BTS FREEEMG 100 RT User Manual
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BTS FREEEMG 100 RT User Manual

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english
version 2.0.3

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Summary of Contents for BTS FREEEMG 100 RT

  • Page 1 user manual english version 2.0.3...
  • Page 2 Document Number : EREMB-01091-06 Published: June 2013 Copyright © 2010 - 2013 BTS SpA. All Rights Reserved.

  • Page 3: Table Of Contents

    (WEEE) intended use regulatory label receiving unit regulatory label EMG wireless probes regulatory label AUX wireless probes regulatory label BTS charger regulatory label warnings copyright introduction general description case contents system components receiving unit...
  • Page 4 PC BTS EMG-Analyzer configuration check acquisition protocol appendix A – technical specifications wireless probes receiving unit BTS internal coding appendix B – environmental specifications appendix C – power supply and switch off appendix D –...

  • Page 5: Icons, Symbols And Acronyms

    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...
  • Page 6 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 BTS Bioengineering...
  • Page 7 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...
  • Page 8 Symbol on the equipment: Symbol located next to the model number (ref.to catalogue). Symbol on the equipment: Symbol located next to the series number on the equipment. Acronyms used in this manual: Receiving Unit EMG Electromyography Workstation BTS Bioengineering...

  • Page 9: Radio Regulation

    (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. BTS Bioengineering...

  • Page 10: Disposal (Weee)

    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. BTS Bioengineering...

  • Page 11: Intended Use

    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: Regulatory Label

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

  • Page 13: Aux Wireless Probes 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...

  • Page 14: Bts Charger Regulatory Label

    BTS Charger Regulatory label BTS Bioengineering...

  • Page 15: Warnings

    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.
  • Page 16 • 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.
  • Page 17 • 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.

  • Page 18: Copyright

    BTS product. All trademarks are registered by the respective owners. This publication contains reserved information which is the property of BTS S.p.A.

  • Page 19: Introduction

    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.

  • Page 20: Case Contents

    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.
  • Page 21 • 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...
  • Page 22 • 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. BTS Bioengineering...

  • Page 23: 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.

  • Page 24: Wireless Emg Probes

    All the probe combinations that respect what indicated above are possible. WiFi transmission 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.
  • Page 25 • 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...
  • Page 26 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. BTS Bioengineering...

  • Page 27: 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.
  • Page 28 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. BTS Bioengineering...

  • Page 29: On-Off Analysis (Optional)

    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...
  • Page 30 (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.

  • Page 31: Electrogoniometers (Optional)

    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.

  • Page 32: Charger

    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.
  • Page 33 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...
  • Page 34 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. BTS Bioengineering...

  • Page 35: Installation

    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...

  • Page 36: 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.
  • Page 37 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...
  • Page 38 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. BTS Bioengineering...

  • Page 39: Description Of The Software On The User Pc

    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.

  • Page 40: Bts Emg-Analyzer Configuration Check

    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.
  • Page 41 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...
  • Page 42 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. BTS Bioengineering...

  • Page 43: Acquisition Protocol

    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.
  • Page 44 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: BTS Bioengineering...
  • Page 45 EGN already selected in the protocols, otherwise the protocol won’t be valid and the software won’t 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...
  • Page 46 - 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 BTS Bioengineering...
  • Page 47 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” won’t be modified. BTS Bioengineering...

  • Page 49: Appendix A - Technical Specifications

    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: Dimensions: 82x44x22,5mm Weight: 80 gr BTS Bioengineering...

  • Page 50: Bts Internal Coding

    Name of device, components, parts and/or Identifier for accessories as per product label device (bar code, catalogue, model or part number) FREEEMG 100 RT USB receiving unit FREEEMG 100 RT EMG wireless probes FSW/EGN wireless probe Foot switches: Insole individual foot switches for the automatic identification of the gait events.

  • Page 51: Appendix B - Environmental Specifications

    Note Operating Temperature -20° +45° Relative, Operating Humidity non-condensing Storage and Transport 0° +40° Temperature Storage and Transport Relative, Humidity non-condensing Altitude 2000m Degrees of protection provided by the dangerous enclosures of water and dust (IEC 60529): IPX0. BTS Bioengineering...

  • Page 52: Appendix C - Power Supply And Switch Off

    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”. BTS Bioengineering...

  • Page 53: Appendix D Battery

    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...

  • Page 54: Appendix E Troubleshooting Guide

    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. BTS Bioengineering...

  • Page 55: Appendix F - Declaration Of Conformity

    Fax +39 049 792 9260 declare under our sole responsibility that the product(s): name / description: Electromyographic system / device for recording myoelectrical activity. FreeEMG 100 RT model: S/N: 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.

  • Page 56: Appendix G Regulatory Notice

    FDA Medical Device Reporting System—Reportable 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.

  • Page 57: Adverse Event Report (21 Cfr 803.32)

    Gender Female Male Weight 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...
  • Page 58 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 influenced the event) BTS Bioengineering...
  • Page 59 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 # Lot # Catalog # Expiration Date (MM/DD/YYYY) Serial # Other # BTS Bioengineering...
  • Page 60 Date of system installation (MM/DD/YYYY) Device available for evaluation? (Do not send to FDA) 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? Occupation (include speciality if appropriate) Initial reporter also sent a copy of report to FDA? BTS Bioengineering...
  • Page 62 (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? (MM/DD/YYYY) Report sent to manufacturer? (MM/DD/YYYY) BTS Bioengineering...
  • Page 63 Location where event Hospital occurred Home Nursing Home Outpatient Treatment Facility Outpatient Diagnostic Facility Ambulatory Surgical Facility other: (specify) Manufacturer Name/Address BTS Bioengineering...
  • Page 64 BTS Bioengineering Corp. BTS S.p.A. 147 Prince Street - Suite 11 viale Forlanini 40 11201 Brooklyn NY 20024 Garbagnate M.se MI Italy info: +1 347 204 7027 tel +39 02 366 490 00 helpdesk: +1 646 575 0426 fax +39 02 366 490 24 www.btsbioengineering.com...

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