Lifelines Trackit t4A User Manual
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Lifelines Trackit t4A User Manual

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t
4
A EEG Am plifie r
Use r M a n u a l
Doc No: 51305- 006
Creat ed
Digitally signed by Geoff
Salter
Date: 2019.08.01
09:34:20 +01'00'
Check ed
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
email=david.hulin@llines.com, c=GB
Date: 2019.08.01 10:01:47 +01'00'
Part no. 1606
Approved
Digitally signed by Geoff
Salter
Date: 2019.08.01 10:08:39
+01'00'
I ssue 1.3

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Summary of Contents for Lifelines Trackit t4A

  • Page 1 Doc No: 51305- 006 Creat ed Check ed Approved Digitally signed by Geoff Digitally signed by Geoff Digitally signed by David Hulin Salter DN: cn=David Hulin, o=Lifelines Ltd, Salter ou=Development, Date: 2019.08.01 Date: 2019.08.01 10:08:39 email=david.hulin@llines.com, c=GB Date: 2019.08.01 10:01:47 +01'00' 09:34:20 +01'00'...

  • Page 2: Version Hist Ory

    Trackit t 4A EEG Am plifier User Manual Version History V 1.0 ( 2 May 2018) • First release V 1.1 ( 31 May 2018) • Added pow er requirem ent s for bat t ery charger • Added warning relat ing t o t he bat t ery charger m ains isolat ion •...
  • Page 3 Trackit t 4A EEG Am plifier User Manual Lifelines Lt d, 7 Clarendon Court , Over Wallop, near St ockbridge, Ham pshire SO20 8HU, UK Telephone + 44 ( 0) 1264 782226 www.LLines.com sales@LLines.com 0 0 8 6...

  • Page 4: Disclaimers & Warranties

    The inform at ion in t his sect ion is subj ect t o change wit hout not ice. Except as st at ed below, Lifelines Lt d m akes no warrant y of any kind wit h regard t o t his m at erial, including, but not lim it ed t o, t he im plied warrant ies of m erchant abilit y and fit ness for a part icular purpose.

  • Page 5: Software And Virus Protection

    Software and Virus Protection Lifelines t akes all reasonable st eps t o ensure t hat it s soft ware is virus- free. I n line wit h m odern com put ing pract ice, it is advisable t hat cont inual prot ect ion against viruses, t roj ans, m alware, ad- ware et c.

  • Page 6: Table Of Contents

    Trackit t 4A EEG Am plifier User Manual Contents Version Hist ory Disclaim ers & Warrant ies Tradem arks Responsibilit y of m anufact urer Soft ware and Virus Prot ect ion Overview and Technical Descript ion General descript ion Caut ions and Warnings Explanat ion of sym bols The Am plifier and it s part s...
  • Page 7 Trackit t 4A EEG Am plifier User Manual I dent ifying a recording Appendix 1: Trackit t 4A Am plifier Specificat ions Appendix 2: Addit ional Event s I nform at ion Appendix 3: PC Set up Appendix 4: Addit ional Bluet oot h I nform at ion Syst em overview Appendix 5: SD Card I nform at ion Appendix 6: Default Set up on Am plifier...
  • Page 8 Trackit t 4A EEG Am plifier User Manual Illustrations Figure 1: Connect ing t he Trackit t 4A Am plifier – Clinical Use Figure 2: Connect ing t he Trackit t 4A Am plifier - Hom e Use Figure 3: Bat t ery replacem ent Figure 4: Bat t ery capacit y display Figure 5: Connect ing t he Trackit t 4A Am plifier ( PCU/ front face) Figure 7: Releasing t he dat a cable...

  • Page 9: Overview And Technical Description

    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 t he risk of elect ric shock, t his equipm ent m ust only be connect ed t o a supply...
  • Page 10 W ARN I N G: Do not open or m odify t he equipm ent wit hout t he aut horizat ion of t he m anufact urer. W ARN I N G: Replace t he Lit hium polym er bat t ery packs wit h Lifelines supplied bat t ery pack s only.

  • Page 11: Explanation Of Symbols

    Trackit t 4A EEG Am plifier User Manual 1. 3 Explanation of symbols Type BF applied part Follow operat ing inst ruct 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 t he end of it s useful life, it m ust be disposed of in an environm ent ally- friendly way.

  • Page 12: The Amplifier And Its Parts

    Only use t he PC supplied or aut horised 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 t 4A EEG Am plifier com prises t he following com ponent s:...

  • Page 13: Description Of The Components

    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 elect rodes. The Am plifier accept s st andard 1.5 m m t ouchproof elect rodes using DI N 42802- st yle connect ors.

  • Page 14: Replaceable Parts

    1. 7 Replaceable parts Lifelines Lt d. will m ake available on request circuit diagram s, com ponent par t list s, descript ions, calibrat ion inst ruct ions, or ot her inform at ion t hat will assist service personnel t o repair t hose part s t hat are designat ed by Lifelines Lt d.

  • Page 15: Environmental Parameters For Operation

    The m ains power supply m ust be a special m edical- grade t ype wit h appropriat e 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.

  • Page 16: Battery Operation

    Trackit t 4A EEG Am plifier User Manual 2. 4 Battery Operation Li-Polymer battery pack The Trackit t 4A am plifier is powered fr om one or t wo bat t ery packs. When fully charged, t wo bat - t ery packs will t ypically 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 bat t ery pack is used) .

  • Page 17: Interference

    30 cm ( 12 inches) t o any part of t he Trackit t 4A, including cables specified by Lifelines Lt d. Ot herwise, degradat ion of t he perform ance of t his equipm ent could result .

  • Page 18: Disposal Of Equipment

    Trackit t 4A EEG Am plifier User Manual 2. 9 Disposal of equipment When t he device and it s part s and accessories has reached t he end of it s operat ing life, it should be disposed of in accordance wit h local wast e regulat ion aut horit y t hat is t ypically wit hin t he local gov- ernm ent office.

  • Page 19: Laptop Installation And Operation

    3. 3 Fitting the battery packs W ARN I N G: Only fit bat t ery packs supplied or aut horised by Lifelines, wit h t he correct par t num ber ( PN 1603) . Use of ot her bat t ery packs m ay present a risk of fire or explosion.

  • Page 20: Connecting The Trackit T4A Amplifier

    Figu r e 4 : Ba t t e r y ca pa cit y displa y 3. 4 Connecting the Trackit t4A Amplifier The t op face of t he Trackit t 4A houses t he display, t he pat ient event pushbut t on and t he am - bient light sensor.
  • Page 21 Trackit t 4A EEG Am plifier User Manual EEG Electrode Connection The Pat ient Connect ion Unit ( PCU) of t he am plifier is laid out in a st andard 10- 20 configurat ion, as shown in Figure 5. I t accom m odat es st andard t ouch- proof elect rode leads fit t ed wit h DI N 42802 connect ors.

  • Page 22: Switching The Amplifier On And Off

    Pat ient Event rem ot e swit ch: t his 3.5m m j ack connect or allows for t he connect ion of an op- t ional Pat ient Event Thum b Swit ch. CAUTI ON : Only t he Pat ient Event Thum b Swit ch provided by Lifelines should be plugged int o t his connect or.
  • Page 23 Trackit t 4A EEG Am plifier User Manual Switching off The am plifier will aut om at ically swit ch off ( aft er a period of inact ivit y) when not recording and dis- connect ed fr om t he PC. The inact ivit y t im eout is configurable in soft ware. Indicators Display The t 4A am plifier’s St at us screen is shown below:...

  • Page 24: Bluetooth

    Trackit t 4A EEG Am plifier User Manual Displayed when recording and t he rem aining SD card space is low ( < 8 m inut es) . ( accom panied by audit ory beep every 30 seconds) Display Backlight The display feat ures a whit e LED backlight .

  • Page 25: Sd Card

    • Form at t ed t o FAT32 ( Lifelines recom m ends t hat t he SD card is form at t ed using t he SD For- m at t ing soft ware supplied on t he Lifelines CD) .

  • Page 26: The T4A Bag

    Trackit t 4A EEG Am plifier User Manual I f t hese requirem ent s are not m et , t he t 4A Am plifier m ay not be able t o read t he card and will not be able t o st art t he recor ding.
  • Page 27 Trackit t 4A EEG Am plifier User Manual Close t he zips around t he elect rode cables Fold t he hood over t he EEG leads and zips. The hood provides addit ional wat er ingress prot ect ion. To prevent t he EEG leads from pulling up t he flap, t he EEG leads should be st rapped / t apped t o t he shoulder st rap buckle t o prevent t he leads from pulling.

  • Page 28: Remote Patient Event Thumb Switch (Optional)

    Trackit t 4A EEG Am plifier User Manual 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 t o reduce t he possibilit y of pat ient ent anglem ent or st rangulat ion. Removing the amplifier from the bag To rem ove t he am plifier from t he bag: 1.
  • Page 29 The 4- bay bat t ery charger is capable of charging up t o four bat t ery packs sim ult aneously. The bat - t ery packs are charged independent ly of each ot her. Refer t o t he inst ruct ion sheet included wit h t he charger ( which can be found on t he Lifelines CD) . •...

  • Page 30: Trackit Software - Setup And Recording Software

    4. 1 Overview The Trackit soft ware is available on t he included CD/ USB disk or on t he Lifelines FTP sit e. A readm e file describes inst allat ion. The Trackit Soft ware version 2.8.1.7 ( or lat er) support s t he Trackit t 4A.
  • Page 31 1: Wizard On/ Off. The wizard guides t he user t hrough t he recording set up when st art ing t he Trackit soft ware. 2: Soft ware regist rat ion. 3: Trackit Soft ware Version inform at ion 4: User m anuals for various Trackit and Lifelines product s.

  • Page 32: Trackit Control Panel

    Trackit t 4A EEG Am plifier User Manual 4. 2 Trackit Control Panel The Trackit Cont rol Panel shows t he st at us of t he connect ed Tr ackit am plifier and provides quick access t o t he com m on funct ions ( “ Connect ” , “ Disconnect ” , “ Send Set up” and “ Set up Recording” ) . The Trackit Cont rol Panel can be accessed by clicking on t he “...
  • Page 33 Trackit t 4A EEG Am plifier User Manual Select t he “ USB” checkbox. The nam e and serial num ber of t he t 4A will appear in t he drop- down list . I f m ult iple Trackit am plifiers are connect ed t o t he com put er, t his drop- down will list all t he connect ed am plifier.

  • Page 34: Defining Input Signals

    Trackit t 4A EEG Am plifier User Manual Menu Options The Trackit Cont rol panel has t wo m enu opt ions: “ Ot her Com m ands” and “ Advanced Oper at ions” . Refer t o Sect ion 4.13 Advanced Set t ings for m ore det ails on t hese opt ions. Figu r e 1 8 : Tr a ck it t A "...
  • Page 35 Trackit t 4A EEG Am plifier User Manual Figu r e 1 9 : Sign a l List 3 Double click on t he signal you want t o edit . This brings up t he Signal edit or t ab, allowing you t o creat e a relevant signal or label t o be ent ered int o t he signal list .

  • Page 36: Setting Up The Inputs And Recording Channels

    Trackit t 4A EEG Am plifier User Manual 4. 4 Setting up the Inputs and Recording channels Defining input s, recording channels and m ont age is usually only done once per set up t ype. This en- t ire set up can t hen be saved and recalled for fut ure use. To open a saved set up or t o creat e a new set up, proceed as follows: 1 Select t he “...
  • Page 37 Trackit t 4A EEG Am plifier User Manual • Poly Channels: Poly 1 – Poly 4 ( channels 29+ / - t o 32 + / - ) • Aux Channels: Event – Rem ot e pat ient event t hum b swit ch Trip I / P –...

  • Page 38: Starting A Recording

    Trackit t 4A EEG Am plifier User Manual When t he Am plifier input s and recording configurat ion have been com plet ed, t he set up can be saved ( in a * .t su file) . I f t he t 4A is connect ed and online, t he new set up can be sent t o t he am pli- fier by select ing t he “...
  • Page 39 Trackit t 4A EEG Am plifier User Manual 3. Once t he pat ient det ails have been ent ered, click “ OK” . 4. Select eit her t he “ Am b Rec” , “ PC Rec” or “ Dual Rec” but t on from t he Hom e t oolbar. N ot e : I f t he pat ient det ails have not been ent ered beforehand, t he Pat ient Det ails window ( Fig- ure 26 or Figure 27) will appear first .

  • Page 40: Recording Control Panel

    Trackit t 4A EEG Am plifier User Manual 4. 6 Recording Control Panel Click on t he ‘Set up Recording’ but t on in t he Trackit Cont rol Panel t o open t he Recording Cont rol di- alog box ( Figure 27) . The Recording Cont rol panel is also displayed by pressing t he “ Am b Rec” or “...

  • Page 41: View Eeg Signal Traces

    Trackit t 4A EEG Am plifier User Manual Tim e d: Trackit t 4A records for a specified period of t im e. 1 Under Recor d Mode, choose Tim ed. 2 I n t he Recor ding Cont rol dialog box, set a st art t im e t o st art t he recording, using t he St art slider.

  • Page 42: Calibration Check

    Trackit t 4A EEG Am plifier User Manual N ot ch filt e r : t o set a not ch filt er, open t he Trackit ‘Opt ions’ window from t he Set t ings t oolbar. Not ch filt ers are eit her 50Hz or 60Hz depending on where t he syst em is t o be used ( USA 60Hz;...

  • Page 43: Events

    Trackit t 4A EEG Am plifier User Manual The “ View signals” opt ion will st art t he ongoing t races display. Clicking on ‘Exit ’ will st op t he I m pedance check on t he am plifier. Clicking on “...

  • Page 44: Montage Editor

    Trackit t 4A EEG Am plifier User Manual 1 2 3 3 4 5 Key: 1 Opens t he list of event t ypes I cons 2- 6 are not used. Figu r e 3 2 : Eve n t Vie w e r The event list allows t he user not only t o see when event s t ook place, but t o also view t he dat a be- hind t hose event s.

  • Page 45: Reading An Eeg Recording

    BDF form at , readable in all BDF- com pat ible EEG browsers. I n a BDF- com pat ible browser, t he pat ient ’s nam e and recording I D are displayed in t he t est pr opert ies. Lifelines current ly recom m ends: ...

  • Page 46: Advanced Settings

    Trackit t 4A EEG Am plifier User Manual 4. 13 Advanced Settings There are t w o m enus under t he Trackit Cont rol Panel: Ot her Com m ands   Advanced Operat ions Other Commands By default , t hese opt ions are greyed out as t hey are not available t o t he t ypical user. Ot her Com m ands duplicat es som e of t he cont rols on t he hom e t oolbar and recording cont rol.
  • Page 47 Trackit t 4A EEG Am plifier User Manual Figu r e 3 4 : T4 D e fa u lt s Ta b 1 To save new default s t o Trackit t 4A, press ‘Send t hese values t o Trackit ’, followed by ‘Save current values’.
  • Page 48 Trackit t 4A EEG Am plifier User Manual T4 A D e fa u lt s Ta b 2 Addit ional set up param et ers are accessed via t ab 2 of T4 Default s panel, as shown in Figure 35 below.
  • Page 49 Configurat ion gives access t o t he Trackit ’s fact ory configurat ion. The code displayed can be copied and em ailed t o Lifelines for an act ivat ion code t o be sent back. Backup battery charge ON / OFF [ >...

  • Page 50: The Ambulatory Recording

    Trackit t 4A EEG Am plifier User Manual 5 The ambulatory recording 5. 1 Preparing the Ambulatory Recording The procedur e t o set up an am bulat ory recording is as follows: 1. Fit one or t wo fu lly ch a r ge d bat t ery packs int o t he t 4A am plifier ( see Sect ion 3.3) . One bat t ery packs will record for approxim at ely 37 hours @ 250sps Two bat t ery packs will record for approxim at ely 74 hours @ 250sps 2.

  • Page 51: Appendix 1: Trackit T4A Amplifier Specifications

    Appendix 1: Trackit t4A Amplifier Specifications N ot e : Lifelines reserves t he right t o change product specificat ions at any t im e wit hout not ice. This is in- line wit h t he com pany’s policy of cont inual product developm ent .
  • Page 52 Trackit t 4A EEG Am plifier User Manual Out put frequency 2.402 - 2.480 GHz, I SM band Dat a rat e 1.0 Mbps m ax. Prot ocols St andard Bluet oot h - SPP, GATT, PAN Modulat ion GFSK, DQPSK. Frequency Hopping Spread- Spect rum ( FHSS) Error correct ion Forward Error Correct ion ( FEC) , Aut om at ic repeat request ( ARQ) .
  • Page 53 Trackit t 4A EEG Am plifier User Manual Cla ssifica t ion of syst e m Cla ssifica t ion Clin ica l u se H om e u se Degree of pr ot ect ion against I nt ernally powered; or it can Trackit t 4A Am plifier: elect rical shock be connect ed t o a PC which is...

  • Page 54: Appendix 2: Additional Events Information

    Trackit t 4A EEG Am plifier User Manual Appendix 2: Additional Events Information For t he t 4A EEG Am plifier, event s t ypes are as shown below. • 56 Aut om at ic event s ( hardware event s, phot ic st art / st op, video st art / st op et c.) •...
  • Page 55 Trackit t 4A EEG Am plifier User Manual Clicking on t he Event s icon on t he m ain program window allows t hese configurable event s t o be edit ed as shown below. I f t he syst em is recording, select ing an event m arks it in t he recording. I f not recording, select ing an event allows it t o be edit ed.
  • Page 56 Trackit t 4A EEG Am plifier User Manual During playback, all t he event s are displayed for t he file by clicking on t he Event s icon. Double- clicking on an event in t he list j um ps t o t hat point in t he recording. All t he event s are also dis- played in t heir correct posit ion in relat ion t o t he EEG along t he bot t om of t he m ain window.

  • Page 57: Appendix 3: Pc Setup

    Trackit t 4A EEG Am plifier User Manual Appendix 3: PC Setup The Opt ions panel is accessed by pr essing t he “ Opt ions” icon on t he Set t ings t oolbar. Options | Tab 1 The Opt ions panel Tab 1 cont ains general set t ings which are self- explanat ory as shown below. Figu r e 4 0 : Opt ion s Ta b 1 Options | Tab 2 The second t ab in Opt ions is shown below.
  • Page 58 Trackit t 4A EEG Am plifier User Manual The following opt ions are applicable t o t he t 4A: Networking and PC recording Options • Au t o T4 con n e ct . I f t icked t his will cause t he applicat ion t o at t em pt t o reconnect t o t he desig- nat ed t 4A aft er a disconnect .
  • Page 59 Trackit t 4A EEG Am plifier User Manual Options | Tab 3 Figu r e 4 2 : Opt ion s Ta b 3 The following opt ions are applicable t o t he t 4A: • St a r t u p w it h W iz a r d. I f checked, t he Trackit program will next st art wit h t he Wizard. •...

  • Page 60: Appendix 4: Additional Bluetooth Information

    Trackit t 4A EEG Am plifier User Manual Appendix 4: Additional Bluetooth Information System overview The Bluet oot h m odule is Bluet oot h Qualified v4.2. For full specificat ions, refer below. Bluet oot h is a device- t o- com put er wireless connect ion and will connect t o any suit ably cert ified Bluet oot h host , like a PC or lapt op.

  • Page 61: Appendix 5: Sd Card Information

    Trackit t 4A EEG Am plifier User Manual Appendix 5: SD Card Information BDF File Format The Trackit t 4A Am plifier records EEG dat a t o t he SD card in BDF form at , which is t he 24- bit varia- t ion of t he nat ive EDF ( European Dat a Form at ) .
  • Page 62 Trackit t 4A EEG Am plifier User Manual SD Card Capacity Calculation To det erm ine t he required SD card capacit y, use t he following t able and calculat ion. The t able below shows t he am ount of dat a t hat will be st ored t o t he card in a 2 4 h ou r r e cor din g. The num ber in bracket s is t he m inim um card size t hat should be used for t he select ed configura- t ion.

  • Page 63: Appendix 6: Default Setup On Amplifier

    Trackit t 4A EEG Am plifier User Manual Appendix 6: Default Setup on Amplifier Ch a n n e l Sign a l Type Ch a n n e l Ph ysica l Sign a l Ra n ge La be l M in M a x Un it s...

  • Page 64: Appendix 7: Troubleshooting Guide

    Trackit t 4A EEG Am plifier User Manual Appendix 7: Troubleshooting Guide COM port problems with Bluetooth communication to Trackit t4A The COM port is available but is being used by another application. This could well be t he case if an applicat ion such Microsoft Act ive Synch is inst alled and polling t he COM port for a Windows CE device.

  • Page 65: Appendix 8: Manufacturer' S Declaration

    30 cm ( 12 inches) t o any part of t he Trackit t 4A, including cables specified by Lifelines Lt d. Ot herwise, degradat ion of t he perform ance of t his equipm ent could result .
  • Page 66 Trackit t 4A EEG Am plifier User Manual Guidance and Manufacturer’ s Declaration Electromagnetic Emissions IEC 60601-1-2 / EN 60601-1-2 The Trackit t 4A is int ended for use in t he elect rom agnet ic environm ent specified below. The cus- t om er or user of t he t 4A should assure t hat it is used in such an environm ent .
  • Page 67 Trackit t 4A EEG Am plifier User Manual I m m unit y Te st I EC 6 0 6 0 1 Te st Le ve l Com plia nce Le ve l Ele ct r om a gne t ic Envir onm e nt Guida nce Power frequency 3 A/ m , 30A/ m 3 A/ m...
  • Page 68 Risk Managem ent file Recommended separation distance between portable and mobile RF communications equipment and the Trackit t4A EEG System IEC 60601-1-2 / EN 60601-1-2 The t 4A is int ended for use in t he elect rom agnet ic environm ent in which radiat ed RF dist ur bances are cont rolled.
  • Page 69 Trackit t 4A EEG Am plifier User Manual...

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