YQH-BTSWEMGWireless EMG sensor for EMG system

BTS FREEEMG version 3.1.0e user manual english Document Number : ERFNC-00782-01e Published: October 2010 Copyright © 2010 BTS SpA. All Rights Reserved. 1 BTS Bioengineering BTS FREEEMG contents 1 icons, symbols and acronyms 5 disposal (WEEE) 8 intended use 9 label 9 warnings 10 copyright 13 introduction 14 general description 14 case contents 16 system components 19 physical description 19 acquisition unit 20 PDA (Personal Digital Assistant) 22 wireless EMG probes 24 wireless FSW/EGN probes 28 on-off analysis (optional) 29 electrogoniometers (optional) 30 charger 31 docking station 33 installation 38 user PC minimum configuration 38 installation of the Wi-Fi interface 38 description of the software on the user PC 40 switching on BTS FREEEMG 300 41 contents 2 BTS Bioengineering BTS FREEEMG contents first connection 43 connection check 43 correct data visualization check 45 acquisition protocol 47 create a new protocol 47 fitting the patient 52 guide to the use of onboard software 55 initial screen 55 “Active” button 55 selecting the work mode 59 description of the main bars and menu 60 protocol 63 probes setup 64 digital oscilloscope (gane) 67 digital oscilloscope (cross check) 70 footswitches 72 “Local” button: holter mode 74 “Remote” button: lab mode 86 “Download” button 90 “Config” button 92 “Exit” button 101 BTS FREEEMG 300 updating 102 updating the onboard software 102 creating a backup image 103 maintenance and cleaning 105 appendix A – technical specifications 107 wireless probes 107 receiving unit 107 3 BTS Bioengineering BTS FREEEMG contents appendix B – environmental specifications 109 appendix C – power supply and switch off 110 appendix D – battery 111 appendix E – declaration of conformity 113 appendix F – troubleshooting guide 114 1708 error - Incorrect IP address or port set up 114 1709 error - Impossibility to connect to the unit 115 backup restoring 115 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 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. 6 BTS Bioengineering BTS FREEEMG icons, symbols and acronymi Symbol on the equipment: Attention, read the information in the users’ manual carefully before using the equipment. 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 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: 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: The double square indicates that the product is a Class II device according to EN 60601-1. The device must be operated with the provided power supply unit. Radio equipment identification EMG probes: FCC ID: YQH-BTSWEMG IC: 9188A-BTSWEMG FSWEGN probes: FCC ID: YQH-BTSWAUX IC: 9188A-BTSWEMG 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. Acronyms used in this manual: AP Access Point AU Acquisition Unit EMG Electromyography FSW Footswitch PDA Personal Digital Assistant RU Receiving Unit WS Workstation 8 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 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. disposal (WEEE) 9 BTS Bioengineering BTS FREEEMG 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 utilised. Acquisition Unit Regulatory label intended use XX-XX-XX BTSWEMG Internally powered device 0123 BTS SpA V.le Forlanini 40 Garbagnate M.se I-20024 Italy btsbioengineering.com 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 inte…

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BTS Bioengineering FreeEMG EMG Sensor Hardware Block Diagram 01/08/2010 Doc ID: ERFNC-00825-00 FreeEMG Pag 1/1 EMG Sensor Block Diagram FCC ID: YQH-BTSWEMG IC: 9188A-BTSWEMG Figure 1 Block Diagram Table 1 Crystal frequencies

TT&T Laboratory Test Report No. ARSK00192 Date 2010-11-15 page 39 of 41 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 8 PHOTOGRAPHIC DOCUMENTATION 8.1 EUT IDENTIFICATION External view of EUT Internal view of EUT

BTS Bioengineering BTSWEMG Regulatory Label 01/08/2010 Doc ID: ERFNC-00835-00 FreeEMG Pag 1/1 Radio Certification BTSWEMG Regulatory Label content, size and position Device Name: FreeEMG 300 Model Name: BTSWEMG Regulatory Body: FCC Regulatory Body: Industry Canada ID: YQH-BTSWEMG ID: 9188A-BTSWEMG Category: N/D Category: Class I radio device The device is too small for a label, so the regulatory labelling (FCC ID, IC ID, EU Medical Devices, EU WEEE) is placed in the manual. XX-XX-XX BTSWEMG Internally powered device 0123 BTS SpA V.le Forlanini 40 Garbagnate M.se I-20024 Italy btsbioengineering.com 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. FCC ID: YQH-BTSWEMG IC: 9188A-BTSWEMG

The FCC ID and IC Certification Number will appear on the device. Due to the size of the equipment, the compliance statements will appear in the user manual.

TT&T Laboratory Test Report No. ARSK00186 Date 2010-11-19 page 40 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 8 PHOTOGRAPHIC DOCUMENTATION 8.1 EUT IDENTIFICATION External view of EUT Internal view of EUT

BTS Bioengineering BTSWEMG Technical Description 01/08/2010 Doc ID: ERFNC-00829-00 FreeEMG300 Pag 1/1 Radio Certification Technical Description of Device Device Name: FreeEMG 300 Model Name: BTSWEMG Regulatory Body: FCC Regulatory Body: Industry Canada ID: YQH-BTSWEMG ID: 9188A-BTSWEMG Category: N/D Category: Class I radio device Description: The FreeEMG 300 wireless EMG sensor (“Sensor”) is a battery powered, wireless sensor designed to measure the body surface electric activity generated by the muscles activation. The Sensor is one of the components that make up a device used for “surface electromyography”. The Sensor is intended to be used exclusively with a FreeEMG 300 Acquisition Unit (“AU”) manufactured by BTS. The Sensor establishes a wireless data link with an AU, receives commands from it sends back data and status information. The radio link uses the IEEE 802.15.4 standard and operates in the 2.4GHz band. The Sensor’s EIRP is less than 10mW. The Sensor is physically connected to a set of disposable electrodes which are then placed on the body skin. The myoelectric signal that is generated by the muscles is measured by the Sensor, sampled by its A/D converter and sent to the AU via the wireless link. The internal Li-Ion battery is charged by its Charging Station via the same plugs used to connect the electrodes, therefore the device cannot operate while recharging.

TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 2 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY CONTENTS 1 GENERAL DESCRIPTION OF EQUIPMENT UNDER TEST ......................... 1-3 1.1 APPLICANT.................................................................................................... 1-3 1.2 MANUFACTURER..........................................................................................1-3 1.3 EQUIPMENT CLASSIFICATION .................................................................... 1-3 1.4 BASIC DESCRIPTION OF EQUIPMENT UNDER TEST ............................... 1-4 1.5 FEATURE OF EQUIPMENT UNDER TEST ................................................... 1-5 2 TEST CONFIGURATION OF EQUIPMENT UNDER TEST ........................... 2-7 2.1 ENVIRONMENTAL CONDITIONS ................................................................. 2-7 2.2 DESCRIPTION OF SUPPORT EQUIPMENT................................................. 2-7 2.3 INTERFACE IDENTIFICATION AND CONNECTION DIAGRAM OF TEST SYSTEM ......................................................................................................... 2-8 3 OPERATION OF EQUIPMENT UNDER TEST............................................... 3-9 3.1 OPERATING TEST CONDITIONS ................................................................. 3-9 4 TESTS IDENTIFICATION AND RESULTS .................................................. 4-10 4.1 METHODS OF MEASUREMENT ................................................................. 4-11 4.2 FREQUENCY RANGE INVESTIGATED ...................................................... 4-11 5 MEASUREMENTS AND TESTS DATA........................................................ 5-12 6 ADDITIONAL TECHNICAL INFORMATION ................................................ 6-39 6.1 ELECTROMAGNETICALLY RELEVANT COMPONENTS:.......................... 6-39 6.2 RFI SUPPRESSION DEVICES: ................................................................... 6-39 6.3 EMI PROTECTION DEVICES: ..................................................................... 6-39 7 TECHNICAL DOCUMENTATION................................................................. 7-39 8 PHOTOGRAPHIC DOCUMENTATION ........................................................ 8-40 8.1 EUT IDENTIFICATION ................................................................................. 8-40 8.2 TEST SET-UP .............................................................................................. 8-41 9 MEASUREMENT AND TEST EQUIPMENT INSTRUMENTATION ............. 9-42 TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 3 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 1 GENERAL DESCRIPTION OF EQUIPMENT UNDER TEST 1.1 APPLICANT NAME BTS S.p.A. ADDRESS Viale Forlanini, 40 – 20024 Garbagnate Milanese (MI) COUNTRY ITALY 1.2 MANUFACTURER NAME BTS S.p.A. ADDRESS Viale Forlanini, 40 – 20024 Garbagnate Milanese (MI) COUNTRY ITALY 1.3 EQUIPMENT CLASSIFICATION According to the definition 15.3 (o) EUT is a Intentional Radiator operating within the bands 2400-2483,5 MHz so it shall fulfil provisions of 47CFR Part 15 Subpart C – Intentional radiators – and Section 15.247. TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 4 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 1.4 BASIC DESCRIPTION OF EQUIPMENT UNDER TEST Parameters Value Type of equipment : WIRELESS EMG SENSOR FOR EMG SYSTEM Model: BTSWEMG FCC ID. : YQH-BTSWEMG Trade Name: BTS BIOENGINEERING Data cable : / Telecom cable : / Power supply type : dedicated Li-Ion battery pack AC power input cable : / DC power input cable : / Model tested Description BTSWEMG Portable wireless sensor Derivate model Description N.A. N.A. TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 5 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 1.5 FEATURE OF EQUIPMENT UNDER TEST Power specification / Operating frequency: 2405 ÷ 2480 MHz Maximum RF radiated power: 6.00 dBm Modulation: DTS Channel Spacing: 5 MHz Antenna: Integral antenna RX sensitivity: / Main SW identification / Main HW Board identification / Peripherals included (for system application) None Interfaces : None Integrated interfaces : None AC adapter: None TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 6 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY CHANNEL CONFIGURATION Channel (No.) Frequency (MHz) 11 2405 12 2410 13 2415 14 2420 15 2425 16 2430 17 2435 18 2440 19 2445 20 2450 21 2455 22 2460 23 2465 24 2470 25 2475 26 2480 TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 7 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 2 TEST CONFIGURATION OF EQUIPMENT UNDER TEST 2.1 ENVIRONMENTAL CONDITIONS TEST CONDITIONS MEASURED Ambient Temperature 20 ÷ 25 °C Relative Humidity 50 ÷ 60 % Atmospheric Pressure 900 ÷ 1000 mbar 2.2 DESCRIPTION OF SUPPORT EQUIPMENT Here following the details concerning equipment needed for correct operation or loading of the EUT: EQUIPMENT MANUFACTURER MODEL Acquisition Unit BTS FREEEMG 300 TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 8 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 2.3 INTERFACE IDENTIFICATION AND CONNECTION DIAGRAM OF TEST SYSTEM # Port Description Max length Ref. Document 1 Enclosure Plastic case / / 2 AC power input dedicated Li-Ion battery pack / / 2 AC power output Not present / / 3 DC power input Not present / / 4 Earth Non present / / 5 Telecommunication Non present / / 6 Signal Wireless network / / 6 Control Non present / / 7 Antenna Integral antenna / / E U T Antenna Port AC Power Port Earth Port Telecommunication Port Signal/Control Port DC Power Port Enclosure Port TT&T Laboratory Test Report No. ARSK00186 Date 2010-12-03 page 9 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 3 OPERATION OF EQUIPMENT UNDER TEST 3.1 OPERATING TEST CONDITIONS Ref. Description #1 Continuous t…

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TT&T Laboratory Test Report No. ARSK00186 Date 2010-11-19 page 41 of 42 T ELECOMMUNICATIONS & T ELEMATICS FOR T RANSPORTS L ABORATORY 8.2 TEST SET-UP Set up of Radiated emission test