Lifelines trackit Mk3 User manual

USER MANUAL
Imagine EEG Anywhere
Ambulatory EEG Recorder

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: 51336-006
Part No: 1114
Issue: 3.0
CCN: CCN126
Created
Checked
Approved
Digitally signed by Geoff
Salter
Date: 2020.07.07 09:44:33
+01'00'
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2020.07.08 09:23:29 +01'00'
Digitally signed by Geoff
Salter
Date: 2020.07.09 16:57:19
+01'00'

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Customer Responsibility
The Trackit Mk3 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 60601-1-2
and IEC 60601-1-11 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 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 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 Mk3 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 and Windows 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 Trackit Mk3 is supplied by third-party providers recommended by the
manufacturer;
yassembly operations, extensions, readjustments, modifications, or repairs are carried out by person authorised
by the manufacturer;
ythe electrical installation of the relevant room complies with the appropriate requirements;
ythe equipment is used by a healthcare 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:
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
1 System Overview ........................................................................................................................................................ 7
1.1 General description.....................................................................................................................................................................................7
1.2 Warnings and Cautions............................................................................................................................................................................8
1.3 Explanation of symbols ..........................................................................................................................................................................10
1.4 The Trackit Mk3 and its parts.............................................................................................................................................................11
1.5 Specifications and safety......................................................................................................................................................................12
1.6 Description of the components.......................................................................................................................................................13
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 Use in the home environment...........................................................................................................................................................16
2.5 Use with other equipment ...................................................................................................................................................................17
2.6 Interference.....................................................................................................................................................................................................17
2.7 Maintenance and cleaning..................................................................................................................................................................18
2.8 Disposal of equipment............................................................................................................................................................................18
3 Connections and Usage........................................................................................................................................ 19
3.1 Overview............................................................................................................................................................................................................19
3.2 Connecting the Trackit Mk3..............................................................................................................................................................20
3.3 Switching the Trackit Mk3 Recorder On and Off .............................................................................................................21
3.4 Symbols on the display.........................................................................................................................................................................22
3.5 Bluetooth .........................................................................................................................................................................................................23
4 Trackit Software - overview............................................................................................................................... 24
5 The ambulatory recording.................................................................................................................................. 25
5.1 Changing batteries and cards .........................................................................................................................................................25
5.2 Fitting the Clickon PCU........................................................................................................................................................................ 30
5.3 Event marking...............................................................................................................................................................................................32
5.4 Ending a recording...................................................................................................................................................................................32
5.5 Identifying a recording..........................................................................................................................................................................32
5.6 Reading an ambulatory recording................................................................................................................................................33
Version History ...................................................................................................................................................................68

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Appendices
Appendix 1: Trackit Mk3 Specifications ................................................................................................................................................34
Appendix 2: Advanced Trackit Settings (Defaults)........................................................................................................................37
Appendix 3: Trackit Mk3 Options ..............................................................................................................................................................42
Appendix 4: Photic Stimulator and Hyperventilation...........................................................................................................................45
Appendix 5: Bluetooth Wireless .................................................................................................................................................................48
Appendix 6: Troubleshooting Guide........................................................................................................................................................62
Appendix 7: Manufacturer’s Declaration..............................................................................................................................................64
Illustrations
Figure 1: Connecting the Trackit Mk3 – Clinical use ..................................................................................................................19
Figure 2: Connecting the Trackit Mk3 – Home Use ...................................................................................................................20
Figure 3 Connecting the Trackit Mk3 recorder ..............................................................................................................................20
Figure 4 Trackit Mk3 recorder: front panel......................................................................................................................................... 21
Figure 5: The Trackit Mk3 display ............................................................................................................................................................. 22
Figure 6: Opening the rear battery box/door...................................................................................................................................25
Figure 7: Removing and replacing 9V PP3 batteries..................................................................................................................26
Figure 7 Removing and replacing Lithium rechargeable battery .....................................................................................27
Figure 9: Closing the rear battery box/door......................................................................................................................................28
Figure 10: Removing and replacing the flash card ...................................................................................................................... 29
Figure 11: Removing the flash card...........................................................................................................................................................30
Figure 12: Clickon PCU Retaining screw location.........................................................................................................................30
Figure 13: Detach the PCU............................................................................................................................................................................... 31
Figure 14: Lift the PCU away from the Trackit Mk3....................................................................................................................... 31
Figure 15: Locating the PCU.......................................................................................................................................................................... 32
Figure 16: Trackit Defaults Tab 1...................................................................................................................................................................37
Figure 17: Trackit Defaults | Tab 2...............................................................................................................................................................39
Figure 18 Pulse oximeter and oximeter probe ................................................................................................................................. 42
Figure 19: Connecting the oximeter to Trackit Mk3.....................................................................................................................43
Figure 20: Connecting the oximeter to the oximeter probe..................................................................................................43
Figure 21: Attaching the oximeter probe to the finger...............................................................................................................44
Figure 22: Display of SaO2..............................................................................................................................................................................44

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Figure 23: Photic Stimulation (using Trackit Plus software).................................................................................................45
Figure 24: Photic Stimulation control window................................................................................................................................45
Figure 25: Photic trigger signal definition...........................................................................................................................................46
Figure 26: Hyperventilation.............................................................................................................................................................................47
Figure 27: Hyperventilation control window......................................................................................................................................47
Figure 28: Trackit Mk3 with Internal Bluetooth Module..........................................................................................................50
Figure 29: The Trackit Control Panel .......................................................................................................................................................51
Illustrations (contd)

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1 System Overview
1.1 General description
Federal (USA) law restricts this device to sale by or on the order of a physician.
Intended use
The Trackit Mk3 is intended to measure and record EEG signals.
Indications for use
The Trackit Mk3 is used as an aid in the diagnosis of neurophysiological disorders such as epilepsy.
General description
The Trackit Mk3 is a multi-channel, ambulatory, electroencephalograph recorder. It is a compact body-worn device
that is battery powered and the data is stored on a Compact Flash card.
The device is suitable for use in a clinical environment and in an outpatient setting. 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 Compact Flash card is reviewed by a clinician
using review and analysis software on a PC.
This device is intended only as an adjunct device in patient assessment; it must be used in conjunction with other
methods of patient diagnosis.
The device 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 Mk3 EEG Recorder in an MRI environment, in an explosive atmosphere 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 is 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 to be used for the
determination of brain death.
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.
Lifelines does not supply the Nonin sensor. Only use the ‘PureLight’ sensors specified by Nonin to be
used with their Oximeters.
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.
Do not touch simultaneously any accessible USB or other contacts on the PC and the patient.
Only use the PC and the medical-grade power supply as supplied or authorised by Lifelines.
Do not plug the USB connector into any device other than the PC supplied or authorised by Lifelines.
The conductive part of connectors and transducers should not contact other conductive parts
including earth. Always ensure that the transducer fitted is suitaªble for a connection of Type BF
isolation.
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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.
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 Mk3 EEG
Recorder, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of
this equipment could result.
When in close proximity to the Trackit Mk3 EEG Recorder, do not use mobile phones, transmitters,
power transformers, motors, or other equipment that generates magnetic fields. Refer to Appendix 7
for more information.
Only use approved sensors as specified by Lifelines.
The Trackit Mk3 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 Symbol Meaning
Type BF applied part Follow operating instructions
Input/output connection Input connection
Special recycling required* Bluetooth
Consult warnings in User Manual Manufacturer
Push to eject Compact Flash card 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 Trackit Mk3 and its parts
The Trackit Mk3 recorder is a multi-channel ambulatory electroencephalograph designed for use in a variety of
monitoring applications, including those concerned with neurological and sleep disorders.
NOTE: Trackit Mk3 is available in a number of versions, including a 32-channel (Trackit-32/0 or Trackit-24/8),
a 24-channel (Trackit 24/0) and a 12-channel (Trackit-12/0). The version is displayed on the Trackit Mk3 LCD at
switch-on. This manual applies to all versions, the only dierence being the number of channels.
The Trackit Mk3 recorder comprises the following components:
Component Part Number
Recorder
Trackit-32/0 (32 EEG) 1186
Trackit-24/0 (24 EEG) 1187
Trackit-12/0 (12 EEG) 1189
Trackit-20/4 (20 EEG, 4 POLYGRAPHIC) 1184
Trackit-18/8 (18 EEG, 8 POLYGRAPHIC) 1185
Trackit-24/8 (24 EEG, 8 POLYGRAPHIC) 1188
Recorder with internally fitted wireless Bluetooth option
Trackit-32/0 (32 EEG) 1171
Trackit-24/0 (24 EEG) 1172
Trackit-12/0 (12 EEG) 1174
Trackit-20/4 (20 EEG, 4 POLYGRAPHIC) 1169
Trackit-18/8 (18 EEG, 8 POLYGRAPHIC) 1170
Trackit-24/8 (24 EEG, 8 POLYGRAPHIC) 1173
Patient connection unit (PCU) Clickon
PCU-clickon Short 1181
Patient connection unit (PCU) Cabled
PCU-cabled 24/0 1104
PCU-cabled-Extended 32/0 (universal) 1136
Cable, PCU 32ch 1m 1106
Cable, PCU 32ch 0.5m 1105
Accessories and components
Cable, USB 3m 1277
Trackit Mk3 strap, adult 1117
Trackit Mk3 strap, child 1118
Trackit Mk3 bag with PCU-clickon 1259
Trackit Mk3 set up software 1009
Trackit Mk3 User Manual 1114
Battery Box PP3 1111
Battery Box PP3-Small 1140
Battery Box Li 1112
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1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The Trackit Mk3 has been certified and complies with the following standards:
Standard Description
IEC 60601-1 and
IEC 60601-2-26
International 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
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 International standard for medical electrical equipment, EMC
requirements, calling:
*CISPR11 Conducted Emissions, Group 1, Class B
CISPR11 Radiated Emissions, Group 1, Class B
IEC 61000-4-2 Electrostatic Discharges
IEC 61000-4-3 Immunity - Radiated RF Field
*IEC 61000-4-4 Immunity - Transients Bursts
*IEC 61000-4-5 Immunity – Surges
IEC 61000-4-6 Immunity – Conducted
IEC 61000-4-8 Immunity – Power frequency fields
*IEC 61000-4-11 Immunity – Voltage dips, interruptions
*IEC 61000-3-2 Harmonic Emissions
*IEC 61000-3-3 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 USB powered
by PC using Class I or Class II mains
isolated medical grade power supply.
Type BF applied parts.
Trackit Mk3 recorder:
Internally powered.
Type BF applied parts.
If a PC is supplied, the PC has no
electrical connection to the recorder
and has no applied parts.
Degree of protection
against harmful ingress of
water
Ordinary (no protection) or IP22
(recorder in bag)
IP22 (recorder 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 Mk3 recorder
The Trackit Mk3 is a multi-channel recording device designed for use in recording a patient’s EEG signals. It
comprises a 24-channel EEG (monopolar) recorder acquisition board, an 8-channel polygraphic acquisition board
and control board with all the I/O interface for serial and patient communication. When connected to a host PC,
the device has built-in isolation for patient safety. The device may be powered either by its own batteries or a
PC USB port. EEG data is stored on an internal CF card. The data format is native European Data Format (EDF),
allowing the EEG files to be reviewed by any EDF-compatible EEG reader.
Patient Connection Unit
The Patient Connection Unit (PCU) connects the standard 1.5mm touchproof EEG recording electrodes attached to
the patient to the Trackit Mk3 unit. It is available either as a ‘Cabled’ type which is connected via a screened cable
or a ‘Clickon’ type which fits on the Trackit Mk3 directly without needing a cable.
Lifelines does not supply EEG electrodes. The PCU 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.
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PC Connection Cable
For non-ambulatory applications the Trackit Mk3 can be plugged directly into a USB port on the PC.
Batteries
Three 9V/PP3 disposable alkaline batteries are optionally supplied with the Trackit Mk3 recorder. Alternatively, a
rechargeable Lithium battery option and a small (single) 9V/PP3 option is available.
CF flash card
A Compact Flash (‘CF’) card is used to store the EEG data recorded by Trackit Mk3. Storage cards of varying
capacity are available in the CF format.
Bags and straps for ambulatory applications
The Mk3 bag houses the recorder when used in ambulatory applications. The bag protects the recorder from water
and dust (IP22 protection).
Trackit setup 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 Trackit Mk3 recorder for an ambulatory recording session.
The Trackit Mk3 recorder is connected to the PC via the connection cable or wirelessly with Bluetooth. The
recording setup/montage, and patient information/ID is downloaded to the device, and a short review is made to
verify that all the electrodes have been attached correctly.
The recorder is then disconnected from the PC and the ambulatory recording is started.
Functions of the setup software (Refer to the Trackit Plus Software manual for full details):
yDownload the recording template. This includes which electrodes are used and the recording montage.
yPerform a calibration check of the recorder.
yPerform an Impedance check on the recorder.
yPerform an EEG recording.
yView on-going EEG traces.
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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. Assembly instructions for third-party products will be found in their packing cases. It is recommended that
these instructions be filed with Trackit Mk3 technical reference materials.
4. 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 +10°C to +40°C
(+50°F to +104°F) Temperature -10°C to +50°C (14°F to +122°F)
Relative humidity 25% to 95%
non-condensing Relative humidity 10% to 95% non-condensing
Atmospheric pressure 700 hPa to 1060 hPa Atmospheric pressure 500 hPa to 1060 hPa
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Installation and Maintenance
2.3 Power supply connections
Trackit Mk3
Power requirements Standard PC USB port or 9V PP3 batteries when operating independently.
No Protective earth required.
Power consumption Maximum power from USB port: 2.5W.
The Trackit Mk3 must only be used with the USB cable provided with the unit.
2.4 Use in the home environment
The equipment is intended to be operated in its bag where it is protected against ingress of solid objects and
water to a degree of IP22.
An approved laptop PC is optional in the home environment and may be used for video recordings. There is no
cable connection between the PC and Mk3 recorder unit, as all communication is accomplished wirelessly , over
Bluetooth.
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 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 optional, internal Bluetooth radio is an approved industry-standard type which presents minimal risk of
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2.5 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 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 instrument is designed to comply with IEC 60601-1, the international standard for medical electronic
equipment, which specifies the permissible levels of leakage current from individual products. A potential hazard
exists in the summation of leakage currents caused by connecting several pieces of equipment together. Because
this instrument can be used in conjunction with standard electronic devices, the total leakage current should be
tested at regular intervals.
2.6 Interference
Trackit Mk3 will continue to operate in the presence of radio frequency magnetic fields (RF) and the eects of
electrostatic discharges (ESD) and other interference, in accordance with the requirements of IEC60601-1-2.
However, Trackit Mk3 records signals of very low amplitude, and these signals themselves are not immune to the
eects of RF, ESD and low-frequency magnetic field interference. Such interference may cause signal artefacts.
The optional, internal Bluetooth radio is an approved industry-standard type which presents minimal risk of reciprocal
interference with other equipment.
However, when the equipment is operated with or without 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.
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 Mk3, including cables specified by
Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
When in close proximity to the Trackit Mk3, do not use mobile phones, transmitters, power transformers, motors,
or other equipment that generates magnetic fields. Refer to Appendix 7 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.
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2.7 Maintenance and cleaning
The Trackit Mk3 contains no user-serviceable parts (apart from replaceable batteries). The system uses solid state
components and requires no routine testing or maintenance procedures apart from occasional cleaning and
checking for wear and damage to all parts including the accessories.
All the outer surfaces of the individual pieces of equipment of the Trackit system may be cleaned using a soft
cloth moistened with water and a mild detergent. Each item may also be cleaned using a low-pressure airline or a
vacuum cleaner.
Disinfection of the equipment can be carried out by the use of QAC-based disinfectants. Wipes are recommended
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.), Mikro-Kill disinfectant
wipes (Medline Industries, Inc.), Sani-Cloth HB Germicidal Wipes (PD International, Inc).
Do not allow any liquid to enter the case of the instrument or connector.
Do not use acetone on any of the instruments.
2.8 Disposal of equipment
When the equipment has reached the end of its operating life, it should be disposed of in accordance with local
waste regulation authority that is typically within the local government oice.
Do not dispose of battery packs into fire or by incineration.
Installation and Maintenance