Lifelines trackit T4A User manual

t4AEEG Am plifier
Use r M a n u a l
Doc No: 51305-006
I ssue 1.
3
Part no. 1606
Creat ed
Check ed
Appr oved
Digitally signed by Geoff
Salter
Date: 2019.08.01
09:34:20 +01'00'
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2019.08.01 10:01:47 +01'00'
Digitally signed by Geoff
Salter
Date: 2019.08.01 10:08:39
+01'00'

Trackit t4A EEG Am plifier User Manual
2
Version History
V 1.0 (2 May 2018)
•First release
V 1. 1 ( 31 May 2018)
•Added pow er requirem ent s for bat tery charger
•Added warning relat ing t o the bat t ery charger m ains isolation
•Updat ed bat tery com partm ent im age.
V 1. 2 ( 26 Nov 2018)
•4- bay bat ter y charger added.
•Addit ional cleaning wipes added for US cust om ers.
•Bluet oot h infor m at ion m oved to Sect ion 3.6.
•Added explanat ion t hat PG1 and PG2 can be reconfigured as r equired.
•Added warning about bat ter y packs falling out if door is open.
•Tem perat ure values expr essed in ° C and ° F.
•Recom m ended SD car d type added.
•Trackit Soft ware Section based on soft w are Version 2.8.1.7
V 1. 3 ( 19 Jul 2019)
•t4A im ages updat ed wit h new PCU graphic
•Default set up updat ed ( PG1 & PG2 rem oved)
•St atus display icons updat ed
•EMC w ar nings and inform at ion updat ed

Trackit t4A EEG Am plifier User Manual
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Lifelines Lt d, 7 Clarendon Court,
Over Wallop, near St ockbridge,
Ham pshire SO20 8HU, UK
Teleph one + 44 ( 0) 12 64 78 22 26
www.LLines.com
[e-mail]
00 8 6

Trackit t4A EEG Am plifier User Manual
4
Disclaimers & Warranties
The in for m at ion in t his sect ion is subj ect t o chan ge w it hout n ot ice.
Except as st ated below, Lifelines Lt d m ak es no w ar rant y of any kind wit h regard to this m at er ial,
including, but not lim it ed t o, t he im plied w arrant ies of m er chant abilit y and fit ness for a par ticular
purpose. Lifelines shall not be liable for errors cont ained herein or for incident al or consequential
dam ages in connection with t he furnishing, perform ance or use of t his m aterial.
Lifelines shall warr ant it s product s against all defect s in m at erial and wor km anship for one year
from t he date of delivery.
Misuse, accident, m odificat ion, unsuit able physical or operating environm ent , im pr oper m aint e-
nance or dam age caused by a product for which Lifelines is not responsible will void t he warrant y.
Lifelines do not warrant unint errupt ed or error-free operation of it s product s.
Lifelines or its aut horised agent s w ill repair or replace any products t hat prove t o be defect ive dur-
ing the warrant y period, provided t hat t hese product s are used as prescr ibed in the operat ing in-
st ruct ions in t he user’s and service m anuals.
No ot her part y is aut horised to m ake any war rant y to assum e liabilit y for Lifelines product s. Life-
lines will not recognise any ot her warranty, eit her im plied or in w riting. I n addit ion, ser vices per-
for m ed by som eone ot her than Lifelines or it s aut horised agents or any t echnical m odificat ion or
changes of pr oduct s wit hout Lifelines prior , writ ten consent m ay be cause for voiding this w ar rant y.
Defect iv e pr odu ct s or par t s m u st be r et ur ned to Lifelin es or it s aut hor ised agen ts, along w it h an
explanation of the failure. Shipping cost s m ust be prepaid.
Lifelines Lt d. m anufact ures hardware and soft ware t o be used on or with standard PC-com pat ible
com put ers and oper at ing soft w are. Lifelines, however, assum es no responsibilit y for t he use or reli-
abilit y of it s soft war e or har dware wit h equipm ent t hat is not fur nished by t hird-party m anufact ur-
ers accept ed by Lifelines at the dat e of purchase.
All warrant ies for thir d-party product s used wit hin the Trackit t4A syst em are the responsibilit y of
t he r elev ant m anuf act ur er . Please r efer t o t he r elev an t docum ent at ion on each pr odu ct for fur t her
det ails.
This docum ent contains propriet ary infor m ation that is prot ected by copyright . All right s are re-
ser ved. No par t of t his docum ent m ay be phot ocopied, reproduced in any ot her for m or t ranslat ed
into anot her language wit hout t he prior writ t en consent of Lifelines.
Trademarks
Microsoft , Window s and Window s NT are regist ered tradem arks of the Micr osoft Corporation. All
ot her t radem arks and product nam es are t he property of their relevant ow ners.
Responsibility of manufacturer
The m anufacturer and dist ribut or consider t hem selves responsible for t he equipm ent’s safet y, relia-
bilit y and perform ance only if:
any peripheral equipm ent t o be used wit h t he Trackit t4A sy stem is supplied by third-par t y pro-
viders recom m ended by t he m anufact urer;
assem bly oper at ion s, ex ten sions, readj ust m ent s, m odificat ion s, or repair s are carr ied out by
per sons aut horised by the m anufact urer ;
the elect rical installat ion of t he relevant room com plies w ith t he appr opr iat e requirem ents;
t he equipm ent is used by a healt h-care professional and in accordance wit h the instructions for
use.
N ot e : the m anufact urer has a policy of cont inual product im provem ent; hence t he equipm ent
specif icat ion s ar e subj ect t o ch an ge w it hout n ot ice.
Check wit h Lifelines or your distribut or if a soft w are updat e is available.
N ot e : Medical elect rical equipm ent needs special precaut ions regarding EMC and needs t o be in-
st alled and put int o service according to t he EMC inform at ion provided in the Appendix.

Trackit t4A EEG Am plifier User Manual
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Software and Virus Protection
Lifelines takes all reasonable steps t o ensure that it s softwar e is virus-fr ee. I n line wit h m odern
com put ing pract ice, it is advisable t hat cont inual prot ection against viruses, troj ans, m alware, ad-
ware etc. is provided on the PC used for installat ion and the sur rounding syst em s. Please not e t he
following recom m endat ions which should be supported by your internal I T/ Com put ing departm ent
pr ocedures and pract ices:
1. Virus protect ion soft w are 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 aut om at ic if desired but at a t im e w hen
the syst em is not being used.
3. All progr am s offer ing aut o-updat e feat u res, including Win dow s, should be set to m anual or
aut om atic if desired but at a tim e w hen the system is not being used.
4. Adopt for m al depar tm ent al or organisat ional pr ocedu res t o ensur e t he int egr it y an d saf e
operation of t he m edical equipm ent and suppor ting syst em s.

Trackit t4A EEG Am plifier User Manual
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Contents
Version Hist ory 2
Disclaim ers & Warrant ies 4
Tradem arks 4
Responsibilit y of m anufact u rer 4
Soft ware and Virus Protect ion 5
1Overview and Technical Descript ion 9
1.1 General descript ion 9
1.2 Caut ions and Warnings 9
1.3 Ex planat ion of sym bols 11
1.4 The Am plifier and it s parts 12
1.5 Specifications and safet y 12
1.6 Descript ion of t he com ponents 13
1.7 Replaceable parts 14
2I nstallat ion and Maint enance 14
2.1 Checks for com plet eness and integr ity 14
2.2 Environm ent al param eters for oper at ion 15
2.3 Power supply connect ions 15
2.4 Bat t ery Operat ion 16
2.5 Use in the hom e environm ent 16
2.6 Use wit h ot her equipm ent 16
2.7 I nt erference 17
2.8 Maintenance and cleaning 17
2.9 Disposal of equipm ent 18
3Connect ions and usage 18
3.1 Overview 18
3.2 Lapt op inst allat ion and operat ion 19
3.3 Fit t ing the bat t ery packs 19
3.4 Connect ing the Track it t 4A Am plifier 20
3.5 Swit ching the Am plifier on and off 22
3.6 Bluet oot h 24
3.7 SD Card 25
3.8 The t 4A Bag 26
3.9 Rem ot e Pat ien t Ev ent Th um b Swit ch ( opt ion al) 28
3.10 Battery Pack Charging 28
4Trackit Soft ware - set up and recording soft w are 30
4.1 Overview 30
4.2 Trackit Cont rol Panel 32
4.3 Defining I nput signals 34
4.4 Set t ing up the I nput s and Recording channels 36
4.5 St arting a Recording 38
4.6 Recording Cont rol Panel 40
4.7 View EEG Signal Traces 41
4.8 Calibration Check 42
4.9 I m pedance Check 42
4.10 Events 43
4.11 Mon t age Edit or 44
4.12 Reading an EEG recording 45
4.13 Advanced Set t ings 46
5The am bulat ory r ecording 50
5.1 Preparing the Am bulat ory Recording 50
5.2 Pat ient I nst ruction Sheet 50
5.3 Ev ent m ark ing 50
5.4 Ending a recording 50

Trackit t4A EEG Am plifier User Manual
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5.5 I dent ifying a recor ding 50
Appendix 1: Trackit t 4A Am plifier Specificat ions 51
Appendix 2: Addit ional Events I nform at ion 54
Appendix 3: PC Setup 57
Appendix 4: Addit ional Bluet oot h I nform ation 60
Syst em over view 60
Appendix 5: SD Card I nfor m at ion 61
Appendix 6: Default Setup on Am plifier 63
Appendix 7: Troubleshoot ing Guide 64
COM port pr oblem s w ith Bluet oot h com m unication to Track it t 4A 64
Problem s st arting the recording 64
Appendix 8: Manufact ur er’s Declarat ion 65
EMC Com pat ibilit y 65

Trackit t4A EEG Am plifier User Manual
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Illustrations
Figur e 1: Connecting the Track it t 4A Am plifier – Clinical Use 18
Figur e 2: Connecting the Track it t 4A Am plifier - Hom e Use 19
Figur e 3: Bat t ery replacem ent 20
Figure 4: Batt ery capacit y display 20
Figur e 5 : Conn ect ing t he Tr ack it t 4A Am plifier ( PCU/ fr ont face) 21
Figure 7: Releasing the data cable 22
Figure 8: Tr ackit t 4A display 23
Figure 9: Bluet oot h pairing 25
Figure 10: SD Card locat ion 26
Figure 11: Pat ient Event Thum b Swit ch 28
Figure 12: Tr ackit Soft w are ‘File’ Toolbar 30
Figur e 13: Tr ackit Software ‘Hom e’ Toolbar 31
Figure 14: Trackit Software "Set t ings Toolbar 31
Figure 15: Tr ackit Soft w are 'Help' Toolbar 31
Figure 16: Tr ackit Control Panel 32
Figure 17: Connect Dialog Box 32
Figure 18: Trackit t 4A "Status B" 34
Figure 19: Signal List 35
Figure 20: Signal Edit ing Tool 35
Figure 21: EEG setup 36
Figure 22: Set up Recording dialog 36
Figure 23: Channel set up 37
Figure 24: Recording Channel edit ing 37
Figure 25: New Pat ient dialog 38
Figure 26: New Pat ient dat abase 38
Figure 27: Recording Cont rol panel 40
Figure 28: EEG Signal trace display 41
Figur e 29: Adj ust display par am et er s 42
Figure 30: I m pedance check 43
Figur e 31: Cont inuous I m pedance Check 43
Figure 32: Event Viewer 44
Figure 33: Mont age Edit or 45
Figure 34: T4 Default s Tab 1 47
Figure 35: T4 Default s | Tab 2 48
Figure 36: User Event s 55
Figure 37: Event s Tem plat e set up 55
Figure 38: Free-t ext Event 55
Figure 39: Event List 56
Figure 40: Opt ions Tab 1 57
Figure 41: Opt ions Tab 2 57
Figure 42: Opt ions Tab 3 59

Trackit t4A EEG Am plifier User Manual
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1Overview and Technical Description
1. 1 General description
I n dica t ion s f or u se
The Trackit t4A EEG Am plifier is int ended t o be used as a front -end am plifier t o acquire, st ore and
t ransm it elect roph ysiological signals ( wir eless or cabled) .
CAUTI ON: Federal ( USA) law rest ricts this device t o sale by or on the order of a physician.
Ge ne r a l d e scr ip t io n
The Track it t4A EEG am plifier is a 32-channel elect roencephalogr aph recorder and is int ended for
use in am bulat ory EEG and lab m onit oring applications. The Trackit t4A Am plifier is intended to be
used in a Pr ofessional healt hcare Environm ent and a Hom e ( healt hcare) environm ent.
The Trackit t4A am plifier is pow er ed by one or t wo lit hium -polym er bat tery packs and is fit t ed w ith
an int ernal lit hium -ion back up bat ter y. The am plifier feat ures a local event pushbut t on and has
conn ect ion for an opt ion al r em ot e ( cabled) even t pu shbut t on. The input channels of the t4A
am plifier have built -in calibr at ion and elect rode im pedance m easurem ent . Com m unication t o a PC
is through a wireless (Bluet oot h) interface and a cabled ( USB) int erface. Recorded dat a is stored on
a rem ovable SD m em or y card. A pouch is pr ovided t o carry and prot ect t he am plifier in am bulat ory
use.
The Trackit t4A am plifier is int ended to be configur ed and set up by a t r ained healt hcare
pr ofessional. I n an am bulat ory sit uat ion, the EEG elect rodes are fit ted to t he pat ient by t he
healt hcare professional prior to the pat ient being sent hom e. The pat ient is intended to have
m inim al interact ion wit h t he Trackit t4A am plifier, wit h the only interact ing being pressing the
ev ent pu shbu tt on( s) .
Upon com plet ion of t he recor ding, the dat a, w hich is st or ed on t he SD car d, is reviewed by a
clinician using review and analysis soft ware on a PC.
The am plifier is int ended t o be bat t er y powered in am bulat ory applicat ions and com m unicates
wirelessly w it h a host com put er through Bluet oot h. Alt ernat ively it can be connect ed t o a USB port
on a PC w hich is pow ered from a medically approved power supply.
Two fully char ged bat ter y packs pr ovide sufficient pow er t o pow er the Am plifier for a m inim um of
72 hours. The bat t ery packs are intended t o be replaced when the am plifier is not recording and
not fit ted to the pat ient . The t4A am plifier does not recharge the bat t ery packs. The bat ter y packs
m ust be rem oved from the am plifier and recharged using a desktop charger.
This equipm en t is in ten ded only as an adj u nct dev ice in pat ient assessm ent ; it m ust be u sed in
conj unct ion with other methods of pat ient diagnosis. The equipm ent does not sustain or support
life.
I ntended Use r
The int ended user of the equipm ent is a healt hcare professional who has t he t raining and
knowledge to undertake EEG ex am inat ions and is fam iliar wit h EEG equipm ent and pract ice.
1. 2 Cautions and Warnings
W ARN I N G: Do not use the Trackit t4A EEG Am plifier in an MRI environm ent , in an oxygen rich
environm ent or during defibrillation.
W ARN I N G: This equipm ent is intended t o be used by a healt hcare professional and in accordance
wit h t hese inst ruct ions for use w hich m ust be read in their ent iret y before t he dev ice is used.
W ARN I N G: This equipm ent in int ended only as an adj u nct dev ice in pat ient assessm ent ; it m ust
be used in conj unct ion with ot her m ethods of pat ient diagnosis. This equipm ent is not be used for
t he det erm ination of brain deat h.
W ARN I N G: Only use t he PC and t he m edical-gr ade power supply as supplied or aut horised by
Lifelines.
W ARN I N G: To avoid t he r isk of electric shock, t his equipm ent m ust only be connect ed to a supply
m ains wit h prot ective ear th.

Trackit t4A EEG Am plifier User Manual
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W ARN I N G: Lifelines does not supply EEG elect rodes. The unit accept s standard 1.5 m m
t ouchproof electrodes using DI N 42802-style connect ors. To ensure pat ient safet y, the elect rodes
used m ust be approved t o the Medical Device Directive 93/ 42/ EEC in Europe or FDA cleared for use
in USA.
CAU TI ON : The conduct ive part of electrodes and their connect ors, including t he Neut ral electrode,
should not cont act ot her conduct ive parts including eart h conduct ors.
W ARN I N G: Do not plug the USB connector int o any device ot her t han the PC supplied or
aut horised by Lifelines. Do not connect any ot her equipm ent to the PC.
CAU TI ON : Do not t ouch sim ult aneously any accessible USB or other cont act s on the PC and the
patient.
W ARN I N G: St rangulat ion hazard due t o long cables. As wit h all m edical equipm ent , carefully
rout e pat ient cabling to reduce t he possibilit y of pat ient entanglem ent or st rangulat ion.
CAU TI ON : Ensure t hat carrying bag and straps are worn over clot hing t o prev ent any possibilit y of
skin irritat ion.
CAU TI ON : Medical electrical equipm ent needs special precaut ions regarding EMC and needs t o be
inst alled and put int o serv ice according to the EMC inform at ion provided in the Appendix.
CAU TI ON : Portable RF com m unications equipm ent ( including per iph er als such as ant enn a cables
and external ant ennas) should be used no closer t han 30 cm ( 1 2 in ches) t o any par t of t h e Track it
t4A, including cables specified by Lifelines Lt d. Otherwise, degradat ion of the per for m ance of this
equipm ent could result .
CAU TI ON : When in close proxim it y t o the t4A Am plifier , do not use m obile phones, transm it t ers,
power transform er s, m otors, or ot her equipm ent t hat gener at es m agnet ic fields. Refer t o t he
Appendix for m ore inform at ion.
W ARN I N G: The funct ion or safet y of the equipm ent could be im paired if it has been subj ect ed to
unfavourable condit ions in st orage or in transit. I f at any t im e funct ion or safety is thought to be
im pair ed, t he instrum ent should be taken out of operation and secured against unint ended use.
W ARN I N G: Do not open or m odify t he equipm ent wit hout t he aut hor izat ion of t he m anufact urer .
W ARN I N G: Replace t he Lit hium poly m er bat ter y packs wit h Lifelines supplied bat ter y pack s only.
Use of anot her batt ery m ay present a risk of fire or explosion.
W ARN I N G. I f the Tr ackit t 4A am plifier is not t o be used for som e tim e, t he bat t ery packs should
be rem oved.
CAU TI ON : Do not t ouch t h e bat t ery cont act s ( in t he Trackit t4A bat t ery housing) and the pat ient
sim ult aneously .
CAU TI ON : The lit hium -poly m er bat ter y packs used in this device m ay pr esent a fire or chem ical
burn hazard if m istreat ed. Do not disassem ble, heat above 100° C ( 212° F) or incinerat e.
CAU TI ON : Federal ( USA) law rest ricts this device t o sale by or on the order of a physician.
CON TRAI N D I CATI ON S: There are no know n contraindications to t he use of this equipm ent.

Trackit t4A EEG Am plifier User Manual
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1. 3 Explanation of symbols
Type BF applied part Follow operat ing instruct ions
I nput / out put connect ion I nput connect ion
Special recycling required, do not dispose of in landfill. When t his equipm ent has
reached the end of it s useful life, it must be disposed of in an env ironm entally-
fr iendly w ay . Wast e elect r ical and elect r onic equipm en t ( WEEE) requires special
procedures for recycling or disposal. This includes bat t eries, print ed circuit boards,
elect ronic com ponent s, wir ing and ot her elem ent s of electronic dev ices. Follow all
of your respective local laws and r egulat ions for the proper disposal of such
equipm ent . Cont act your local distribut or for inform at ion concerning this.
Consult warnings in User Manual Bluet oot h
Rem ot e ev ent pushbutton Mem or y card read/ writ e
Manufact urer On/ Off and pat ient event sw it ch
I nt er nal bat ter y hazar d Bat tery door access
- refer t o section 1.7 - refer to section 3.3
Bat tery pack ident ifier
Storage and transport symbols
Tem per at ure lim it s Fragile Keep dry
Relat ive hum idit y lim it s At m ospheric pressure lim it s
I nt er nat ional prot ect ion code
Prot ect ed ag ainst ingr ess of solid obj ect 1 2. 5 m m diam et er .
Pr ot ect ed against access t o hazardous par t s wit h finger.
Pr ot ect ed again st in gr ess of wat er dr ippin g ( 1 5° t ilt ed) .
-25
+70
°C
0
93
%RH
500
1060
hPa
I P2 2

Trackit t4A EEG Am plifier User Manual
12
1. 4 The Amplifier and its parts
The Track it t4A EEG Am plifier is a 32-channel electroencephalograph recorder int ended t o acquire
EEG signals in an am bulat ory environm ent . I t is power ed by eit her one or t wo lit hium - polym er bat -
tery packs and is fit t ed wit h an internal, non-replaceable, lit hium -ion backup bat tery . The am plifier
feat ures a local event pushbut ton and has connection for an opt ional rem ote ( cabled) event
pushbut t on.
In am bulat ory applicat ions t he am plifier com m unicat es wit h a host com put er , wirelessly, t hrough
Bluet oot h. Alt ernat ively it can be connect ed t o a USB port on a PC w hich is pow ered from a m edi-
cally approved power supply. Refer t o section 3.1 for det ails.
Ca u t ion :
Only use t he PC supplied or author ised by Lifelines
Only use t he m edical-grade m ains power supply wit h it as supplied or aut horised by Lifelines
The Trackit t4A EEG Am plifier com pr ises t he follow ing com ponen t s:
Trackit t4A Am plifier part num ber: 1600
Trackit t 4A Am plifier USB cable part num ber: 1601
Trackit t4A bag and st raps part num ber: 1602
Trackit t 4A Lit hium -poly m er bat t er y pack ( x2) part num ber: 1603
Single bay battery char ger wit h power supply part num ber: 1604
Trackit soft ware CD, st andard part num ber : 1009
Trackit T4A User Manual ( t his docu m ent ) part num ber : 1606
Trackit T4A Quick St art Guide part num ber : 1607
Trackit T4A Patient I nstruct ion Sheet par t num ber : 1608
Trackit T4/ T4A Tool part num ber : 1408
The t 4A EEG Am plifier can be used w ith the following accessories:
Pat ient event sw itch part num ber: 1353
Lenovo ThinkPad lapt op com puter part num ber: 1389
Medical grade power supply part num ber: 1390
4- Bay Bat t ery Charger and Power supply part num ber : 1605
Mains cable, UK part num ber: 1066
Part num bers m ay be pr eceded by ‘L14’ on labelling or packaging.
1. 5 Specifications and safety
Refer t o Appendix 1 for specifications.
The Trackit t 4A am plifier has been certified and com plies wit h t he following st andar ds:
I EC 60601-1 and
I EC 60601- 2 - 26
St andard for m edical elect rical equipm ent , gener al requirem ent s
and par ticular requirem ent s for EEG syst em s.
I EC 60601- 1- 11 Collat eral standard for m edical elect rical equipm ent used in the
hom e healt hcar e environm ent .
I EC 60601- 1 - 6
Collateral st andard for usability.
ANSI / AAMI ES 60601- 1
AAMI Deviat ions from I EC 60601-1 ( USA) .
CAN/ CSA 22.2 No 601.1 M90 Canadian st andard for m edical elect rical equipm ent , gen er al re-
quirem ent s.
I EC 60601- 1- 2 St andard for m edical electrical equipm ent , EMC r equirem ent s,
calling:
*
CI SPR11
Conducted Em issions, Group 1, Class B
CI SPR11
Radiat ed Em issions, Group 1, Class B
I EC61000- 4- 2
Electrost atic Discharges
I EC61000- 4- 3
I m m unit y - Radiat ed RF Field
*
I EC61000- 4- 4
I m m unit y - Transient s Burst s
*
I EC61000- 4- 5
I m m unit y – Surges
I EC61000- 4- 6
I m m unit y – Conducted
I EC61000- 4- 8
I m m unit y – Power frequency fields
*
I EC61000- 4- 11
I m m unit y – Volt age dips, int errupt ions

Trackit t4A EEG Am plifier User Manual
13
*
I EC61000- 3- 2
Harm onic Em issions
*
I EC61000- 3- 3
Volt age Fluctuat ions/ flicker
*
Not e: Com pliance is provided by t he PC.
Cla ssif ica t io n o f sy st e m
Cla ssif ica t io n Clinica l use Hom e use
Degree of pr ot ection against
electrical shock
I nt er nally pow ered; or it can
be conn ect ed t o a PC which is
powered by a m edical grade
Class I power supply.
Type BF applied part s.
Trackit t 4A Am plifier:
I nt er nally powered.
Type BF applied part s.
I f a PC is supplied, the PC has no
electrical connect ion to t he
Am plifier & has no applied parts.
Degree of pr ot ection against
harm ful ingr ess of wat er
Or din ar y ( no pr ot ect ion) or
I P2 2 ( Am plif ier in bag)
I P2 2 ( Am plif ier in bag)
Mode of operation Continuous operation Continuous operat ion
Suit ability for use in an
oxygen rich env ironm ent
Not suit able Not suit able
1. 6 Description of the components
The Trackit t4A Amplifier
The Trackit t4A am plifier provides 32 channels ( 28 referent ial, 4 bipolar) with built -in calibr at ion
and electrode im pedance m easurem ent. The am plifier has built in type-BF pat ient isolat ion and has
a USB interface t o t he PC. Bluet oot h w ireless com m unicat ion is included for am bulat ory applica-
tions. EEG dat a is r ecorded t o a rem ovable SD card. The am plifier has a built -in posit ion sensor
( acceler om et er ) and light sensor.
Applie d parts, t y pe BF
EEG Ele ct r ode s
The am plifier connects t o standard 1.5m m t ouchproof EEG recording electrodes arranged in a
st andard 10-20 pat t ern , at t ached t o t he pat ient ’s head.
W ARN I N G: Lifelines does not supply EEG electrodes. The Am plifier accept s st andar d 1. 5 m m
t ouchproof electrodes using DI N 42802-style connect ors. To ensure pat ient safet y, the elec-
t rodes used m ust be approved to t he Medical Device Dir ective 93/ 42/ EEC in Europe or t o t he
relevant local st andards out side Europe.
CAU TI ON : The conduct ive part of electrodes and their connect ors, including the Neutral elec-
trode, should not cont act ot her conduct ive parts including earth.
Pa t ie n t Ev e nt p ush bu t t on
The Pat ient Event Pushbut ton is used by the pat ient t o m ark the instance of a significant event .
Lit h iu m Po ly m e r Ba t t e r y Pa ck s
The Trackit t4A am plifier has provision to fit t wo Lit hium -Polym er bat tery packs, which pr ov ide t he
m ain power sour ce for the am plifier . The bat tery packs are housed in the bat ter y com part m ent of
the Trackit t4A am plifier and connect ed in parallel, so t he Trackit t4A can operat e with only one
batt ery pack fit t ed. The Trackit t4A does not have t he capabilit y to recharge t he bat t ery packs and
t he bat ter y pack s m ust be rem oved from t he Trackit t4A t o be recharged in a deskt op char ger. De-
tails f or char gin g t he bat t er ies are provided in Sect ion 3.10.
SD Mem ory Card
The SD card is used to st or e the EEG dat a recorded by Trackit t 4A. St orage cards of varying capac-
it y ar e available in the SD form at . The Trackit t 4A supports SD cards wit h a capacit y up to 32GB
wit h a FAT32 file syst em .
Bags a nd st r a ps f or a m b ula t or y a pp lica t ion s
The t4A bag houses the Am plifier w hen used in am bulat ory applicat ion. The bag prot ects t he am pli-
fier fr om w at er and dust ( I P22 pr ot ect ion) .

Trackit t4A EEG Am plifier User Manual
14
USB Ca ble fo r co nn e ct ion t o PC
For non- am bulat ory applicat ions the Am plifier can be plugged direct ly into a USB port on the PC.
W ARN I N G: The Am plifier m ust only be used w ith t he USB cable provided wit h t he unit .
Medical gr a de AC/ DC m ain s pow er su pply m odule for La ptop PC
Where EEG st udies are conduct ed w it hin the pat ient environm ent t he leak age current m ust be con-
trolled. The laptop PC m ains pow er supply m ust be a special m edical-grade type wit h appr opriat e
safety standards, supplied or authorised by Lifelines.
W ARN I N G: Th e la p t op m ust only be con ne ct e d t o t h e m e dica l-gr a de la p t op pow e r supply
supplie d or author ise d by Lifelin e s. Do not u se a st a n dar d la ptop pow e r supply.
Only use t he la pt op su pplie d or authorised by Lifelines.
The Set up and Re cor ding Sof t w a r e
The Track it set up soft w are runs under Microsoft Windows XP, Windows Vist a, Window s 7, 8 or 10
on t he host PC and is used to set up and review the t4A Am plifier and to r ecord on to t he PC.
The Track it t4A am plifier is conn ect ed t o t he PC v ia t he USB cable or wirelessly wit h Bluetooth. The
recor ding set up is downloaded t o the device and checks can be m ade to verify that all t he elec-
trodes have been at tached correctly . The Am plifier is then disconnect ed from t he PC and t he re-
cording is st arted.
Funct ions of t he sof t ware:
Dow nload the recording t em plat e. This includes which electrodes are used and the recor ding
m ont age. See section 4.11.
Perform a calibration check of the Am plifier. See sect ion 4.8.
Perform an I m pedance check on t he Am plifier. See Section 4.9.
Perform an EEG recording. See section 4.5.
View on-going EEG t races. See section 4.7.
1. 7 Replaceable parts
Lifelines Lt d. will m ak e available on request cir cuit diagr am s, com ponent par t list s, descript ions,
calibration inst ruct ions, or ot her inform at ion that will assist serv ice personnel to repair those part s
that are designat ed by Lifelines Lt d. as repairable by service per sonnel.
I nt e r nal battery r eplacem ent – service personnel on ly
The Trackit t4A am plifier cont ains a lit hium ion rechargeable coin cell, type LI R2450.
W ARN I N G: Bat t ery replacem ent by inadequat ely t rained personnel could result in a haz-
ard. I t m ust be replaced only wit h t he correct t ype. Refer t o t he Trackit t4A Service I n-
st ructions.
2Installation and Maintenance
W ARN I N G: The following section m ust be read and under st ood before t he equipm ent is swit ched ON.
N ot e : Medical elect rical equipm ent needs special precaut ions regarding EMC and needs t o be in-
st alled and put int o service according t o t he EMC inform ation provided in t he Appendix.
The funct ion or safet y of the equipm ent could be im paired if it has been subj ect ed to unfavourable
condit ions in st orage or in transit . I f at any tim e function 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 anuf act ur er shou ld be con tact ed ( det ails on page 3 ) for assist ance, if needed, in set t in g u p,
using or m aint aining the equipm ent; or to repor t unexpect ed operation or event s.
The assem bly of t he syst em and any m odificat ions during it s service life require evaluation t o t he
requirem ent s of I EC 60601-1.
2. 1 Checks for completeness and integrity
1 Rem ov e t he equ ipm ent f rom t he packagin g case( s) .
2 Use t he parts list to check that all or dered it em s have been r eceiv ed.

Trackit t4A EEG Am plifier User Manual
15
3 Check for signs of dam age that m ay hav e occur red during transit or st orage. I f any dam age is
found, do not use t he inst rum ent ; cont act your dist ribut or.
2. 2 Environmental parameters for operation
The oper at ional and st or age/ t ran spor t at ion envir onm ental condit ions are as follows:
Operational:
Tem perat ur e + 5° C t o + 40° C (+ 41° F to + 104° F)
Relat ive hum idit y 15% t o 93% non-condensing
At m ospher ic pr essure 700 hPa to 1060 hPa
Storage and transport:
Tem perat ur e -25° C to + 70° C (-13° F t o + 158° F)
Relat ive hum idit y Up to 93% non-condensing at + 70° C ( 158 ° F)
At m ospher ic pr essure 500 hPa t o 1060 hPa
2. 3 Power supply connections
Power requirements
3.7V Lit hium - Polym er bat t ery pack or St andard USB port ( 5 V)
Power consumption
Maxim um power from USB por t: 2.5W.
Medical grade AC mains power supply module for Laptop PC
Where EEG st udies are conduct ed wit hin t he pat ient env ironm ent t he leakage current m ust be con-
t rolled. The m ains power supply m ust be a special m edical-grade t ype w it h appropriate safet y
st andards, as supplied or aut horised by Lifelines.
Mains power input : 100–240 Vac, 47–63 Hz, 1.4 A @ 115 Vac, 0.7 A @ 230 Vac.
Out put: 20 Vdc, 5.25 A.
W ARN I N G: Th e la pt o p m u st on ly be con n e ct e d t o t h e m e dica l-gr a de la ptop pow e r supply
supplie d or author ise d by Lifelin e s. Do not u se a st a n dar d la ptop pow e r supply.
Only use t he la pt op su pplie d or authorised by Lifelines.
W ARN I N G: To a v oid t h e r isk of ele ct r ic sh ock , t his e q uip m e nt m u st o nly be con n ect e d t o
a su pp ly m a in s w it h p ro t ect iv e ea r t h .
W ARN I N G: Th e Am p lifi er m u st on ly b e u se d w it h t h e USB ca b le pr o vi de d w it h t h e un it .
Single Bay batt ery charger (P/ N 1604)
AC/ DC pow er adapt e r
Mains Power input : 100-240VAC, 50/ 60Hz, 0.35A m ax.
Out put: 5VDC, 1A Max. Micro-USB connect or
Ba t t e r y ch ar g in g cr a dle
Power input: 5VDC, 1A nom .
Out put : 4.2VDC, 1A m ax .
Four Bay batt ery charger (P/ N 1605)
AC/ DC pow er adapt e r
Mains Power input : 100-240VAC, 50/ 60Hz, 1.5A m ax.
Out put : 12VDC, 4.2A Max.
Ba t t e r y ch ar g in g cr a dle
Power input: 12VDC, 3. 3A nom .
Out put : 4.2VDC, 1A m ax ( x 4 ) .

Trackit t4A EEG Am plifier User Manual
16
2. 4 Battery Operation
Li-Polymer battery pack
The Track it t4A am plifier is power ed fr om one or two bat t ery packs. When fully charged, t wo bat -
tery packs w ill t ypically pow er the unit for 72 hours depending on t he num ber of channels, sam ple
rat e and w ireless usage ( 36 hours if only one bat t ery pack is used) .
The typical service life of the bat t ery packs is 500 charge-dischar ge cycles.
A deskt op charger is required t o recharge t he batt ery packs. The Trackit t4A am plifier does not re-
charge t he bat t ery packs.
The healt hcare professional is intended to replace the bat t er y pack( s) . This should be done before
a recording is st arted. The pat ient should not replace t he bat t ery packs.
Li-Polymer battery pack Instructions for Use
•The bat t ery packs are charged using the specified desk t op charger. Refer t o t he instruc-
tions supplied w ith the charger.
•Oper at ing tim e w ill be shor ter t han usu al at low t em per at ur es. The bat t er y can be used be-
tween 0° C ( 3 2° F) and 45° C ( 11 3° F) , but will giv e best perfor m ance bet ween 10° C ( 50 ° F)
and 30° C ( 86 ° F) .
•I f t he bat ter y pack start to give less operating tim es t han usual, they hav e reached the end
of their life and m ust be replaced. Dispose of used bat tery packs pr om pt ly and keep aw ay
from children.
•Since t he bat ter y packs will nat urally dischar ge it self over a period of tim e, it is best t o
charge t he bat t ery packs a day or t wo before planning t o use it.
Internal Li-Ion backup battery
The int ernal backup bat t ery will enable t he unit to cont inue operating for a short period of t im e (30
m ins appr ox .) t o allow t he m ain bat t ery pack to be replaced. I t is rechar ged aut om at ically, while
t he am plifier is swit ched on and eit her connect ed over USB or fit t ed wit h a bat ter y pack. The stat e
of charge is displayed, as descr ibed in sect ion 3.5, whenever the unit is powered from t he backup
batt ery.
The t ypical service life is 500 charge-discharge cycles. The backup bat t ery is replaceable by service
personnel only
2. 5 Use in the home environment
Where t he equipm ent is intended t o be used in the hom e, the unit should be operated in it s bag
where it is protect ed against ingress of solid obj ects and wat er to a degree of I P22.
The lapt op PC is opt ional in the hom e environm ent and m ay be used for video recordings. There is
no cable connect ion bet ween t he PC and the t4A Am plifier unit , as all com m unicat ion is accom -
plished wirelessly.
Keep the equipm ent away from sources of heat .
Do not use m obile phones.
Do not allow pet s or children to interfere wit h the equipm ent or sensor cables.
When the equipm ent is oper at ed w it h or wit hout it s Bluet oot h connected, other devices in the vi-
cinit y should be m oved aw ay or t ur ned off to reduce t he likelihood of int erfer ence t o t he equipm ent
or by the equipm ent .
The Trackit t4A has an internal Bluet oot h radio fit t ed. This is an approved indust ry-st andard type
which present m inim al risk of reciprocal int er ference w it h ot her equipm ent.
2. 6 Use with other equipment
Defibrillators and HF surgical equipment
The equipm ent is not defibr illat or proof and should not be used in sit uat ions wher e a defibrillat or is
likely to be used.
The equipm ent should not be used w ith, or in the presence of, high frequency surgical equipm ent .

Trackit t4A EEG Am plifier User Manual
17
Other patient-connected equipment
When used sim ult aneously wit h ot her pat ient -connect ed equipm ent, for exam ple a car diac pace-
m aker or ot her elect rical stim ulat or, it is unlik ely t hat a safet y hazard will arise. How ever alw ays
consult t he docum ent at ion supplied wit h t he ot her pat ient -connect ed equipm ent to ensure t hat all
hazards, warnings and caut ions are considered before the equipm ent is used toget her .
Leakage current
This syst em is designed to com ply wit h I EC 60601-1, the int ernat ional st andard for m edical elec-
t ronic equipm ent, which specifies t he perm issible levels of leakage current . A pot ential hazard ex-
ist s in the sum m at ion of leak age current s caused by connect ing sever al pieces of equipm ent to-
get her. Because this system can be used in conj unction wit h st andard electronic devices, the tot al
leakage current should be test ed whenev er t he sy stem is m odified.
Ther e should be n o elect r ical connect ion s bet w een t he sy st em eq uipm en t, w hich is pow er ed via a
m edical gr ade pow er supply, and any other equipm ent powered fr om another m ains supply.
2. 7 Interference
The Trackit t4A will cont inue t o operat e in the pr esence of radio frequency m agnetic fields ( RF) and
t he effect s of elect rost at ic disch ar ges ( ESD) an d ot her in t er fer ence, in accor dance w it h t he r equir e-
m ent s of I EC60601- 1- 2. However, the Trackit t4A am plifier records signals of very low am plit ude,
and these signals them selv es are not im m une to the effect s of RF, ESD and low-frequency m ag-
netic field interference. Such int er ference m ay cause signal artefact s.
The Trackit t4A has an internal Bluet oot h radio fit ted. This is an approved indust ry-standar d t ype
which present m inim al risk of reciprocal int er ference w it h ot her equipm ent.
However , w hen the equipm ent is operated wit h or wit hout Bluet oot h connect ed, ot her devices in
the vicinity should be m oved away or turned off t o reduce the likelihood of inter ference t o t he
equipm ent or by t he equipm ent
CAU TI ON : Portable RF com m unications equipm ent ( including per iph er als such as ant enn a cables
and external ant ennas) should be used no closer t han 30 cm (12 inches) t o any part of the Trackit
t4A, including cables specified by Lifelines Ltd. Otherwise, degradat ion of the per for m ance of this
equipm ent could result .
CAU TI ON : When in close proxim it y t o the t4A Am plifier , do not use m obile phones, transm it t ers,
power transform ers, m ot ors, or ot her equipm ent that generat es m agnet ic fields. Refer t o t he
Appendix for m ore inform at ion.
N ot e : Medical elect rical equipm ent needs special precaut ions regarding EMC and needs t o be in-
st alled and put int o service according to t he EMC inform at ion provided in the Appendix.
2. 8 Maintenance and cleaning
The t4A Am plifier and its accessor ies require no rout ine t esting, calibrat ion or m aint enance proce-
dures apart from occasional cleaning and checking for wear and dam age to all parts including the
accessories.
No servicing or m aintenance of t he equipm ent should take place while in use wit h a pat ient .
Cleanin g a nd d isin fe ct ion
Prior to each re- use of the syst em , all t he outer surfaces of the t4A Am plifier and it s bag m ay be
cleaned, as required, wit h a cloth m oistened wit h a m ild det ergent solution.
Disinfection of t he equipm ent can be carried out by the use of QAC-based disinfect ant s. Wipes are
recom m ended in order t o prevent t he ingress of any liquid int o t he equipm ent . Suit able product s
in clude Mik rozid Sensit iv e Wipes ( Sch ülk e & Mayr Gm bH) , Micr obac for t e ( Paul Har t m ann AG) , Dis-
t el Wipes ( Trist el Lt d. ) , Mikro- Kill disinfect ant wipes ( Medline I ndust ries, I nc.), Sani-Clot h HB Ger-
m icidal Wipes ( PD I n t er nat ional, I n c) .
For cleaning inst ruct ions for t he lapt op r efer t o t he m anufact ur er’s docum ent at ion.
Ca u t ion : Do not allow any liquid t o enter t he case of the inst rum ent or connect or. Do not use ace-
t one on any of the inst rum ent s.

Trackit t4A EEG Am plifier User Manual
18
2. 9 Disposal of equipment
When the device and its parts and accessor ies has reached the end of its operating life, it should be
disposed of in accordance wit h local wast e regulat ion aut horit y that is t ypically wit hin the local gov-
ernm ent office.
Dispose of used bat t ery packs prom pt ly and keep away fr om children.
Ca u t ion : Do not dispose of bat t ery packs int o fire or by incineration.
3Connections and usage
3. 1 Overview
Figur e 1 : Con nect ing the Tr a ck it t4A Am plifier – Clin ical U se
Clinica l Use
During Clinical use, the Trackit t4A Am plifier can be con nect ed t o a PC eit her usin g t h e USB cable
or through a wireless Bluet oot h connect ion ( See Figure 1) . Housing the am plifier in t he t 4A bag is
opt ional and m ay be used to pr ot ect and secure the am plifier.
Not e: I n transport able, i.e. body-worn sit uat ions w ithin the clinic, the Am plifier m ust be housed in-
side it s bag after being disconnect ed from t he PC, for prot ection against spillage of liquids, high
lev els of st at ic elect ricit y discharge and physical dam age.
Where the entire Trackit t4A system including the PC is used within the pat ient env ironm ent , t he
m ains leakage currents and safet y and regulat or y requirem ent s are m et by t he use of the special
m edical-gr ade lapt op power supply.
Hom e Use
Dur ing hom e use, the Trackit t4A Am plifier is bat t ery pow ered and is housed inside it s bag w here it
is prot ected against ingress of solid obj ects and wat er t o a degree of I P22. The lapt op PC is op-
tional and m ay be used for video recordings. There is no cable connect ion bet ween t he PC and the
t4A Am plifier, as all com m unication is accom plished w irelessly (See Figure 2) .

Trackit t4A EEG Am plifier User Manual
19
Not e t hat for Hom e Use applications, the pat ient should be given a Patient I nst ruct ion Sheet , which
det ails essent ial usage and safet y instruct ions concerning the equipm ent . Refer t o t he Pat ient I n-
st ruction Sheet for det ails.
Figur e 2 : Con nect ing the Tr a ck it t 4A Am plifie r - H om e Use
3. 2 Laptop installation and operation
W ARN I N G: Th e la p t op m u st o nly be con n ect e d t o t he m e d ica l-grade la ptop pow er supply
supplie d or author ise d by Lifelin e s. Do not u se a st a n dar d la ptop pow e r supply.
Only use t he la pt op su pplie d or authorised by Lifelines.
1. Connect t he pow er cor d t o t he m edical-grade pow er supply .
2. Connect t he power supply output to the power input connector on the lapt op.
3. Connect t he pow er cor d t o m ain s pow er out let .
4. Not e t hat t he m ains power cor d serves as a power disconnect dev ice. I t should be inst alled
near t he equipm ent and be easily accessible.
5. For lapt op installat ion and oper at ion r efer t o t he m anufact urer ’s inst ruct ions supplied wit h it .
6. I f t he USB cable is used in t he hom e, the lapt op and power supply m ust be placed 1.5m aw ay
from the pat ient. This is t o prevent EMC disturbances on the EEG signals caused by the lapt op
or power supply.
3. 3 Fitting the battery packs
W ARN I N G: Only fit bat tery packs supplied or aut horised by Lifelines, wit h t he cor rect part num ber
( PN 16 03) . Use of ot her bat t ery packs m ay present a risk of fire or explosion.
W ARN I N G. I f the Tr ackit t 4A am plifier is not t o be used for som e t im e, the bat tery packs should
be rem oved.
For am bulat ory , body- worn applications t he Trackit t 4A is pow er ed fr om t he bat t ery pack( s) . The
fully charged bat t er y pack(s) should be fit t ed into the t4A Am plifier bef ore set t ing up an am bula-
t ory recor ding. I f t he am plifier is t o be used in a Clinical environm ent wit h t he USB cable, the use
of the bat t ery packs is opt ional as t he am plifier will be powered from t he USB port.

Trackit t4A EEG Am plifier User Manual
20
1. Flip the t4A over, so t he base is facing up.
2. Using t he T4/ t4A Tool, open the bat t ery door by pressing the door -release but -
t on. The bat t er y door w ill spr ing open . See Figure 3.
3. I f ther e are bat teries in the unit , rem ove t hese first .
4. I nser t t he bat t er y pack ( s) ( bat t er y con t act s facin g dow n) in to t h e am plifier . I f
only fit t ing one bat t ery pack, fit t he bat t ery in bat t ery location 1.
5. Gent ly push t he bat t ery door closed. The door w ill click shut and lock aut om at ically.
CAU TI ON : Do not t ouch t h e bat t ery cont act s ( in t he Trackit t4A bat t ery com partm ent ) and t he pa-
t ient sim ult aneously .
Figur e 3: Ba t t e ry re place m e nt
While t he bat tery door is open, and t he am plifier is pow ered on, t he display will show t he rem ain-
ing capacit y of the fit t ed bat tery packs. I f a bat ter y pack is not fit ted, t he display will show t wo
dashes, as shown below. This view will rem ain on t he display for 10 seconds aft er closing t he bat -
tery door. Pressing the event button will reset t he display back to t he status screen.
N ot e : Th e ba t t er y pa ck s a r e not se cu r ed in t he t4A w h ile t h e do or is o pe n . Ca re sh ou ld be
t a k e n w h ile t h e d oo r is ope n a s t he b at t e r y pa ck s ca n fa ll out if t he a m p lif ie r is t ip pe d
over.
Figur e 4: Ba t t e r y ca pa cit y disp la y
3. 4 Connecting the Trackit t4A Amplifier
The t op face of the Trackit t4A houses the display, the pat ient even t pushbu tt on and the am -
bient light sensor. For display det ails refer to section 3.5 below. Pressing the pushbutton r ecords a
pat ient ev ent and illum inat es t he back-light of the display.
Adj acent t he pushbut ton is a circular apert ure which houses a sensor to m easure t he am bient light
level.
BATTERY 1:100%
BATTERY 2: --