BIO electronica Sessantaquattro User manual

User Manual v 1.1

sessantaquattro

Portable bioelectrical signal amplifier

Read this manual carefully before using the sessantaquattro amplifier.

sessantaquattro user manual v1.1 - June 2017

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sessantaquattro user manual v1.1 - June 2017

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Index

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

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

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

3.1 CONTRAINDICATIONS ......................................................................................................................... 5

3.2 SIDE EFFECTS................................................................................................................................... 5

4SAFETY CAUTIONS AND OTHER WARNINGS ........................................................................ 6

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 ...................................................................................................... 10

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.......................................................................................................... 13

8USE OF SESSANTAQUATTRO ............................................................................................... 14

8.1 SESSANTAQUATTRO WIFI INTERFACE ................................................................................................... 14

8.2 SIGNALS ....................................................................................................................................... 15

8.3 ELECTRODE AND RECHARGE ADAPTERS .................................................................................................. 16

8.4 WIRELESS DATA TRANSFER ................................................................................................................ 21

8.5 MICROSD DATA LOGGING.................................................................................................................. 22

8.6 WEBPAGE SETUP ............................................................................................................................. 23

8.7 PATIENT CONNECTION ...................................................................................................................... 27

9TROUBLESHOOTING ........................................................................................................... 28

10 SESSANTAQUATTRO MAINTENANCE AND STORAGE .......................................................... 29

11 TECHNICAL CHARACTERISTICS.......................................................................................... 30

12 WARRANTY ......................................................................................................................... 31

12.1 WARRANTY CONDITIONS ................................................................................................................... 31

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1GENERAL DESCRIPTION

The sessantaquattro is a multichannel amplifier and datalogger for bioelectrical signals. It can

detect surface electromyographic (sEMG) signals and electroencephalographic (EEG) signals.

The sessantaquattro allows the detection and recording of the electric signals generated by 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

www.otbioelettronica.it, under the download page.

The sessantaquattro 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

requirement for devices with an electronic part applied to the patient.

Sessantaquattro has different adapters for the connection to different electrode configurations.

Each of them makes also available two inputs for auxiliary signals.

2SESSANTAQUATTRO KIT CONTENT

1 portable multichannel amplifier sessantaquattro

cable adapters to connect electrodes to the amplifier;

1 conductive cream package;

3 reference straps for the ankle;

3 reference straps for the wrist;

3 reference cables;

1 USB cable type A-C;

Arrays and matrix of electrodes of different sizes, depending on the customer request;

1 sessantaquattro user manual.

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3END USER

Sessantaquattro multichannel amplifier allows non invasive recording of biopotentials (sEMG, EEG)

detected by superficial electrode.

The end user must be familiar with the technique and received a 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 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.

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4SAFETY CAUTIONS 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.

The following cautions 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 hard shocks suffered by the sessantaquattro (like a drop to

the floor, etc.), verify that no crack or any other kind of damage of the box resulted from the

shock. In case of 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.

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5SYMBOLS USED ON SESSANTAQUATTRO AND IN THE USER MANUAL

Class BF for circuitry applied to patient.

Read carefully the instruction remarks before use.

Signals input.

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6TECHNICAL SPECIFICATIONS

Sessantaquattro is a battery powered device designed to guarantee an 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 supply the quattrocento 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

Eigth 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. A 2 mm female banana for the patient reference connection.

AD1x16SE

A 16 pin connector for linear electrode arrays. An additional four poles 3.5 mm

jack for two auxiliary signals. A 2 mm female banana for the patient reference

connection.

AD2x32SE

Two 32 pin connectors for 32 electrode matrixes. An additional four poles 3.5

mm jack for two auxiliary signals. A 2 mm female banana for the patient

reference connection.

AD1x64SE

A 70 pin connectors for 64 electrode matrixes or 64 electrode EEG caps. An

additional four poles 3.5 mm jack for two auxiliary signals. A 2 mm female

banana for the patient reference connection.

TAB. 6.1: list of sessantaquattro available adapters.

Additional adapter can be realized under user request to interface other type of electrodes or

sensor.

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Sessantaquattro technical specifications are shown in TAB. 6.2.

EMG/EEG channels

Number of channels

Gain

1, 2, 4, 8 V/V

Low pass filter

~ FSAMP/4

High pass filter

DC coupled or 10 Hz digital

Noise level referred to input

4 VRMS

Input resistance

500 M

Input range

0 –3.3 V

Auxiliary channels

Number of channels

Gain

0.5 V/V

Low pass filter

~ FSAMP/4

High pass filter

DC coupled

Noise level referred to input

4 VRMS

Input resistance

500 M

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

TAB. 6.2: sessantaquattro technical specification

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7DETAILED DESCRIPTION

Sessantaquattro is a battery portable equipment for 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 acces point or connect to an existing network provided

by an external access point. In both cases, sessantaquattro has an IP address where a web page

can be reached using any browser, for configuration, control and firmware update.

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 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.

7.1.1 Input and recharge connector

The 80 pins connector is the interface between sessantaquattro and its adapters. The different

adapters allow to connect the device with different type of electrodes and sensors or to recharge

the battery. The pinout of the connector is available on request for custom developments. Refer to

section 8.3 for additional details about the available adapters.

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