YQH-BTSWEMG2Wireless EMG sensor for EMG system

version 2.0.3 user manual english Document Number : EREMB-01091-06 Published: June 2013 Copyright © 2010 - 2013 BTS SpA. All Rights Reserved. 1 BTS Bioengineering contents 1 icons, symbols and acronyms 3 radio regulation 7 disposal (WEEE) 8 intended use 9 regulatory label 10 receiving unit regulatory label 10 EMG wireless probes regulatory label 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 2 BTS Bioengineering contents hardware installation 34 description of the software on the user PC 37 BTS EMG-Analyzer configuration check 38 acquisition protocol 41 appendix A – technical specifications 47 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) 55 3 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 manufacturer’s symbol refer to the place of manufacture of the equipment itself. Symbol on the equipment: The “FCC” simbol refers to the Federal Communication Commission of the USA. The device complies with the relevant regulations put forth by the FCC as long as it is operated according to the instructions contained in this manual and to all national and local regulations. 4 BTS Bioengineering 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 5 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. 6 BTS Bioengineering icons, symbols and acronyms REF Symbol on the equipment: Symbol located next to the model number (ref.to catalogue). SN Symbol on the equipment: Symbol located next to the series number on the equipment. Acronyms used in this manual: RU Receiving Unit EMG Electromyography WS Workstation 7 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 user’s authority to operate the equipment under FCC rules. 8 BTS Bioengineering 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. 9 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. 10 BTS Bioengineering Probe ID regulatory label Receiving Unit Regulatory label EMG Wireless Probes Regulatory label Label on the probes: 11 BTS Bioengineering regulatory label Label not on actual probes due to size constraints: AUX Wireless Probes Regulatory label Label…

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BTS FREEEMG version 4.0.3 user manual english Document Number : ERFNC-00782-16 Published: June 2013 Copyright © 2010 - 2013 BTS SpA. All Rights Reserved. 1 BTS Bioengineering BTS FREEEMG contents 1 icons, symbols and acronyms 5 radio regulation 9 disposal (WEEE) 10 intended use 11 regulatory label 12 acquisition unit regulatory label 12 EMG wireless probes regulatory label 12 AUX wireless probes regulatory label 13 BTS charger regulatory label 14 BTS docking station regulatory label 14 warnings 15 copyright 18 introduction 19 general description 19 case contents 20 system components 24 physical description 24 acquisition unit 25 PDA (Personal Digital Assistant) 27 wireless EMG probes 29 wireless FSW/EGN probes (optional) 33 on-off analysis (optional) 34 electrogoniometers (optional) 35 charger 36 contents 2 BTS Bioengineering BTS FREEEMG contents docking station (optional) 38 installation 43 user PC minimum configuration 43 installation of the Wi-Fi interface 43 description of the software on the user PC 45 switching on BTS FREEEMG 300 45 first connection 47 connection check 48 correct data visualization check 50 acquisition protocol 52 fitting the patient 57 guide to the use of onboard software 60 initial screen 60 “Active” button 60 selecting the work mode 64 description of the main bars and menu 65 protocol 68 probes setup 69 digital oscilloscope (gane) 72 digital oscilloscope (cross check) 75 footswitches 77 “Local” button: holter mode 78 “Remote” button: lab mode 91 “Download” button 95 “Config” button 97 “Exit” button 106 BTS FREEEMG 300 updating 107 updating the onboard software 107 creating a backup image 108 3 BTS Bioengineering BTS FREEEMG contents maintenance and cleaning 110 appendix A – technical specifications 113 wireless probes 113 receiving unit 113 BTS internal coding 114 appendix B – environmental specifications 116 appendix C – power supply and switch off 117 appendix D – battery 118 appendix E – declaration of conformity 120 appendix F – troubleshooting guide 121 1708 error - Incorrect IP address or port set up 121 1709 error - Impossibility to connect to the unit 122 backup restoring 122 receiving unit hardware reset 124 5 BTS Bioengineering 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 manufacturer’s 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. 6 BTS Bioengineering 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. 7 BTS Bioengineering BTS FREEEMG icons, symbols and acronyms 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. 8 BTS Bioengineering 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: APAccess PointPDAPersonal Digital Assistant AUAcquisition UnitRUReceiving Unit EMGElectromyographySWWorkstation FSWFootswitch 9 BTS Bioengineering BTS FREEEMG 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 user’s authority to operate the equipment under FCC rules. radio regulation 10 BTS Bioengineering BTS FREEEMG 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 d…

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version 3.0.0 user manual english BTS TMJOINT Document Number : ERTMJ-00998-04 Published: January 2013 Copyright © 2010 - 2013 BTS SpA. All Rights Reserved. 1 BTS Biomedical BTS TMJOINT contents 1 icons, symbols and acronyms 5 radio regulation 9 disposal (WEEE) 10 intended use 11 regulatory label 12 receiving unit regulatory label 12 EMG wireless probes regulatory label 12 charger regulatory label 13 warnings 14 copyright 17 introduction 18 general description 18 case contents 20 system components 22 receiving unit 22 wireless EMG probes 23 charger 26 installation 28 user PC minimum configuration 28 connections 28 description of the software on the user PC 29 software installation 29 hardware installation 31 first software use 34 contents 2 BTS Biomedical BTS TMJOINT contents patient setup 37 POC4 protocol 37 POC6 protocol 39 guide to the use of BTS DCA 41 initial screen 41 menu bar 42 tool bar 47 probes status bar 47 patient list and research filter 49 patient, session and trial information 52 trial viewing and report generation area 53 main features of the BTS DCA software 59 new patient 59 new session 59 edit pathology 62 new trial 63 data acquisition 66 edit patient 72 edit session 73 delete patient 74 delete session 75 delete trial 76 more features of the BTS DCA software 77 database and data folder 77 managing files in the recycle bin 80 guide to of the data report reading 83 INT tab 83 EXT tab 89 POC tab 94 3 BTS Biomedical BTS TMJOINT contents ISTO tab 96 MAST tab 98 INFO tab 100 appendix A – technical specifications 103 wireless probes 103 receiving unit 103 appendix B – environmental specifications 105 appendix C – power supply and switch off 106 appendix D – battery 107 appendix E – troubleshooting guide 108 warning – invalid trigger mode 108 appendix F – declaration of conformity 109 appendix G– bibliography 110 5 BTS Biomedical 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 manufacturer’s symbol refer to the place of manufacture of the equipment itself. Symbol on the equipment: The “FCC” simbol refers to the Federal Communication Commission of the USA. The device complies with the relevant regulations put forth by the FCC as long as it is operated according to the instructions contained in this manual and to all national and local regulations. 6 BTS Biomedical 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 7 BTS Biomedical BTS TMJOINT 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. 8 BTS Biomedical 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. Acronyms used in this manual: RU Receiving Unit EMG Electromyography WS Workstation DCA Dental Contact Analyzer POC Percent Overlapping Coefficent MVC Maximum Voluntary Contraction 9 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 user’s authority to operate the equipment under FCC rules. 10 BTS Biomedical 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. 11 BTS Biomedical BTS TMJOINT intended use This equipment is an instrument for the EMG surface analysis, classified as medical equi…

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BTS spa – BTSWEMG2 FCC ID YQH-BTSWEMG2 External photos

BTS spa – BTSWEMG2 FCC ID YQH-BTSWEMG2 Label Label position

BTS spa – BTSWEMG2 FCC ID YQH-BTSWEMG2 Internal photos

IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 2 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY 1. GENERAL DATA SAMPLE Samples received on 2012-12-20 (item sent and sampling by applicant) IMQ reference samples BEM 66684 Samples tested No. 1 Object under analysis recognition Not carried out Except where stated, characteristics of products were taken from client description and were not verified by the laboratory TEST LOCATION Testing dates 2012-12-20 ÷ 2013-01-16 Testing laboratory. IMQ S.p.A. - Via Quintiliano, 43 – I-20138 Milano Testing site Viale Lombardia, 20 – I-20021 Bollate (MI) ENVIRONMENTAL CONDITIONING Parameter Measured Ambient Temperature 25 ÷ 35 °C Relative Humidity 50 ÷ 60 % Atmospheric Pressure 900 ÷ 1000 mbar IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 3 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY 2. REFERENCE DOCUMENT DOCUMENT DATE TITLE 47 CFR Part 15 2008 Radio Frequency Device ANSI C63.4 2009 Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz ANSI C63.10 2009 American National Standard for Testing Unlicensed Wireless Devices IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 4 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY 3. UNIT UNDER TEST (EUT) DETAILS GENERAL DATA MODEL (basic) Description BTSWEMG2 Wireless probe for EMG system VARIANTS (derived) Description / / FCC ID BTS S.p.A. – Viale Forlanini, 40 – I-20024 Garbagnate Milanese (MI) Manufacturer Type of equipment Wireless EMG probe for EMG system Operating frequency: 2405 ÷ 2480 MHz Maximum RF radiated power: -6.55 dBm Modulation: DTS Channel Spacing: 5 MHz Antenna: Integral antenna RX sensitivity: / Main SW identification / Main HW Board identification / Peripherals included (for system application) / Interfaces : / Integrated interfaces : / AC adapter: AC/DC power supply XP Power model VEP24US09 + Docking station BTS model BTSFE3CHG IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 5 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY 4. TEST CONFGURATION OF UNIT UNDER TEST EUT PORTS Port Description Max length Enclosure Plastic and metal / AC power / / DC power 3.7 V DC dedicated lithium battery pack / Earth / / Telecommunication / / Signal / / Control / / Antenna Integral / CHANNEL CONFIGURATION Channel (No.) Frequency (MHz) Channel (No.) Frequency (MHz) 11 2405 19 2445 12 2410 20 2450 13 2415 21 2455 14 2420 22 2460 15 2425 23 2465 16 2430 24 2470 17 2435 25 2475 18 2440 26 2480 EUT Antenna Port AC Power Port Earth Port Telecommunication Port Signal/Control Port DC Power Port Enclosure Port IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 6 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY STATE OF THE EUT DURING TESTS Ref. Mode Description #1 Operating Continuous transmission (single channel transmission) SUPPORT EQUIPMENT Defined as equipment needed for correct operation or loading of the EUT, but not considered as tested: Equipment Manufacturer Model Acquisition unit BTS BTS FREEEMG 300 ELECTROMAGNETICALLY RELEVANT COMPONENTS Component No. Manufacturer Model Main board with RF module 1 BTS PRO-P0 EMG-02 Antenna board 1 BTS PRO-P0-EMGANT-03 RFI SUPPRESSION DEVICES Component No. Manufacturer Model / / / / EMI PROTECTION DEVICES Component No. Manufacturer Model / / / / EUT TECHNICAL DOCUMENTATION Document Reference User manual BTSFREEMG300 version 4.0.0 IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 7 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY 5. METHODS OF MEASUREMENT All compliance measurements have been carried out using the procedures described in the standard ANSI C63.4-2009, ANSI C63.10-2009 and Section 15.31 of CFR47 Part 15 – Subpart A (General). Additional test requirements have been adopted according to the reference Section indicated in the § 6 of this test report. FREQUENCY RANGE INVESTIGATED Radiated emission tests: from 9 kHz to tenth harmonic of fundamental. IMQ S.p.A. – Società con Socio Unico Via Quintiliano, 43 I-20138 MILANO tel 0250731 – [email protected] – www.imq.it Test Report No. ARSM00136/1 Date: 2013-06-21 Page 8 of 47 Mod. TRF FCC - C/2 RTTE AND A UTOMOTIVE COMPONENTS L ABORATORY 6. SUMMARY OF TEST RESULTS POSSIBLE TEST CASE VERDICTS: Test object does meet the requirement PASS Test object does not meet the requirement FAIL Test case does not apply to the test object N.A. Test not performed N.P. CFR47 Part 15 TITLE RESULT § 15.203 § 15.247 (b)(4)(i) Antenna Requirements PASS § 15.207 (a) Conducted Emission PASS 1 § 15.209 (a) (f) Radiated Emission PASS § 15.247 (a) Frequency Hopping Spread Spectrum Specifications § 15.247(a) 20 dB Bandwidth N.A. 2 § 15.247(a)(1) Carrier frequency (Hopping Channel) Separation N.A. 2 § 15.247(a)(1)(iii) Number of Hopping Channels Used N.A. 2 § 15.247(a)(1)(iii) Time occupancy (Dwell Time) of Each Ch. within a 0,4 x Nch (sec) Period N.A. 2 § 15.247(a)(2) 6dB Minimum Bandwidth PASS § 15.247(b) Maximum Peak Output Power § 15.247(b) (1) Peak Output Power N.A. § 15.247(b) (3) RF power output, radiated (EIRP) PASS § 15.247(b) (4) Antenna gain N.A. § 15.247(c) Operation with directional antenna gains greater than 6 dBi N.A. § 15.247 (d) 100 kHz Bandwidth of Frequency Band Edges PASS § 15.…

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BTS spa – BTSWEMG2 FCC ID YQH-BTSWEMG2 setup photos