BRAINTRONICS BRAINBOX EEG-1142 Manual de usuario

BRAINBOX®EEG-1142

BRAINTRONICS B.V.

Gildemark 130

1351 HL ALMERE

The Netherlands

Phone : 036-5315088

Fax.: 036-5315253

Internet: http://www.braintronics.nl

email: info@braintronics.nl

File name 860150 V1.10.doc

USERS MANUAL

EEG AMPLIFIER FOR EPILEPSY MONITORING

BRAINBOX®EEG-1142

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 2 of 47

File name: 860150 V1.10.doc

Table of contents

Chapter Description Page

1GENERAL .........................................................................................5

1.1 Point of attention.............................................................................................................5

1.2 Introduction.....................................................................................................................5

1.3 Features.........................................................................................................................6

1.4 References.....................................................................................................................7

1.5 Guarantee ......................................................................................................................8

1.6 Document status.............................................................................................................8

2SAFETY ASPECTS...........................................................................9

2.1 General warnings ...........................................................................................................9

2.2 Symbols .........................................................................................................................9

2.3 Maintenance.................................................................................................................11

2.3.1 Cleaning of the instrument............................................................................................11

2.3.2 Repair and Modification................................................................................................11

2.4 Handling precautions....................................................................................................11

2.5 Operator skills ..............................................................................................................11

2.5.1 Operator Profile............................................................................................................12

2.6 Connections .................................................................................................................13

2.6.1 General information regarding mating of connectors ....................................................13

2.6.2 Power supply for the BRAINBOX®EEG-1142 .............................................................13

2.6.3 Ground connections .....................................................................................................14

2.6.4 Connection to other equipment.....................................................................................14

2.6.5 Restriction of use of the BRAINBOX®ETHERNET SYSTEM .......................................15

2.6.6 Cables..........................................................................................................................15

2.7 Environment.................................................................................................................15

2.7.1 Patient environment and applied part ...........................................................................16

2.8 End of life disposal .......................................................................................................17

3PLACE IN SYSTEM.........................................................................18

3.1 BRAINBOX®ETHERNET SYSTEM overview..............................................................18

3.2 System Features using the BRAINBOX®EEG-1142....................................................19

3.3 System input using the BRAINBOX®EEG-1142..........................................................20

3.4 Parts to use with BRAINBOX®EEG-1142....................................................................20

3.4.1 Touchproof input boxes................................................................................................ 20

3.5 Ground Reference Electrode........................................................................................21

3.6 Input Protection ............................................................................................................21

3.7 Operating modes..........................................................................................................21

3.7.1 EEG mode....................................................................................................................22

3.7.2 CAL mode ....................................................................................................................22

3.7.3 KOHM mode................................................................................................................. 24

3.7.4 System Characteristics mode (firmware V0.2 and higher) ............................................24

4SPECIFICATIONS...........................................................................25

4.1 General ........................................................................................................................25

4.2 Safety...........................................................................................................................25

4.2.1 Safety provided by the total BRAINBOX®ETHERNET SYSTEM .................................25

4.2.2 Safety provided by BRAINBOX®EEG-1142 ................................................................25

4.3 EMI Protection..............................................................................................................25

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 3 of 47

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4.4 Inputs ...........................................................................................................................26

4.5 Calibration (For high accuracy see par. 4.9).................................................................26

4.6 Electrode check............................................................................................................27

4.7 Continuous KOhm range output ...................................................................................27

4.8 EEG Amplifiers (For high accuracy see par. 4.9)..........................................................27

4.9 High accuracy EEG channels....................................................................................... 28

4.10 CMRR, practical Common Mode Rejection Ratio .........................................................28

4.11 A/D Conversion EEG channels..................................................................................... 29

4.12 Digital FIR filter EEG channels .....................................................................................29

4.13 DC Amplifiers ...............................................................................................................29

4.14 A/D Conversion DC channels....................................................................................... 30

4.15 Interface (BRAINBUS)..................................................................................................30

4.16 System characteristics..................................................................................................30

4.17 Electromagnetic compatibility .......................................................................................31

4.18 Environment.................................................................................................................31

5CONNECTIONS..............................................................................32

5.1 EEG-signal inputs and GND references .......................................................................32

5.2 SpO2 and EVENT input................................................................................................33

5.2.1 SpO2 and EVENT output..............................................................................................34

5.3 BRAINBUS...................................................................................................................34

5.4 BRAINBUS Terminating Connector..............................................................................35

6DIRECTIONS FOR SOFTWARE DEVELOPMENT .........................36

6.1 Control code................................................................................................................. 36

6.2 Calibration Mode ..........................................................................................................37

6.3 EEG Mode....................................................................................................................38

6.4 Electrode Impedance Check.........................................................................................38

6.5 Channel definition.........................................................................................................40

7GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY...............41

7.1 Guidance and manufacturers declaration .....................................................................41

7.1.1 Electromagnetic emissions...........................................................................................41

7.1.2 Electromagnetic immunity.............................................................................................42

7.2 General guidelines to avoid EMC problems..................................................................44

7.2.1 Disturbance caused by 50/60 Hz. mains voltage ..........................................................44

7.2.2 Precautions to prevent electromagnetic disturbances...................................................44

7.2.3 What to do if you need to make an EEG in a bad environment.....................................45

Appendix A. Characteristics of Digital FIR filter in all BRAINBOX®amplifiers............................. 46

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 4 of 47

File name: 860150 V1.10.doc

Table of figures

Figure Description Page

Figure 1: Patient environment. ........................................................................................................................ 16

Figure 2: General block diagram BRAINBOX®ETHERNET SYSTEM........................................................... 18

Figure 3: Internal functions of System Components for 1 amplifier system.................................................... 19

Figure 4: Photo of BRAINBOX®EEG-1142 with INBOX-1142....................................................................... 20

Figure 5: Level CAL step response of EEG amplifier...................................................................................... 23

Figure 6: Overshoot on Level CAL signal........................................................................................................ 23

Figure 7: BRAINBOX®EEG-1142 EEG electrode connector......................................................................... 33

Figure 8: BRAINBOX®EEG-1142 EVENT, SpO2 and BRAINBUS connectors............................................ 33

Figure 9: SpO2 and EVENT inputs seen form outside.................................................................................... 34

Figure 10: BRAINBUS connectors seen from outside.................................................................................... 34

Figure 11: Diagram of the Impedance test signal............................................................................................ 39

Figure 12: Frequency vs. Gain response of analog input plus AA filter and digital filter................................. 47

Table of tables

Table Description Page

Table 1: Electrode input connector pin description ......................................................................................... 32

Table 2: Connector layout EVENT connector.................................................................................................. 33

Table 3: Connector layout SpO2 connector. ................................................................................................... 33

Table 4: Connector layout BRAINBUS. .......................................................................................................... 34

Table 5: BRAINBUS Terminating Connector.................................................................................................. 35

Table 6: Control Bytes for the BRAINBOX®EEG-1142 amplifier................................................................... 36

Table 7: Mode bits definitions.......................................................................................................................... 37

Table 8: Values of Electrode Test Level.......................................................................................................... 37

Table 9: Values of Amplifier Test Level........................................................................................................... 37

BRAINBOX®is a registered trademark of BRAINTRONICS.

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 5 of 47

File name: 860150 V1.10.doc

1 GENERAL

1.1 Point of attention

The BRAINBOX® EEG-1142 is always to be used in combination with other Braintronics equipment to form a

BRAINBOX® ETHERNET SYSTEM. This cannot act as a complete EEG system, and always has to be used

with a PC with EEG analysis software not delivered by Braintronics BV, this manual is written from the

perspective of the System Integrator. The System Integrator therefore has to include all information needed

by the End User in his own user manuals. Special attention has to be given to all safety aspects and EMC

requirements included in this manual. Also see paragraph 1.4 for references to other manuals to be used for

system configuration, installation and software development.

1.2 Introduction

THE PERFECT FRONT END FOR EPILEPSY MONITORING

The BRAINBOX®EEG-1142 is part of a family of EEG amplifiers all having their own specific area of

application. The BRAINBOX®EEG-1142 amplifier is the perfect choice as front-end for computer based

small EEG systems, especially for ambulatory monitoring of epilepsy patients and polysomnography. The

system is designed for OEM users who market EEG analysis software and need an EEG amplifier front-end

to complete the EEG system. Braintronics can supply all BRAINBOX®equipment with a customized text

plate with name and logo’s as required.

HIGH END PERFORMANCE

The BRAINBOX®EEG-1142 is always to be used with a PC and EEG analysis software which are not

delivered by Braintronics BV. For interfacing to a standard Ethernet 10/100 Mbit LAN, Braintronics BV

delivers the ETHERNET-102 interface. For isolation Braintronics BV delivers the ISO-101. These system

parts together with all necessary cables form the BRAINBOX®ETHERNET SYSTEM. Additional to the

excellent performance of the EEG amplifier, the BRAINBOX®ETHERNET SYSTEM brings you features not

easily found in such a very compact system: Real Input Calibration, Electrode Impedance Check, excellent

digital filtering and anti aliasing of –40 dB at ½ sample rate. The small amplifier box with its thin flexible cable

makes it easy for the patient to move around freely during long term monitoring.

16 BIT AD CONVERTER BUILT IN

The BRAINBOX®EEG-1142 uses a 16 bit AD Converter for each EEG-channel. Assuring high quality

parallel sampling for all channels at the same time to prevent phase shifts between channels. The sample

rate of the ADC is 32768 Hz for the EEG channels of a BRAINBOX®amplifier, a 32x over sampling. DC

channels are sampled at a high 1024 Hz rate. In a daisy chained system simultaneous sampling of all

channels is also maintained.

LOW SENSITIVITY TO NOISE

Thanks to its high input isolation, the BRAINBOX®amplifiers are extremely insensitive to noisy

environments. The floating inputs give a very high rejection against common mode signals like 50/60 Hz.

interference. To further reduce 50/60 Hz interference under difficult noise situations, an active common mode

suppression system (G1/G2) is available.

FAST RECOVERY

The EEG amplifiers in the BRAINBOX®EEG-1142 are designed to have a fast recovery time when the

electrodes are first connected and also when disturbances occur due to electrode movement.

INPUT ISOLATION

The ultra portable BRAINBOX®EEG-1142 amplifiers do not have input isolation themselves. The isolation of

the total system is performed by the ISO-101. Total input isolation is according to EN60601-1, class II, and

type CF.

EMC PROTECTION

All parts of the BRAINBOX®EEG-1142 are shielded inside, all inputs are filtered for high frequency

interference and all inputs have a protection circuit against electrostatic discharge (ESD).

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 6 of 47

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SIMPLE INTERFACING TO ANY PC BASED PLATFORM

The separate ETHERNET-102 Interface contains a complete TCP/IP protocol stack to communicate in a

simple way with a PC-application, based on a WINDOWS socket protocol. No extra hardware inside the PC

is needed.

FLEXIBILITY

A BRAINBOX® ETHERNET SYSTEM is easily adaptable to the users need. From a simple 32 channel EEG

only system up to a full 256 channel system. Furthermore features as DC channels, SpO2 handling, EVENT,

general digital I/O, LED impedance indication and Photic stimulation, are possible with specific BRAINBOX®

devices.

COMPLIANCE WITH THE MEDICAL DEVICE DIRECTIVE

The BRAINBOX®EEG-1142 is designed to comply fully with the Medical Device Directive 93/42/EEC of the

European Community.

45 YEARS OF EXPERIENCE

The design of the BRAINBOX®EEG-1142 is based on more than 45 years of experience in the field of

Neurophysiology.

1.3 Features

FULLY SOFTWARE CONTROLLED

The design of the BRAINBOX®ETHERNET SYSTEM is optimized for maximum convenience and the best

possible efficiency during use: it is fully remote controlled from the operator PC screen. This means you can

Check Electrodes, switch the amplifier input to a Calibration Voltage, select the amplitude of the calibration,

change the sample rate of the interface, etc., from inside the application software. All the communication is

done over an ETHERNET-LAN by using Braintronics proprietary protocol on top of the TCP/IP protocol.

LOW PRICE

The price of the BRAINBOX®ETHERNET SYSTEM is low enough to be interesting even when only 32

channels will actually be used.

LOW NOISE

The BRAINBOX®EEG-1142 amplifier has input amplifiers with FET (Field Effect Transistor) inputs. The

use of FET inputs makes sure that the amplifier not only has a low noise during calibration, but also in the

practical situation, with electrodes having a higher source impedance. The very low current noise of the FET

keeps the total noise low.

LOW INPUT BIAS CURRENT

The use of an FET input stage for the EEG amplifiers also guarantees a very low Input Bias Current. This is

the Amplifier DC input current-flow through the electrode. A very low Input Bias Current allows the use of

high impedance electrodes such as very small electrodes.

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 7 of 47

File name: 860150 V1.10.doc

1.4 References

860071.doc

User information for the active GND reference system

860129.doc

Software manual ETHERNET-102

860141.doc

Software manual BRAINBOX®EEG-1166

860142.doc

Software manual FLASH-201

860143.doc

Software manual BRAINBOX®EEG-1042

860144.doc

Software manual BRAINBOX®EEG-1142

860148.doc

Software manual BRAINBOX®EEG-1164

860135.doc

User manual BRAINBOX®ETHERNET SYSTEM

860147.doc

User manual BRAINBOX®EEG-1164

860149.doc

User manual BRAINBOX®EEG-1166

860150.doc

User manual BRAINBOX®EEG-1142

860151.doc

User manual BRAINBOX®EEG-1042

860167.doc

User manual FLASH-201

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 8 of 47

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1.5 Guarantee

All our instruments are guaranteed for 3 years against factory defects. Within the guarantee period,

instruments or parts of instruments are repaired in our factory free of charge if all transport costs are paid by

the customer.

Guarantee does not apply to parts which are normally exposed to wear or when a defect or malfunction is

caused by improper use and/or handling by unskilled people.

This product is designed and manufactured by BRAINTRONICS B.V. in The Netherlands and its quality and

performance are based on more than 45 years of experience in the field of EEG equipment.

Specifications and illustrations are not binding and subject to change without notice.

1.6 Document status

Copyright: Braintronics BV

Document identification: 860150.doc

Document status : Published

Revision: V1.10

Publishing date: 2018-11-15

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 9 of 47

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2 SAFETY ASPECTS

2.1 General warnings

ALWAYS READ THE WHOLE MANUAL BEFORE USING THE

BRAINBOX

ETHERNET SYSTEM

DO NOT INSTALL SUBSTITUTE PARTS OR PERFORM ANY UNAUTHORIZED MODIFICATION TO THIS

PRODUCT.

RETURN THIS PRODUCT TO BRAINTRONICS FOR SERVICE AND REPAIR TO ENSURE THAT

SAFETY FEATURES ARE MAINTAINED.

BE AWARE THAT THE

BRAINBOX

EEG-1142

NEEDS SPECIAL PRECAUTIONS REGARDING EMC

AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION

GIVEN IN THIS MANUAL IN PARAGRAPH 7.

READ THE POINT OF ATTENTION IN PARAGRAPH 1.1

WHEN USED AS PART OF THE

BRAINBOX

ETHERNET SYSTEM,

THE

BRAINBOX

EEG-1142

PROVIDES ELECTRICAL SAFETY AT EN60601-1 CF LEVEL. IT IS THE RESPOSIBILITY OF THE USER

TO MAINTAIN THE SAFETY LEVEL IF THE CONNECTED PC IS WITHIN REACH OF THE PATIENT

SPECIFIC WARNINGS ARE INDICATED IN THE TEXT WITH BOLD TEXT WARNING, FOLLOWED BY A

DESCRIPTION OF THE WARNING.

2.2 Symbols

Symbol for

EN60601-1 class II

Symbol for

EN60601-1

CF applied part

Symbol for “Attention:

Consult accompanying

documents"

0344

Symbol for

“Conformité

European” with

notified body

identification

Symbol for "Attention:

Observe precautions for

handling ESD sensitive

Devices"

Symbol for

Manufacturing year.

EN980:2003

USERS MANUAL BRAINBOX®EEG-1142 Rev. 1.10 Publ. 860150

BRAINTRONICS B.V Gildemark 130 1351 HL ALMERE THE NETHERLANDS

Phone +31 36 53 15 088Fax: +31 36 53 15 253 email: sales@braintronics.nl internet: http://www.braintronics.nl Page 10 of 47

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Symbol for

Manufacturer

EN980:2003

Symbol for separate

collection of electric

and electronic waste

Symbol for operating

instructions

ISO 7000-1641

Symbol for

connector mating

direction

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