Lifelines trackit T4A User manual

USER MANUAL
Imagine EEG Anywhere

USER
MANUAL
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
Doc No: 51305-006
Part No: 1606
Issue: 2.0
CCN: CCN119
Created
Checked
Approved
Digitally signed by Geoff
Salter
Date: 2019.10.14 08:56:20
+01'00'
Digitally signed by Michael
Hulin
Date: 2019.10.15 15:29:51
+01'00'
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2019.10.15 15:54:15 +01'00'

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Customer Responsibility
The Trackit T4A 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
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 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 Trackit T4A 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 Trackit T4A 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........................................................................................................................................................................................17
2.5 Use in the home environment........................................................................................................................................................... 18
2.6 Use with other equipment ................................................................................................................................................................... 18
2.7 Interference..................................................................................................................................................................................................... 19
2.8 Maintenance and cleaning.................................................................................................................................................................. 19
2.9 Disposal of equipment............................................................................................................................................................................ 19
3 Connections and usage ........................................................................................................................................20
3.1 Overview...........................................................................................................................................................................................................20
3.2 Laptop installation and operation.................................................................................................................................................. 21
3.3 Fitting the battery packs...................................................................................................................................................................... 22
3.4 Connecting the Trackit T4A Amplifier........................................................................................................................................ 23
3.5 Switching the Amplifier on and off ..............................................................................................................................................25
3.6 Bluetooth ...........................................................................................................................................................................................................27
3.7 SD Card .............................................................................................................................................................................................................29
3.8 The T4A Bag.................................................................................................................................................................................................... 31
3.9 Remote Patient Event Thumb Switch (optional)................................................................................................................ 32
3.10 Battery Pack Charging...........................................................................................................................................................................33
4 Trackit Software - overview................................................................................................................................36

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5 The ambulatory recording...................................................................................................................................37
5.1 Preparing the Ambulatory Recording.........................................................................................................................................37
5.2 Patient Instruction Sheet ......................................................................................................................................................................37
5.3 Event marking................................................................................................................................................................................................37
5.4 Ending a recording....................................................................................................................................................................................37
5.5 Identifying a recording...........................................................................................................................................................................37
Version History ....................................................................................................................................................................52
Illustrations
Figure 1: Connecting the Trackit T4A Amplifier – Clinical Use...........................................................................................20
Figure 2: Connecting the Trackit T4A Amplifier - Home Use............................................................................................... 21
Figure 3: Battery replacement....................................................................................................................................................................22
Figure 4: Battery capacity display...........................................................................................................................................................22
Figure 5: Connecting the Trackit T4A Amplifier (PCU/front face) ..................................................................................23
Figure 6: Connections and indicators on the T4A Amplifier, connector end ......................................................... 24
Figure 7: Releasing the data cable ..........................................................................................................................................................25
Figure 8: Trackit T4A display ........................................................................................................................................................................26
Figure 9: Bluetooth pairing............................................................................................................................................................................28
Figure 10: SD Card location...........................................................................................................................................................................30
Figure 11: Patient Event Thumb Switch.................................................................................................................................................32
Appendices
Appendix 1: Trackit T4A Amplifier Specifications....................................................................................................38
Appendix 2: Additional Events Information................................................................................................................. 41
Appendix 3: Additional Bluetooth Information......................................................................................................... 42
Appendix 4: SD Card Information..................................................................................................................................... 44
Appendix 5: Default Setup on Amplifier .......................................................................................................................46
Appendix 6: Troubleshooting Guide ................................................................................................................................47
Appendix 7: Manufacturer’s Declaration...................................................................................................................... 48

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1 Overview and Technical Description
1.1 General description
Indications for use
The Trackit T4A 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 T4A EEG amplifier is a 32-channel electroencephalograph recorder and is intended for use in
ambulatory EEG and lab monitoring applications. The Trackit T4A Amplifier is intended to be used in a Professional
healthcare Environment and a Home (healthcare) environment.
The Trackit T4A amplifier is powered by one or two lithium-polymer battery packs and is fitted with an internal
lithium-ion backup battery. The amplifier features a local event pushbutton and has connection for an optional
remote (cabled) event pushbutton. The input channels of the T4A amplifier have built-in calibration and electrode
impedance measurement. Communication to a PC is through a wireless (Bluetooth) interface and a cabled (USB)
interface. Recorded data is stored on a removable SD memory card. A pouch is provided to carry and protect the
amplifier in ambulatory use.
The Trackit T4A amplifier is intended to be configured and set up by a trained healthcare professional. In an
ambulatory situation, the EEG electrodes are fitted to the patient by the healthcare professional prior to the patient
being sent home. The patient is intended to have minimal interaction with the Trackit T4A amplifier, with the only
interacting being pressing the event pushbutton(s).
Upon completion of the recording, the data, which is stored on the SD card, is reviewed by a clinician using review
and analysis software on a PC.
The amplifier is intended to be battery powered in ambulatory applications and communicates wirelessly with a
host computer through Bluetooth. Alternatively it can be connected to a USB port on a PC which is powered from
a medically approved power supply.
Two fully charged battery packs provide suicient power to power the Amplifier for a minimum of 72 hours. The
battery packs are intended to be replaced when the amplifier is not recording and not fitted to the patient. The
T4A amplifier does not recharge the battery packs. The battery packs must be removed from the amplifier and
recharged using a desktop charger.
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 Trackit T4A 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 PC and the medical-grade power supply as 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 conductors.
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.
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.
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Do not open or modify the equipment without the authorization of the manufacturer.
Replace the Lithium polymer battery packs with Lifelines supplied battery packs only. Use of another
battery may present a risk of fire or explosion.
Do not touch the battery contacts (in the Trackit T4A battery housing) and the patient
simultaneously.
The lithium-polymer battery packs used in this device may present a fire or chemical burn hazard if
mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate.
The laptop must only be connected to the medical-grade laptop power supply supplied or
authorised by Lifelines. Do not use a standard laptop power supply.
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 T4A, including
cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could
result.
When in close proximity to the T4A Amplifier, do not use mobile phones, transmitters, power
transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for
more information.
If the Trackit T4A amplifier is not to be used for some time, the battery packs should be removed.
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.
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1.3 Explanation of symbols
Symbol Meaning
Type BF applied part
Input/output connection
Special recycling required*
Consult warnings in User Manual
Remote event pushbutton
Manufacturer
Internal battery hazard
- refer to section 1.7
Battery pack identifier
Symbol Meaning
Follow operating instructions
Input connection
Bluetooth
Memory card read/write
On/O and patient event switch
Battery door access
– refer to section 3.3
European Representative
* 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.
Storage and transport symbols
Symbol Meaning Symbol Meaning Symbol Meaning
Temperature limits Fragile Keep dry
Relative humidity
limits
Atmospheric
pressure limits IP22 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)
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1.4 The Amplifier and its parts
The Trackit T4A EEG Amplifier is a 32-channel electroencephalograph recorder intended to acquire EEG signals
in an ambulatory environment. It is powered by either one or two lithium-polymer battery packs and is fitted with
an internal, non-replaceable, lithium-ion backup battery. The amplifier features a local event pushbutton and has
connection for an optional remote (cabled) event pushbutton.
In ambulatory applications the amplifier communicates with a host computer, wirelessly, through Bluetooth.
Alternatively it can be connected to a USB port on a PC which is powered from a medically approved power
supply. Refer to section 3.1 for details.
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 Trackit T4A EEG Amplifier comprises the following components:
Component Part Number
Trackit T4A Amplifier 1600
Trackit T4A Amplifier USB cable 1601
Trackit T4A bag and straps 1602
Trackit T4A Lithium-polymer battery pack (x2) 1603
Single bay battery charger with power supply 1604
Trackit software CD, standard 1009
Trackit T4A User Manual (this document) 1606
Trackit T4A Quick Start Guide 1607
Trackit T4A Patient Instruction Sheet 1608
Trackit T4/T4A Tool 1408
The T4A EEG Amplifier can be used with the following accessories:
Accessory Part Number
Patient event switch 1353
Lenovo ThinkPad laptop computer 1389
Medical grade power supply 1390
4-Bay Battery Charger and Power supply 1605
Mains cable, UK 1066
Trackit T4A Amplifier USB cable (170mm) 1611
Part numbers may be preceded by ‘L14’ on labelling or packaging.
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1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The Trackit T4A amplifier has been certified and complies with the following standards:
Standard Description
IEC 60601-1 and
IEC 60601-2-26
Standard for medical electrical equipment, general requirements and particular
requirements for EEG systems.
IEC 60601-1-11 Collateral standard for medical electrical equipment used in the home
healthcare environment.
IEC 60601-1-6 Collateral standard for usability.
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 requirements.
IEC 60601-1-2 Standard for medical electrical equipment, EMC requirements, 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.
Trackit T4A Amplifier:
Internally powered.
Type BF applied parts.
If a PC is supplied, the PC has no
electrical connection to the Amplifier
and 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 Trackit T4A Amplifier
The Trackit T4A amplifier provides 32 channels (28 referential, 4 bipolar) with built-in calibration and electrode
impedance measurement. The amplifier has built in type-BF patient isolation and has a USB interface to the PC.
Bluetooth wireless communication is included for ambulatory applications. EEG data is recorded to a removable
SD card. The amplifier has a built-in position sensor (accelerometer) and light sensor.
Applied parts, type BF
EEG Electrodes
The amplifier connects to standard 1.5mm touchproof EEG recording electrodes arranged in a standard 10-20
pattern, attached to the patient’s head.
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
approved to the Medical Device Directive 93/42/EEC in Europe or to the relevant local standards
outside Europe.
The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
Patient Event pushbutton
The Patient Event Pushbutton is used by the patient to mark the instance of a significant event.
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Lithium Polymer Battery Packs
The Trackit T4A amplifier has provision to fit two Lithium-Polymer battery packs, which provide the main power
source for the amplifier. The battery packs are housed in the battery compartment of the Trackit T4A amplifier and
connected in parallel, so the Trackit T4A can operate with only one battery pack fitted. The Trackit T4A does not
have the capability to recharge the battery packs and the battery packs must be removed from the Trackit T4A to
be recharged in a desktop charger. Details for charging the batteries are provided in Section 3.10.
Replace the Lithium polymer battery packs with Lifelines supplied battery packs only. Use of
another battery may present a risk of fire or explosion.
SD Memory Card
The SD card is used to store the EEG data recorded by Trackit T4A. Storage cards of varying capacity are available
in the SD format. The Trackit T4A supports SD cards with a capacity up to 32GB with a FAT32 file system.
Bags and straps for ambulatory applications
The T4A bag houses the Amplifier when used in ambulatory application. The bag protects the amplifier from water
and dust (IP22 protection).
USB Cable for connection to PC
For non-ambulatory applications the Amplifier can be plugged directly into a USB port on the PC.
The Amplifier must only be used with the USB cable provided with the unit.
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, supplied
or authorised by Lifelines.
The laptop must only be connected to the medical-grade laptop power supply supplied or
authorised 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 XP, Windows Vista, Windows 7, 8 or 10 on the host PC
and is used to setup and review the T4A Amplifier and to record on to the PC.
The Trackit T4A amplifier is connected to the PC via the USB cable or wirelessly with Bluetooth. The recording
setup is downloaded to the device and checks can be made to verify that all the electrodes have been attached
correctly. The Amplifier is then disconnected from the PC and the recording is started.
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Functions of the software: Refer to the Trackit Plus software manual
yDownload the recording template. This includes which electrodes are used and the recording montage.
yPerform a calibration check of the Amplifier.
yPerform an Impedance check on the Amplifier. .
yPerform an EEG recording.
yView on-going EEG traces.
1.7 Replaceable parts
Lifelines Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, 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 Trackit T4A amplifier contains a lithium ion rechargeable coin cell, type LIR2450.
Battery replacement by inadequately trained personnel could result in a hazard. It must be replaced
only with the correct type. Refer to the Trackit T4A Service Instructions.
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Installation and Maintenance
2 Installation and Maintenance
The following section must be read and understood before the equipment is switched ON.
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 ii) 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: Storage and transport:
Temperature +5°C to +40°C
(+41°F to +104°F)
Temperature -25°C to +70°C
(-13°F to +158°F)
Relative humidity 15% to 93%
non-condensing
Relative humidity Up to 93% non-
condensing at +70°C
(158°F)
Atmospheric pressure 700 hPa to 1060 hPa Atmospheric pressure 500 hPa to 1060 hPa

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2.3 Power supply connections
Trackit T4A Amplifier
Power requirements 3.7V Lithium-Polymer battery pack or Standard USB port (5V)
Power consumption Maximum power from USB port: 2.5W.
The Amplifier must only be used with the USB cable provided with the unit.
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
authorised by Lifelines.
Medical grade AC mains power supply module for Laptop PC
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.
The laptop must only be connected to the medical-grade laptop power supply supplied or
authorised by Lifelines. Do not use a standard laptop power supply.
Only use the laptop 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.
Single Bay battery charger (P/N 1604)
AC/DC power adapter Battery charging cradle
Mains Power input: 100-240VAC, 50/60Hz, 0.35A max. Power input: 5VDC, 1A nom.
Output: 5VDC, 1A Max. Micro-USB connector Output: 4.2VDC, 1A max.
Four Bay battery charger (P/N 1605)
AC/DC power adapter Battery charging cradle
Mains Power input: 100-240VAC, 50/60Hz, 1.5A max. Power input: 12VDC, 3.3A nom.
Output: 12VDC, 4.2A Max. Output: 1A max (x 4).
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2.4 Battery Operation
Li-Polymer battery pack
Replace the Lithium polymer battery packs with Lifelines supplied battery packs only. Use of another
battery may present a risk of fire or explosion.
The lithium-polymer battery packs used in this device may present a fire or chemical burn hazard if
mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate.
If the Trackit T4A amplifier is not to be used for some time, the battery packs should be removed.
The Trackit T4A amplifier is powered from one or two battery packs. When fully charged, two battery packs will
typically power the unit for 72 hours depending on the number of channels, sample rate and wireless usage (36
hours if only one battery pack is used).
The typical service life of the battery packs is 500 charge-discharge cycles.
A desktop charger is required to recharge the battery packs. The Trackit T4A amplifier does not recharge the
battery packs.
The healthcare professional is intended to replace the battery pack(s). This should be done before a recording is
started. The patient should not replace the battery packs.
Li-Polymer battery pack Instructions for Use
yThe battery packs are charged using the specified desktop charger. Refer to the instructions supplied with the
charger.
yOperating time will be shorter than usual at low temperatures. The battery can be used between 0°C (32°F) and
45°C (113°F), but will give best performance between 10°C (50°F) and 30°C (86°F).
yIf the battery packs start to give less operating times than usual, they have reached the end of their life and
must be replaced. Dispose of used battery packs promptly and keep away from children.
ySince the battery packs will naturally discharge itself over a period of time, it is best to charge the battery packs
a day or two before planning to use it.
Internal Li-Ion backup battery
The internal backup battery will enable the unit to continue operating for a short period of time (30 mins approx.)
to allow the main battery pack to be replaced. It is recharged automatically, while the amplifier is switched on and
either connected over USB or fitted with a battery pack. The state of charge is displayed, as described in section 3.5,
whenever the unit is powered from the backup battery.
The typical service life is 500 charge-discharge cycles. The backup battery is replaceable by service personnel only.
Installation and Maintenance

USER
MANUAL
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2.5 Use in the home environment
Where the equipment is intended to be used in the home, the unit 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 cable
connection between the PC and the T4A 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 equipment or sensor cables.
When the equipment is operated with or without its Bluetooth connected, other devices in the vicinity should be
moved away or turned o to reduce the likelihood of interference to the equipment or by the equipment.
The Trackit T4A has an internal Bluetooth radio fitted. This is an approved industry-standard type 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 documentation
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 equipment, 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 system 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.
Installation and Maintenance