Lifelines trackit T4A User manual

t4AEEG Am plifier
Use r M a n u a l
I ssue 1.0
Doc No: 51305-006 Part no. 1606
Cr eat ed Checked Appr oved
Digitally signed by
Geoff Salter
Date: 2018.05.02
12:03:18 +01'00'
Digitally signed by Michael Hulin
Date: 2018.05.02 12:44:29 +01'00'
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development, [email protected],
c=GB
Date: 2018.05.02 12:53:08 +01'00'

Tr ackit t 4A EEG Am plifier User Manual
2
Version History
V 1.0 ( 2 May 2018)
•First release

Tr ackit t 4A EEG Am plifier User Manual
3
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]
008 6

Tr ackit t 4A EEG Am plifier User Manual
4
Disclaimers & Warranties
The inform at ion in t his sect ion is subj ect to change w it hout notice.
Except as stat ed below, Lifelines Lt d m akes no warrant y of any kind wit h regar d to t his m at erial,
including, but not lim it ed to, the im plied warranties of m erchant abilit y and fit ness for a particular
purpose. Lifelines shall not be liable for errors contained herein or for incident al or consequent ial
dam ages in connection with t he furnishing, perform ance or use of t his m at erial.
Lifelines shall warrant its product s against all defect s in m aterial and workm anship for one year
from t he dat e of delivery.
Misuse, accident, m odificat ion, unsuit able physical or operating environm ent , im proper m aint e-
nance or dam age caused by a product for which Lifelines is not responsible will void the warrant y.
Lifelines do not warrant unint errupted or error-free operat ion of it s products.
Lifelines or it s aut horised agents will repair or replace any product s t hat prove to be defective dur-
ing the warrant y period, provided that these products are used as prescribed in the operat ing in-
st r uct ions in t he u ser’s an d serv ice m anuals.
No other part y is aut horised t o m ake any warrant y t o assum e liabilit y for Lifelines product s. Life-
lines w ill not recognise any ot her war rant y, eit her im plied or in w rit ing. I n addit ion, ser vices per -
form ed by som eone ot her than Lifelines or it s authorised agents or any t echnical m odificat ion or
changes of product s without Lifelines prior, writ t en consent may be cause for voiding t his warranty.
Defective product s or part s m ust be ret urned t o Lifelines or it s aut horised agent s, along wit h an
explanat ion of t he failure. Shipping cost s m ust be pr epaid.
Lifelines Ltd. m anufact ures hardware and soft ware t o be used on or wit h st andard PC-com pat ible
com put ers and operating soft ware. Lifelines, however, assum es no responsibility for t he use or reli-
abilit y of it s soft ware or hardware wit h equipm ent t hat is not furnished by third-par t y m anu fact ur -
ers accepted by Lifelines at the dat e of purchase.
All warranties for t hird-p art y product s used wit hin the Trackit t4A system are t he responsibilit y of
t he r elev ant m anu facturer. Please refer t o t he relevant docum ent ation on each product for furt her
det ails.
This docum ent cont ains propriet ary infor m at ion t hat is prot ected by copy right . All right s are re-
served. No part of this docum ent m ay be photocopied, reproduced in any other form or translat ed
into anot her language without the prior writt en consent of Lifelines.
Trademarks
Microsoft , Windows and Windows NT are regist ered tradem arks of t he Microsoft Corporat ion. All
ot her tradem arks and product nam es are t he property of t heir relevant owners.
Responsibility of manufacturer
The m anufact urer and distribut or consider t hem selves responsible for the equipm ent ’s safety, relia-
bilit y and perform ance only if:
any peripher al equipm ent to be used w it h t he Trackit t4A sy st em is supplied by t hird-par t y pr o-
viders recom m ended by t he m anufact urer ;
assem bly operations, ext ensions, readj ust m ents, m odificat ions, or repairs are carried out by
per sons aut hor ised by t he m anufact u rer ;
the elect rical inst allation of t he relevant room com plies wit h t he appropriate requirem ent s;
t he equipm ent is used by a healt h-care professional and in accordance wit h the instructions for
use.
N ot e : t he m anufact urer has a policy of cont inual pr oduct im provem ent ; hence t he equipm ent
specificat ions are subj ect t o change wit hout not ice.
Check wit h Lifelines or your distribut or if a soft ware updat e is available.
N ot e : Medical elect rical equipm ent needs special precautions 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 t he Appendix.

Tr ackit t 4A EEG Am plifier User Manual
5
Software and Virus Protection
Lifelines t akes all reasonable st eps t o ensure t hat its soft ware is virus-free. I n line wit h m odern
com p ut ing pr act ice, it is advisable that continual protect ion against viruses, troj ans, m alw are, ad-
ware et c. is provided on t he PC used for installat ion and the sur rou nding syst em s. Please not e t he
following recom m endat ions w hich should be suppor ted by y our int er nal I T/ Com put ing depart m ent
procedur es and pract ices:
1. Virus protect ion soft ware should be installed on every com put er 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 tim e when
t he system is not being used.
3. All program s offering aut o-updat e feat ures, including Windows, should be set t o m anual or
aut om at ic if desired but at a t im e when the syst em is not being used.
4. Adopt form al depart m ent al or organisat ional procedures to ensure t he int egrit y and safe
operat ion of t he m edical equipm ent and support ing syst em s.

Tr ackit t 4A EEG Am plifier User Manual
6
Contents
Version Hist ory 2
Disclaim er s & War ran t ies 4
Tradem arks 4
Responsibilit y of m anufact urer 4
Soft ware and Virus Prot ection 5
1Overview and Technical Descript ion 9
1.1 General descript ion 9
1.2 Caut ions and War nin gs 9
1.3 Explanat ion of sym bols 11
1.4 The Am plifier and it s p ar t s 12
1.5 Specificat ions and safet y 12
1.6 Descript ion of t he com ponent s 13
1.7 Replaceable part s 14
2I nst allat ion and Maint enance 14
2.1 Checks for com pleteness and int egrit y 14
2.2 Environm ent al param et er s for operat ion 15
2.3 Power supply connect ions 15
2.4 Bat t ery Operat ion 15
2.5 Use in t he hom e environm ent 16
2.6 Use wit h ot her equipm ent 16
2.7 I nt erfer ence 16
2.8 Maint enance and cleaning 17
2.9 Disposal of equipm ent 17
3Connect ions and usage 18
3.1 Overview 18
3.2 Lapt op inst allat ion and operation 19
3.3 Fit t ing t he bat t ery packs 19
3.4 Connect in g t he Tr ackit t4A Am plifier 20
3.5 Swit ching t he Am plifier on and off 22
3.6 SD Card 24
3.7 The t 4A Bag 25
3.8 Rem ot e Patient Ev ent Thum b Swit ch ( opt ional) 26
3.9 Bat t er y Pack Char ging 27
4The set up and recording software 27
4.1 Overview 27
4.2 Trackit Cont rol Panel 29
4.3 Defining I nput signals 31
4.4 Set t ing up t he I nput s and Recor ding channels 32
4.5 St art ing a Recording 34
4.6 Recording Cont rol Panel 36
4.7 View Ongoing Traces 38
4.8 Calibration Check 39
4.9 I m pedance Check 39
4.10 Event s 40
4.11 Mont age Editor 41
4.12 Reading an EEG recording 42
4.13 Advanced Sett ings 43
5The am bulat ory recording 47
5.1 Preparing t he Am bulat ory Recording 47
5.2 Pat ient I nst ruct ion Sheet 47
5.3 Event m arking 47
5.4 Ending a recor ding 47
5.5 I dent ifying a r ecording 47

Tr ackit t 4A EEG Am plifier User Manual
7
Appendix 1: Trackit t4A Am plifier Specificat ions 48
Appendix 2: Addit ional Event s I nform at ion 51
Appendix 3: PC Set up 54
Appendix 4: Bluet oot h 57
I nt roduct ion 57
Sy st em ov erv iew 57
Connect ion and use 57
Appendix 5: SD Car d I nfor m at ion 60
Appendix 6: Default Set up on Am plifier 62
Appendix 7: Troubleshoot ing Guide 63
COM port problem s wit h Bluet ooth com m unication to Trackit t 4A 63
Problem s start ing t he recor ding 63
Appendix 8: Manu fact ur er’s Declar at ion 64
EMC Com pat ibilit y 64

Tr ackit t 4A EEG Am plifier User Manual
8
Illustrations
Figur e 1: Connect ing t he Trackit t4A Am plifier – Clinical Use 18
Figur e 2: Connect ing t he Trackit t4A Am plifier - Hom e Use 19
Figure 3 : Bat t er y r eplacem ent 20
Fig ur e 4 : Bat t ery capacity display 20
Figure 5: Connect ing the Trackit t 4A Am plifier (front face) 21
Figur e 6: Connect ions and indicat ors on t he Trackit t4A Am plifier, connect or end21
Figure 7: Releasing t he data cable 22
Fig ur e 8 . Tr ack it t 4A display 23
Figure 9: SD Card locat ion 24
Figure 10 Patient Event Thum b Swit ch 27
Figure 11: Trackit Soft ware ‘File’ Toolbar 28
Figur e 12: Trackit Soft ware ‘Hom e’ Toolbar 28
Figure 13: Trackit Software "Sett ings Toolbar 29
Figure 14: Trackit Soft ware 'Help' Toolbar 29
Figure 15: Trackit Cont rol Panel 29
Fig ur e 1 6: Tr ack it t 4A " St at us B" 31
Figure 17: Signal List 31
Figure 18: Signal Edit ing Tool 32
Figure 19 EEG setup 32
Figure 20: Set up Recording dialog 33
Figure 21: Channel set up 34
Figure 22: Recording Channel editing 34
Figure 23: New Patient dialog 35
Fig ur e 2 4: New Pat ient dat abase 35
Figure 25 Recording Cont rol panel 37
Figure 26 Ongoing trace display 38
Figur e 27 : Adj ust display par am et er s 39
Figure 28 I m pedance check 40
Figure 29 : Cont inuous I m p edance Check 40
Figure 30 Online Event Viewer 41
Figure 31 Mont age Editor 42
Figure 32 T4 Default s Tab 1 44
Figure 33 T4 Default s | Tab 2 45
Figure 34 User Event s 52
Figure 35 Event s Tem plat e set up 52
Figure 36 Free-t ext Event 52
Figure 37 Event List 53
Figure 38 Opt ions Tab 1 54
Figure 39 Opt ions Tab 2 54
Figure 40 Opt ions Tab 3 56

Tr ackit t 4A EEG Am plifier User Manual
9
1Overview and Technical Description
1. 1 General description
I nd ica t ion s for u se
The Trackit t4A EEG Am plifier is intended t o be used as a front -end am plifier t o acquir e, st or e and
t ransm it electrophysiological signals ( wireless or cabled).
CAUTI ON: Feder al ( USA) law r est r ict s t his dev ice t o sale b y or on t he or der of a phy sician .
Gene r a l de scr ipt ion
The Trackit t4A EEG am plifier is a 32-channel elect roencephalograph recorder and is int ended for
use in am bulatory EEG and lab m onitoring app licat ions. The Trackit t4A Am plifier is int ended to be
used in a Professional healt hcare Environm ent and a Hom e ( healt hcare) envir onm ent .
The Trackit t4A am plifier is power ed by one or tw o lithium -polym er bat t ery packs and is fit ted wit h
an int ernal lit hium -ion backup bat t er y. The am plifier feat ur es a local event pushbut t on and has
connect ion for an opt ional rem ot e ( cabled) event push but t on. The in put chan nels of t he t4A
am plifier have built -in calibrat ion and elect rode im pedance m easurem ent . Com m unication t o a PC
is t hr ough a wir eless ( Bluet oot h) int er face and a cabled ( USB) int er face. Recor ded dat a is stored on
a rem ovable SD m em ory car d. A pouch is prov ided t o carry and pr ot ect t he am plifier in am bulat ory
use.
The Trackit t4A am plifier is int ended to be configured and set up by a t rained clinician. I n an
am bulatory sit uation, t he EEG elect rodes are fitt ed to t he pat ient by the clinician prior t o t he
pat ient being sent hom e. The patient is int ended t o have m inim al int eract ion wit h t h e Trackit t4A
am plifier, wit h t he only int eracting being pressing the event pushbut t on(s) .
Upon com plet ion of t he recor ding, the dat a, which is st ored on the SD card, is reviewed by a
clin ician using r ev iew and analy sis soft w are on a PC.
The am plifier is int ended t o be bat ter y powered in am bulat ory applicat ions and com m unicat es
wirelessly wit h a host com put er t hr ough Bluet oot h. Alt ernatively it can be connect ed t o a USB port
on a PC which is powered fr om a m edically approved power supply.
Two fully charged bat t ery packs provide sufficient power t o power t he Am plifier for a minim um of
72 hours. The bat t ery packs are int ended t o be replaced when the am plifier is not recording and
not fit ted t o t he pat ient . The t4A am plifier does not recharge the bat t ery packs. The bat t er y packs
m ust be rem oved from t he am plifier and recharged using a deskt op charger.
This equipm ent is int ended only as an adj unct device in pat ient assessm ent ; it m ust be used in
conj unction wit h other m et hods of pat ient diagnosis. The equipm ent does not sustain or support
life.
I nt e n de d U se r
The int ended user of t he equipm ent is a healt hcare professional w ho has t he t r aining and
knowledge t o undert ake EEG exam 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 defibrillat ion.
W ARN I N G: This equipm ent is intended t o be used by a healt hcare professional and in accordance
wit h these inst ructions for use which m ust be read in their entirety before t he device is used.
W ARN I N G: This equipm ent in int en ded only as an adj unct device in pat ient assessm ent ; it m ust
be used in conj unct ion wit h ot her m et hods of pat ient diagnosis. This equipm ent is not be used for
t he det erm inat ion of br ain deat h.
W ARN I N G: Only use t he PC and t he m edical-grade power supply as supplied or aut horised by
Lifelines.
W ARN I N G: To avoid the risk of electric shock, this equipm ent must only be connect ed t o a supply
m ains wit h pr otect ive earth.

Tr ackit t 4A EEG Am plifier User Manual
10
W ARN I N G: Lifelines does not supply EEG elect rodes. The unit accept s standar d 1.5 m m
touchproof elect rodes using DI N 42802-style connectors. To ensure pat ient safet y, the elect rodes
used m ust be approved to t he Medical Device Directive 93/ 42/ EEC in Europe or FDA cleared for use
in USA.
CAUTI ON : The conductive part of electrodes and their connectors, including t he Neut ral elect rode,
should not cont act ot her conduct ive part s including eart h.
W ARN I N G: Do not plug t he USB connect or 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 t he PC.
CAUTI ON : Do not t ouch sim ult aneously any accessible USB or ot her cont act s on t he PC and t he
pat ient .
W ARN I N G: St rangulat ion hazard due to long cables. As wit h all m edical equipm ent , carefully
rout e patient cabling to reduce t he possibility of pat ient ent anglem ent or st rangulation.
CAUTI ON : Ensure that carrying bag and st raps are worn over clot hing to prevent any possibility of
skin irrit ation.
CAUTI ON : When in close proxim it y t o t he Am plifier, do not use m obile phones, transm it t ers,
power t ransform ers, m ot ors, or ot her equipm ent that generat es m agnet ic fields. Refer t o the
Appendix for m or e inform at ion. Medical elect rical equipm ent needs special precaut ions regarding
EMC and needs t o be inst alled and put int o service according t o the EMC inform ation provided in
t he Appendix.
W ARN I N G: The function or safet y of the equipm ent could be im paired if it has been subj ected to
unfavourable condit ions in storage or in transit . I f at any t im e funct ion or safet y is thought to be
im paired, t he instrum ent should be t aken out of operat ion and secured against unint ended use.
W ARN I N G: Do not open or m odify the equipm ent wit hout t he authorizat ion of t he m anufact urer.
W ARN I N G: Replace the Lithium polym er bat tery packs with Lifelines supplied bat t ery packs only.
Use of anot her bat t ery m ay present a risk of fire or explosion.
W ARN I N G. I f t he Trackit t 4A am plifier is not to be used for som e tim e, the bat t ery packs should
be r em oved.
CAUTI ON : Do not t ouch t he batt ery board or bat t ery cont act s ( in t he Trackit t4A batt ery housing)
and t he pat ient sim ult aneously.
CAUTI ON : The lit hium -polym er bat tery packs used in t his device m ay present a fire or chem ical
burn hazard if m ist reated. Do not disassem ble, heat above 100° C ( 212° F) or incinerate.
CAUTI ON : Federal ( USA) law rest rict s this device t o sale by or on t he order of a physician.
CON TRAI N D I CATI ON S: There are no known cont raindicat ions to t he use of t his equipm ent.

Tr ackit t 4A EEG Am plifier User Manual
11
1. 3 Explanation of symbols
Type BF applied part Follow operating instructions
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 m ust be disposed of in an environm entally-
fr iendly way. Wast e elect rical and electronic equipm ent ( WEEE) requires special
procedures for recycling or disposal. This includes bat t eries, print ed circuit boards,
elect ronic com ponent s, wiring and ot her elem ent s of elect ronic devices. Follow all
of your respective local laws and regulat ions for the proper disposal of such
equipm ent . Cont act y our local dist ribut or for inform at ion concerning t his.
Consult warnings in User Manual Bluet ooth
Rem ot e event pushbut t on Mem or y car d r ead / w rit e
Manu fact u rer On/ Off and patient event swit ch
I nt er nal bat t er y hazar d Bat t er y door access
- refer t o sect ion 1. 7 - refer to section 3.3
Bat t er y pack ident ifier
Storage and transport symbols
Tem perat ur e lim it s Fragile Keep dry
Relat ive hum idit y lim it s At m ospher ic pr essure lim it s
I nt ernat ional pr otect ion code
Prot ect ed against ingress of solid obj ect 12.5 m m diam et er.
Pr ot ect ed against access t o hazar dous part s wit h fin ger .
Prot ect ed against ingress of wat er dripping (15° tilt ed) .
-25
+70
°C
0
93
%RH
500
1060
hPa
I P2 2

Tr ackit t 4A EEG Am plifier User Manual
12
1. 4 The Amplifier and its parts
The Trackit t4A EEG Am plifier is a 32-channel electroencephalograph recorder intended t o acquire
EEG signals in an am bulat ory environm ent . I t is powered by eit her one or t wo lit hium -polym er bat -
tery packs and is fit t ed with an int ernal, non-replaceable, lit hium -ion backup bat tery. The am plifier
feat ures a local event pushbut t on and has connect ion for an opt ional r em ot e ( cabled) ev ent
pushbut t on.
In am bulat ory applicat ions t he am plifier com m unicates wit h a host com put er, wirelessly, t hr ough
Bluet oot h. Alt er nat ively it can be connect ed t o a USB por t on a PC which is power ed from a m edi-
cally approved power supply. Refer t o sect ion 3.1 for det ails.
Ca ut i on :
Only use t he PC supplied or aut horised by Lifelines
Only use t he m ed ical-grade m ains power supply with it as supplied or authorised by Lifelines
The Trackit t4A EEG Am plifier com prises t he following com ponent s:
Trackit t4A Am plifier par t num ber : 1600
Tr ackit t 4A Am plifier USB cable par t num ber : 1601
Trackit t4A bag and st raps par t num ber : 1602
Tr ackit t 4A Lit hium -polym er bat ter y pack ( x2) par t num ber : 1603
Single bay bat t ery charger wit h power supply part num ber: 1604
Tr ackit soft w are CD, st an dar d par t num ber : 1009
Trackit T4A User Manual ( t his docu m ent ) par t num ber : 1606
Trackit T4A Quick St art Guide par t num ber : 1607
Trackit T4A Pat ient I nst ru ct ion Sheet par t num ber : 1608
The t 4A EEG Am plifier can be used wit h t he following accessories:
Pat ient event swit ch par t num ber : 1353
Lenov o ThinkPad lapt op com put er par t num ber : 1389
Medical grade power supply par t num ber : 1390
Mains cable, UK par t num ber : 1066
Part num bers m ay be preceded 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 cert ified and com plies with t he following st andards:
I EC 60601-1 and
I EC 60601- 2- 26
St andard for m edical elect rical equipm ent , general requir em ent s
and par t icular r equir em ent s for EEG sy st em s.
I EC 60601- 1 - 11 Collateral standard for m edical electrical equipm ent used in t he
hom e healt hcare envir onm ent .
I EC 60601- 1- 6
Collateral standard for usabilit y.
ANSI / AAMI ES 60601- 1
AAMI Dev iat ions from I EC 6 0601-1 ( USA) .
CAN/ CSA 22.2 No 601.1 M90 Canadian st andar d for m edical elect r ical equipm ent , general re-
quirem ent s.
I EC 60601-1-2 St and ar d for m ed ical elect r ical equipm ent , EMC r equir em ent s,
calling:
*
CI SPR11
Conduct ed Em issions, Group 1, Class B
CI SPR11
Radiat ed Em issions, Group 1, Class B
I EC61000- 4- 2
Elect rostat ic Discharges
I EC61000- 4- 3
I m m unit y - Radiat ed RF Field
*
I EC61000- 4- 4
I m m unit y - Tr ansient s Bur st s
*
I EC61000- 4- 5
I m m unit y – Surges
I EC61000- 4- 6
I m m unit y – Cond uct ed
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
*
I EC61000- 3- 2
Harm onic Em issions
*
I EC61000- 3- 3
Volt age Fluctuations/ flicker

Tr ackit t 4A EEG Am plifier User Manual
13
*
Not e: Com pliance is provided by t he PC.
Classification of syst e m
Cla ssificat ion Clinical use H om e u se
Degree of protect ion against
elect rical shock
I nt ernally pow er ed; or it can
be connect ed t o a PC which is
powered by a m edical grade
Class I power supply.
Type BF applied part s.
Tr ackit t 4A Am plifier:
I nt ernally pow er ed.
Type BF applied part s.
I f a PC is supplied, t he PC has no
elect rical connect ion t o t he
Am plifier & has no applied part s.
Degree of protect ion against
har m ful ingr ess of w at er
Ordinary ( no prot ect ion) or
I P22 ( Am plifier in bag)
I P22 ( Am plifier in bag)
Mode of operation Cont inuous operat ion Cont in uous operat ion
Suit ability for use in an
oxygen rich environm ent
Not suit able Not suitable
1. 6 Description of the components
The Trackit t4A Amplifier
The Trackit t4A am plifier provides 32 channels ( 28 referent ial, 4 bipolar) wit h built-in calibration
and electrode im pedance m easurem ent . The am plifier has built in t ype-BF pat ient isolat ion and has
a USB int erface t o t he PC. Bluet oot h wir eless com m unication is included for am bulat ory applica-
tions. EEG dat a is recorded t o a rem ovable SD car d. The am plifier has a built -in accelerom et er and
light sensor.
Ap pli ed p a rt s, t y pe BF
EEG Ele ct r od e s
The am plifier connect s to st andard 1.5m m t ouchproof EEG recording electrodes arranged in a
st an dar d 10 -20 patt ern, at tached to t he pat ient ’s head.
W ARN I N G: Lifelines does not supply EEG elect rodes. The Am plifier accept s st andar d 1. 5 m m
t ouchpr oof elect rodes using DI N 4 2802-st yle connect ors. To ensure pat ient safet y, t he elec-
trodes 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 andards out side Europe.
CAUTI ON : The conduct ive part of electrodes and t heir connectors, including the Neut ral elec-
trode, should not cont act ot her conduct ive parts including eart h.
Pa t ie n t Ev en t pu shb ut t o n
The Pat ient Event Pushbut ton is used by the pat ient t o m ark t he instance of a significant event .
Lit h iu m Poly m e r Ba t t e r y Pa ck s
The Trackit t4A am plifier has prov ision t o fit t wo Lit h iu m -Polym er bat t ery packs, w hich provide t he
m ain power sour ce for the am plifier. The bat t ery packs are housed in t he bat t ery com part m ent of
t he Trackit t4A am plifier and connected in parallel, so t he Trackit t4A can operate wit h only one
bat t ery pack fit t ed. The Tr ackit t4A does not have t he capabilit y t o recharge t he bat t ery packs and
the bat t ery packs must be rem oved from t he Trackit t4A t o be recharged in a desktop charger. De-
tails for char ging t he batt eries are provided in Sect ion 3.9.
SD M e m or y Ca r d
The SD card is used t o store the EEG data recorded by Trackit t 4A. St or age cards of var yin g capac-
it y are available in t he SD form at . The Trackit t 4A suppor t s SD car ds wit h a capacit y up t o 64GB.
Bags a n d st r a ps f or a m bu la t or y a pp lica t ion s
The t4A bag houses t h e Am plifier when used in am bulat ory applicat ion. The bag prot ect s t he am pli-
fier from wat er and dust ( I P22 pr otect ion) .
USB Ca ble for con ne ct io n t o PC
For non-am bulat ory applicat ions t he Am plifier can be plugged direct ly int o a USB por t on t he PC.

Tr ackit t 4A EEG Am plifier User Manual
14
W ARN I N G: The Am plifier m ust only be used wit h t he USB cable provided wit h the unit .
Me dica l gr ade AC/ D C m a ins pow er supply m odule for La pt op PC
Where EEG studies are conducted wit hin t he pat ient environm ent t he leakage current m ust be con-
trolled. The laptop PC m ains power supply m ust be a special m edical-grade t ype wit h appropriat e
safet y standards, supplied or aut horised by Lifelines.
W ARN I N G: Th e la pt op m u st on ly be con ne ct e d t o t h e m e d ica l-g ra d e la p t op pow er supply
supplie d or aut hor ise d by Lif e line s. Do not use a st a n da r d la pt op pow er supply.
Only use t he la pt op supplie d or aut h or ise d by Life lines.
The Se t u p a n d Re cordin g Soft w a re
The Tr ackit set up soft w ar e runs under Micr osoft Windows XP, Wind ows Vist a, Windows 7, 8 or 10
on t he host PC and is used to set up and review t he t4A Am plifier and t o r ecord on t o t he PC.
The Tr ack it t 4A am plifier is connect ed t o t he PC via t he USB cable or wirelessly with Bluet oot h. The
recording set up is downloaded to t he device and checks can be m ade to verify t hat all t he elec-
trodes have been at t ached correct ly. The Am plifier is then disconnect ed from t he PC and the re-
cor din g is st ar t ed.
Funct ions of t he sof t ware:
Download t he recor ding t em plat e. This includes w hich elect rodes ar e used and the recording
m ont age. See sect ion 4.11.
Perform a calibrat ion check of t he Am plifier . See sect ion 4.8.
Per form 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 Ltd. will m ake available on request circuit diagram s, com ponent part list s, descriptions,
calibr at ion inst ruct ions, or ot her inform at ion t hat will assist service personnel t o r epair t hose p ar t s
that are designat ed by Lifelines Lt d. as repairable by service personnel.
I nt e r n al b at t e r y r e pla ce m e nt – se rv ice pe rson n el only
The Trackit t4A am plifier cont ains a lit hium ion r echar geable coin cell, t ype 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 with the correct t ype. Refer to t he Trackit t4A Serv ice I n-
st ruct ions.
2Installation and Maintenance
W ARN I N G: The following sect ion m ust be read and understood before the equipm ent is swit ched ON.
N ot e : Medical elect rical equipm ent needs special precautions 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 t he Appendix.
The function or safet y of t he equipm ent could be im paired if it has been subj ected to unfavourable
condit ions in storage or in t ransit. I f at any t im e function or safet y is t hought 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 acted ( details on page 3) for assistance, if needed, in set t ing up,
using or m aint aining t he equipm ent ; or t o report unexpected operation or events.
The assem bly of t he syst em and any m odificat ions during it s service life require evaluat ion t o t he
requir em ent s of I EC 60601 -1.
2. 1 Checks for complet eness and integrity
1 Rem ove t he equipm ent from t he packaging case( s) .
2 Use t he part s list to check t hat all ordered item s have been received.
3 Check for sig ns of dam age t hat m ay hav e occur red dur ing t r ansit or st or age. I f any dam age is
found, do not use the instrum ent ; cont act your distribut or.

Tr ackit t 4A EEG Am plifier User Manual
15
2. 2 Environmental parameters for operation
The oper at ional and st or age/ t ransp ort ation environm ent al condit ions are as follows:
Operational:
Tem per at ur e + 5° C t o + 40° C
Relat ive hum idit y 15% to 93% non-condensing
At m ospher ic pr essur e 700 hPa t o 1060 hPa
Storage and transport :
Tem per at ur e -25° C t o + 70° C
Relat ive hum idit y Up to 93% non-condensing at + 70° C
At m ospher ic pr essur e 500 hPa t o 1060 hPa
2. 3 Power supply connections
Power requirements
3.7V Lit hium -Polym er bat tery pack or St andard USB port ( 5V)
Power consumption
Maxim um power from USB port : 2.5W.
Medical grade AC mains power supply module for Laptop PC
Where EEG studies are conducted wit hin t he pat ient environm 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 with appropriat e safet y
st an dar ds, as supplied or aut horised by Lifelines.
Mains pow er inpu t : 100–240 Vac, 47–63 Hz, 1.4 A @ 115 Vac, 0.7 A @ 230 Vac.
Output : 20 Vdc, 5.25 A.
W ARN I N G: Th e la pt op m ust on ly be con n e ct e d t o t h e m e dica l-g ra d e la p t op po w e r su pp ly
supplie d or aut hor ise d by Lif e line s. Do not use a st a n da r d la pt op pow e r supply.
Only use t h e la pt op su p plie d or a ut h or ise d by Lif e lin e s.
W ARN I N G: To avoid t h e r isk of ele ct r ic shock, this e qu ipm e nt m ust on ly be conne ct e d t o
a sup ply m a in s w it h pr ot e ct iv e e a r t h.
W ARN I N G: The Am plif ie r m ust on ly be use d w it h th e USB ca ble pr ov ide d w it h t he unit .
2. 4 Battery Operation
Li-Polymer battery pack
The Tr ack it t 4A am plifier is power ed from one or t w o bat t er y packs. When fully char ged, t wo bat -
t er y packs will typically power t he unit for 72 hours depending on t he num ber of channels, sam ple
rat e and wireless usage ( 36 hours if only one batt ery pack is used) .
The t ypical service life of t he bat t er y pack s is 500 charge-discharge cycles.
A deskt op charger is required to recharge t he batt ery packs. The Trackit t4A am plifier does not re-
char ge t h e bat t er y packs.
The clinician is int ended t o r eplace b at t er y pack( s) . This should be done before a recording is
st ar t ed. The pat ient should not replace t he bat t ery packs.
Li-Polymer batt ery pack Instructions for Use
•The bat t ery packs are charged using the specified deskt op charger. Refer to t he inst ruc-
tions supplied wit h the charger.
•Operat ing tim e will be short er t han usual at low tem perat ures. The bat t ery can be used be-
tween 0 C and 45 C, but will give best perform ance between 10 C and 30 C.
•I f t he bat t ery pack start to give less operat ing t im es t han usual, they have reached the end
of t heir life and m ust be replaced. Dispose of used bat t ery packs prom ptly and keep away
from children.
•Since the bat tery packs will nat urally discharge it self over a period of t im e, it is best t o
charge t he batt ery packs a day or t wo before planning to use it.

Tr ackit t 4A EEG Am plifier User Manual
16
Internal Li-Ion backup battery
The int ernal backup bat t ery will enable t he unit to cont inue operat ing for a short period of t im e ( 30
m ins appr ox.) to allow t he m ain bat t ery pack t o be replaced. I t is recharged aut om at ically, while
the am plifier is switched on and either connect ed over USB or fit t ed wit h a bat t er y p ack. The st at e
of char ge is displayed, as described in section 3.5, whenever t he unit is powered from t he backup
bat t ery.
The t ypical service life is 500 charge-discharge cycles.
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 operat ed in it s bag
where it is prot ect ed against ingress of solid obj ect s and wat er t o a degree of I P22.
The laptop 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 t he t4A Am plifier unit , as all com m unicat ion is accom -
plished wirelessly.
Keep t he equipm ent away from sources of heat .
Do not use m obile phones.
Do not allow pets or children t o int erfere wit h the equipm ent or sensor cables.
When t he equipm ent is operat ed wit h or wit hout it s Bluet oot h connect ed, ot her devices in the vi-
cinit y should be m oved away or t urned off t o reduce t he likelihood of int erference t o t he equipm ent
or by t he equipm ent .
The Trackit t4A has an int ernal Bluet oot h radio fit t ed. This is an approved industry-st andard type
which present m inim al risk of reciprocal int erference wit h ot her equipm ent .
2. 6 Use with other equipment
Defibrillators and HF surgical equipment
The equipm ent is not defibrillator proof and should not be used in sit uations where a defibrillator is
likely to be used.
The equipm ent should not be used with, or in t he presence of, 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 ex am ple a cardiac pace-
m aker or other electrical stim ulator, it is unlikely that a safet y hazard will arise. However always
consult the docum ent at ion supplied wit h the ot her patient -connect ed equipm ent t o ensur e t hat all
hazar ds, war nin gs and cau t ions are considered before t he equipm ent is used toget her.
Leakage current
This syst em is designed t o com ply wit h I EC 60601-1, t he int ernat ional st andard for m edical elec-
t ronic equipm ent , w hich specifies t he per m issible lev els of leakage current . A pot ent ial hazard ex-
ist s in t he sum m at ion of leakage curr ent s caused by connecting several pieces of equipm ent t o-
get her. Because t his syst em can be used in conj unct ion wit h st andard elect ronic devices, t he tot al
leakage current should be t ested whenever t he syst em is m odified.
There should be no elect rical connect ions bet ween t he syst em equipm ent , which is powered via a
m edical grade power supply, and any ot her equipm ent powered from anot her m ains supply.
2. 7 Interference
The Trackit t4A will cont inue to operate in the presence of radio frequency m agnetic fields (RF) and
the effects of electrost at ic discharges ( ESD) and ot her int erference, in accordance wit h t he require-
m ent s of EN60601- 1- 2. However, t he Trackit t4A am plifier r ecor ds signals of ver y low am plit ude,
and t hese signals them selves are not im m une t o the effect s of RF, ESD and low-frequency m ag-
net ic field interference. Su ch int er fer ence m ay cause signal ar t efact s.
The Trackit t4A has an internal Bluet oot h radio fitt ed. This is an approved industry-standard t ype
which present m inim al risk of reciprocal int erference wit h ot her equipm ent .
However , w hen t he equipm ent is oper at ed wit h or wit hout Bluetoot h conn ect ed, ot her devices in
the vicinit y should be m oved away or t urned off t o reduce t he likelihood of int erference t o t he
equipm ent or by t he equipm ent

Tr ackit t 4A EEG Am plifier User Manual
17
Ca ut i on : When in close proxim it y to t he am plifier, do not use m obile phones, transm it t ers, power
transform ers, m otors, or ot her equipm ent t hat generat es m agnetic fields. Refer t o t he Appendix for
m ore infor m at ion.
N ot e : Medical elect rical equipm ent needs special precautions 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 t he Appendix.
2. 8 Maintenance and cleaning
The t4A Am plifier and it s accessor ies require no routine t esting, calibration or m aint enance proce-
dures apart from occasional cleaning and checking for wear and dam age to all part s including t he
accessories.
No servicing or m aint enance of t he equipm ent should take place while in use wit h a pat ient.
Cle a ning a n d d isin fe ct io n
Prior t o each re-use of t he syst em , all the outer surfaces of t he t4A Am plifier and it s bag m ay be
cleaned, as required, wit h a clot h m oist ened wit h a m ild det ergent solut ion.
Disinfection of the equipm ent can be carried out by t he use of QAC-based d isinfect ant s. Wipes ar e
recom m ended in order t o prevent the ingress of any liquid into t he equipm ent . Suit able products
include Mikrozid Sensitive Wipes ( Schülk e & May r Gm bH) , Micr obac for t e ( Paul Har t m ann AG) , Dis-
tel Wipes (Trist el Ltd.) .
For cleaning inst ructions for the lapt op refer t o the m anufact urer’s docum ent at ion.
Ca ut i on : Do not allow any liquid t o ent er the case of t h e instrum ent or connect or. Do not use ace-
t one on any of t he inst rum ent s.
2. 9 Disposal of equipment
The expect ed service life of t he equipm ent , par t s and accessor ies is t hree years. When t he device
and it s par t s and accessor ies has reached t he end of its operating life, it should be disposed of in
accordance wit h local waste regulat ion aut horit y t hat is typically within the local governm ent office.
Dispose of used bat t ery packs prom pt ly and keep away from children.
Ca ut i on : Do not dispose of batt ery packs into fire or by incineration.

Tr ackit t 4A EEG Am plifier User Manual
18
3Connections and usage
3. 1 Overview
Figu r e 1 : Con ne ct in g t h e Tr a ckit t4A Am plifier – Clinical Use
Clinical Use
During Clinical use, t he Trackit t4A Am plifier can be connect ed t o a PC eit her using t he USB cable
or t hrough a wireless Bluet ooth connect ion (See Figure 1) . Housing t he am plifier in t he t 4A bag is
optional and m ay be used t o prot ect and secure the am plifier.
Not e: I n t ranspor table, i.e. body-worn sit uations wit hin the clinic, t he Am plifier m ust be housed in-
side it s bag aft er being disconnected from t he PC, for prot ect ion against spillage of liquids.
Where t he ent ire Trackit t4A syst em including the PC is used wit hin the patient environm ent , t he
m ains leakage current s and safet y and regulat ory requirem ent s are m et by t he use of t he special
m edical-grade lapt op power supply.
Hom e Use
Dur ing hom e use, t h e Trackit t4A Am plifier is bat t er y power ed and is housed inside it s bag where it
is prot ect ed against ingress of solid objects and wat er t o a degree of IP22. The laptop PC is op-
tional and m ay be used for video recordings. There is no cable connection bet ween t he PC and t he
t4A Am plifier, as all com m unicat ion is accom plished w irelessly ( See Figure 2) .
Note t hat for Hom e Use applicat ions, t he pat ient should be given a Patient Inst ruct ion Sheet, which
det ails essent ial usage an d safet y inst r uct ions concerning t he equipm ent . Refer t o t he Pat ient I n-
st ruct ion Sheet for details.

Tr ackit t 4A EEG Am plifier User Manual
19
Figu r e 2 : Con ne ct in g t h e Tr ack it t 4A Am plifie r - Hom e Use
3. 2 Laptop installation and operation
W ARN I N G: Th e la p t op m u st on ly b e con n ect e d t o t h e m e dica l-gr a de la p t op po w e r sup ply
supplie d or aut hor ise d by Lif e line s. Do not use a st a n da r d la pt op pow e r supply.
Only use t he la pt op supplie d or aut h orise d by Life lines.
1. Connect t he power cord to t he m edical-grade power supply.
2. Connect the power supply output to the power input connect or on t he laptop.
3. Connect the power cord to m ains power out let .
4. Note t hat t he m ains power cord serves as a power disconnect device. I t should be inst alled
near t he equipm ent and be easily accessible.
5. For lapt op inst allat ion and operat ion r efer t o t he m anufact urer’s inst ruct ions supplied wit h it .
3. 3 Fitting the battery packs
W ARN I N G: Only fit batt ery packs supplied or aut horised by Lifelines, wit h the correct part num ber
( PN 1603). Use of ot her bat t ery packs m ay present a risk of fire or explosion.
W ARN I N G. I f t he Trackit t 4A am plifier is n ot t o be use d fo r som e t im e , t he ba t t e r y pa ck s
should be rem ov e d.
For am bulat ory, body-worn applicat ions t he Trackit t 4A is powered from the bat t er y pack( s) . The
fully charged bat t ery pack( s) should be fit t ed into the t4A Am plifier before sett ing up an am bula-
t ory recording. I f t he am plifier is t o be used in a Clinical environm ent wit h t he USB cable, t he use
of t he bat t er y packs is opt ional as t he am plifier will be powered from t he USB port .
1. Open the bat t ery door by pressing t he door-release but t on wit h a pointed obj ect
(for exam ple, a pen). The bat t ery door will spring open. See Figure 3.
2. I f there are batt eries in t he unit , rem ove t hese first .
3. I nser t t he bat t er y pack ( s) ( bat t er y cont act s facing down) in t o t h e am plifier . I f only fit t ing one
bat t ery pack, fit t he batt ery in bat tery location 1.
4. Gent ly push the batt ery door closed. The door will click shut and lock aut om at ically.

Tr ackit t 4A EEG Am plifier User Manual
20
CAUTI ON : Do not touch t he bat t ery board or bat t ery cont act s (in t he Trackit t4A batt ery com par t-
m en t ) and t he pat ient sim ult aneously.
Figu r e 3: Ba tt ery r e placem e nt
While t he bat t ery door is open, and t he am plifier is powered on, t he display will show t he rem ain-
ing capacity of the fit ted bat tery packs. I f a bat t er y pack is not fitt ed, t he display will show t w o
dashes, as shown below. This view will be cleared when the bat t ery door is closed or t he user
presses t he event but t on.
Figu r e 4: Ba t t er y ca pa cit y d isp la y
3. 4 Connecting the Trackit t4A Amplifier
The t op face of t he Trackit t4A houses t he display , t he pat ient event pushb ut t on and t he am -
bient light sensor. For display det ails refer to sect ion 3.5 below. Pressing t he pushbut ton records a
pat ient event and illum inat es t he back-light of the display.
Adj acent t he pu shbut t on is a cir cular aper t ur e w hich h ouses a sensor t o m easure t he am bient light
level.
BATTERY 1: 100%
BATTERY 2: --