Lifelines trackit T4 User manual

T4 EEG Amplifier User Manual
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Version History
V 1 (23 June 2016)
•Initial release
V 1.1 (09 Aug 2016)
•Amended part numbers in section 1.4.
V 1.2 (28 Sep 2016)
•Various amendments for IEC 60601-1.
V 1.3 (13 Dec 2016)
•Amendments to Nonin and Aux Input specifications in section 1.6.
•Changed ‘Contraindication’ to ‘Warning’ in section 1.2. There are no contraindications for this device.
V 1.4 (08 February 2017)
•Added to section 1.2 “CONTRAINDICATIONS: There are no known contraindications to the use of this
equipment”.
•Added to section 1.2 and 2.3 “WARNING: To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth”.
•Removed drawing numbers in section 1.4.
•Amended section 2.4: Internal Li-Ion backup battery operation.
•Added to Section 4.1: “Note: If a Setup that uses greater than 32 channels plus the Nonin is at-
tempted...”.
•Added to section 3.3 details of battery replacement frequency.
V 1.5 (10 March 2017)
•Amended instructions concerning oximeter and Aux. input sensors.
V 1.6 (13 March 2017)
•Further amendments to instructions concerning oximeter and Aux. input sensors.
V 1.7 (22 March 2017)
•Added to Aux DC Input instructions – “for hospital and clinic use. Not for home use” in section 1.6 and
3.3.
V1.8 (18 August 2017)
•Photic operation added in Appendix 2.
•Wireless operation added in Appendix 5.
V1.9 (08 November 2017)
•Added disinfection information in section 2.8.
•Change of N.B. to 0086 (BSI).
V1.10 (5th September 2018)
•Added T4-PCU 32+3.
•Added further disinfection information in section 2.8.
V1.11 (7th October 2019)
•Updated EMC declaration and warnings.
•Changed Notified body and added EC Rep.
•Document style and images update.
•Software section updated

T4 EEG Amplifier User Manual
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Lifelines Ltd,
7 Clarendon Court,
Over Wallop, near Stockbridge,
Hampshire SO20 8HU, UK
Telephone [phone]
www.LLines.com
[e-mail]
Incereb Ltd.
3015 Lake Drive
Citywest
Dublin
D24 DKP4
Ireland
2797
Doc No: 51285-006
Part No: 51285-006
Issue: 1.11
CCN: CCN114 & CCN120
Created:
Checked:
Approved:
Digitally signed by Geoff Salter
Date: 2019.10.11 10:15:22
+01'00'
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2019.10.23 08:41:48 +01'00'
Digitally signed by Michael Hulin
Date: 2019.10.23 11:29:26 +01'00'

T4 EEG Amplifier User Manual
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Disclaimers & Warranties
The information in this section is subject to change without notice.
Except as stated below, Lifelines Ltd makes no warranty of any kind with regard to this material, including, but
not limited to, the implied warranties of merchantability and fitness for a particular purpose. Lifelines shall not
be liable for errors contained herein or for incidental or consequential damages in connection with the furnish-
ing, performance or use of this material.
Lifelines shall warrant its products against all defects in material and workmanship for one year from the date
of delivery.
Misuse, accident, modification, unsuitable physical or operating environment, improper maintenance or dam-
age caused by a product for which Lifelines is not responsible will void the warranty.
Lifelines do not warrant uninterrupted or error-free operation of its products.
Lifelines or its authorised agents will repair or replace any products that prove to be defective during the war-
ranty period, provided that these products are used as prescribed in the operating instructions in the user’s
and service manuals.
No other party is authorised to make any warranty to assume liability for Lifelines products. Lifelines will not
recognise any other warranty, either implied or in writing. In addition, services performed by someone other
than Lifelines or its authorised agents or any technical modification or changes of products without Lifelines
prior, written consent may be cause for voiding this warranty.
Defective products or parts must be returned to Lifelines or its authorised agents, along with an explanation of
the failure. Shipping costs must be prepaid.
Lifelines Ltd. manufactures hardware and software to be used on or with standard PC-compatible computers
and operating software. Lifelines, however, assumes no responsibility for the use or reliability of its software or
hardware with equipment that is not furnished by third-party manufacturers accepted by Lifelines at the date
of purchase.
All warranties for third-party products used within the T4 system are the responsibility of the relevant manu-
facturer. Please refer to the relevant documentation on each product for further details.
This document contains proprietary information that is protected by copyright. All rights are reserved. No part
of this document may be photocopied, reproduced in any other form or translated into another language with-
out the prior written consent of Lifelines.
Trademarks
Microsoft, Windows and Windows NT are registered trademarks of the Microsoft Corporation. All other trade-
marks and product names are the property of their relevant owners.
Responsibility of manufacturer
The manufacturer and distributor consider themselves responsible for the equipment’s safety, reliability and
performance only if:
•any peripheral equipment to be used with the T4 system is supplied by third-party providers recom-
mended by the manufacturer;
•assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons
authorised by the manufacturer;
•the electrical installation of the relevant room complies with the appropriate requirements;
•the equipment is used by a health-care professional and in accordance with the instructions for use.
Note: the manufacturer has a policy of continual product improvement; hence the equipment specifications
are subject to change without notice.
Check with Lifelines or your distributor if a software update is available.
Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the Appendix.

T4 EEG Amplifier User Manual
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Software and Virus Protection
Lifelines takes all reasonable steps to ensure that its software is virus-free. In line with modern computing prac-
tice, it is advisable that continual protection against viruses, trojans, malware, adware etc. is provided on the
PC used for installation and the surrounding systems. Please note the following recommendations which
should be supported by your internal IT/Computing department procedures and practices:
1. Virus protection software should be installed on every computer at risk of infection. This software
should have a resident (online) shield and provide email scanning if appropriate.
2. Virus scanning should be set to manual mode or automatic if desired but at a time when the system is
not being used.
3. All programs offering auto-update features, including Windows, should be set to manual or automatic
if desired but at a time when the system is not being used.
4. Adopt formal departmental or organisational procedures to ensure the integrity and safe operation of
the medical equipment and supporting systems.

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Contents
Version History 2
Disclaimers & Warranties 4
Trademarks 4
Responsibility of manufacturer 4
Software and Virus Protection 5
Contents 6
Illustrations 8
1Overview and Technical Description 9
1.1 General description 9
1.2 Cautions and Warnings 9
1.3 Explanation of symbols 11
1.4 The Amplifier and its parts 12
1.5 Specifications and safety 12
1.6 Description of the components 13
1.7 Replaceable parts 14
2Installation and Maintenance 15
2.1 Checks for completeness and integrity 15
2.2 Environmental parameters for operation 15
2.3 Power supply connections 15
2.4 Battery Operation Time 16
2.5 Use in the home environment 16
2.6 Use with other equipment 16
2.7 Interference 16
2.8 Maintenance and cleaning 17
2.9 Disposal of equipment 17
3Connections and usage 18
3.1 Overview 18
3.2 Laptop installation and operation 19
3.3 Connecting the T4 System 19
3.4 Starting the system 21
3.5 Shutdown of the system 22
3.6 Battery replacement and charging 22
4The setup and recording software 24
4.1 Overview 24
4.2 Trackit Control Panel 25
4.3 Defining Input Signals 28
4.4 Setting up the Amplifier Inputs and Recording channels 29
4.5 Starting a Recording 32
4.6 Recording Control Panel (Amplifier recording) 33
4.7 View EEG Signal Traces 35
4.8 Calibration Check 36
4.9 Impedance Check 36
4.10 Events 37
4.11 Montage Editor 38
4.12 Reading an EEG recording 39
4.13 Advanced Settings 39
Appendix 1: Specifications 44
Appendix 2: Photic Stimulation 47
Appendix 3: Additional Events Information 49
Appendix 4: PC Setup 52

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Appendix 5: Wireless 54
Introduction 54
System overview 54
Connection and use 54
Appendix 6: Troubleshooting Guide 59
Appendix 7: Manufacturer’s Declaration 60
EMC Compatibility 60

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Illustrations
Figure 1 Connecting the T4 Amplifier – Clinical Use 18
Figure 2 Connecting the T4 Amplifier - Home Use 18
Figure 3 Connecting the T4 Amplifier (front face) 20
Figure 4 Connecting the T4 Amplifier (back face) 21
Figure 4: Trackit Software ‘File’ Toolbar 24
Figure 5: Trackit Software ‘Home’ Toolbar 24
Figure 6: Trackit Software "Settings Toolbar 25
Figure 7: Trackit Software 'Help' Toolbar 25
Figure 8: Trackit Control Panel 26
Figure 9: Connect Dialog Box 26
Figure 10: Trackit Control Panel "Status B" 28
Figure 11: Signal List 28
Figure 12: Signal Editing Tool 29
Figure 21: EEG setup 29
Figure 14: Setup Recording dialog 30
Figure 15: Channel setup 31
Figure 16: Recording Channel editing 31
Figure 25: New Patient dialog 32
Figure 18: New Patient database 32
Figure 19: Recording Control panel 34
Figure 20: EEG Signal trace display 35
Figure 21: Adjust display parameters 35
Figure 22: Impedance check 36
Figure 23: Continuous Impedance Check 37
Figure 24: Event Viewer 37
Figure 25: Montage Editor 39
Figure 26: Defaults Tab 1 41
Figure 27: Defaults | Tab 2 42
Figure 21 Photic Stimulation control window 47
Figure 22 Photic trigger signal definition 48
Figure 23 User Events 50
Figure 24 Events Template setup 50
Figure 25 Free-text Event 50
Figure 26 Event List 51
Figure 27 Options Tab 1 52
Figure 28 Options Tab 2 52
Figure 29 Options Tab 3 53

T4 EEG Amplifier User Manual
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1Overview and Technical Description
1.1 General description
Indications for use
The T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit
electrophysiological signals (wireless or cabled).
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
General description
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab
monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the
EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No
subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored
on a memory card is reviewed by a clinician using review and analysis software on a PC.
It is a compact USB amplifier which provides 32 channels (or 68 channels with internal expansion option) with
built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface,
a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN
WiFi).
There are two variants of the Trackit T4 EEG Amplifier:
•Trackit T4-32 providing 24 referential + 8 poly channels.
•Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board).
Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68
channels (model T4-PCU 64+4).
Also available is model T4-PCU 32+3 Patient Connection Unit which provides a dedicated Electrocap D-type
connector plus an additional 10 channels of EEG and 3 poly bipolar channels.
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved
power supply. In addition it can be battery powered in ambulatory applications.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with
other methods of patient diagnosis. The equipment does not sustain or support life.
Intended User
The intended user of the equipment is a healthcare professional who has the training and knowledge to
undertake EEG examinations and is familiar with EEG equipment and practice.
1.2 Cautions and Warnings
WARNING: Do not use the T4 EEG Amplifier in an MRI environment, in an oxygen rich environment or during
defibrillation.
WARNING: This equipment is intended to be used by a healthcare professional and in accordance with these
instructions for use which must be read in their entirety before the device is used.
WARNING: This equipment in intended only as an adjunct device in patient assessment; it must be used in
conjunction with other methods of patient diagnosis. This equipment is not be used for the determination of
brain death.
WARNING: Only use the PC and the medical-grade power supply as supplied or authorised by Lifelines.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
WARNING: Lifelines does not supply EEG electrodes. The unit accepts standard 1.5 mm touchproof electrodes
using DIN 42802-style connectors. To ensure patient safety, the electrodes used must be approved to the
Medical Device Directive 93/42/EEC in Europe or FDA cleared for use in USA.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
WARNING: Do not plug the USB connector into any device other than the PC supplied or authorised by
Lifelines. Do not connect any other equipment to the PC.
CAUTION: Do not touch simultaneously any accessible USB or other contacts on the PC and the patient.

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WARNING: Strangulation hazard due to long cables. As with all medical equipment, carefully route patient ca-
bling to reduce the possibility of patient entanglement or strangulation.
CAUTION: Ensure that carrying bag and straps are worn over clothing to prevent any possibility of skin irrita-
tion.
CAUTION: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the Trackit T4, including cables
specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
CAUTION: When in close proximity to the Amplifier, do not use mobile phones, transmitters, power
transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for more
information. Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the Appendix.
WARNING: The function or safety of the equipment could be impaired if it has been subjected to unfavourable
conditions in storage or in transit. If at any time function or safety is thought to be impaired, the instrument
should be taken out of operation and secured against unintended use.
WARNING: Do not open or modify the equipment without the authorization of the manufacturer.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
CONTRAINDICATIONS: There are no known contraindications to the use of this equipment.