Lifelines trackit Mk3 User manual

Trackit Mk3
Use r M a nu a l
Part no. 1114
I ssue 2.4
28 February 2018
Cr eat ed Checked Appr oved
Digitally signed by Michael
Hulin
Date: 2018.03.02 10:39:47 Z
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development, [email protected],
c=GB
Date: 2018.03.02 11:05:11 Z
Digitally signed by Michael
Hulin
Date: 2018.03.02 11:58:46 Z

Trackit Mk3 User Manual
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Version History
V2.4 ( February 2018)
•Added disinfect ion infor m at ion in sect ion 2.7.
•Changed N.B. t o 0086 ( BSI ) .
V2 .3 ( May 2014)
•Lat est 4th Generation int ernal Bluetoot h details added in Appendix 5
•Bluet oot h recording t im es and range details added
•Latest version low-power XPOD Pulse Oxim et er det ails added in Appendix 2
V2.2 ( Septem ber 2011)
•Trackit Mk3 int roduced: USB I nt er face detail added to Sect ions 1.2, 1.3, 3.1, 3.2 and 4.2.
•Large m em ory cards ( FAT32) added in Sect ion 5.6.
•Aux Box 2 added in Appendix 2.
•More Set up param et er s added t o Appendix 5.
•Quick Setup Guide adj ust ed in Appendix 6.
•Troubleshoot ing adj ust ed in Appendix 8.
V2.1 ( June 2010)
•Added Bluet oot h indicat or to Figure 6
•Added ‘I nt ernal Bluet oot h’ paragraph t o Appendix 5
•Minor am endm ents t o sect ion 5.7 ‘Reading an am bulat ory recording’
•Minor am endm ent s t o Appendix 4 ‘Net work Connect ion’
V2.0 ( April 2010)
•Refor m at t ed t o A4 page size
•Added full docum ent at ion t o Appendix 4:
oSect ion 1 Record to PC
oSect ion 2 Net work Connection
oSect ion 3 Video
•Added full docum ent at ion t o Appendix 5: Bluet oot h Wireless
•Appendix 7: Troubleshoot ing guide m oved t o Appendix 8
•Appendix 8: Manufact urer’s Declar at ion m oved t o Appendix 9
•Added Appendix 7: Trackit Set up Wizard
V1.8 ( 28 January 2010)
•Vir us prot ect ion recom m endat ions added, Page 5.
•Lifelines logo adj ust ed, Page 3.
•References to Windows 98 and ME rem oved, Sections 1.4 and 4.
•Check wit h dist ributor for later soft war e version added, Sect ion 4.
•Picture of lat est m ain Toolbar updat ed, Figure 16, and t able below updated.
•Picture of m ain ongoing display window updat ed, Figure 23.
•Appendix 3 added, Photic and Hypervent ilat ion. Phot ic refer s t o separat e docum ent at ion. Old
Appendix 3 now Appendix 4.
•Appendix 4 added, Trackit Plus and Plus wit h Video Soft ware. Both refer to separat e docu-
m ent at ion. Old Appendix 4 now Appendix 5.
•Appendix 5 added, Bluet oot h Wireless. Refer to separat e docum ent at ion. Old Appendix 5 now
Appendix 6.

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Trackit m anu fact ur ed by:
Lifelines Ltd, 7 Clarendon Court ,
Over Wallop, near St ockbridge,
Ham pshir e SO20 8HU, UK
Telephone + 44 (0)1264 782226
www .LLines.com
[e-mail]
00 86

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Disclaimers & Warranties
The inform ation in t his sect ion is subj ect to change without notice.
Except as stated below, Lifelines Ltd m akes no warrant y of any kind with regard t o t his m at erial,
including, but not lim it ed to, t he im plied warrant ies of m erchantability and fit ness for a particular
purpose. Lifelines shall not be liable for errors contained herein or for incidental or consequential
dam ages in connect ion with t he furnishing, perform ance or use of t his m at erial.
Lifelines shall warrant it s products against all defect s in m aterial and workm anship for one year
from the dat e of delivery.
Misuse, accident , m odificat ion, unsuitable physical or operating environm ent, im proper m ainte-
nance or dam age caused by a product for which Lifelines is not responsible will void t he warranty.
Lifelines do not warrant uninterrupt ed or error-free operation of it s product s.
Lifelines or it s authorised agent s will repair or replace any products that prove t o be defect ive dur-
ing t he warrant y period, provided t hat t hese products are used as prescribed in t he operat ing in-
st r uct ions in t he user’s an d ser vice m an uals.
No ot her party is aut horised t o m ake any warrant y to assum e liability for Lifelines products. Life-
lines will not recognise any other warrant y, either im plied or in writ ing. I n addit ion, services per-
form ed by som eone ot her t han Lifelines or its aut horised agent s or any t echnical m odificat ion or
changes of product s wit hout Lifelines prior, writ t en consent m ay be cause for voiding t his warranty.
Defect ive product s or parts m ust be ret urned to Lifelines or its aut horised agents, along with an
explanat ion of t he failure. Shipping cost s m ust be prepaid.
Lifelines Ltd. m anufact ures hardware and software t o be used on or with standard PC-com pat ible
com put er s and operat ing soft ware. Lifelines, however, assum es no responsibility for t he use or reli-
ability of it s software or hardware wit h equipm ent that is not furnished by third-part y m an ufact ur -
ers accept ed by Lifelines at t he date of purchase.
All warranties for t hird-par t y products used within t he Trackit syst em are t he responsibility of t he
relevant m anufact urer. Please refer to t he relevant docum entat ion on each product for further de-
tails.
This docum ent cont ains pr opriet ary inform at ion t hat is prot ect ed by copyright . All r ight s ar e r e-
served. No part of this docum ent m ay be phot ocopied, reproduced in any other form or translat ed
into another language without the prior writt en consent of Lifelines.
Trademarks
Microsoft , Windows and Windows NT are regist ered t radem arks of t he Microsoft Corporation. All
ot her t radem arks and product nam es are the propert y of t heir relevant owners.
Responsibility of manufacturer
The m anufact urer and dist ribut or consider t hem selves responsible for the equipm ent’s safet y, relia-
bilit y and perform ance only if:
any peripheral equipm ent to be used wit h Trackit is supplied by t hird-part y provider s recom -
m ended by t he m anufact urer;
assem bly operations, extensions, readj ust m ent s, m odificat ions, or repairs are carried out by
persons authorised by t he m anu fact urer ;
the electrical inst allat ion of t he relevant room com plies wit h t he appropriat e requirem ent s;
t he equipm ent is used by a healt h-care professional and in accordance with t he instructions for
use.
N ot e : t he m anufact urer has a policy of cont inual product im provem ent ; hence t he equipm ent
specificat ions are subj ect to change without not ice.
Check with Lifelines or your distribut or if a soft ware updat e is available.

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N ot e : Medical electrical equipm ent needs special precaut ions regarding EMC and needs to be in-
st alled and put into service according to t he EMC inform at ion provided in the Appendix.
Software and Virus Protection
Lifelines t akes all reasonable st eps to ensure t hat it’s software is virus-free. I n line with m odern
com put ing pract ice, it is advisable that continual prot ect ion against viruses, troj ans, m alw ar e, ad-
ware et c. is provided on t he PC used for installation and t he sur rounding syst em s. Please note the
following recom m endations which should be support ed by your internal I T/ Com put ing departm ent
procedur es and pr act ices:
1. Virus prot ection software should be inst alled on every com puter at risk of infect ion. This soft-
ware should have a resident (online) shield and provide em ail scanning if appropriat e.
2. Virus scanning should be set t o m anual m ode or autom at ic if desired but at a tim e when t he
system is not being used.
3. All pr ogram s offering aut o-update feat ures, including Windows, should be set t o m anual or
aut om at ic if desired but at a tim e when t he system is not being used.
4. Adopt form al depart m ental or organisational procedures to ensure the int egrit y and safe op-
erat ion of t he m edical equipm ent and support ing system s.

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Contents
Version Hist ory 2
Disclaim er s & War rant ies 4
Tradem ar ks 4
Responsibilit y of m anufact ur er 4
Software and Virus Protection 5
Contents 6
I llust rat ions 8
1Sy st em Ov er view 10
1.1 General descript ion 10
1.2 Caut ions and War nings 10
1.3 Explanat ion of sym bols 11
1.4 The syst em and it s part s 12
1.5 Specificat ions and safet y 12
Description of t he com ponent s 13
2I nst allat ion and Maint enance 15
2.1 Checks for com plet eness and int egrit y 15
2.2 Envir onm ent al par am et ers for operat ion 15
2.3 Use in t he hom e environm ent 15
2.4 Power supply connections 15
2.5 Use w it h ot her equipm ent 16
2.6 I nt er ference 16
2.7 Maint enance an d cleaning 16
2.8 Disposal of equipm ent 16
3Connect ions for Trackit Mk3 set up 17
3.1 Overview 17
3.2 Connecting t he Trackit Mk3 18
3.3 Switching on 18
3.4 Warning sym bols on t he display 19
4The set u p soft war e 20
4.1 Set t ing up a recording protocol 20
4.2 Configuring t he recorder 25
4.3 Montage Editor 31
5The am bulat or y recording 33
5.1 Changing batteries and cards 33
5.2 Fit ting t he Clickon PCU 37
5.3 Event m arking 38
5.4 Ending a recor ding 38
5.5 I dent ifying a recording 39
5.6 Advanced Set t ings 39
5.7 Reading an am bulat or y r ecording 43
Appendix 1: Trackit Mk3 Specifications 44
EEG input s 44
Polygraphy input s 44
Aux. high-level DC I nput s 45
Modes of operat ion 45
Connect ions, port s and controls 45
Back-light display 45
Recor ding form at 45
Physical charact er ist ics 45
Safet y and EMC st andards 46

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Appendix 2: Trackit Mk3 opt ions 47
Nonin XPOD pulse oxim et er 47
Appendix 3: Phot ic St im ulat or and Hyper vent ilat ion 50
Phot ic St im ulation 50
Hypervent ilation 51
Appendix 4: Record to PC and Synchronised Video 53
1Record t o PC 53
2Net work Connect ion 53
3Video 57
Appendix 5: Bluet oot h Wireless 61
I nt roduct ion 61
Sy st em over view 62
Connect ion and use 63
Application PC Set up 66
Trackit and Bluet oot h Module Set up 69
Trackit Bluet oot h Module Specifications 78
Par am et er Dat a 78
Regulat ory 79
FCC St at em ent 80
I C Com pliance 80
Guidelines for Efficient and Safe Use 81
Trackit Bluet ooth Bat t er y Power Consum pt ion 83
Bluetoot h Range 83
Bluetoot h Knowledge Base 85
Appendix 6: Trackit quick setup and operat ion guide 86
Appendix 7: Trackit Set up Wizard 87
Appendix 8: Troubleshoot ing guide 88
COM port problem s with Bluet ooth com m unication t o Trackit Mk3 88
Problem s st art ing t he r ecording 88
File r eview problem s 89
Appendix 9 : Manufact u rer’s Declarat ion 90
EMC Com pat ibilit y 90

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Illustrations
Figure 1 Connect ing t he Trackit Mk3 for recorder set -up 17
Figure 2 Connect ing t o t he Trackit Mk3 recorder 18
Figure 3 Trackit Mk3 recorder: front panel 19
Figure 4 The Trackit Mk3 display 19
Figure 5 New Pat ient dialog 20
Figure 6 New Pat ient database 21
Figure 7 Signal list 21
Figure 8 Signal editing t ool 22
Figur e 9 EEG set u p 22
Figure 10 Setup Recording dialog 23
Figure 11 View Hookup 23
Figure 12 Channel set up 24
Figure 13 Recording Channel editing 25
Figure 14 Trackit soft ware t oolbar 25
Figure 15 Trackit Cont rol Panel 26
Figure 1 6 Tr ack it st at us 'B' 27
Figure 17 Recording Cont rol 27
Figure 18 Ongoing t race display 29
Figur e 1 9 Ad j ust display par am et er s 30
Figure 20 Im pedance check 30
Figure 21 The online event viewer 31
Figure 22 Montage Editor 32
Figure 23 Opening t he rear bat t ery box/ door 33
Figure 24 Rem oving and replacing PP3 bat teries 34
Figure 25 Rem oving and replacing Lithium rechargeable bat t ery 34
Figure 26 Closing t he rear Bat t ery box/ door 35
Figure 27 Rem oving and replacing the flash card 36
Figure 28 Rem oving t he flash card 36
Figure 29 Clickon PCU Ret aining screw location 37
Figure 30 Detach t he PCU 37
Figure 31 Lift t he PCU away from t he Trackit Mk3 38
Figure 32 Locating t he PCU 38
Figure 3 3 Tr ack it Defau lt s Tab 1 40
Figure 34 Trackit Default s | Tab 2 41
Figure 35 Pulse oxim eter and oxim et er probe 47
Figure 36 Connect ing t he oxim eter t o Trackit Mk3 48
Figure 37 Connect ing t he oxim et er to the oxim et er probe 48
Figure 38 Attaching t he oxim eter probe to t he finger 48
Figure 39 Display of SaO2 49
Figure 40 Phot ic St im ulation 50
Figure 41 Phot ic St im ulation contr ol window 50
Figure 42 Phot ic t rigger signal definit ion 51
Figure 43 Hypervent ilation 51
Figure 44 Hypervent ilation cont rol window 52
Figure 45 Trackit video preview 59
Figure 46 Trackit Mk3 wit h I nternal Bluet oot h Module 62
Figure 47 The Trackit Cont r ol Panel 63
Figure 48 A t ypical Bluet ooth Places view 64
Figure 49 Trackit Main Screen 65
Figure 50 Opt ions Tab 1 66
Figure 51 Opt ions Tab 2 67
Figure 5 2 Tr ack it Defau lt s Tab1 69
Figure 5 3 Tr ack it Defau lt s Tab2 70
Figure 54 Trackit Default s Tab 3 70
Figure 5 5 Tr ack it Defau lt s Tab 4 72

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Figure 56 Trackit Defaults | Bluet oot h Set up Tab 1 ( General) 73
Figure 57 Trackit Defaults | Bluetoot h Set up Tab 2 ( Profile) 74
Figure 58 Trackit Defaults | Bluetoot h Set up Tab 3 ( Serial) 75
Figure 59 Trackit Defaults | Bluetoot h Set up Tab 4 ( Version) 76
Figure 60 Trackit Defaults | Bluetoot h Set up Tab 5 ( Misc) 76
Figure 61 Trackit Defaults | Bluetoot h Set up Tab 6 ( Pairing) 77

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1System Overview
1. 1 General description
I nt e n de d use
The Trackit Mk3 is intended t o m easure and record EEG signals.
I nd ica t ion s f or u se
The Trackit Mk3 is used as an aid in t he diagnosis of neurophysiological disorders such as epilepsy.
Ge ne r a l d escr ip t io n
The Trackit Mk3 is a m ult i-channel, am bulat or y, electr oencephalograph recorder. I t is a com pact
body-w or n dev ice t h at is bat t er y pow ered and t he d at a is st ored on a Com pact Flash car d.
The device is suitable for use in a clinical environm ent and in an out patient sett ing. The EEG
elect rodes are fitted t o t he pat ient by a t rained clinician prior to t he pat ient being sent hom e. No
subsequent int ervention is required by t he pat ient .
Upon com pletion of t he recording, t he dat a which is st ored on a Com pact Flash card is reviewed by
a clinician using review and analysis soft ware on a PC.
This device is int ended only as an adj unct device in pat ient assessm ent; it m ust be used in
conj unct ion with other m et hods of patient diagnosis.
The device does not sustain or support life.
I nt e n de d U se r
The int ended user of t he device is a healt hcare professional who has the training and knowledge to
under take EEG exam inat ions and is fam iliar wit h EEG equipm ent and pract ice.
1. 2 Cautions and Warnings
CON TRAI N DI CATI ON S: Do not use the Trackit Mk3 in an MRI envir onm ent, in an explosive
at m ospher e or during defibrillat ion.
W ARN I N G: This device is int ended t o be used by a healthcare professional and in accordance wit h
these inst ruct ions for use which m ust be read in t heir ent iret y before t he device is used.
W ARN I N G: This device in int ended only as an adjunct device in patient assessm ent ; it m ust be
used in conj unct ion wit h ot her m et hods of pat ient diagnosis.
W ARN I N G: Lifelines does not supply EEG electrodes. The unit accept s st andard 1.5 m m
t ouchproof elect rodes using DI N 42802-style connectors. To ensure pat ient safety, the elect rodes
used m ust be approved t o t he Medical Device Directive 93/ 42/ EEC in Europe or t o t he relevant
local st andar ds out side Europe.
CAUTI ON : The conduct ive part of electrodes and t heir connectors, including t he Neutral elect rode,
should not contact ot her conductive part s including eart h.
W ARN I N G: Lifelines does not supply t he Nonin sensor. Only use t he ‘PureLight ’ sensors specified
by Nonin t o be used wit h t heir Oxim et ers.
W ARN I N G: St rangulat ion hazard due t o long cables. As with all m edical equipm ent, carefully
rout e patient cabling to reduce t he possibilit y of pat ient ent anglem ent or strangulation.
CAUTI ON : When in close proxim it y to the recorder, do not use m obile phones, transm itt ers, power
transform ers, m ot ors, or other equipm ent that generates m agnet ic fields. Refer t o the Appendix for
m ore inform at ion. Medical electrical equipm ent needs special precautions regarding EMC and needs
to be installed and put int o service according t o t he EMC inform ation provided in t he Appendix.
W ARN I N G: The funct ion or safet y of t he equipm ent could be im paired if it has been subjected t o
unfavourable conditions in storage or in t ransit. If at any t im e funct ion or safet y is thought t o be
im paired, the instrum ent should be t aken out of operat ion and secured against unint ended use.
W ARN I N G: Do not open t he equipm ent .
W ARN I N G: Do not m odify this equipm ent wit hout t he authorizat ion of t he m anufact urer.

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1. 3 Explanation of symbols
Type BF equipm ent Follow operating instructions
I nput / out put connect ion I nput connect ion
Special recycling r equired, do not dispose of in landfill. When t his equipm ent has
reached t he end of it s useful life, it m ust be disposed of in an environm ent ally-
frien dly way . Wast e elect r ical and elect r onic equipm ent ( WEEE) requires special
procedures for recycling or disposal. This includes bat t eries, printed circuit boards,
elect ronic com ponent s, wiring and ot her elem ents of electronic devices. Follow all
of your respective local laws and regulat ions for t he proper disposal of such
equipm ent . Cont act your local dist ributor for inform at ion concerning t his.
Consult warnings in User Manual Bluetoot h
Push to ej ect Com pact Flash card Manufact ur er
Storage and transport symbols
Tem perat ur e lim it s Fragile
Keep dry Relat ive hum idit y lim it s
Bar om et ric pressur e lim its
I nt ernat ional prot ect ion code
Prot ected against ingress of solid object 12.5 m m diam et er.
Pr ot ect ed against access t o hazar dous part s w it h finger.
Prot ected against ingress of water dripping (15° t ilted).
-10
+50
°C
10
95
%RH
500
1060
hPa
I P2 2

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1. 4 The system and its parts
The Trackit Mk3 recor der is a m ult i-channel1am bulat or y elect roencephalograph designed for use in
a variet y of m onit oring applicat ions, including t hose concerned wit h neurological and sleep disor-
ders.
Note 1: Trackit Mk3 is available in a num ber of versions, including a 32-channel ( Tr ackit -32/ 0 or
Tr ackit -24/8), a 24-channel ( Tr ack it 2 4/ 0 ) and a 12-chan nel ( Tr ack it -24/ 0). The version is dis-
played on t he Trackit Mk3 LCD at swit ch-on. This manual applies t o all versions, t he only difference
being t he num ber of channels.
The Trackit Mk3 recor der com prises t he following com ponents:
Recorder
Tr ackit -32/ 0 (32 EEG) par t num ber 1186
Tr ackit -24/ 0 (24 EEG) par t num ber 1187
Tr ackit -12/ 0 (12 EEG) par t num ber 1189
Tr ackit -20/ 4 ( 20 EEG, 4 POLYGRAPHI C) part num ber 1184
Tr ackit -18/ 8 ( 18 EEG, 8 POLYGRAPHI C) par t num ber 1185
Tr ackit -24/ 8 ( 24 EEG, 8 POLYGRAPHI C) par t num ber 1188
Recorder wit h internally fitted wireless Bluet ooth opt ion
Tr ackit -32/ 0 (32 EEG) par t num ber 1171
Tr ackit -24/ 0 (24 EEG) part num ber 1172
Tr ackit -12/ 0 (12 EEG) par t num ber 1174
Tr ackit -20/ 4 ( 20 EEG, 4 POLYGRAPHI C) par t num ber 1169
Tr ackit -18/ 8 ( 18 EEG, 8 POLYGRAPHI C) par t num ber 1170
Tr ackit -24/ 8 ( 24 EEG, 8 POLYGRAPHI C) par t num ber 1173
Patient connection unit ( PCU) Clickon
PCU-clickon Short par t num ber 1181
Patient connection unit ( PCU) Cabled
PCU-cabled 24/ 0 par t num ber 1104
PCU-cabled-Ext ended 32/ 0 ( universal) par t num ber 1136
Cable, PCU 32ch 1m part num ber 1106
Cable, PCU 32ch 0.5m par t num ber 1105
Cable, USB 3m part num ber 1277
Trackit Mk3 st r ap, adult par t num ber 1117
Trackit Mk3 st rap, child par t num ber 1118
Trackit Mk3 bag wit h PCU-clickon part num ber 1259
Trackit Mk3 set up soft w ar e par t num ber 1009
Trackit Mk3 User Manual part num ber 1114
Bat t ery Box PP3 part num ber 1111
Bat t ery Box PP3-Sm all par t num ber 1140
Bat t ery Box Li par t num ber 1112
1. 5 Specifications and safety
Refer to Appendix 1 for specifications.
The system has been cert ified and com plies with t he following standards:
EN60601-1 and
EN60601- 2 -26
European st an dar d for m edical elect r ical equipm ent , general re-
quirem ent s and EEG syst em s.
UL60601-1: 2003 USA standard for m edical elect rical equipm ent , general require-
m ent s.
CAN/ CSA 22.2 No 601.1 M90 Canadian st andard for m edical elect rical eq uipm ent , general re-
quir em ent s.
EN60601- 1 -2: 2001 European standard for m edical elect rical equipm ent , EMC require-
m ent s, calling:
EN55011
Conduct ed Em issions, Group 1, Class B
EN55011
Radiated Em issions, Group 1, Class B
EN61000- 4 -2
Elect rost at ic Discharges

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EN61000- 4 -3
I m m unit y - Radiat ed RF Field
EN61000- 4 -4
I m m unit y - Tr an sien t s Bur st s
EN61000- 4 -5
I m m unit y – Surges
EN61000- 4 -6
I m m unit y – Conduct ed
EN61000- 4 -8
I m m unit y – Power frequency fields
EN61000- 4 -11
I m m unit y – Voltage dips, int errupt ions
EN61000- 3 -2
Harm onic Em issions
EN61000- 3 -3
Voltage Fluct uations/ flicker
Degree of prot ect ion against electrical shock ( when con-
nect ed t o host syst em )
Type BF
Type of prot ect ion against elect rical shock ( when con-
nect ed t o host syst em )
I nt ernally powered
or Mains powered Class 1 or 2 ( Mk2)
or USB powered ( Mk3)
Degree of prot ect ion against harm ful ingress
of wat er
Ordinary ( no protect ion)
Mode of operation
Cont inuous
Degree of safet y of applicat ion in t he presence of a
flam m able anaest het ic m ixt ur e wit h air or wit h oxygen
or nit rous oxide
Not suitable
Description of the components
The Trackit Mk3 recorder
The Trackit Mk3 is a m ult i-channel recording device designed for use in recording a pat ient ’s EEG
signals. I t com prises a 24-channel EEG ( m onopolar) am plifier acquisit ion board, an 8-channel poly-
graphic acquisit ion board and cont rol board with all the I / O int erface for serial and pat ient com m u-
nicat ion. When connected t o a host PC, t he device has built -in isolat ion for pat ient safet y. The de-
vice m ay be powered either by its own bat t eries or a PC USB port . EEG data is stored on an int er-
nal CF car d. The dat a for m at is nat iv e European Dat a Form at ( EDF), allowing t he EEG files t o be
reviewed by any EDF-com pat ible EEG reader.
Patient Connection Unit
The Pat ient Connection Unit (PCU) connects the st andard 1.5m m t ouchproof EEG recording elec-
trodes att ached t o t he patient t o t he Tr ackit Mk3 unit . I t is available eit her as a ‘Cabled’ t y pe w hich
is connect ed via a screened cable or a ‘Clickon’ t ype which fits on t he Trackit Mk3 direct ly wit hout
needing a cable.
W ARN I N G: Life lin e s doe s not supply EEG e lect rodes. The PCU a cce pt s st anda r d 1 .5 m m
t ouch pr oof e le ct r ode s u sing DI N 4 2 8 0 2 -style connect or s. To e nsu r e pa t ie n t sa fe t y , t h e
electr odes use d m ust be a pproved t o t he M e dica l De vice Dire ctive 9 3 / 4 2 / EEC in Europe
or t o t h e r e le va nt l oca l st a n da rd s o ut sid e Eu r ope .
CAU TI ON : Th e con duct ive pa r t of e le ct r od es a n d t h e ir con ne ct or s, inclu din g t h e N e u t ra l
e le ct r ode , sh ou ld n ot con t a ct ot h er con du ct iv e pa rt s in clu din g e a r t h .
PC Connection Cable
The Trackit Mk3 plugs direct ly into a USB port on t he PC.
Batteries
3 PP3 disposable alkaline batteries are opt ionally supplied with t he Trackit Mk3 recorder. Alterna-
tively, a rechargeable Lithium battery opt ion is available and a sm all ( single) PP3 opt ion.
CF flash card
A Com pact Flash ( ‘CF’) card is used t o store the EEG dat a recorded by Trackit Mk3. St orage cards
of varying capacit y ar e av ailable in the CF form at .

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Trackit setup software
The Tr ackit set u p soft war e runs under Micr osoft Windows 2000 ( with SP2) , Windows XP, Windows
Vista or Windows 7 on the host PC and is used t o setup and review the Trackit Mk3 recorder for an
am bulat or y r ecording session.
The Trackit Mk3 recorder is connected t o t he PC via t he connection cable or wirelessly wit h Blue-
t oot h. The recording set up/ m ont age, and pat ient inform at ion/ I D is downloaded t o the device, and a
short review is m ade to verify t hat all t he elect rodes have been at t ached correct ly.
The recorder is then disconnected from the PC and t he am bulat ory recording is start ed.
Funct ions of t he set up sof t ware:
Download t he recording t em plat e. This includes:
which elect rodes are t urned on or off;
t he recording m ont age;
any tim ed recording m odes.
Download t he unique pat ient ident ifier ont o t he card so that no confusion can arise as to whom
the recording belongs t o.
Perform a calibration of t he Trackit Mk3 device
Sy nchr onise t h e Tr ackit Mk3 tim e and date to t hat of t he host .
Perform a rout ine EEG recording prior to t he patient’s am bulat ory EEG recording.
What does a recording consist of?
2–36 channels of recorded EEG/ polygraphic signals
Signals recorded over a period usually not less t han 24 hours
Patient event m arkers correlat ed in t im e wit h t he real t im e clock displayed on Trackit Mk3 LCD
display
Data and results stored t o card for future evaluation
Dat a r eview post -recording using any com patible EDF review program

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2Installation and Maintenance
W ARN I N G: The follow ing se ct ion m u st be re a d and u n de r st ood before t he e quipm e nt is
sw it ch e d ON .
N ot e : Medical electrical equipm ent needs special precaut ions regarding EMC and needs to be in-
st alled an d put int o service according t o t he EMC inform at ion provided in t he Appendix.
The funct ion or safet y of t he equipm ent could be im paired if it has been subj ected t o unfavourable
conditions in st orage or in transit . I f at any t im e funct ion or safet y is thought to be im paired, t he
inst rum ent should be taken out of operation and secured against unint ended use.
The m anufacturer should be cont act ed ( details on page 3) for assistance, if needed, in set t ing up,
using or m aint aining the equipm ent ; or to report unexpected operat ion or events.
2. 1 Checks for completeness and integrity
1 Rem ove the equipm ent from t he packaging case( s).
2 Use t he parts list t o check t hat all ordered it em s have been received.
3 Assem bly inst ruct ions for t hird-part y products will be found in their packing cases. I t is recom -
m ended t hat these inst ruct ions be filed wit h Trackit Mk3 t echnical r ef er ence m at erials.
4 Check for signs of dam age t hat m ay have occur red d ur ing t r ansit or st orage. I f an y d am age is
found, do not use t he inst rum ent ; contact your dist ributor.
2. 2 Environmental parameters for operation
Operation
The instrum ent is designed t o operate wit hin t he following ranges:
Tem per at ur e + 10° C t o + 40° C
Relat ive hum idit y 25% to 95% non-condensing
At m ospheric pressur e 700m B t o 1060m B
D o n ot ob st r u ct a ny coolin g slot s.
Posit ion t h e i nst r um e nt so t h a t a ir f low s f r ee ly.
Storage and transport
When t he inst rum ent is in store or being t ransported, t he following ranges are tolerat ed:
Tem per at ur e - 10° C t o + 50° C
Relat ive hum idit y 10% to 95% non-condensing
At m ospheric pressur e 500m B t o 1060m B
2. 3 Use in the home environment
The equipm ent is intended t o be operat ed in it s bag where it is prot ect ed against ingress of solid
obj ect s and w at er t o a degree of I P2 2.
Keep t he equipm ent away fr om sour ces of heat .
Do not use m obile phones.
Do not allow pets or children t o interfere wit h t he sensor cables.
2. 4 Power supply connections
Power requirements
St andard PC USB port or 9V PP3 bat t eries when operating independently.
No prot ect ive eart h required.
Power consumption
Maxim um pow er from USB port : 2.5W
Leakage current
This inst rum ent is designed t o com ply wit h I EC 601-1, t he internat ional st andard for m edical elec-
t ronic equipm ent , w hich specifies t he perm issible levels of leak age current from individual prod-
uct s. A pot ent ial hazard ex ist s in t he sum m at ion of leakage cur rent s caused by connect ing sever al
pieces of equipm ent toget her. Because this inst rum ent can be used in conj unct ion wit h standard
electronic devices, t he t ot al leakage current should be test ed at regular int er vals.

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16
2. 5 Use with other equipment
Defibrillators and HF surgical equipment
The equipm ent is not defibrillat or proof and should not be used in situat ions where a defibrillator is
likely t o be used.
The equipm ent should not be used wit h high frequency surgical equipm ent .
Other patient-connected equipment
When used sim ult aneously wit h ot her pat ient -connect ed equipm ent , for exam ple a cardiac pace-
m aker or ot her electrical stim ulator, it is unlikely that a safet y hazard will arise. However always
consult t he docum entat ion supplied with t he ot her pat ient -connected equipm ent t o ensure t hat all
hazards, warnings and caut ions are considered before the equipm ent is used t oget her.
2. 6 Interference
Trackit Mk3 will cont inue to operate in t he presence of radio frequency m agnet ic fields ( RF) and t he
effect s of elect rostatic discharges ( ESD) and ot her int erference, in accordance with the require-
m ent s of EN60601- 1 - 2. However, Trackit Mk3 records signals of ver y low am plit ude, and t hese sig-
nals them selves are not im m une t o t he effect s of RF, ESD and low-frequency m agnet ic field int er-
ference. Such int er fer ence m ay cause signal art efact s.
Ca ut ion: w he n in close prox im it y t o t he r e cord e r , do not u se m obile ph one s, t r a n sm it -
t e r s, pow e r t ra nsf or m e r s, m ot or s, or ot he r e quipm e nt t ha t ge ne r a t e s m a gn e t ic fields.
Re fe r t o t h e Ap pe ndix for m o re in for m a t ion .
N ot e : Medical electrical equipm ent needs special precaut ions regarding EMC and needs to be in-
st alled and put into service according to t he EMC inform at ion provided in the Appendix.
2. 7 Maintenance and cleaning
The Trackit Mk3 cont ains n o u ser-serv iceab le part s ( apar t fr om r eplaceable b at t er ies) . The sy st em
uses solid-st ate com ponents and requires no rout ine t est ing or m aintenance procedures apart from
occasional cleaning and checking for wear and dam ag e t o all par t s includ ing t he accessor ies.
All t he out er surfaces of the individual pieces of equipm ent of t he Trackit syst em m ay be cleaned
using a soft cloth m oist ened wit h w at er and a m ild det ergent. Each it em m ay also be cleaned using
a low- p ressur e air-line or a vacuum cleaner.
Disinfection of t he equipm ent can be carried out by t he use of QAC-based disin fect ant s. Wipes ar e
recom m ended in order t o prevent the ingress of any liquid int o t he equipm ent . Suitable products
include Mikrozid Sensitiv e Wipes ( Schülke & Mayr Gm bH) , Micr obac for t e ( Paul Har t m ann AG) , Dis-
tel Wipes (Trist el Lt d.) .
Ca ut ion : D o not allow a ny liquid t o ent e r t he ca se of a ny inst r u m e nt or conn e ct or .
Do not use a ce t one on a ny of t he inst r u m e n t s.
2. 8 Disposal of equipment
The expect ed service life of t he equipm ent is five years. When it has reached the end of its operat -
ing life, it should be disposed of in accordance wit h local waste regulat ion authorit y t hat is typically
wit hin t he local governm ent office.
Ca ut ion : d o n ot d isp ose of b at t e r ie s b y in cin e ra t ion.

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3Connections for Trackit Mk3 setup
3. 1 Overview
Below is an over view diagram showing t he principal com ponent s when connect ed t o a PC during
sy st em set up.
Figur e 1 Con ne ct in g t h e Tr ack it Mk3 for recor de r se t -up
List of parts supplied by Lifelines:
Trackit Mk3 recorder plus bag
Patient Connect ion Unit (PCU), for elect rode connect ion
1 x CF flash car d ( opt ional)
3 x PP3 bat t eries (opt ional)
PC USB cables
List of optional parts supplied by third parties:
Host PC/ laptop with power cable
CF cards
Bat t eries
Bat t er y charger

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3. 2 Connecting the Trackit Mk3
The Trackit Mk3 is sim ply plugged int o t he PC USB port using t he cable supplied. Not e: only use
the USB cable part num ber 1277 (wit h t he red t ip) for t he Trackit Mk3 as shown below:
Figur e 2 Con n ect in g t o t h e Tr ack it M k 3 recorde r
The necessary USB drivers will be found on t he inst allat ion CD. Upon first connection of t he Trackit
Mk3 t o t he PC USB port, at t he Windows prom pt, browse to t he folder CD Drive: \USB Drivers. From
there, Windows will find t he correct drivers for t he version of Windows being used.
3. 3 Switching on
Turn on t he unit by pressing t he button on t he right of the LCD display on t he front panel of t he re-
corder.
Trackit
RJ45 Connection

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19
Figur e 3 Track it M k 3 r e cor de r : f r on t p a ne l
Aft er sev er al seconds t he LCD display indicat es t hat Tr ack it Mk3 is perform ing a self-t est for sy s-
t em int egrit y. On com pletion of t he self-test the LCD indicat es t he status of t he Trackit Mk3 re-
corder.
Indicators
The following indicators are available depending on Trackit Mk3 st at us:
Û~11:49 Û~00:00
Û~71 %âÛ Û~2049M
Figur e 4 The Trackit M k 3 displa y
Key:
1 Tim e of day
2 Recor ding t im e
3 Bat t er y capacit y r em aining
4 I nt ernal Bluet oot h on/ off
5 Rear door open warning
6 CF Car d capacit y r em aining
Tim e of day The bat t ery-backed, real t im e clock which is synchronized
to t he host during set up.
Recording tim e of t his recording
If not recording, ‘00: 00’ is displayed.
Disk capacit y Rem aining st or ag e capacit y in MB. I f t her e is no car d pre-
sent, ‘0’ is displayed.
Bat t er y capacit y Appr oxim at e bat t ery capacit y r em aining ( as % of full bat -
t er y capacit y ) .
Rear -door open war ning sym bol
Flashes when t he rear bat t ery door is open.
I nt ernal beeper
Warning of low bat t ery or rear-door open.
3. 4 Warning symbols on the display
Low card capacit y Sym bol L accom panied by beeping ever y 30 seconds.
Special recording m ode
Tim ed or sam pled recordings ar e indicat ed by t he sym bol
S.
Recording t o card
The sy m bol R nex t t o car d capacit y.
I nt ernal Bluet oot h on/ off When t he I nt ernal Bluet oot h opt ion is fit ted t o t h e Tr ack it
Mk3, t he u nit will display whether it is enabled or disabled
with a large ‘B’ (enabled) or small ‘β’ (disabled) next to
the ‘% ’ indication. To t oggle t he current selection t he
pushbut t on is pressed 5 tim es within 3 seconds. The dis-
play will change t o indicate t he new stat e.
Refer to Appendix 5 for furt her infor m at ion on Bluet oot h.
2
1
4 5
3
6

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4The setup software
The setup soft ware is available on CD. A readm e file describes installation. Check with your distrib-
ut or or Lifelines if a newer version of soft war e is av ailable.
Tr ackit set u p soft war e is supported on Microsoft Windows 2000 ( with SP2) , Windows XP, Windows
Vist a an d Windows 7.
When Tr ackit Mk3 is connect ed to t he host PC, t he soft ware allows the user t o define param et ers
for t he recording, such as r ecording m ont age, st art t im e and st op t im e, m ode of recording et c.
The setup soft ware has the following funct ions:
Define signal types: create labels t o att ach t o input s
At t ach t he desired signal type (label) to t he recording input . For exam ple, input 1 with a signal
type FP1
Create a recording m ontage and download it t o t he recorder
Perform a calibration of t he inputs
View signals online and adj ust display par am et er s such as chart speed and display sensit iv it y
St ar t and st op a Tr ack it recording session
4. 1 Setting up a recording protocol
Summary
St ep 1 Define the patient ID
St ep 2 Define the signals
St ep 3 Define the input s
St ep 4 Define the recording channels
St ep 5 Activat e t he recording cont rol
St ep 6 Connect t he Trackit Mk3 for setup
St ep 7 Check Trackit Mk3 st at u s
St ep 8 St art a recording
St ep 9 View the ongoing EEG traces
Step 1 Define the patient ID
1 Select the New pat ient icon on the t oolbar.
New Patient icon
2 Ent er t he patent nam e and Recording I D int o the New Pat ient di-
alog.
This infor m at ion is saved wit h t he recording setup for download
to t he recorder in a future recording.
I t is possible to configure the syst em t o use a pat ient dat abase ( Figure 6) inst ead of t he sim ple di-
alog shown above.
Figur e 5 N e w Pa t ie n t dia -
log