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

T4 EEG Amplifier User Manual
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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.

T4 EEG Amplifier User Manual
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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.

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1.3 Explanation of symbols
Type BF applied part Follow operating instructions
Input/output connection Input connection
Special recycling required, do not dispose of in landfill. When this equipment has reached the
end of its useful life, it must be disposed of in an environmentally-friendly way. Waste
electrical and electronic equipment (WEEE) requires special procedures for recycling or
disposal. This includes batteries, printed circuit boards, electronic components, wiring and
other elements of electronic devices. Follow all of your respective local laws and regulations
for the proper disposal of such equipment. Contact your local distributor for information
concerning this.
Consult warnings in User Manual Bluetooth
Pushbutton WLAN WiFi
Manufacturer Nonin Xpod Pulse Oximeter
Memory card read/write Internal battery hazard
- refer to section 1.7
On/Off and patient event switch European Representative
Storage and transport symbols
Temperature limitsFragile Keep dry
Relative humidity limits Atmospheric pressure limits
International protection code
Protected against ingress of solid object 12.5 mm diameter.
Protected against access to hazardous parts with finger.
Protected against ingress of water dripping (15° tilted).
-25
+70
°C
0
93
%RH
500
1060
hPa
IP22

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1.4 The Amplifier and its parts
The T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab moni-
toring applications.
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. A Nonin XPOD interface is provided, a Patient
Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Amplifier is intended to be connected to a specific PC and a medical grade power supply. Refer section 3.1
for details.
Caution:
Only use the PC supplied or authorised by Lifelines
Only use the medical-grade mains power supply with it as supplied or authorised by Lifelines
The T4 EEG Amplifier comprises the following components:
T4-32 Amplifier part number 1505
T4-68 Amplifier part number 1501
T4-PCU 24+8 part number 1552
T4-PCU 64+4 part number 1553
T4-PCU 32+3 part number 1556
USB Power Bank battery part number 1560
Battery cable part number 1561
T4 bag and straps part number 1562
Patient event switch part number 1353
Xpod Pulse Oximeter Nonin part number 1327
Trackit tool part number 1115
Amplifier USB cable part number 1277
Lenovo ThinkPad laptop computer part number 1389
Medical grade power supply part number 1390
Mains cable, UK part number 1066
Trackit software CD, standard part number 1009
Part numbers may be preceded by ‘L14’ on labelling or packaging.
1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The Amplifier has been certified and complies with the following standards:
IEC 60601-1 and
IEC 60601-2-26
International standard for medical electrical equipment, general require-
ments and particular requirements for EEG systems.
ANSI/AAMI ES 60601-1
AAMI Deviations from IEC 60601-1 (USA).
CAN/CSA 22.2 No 601.1 M90
Canadian standard for medical electrical equipment, general require-
ments.
IEC 60601-1-2
International standard for medical electrical equipment, EMC require-
ments, calling:
*CISPR11
Conducted Emissions, Group 1, Class B
CISPR11
Radiated Emissions, Group 1, Class B
IEC61000-4-2
Electrostatic Discharges
IEC61000-4-3
Immunity - Radiated RF Field
*IEC61000-4-4
Immunity - Transients Bursts
*IEC61000-4-5
Immunity – Surges
IEC61000-4-6
Immunity – Conducted
IEC61000-4-8
Immunity – Power frequency fields
*IEC61000-4-11
Immunity – Voltage dips, interruptions
*IEC61000-3-2
Harmonic Emissions
*IEC61000-3-3
Voltage Fluctuations/flicker
*
Note: Compliance is provided by the PC.

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Classification of system
Classification Clinical use Home use
Degree of protection against
electrical shock
Internally powered; or it can be
connected to a PC which is
powered by a medical grade Class
I power supply.
Type BF applied parts.
Internally powered.
Type BF applied parts.
If a PC is supplied, it has no electrical
connection to the Amplifier & has no
applied parts.
Degree of protection against
harmful ingress of water
Ordinary (no protection) or
IP22 (Amplifier in bag)
IP22 (Amplifier in bag)
Mode of operation Continuous operation Continuous operation
Suitability for use in an oxygen
rich environment
Not suitable Not suitable
1.6 Description of the components
The T4 Amplifier
The T4 USB amplifier provides 32 channels (or 68 channels with internal expansion option) with built-in calibra-
tion and electrode impedance measurement. A Nonin XPOD interface is provided, a Patient Event input, an Aux
DC input and an Electrocap connector. The Amplifier has built in type-BF patient isolation and has a USB inter-
face to the PC. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Patient Connection Unit (PCU) connects the standard 1.5mm touchproof EEG recording electrodes at-
tached to the patient to the T4 unit. It is available either as a T4-PCU 24+8 (32 channel) unit or a T4 PCU 64+4
(68 channel). The PCU is plugged into the front of the unit and retained with two screws operated by the sup-
plied special tool.
Applied parts, type BF
EEG Electrodes
The amplifier connects to standard 1.5mm touchproof EEG recording electrodes arranged in a standard 10-
20 pattern (T4 PCU 24+8) or the grid layout (T4 PCU 64+4), attached to the patient’s head.
WARNING: Lifelines does not supply EEG electrodes. The Amplifier accepts standard 1.5 mm touchproof
electrodes using DIN 42802-style connectors. To ensure patient safety, the electrodes used must be ap-
proved to the Medical Device Directive 93/42/EEC in Europe or to the relevant local standards outside Eu-
rope.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode, should
not contact other conductive parts including earth.
Oximeter Sensor
The amplifier is approved for use with a Nonin 8000AA sensor which attaches to the patient’s finger.
Patient Event pushbutton
The Patient Event Pushbutton is used by the patient to record the instance of a significant event.
Aux DC Input
The amplifier is approved for use with a SleepSense body position sensor, type 1575, for hospital and clinic
use. Not for home use.
CAUTION: Only use approved sensors as specified by Lifelines.
USB Cable
The Amplifier plugs directly into a USB port on the PC.
WARNING: The Amplifier must only be used with the USB cable provided with the unit.
USB Power Bank battery pack for ambulatory applications
The Amplifier plugs directly into the USB port on the Power Bank.
WARNING: The Amplifier must only be used with the USB Power Bank supplied or authorised by Lifelines.

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Micro-SD Memory Card
The micro-SD card is used to store the EEG data recorded by T4. Storage cards of varying capacity are available
in the micro-SD format.
Bags and Straps for ambulatory applications
The Bag houses the Amplifier and battery.
Medical grade AC/DC mains power supply module for Laptop PC
Where EEG studies are conducted within the patient environment the leakage current must be controlled. The
laptop PC mains power supply must be a special medical-grade type with appropriate safety standards, sup-
plied or authorised by Lifelines.
WARNING: The laptop must only be connected to the medical-grade laptop power supply supplied or author-
ised by Lifelines. Do not use a standard laptop power supply.
Only use the laptop supplied or authorised by Lifelines.
The Setup and Recording Software
The Trackit setup software runs under Microsoft Windows 2000 (with SP2), Windows XP, Windows Vista, Win-
dows 7, 8 or 10 on the host PC and is used to setup and review the T4 Amplifier and to record on to the PC.
Functions of the software:
Download the recording template. This includes which electrodes are used and the recording mon-
tage. See section 4.4 & 4.11
Perform a calibration check of the Amplifier. See section 4.8.
Perform an Impedance check on the electrode inputs. See Section 4.9.
Perform an EEG recording. See section 4.5.
View on-going EEG traces. See section 4.7.
1.7 Replaceable parts
Lifelines Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibration in-
structions, or other information that will assist service personnel to repair those parts that are designated by
Lifelines Ltd. as repairable by service personnel.
Internal battery replacement – service personnel only
The T4 amplifier contains a replaceable lithium ion rechargeable coin cell, type LIR2450.
WARNING: Battery replacement by inadequately trained personnel could result in a hazard. It must
be replaced only with the correct type and it must be installed correctly with +ve uppermost.
1. Remove PCU and the four screws from underside of instrument, two from the front and two from the rear
mouldings. Remove bottom of case.
2. Un-clip the wrap-around screen to expose the battery beneath.
3. Grasp battery between thumb and forefinger and pull it from the socket.
4. Push replacement battery into the socket ensuring +ve is uppermost.
5. Re-clip the wrap-around screen and reassemble the case.
Battery safety instructions
Do not attempt to open, puncture, disassemble or modify the battery in any way.
Do not subject the battery to sudden shock or heat.
Do not dispose of battery in fire.

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2Installation and Maintenance
WARNING: The following section must be read and understood before the equipment is switched ON.
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.
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.
The manufacturer should be contacted (details on page 3) for assistance, if needed, in setting up, using or
maintaining the equipment; or to report unexpected operation or events.
The assembly of the system and any modifications during its service life require evaluation to the requirements
of IEC 60601-1.
2.1 Checks for completeness and integrity
1 Remove the equipment from the packaging case(s).
2 Use the parts list to check that all ordered items have been received.
3 Check for signs of damage that may have occurred during transit or storage. If any damage is found, do not
use the instrument; contact your distributor.
2.2 Environmental parameters for operation
The operational and storage/transportation environmental conditions are as follows:
Operational:
Temperature +5°C to +40°C
Relative humidity 15% to 93% non-condensing
Atmospheric pressure 700 hPa to 1060 hPa
WARNING: Do not obstruct any cooling slots. Position the equipment so that air flows freely.
Storage and transport:
Temperature -25°C to +70°C
Relative humidity Up to 93% non-condensing at +70°C
Atmospheric pressure 500 hPa to 1060 hPa
2.3 Power supply connections
Power requirements
Standard USB port.
Power consumption
Maximum power from USB port: 2.5W.
Medical grade AC mains power supply module for Laptop PC
Where EEG studies are conducted within the patient environment the leakage current must be controlled. The
mains power supply must be a special medical-grade type with appropriate safety standards, as supplied or au-
thorised by Lifelines.
Mains power input: 100–240 Vac, 47–63 Hz, 1.4 A @ 115 Vac, 0.7 A @ 230 Vac.
Output: 20 Vdc, 5.25 A.
WARNING: The laptop must only be connected to the medical-grade laptop power supply supplied or author-
ised by Lifelines. Do not use a standard laptop power supply.
Only use the laptop 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: The Amplifier must only be used with the USB cable provided with the unit.

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2.4 Battery Operation Time
USB Powerbank Li-Polymer battery pack
When fully charged the battery pack will typically power the unit for 36 hours depending on the number of
channels, sample rate and wireless usage.
The typical service life is 2 years.
Internal Li-Ion backup battery
The internal backup battery will enable the unit to continue operating for a short period of time (15 mins ap-
prox.) to allow the main battery pack to be replaced. It is recharged automatically, whenever the main battery
pack is connected, with acquire off. The state of charge is displayed, as described in section 3.4, whenever the
unit is internally powered from the backup battery. To charge manually, operate the pushbutton several times
to activate the backlight and if the reading drops below approximately 70%, charge the battery for about 10
minutes by connecting the main battery pack or connecting to a USB port.
The typical service life is 500 charge-discharge cycles.
2.5 Use in the home environment
Where the equipment is intended to be used in the home, the unit and its battery should be operated in its bag
where it is protected against ingress of solid objects and water to a degree of IP22.
The laptop PC is optional in the home environment and may be used for video recordings. There is no connec-
tion between the PC and the T4 Amplifier unit, as all communication is accomplished wirelessly.
Keep the equipment away from sources of heat.
Do not use mobile phones.
Do not allow pets or children to interfere with the sensor cables.
When the equipment is operated with or without its Bluetooth or WiFi on, other devices in the vicinity should
be moved away or turned off to reduce the likelihood of interference to the equipment or by the equipment.
The T4 may have internal radios fitted. These are approved industry-standard Bluetooth and Wi-Fi types which
present minimal risk of reciprocal interference with other equipment.
2.6 Use with other equipment
Defibrillators and HF surgical equipment
The equipment is not defibrillator proof and should not be used in situations where a defibrillator is likely to be
used.
The equipment should not be used with, or in the presence of, high frequency surgical equipment.
Other patient-connected equipment
When used simultaneously with other patient-connected equipment, for example a cardiac pacemaker or
other electrical stimulator, it is unlikely that a safety hazard will arise. However always consult the documenta-
tion supplied with the other patient-connected equipment to ensure that all hazards, warnings and cautions
are considered before the equipment is used together.
Leakage current
This system is designed to comply with IEC 60601-1, the international standard for medical electronic equip-
ment, which specifies the permissible levels of leakage current. A potential hazard exists in the summation of
leakage currents caused by connecting several pieces of equipment together. Because this system can be used
in conjunction with standard electronic devices, the total leakage current should be tested whenever the sys-
tem is modified.
There should be no electrical connections between the system equipment, which is powered via a medical
grade power supply, and any other equipment powered from another mains supply.
2.7 Interference
The T4 will continue to operate in the presence of radio frequency magnetic fields (RF) and the effects of elec-
trostatic discharges (ESD) and other interference, in accordance with the requirements of EN60601-1-2. How-
ever, the T4 amplifier records signals of very low amplitude, and these signals themselves are not immune to

T4 EEG Amplifier User Manual
17
the effects of RF, ESD and low-frequency magnetic field interference. Such interference may cause signal arte-
facts.
The T4 may have internal radios fitted. These are approved industry-standard Bluetooth and Wi-Fi types which
present minimal risk of reciprocal interference with other equipment.
However, when the equipment is operated with or without its Bluetooth or WiFi on, other devices in the vicin-
ity should be moved away or turned off to reduce the likelihood of interference to the equipment or by the
equipment
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 transform-
ers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for more information.
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.
2.8 Maintenance and cleaning
The T4 Amplifier and its accessories require no routine testing, calibration or maintenance procedures apart
from occasional cleaning and checking for wear and damage to all parts including the accessories.
No servicing or maintenance of the equipment should take place while in use with a patient, except for replace-
ment of the external battery.
Cleaning
Prior to each re-use of the system, all the outer surfaces of the T4 Amplifier, bag and power pack may be
cleaned, as required, with a cloth moistened with a mild detergent solution.
Disinfection of the equipment can be carried out by the use of QAC-based disinfectants. Wipes are recom-
mended in order to prevent the ingress of any liquid into the equipment. Suitable products include Mikrozid
Sensitive Wipes (Schülke & Mayr GmbH), Microbac forte (Paul Hartmann AG), Distel Wipes (Tristel Ltd.), Micro-
Kill Disinfectant Wipes, Sani-Cloth HB Germicidal Wipes (Medline).
For cleaning instructions for the laptop refer to the manufacturer’s documentation.
Caution: Do not allow any liquid to enter the case of any instrument or connector. Do not use acetone on any
of the instruments.
2.9 Disposal of equipment
The expected service life of the equipment, parts and accessories is three years, except for the USB Powerbank
battery pack which is two years. When the device and its parts and accessories has reached the end of its oper-
ating life, it should be disposed of in accordance with local waste regulation authority that is typically within
the local government office.
Caution: Do not dispose of batteries by incineration.

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3Connections and usage
3.1 Overview
Mains
power
Medical grade
laptop mains
PSU
Laptop PC
Patient
EEG
electrodes
T4 Amplifier
Battery pack & bag
optional
Patient
isolation
zone
To USB
port
Clinical use:
Wireless or USB cable connection
Type BF
AUX
SpO
2
Pushbutton
Figure 1 Connecting the T4 Amplifier – Clinical Use
Where the entire T4 system including the PC is used within the patient environment, the mains leakage cur-
rents and safety and regulatory requirements are met by the use of the special medical-grade laptop power
supply.
Mains
power
Medical grade
laptop mains
PSU
Laptop PC
optional for
home use
Patient
EEG
electrodes
T4 Amplifier
With battery pack
in bag
Patient
isolation
zone
Hom e use:
Wireless only (no electrical
connection to PC)
Type BF
AUX
SpO
2
Pushbutton
Figure 2 Connecting the T4 Amplifier - Home Use

T4 EEG Amplifier User Manual
19
The laptop PC is optional for home use where it may be used for video recordings. There is no connection be-
tween the PC and the T4 Amplifier unit, as all communication is accomplished wirelessly.
3.2 Laptop installation and operation
WARNING: The laptop must only be connected to the medical-grade laptop power supply supplied or author-
ised by Lifelines. Do not use a standard laptop power supply.
Only use the laptop supplied or authorised by Lifelines.
1. Connect the power cord to the medical-grade power supply.
2. Connect the power supply output to the power input connector on the laptop.
3. Connect the power cord to mains power outlet.
4. Note that the mains power cord serves as a power disconnect device. It should be installed near the
equipment and be easily accessible.
5. For laptop installation and operation refer to the manufacturer’s instructions supplied with it.
3.3 Connecting the T4 System
Clinical Use
The T4 Amplifier is optionally housed inside its bag with battery or used standalone. It is plugged into the PC
USB port using the cable supplied, part number 1277 as shown below, or a wireless connection can be used
instead. The USB Cable is plugged into the rear housing of the T4 Amplifier using the RJ45 plug and into any
USB port on the laptop PC.
Warning: Do not plug the cable into any other equipment other than the laptop PC provided with the system.
Note: In transportable, i.e. body-worn situations within the clinic, the Amplifier must be housed inside its bag
after being disconnected from the PC, for protection against spillage of liquids.
Home Use
The T4 Amplifier is battery powered and is housed inside its bag where it is protected against ingress of solid
objects and water to a degree of IP22. The laptop PC is optional and may be used for video recordings. There is
no connection between the PC and the T4 Amplifier unit, as all communication is accomplished wirelessly.
Note that for Home Use applications, the patient should be given a Patient Instruction Sheet, which details es-
sential usage and safety instructions concerning the equipment and battery replacement. Refer to the Patient
Instruction Sheet for details.
Estimating the precise recording time of the battery is difficult as it depends on the number of channels,
whether Bluetooth or Wi-Fi are enabled, oximeter use, etc. For recordings over 24 hours in length it is recom-
mended that the patient is given instructions to replace the battery every 24 hours.
Connecting the T4 Amplifier
The top face of the T4 houses the display and the patient event pushbutton. For display details refer to section
3.3 below. Pressing the pushbutton records a patient event and illuminates the back-light of the display.
Above the pushbutton is a circular aperture which houses a light level sensor.

T4 EEG Amplifier User Manual
20
Figure 3 Connecting the T4 Amplifier (front face)
The front face of the Amplifier’s PCU is laid out in a standard 10-20 format (T4 PCU 24+8) or a grid layout (T4
PCU 64+4). It accommodates standard touchproof electrode leads fitted with DIN 42802 connectors.
The T4-PCU 32+3 has a standard 25-way D-type Electrocap socket providing 21 EEG channels. It uses the stand-
ard mapping Fp1 – Pz mapped to EEG channels 1 – 21, plus Ref and Gnd. An additional 10 independent EEG
channels are provided by individual touchproof connectors, mapped to EEG channels 22 – 31. This takes ac-
count of users who may not want the Electrocap or maybe want to use some extra channels as well. These are
labelled EEG 1 (22), EEG 2 (23) etc. Also provided are 3 bipolar channels.
The connections and channel mapping are as follows:
Electrocap connector
Electrode EEG channel No. D25 pin No. Electrode EEG channel No. D25 pin No.
Fp1
1
1
Fp2
2
14
F3
3
2
F4
4
15
C3
5
3
C4
6
16
P3
7
4
P4
8
17
O1
9
5
O2
10
18
F7
11
6
F8
12
19
T3
13
7
T4
14
20
T5
15
8
T6
16
21
NEUT
N
9
Cz
20
22
Fz
19
10
Pz
21
23
A1
17
11
A2
18
24
REF
R
13
Touchproof connectors
Electrode
Channel No.
1
22
22
223
23
324
24
4
25
25
526
26
627
27
7
28
28
829
29
930
30
10
31
31
REF
-
GND
-
Bipolar channels