Related Manuals for OT Bioelettronica Sessantaquattro+
Summary of Contents for OT Bioelettronica Sessantaquattro+
- Page 1 User Manual v.2.0 Sessantaquattro+ Portable bioelectrical signal amplifier Read this manual carefully before using Sessantaquattro+...
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Page 3: Table Of Contents
Sessantaquattro+ User Manual v.2.0 – March 2023 GENERAL DESCRIPTION ....................5 SESSANTAQUATTRO+ KIT CONTENT ................5 END USER ........................6 ......................6 ONTRAINDICATIONS ......................... 6 IDE EFFECTS SAFETY PRECAUTIONS AND OTHER WARNINGS ............6 SYMBOLS USED ON SESSANTAQUATTRO+ AND IN THE USER MANUAL ....8 TECHNICAL SPECIFICATIONS ................... - Page 4 Sessantaquattro+ User Manual v.2.0 – March 2023 ....................29 IRELESS DATA TRANSFER ....................30 ICRO DATA LOGGING ......................31 EBPAGE SETUP ......................39 ATIENT CONNECTION .....................40 THER ACQUISITION METHOD TROUBLESHOOTING ....................41 SESSANTAQUATTRO+ MAINTENANCE AND STORAGE ..........42 RISK ANALYSIS ......................43 11.1 CEI EN 60601-1-2 ....43 ENERAL REQUIREMENT FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE INTENDED USE......................
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Page 5: General Description
Sessantaquattro+ User Manual v.2.0 – March 2023 GENERAL DESCRIPTION Sessantaquattro+ is a multichannel amplifier and data logger for bioelectrical signals. The Sessantaquattro+ device detects and records electric signals generated by the human body. The signals acquired by the instrument are amplified, filtered, digitally converted and then transferred to a PC, through a WiFi connection, for real-time visualisation and storage, or stored in a MicroSD card. -
Page 6: End User
Sessantaquattro+ User Manual v.2.0 – March 2023 END USER Sessantaquattro+ multichannel amplifier allows non-invasive recording of biopotentials (sEMG, EEG) detected by superficial electrodes. The end user must be familiar with the technique and have received proper training in EMG or EEG detection and interpretation. Contraindications Sessantaquattro+ has no particular contraindications when used jointly with personal computers, provided that all the electrical devices connected to it comply with the safety rules and standards... - Page 7 Sessantaquattro+ User Manual v.2.0 – March 2023 • In proximity of inflammable substances (especially inflammable liquids and gases) or in environments with high concentration of oxygen. • On patients carrying life-supporting equipment that might be adversely affected by electromagnetic interferences, such as pacemakers, etc. The following precautions should be observed: •...
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Page 8: Symbols Used On Sessantaquattro+ And In The User Manual
Sessantaquattro+ User Manual v.2.0 – March 2023 SYMBOLS USED ON SESSANTAQUATTRO+ AND IN THE USER MANUAL Serial number Indicates the manufacturer’s catalogue number so the medical device can be identified Identifies a type BF applied part complying with IEC 60601-1 Manufacturer Do not dispose of this product as non-differentiated waste. - Page 9 Sessantaquattro+ User Manual v.2.0 – March 2023 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 Indicates that the electronic equipment is in compliance with the RoHS Directive on the restriction of the use of hazardous substances...
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Page 10: Technical Specifications
Sessantaquattro+ User Manual v.2.0 – March 2023 TECHNICAL SPECIFICATIONS Sessantaquattro+ is a battery powered device designed to guarantee a high safety level for the patient and the operator in all operating conditions. The insulation between Sessantaquattro+ and the PC for real time data display and storage, is intrinsically achieved by the wireless data transfer and communication. - Page 11 Sessantaquattro+ User Manual v.2.0 – March 2023 Additional adapters can be made under upon request to interface other types of electrodes or sensors. The Sessantaquattro+ technical specifications are shown in Table 6.2. EMG/EEG channels Number of channels Gain 1 V/V Band pass filter EMG 10 - 500 Hz Band pass filter EEG...
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Page 12: Detailed Description
Sessantaquattro+ User Manual v.2.0 – March 2023 DETAILED DESCRIPTION Sessantaquattro+ is a battery powered portable device for the acquisition of surface EMG and EEG. Signals can be transferred to a PC for real time display and recording or directly stored on a MicroSD card by the device. -
Page 13: Input And Recharge Connector
Sessantaquattro+ User Manual v.2.0 – March 2023 7.1.1 Input and recharge connector The 80 pins connector is the interface between Sessantaquattro+ and its adapters. The different adapters allow you to connect the device with different types of electrodes and sensors or to recharge the battery. - Page 14 Sessantaquattro+ User Manual v.2.0 – March 2023 The three LEDs are independent, and the information provided from each one is displayed cyclically by a given number of blinks. In Table 7.1 the different states and related number of LEDs blinks are highlighted.
- Page 15 Sessantaquattro+ User Manual v.2.0 – March 2023 Regardless of the Sessantaquattro+ role, three blinks indicate that Sessantaquattro+ is connected as a client to a TCP socket generated by a server device (usually the PC used for real time data display and recording);...
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Page 16: Start/Stop Rec Pushbutton
Sessantaquattro+ User Manual v.2.0 – March 2023 data buffers size (refer to section 8.2 for additional details). If this condition is temporary (e.g., Sessantaquattro+ for a limited time is too far from the PC for the acquisition), and the data transfer restarts properly, the red LED will stop to blink. - Page 17 Sessantaquattro+ User Manual v.2.0 – March 2023 data logging. A second function of the pushbutton is obtained if it is pressed for about 5 seconds while the device is on. In this condition, all the three LEDs start flashing simultaneously for four times and the Sessantaquattro+ role is forced to be “access point”.
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Page 18: Use Of Sessantaquattro
Windows and the freeware software OT BioLab+. In case a different type of operative system is used, or if the user interface needs to be customised the configuration and communication protocol of Sessantaquattro+ is available as Matlab examples. Please contact OT Bioelettronica to receive the additional manual and examples. -
Page 19: Signals
Sessantaquattro+ User Manual v.2.0 – March 2023 external WiFi network, at start-up, it tries to connect to one of the networks in its list and, when successfully connected, the white led blinks twice. In this condition, a service called mDNS running on Sessantaquattro+ can be used to find its IP address. - Page 20 Sessantaquattro+ User Manual v.2.0 – March 2023 are connected to the patient reference (midpoint of the power supply). The least significant bit (LSB) of the signals is obtained by: LSB = ADC = 286.1 nV RANGE On the standard adapters, that have the jack connector for the collection of the two auxiliary signals, a simple circuit allows you to extend the input range to ±...
- Page 21 Sessantaquattro+ User Manual v.2.0 – March 2023 Additionally, to the biological and auxiliary signals, 4 channels from an inertial sensor and 2 accessory channels have been added to the set signals, both when data is transferred via WiFi and when signals are recorded on the MicroSD card.
- Page 22 Sessantaquattro+ User Manual v.2.0 – March 2023 FIG. 8.1: Positioning and positioning of the IMU inertial sensor. The two accessory channels contain information about the RF synchronisation signal sent by the SyncStation, the use of the Sessantaquattro+ internal memory buffer and a sample counter. In particular, the first channel provides information about the internal buffer usage and the trigger state.
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Page 23: Electrode And Recharging Adapters
Sessantaquattro+ User Manual v.2.0 – March 2023 Electrode and recharging adapters The different adapters essentially provide access to an input connector. Each adapter is intended for the connection to particular types of electrodes or for battery recharging. A predefined detection mode is associated to each adapter. - Page 24 Sessantaquattro+ User Manual v.2.0 – March 2023 The integrated circuit that controls the battery recharge is in the adapter itself that implements different recharge techniques depending on the battery level: battery conditioning, constant current and constant voltage. The constant current phase is the one that lasts longer and produces a more efficient battery recharge.
- Page 25 Sessantaquattro+ User Manual v.2.0 – March 2023 At the same time, this electrode fixes the standard patient body potential mode to the midpoint of the power supply of the Sessantaquattro+ and feed the negative inputs of all the channels. This adapter is intended for the detection of 8 bipolar signals obtained as a difference between each electrode pair.
- Page 26 Sessantaquattro+ User Manual v.2.0 – March 2023 supply; thus, unregulated absorption can generate noise on the biopotential signals. Figure 8.5 shows the pinout of the auxiliary input connector. The input swing for the AUX IN signals is ± 3.3 V. Refer to section 8.2 for further details about the AUX IN signals conversion.
- Page 27 Sessantaquattro+ User Manual v.2.0 – March 2023 The patient reference connection is available as a 2 mm banana connector and as well as two additional auxiliary inputs. Refer to previous described adapters for further details about patient reference connection and auxiliary inputs. FIG.
- Page 28 Sessantaquattro+ User Manual v.2.0 – March 2023 • Electrode matrices FIG. 8.11: Electrode matrices: wet. FIG. 8.12: Double adhesive foam for wet electrode matrices application.
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Page 29: Wireless Data Transfer
Sessantaquattro+ User Manual v.2.0 – March 2023 Wireless data transfer Signals acquired with Sessantaquattro+ can be read with a WiFi interface using a TCP connection. A TCP socket has to be opened by the computer (or tablet, smartphone) running OT BioLab+ or other custom applications. -
Page 30: Microsd Data Logging
Sessantaquattro+ User Manual v.2.0 – March 2023 MicroSD data logging Sessantaquattro+ can work as a data logger by recording the data onto a MicroSD card. The MicroSD card has to be formatted as FAT16 or FAT32. Acquisition parameters: sampling frequency, number of channels to be acquired, resolution, high pass filter and detection mode, can be set through the embedded webpage (refer to section 8.6), with OT BioLab+ software or with custom software using the communication protocol available on request. -
Page 31: Webpage Setup
Sessantaquattro+ User Manual v.2.0 – March 2023 Since the ON/OFF switch completely disconnects the battery from the circuit, the internal real time clock loses time and date. The correct time and date can be easily passed to Sessantaquattro+ from a computer automatically when opening the Sessantaquattro+ embedded web page or connecting to it with OT BioLab+. - Page 32 Sessantaquattro+ User Manual v.2.0 – March 2023 Two different views are available depending on the network role of Sessantaquattro+. Few options are common between the two views and others are specifically related to the network role. Figures 8.14 and 8.15 show an example of the two views. When loading the web page automatically the time and date of the device used to access the page are transferred to the Sessantaquattro+ device to update its internal real-time clock.
- Page 33 , in fact, the Sessantaquattro+ device searches for the upgrade files in a specific folder in the OT Bioelettronica drop box account and, if a new file is found, it automatically downloads the file and updates itself. The firmware upgrade will open a new page and display the progress in the process.
- Page 34 Sessantaquattro+ User Manual v.2.0 – March 2023 IP Settings (Access Point mode) When Sessantaquattro+ is the access point, it can also provide the IP settings to the devices connected to its network. The parameters of this section let the user set the IP address of Sessantaquattro+ and the range of available addresses for providing the IP to other connected devices.
- Page 35 Sessantaquattro+ User Manual v.2.0 – March 2023 SyncStation Settings (Using SyncStation as external Access point) When using the SyncStation, the IP settings of the Sessantaquattro+ are assigned by the SyncStation itself and are fixed, they depend only on the selection of the device ID (ID = 1 or 2). Sessantaquattro+ connects to the SyncStation as device number 5 or 6 depending on the ID selection.
- Page 36 Sessantaquattro+ User Manual v.2.0 – March 2023 FIG. 8.14: Embedded web page of Sessantaquattro+ when it acts as access point...
- Page 37 Sessantaquattro+ User Manual v.2.0 – March 2023 FIG. 8.15: Embedded web page of Sessantaquattro+ when an external access point is used...
- Page 38 Sessantaquattro+ User Manual v.2.0 – March 2023 FIG. 8.16: Embedded web page of Sessantaquattro+ when is used with SyncStation...
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Page 39: Patient Connection
Sessantaquattro+ User Manual v.2.0 – March 2023 Patient connection Regardless of the adapter used and the detection mode, Sessantaquattro+ needs to be connected to the patient with a reference strap or electrode. This is necessary to fix the standard body potential mode of the patient to the midpoint of the Sessantaquattro+ power supply. -
Page 40: Other Acquisition Method
Sessantaquattro+ User Manual v.2.0 – March 2023 biological signals from the electrodes and the AC signal. They can be separated by appropriate digital filters. The value of the impedance can be obtained by considering that the standard patient mode voltage is fixed through the patient reference to the middle supply. -
Page 41: Troubleshooting
TROUBLESHOOTING This section describes the most common problems that may be found by Sessantaquattro+ users, with some suggestions to solve them. For problems not described in this section contact the technical support team of OT Bioelettronica. GENERAL PROBLEMS Problem Possible cause Solution The battery level is too low. -
Page 42: Sessantaquattro+ Maintenance And Storage
Sessantaquattro+ User Manual v.2.0 – March 2023 SESSANTAQUATTRO+ MAINTENANCE AND STORAGE Sessantaquattro+ has to be used in the following conditions: Temperature: from 0°C to +40°C Maximum relative humidity: Atmospheric pressure: from 700 hPa to 1060 hPa It is recommended to turn off the Sessantaquattro+ device at the end of each measurement session, and to remove all the connections. -
Page 43: Risk Analysis
Sessantaquattro+ User Manual v.2.0 – March 2023 RISK ANALYSIS 11.1 General requirement for basic safety and essential performance CEI EN 60601-1-2 EN 60601-1 Medical electrical equipment - Part 1: General safety requirement EN 60601-1-2 Medical electrical equipment - Part 1: General requirement for basic safety and essential performance Sessantaquattro+ is designed to be used in an electromagnetic environment with the characteristics specified below. - Page 44 Sessantaquattro+ User Manual v.2.0 – March 2023 Manufacturer’s declaration and guidelines – electromagnetic immunity – casing door Phenomenon EMC reference standard or Immunity test levels - test method Professional healthcare environment Electrostatic discharges IEC 61000-4-2 +/- 8 kV contact +/- 2 kV, +/- 4 kV, +/- 8 kV in air Radiated RF EM fields IEC 61000-4-3 3 V/m 80 MHz –...
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Page 45: Intended Use
Sessantaquattro+ User Manual v.2.0 – March 2023 INTENDED USE The Sessantaquattro+ 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 46: Technical Characteristics
Sessantaquattro+ User Manual v.2.0 – March 2023 TECHNICAL CHARACTERISTICS Model: Sessantaquattro+ Risk class: I in compliance with Regulation 745/2017. Insulation class: BF type applied part, in compliance with the European standard EN 60601-1. Classification: IP20, about the penetration of fluids and dust; device not protected. Basic UDI 805697785PORTABLEEMG002SF Case:... -
Page 47: Warranty
Sessantaquattro+ User Manual v.2.0 – March 2023 WARRANTY Sessantaquattro+ 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. Warranty conditions are reported hereinafter. - Page 49 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...