BTS FREEEMG 100 RT User Manual Download Page 60

Page: 60 / 64

BTS

Bioengineering

appendix

Operator of the device

(delete not applicable)

health professional
patient
lay user
other:

(specify)

Date of system installation

(MM/DD/YYYY)

Device available for

evaluation?

(Do not send to FDA)

yes
no
Returned to BTS S.p.A.

or its agents on:

(MM/DD/YYYY)

Concomitant medical products and therapy dates

(do not report products that were used to treat the event)

Summary of Contents for FREEEMG 100 RT

Page 1: ...version 2 0 3 user manual english ...

Page 3: ...bel 10 AUX wireless probes regulatory label 11 BTS charger regulatory label 12 warnings 13 copyright 16 introduction 17 general description 17 case contents 18 system components 21 receiving unit 21 wireless EMG probes 22 wireless FSW EGN probes optional 25 on off analysis optional 27 electrogoniometers optional 29 charger 30 installation 33 user PC minimum configuration 33 connections 33 contents...

Page 4: ...7 wireless probes 47 receiving unit 47 BTS internal coding 48 appendix B environmental specifications 49 appendix C power supply and switch off 50 appendix D battery 51 appendix E troubleshooting guide 52 warning invalid trigger mode 52 appendix F declaration of conformity 53 appendix G regulatory notice 54 FDA medical device reporting system reportable events 54 adverse event report 21 CFR 803 32...

Page 5: ...ussion of the subject in hand Symbol on the equipment The data appearing next to the manufacturer s symbol refer to the place of manufacture of the equipment itself Symbol on the equipment The FCC simbol refers to the Federal Communication Commission of the USA The device complies with the relevant regulations put forth by the FCC as long as it is operated according to the instructions contained i...

Page 6: ...e 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 st...

Page 7: ...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 o...

Page 8: ...EF Symbol on the equipment Symbol located next to the model number ref to catalogue SN Symbol on the equipment Symbol located next to the series number on the equipment Acronyms used in this manual RU Receiving Unit EMG Electromyography WS Workstation ...

Page 9: ...XLP IC 5969A MATRIXLP This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Modifications not expressly approved by BTS SpA could void the user s authority to operate the equipment under ...

Page 10: ... 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 Oper...

Page 11: ...dical 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 ...

Page 12: ...10 BTS Bioengineering Probe ID regulatory label Receiving Unit Regulatory label EMG Wireless Probes Regulatory label Label on the probes ...

Page 13: ... BTS Bioengineering regulatory label Label not on actual probes due to size constraints AUX Wireless Probes Regulatory label Label on the probes Label not on actual probes due to size constraints Probe ID ...

Page 14: ...12 BTS Bioengineering regulatory label BTS Charger Regulatory label 3A 3A 9V 3A 9V ...

Page 15: ... 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...

Page 16: ...ation 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 u...

Page 17: ...e 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 avai...

Page 18: ...ssion 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 ac...

Page 19: ...e 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 ply...

Page 20: ...phic 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...

Page 21: ...ing 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 ...

Page 22: ...ngineering 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 ...

Page 23: ...ceiving 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 of electromyographic signals up to 2 probes for the connection of 4 switches each used for 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 ac...

Page 24: ...hout 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 connect...

Page 25: ...n 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 o...

Page 26: ...eturns 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 Com...

Page 27: ...d 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 conne...

Page 28: ...ufficiently 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 ...

Page 29: ...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 ...

Page 30: ...ysis 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 t...

Page 31: ...r 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 ...

Page 32: ... 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 thr...

Page 33: ... 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 instruc...

Page 34: ...d 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 ...

Page 35: ...o 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 C...

Page 36: ... 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 ...

Page 37: ...stallation 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 ...

Page 38: ... 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 ...

Page 39: ...y 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 customize...

Page 40: ...lease 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 ...

Page 41: ... 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 ...

Page 42: ... Is possible to disable the sensors that you don t 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 sel...

Page 43: ... 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...

Page 44: ...C 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 ...

Page 45: ... 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 oper...

Page 46: ...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 p...

Page 47: ... 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 availa...

Page 48: ......

Page 49: ...le lithium ion Dimensions 14x41 5x24 8mm mother electrode diameter 16x12mm satellite electrode Weight 13g battery included Frequency used ISM band 2 4GHz standard IEEE802 15 4 Input impedance 10 GOhm CMMR 110 dB 50 60Hz Resolution 16bit Acquisition frequency 1KHz Sensitivity 1μV Accuratezza di misura 2 Receiving Unit Connection USB Dimensions 82x44x22 5mm Weight 80 gr appendix A technical specific...

Page 50: ...duct label Identifier for device bar code catalogue model or part number FREEEMG 100 RT USB receiving unit EMG wireless probes 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 FRESPU12 EMG Analyzer software application for EMG ...

Page 51: ...ting Temperature 20 45 Operating Humidity 50 80 Relative non condensing Storage and Transport Temperature 0 40 Storage and Transport Humidity 50 80 Relative non condensing Altitude 0m 2000m Degrees of protection provided by the dangerous enclosures of water and dust IEC 60529 IPX0 ...

Page 52: ...ch 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 ...

Page 53: ...ccess to the internal circuit components Batteries are equipped with battery protection circuit to over voltage threshold 4 3V under voltage threshold 2 8V short circuits The specific characteristic of the Wireless probes equipped with the battery are Quantity 1 per each EMG probe Technology lithium polymer Li Poly Removable NO BTS technical service is required appendix D battery ...

Page 54: ...t 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...

Page 55: ...erformance IEC 60601 1 2 Medical Electrical Equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard electromagnetic compatibility Requirements and tests IEC 60601 1 6 Medical Electrical Equipment Part 1 6 General Requirements for basic safety and essential performance collateral Standard Usability EN 62304 Medical device software Software life cycle p...

Page 56: ...nistration Medical Device Reporting System Reportable 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 accor...

Page 57: ...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 Female Male Weight 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 ...

Page 58: ...ermanent impairment damage Devices Disability or permanent damage Congenital Anomaly Birth Defect Other Serious Important Medical Events Date of Event MM DD YYYY Date of this report 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 in...

Page 59: ...er 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 Lot Catalog Expiration Date MM DD YYYY Serial Other ...

Page 60: ...ssional patient lay user other specify Date of system installation MM DD YYYY Device available for evaluation Do not send to FDA yes no Returned to BTS S p A or its agents on MM DD YYYY Concomitant medical products and therapy dates do not report products that were used to treat the event ...

Page 61: ...For the reporter who initially provided information to you or to the manufacturer or distributor Name Address Telephone Number E mail Address Health Professional Yes No Occupation include speciality if appropriate Initial reporter also sent a copy of report to FDA Yes No ...

Page 62: ...er Facility Address Contact Person Phone Number Date User Facility became aware of event MM DD YYYY Type of Report Initial Follow up Date of this Report MM DD YYYY Approximate age of system Event problem Codes refer to MED WATCH Medical Device Reporting Code Instructions Report sent to FDA Yes MM DD YYYY No Report sent to manufacturer Yes MM DD YYYY No ...

Page 63: ...ioengineering appendix Location where event occurred Hospital Home Nursing Home Outpatient Treatment Facility Outpatient Diagnostic Facility Ambulatory Surgical Facility other specify Manufacturer Name Address ...

Page 64: ...Street Suite 11 11201 Brooklyn NY USA info 1 347 204 7027 helpdesk 1 646 575 0426 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 www btsbioengineering com info btsbioengineering com ...

Search results

Summary of Contents for FREEEMG 100 RT

Reviews:

Related manuals for FREEEMG 100 RT

Brands by name

Popular brands

BTS FREEEMG 100 RT, User Manual

Search results

Summary of Contents for FREEEMG 100 RT

Reviews:

Related manuals for FREEEMG 100 RT

Brands by name

Popular brands