OT Bioelettronica Muovi+Lite User Manual

OT Bioelettronica Muovi+Lite User Manual

Portable bioelectrical signal amplifier

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User Manual v.1.1
Muovi+Lite
Portable bioelectrical signal amplifier
Read carefully this manual before using the device.

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Summary of Contents for OT Bioelettronica Muovi+Lite

  • Page 1 User Manual v.1.1 Muovi+Lite Portable bioelectrical signal amplifier Read carefully this manual before using the device.
  • Page 4: Table Of Contents

    END USER ..........................7 ........................8 ONTRAINDICATIONS ..........................8 IDE EFFECTS SAFETY PRECAUTIONS AND OTHER WARNINGS .................9 SYMBOLS USED ON MUOVI+LITE AND IN THE USER MANUAL ..........11 TECHNICAL SPECIFICATIONS ....................13 DETAILED DESCRIPTION ......................15 – C ............. 15 UOVI...
  • Page 5 User Manual Muovi+Lite v.1.1 - January 2024 8.1.5 Wireless data transfer ....................26 8.1.6 Muovi+ internal web page ....................26 TROUBLESHOOTING ........................ 30 MUOVI+LITE MAINTENANCE AND STORAGE ................31 RISK ANALYSIS ......................... 33 11.1 CEI EN 60601-1-2..... 33 ENERAL REQUIREMENT FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE INTENDED USE .........................
  • Page 6: General Description

    User Manual Muovi+Lite v.1.1 - January 2024 GENERAL DESCRIPTION Muovi+Lite is a modular system for the acquisition of up to 64 EMG signals. It is composed by one Muovi+ probe and a recharger called Muovi+SC. The Muovi+ probe is a wireless amplifier with 64 channels that is a miniaturized and wearable device.
  • Page 7: Muovi+Lite Kit Content

    Matrices of electrodes of different sizes, depending on the customer request END USER Muovi+Lite allows non-invasive recording of biopotentials (sEMG, EEG) detected by superficial electrodes. The end user must be familiar with the technique and have received a proper training in EMG or EEG detection and interpretation.
  • Page 8: Contraindications

    Nationality: indifferent Contraindications Muovi+Lite is a battery-powered device having parts in contact with the patient. It has no particular contraindications when used jointly with personal computers, provided that all the electrical devices connected to it comply with safety rules and standards concerning grounding and leakage currents.
  • Page 9: Safety Precautions And Other Warnings

    If in doubt, please contact the manufacturer. • The Muovi+Lite is subject to electromagnetic interference that is not dangerous for the patient (such as electrostatic or electromagnetic interference generated by electrical motors and other sources).
  • Page 10 User Manual Muovi+Lite v.1.1 - January 2024 • The use of the Muovi+Lite is restricted to skilled personnel. • Incorrect measurements can arise when unskilled personnel use the device in presence of strong sources such as electromagnetic interference (e.g., strong electromagnetic fields). The presence of interference in the signals is easily recognised by skilled personnel.
  • Page 11: Symbols Used On Muovi+Lite And In The User Manual

    User Manual Muovi+Lite v.1.1 - January 2024 SYMBOLS USED ON MUOVI+LITE AND IN THE USER MANUAL Serial number Indicates the manufacturer’s catalogue number so the medical device can be identified Identifies a type B applied part complying with IEC 60601-1 Manufacturer Do not dispose of this product as non-differentiated waste.
  • Page 12 User Manual Muovi+Lite v.1.1 - January 2024 Indicates the range of humidity to which the medical device can be safely exposed Indicates the range of atmospheric pressure to which the medical device can be safely exposed Indicates that natural rubber latex was not used in the manufacture of the product, its container or packaging.
  • Page 13: Technical Specifications

    User Manual Muovi+Lite v.1.1 - January 2024 TECHNICAL SPECIFICATIONS Muovi+Lite is a battery-operated device designed to ensure a high level of safety for the patient and the operator in all conditions of use. Isolation between the Muovi+ probe and the PC for displaying and recording real-time data is inherently achieved via wireless data transfer.
  • Page 14 User Manual Muovi+Lite v.1.1 - January 2024 Functions Acquisition of 64 EMG or EEG signals Number of channels Low pass filter SAMP High pass filter DC coupling or 10 Hz digital filter Noise level referred to the input < 4 V Input resistance 500 M...
  • Page 15: Detailed Description

    User Manual Muovi+Lite v.1.1 - January 2024 DETAILED DESCRIPTION Muovi+Lite is a portable, battery powered device for the acquisition of surface EMG. Data can be acquired using Muovi+ probe. Signals are transferred to a PC for real time display and recording. The Muovi+ probe has a fixed IP address with which you can reach its web page, using any browser.
  • Page 16: Input Connection Port And Charging

    User Manual Muovi+Lite v.1.1 - January 2024 The Muovi+ probe can be fully configured via its web page, while the ON/OFF button provides only quick access to basic functions, displayed by LEDs. 7.1.1 Input connection port and charging The 74-pin input connection port is the interface between Muovi+ and the electrodes and is also used for charging the internal battery.
  • Page 17 User Manual Muovi+Lite v.1.1 - January 2024 White LED This LED indicates the status of the WiFi connection and data transfer through a TCP socket. The white LED provides different information depending on the state of Muovi+. When Muovi+ is acting as an access point: (a) one flash of the white LED indicates that the network has been generated and is available for connection from another device.
  • Page 18: Patient Ref Connector

    User Manual Muovi+Lite v.1.1 - January 2024 Red LED The red LED is used to alert the user of an error or critical condition. A single blink of the red LED indicates that samples have been lost during the wireless data transfer, this situation occurs when the internal data buffer of the Muovi+ is full and data transmission is not possible, acquisition of the next signal sample will create a reset of the internal data buffer with the loss of data, equal to the buffer size.
  • Page 19: Use Of Muovi+Lite

    User Manual Muovi+Lite v.1.1 - January 2024 USE OF MUOVI+LITE This manual refers to the use of the Muovi+Lite system together with the PC running Windows and the free OT BioLab+ software. In case the user wants to use an operating system different from Windows,...
  • Page 20: Signals

    User Manual Muovi+Lite v.1.1 - January 2024 Regardless of the mode of operation used, the IP address of the Muovi+ probe is 192.168.14.ID, where ID represents the probe's identification number. The subnet mask is fixed and equal to 255.255.255.0. Typing the IP address on any browser will display the internal configuration page (refer to section 8.1.5).
  • Page 21 User Manual Muovi+Lite v.1.1 - January 2024 Where α is equal to 1/2 . The result is a high-pass filter with a cutoff frequency of 10.5 Hz, when sampling signals at 2000 Hz. More generally, the high-pass cut off frequency is F /190.
  • Page 22 User Manual Muovi+Lite v.1.1 - January 2024 In addition to the biological signals, there are 4 channels from an inertial sensor and 2 accessory channels. All 6 channels are represented on 16 or 24 bits consistent with the resolution of the bioelectrical signals.
  • Page 23 User Manual Muovi+Lite v.1.1 - January 2024 FIG. 8.1: IMU sensor placement and axis orientation. The two accessory channels contain information related to the RF synchronisation signal sent by the SyncStation, the use of the internal memory buffer of the Muovi+ probe, and a sample counter. In particular, the channel 69 provides information about the internal buffer usage and the trigger state.
  • Page 24: Acquisition Electrodes And Patient Connection

    User Manual Muovi+Lite v.1.1 - January 2024 8.1.3 Acquisition electrodes and patient connection The Muovi+ probe connects directly to the acquisition electrodes, so no additional adapters or cables are required. In the case of HD-sEMG signal acquisition, three matrix models are available that can be...
  • Page 25: Recharge Of The Muovi+ Probes

    User Manual Muovi+Lite v.1.1 - January 2024 Regardless of the acquisition matrix used, the Muovi+ probe must be connected to the patient with a clamp or reference electrode, this operation is necessary to fix the potential of the patient's body, to the internal reference potential of the Muovi+ probe, for this purpose, a 2mm female banana connector is available on the probe.
  • Page 26: Wireless Data Transfer

    User Manual Muovi+Lite v.1.1 - January 2024 8.1.5 Wireless data transfer The communication between the Muovi+ probe and PC is direct so the network is generated by the Muovi+ probe (refer to paragraph 8.1.1) but it is the PC (or tablet, smartphone) that has to open a TCP socket with the role of server to which the Muovi+ probe will try to connect.
  • Page 27 User Manual Muovi+Lite v.1.1 - January 2024 Alternatively, the OT BioLab+ software can be used to reach the web page. When the Muovi+ probe is set up as a Device, a "WebPage" button is available in the OT BioLab+ SW that can be accessed from Setup by selecting the Muovi+ device in the list.
  • Page 28 User Manual Muovi+Lite v.1.1 - January 2024 FIG. 8.3: Muovi+ internal web page. General Information This section provides information that cannot be changed: serial number, MAC address, firmware version and battery level. To update the battery indicator you need to refresh the web page.
  • Page 29 User Manual Muovi+Lite v.1.1 - January 2024 It is possible to make this mode the default one so that the probe will always start in this mode regardless of how long the button is pressed. Network information This section shows information about the Muovi+'s network that cannot be changed.
  • Page 30: Troubleshooting

    User Manual Muovi+Lite v.1.1 - January 2024 TROUBLESHOOTING This section describes the most common problems that may be found by Muovi+Lite users, with some suggestions to solve them. For problems not described in this section contact the technical support team of OT Bioelettronica.
  • Page 31: Muovi+Lite Maintenance And Storage

    700 hPa to 1060 hPa It is recommended to turn off the Muovi+Lite system at the end of each measurement session, and to remove all connections. The Muovi+Lite system should be stored with all the enclosed accessories on a Warnings.
  • Page 32 Dispose of the device and accessories according to local regulations. Follow the regulations regarding the disposal of your country to ensure the correct disposal of Muovi+Lite and its accessories. For more information on disposal of this device, contact the Environment Department and local authorities.
  • Page 33: Risk Analysis

    Compatibility Muovi+Lite is designed to be used in an electromagnetic environment with the characteristics specified below. The purchaser or user of Muovi+Lite is obliged to ensure that the device is used in an environment that complies with these specifications. Manufacturer’s declaration and guidelines – electromagnetic emissions...
  • Page 34 User Manual Muovi+Lite v.1.1 - January 2024 Manufacturer’s declaration and guidelines – electromagnetic immunity – casing door EMC reference Immunity test levels - Phenomenon standard or test Professional healthcare environment method EN 60601-1-2, EN 60601-2-40 and ETSI EN 301 489-1...
  • Page 35: Intended Use

    User Manual Muovi+Lite v.1.1 - January 2024 INTENDED USE Muovi+Lite is a medical device intended for the study of the biomechanics of movement and the acquisition of bioelectrical signals from the neuromuscular system. The clinical applications of the system are in the context of:...
  • Page 36: Technical Characteristics

    User Manual Muovi+Lite v.1.1 - January 2024 TECHNICAL CHARACTERISTICS Model: Muovi+Lite Risk Class: I in compliance with the Regulation MDR 2017/745. Insulation Class: BF type with applied parts, in compliance with the European standard EN 60601-1 Basic UDI: 805697785PORTABLEEMG002SF Classification: IP20, based on liquids’...
  • Page 37: Warranty

    User Manual Muovi+Lite v.1.1 - January 2024 WARRANTY Muovi+Lite electronic parts are covered by a 24-month warranty starting from the purchasing date. Connection cables are covered by a 24-month warranty. The warranty is void in case of device violation or in case of intervention from unauthorised staff.
  • Page 40 Designed and produced by: OT Bioelettronica s.r.l. Via San Marino 21 10134 – Torino (TO) - ITALY Tel: +39.011.19720518 Fax: +39.011.19720519 www.otbioelettronica.it mail@otbioelettronica.it...

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