the patient database;
The Laboratory menu from which to configure the EMG devices to use;
The Options menu which allows setting the software languages and the chart property;
The Help menu which supplies the software version number. The following functions can be accessed from the Database pop-down menu:
New Patient to add a new patient to the Database. New Session to add a session to the patient already inserted in the Database. New Trial to capture or import trials to an existing session. 42 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT Edit Patient to modify the information about a patient. Edit Session to modify the information associated with a session. Remove Patient to eliminate the selected from the database. A confirmation is requested. Remove Session confirmation is requested;
Remove Trial to eliminate the selected trial. A confirmation is requested. the selected session. A to eliminate From the database menu by selecting the voice Database & Data folder it is also possible to select an other Database or create a new one, modify the data folder path and select an application to read reports in PDF format. The second menu of the menu bar is the Laboratory menu:
From this menu the voice Set Emg Device may be accessed:
BTS TMJOINT use an Embedded EMG device, for this reason be sure that this option is selected. The BTS Dental Contact Analyzer software can interface itself also with the BTS FREEEMG systems for the data acquisition. Anyway the procedure of use of DCA with these other devices is not described in this manual. BTS Biomedical 43 BTS TMJOINT guide to the use of BTS DCA The following windows will be displayed:
This window is divided in two areas:
the Device area containing the information related to the Port and to the RF Channel for the data transmission;
the Sensors area containing the information related to the 4 or 6 probes (depending on the version installed) and in particular for each probes is indicated:
- the MAC Address containing the probe identificative code printed on the clip of the same probe.
- the number indicated on the probe label
- the identificative color of the probe label
- the name of the muscle associated to that probe. All these value can be modified by the user. 44 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT If any change has been done, click on Update to make the changes effective, while clicking on Cancel the values previously saved wont be changed. The next menu is the Options one:
From this menu the following functions may be accessed:
Language selection to choose between Italian and English. Select this command to call up the window in the figure:
Click on Save and restart the programme to make the changes effective, or close this windows to come back to the previous screen. Chart properties to set the visualization parameters of the graphs of the acquired EMG signals and in particular the abscissa unit of measure and the text, background and line color and the line tight. BTS Biomedical 45 BTS TMJOINT guide to the use of BTS DCA 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:
46 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT To close this windows and come back to the previous screen, just click on the top right hand corner cross. Tool bar The tool bar provides rapid access to the most used functions:
New Patient to insert a new patient in the Database. New Session to add a session to a patient already in the Database. New Trial to manage the acquisition or import of a trial in an existing session. Edit Patient to correct details about a patient. Edit Session to modify the information associated with a session. Remove Trial to eliminate the selected trial. A confirmation is required before proceeding with the operation. The deleted trial is moved to the recycle bin. Exit to leave the programme. Probes status bar The probes stratus bar, located in the top right hand area of the main screen, allows knowing immediately at any time the connection status of the 4 or 6 supplied probes. BTS Biomedical 47 BTS TMJOINT guide to the use of BTS DCA The LED can appear:
- blinking GREEN if the probe is active;
- blinking RED if the probe is not active;
- GRAY if the probe is not enabled. It is also possible to know the active probes battery status by clicking on the button marked by the symbol >>:
48 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT Patient list and research filter On the left side of the screen there is the area to manage the patients inserted in the database. At the software startup, it appears empty:
By opening the drop box menu marked with the red ellipse, a list of all the patients inserted in the Database will appear. Each patient is identified by a surname, first name and if available among the patient data, by his or her internal code. The patients are ordered, according to the alphanumeric characters, respect the field indicated in the drop box menu Search for, in the BTS Biomedical 49 BTS TMJOINT guide to the use of BTS DCA example Surname. It is possible to search for the patient via Surname or Internal Code. When the number of patient included in the database is high, it is possible to use a search filter to restrict the number of patients displayed in the drop box menu. To do that, select the search criteria to be used between the two voice of the drop box menu Search for (Surname and Internal Code) and type in the underlying white box the letters or the numbers to be used as filter (i.e. if you are looking for the patient JOHN SMITH you have to select the Surname search criteria and type the letters S, M...). Once selected a patient from the list, it will be loaded in the underlying area, and all his sessions and trials will be available for the elaboration organized in tree structure. Click the + symbol to expand the patient node and access the list of the sessions for that patient. Expanding the session node obtains the list of the trials for that session. If a patient or a session doesnt have the + symbol it doesnt contain any 50 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT data. To compact the list and hide the trials or the sessions click the - symbol. When the node is selected, the node icon is substituted by an azure arrow. In this way the patient, the session, or the selected trial, can always be identified.. Besides the name of the patient there is an ID number that is a code assigned automatically by the software to the patient and cannot be changed. It identify all the data related to this patient saved in the PC. If the file is not physically present in the current data folder, the icon alongside the node is cancelled with a cross The information continues to be present in the database, but it is not possible to use them. When a node is selected to which data is no longer associated, the arrow appears within a prohibited symbol. The icon of a full recycle bin at the bottom on the right indicates that there are data (patients, sessions or trials) which have been deleted but can be recovered. To recover them double click the full recycle bin symbol to access the deleted files. The empty recycle bin symbol indicates that there are no files which can be recovered. BTS Biomedical 51 BTS TMJOINT guide to the use of BTS DCA Patient, session and trial information In the bottom left hand corner area of the main screen there are the information of the selected patient, session and trial. There are two main panels:
- the first one contains the information related to the patient that are:
Name Surname Birthdate Click the More patient information button to open a table which records all the information related to that patient: :
To close the table click the Close patient information button.
- The second one contains information related to the trial and in particular:
Acquisition date;
Trial notes (max 255). This last field can be updated by editing the notes field and clicking the Save icon. 52 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT It is also possible to visualize the information of the session that contains the selected trial by clicking on Session information. Close session information close the panel. Trial viewing and report generation area The trial viewing and report generation area is made of the following panels:
- Patient reports: consists of a drop box menu containing all the saved report of the selected patient. After selecting a report from the drop box menu the Open button became active. By clicking the Open button the application for the PDF reading will be loaded and the selected report will be visualized.
- Trial to process: this panel contains all the trials among whom selected the trials for the report generation. To insert a trial in the Trial to process panel is enough a double-click on the trial from the tree of the selected patient and it will be added immediately to the trial list. BTS Biomedical 53 BTS TMJOINT guide to the use of BTS DCA To proceed with the report generation, it is necessary to identify the type of trial by using the 8 button at the left of the panel:
The software will automatically assign a typology among COT, CLE, ROT, MASTDX, MASTSX, to each trial loaded. The POST label will be assigned to the second trial of the same type loaded, while all other trials of this typology loaded after wont 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. 54 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT To facilitate the procedure of classification, when one trial is selected the Acquisition date and any Trial notes are displayed on the right side of the panel:
To remove a label from a trial in the list, select it and click on CLEAR. To remove all the trial from the panel Trial to process is enough to click on the recycled bin icon. Once the trial labeling procedure has been properly executed it is possible to create the report by clicking the REPORT button:
The report could be created only if:
at least one COT type trial and one CLE trial have been loaded;
a MASTDX and/or MASTSX type trial have been loaded. If at least one of these two condition is not verified a warning BTS Biomedical 55 BTS TMJOINT guide to the use of BTS DCA massage will be displayed. For example:
When a PRE-POSt report must be created it is possible to use two different trials of cotton type labeled as COT and COT POST(typically when we need to compare trials acquired in different days), or to use just on COT type trial that will be used to normalize both the CLE trial and the CLE POST trial (typically when we need to compare trials acquired the same day, without modify the position of the electrodes, such as clench test executed with and without bite). Only the trials witch have been marked with a color correspondent to one of the 8 trial typologies, among all the trial present in the list Trial to processed will be used to construct the report. If all the operation have been executed correctly the window for the report management will be displayed. From that window it is possible to select all the element to be inserted in the report. There will be also the button to open the print preview, to launch the print or to save the report in the database to recall it in a second time. The windows is divided in two area:
56 BTS Biomedical guide to the use of BTS DCA BTS TMJOINT the main area shows, organized in TABS, the graphs, the tables and the info that can be inserted in the report. the button bar contains the Print preview, Print and Save Report buttons, the field report PDF name in witch is visualized the report name automatically assigned by the software (this name can be modified by the user before to click on Save Report), finally there is the Exit button to come back to the main screen of the software.
- Preview of selected trial: in this panel in shown a preview of the Trial selected in the panel Trial to process. BTS Biomedical 57 BTS TMJOINT guide to the use of BTS DCA The scale of the y-axis can be modified selecting the maximum value to be visualized among the value of the drop box menu (+-mV) placed at the right of the panel. 58 BTS Biomedical BTS TMJOINT main features of the BTS DCA software New patient Select New Patient from the menu and tool bar to open the window below:
To insert a new patient simply fill in the fields and click Add Patient. The fields marked with an * are mandatory. Click on Cancel to come back to the previous screen. Any inserted data will be lost. BTS Biomedical 59 BTS TMJOINT main features of the BTS DCA software New session Select New Session from the menu and tool bar to open the window below:
To create a new session simply fill in the fields and click Create Session. In particular it is required to:
give a name to the session to be created. This field is mandatory. To proceed with the creation of the session the session name must been inserted otherwise the following warning message will be displayed:
60 BTS Biomedical main features of the BTS DCA software BTS TMJOINT select the pathology among the voices available in the drop box menu (automatically the first voice of the list respect the alphabetic order will be proposed). the list of pathologies is completed entirely by the user. To add, eliminate or modify a pathology from the list icon, to access the Edit pathology window. click the At the first use of the software the pathology list will be empty. It is necessary to insert at least one pathology to proceed with the session creation. insert any Note about the session (field not mandatory). indicate any previous treatment of the patient. For both these fields there are 255 characters available. modify the session date (if different from the date of the actual day proposed as default). To delete the session creation and come back to the previous screen click on the button Cancel. BTS Biomedical 61 BTS TMJOINT main features of the BTS DCA software Edit Pathology From the New Session window, click the symbol pathology list. to open the In the central panel all the pathology already inserted in the database are listed in alphabetic order. To add a new pathology write the name of the pathology in the field Insert new pathology to add and click the blue arrow to add the pathology to the list. To change a pathology:
Select the pathology from the list. The name is shown in the field Modify the selected pathology. Modify the name of the pathology Click the icon alongside to apply the change to the list. To delete a pathology:
62 BTS Biomedical main features of the BTS DCA software BTS TMJOINT Select the pathology to be deleted Click on the recycle bin icon Confirm the deletion of the trial by clicking Yes. To exit from the window Edit pathology click on Close. New Trial Select New Trial from the menu and tool bar to open the following window:
To create a new trial it is possible to make an acquisition or to import a trial acquired in the past. In any case it is necessary to select a Type among the voices proposed in the drop box menu for the trial to be created. Fill the fields relative to Trial to acquire if you want to proceed with an acquisition, or fill the fields relative to Import TDF file if instead you want to import a trial acquired in the past. BTS Biomedical 63 BTS TMJOINT main features of the BTS DCA software 7 typologies of test are allowed:
COT4: requires the use of 4 probes placed on the temporal and masseter muscles. To the subject it is required to perform a clenching of 5 seconds with two cotton roll interplaced between the two arches, one for each side. CLE4: requires the use of 4 probes placed on the temporal and masseter muscles. To the subject it is required to perform a clenching of 5 seconds. COT6: requires the use of 6 probes placed on the temporal, masseter and sternocleidomastoid muscles. To the subject it is required to perform a clenching of 5 seconds with two cotton roll interplaced between the two arches, one for each side. CLE6: requires the use of 6 probes placed on the temporal, masseter and sternocleidomastoid muscles. To the subject it is required to perform a clenching of 5 seconds. ROT6: requires the use of 6 probes placed on the temporal, masseter and sternocleidomastoid muscles. To the subject it is required to perform a series of head rotations. MASTRT: requires the use of 4 probes placed on the temporal and masseter muscles. To the subject it is required to chew for 15 seconds on the right side. MASTLT: requires the use of 4 probes placed on the temporal and masseter muscles. To the subject it is required to chew for 15 seconds on the left side. Once all the fields have been filled in, click respectively on Acquire to start the process of acquisition (see next chapter), or on Browse... to select the trial to be imported directly from Windows Explorer on your PC. 64 BTS Biomedical main features of the BTS DCA software BTS TMJOINT 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 dont want to enter any notes BTS Biomedical 65 BTS TMJOINT main features of the BTS DCA software simply close the window. The procedure for trial acquisition or import can be repeated several times to add more trials to the same session. Note that the system doesnt 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:
66 BTS Biomedical main features of the BTS DCA software BTS TMJOINT On the top bar is shown the six probes status:
Information displayed are referred in sequence to probes number 1, 2, 3, 4, 5, and 6 starting from left going to right. For each probe there are a status LED and an identification label. The status LED beside each channel can be:
- GREEN: if the probe is active;
- RED: if the probe is not active;
- GREY: if the probe is not allowed for the system. The identification label is linked to the muscle is acquired with that specific probe:
- R_TEM for the right temporal muscle,
- L_TEM for the left temporal muscle,
- R_MAS for the right masseter muscle,
- L_MAS for the left masseter muscle,
- R_SCMCL for the right sternocleidomastoid long head muscle,
- L_SCMCL for the left sternocleidomastoid long head muscle. In case of inactive probes, the label is usually Ch1, Ch2, Ch3, Ch4, Ch5, Ch6. On the central area of the screen the real-time oscilloscope will show the signals coming from the probes. There will be displayed 4 or 6 channels depending on the protocol chosen:
BTS Biomedical 67 BTS TMJOINT main features of the BTS DCA software The oscilloscope allows to verify the correct probes positioning before starting the real acquisition and to verify the proper movement execution required to the patient. For a better signals visualization it is possible to modify the axis scales clicking on the drop down menu on the bottom:
To start the acquisition all probes required in the selected trials 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. 68 BTS Biomedical main features of the BTS DCA software BTS TMJOINT The clenching trials CLE4, COT4, CLE6 and COT6 stop automatically after 5 seconds, while chewing trials MASTRT and MASTLT stop after 15 seconds. By the way it is possible to interrupt before the record clicking on Stop. The acquisition of the rotation trial ROT6 has to be interrupted manually clicking on Stop when the subject executed all the movements required. At the end of the trial data will be automatically downloaded, when this will be complete a signals acquired preview will be shown. It is possible to modify the visualization range to zoom in the signal to evaluate that the trial has been performed properly before save it. For clenching trials, (COT and CLE) at the end of each acquisition, it is possible to visualize a preview of the pie chart related to the RMS mean value clicking on the correct button:
BTS Biomedical 69 BTS TMJOINT main features of the BTS DCA software If more than one acquisition of clenching trials has been performed, besides the pie chart of the current trial, there will be also displaied pie charts of the previous ones (up to two) to allow the verification of the data repeatability:
If the acquisition is good it is possible to save the trial clicking on Save. A window will appear to add, if necessary, notes related to the trial:
After edited the notes, click on Add note while if notes are not required just close the window. Once this operation is done the New Trial window will appear again. 70 BTS Biomedical main features of the BTS DCA software BTS TMJOINT If the trial just acquired is not good enough to be saved, it is possible to proceed with a new acquisition. To do that click on View to restart the real-time oscilloscope and repeat the recording procedure. Data just acquired are not going to be recovered, for that reason a window will ask a confirmation about choosing not to save the last acquisition:
Finally, to exit from the acquisition and go back to the New Trial section, click on Exit. If the last trial has not been saved, the following screen will appear:
Clicking on Yes data will be stored, clicking on No the acquisition window will be closed and last trial data will be canceled, finally clicking on Cancel you go back to the acquisition screen. BTS Biomedical 71 BTS TMJOINT main features of the BTS DCA software Edit patient Select Edit patient from the menu and tool bar to open the following window:
Note that to do this a patient must be selected in the database, otherwise the following warning message will appear:
The Edit patient window will show all the selected patient data previously entered. It is possible to modify them or add new ones. When all changes have been made click on Update patient to save the new data in the database. 72 BTS Biomedical main features of the BTS DCA software BTS TMJOINT Se loperazione andata a buon fine comparir la seguente finestra:
Finally, to exit without making any changes to the data click on Cancel. Any change made will be lost. Edit session Select Edit Session from the menu and tool bar to open the following window:
BTS Biomedical 73 BTS TMJOINT main features of the BTS DCA software Note that to do this a patient must be selected in the database, otherwise the following warning message will appear:
The Edit Session window will show all the selected patient data previously entered. It is possible to modify them or add new ones. When all changes have been made click on Update Session to save the new data in the database. To exit without making any changes to the data click on Cancel. Any change made will be lost. Delete patient To remove a patient from the database, select it and choose Delete Patient from the menu bar. This operation will move the selected patient in the recycled bin together with all sessions and trials related to him. 74 BTS Biomedical main features of the BTS DCA software BTS TMJOINT A conform to the cancellation will be asked:
Note that to do this operation a patient must be selected in the database, otherwise the following warning message will appear:
Delete session To remove a session from the database, select it and choose Delete Session from the menu bar. This operation will move the selected session in the recycled bin together with all the trials related to him. A conform to the cancellation will be asked:
BTS Biomedical 75 BTS TMJOINT main features of the BTS DCA software Note that to do this operation a session must be selected in the database, otherwise the following warning message will appear:
Delete trial To remove a trial from the database, select it and choose Delete Trial from the menu bar. This operation will move the selected trial in the recycled bin. A conform to the cancellation will be asked:
Note that to do this operation a trial must be selected in the database, otherwise the following warning message will appear:
76 BTS Biomedical BTS TMJOINT more features of the BTS DCA software Database and data folder From the menu bar select the Database option, and then the Database
& Data folder function to open the window below:
The field Current database shows the path of the database actually selected. It is possible to lad an other database or to create a new empty one. To create an empty database, click the icon Create an empty database:
a new window in witch enter the name of the new database will appear. Click Save to create a new database. The Current Database field will BTS Biomedical 77 BTS TMJOINT more features of the BTS DCA software be updated accordingly. To work with a different database to the default one:
Click the icon Change current database Browse the folders and select the database desired. Click open to change the database. The Database field will be updated. If you wish to use the new database as a reference, tick the option Set current database as default. If this is not done, the setting will be lost when the BTS Dental Contact Analyzer is closed, and the default database will be loaded at the next launch of the program. To change the data folder:
Click the Change current data folder icon. Select or create the new folder. A sub-folder will be created automatically in which the files will be saved. The name of the subfolder is shown in brackets under Current data folder. In the figure the subfolder is DataPOCAnalyzer. This folder is changed automatically when the current database is changed. Also in this case to set the new folder as the default data folder put a check in the Set current data folder as default. 78 BTS Biomedical more features of the BTS DCA software BTS TMJOINT If this is not done, the setting will be lost when the BTS Dental Contact Analyzer is closed, and the data will be saved in the default folder at the next launch of the program. The reference My Captures folder is that which contains all the file required by the software to work properly. It is therefore recommended to choose a new folder only with the consent of the technical staff of BTS. To change this folder:
Click the icon Change current folder My Captures. Select the new reference folder (which will contain all the file required by the software to work properly) Also in this case to set the new folder as the default data folder put a check in the Set My Captures folder as default. If this is not done, the setting will be lost when the BTS Dental Contact Analyzer is closed, and the old My Captures folder will be used at the next launch of the program. From this screen you can then select the application used to read the report in PDF format. To select the application click on Browse... and select the exe file you want to use. Please note that if no application is selected you can not see the reports. BTS Biomedical 79 BTS TMJOINT more features of the BTS DCA software To apply the changes click Save and exit. Managing files in the recycle bin If you wish to remove a patient, session or trial, the file is moved to the recycle bin. To access the files held in the recycle bin, double click the icon representing the recycled bin which appears in the patient list. The following windows will appear:
In the left side of the panel there are all the data contained in the recycled bin organized per patient with a tree structure. By expanding the nodes it is possible to access to sessions and trials. 80 BTS Biomedical more features of the BTS DCA software BTS TMJOINT In the file tree the node labels may have three different colors:
The black label indicates that the file (patient, session or trial) has been removed from the database together with all the files associated with it. The dark grey label and icon indicate that the file is present in the database, but some elements associated with it have been removed (e.g. a session of a patient has been removed, or a trial from a session). The light grey label indicates that the file has been deleted along with the root file (e.g. a patient main file has been deleted. As a result all of the related sessions and trials have also been removed). Selecting a node which has been removed updates the patient, session and trial information. From the Deleted data window it is possible to carry out four different operations:
This button recovers the selected file. When a session is selected all the associated trials will also be recovered. When a patient is selected all the associated sessions and trials will also be recovered. This button eliminates the selected file permanently. Before eliminating the file, a confirmation will be requested. If you eliminate a file, it cannot be recovered. Eliminating a session also eliminates all the associated trials. Eliminating a patient also eliminates the associated sessions and trials. BTS Biomedical 81 BTS TMJOINT more features of the BTS DCA software If the button is deactivated, it means that the file is not present in the recycle bin (the icon alongside dark grey text), or it may not be recovered individually. In this case it is necessary to select the root file. This button recovers all the files in the recycle bin. All patients, sessions and trials will be available again in the database and the recycle bin will be empty. This button permanently eliminates all the files in the recycle bin. A confirmation must be given for this operation. Confirming the elimination means that the files will no longer be recoverable. At the end of this operation the recycle bin will be empty. 82 BTS Biomedical BTS TMJOINT guide to the report data reading The data report is automatically generated by the software DCA. The results of the data elaborations are organized in tabs: INT, EXT, POC, ISTO and MAST. Moreover there is an INFO tab for the customization of the printed report. INT tab BTS Biomedical 83 BTS TMJOINT guide to the report data reading The elaborated data are divided into PRE and POST sections, for the comparison of two tests of the same acquisition session, or of tests made in different temporal session. This is helpful in evaluating the treatment efficacy and for the patient follow up. The graphic shows a dental arch, which works as a 2D morphological map, on which are superimposed icons target style (they will be so called in the rest of the document), positioned in order to summarize the occlusal condition, according to the calculated indices, whose values are given in the table below. POC: percentage overlapping coefficient It is an index of the standardized contraction symmetry within the same muscular couple. It expresses, in percentage terms, the difference in electrical signal generated by a muscle couple during a maximum voluntary contraction (MVC) compared to its homologous standardized value. If the two homologous muscles of each pair are contracted in perfect symmetry, thanks to a functionally balanced dental occlusion, the POC result is expected close to 100%. While if muscle couples show standardized values in percentage terms different from each other, the POC turns out to be considerably less than 100%. When the POC exceeds 83%, there is a normal muscular symmetry, induced by the contact of the teeth, otherwise, the dental contact is influencing the neuromuscular equilibrium of the patient. With the 4-channel protocol, are calculated the POC of the anterior temporal and masseter muscles, which are respectively indicated by POC TA and POC MM, indicators of the influence of tooth contact on the 84 BTS Biomedical guide to the report data reading BTS TMJOINT neuromuscular balance of the stomatognathic system; with 6-channel protocol, is calculated in addition the coefficient of overlapping percentage of the sternocleidomastoid muscles POC SCM, indicator of the influence of tooth contact on the cranio-cervical neuromuscular balance. For each POC is also indicated which is the predominant muscle and in what percentage it contributes to the total level of asymmetry. In particular, the letter R indicates that there is a prevalence of the right muscle while the letters L that there is prevalence of the left one. POC: graphical representation The central vertical line, dark gray, dotted, corresponds to the 100%
value and the light-gray vertical band indicates the range of normality, up to the value 83%, both right and left of central line, in order to represent the prevalence of right or left muscle activity. The blue target refers to the POC index of the anterior temporal (POC TA), while the red refers to the POC index of the masseters (POC MM). The POC TA index corresponds to the influence of dental contacts of the incisors, canines and first premolars. The index POC MM corresponds to the influence of dental contacts of the premolar and molar teeth. Values of POC out of the norms indicates a quality of contact prevalent or lack of one side respect the controlateral. The target is represented at a distance from the central vertical line corresponding to the calculated value. If the POC value is more than 83%, the target is represented within the gray central band, while if it is lower it is represented outside the normal BTS Biomedical 85 BTS TMJOINT guide to the report data reading range. So it is easy to observe the predominance of the right or left temporal in the anterior quadrants, and the masseter, left or right, in the posterior quadrants. The value of the POC SCM does not affect the targets position, but only the percentage of co-contraction of neck muscles during MVC. BAR: Barycenter It provides an estimate of the occlusal barycenter position. It is obtained by calculating the percentage overlapping coefficient between the activities of the couple of temporal and the activities of the couple of masseter (while the POC index compares single homologous muscle). When the contact points tend to focus on the molars, the masseters record a major contraction respect to the correspondent temporalis
(Posterior barycenter). Instead, in the occlusal condition in which the barycenter moves in the anterior-lateral areas, that means until the first-second premolar, the temporalis express major contraction forces (Anterior barycenter). In this case there is a bilateral overload of the joints that, with the passing of time, can lead to pathological conditions. For the BAR index if the position of the barycenter is mainly anterior, there will be the letter A, will also be indicated in what percentage the anterior temporal muscles contribute to move the barycenter upwards. Vice versa there will be the letter P and will also be indicated in what percentage the masseter muscles contribute to move backwards the barycenter. BAR: graphical representation The normal value of the BAR index is > 90%. 86 BTS Biomedical guide to the report data reading BTS TMJOINT The two horizontal dark gray lines with dots, superimposed to dental arch, represent the BAR value equal to 100%, while the gray bands represent the normal range up to 90%. The two targets will be translated at a distance from the relative horizontal line of a value corresponding to the BAR index calculated, upwards or downwards following the prevalence of the BAR index (anterior or posterior), according to the occlusal condition. The value and the direction of the vertical displacement of the two target points are then exactly the same. The BAR value in the normal population always expresses a prevalence of differential activities of the couple of masseter muscles compared to that of temporal. This condition is reversed in the second skeletal class in which the temporal muscles always express a differential electrical activity greater than the masseters 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. BTS Biomedical 87 BTS TMJOINT guide to the report data reading There will be the letter R when there is mainly a torsion to the right, while the letters L when the torsion is mainly to the left. It will be also reported in what percentage the dominant couple contributes to the creation of torque. TORS: graphical representation The resulting action of the temporalis muscle, added to the resulting strength of the contralateral masseter, generates a pair of forces with a moment which tends to laterodeviate the jaw in the direction of the resultant of the anterior temporal. If the right is greater, the target will be not only circular, but it will report an arrow to the right. Similarly, the arrow will be leftward if the coefficient calculated for the couple anterior temporal-right masseter is greater. We must not think that there is a real torsion of the mandible because we are under static conditions. Any clinical condition, which can be likened to pre-contact and then to tooth contact sliding, is therefore already occurred. The TORS index expresses a condition clinically worse because detectable only using instruments, that is the presence of fulcrums. The muscles continue to activate and inhibited themselves in the pursuit of stability. Clinically this corresponds to a contact mainly in the antero lateral area of the dental arch or to a contact qualitatively insufficient in the latero posterior sectors. It is generally associated also with temporomandibular joint problems. If associated with values of IMPACT lower than normal, it may indicate the presence of both, pain and protective mechanism to nociceptive stimulus. 88 BTS Biomedical guide to the report data reading BTS TMJOINT NOTE In the Notes field it is possible to add a text description that the clinicians want to include in the printable report as a comment of the represented data in the INT tab. Add to report checkbox If the check is in the box, the INT tab content will be included in the printed report, otherwise it will be ignored. EXT tab BTS Biomedical 89 BTS TMJOINT 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 coefficients already seen in the previous tab. The referring indices are TA%, MM%, SCM%, ATTIV, TORQUE, POCm, ASIM, CL and IMP. TA%, MM%, SCM%
These indexes represent in percentage the standardized average value of the activity respectively of the anterior temporal muscles, masseters and sternocleidomastoids left and right. The graphical representation includes a 3D model, for a male or female, according to the patient for whom the report relates. The status bars represent the level of electrical intensity, measured in the muscle near which are represented. Depending on the protocol used (4 or 6 channels), 4 or 6 bars are displayed corresponding to the anterior temporal muscles, masseters and sternocleidomastoids. The muscle that expresses the greater amplitude value of the electric potential, percentualized, is represented with a full bar and becomes the reference scale for the bars graphical representation of the other muscles, which will be compared to. In the example shown in the figure the right TA% is 83.57% and is the highest value of the 4. Then the bar will be represented full and the others will be represented in proportion according to the calculated 90 BTS Biomedical guide to the report data reading BTS TMJOINT values: left TA% = 57.92%, right MM = 45.62%, left MM = 38.67%. The bars can be green if the width value is greater than 83%, yellow if the amplitude is less than 83%, but above 75%, red if the width value is less than 75%. Similar interpretation for the SCM muscle, shown in the figure below as an example. The SCM POC is calculated only when using the POC6 protocol. ATTIV: activation Its a parameter similar to the BAR, but computed on the average value of maximum contraction and compared to zero, instead of 100%. BTS Biomedical 91 BTS TMJOINT guide to the report data reading 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 first-second premolar, the temporalis express greater contraction forces and the index becomes negative. Normally this index is always positive except in the second skeletal class in which the index is usually negative. For the resolution of TMJ (temporomandibular joint) acute pain problems it must be find a condition biomechanically favorable to the discharge of the forces burden on the TMJ that leads to a positivization of this index. TORQUE: mandibular torque Its a parameter similar to the TORS, but compared to zero, instead of 100%. The resultant force of the action of the temporalis muscle, added to the resultant force of the controlateral masseter, generates a force couple. The moment of this couple tends to laterodeviate the jaw in the direction of the resultant of the anterior temporal: if the right is greater, the torque values will be negative; while it will be positive it the left TA is predominant. POCm : medium percentage overlapping coefficient It is simply the medium between the TA POC and the MM POC. It 92 BTS Biomedical guide to the report data reading BTS TMJOINT represents the global POC. Also in this case the normality range is on 83% values. ASIM: asymmetry This index allows you to compare the activity of the muscles of the right side with the muscles of the left side. A positive value indicates a greater activation of the right side, while a negative value indicates a greater activation of the left side. The normal range is between -10 and 10. CL: Cervical Load This index is calculated only when using the protocol POC6, which includes the performance of a test of maximum rotation of the head to the right and left, in addition to the trials of clenching with and without cotton roll (thus with maximum intercuspation). Gives the percentage of co-contraction of SCM muscle during clenching:
a cervical load of 0% indicates an absence of recruitment, while a value of 100% indicates that the recruitment is maximum. The normal values occurs at CL 15%. Excessive values of CL indicate an excessive recruitment of neck muscles during the MVC, which may favor the persistence of clinical conditions for neck ache, especially in clencher patients. IMP: Impact this index indicates the muscle work, represented geometrically by the BTS Biomedical 93 BTS TMJOINT guide to the report data reading area under the curve of the electrical activity of muscles examined in the time. The normal range of the index are in the range 100% 15%. Higher values indicated that the subject should be considered a strong clencher. lower than normal may express a condition of Values proprioceptive inhibition acute with presence of pain during MVC, or chronic with presence of a nociceptive protective reflex. If the POC, TORS and BAR indexes are normal the IMP index is related to the vertical dimension. In this case there are indications on the possibility of raising
(index higher than normal) or reducing (index lower than normal) the vertical dimension, compatibly with the aesthetic condition of the patient. Outcome It is possible to add some notes to the report. Write them in this box to put them in the printed report. Add to report Checkbox If the check is in the box, the contents of the EXTtab will be included in the printed report, otherwise it will be ignored. POC tab In this tab the average activity of the four muscles Masseter right and left and Temporal right and left, are represented by pie charts. 94 BTS Biomedical guide to the report data reading BTS TMJOINT The first and second columns show the average activity of 4 muscles in microvolts, relative to clenching trials performed respectively with and without cottons. The third column, instead, shows the percentage value of the average activity of the 4 muscles as the ratio between the values obtained from the clenching trial without cotton and those with cotton. In order to evaluate the occlusal state you must refer to this third column. The dark blue sector represents the left temporal muscle activity while the BTS Biomedical 95 BTS TMJOINT guide to the report data reading 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 96 BTS Biomedical guide to the report data reading BTS TMJOINT The tab ISTO provides an alternate view of the main indices calculated:
Masseter POC, Temporal POC, Sternocleidomastoid POC (where provided 6 channels), TORS and BAR. In the graphs of the POC the activities associated to homologous muscles are represented as histograms. The activity of the right side (identified by white color) is compared with the activity of the left side (identified by red color): for each bar will be colored the data of the dominant muscle activity, while the contralateral muscle will be represented in gray. The values for each bar are calculated considering the average value of muscle activity of the clenching trial normalized with respect to the clenching trial execute with cottons in an interval of 25 ms. When the white is prevalent there is an activity of the muscle of the right side more pronounced, while when is the red to prevail, the left side is dominant. Is then given information on a possible asymmetry of muscle. Regarding the TORS index any torsion attitudes rightward are represented with the color white, while those leftward with the color red. Finally regarding the BAR index the white color indicates that the barycenter is moved anteriorly, while the red color, posteriorly. If you are analyzing two sessions (PRE, POST), the graphs for the second session can be viewed by clicking on Next. The Previous button allows returning to the charts of the first session. BTS Biomedical 97 BTS TMJOINT guide to the report data reading MAST tab The chewing protocol is composed of two separate trials, of 15 seconds each, in which the patient must chew a chewing gum holding it, for the entire duration of the test, on one side only. Produces, as a result, a graph about the coordination of masticatory muscles TA and MM: while, therefore, with the POC and the evaluation of the clenching, we evaluate the neuromuscular balance (Static condition), with the mastication protocol we evaluate the neuromuscular coordination
(Dynamic condition), by analyzing the repeatability of the muscular patterns. 98 BTS Biomedical guide to the report data reading BTS TMJOINT The ideal situation, corresponding to a good level of chewing coordination, is when the two ellipses of confidence are equidistant from the origin and present reduced dimensions. In addition to the graphical representation, some numerical indexes are calculated, for left and right side of chewing:
Frequency (bps) It is the number of masticatory acts per second. ModMed It is the distance from the center of the graph and the center of the ellipse of representation. TA Impact (uV) It is an index of the work done by the anterior temporal muscles during the test. MM Impact (uV) It is an index of the work done by the masseter muscles during the test. SMI: Index of chewing symmetry. It is a unique index, not differentiated by side. The ideal is a value of about 50%. Dental contact analyzer allows processing also a single test: in this case will be represented a single ellipse for the side measured. The index SMI, in this case, will not be calculated. BTS Biomedical 99 BTS TMJOINT guide to the report data reading INFO tab This tab allows you to enter data to customize the report and upload your own logo if desired. To do this, complete the fields of interest and click on Browse to select the image of your logo directly from your PC or put a check next to None if you do not want to use this option. Once you have completed entering the info you need to click on Modify Info to ensure that data is stored and included in the report. At first use, the fields are empty. 100 BTS Biomedical guide to the report data reading BTS TMJOINT Saving the data they will be automatically loaded at the next opening. It is possible to make further changes to the saved data. To save these changes it is necessary to click on Modify info. The following windows will appear:
Clicking on Yes to report information will be updated and will no longer be possible to recover previous data. If the operation has been successful you will see the following screen:
If you do not want to save the changes click on Upload Info to reload the last save. BTS Biomedical 101 Wireless Probes Geometry:
Electrodes:
Separation:
Autonomy:
Battery:
Dimensions:
Weight:
Frequency used:
Input impedance:
CMMR:
Resolution:
Acquisition frequency:
Sensitivity:
Measure accuracy*:
Receiving Unit Connection:
Dimensions:
Weight:
Frequency used:
BTS TMJOINT appendix A technical specifications variable standard with clip connection min: 16mm - max: 66mm 5h of use some days stand-by rechargeable, lithium ion 17x36x8mm mother electrode diameter 17 x 8mm satellite electrode
<9g battery included ISM band 2.4GHz (standard IEEE802.15.4)
>10 GOhm
>110 dB @ 50-60Hz 16bit up to 4KHz 1V 2%
USB 82x44x22,5mm 80 gr ISM band BTS Biomedical 103 BTS TMJOINT appendix 2.4GHz (standard IEEE802.15.4)
* The system is calibrated at the factory. No further calibration is required 104 BTS Biomedical BTS TMJOINT appendix B environmental specifications Operating Temperature Operating Humidity Storage and Transport Temperature Storage and Transport Humidity Altitude Min
-20 50%
0 50%
Note Max
+45 80% Relative, non-condensing
+40 80% Relative, non-condensing 0m 2000m Degrees of protection provided by the dangerous enclosures of water and dust (IEC 60529): IPX0. BTS Biomedical 105 BTS TMJOINT appendix C power supply and switch off The receiving unit is powered by the USB port. To switch off the system the following operation must be done:
- Exit from the DCA application
- Unplug the receiving unit from the USB port.
- Put the probes in Stand-By placing them on the Charger. 106 BTS Biomedical BTS TMJOINT appendix D battery BTS TMJOINT probes are internally powered. The Probe battery replacement can be done only by BTS qualified personnel. The probes are sealed to avoid the access to the internal circuit components. Batteries are equipped with battery protection circuit to:
-over-voltage, threshold 4.3V
-under-voltage, threshold 2.8V
- short-circuits The specific characteristic of the Wireless probes equipped with the battery are:
Quantity:
Technology:
Removable:
1 per each EMG probe lithium polymer (Li-Poly) NO, BTS technical service is required BTS Biomedical 107 BTS TMJOINT appendix E troubleshooting guide Warning Invalid trigger mode During the hardware installation, the USB port dedicated to the receiver, is configured. May happen that these port settings went lost. This event may occur for example when another USB device is connected to the PC and the PC assigns to it the same port previously assigned to the receiver, returning the port setting to the default configuration. In these cases it may occur that by launching an acquisition the following warning message may appear:
In this case to proceed immediately with the acquisition, it is necessary to restart the application, however the same problem will recur in later acquisitions. To resolve this problem you must repeat the USB port configuration procedure described in the Hardware Installation paragraph of the Installation chapter. 108 BTS Biomedical BTS TMJOINT appendix F declaration of conformity DECLARATION OF CONFORMITY Italy Fax +39 049 792 9260 BTS SpA Via della Croce Rossa 11, 35129 Padova (PD) Tel. +39 049 981 5500 name / description:
model:
S/N:
TMJOINT SN declare under our sole responsibility that the product(s):
Electromyographic system / device for the functional analysis of dental occlusion. 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 The product conforms to the following standards:
Applied part type: BF EN ISO 14971 IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 Medical Devices - Application of risk management to medical devices. Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance. Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility -
Requirements and tests. Medical Electrical Equipment - Part 1-6: General Requirements for basic safety and essential performance - collateral Standard: Usability Medical device software - Software life-cycle processes EN 62304 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 products usage manual. Notified Body : TV Product Service GmbH, Zertifizierstelle, Ridierstrasse 65, 80339 Mnchen 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. BTS Biomedical 109 BTS TMJOINT appendix G bibliography appendix 1. Ferrario VF, Sforza C, DAddona 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, DAddona A, Barbini E. Electromyographic activity of human masticatory muscles in normal young people. Statistical evaluation of reference values for clinical applications. J Oral Rehabil. 1993 3. Ferrario VF, Sforza C. Biomechanical model of the human mandible in unilateral clench:
distribution of temporomandibular joint reaction forces between working and balancing sides. J Prosthet Dent. 1994 Aug;72(2):169-76. PubMed PMID: 7932264. 4. Ferrario VF, Sforza C. Coordinated electromyographic activity of the human masseter and temporalis anterior muscles during mastication. Eur J Oral Sci. 1996 Oct-Dec;104(5-6):511-7. PubMed PMID:
9021318. 5. Ferrario VF, Sforza C, Serrao G. The influence of crossbite on the coordinated electromyographic activity of human masticatory muscles during mastication. 110 BTS Biomedical appendix BTS TMJOINT J Oral Rehabil. 1999 Jul;26(7):575-81. PubMed PMID: 10445477. 6. Ferrario VF, Sforza C, Serrao G, Colombo A, Schmitz JH. The effects of a single intercuspal interference on electromyographic characteristics of human masticatory muscles during maximal voluntary teeth clenching. Cranio. 1999 Jul;17(3):184-8. PMID: 10650405. 7. Ferrario VF, Sforza C, Colombo A, Ciusa V. An electromyographic investigation of masticatory muscles symmetry in normo-occlusion subjects. J Oral Rehabil. 2000 Jan;27(1):33-40. PubMed PMID: 10632841. 8. Ferrario VF, Sforza C, Serrao G, Fragnito N, Grassi G. The influence of different jaw positions on the endurance and electromyographic pattern of the biceps brachii muscle in young adults with different occlusal characteristics. J Oral Rehabil. 2001 Aug;28(8):732-9. PubMed PMID: 11556954. 9. Ferrario VF, Marciandi PV, Tartaglia GM, Dellavia C, Sforza C. Neuromuscular evaluation of post-orthodontic experimental protocol. Int J Adult Orthodon Orthognath Surg. 2002;17(4):307-13. PMID:
12596694. stability: an 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. BTS Biomedical 111 BTS TMJOINT appendix 11. Ferrario VF, Sforza C, Tartaglia GM, Dellavia C. Immediate effect of a stabilization splint on masticatory muscle activity in temporomandibular disorder patients. J Oral Rehabil. 2002 Sep;29(9):810-5. PubMed PMID: 12366533. 12. Ferrario VF, Sforza C, Dellavia C, Tartaglia GM. Evidence of an influence of asymmetrical occlusal interferences on the activity of the sternocleidomastoid muscle. J Oral Rehabil. 2003 Jan;30(1):34-40. PubMed PMID: 12485381. 13. Ferrario VF, Tartaglia GM, Maglione M, Simion M, Sforza C. Neuromuscular coordination of masticatory muscles in subjects with two types of implant-supported prostheses. Clin Oral Implants Res. 2004 Apr;15(2):219-25. PubMed PMID:
15008934. 14. Ferrario VF, Sforza C, Zanotti G, Tartaglia GM. Maximal bite forces in healthy young adults as predicted by surface electromyography. J Dent. 2004 Aug;32(6):451-7. PubMed PMID: 15240063. 15. Ferrario VF, Tartaglia GM, Galletta A, Grassi GP, Sforza C. The influence of occlusion on jaw and neck muscle activity: a surface EMG study in healthy young adults. J Oral Rehabil. 2006 May;33(5):341-8. PubMed PMID: 16629892. 16. Ferrario VF, Tartaglia GM, Luraghi FE, Sforza C. The use of surface electromyography as a tool in differentiating temporomandibular disorders from neck disorders. 112 BTS Biomedical appendix BTS TMJOINT Man Ther. 2007 Nov;12(4):372-9. Epub 2006 Sep 14. PubMed PMID:
16973402. 17. Sforza C, Zanotti G, Mantovani E, Ferrario VF. Fatigue in the masseter and temporalis muscles at constant load. Cranio. 2007 Jan;25(1):30-6. PubMed PMID: 17304915. 18. Dellavia C, Romeo E, Ghisolfi M, Chiapasco M, Sforza C, Ferrario VF. Electromyographic evaluation of implant-supported prostheses in hemimandibulectomy-reconstructed patients. Clin Oral Implants Res. 2007 Jun;18(3):388-95. Epub 2007 Feb 13. PMID: 17298492. 19. Ries LG, Alves MC, Brzin 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 different research diagnostic criteria for temporomandibular disorders
(RDC/TMD) groups. Man Ther. 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-
BTS Biomedical 113 BTS TMJOINT appendix 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 Felcio 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 Effetti immediati di uno splint di stabilizzazione sullattivit dei muscoli masticatori in pazienti disfunzionali Immediate effects 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 effect 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 effect of the resilient splint evaluated using surface 114 BTS Biomedical appendix BTS TMJOINT 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 different 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. BTS Biomedical 115 BTS TMJOINT appendix 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 Felcio CM, Ferreira CL, Medeiros AP, Rodrigues Da Silva MA, Tartaglia GM, Sforza C. Electromyographic temporomandibular disorders severity: A correlation study. J Electromyogr Kinesiol. 2012 Apr;22(2):266-72. Epub 2011 Dec 27. PubMed PMID: 22206640. indices, orofacial myofunctional status and 116 BTS Biomedical headquarters viale Forlanini 40 20024 Garbagnate M.se MI Italy tel +39 02 366 490 00 fax +39 02 366 490 24 R&D centre via della Croce Rossa 11 35129 Padova PD Italy tel +39 049 981 5500 fax +39 049 792 9260 www.btsbioengineering.com info@bts.it
frequency | equipment class | purpose | ||
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1 | 2013-08-09 | 2405 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
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1 | Effective |
2013-08-09
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1 | Applicant's complete, legal business name |
BTS SpA
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1 | FCC Registration Number (FRN) |
0019953223
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1 | Physical Address |
Via della Croce Rossa, 11
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1 |
Padova, N/A 35129
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1 |
Italy
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app s | TCB Information | |||||
1 | TCB Application Email Address |
h******@acbcert.com
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 | Grantee Code |
YQH
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1 | Equipment Product Code |
BTSWEMG2
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
V******** B****
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1 | Title |
Regulatory Affairs Manager
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1 | Telephone Number |
+3904********
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1 | Fax Number |
+3904********
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1 |
v******@bts.it
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app s | Technical Contact | |||||
1 | Firm Name |
BTS SpA
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1 | Name |
V******** B******
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1 | Physical Address |
Via della Croce Rossa, 11
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1 |
Padova, 35129
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1 |
Italy
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1 | Telephone Number |
01139********
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1 | Fax Number |
01139********
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1 |
v******@btsbioengineering.com
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app s | Non Technical Contact | |||||
1 | Firm Name |
BTS SpA
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1 | Name |
B**** R******
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1 | Physical Address |
Via della Croce Rossa, 11
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1 |
Padova, 35129
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1 |
Italy
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1 | Telephone Number |
01139********
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1 | Fax Number |
01139********
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1 |
b******@btsbioengineering.com
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app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wireless EMG sensor for EMG system | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power Output is EIRP. Transmitter co-location permitted in accordance with FCC multi-transmitter product procedures. End-users and installers must be provided with instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Istituto Italiano del Marchio di Qualita' S.p.A.
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1 | Name |
E******** G********
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1 | Telephone Number |
00390********
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1 | Fax Number |
00390********
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1 |
f******@imq.it
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2405.00000000 | 2480.00000000 | 0.0002200 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC