Bioelettronica Sessantaquattro User manual

User Manual v 1.3.2

Sessantaquattro

Portable bioelectrical signal amplifier

Read this manual carefully before using Sessantaquattro

Sessantaquattro user manual v1.3.2 - April 2020

1GENERAL DESCRIPTION...................................................................................................................................4

2SESSANTAQUATTRO KIT CONTENT..................................................................................................................4

3END USER..........................................................................................................................................................5

3.1 Contraindications.................................................................................................................................................. 5

3.2 Side effects.......................................................................................................................................................... 5

4SAFETY PRECAUTIONS AND OTHER WARNINGS.............................................................................................5

5SYMBOLS USED ON SESSANTAQUATTRO AND IN THE USER MANUAL ...........................................................7

6TECHNICAL SPECIFICATIONS ..........................................................................................................................8

7DETAILED DESCRIPTION................................................................................................................................10

7.1 Controls, indicators and connector ....................................................................................................................... 10

7.1.1 Input and recharge connector………………………………………………………………………………………………………………………………11

7.1.2 ON/OFF switch……………………………………………………………………………………………………………………………………………………11

7.1.3 MicroSD card slot………………………………………………………………………………………………………………………………………………..11

7.1.4 LEDs indicators……………………………………………………………………………………………………………………………………………………11

7.1.5 Start/Stop REC pushbutton…………………………………………………………………………………………………………………………………..14

8USE OF SESSANTAQUATTRO...........................................................................................................................15

8.1 Sessantaquattro WiFi interface............................................................................................................................. 15

8.2 Signals .............................................................................................................................................................. 16

8.3 Electrode and recharge adapters.......................................................................................................................... 18

8.4 Wireless data transfer ......................................................................................................................................... 27

8.5 MicroSD data logging .......................................................................................................................................... 27

8.6 Webpage setup .................................................................................................................................................. 29

8.7 Patient connection .............................................................................................................................................. 34

8.8 Other acquisition method .................................................................................................................................... 35

Sessantaquattro user manual v1.3.2 - April 2020

9TROUBLESHOOTING .......................................................................................................................................36

10 SESSANTAQUATTRO MAINTENANCE AND STORAGE .....................................................................................38

11 RISK ANALYSIS...............................................................................................................................................39

11.1 General requirement for basic safety and essential performance CEI EN 60601-1-2 .................................................. 39

12 TECHNICAL CHARACTERISTICS .....................................................................................................................41

13 WARRANTY .....................................................................................................................................................42

13.1 Warranty conditions............................................................................................................................................ 42

Sessantaquattro user manual v1.3.2 - April 2020

1GENERAL DESCRIPTION

Sessantaquattro is a multichannel amplifier and datalogger for bioelectrical signals. It can detect surface electromyographic (sEMG)

signals and electroencephalographic (EEG) signals. The Sessantaquattro device allows the detection and recording of the 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 visualization and storage, or stored in a MicroSD card. A freeware

software for real time display and storage, called OT BioLab+, has been designed by OT Bioelettronica and is available for

download at this link: https://otbioelettronica.it/downloads. The Sessantaquattro device is a research instrument designed for

clinical research carried out by qualified researchers. It is completely safe for the patient. The safety is achieved by satisfying the

design requirements for devices with an electronic part applied to the patient. Sessantaquattro has different adapters to connect

different electrode configurations. Each of them also has two inputs for auxiliary signals.

2SESSANTAQUATTRO KIT CONTENT

•1 Sessantaquattro;

•1 Adapter for the battery charging (CUSB01)

•Cable adapters to connect electrodes to the amplifier,

depending on the customer request

•1 Conductive cream package

•1 Reference strap for the wrist

•1 Reference strap for the ankle

•1 Reference cables

•1 USB cable type A-C

•1 MicroSD card

•Arrays and matrix of electrodes of different sizes,

depending on the customer request

•1 Sessantaquattro user manual

Sessantaquattro user manual v1.3.2 - April 2020

3END 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 received proper training in EMG or EEG detection and

interpretation.

3.1 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 concerning grounding and leakage currents.

3.2 Side effects

No significant side effects are known. The materials used for manufacturing all the parts in contact with the patient are

biocompatible. Possible slight cutaneous allergic reactions (e.g. skin reddening) are reduced to a minimum during short duration

of bioelectrical signal acquisitions.

4SAFETY PRECAUTIONS AND OTHER WARNINGS

The use of the multichannel amplifier Sessantaquattro is absolutely forbidden in the following conditions:

•While other monitoring devices are in use with the patient.

•While electro surgery equipment, short waves or microwaves therapy devices are used.

•By mentally impaired people.

•Whenever the equipment is damaged.

•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.

Sessantaquattro user manual v1.3.2 - April 2020

The following precautions should be observed:

•Only use electrodes supplied by the manufacturer: Sessantaquattro is guaranteed to achieve tested performance only if used

with electrodes supplied by the manufacturer.

•Contact the manufacturer immediately if extraneous materials permeate into the device (liquids, powders, etc.). In case of

strong impacts (like dropping on the floor, etc.), verify that no crack or any other kind of damage is visible. If in doubt,

please contact the manufacturer.

•The Sessantaquattro 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). This interference may affect the

measurements of the physiological variables derived from the EMG or EEG signals. These measurements are not meant to

be used for diagnostic purposes, and thus these signal alterations cannot be dangerous for the patient, please always take

into account the presence of noise in your signal processing tasks and evaluations.

•The connection between Sessantaquattro and other electrical devices must be done in compliance with the European

standard EN 60601-1-1 on medical devices.

•The use of the Sessantaquattro is restricted to skilled personnel.

•Incorrect measurements can arise when unskilled personnel use the device in presence of strong sources electromagnetic

interference (e.g. strong electromagnetic fields). The presence of interference in the signals is easily recognised by skilled

personnel. Read carefully the instruction remarks before use

Sessantaquattro user manual v1.3.2 - April 2020

5SYMBOLS USED ON SESSANTAQUATTRO AND IN THE USER MANUAL

Serial number

Class BF for circuitry applied to patient

Read carefully the instruction remarks before use

Do not dispose of this product as non-differentiated waste. Prepare the re-use or separate collection of the product Union

on the disposal of electrical and electronic equipment

Manufacturer

CE marking

Read the instruction

Signal input

Sessantaquattro user manual v1.3.2 - April 2020

6TECHNICAL 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. The same connector is used for electrode interface and battery

recharge avoiding the chance to power the Sessantaquattro device from an external source when it is connected to the patient.

The connector for the auxiliary inputs is intended for the interface with other floating devices (goniometers, accelerometers or

amplifiers for other biological signals). The connection must be done in compliance with the European standard EN 60601-1-1 on

medical devices. Table 6.1 shows the list of available adapters and their connections.

Adapter

Available connections

CUSB01SE

USB type C, for battery recharge

AD8x1SE

Eight four poles 3.5 mm jacks for connection of two bipolar electrode pairs (16 electrodes pairs in total). An additional four

poles 3.5 mm jack for two auxiliary signals. 2 mm female banana for the patient reference connection.

AD1x16SE

16 pin connector for linear electrode arrays. An additional four poles 3.5 mm jack for two auxiliary signals. 2 mm female

banana for the patient reference connection.

AD4x8SE

Adapter for connecting up to 32 bipolar channels plus two auxiliary channels.

AD4x4SE

Adapter for connecting up to 4 arrays from 4 channels each plus 2 auxiliary channels.

AD2x32SE

Two 32 pin connectors for 32 electrode matrixes. An additional four poles 3.5 mm jack for two auxiliary signals. 2 mm female

banana for the patient reference connection.

AD1x64SE

70 pin connectors for 64 electrode matrixes or 64 electrode EEG caps. An additional four poles 3.5 mm jack for two auxiliary

signals. 2 mm female banana for the patient reference connection.

ISO-AUXSE

Isolated adapter for connection with other non-floating instruments.

SyncSE

Isolated adapter for connection with another non-floating instrument and for synchronizing a channel.

TAB. 6.1: list of Sessantaquattro available adapters

Sessantaquattro user manual v1.3.2 - April 2020

Additional adapters can be made under user request to interface other types of electrodes or sensors. The Sessantaquattro

technical specifications are shown in Table 6.2.

TAB. 6 .2: Sessantaquattro technical specification

EMG/EEG channels

Number of channels 64

Gain 1 V/V

Low pass filter

~ F

SAMP

High pass filter

DC coupled or 10 Hz digital

Noise level referred to input

< 1.2

RMS

(in standard mode)

Input resistance 500 MΩ

Input range 0 – 3.3 V

Auxiliary channels

Number of channels 2

Gain 0.5 V/V

Low pass filter ~ FSAMP/4

High pass filter DC coupled

Noise level referred to input

< 6.1

RMS

Input resistance

500 M

Ω

Input range

± 3.3 V

Data conversion and communication

A/D converter resolution

16, 24 bits

A/D converter input dynamics

± 2.4 V

Selectable sample frequency 500, 1000, 2000, 4000 Hz

Data transfer to PC WiFi through TCP socket

Data storage MicroSD

Battery

Battery life – Charging time 8 hours (full charge) – 7 hours

Sessantaquattro user manual v1.3.2 - April 2020

7DETAILED 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. The device can act as a WiFi access

point or connect to an existing network provided by an external access point. In both cases, Sessantaquattro has an IP address

in which a web page can be reached using any browser, for configuration, control and firmware updates. Data transfer to a PC is

obtained through a TCP socket opened by the PC. A configuration string sent to Sessantaquattro can set all the acquisition

parameters and start the data transfer. The communication protocol is available for custom development together with a

demonstration Matlab code.

7.1 Controls, indicators and connector

Sessantaquattro can be fully configured by means of its internal web page, while the LEDs and button just provide a quick access

to basic functions.

FIG. 7.1:

Sessantaquattro controls, connectors and indicators

Table of contents

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