Lifelines trackit T4 User manual

USER MANUAL
®

Lifelines Ltd
1 Tannery House, Tannery Lane,
Woking, Surrey, GU23 7EF UK
Telephone [phone]
www.lifelinesneuro.com
[email protected]
Incereb Ltd.
6 Charlemont Terrace, Crofton Road,
Dun Laoghaire, Dublin, A96 F8W5. Ireland.
Doc No: 51285-006
Part No: 51285-006
Issue: 2.1
CCN: CCN0152
Created
Checked
Approved
Digitally signed by Geoff
Salter
Date: 2021.12.07
18:38:44 Z
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2021.12.08 10:35:02 Z
Digitally signed by Geoff
Salter
Date: 2021.12.08 15:20:05
Z

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Customer Responsibility
The Trackit T4 amplifier is reliable only when operated and maintained in accordance with the instructions
contained in this manual, accompanying labels, and inserts. A defective system should not be used. Parts that may
be broken or missing or those that are clearly worn or contaminated should be replaced immediately with new
original replacement parts that have been manufactured by or are available from Lifelines Neuro.
The owner of this system has the sole responsibility for any malfunction resulting from improper use or
maintenance, or repair done by anyone other than a qualified Lifelines Neuro representative and for any
malfunctions caused by any parts that have been damaged or modified by anyone other than a qualified Lifelines
Neuro representative.
The owner of this system has the sole responsibility for the connection of this product to other systems not
satisfying the electrical safety requirements class I, type BF, standards IEC 60601-1, IEC 60601-2-26, IEC 60601-1-11,
IEC 60601-1-2 for medical devices.
Customer Responsibility

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Disclaimers & Warranties
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 furnishing,
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 damage
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 warranty
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
manufacturer. 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 without the
prior written consent of Lifelines.
Trademarks
Microsoft, Windows and Windows NT are registered trademarks of the Microsoft Corporation. All other trademarks
and product names are the property of their relevant owners.
Safety
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Responsibility of manufacturer
The manufacturer and distributor consider themselves responsible for the equipment’s safety, reliability and
performance only if:
yany peripheral equipment to be used with the T4 system is supplied by third-party providers recommended by
the manufacturer;
yassembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorised
by the manufacturer;
ythe electrical installation of the relevant room complies with the appropriate requirements;
ythe 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.
Software and Virus Protection
Lifelines takes all reasonable steps to ensure that its software is virus-free. In line with modern computing practice,
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:
yVirus 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.
yVirus scanning should be set to manual mode or automatic if desired but at a time when the system is not
being used.
yAll 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.
yAdopt formal departmental or organisational procedures to ensure the integrity and safe operation of the
medical equipment and supporting systems.
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Contents
Disclaimers & Warranties.................................................................................................................................................2
1 Overview and Technical Description............................................................................................................... 6
1.1 General description..................................................................................................................................................................................... 6
1.2 Warnings and Cautions.............................................................................................................................................................................7
1.3 Explanation of symbols ............................................................................................................................................................................9
1.4 The Amplifier and its parts ..................................................................................................................................................................10
1.5 Specifications and safety........................................................................................................................................................................11
1.6 Description of the components........................................................................................................................................................12
1.7 Replaceable parts....................................................................................................................................................................................... 14
2 Installation and Maintenance .............................................................................................................................15
2.1 Checks for completeness and integrity .................................................................................................................................... 15
2.2 Environmental parameters for operation................................................................................................................................. 15
2.3 Power supply connections.................................................................................................................................................................. 16
2.4 Battery Operation Time.......................................................................................................................................................................... 16
2.5 Use in the home environment............................................................................................................................................................17
2.6 Use with other equipment ....................................................................................................................................................................17
2.7 Interference..................................................................................................................................................................................................... 18
2.8 Maintenance and cleaning.................................................................................................................................................................. 18
2.9 Disposal of equipment............................................................................................................................................................................ 18
3 Connections and usage .........................................................................................................................................19
3.1 Overview............................................................................................................................................................................................................ 19
3.2 Laptop installation and operation................................................................................................................................................. 20
3.3 Connecting the T4 System................................................................................................................................................................... 21
3.4 Starting the system .................................................................................................................................................................................. 24
3.5 Shutdown of the system.......................................................................................................................................................................25
3.6 Battery replacement and charging.............................................................................................................................................. 26
3.7 Micro-SD Card..............................................................................................................................................................................................27
4 Trackit Software - overview ................................................................................................................................29
Version History ....................................................................................................................................................................47

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Illustrations
Figure 1: Connecting the T4 Amplifier – Clinical Use..................................................................................................................19
Figure 2: Connecting the T4 Amplifier - Home Use....................................................................................................................20
Figure 3: T4 amplifiers and PCUs .............................................................................................................................................................22
Figure 4: T4 PCU 32+3.......................................................................................................................................................................................23
Figure 5 Connecting the T4 Amplifier (back face).......................................................................................................................24
Figure 6: T4 Amplifier display indicators.............................................................................................................................................25
Figure 7: Battery replacement 1 .................................................................................................................................................................26
Figure 8 Battery replacement 2.................................................................................................................................................................26
Figure 9 Photic Stimulation (using Trackit Plus software)....................................................................................................33
Figure 10 Photic Stimulation control window .................................................................................................................................33
Figure 11: Photic trigger signal definition............................................................................................................................................34
Figure 12: Bluetooth pairing ..........................................................................................................................................................................36
Figure 13: WiFi setup...........................................................................................................................................................................................37
Figure 14: Unsecure network error message .................................................................................................................................. 37
Figure 15: Bluetooth connection quality monitor. ........................................................................................................................38
Appendices
Appendix 1: Trackit T4 Amplifier Specifications .......................................................................................................30
Appendix 2: Photic Stimulation ......................................................................................................................................... 33
Appendix 3: Additional Events Information................................................................................................................ 35
Appendix 4: Wireless............................................................................................................................................................... 36
Appendix 5: Troubleshooting Guide ............................................................................................................................... 42
Appendix 6: Manufacturer’s Declaration.....................................................................................................................43

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1 Overview 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:
yTrackit T4-32 providing 24 referential + 8 poly channels.
yTrackit T4-68 providing 64 referential + 4 poly channels.
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 non-overlapping 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.
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1.2 Warnings and Cautions
Warning sign indicates a situation or
procedures that may be dangerous for
the patient and/or user.
Caution sign indicates a situation or
procedures that may cause equipment
damage or its improper usage.
Do not use the T4 EEG Amplifier in an MRI environment, in an oxygen rich environment or during
defibrillation.
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.
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.
Only use the laptop and the medical-grade power supply as supplied or authorised by Lifelines. Do
not use the standard laptop power supply
The Amplifier must only be used with the USB Power Bank supplied or authorised by Lifelines.
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
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.
The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
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.
Do not touch simultaneously any accessible USB or other contacts on the PC and the patient.
Strangulation hazard due to long cables. As with all medical equipment, carefully route patient
cabling to reduce the possibility of patient entanglement or strangulation.
Ensure that carrying bag and straps are worn over clothing to prevent any possibility of skin irritation.
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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.
Do not open or modify the equipment without the authorization of the manufacturer.
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.
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.
When in close proximity to the T4 Amplifier, do not use mobile phones, transmitters, power
transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for
more information.
Only use approved sensors as specified by Lifelines.
The Amplifier must only be used with the USB cable provided with the unit.
Do not allow any liquid to enter the case of the instrument or connector. Do not use acetone on any
of the instruments.
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.
Overview and Technical Description