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 nua l
Doc No: 51305- 006
Digitally signed by
Creat ed
Geoff Salter
Date: 2018.05.02
12:03:18 +01'00'
Checked
Digitally signed by Michael Hulin
Date: 2018.05.02 12:44:29 +01'00'
Part no. 1606
Approved
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development, email=david.hulin@llines.com,
c=GB
Date: 2018.05.02 12:53:08 +01'00'
I ssue 1.0

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  • Page 1 Part no. 1606 Digitally signed by Creat ed Checked Approved Geoff Salter Digitally signed by David Hulin DN: cn=David Hulin, o=Lifelines Ltd, Digitally signed by Michael Hulin Date: 2018.05.02 ou=Development, email=david.hulin@llines.com, Date: 2018.05.02 12:44:29 +01'00' c=GB 12:03:18 +01'00' Date: 2018.05.02 12:53:08 +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...
  • 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 w it hout not ice. Except as st at ed below, Lifelines Lt d m akes no warrant y of any kind wit h regar d 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 War nings Explanat ion of sym bols The Am plifier and it s part s...
  • Page 7 Trackit t 4A EEG Am plifier User Manual 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: Bluet oot h I nt roduct ion Syst em overview Connect ion and use Appendix 5: SD Card I nfor m at ion...
  • 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 ( front face) Figure 6: Connect ions and indicat ors on t he Trackit t 4A Am plifier, connect or end21...

  • 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 packs 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 part 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: Use In The Home Environment

    Trackit t 4A EEG Am plifier User Manual Internal Li-Ion backup bat tery The int ernal backup bat t ery will enable t he unit t o cont inue operat ing for a short period of t im e ( 30 m ins approx.) t o allow t he m ain bat t ery pack t o be replaced.

  • Page 17: Maintenance And Cleaning

    Trackit t 4A EEG Am plifier User Manual Ca ut ion: When in close proxim it y t o t he am plifier, do not use m obile phones, t ransm it t ers, power t ransform ers, m ot ors, or ot her equipm ent t hat generat es m agnet ic fields. Refer t o t he Appendix for m ore inform at ion.

  • Page 18: Connections And Usage

    Trackit t 4A EEG Am plifier User Manual 3 Connections and usage 3. 1 Overview Figur e 1 : Con ne ct ing t h e Tr a ck it t A Am plifie r – Clinica l Use Clinica l Use During Clinical use, t he Tr ackit t 4A Am plifier can be connect ed t o a PC eit her using t he USB cable or t hrough a wireless Bluet oot h connect ion ( See Figure 1) .

  • 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 part 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

    Figur 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 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 pr ovided by Lifelines should be plugged int o t his connect or.

  • Page 22: Switching The Amplifier On And Off

    Trackit t 4A EEG Am plifier User Manual SD Card act ivit y indicat or. USB Ca ble Con ne ct ion I f t he am plifier is t o be connect ed using a cable, t he supplied USB cable ( PN 1602) is plugged int o t he dat a socket ( it em 3, Figure 6) on t he connect or end of t he t 4A Am plifier and int o any USB port on t he lapt op PC.
  • Page 23 Trackit t 4A EEG Am plifier User Manual Indicators Display The t 4A am plifier’s St at us screen is shown below: Figur e 8 . Tr a ck it t A displa y The following indicat ors are shown on t he display of t he t 4A: Sym bol D e scr ipt ion Clock:...

  • Page 24: 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 25: The T4A Bag

    Trackit t 4A EEG Am plifier User Manual The SD card can be insert ed and rem oved while t he t 4A Am plifier is swit ched on. When t he SD card is insert ed ( and successfully read) or rem oved, an audible beep will sound. Upon card insert ion, t he t 4A will read t he card and t he card capacit y will be indicat ed on t he display, ac- com panied by an audible beep.

  • Page 26: Remote Patient Event Thumb Switch (Optional)

    Trackit t 4A EEG Am plifier User Manual Close t he zip at t he base of t he bag ( connect or end) . Fitting the bag to t he patient The bag can be worn by pat ient over t he shoulder or on a belt . Not e: The bag should always be worn upright ( t he connect or end facing t he ground) .

  • Page 27: Battery Pack Charging

    The set up soft ware is available on CD. A readm e file describes inst allat ion. Check wit h your dist rib- ut or or Lifelines if a newer version of soft ware is available. The Trackit soft ware is designed t o work wit h bot h t he Trackit t 4A Am plifier and wit h t he opt ional Phot ic St im ulat or.
  • Page 28 Trackit t 4A EEG Am plifier User Manual  Define signal t ypes: creat e labels t o at t ach t o input s At t ach t he desired signal t ype ( label) t o t he recording input ...

  • Page 29: Trackit Control Panel

    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. 4. 2 Trackit Control Panel The Trackit Cont rol Panel shows t he st at us of t he connect ed Trackit am plifier and provides quick access t o t he com m on funct ions ( “...
  • Page 30 Trackit t 4A EEG Am plifier User Manual Connecting t he Trackit The Trackit applicat ion soft ware will norm ally connect aut om at ically t o t he t 4A Am plifier as soon as it is plugged in. To connect m anually: I f connect ing via USB, check t hat t he t 4A USB cable is connect ed properly.

  • Page 31: Defining Input Signals

    Trackit t 4A EEG Am plifier User Manual Figur e 1 6 : Tr a ck it t A " St a t us B" 4. 3 Defining Input signals Defining signals is usually done once only or very occasionally. The t 4A Am plifier arrives wit h a de- fault set of signals t hat should suffice for m ost applicat ions, hence it m ay only necessary t o add signal t ypes for polygraphic recordings ( airflow, respirat ion et c) .

  • Page 32: Setting Up The Inputs And Recording Channels

    Trackit t 4A EEG Am plifier User Manual 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 . Figur e 1 8 : Signa l Edit in g Tool 4 Type in t he Signal nam e ( e.g.
  • Page 33 Trackit t 4A EEG Am plifier User Manual 4 Under t he Am plifier Channels t ab select t he signals ( labels) t o be at t ached t o t he physical in- put s. For exam ple, EEG input 1 m ay require t he label Fp1 and so on according t o t he st andard 10/ 20 nom enclat ure.

  • Page 34: Starting A Recording

    Trackit t 4A EEG Am plifier User Manual Define the recording channels This st ep can usually be sk ipped, since t he Aut o Record Set up but t on will copy what t he defined I nput s from t he previous st ep int o t he list of recording channels.
  • Page 35 Trackit t 4A EEG Am plifier User Manual 2. Ent er t he pat ient nam e and Recording I D int o t he “ Pat ient De- t ails” dialog box. This inform at ion is saved wit h t he recording set up for download t o t he recorder in a fut ure recording.

  • Page 36: Recording Control Panel

    Trackit t 4A EEG Am plifier User Manual 6. The new set up will be sent t o t he t 4A ( if required) . A warning will appear if t his is not success- ful. 7. The next dialog box confirm s if video is t o be recorded? Select ‘Yes’ if doing a videom et ry re- cording.
  • Page 37 Trackit t 4A EEG Am plifier User Manual Figur e 2 5 Re cor din g Cont r ol pa ne l Default file names To m ake t he recording file nam e t he sam e as t he pat ient nam e: 1 Choose ‘Opt ions’...

  • Page 38: View Ongoing Traces

    Trackit t 4A EEG Am plifier User Manual Pe r iodic: Trackit t 4A records for specified periods of t im e at a defined int erval ( e.g. for periods of 30 m inut es, wit h a 45- m inut e int erval) : 1 Under Record Mode, choose Periodic.

  • Page 39: 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 40: Events

    Trackit t 4A EEG Am plifier User Manual a value will not be displayed for these channels. The threshold can be set to 2kΩ, 5kΩ, 10kΩ, 20kΩ or 50kΩ on the Impedance Check panel. The “ View signals” opt ion will st art t he ongoing t races display.

  • Page 41: Montage Editor

    Trackit t 4A EEG Am plifier User Manual Event s are displayed in t he online event viewer wit h a descript ion and t im e. Key: 1 Opens t he list of event t ypes Addit ional icons at Playback t im e: 2 Opens an event file for an older re- cording 3 Navigat e forwards or backwards...

  • Page 42: 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 propert ies. Lifelines current ly recom m ends: Lifelines iEEG ...

  • Page 43: Advanced Settings

    Trackit t 4A EEG Am plifier User Manual 4. 13 Advanced Settings There are t wo 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 44 Trackit t 4A EEG Am plifier User Manual Figur e 3 2 T4 D e fa ult 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 45 Trackit t 4A EEG Am plifier User Manual T4 A D e fa ult 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 33 below.
  • Page 46 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 47: The Ambulatory Recording

    Trackit t 4A EEG Am plifier User Manual 5 The ambulatory recording 5. 1 Preparing the Ambulatory Recording The procedure t o set up an am bulat ory recording is as follows: 1. Fit one or t wo fully cha 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 48: 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 49 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 50 Trackit t 4A EEG Am plifier User Manual Cla ssifica t ion of syst e m Cla ssifica t ion Clinica l use H om e use Degree of prot 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 51: Appendix 2: Addit Ional Event S I Nform At Ion

    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 show n 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 52 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 ark s it in t he recording. I f not recording, select ing an event allows it t o be edit ed.
  • Page 53 Trackit t 4A EEG Am plifier User Manual During playback, all t he ev ent 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 54: Appendix 3: Pc Setup

    Trackit t 4A EEG Am plifier User Manual Appendix 3: PC Setup The Opt ions panel is accessed by pressing 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. Figur e 3 8 Opt ions Ta b 1 Options | Tab 2 The second t ab in Opt ions is shown below.
  • Page 55 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 • Aut o T4 con ne 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 56 Trackit t 4A EEG Am plifier User Manual Figur e 4 0 Opt ions 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 iza r d. I f checked, t he Trackit program will next st art wit h t he Wizard. •...

  • Page 57: Appendix 4: Bluetooth

    A Am plifie r : 1: I n t he Windows Bluet oot h opt ions, search for new devices. The t 4A will be shown as Lifelines T4A – xx , w here xx is t he serial num ber.
  • Page 58 Trackit t 4A EEG Am plifier User Manual 5: I f t he pin codes m at ch, press t he Event but t on on t he t 4A am plifier and t he Connect but t on on t he PC.
  • Page 59 Trackit t 4A EEG Am plifier User Manual N ot e : 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 t he EMC inform at ion provided in t he Manufact urers Declarat ion in t he Appendix.

  • Page 60: 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 , w hich is t he 24- bit varia- t ion of t he nat ive EDF ( Eur opean Dat a Form at ) .
  • Page 61 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 hou r r e cor ding. 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 62: Appendix 6: Default Setup On Amplifier

    Trackit t 4A EEG Am plifier User Manual Appendix 6: Default Setup on Amplifier Cha n ne l Signa l Type Cha n ne l Physica l Signa l Ra nge La be l M in M a x Unit s AC Referent ial Fp1- Ref - 375,000...

  • Page 63: 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 anot her 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 64: Appendix 8: Manufacturer' S Declaration

    Trackit t 4A EEG Am plifier User Manual Appendix 8: Manufacturer’ s Declaration EMC Compatibility This sect ion cont ains specific inform at ion regarding t he device’s com pliance wit h EN 60601- 1- 2. 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 at ion provided here.
  • Page 65 Trackit t 4A EEG Am plifier User Manual Guidance and Manufacturer’ s Declaration Electromagnetic Emissions EN 60601-1-2 The t 4A is int ended for use in t he elect rom agnet ic environm ent specified below. The cust om er or user of t he t 4A should assure t hat it is used in such an environm ent .
  • Page 66 Trackit t 4A EEG Am plifier User Manual I m m unit y Te st EN 6 0 6 0 1 Te st Le ve l Com plia n ce Le ve l Ele ct r om a g ne t ic Envir on m e n t Guida nce Port able m obile com m unicat ions...
  • Page 67 Trackit t 4A EEG Am plifier User Manual Recommended separation distance between portable and mobile RF communications equipment and t he t4A EEG System 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 urbances are cont rolled.

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