Lifelines R40 User Manual
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Lifelines R40 User Manual

Eeg amplifier
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EEG Am plifie r
R
40
Use r M a n ua l
Creat ed
Digitally signed by Michael
Hulin
Date: 2018.03.02 10:24:42 Z
Checked
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
email=david.hulin@llines.com, c=GB
Date: 2018.03.02 11:00:57 Z
Part no. 51262- 006
I ssue 1.4
Approved
Digitally signed by Michael
Hulin
Date: 2018.03.02 11:54:15 Z

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Summary of Contents for Lifelines R40

  • Page 1 I ssue 1.4 Creat ed Checked Approved Digitally signed by David Hulin Digitally signed by Michael Digitally signed by Michael DN: cn=David Hulin, o=Lifelines Ltd, Hulin ou=Development, Hulin email=david.hulin@llines.com, c=GB Date: 2018.03.02 10:24:42 Z Date: 2018.03.02 11:54:15 Z Date: 2018.03.02 11:00:57 Z...

  • Page 2: Version Hist Ory

    R40 EEG Am plifier User Manual Version History V1.0 ( 4 March 2015) • I nit ial release V1.1 ( 16 April 2015) • Added “ CAUTI ON: Federal ( USA) law rest rict s t his device t o sale by or on t he order of a physician”...
  • Page 3 R40 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

    R40 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 Cont ent s I llust rat ions Overview and Technical Descript ion...

  • Page 7: Illustrations

    R40 EEG Am plifier User Manual Illustrations Figure 1 Connect ing t he R- 40 Am plifier Figure 2 Connect ing t he R- 40 Am plifier ( t op face) Figure 3 Connect ing t he R- 40 Am plifier ( front face)

  • Page 8: Overview And Technical Description

    W ARN I N G: Lifelines does not supply EEG elect rodes. The unit accept s st andard 1.5 m m t ouchproof elect rodes using DI N 42802- st yle connect ors. To ensure pat ient safet y, t he elect rodes used m ust be approved t o t he Medical Device Direct ive 93/ 42/ EEC in Europe or FDA cleared for use in USA.

  • Page 9: Explanation Of Symbols

    R40 EEG Am plifier User Manual 1. 3 Explanation of symbols Type BF equipm ent 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 10: The Amplifier And Its Parts

    1327 N ot e : The Oxim et er sensor is a consum able and is not supplied by Lifelines. Only use t he ‘Pure- Light ’ sensors specified by Nonin for use wit h t heir Oxim et ers.

  • Page 11: 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 12: 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 13: Power Supply Connections

    The m ains power supply m ust be a special m edical- grade t ype wit h appropriat e safet y st andards, supplied or aut horised by Lifelines. W ARN I N G: The la pt op m ust only be con ne ct e d t o t he m e dica l- gr a de la pt op pow e r su pply supplie d or a ut hor ise d by Lifeline s.

  • Page 14: Maintenance And Cleaning

    R40 EEG Am plifier User Manual 2. 6 Maintenance and cleaning The R- 40 Am plifier requires no rout ine t est ing, calibrat ion or m aint enance procedures apart from occasional cleaning and checking for wear and dam age t o all part s including t he accessories.

  • Page 15: Connecting The R-40 System

    R40 EEG Am plifier User Manual W ARN I N G: The la pt op m ust only be con ne ct e d t o t he m e dica l- gr a de la pt op pow e r su pply supplie d or a ut hor ise d by Lifeline s.

  • Page 16: Starting The System

    R40 EEG Am plifier User Manual Figur e 3 Con ne ct ing t he R- 4 0 Am plifie r ( fr ont fa ce ) Nonin Xpod: t he circular connect or allows for t he connect ion of a Nonin Xpod pulse oxim e- t er for m easuring SpO2.

  • Page 17: The Setup And Recording Soft Ware

    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 recorder and t he R- 40 Am plifier and wit h t he opt ional Phot ic St im ulat or.
  • Page 18 R40 EEG Am plifier User Manual Figur e 5 N e w Pa t ie nt da t a ba se The dat abase allows you t o ent er m ore ext ensive inform at ion about t he pat ient and recording, and save it for fut ure reference.
  • Page 19 R40 EEG Am plifier User Manual Figur e 7 Signa l Edit ing Tool 3 Type in t he Signal nam e ( e.g. Fp1) . Not e t hat for EEG signals t his m ust be case- sensit ive.
  • Page 20 R40 EEG Am plifier User Manual Figur e 9 Se t up Re cor din g dia log The order of t he signal labels in t he pull down list is t he sam e as t he order of t he signals in t he sig- nal list defined using t he signal- edit ing t ool.

  • Page 21: Configuring The Amplifier

    R40 EEG Am plifier User Manual Figur e 1 1 Re cor din g Ch a nne l e dit ing 4. 2 Configuring the amplifier When you have finished set t ing up t he recording prot ocol, connect t he R- 40 t o t he host com put er.
  • Page 22 R40 EEG Am plifier User Manual Step 6 Connect R-40 Check t hat t he R- 40 is connect ed properly. The soft w are will norm ally connect aut om at ically, how- ever t o do t his m anually, in t he Cont rol Panel select t he USB opt ion for t he R- 40 and click on Con- nect .
  • Page 23 R40 EEG Am plifier User Manual To perform a Calibrat ion check, click on t his icon: . The waveform s will show a square wave of am plit ude 8 m V pk- pk and frequency 1 Hz. Step 9 View t he ongoing EEG t races...
  • Page 24 R40 EEG Am plifier User Manual I m pe da nce che ck : t o car ry out an im pedance check , click on t he im pedance check icon on t he Trackit t oolbar. I f recording has st art ed , t he im pedance check is displayed on t he t race display wit h an im pedance check event .

  • Page 25: Montage Editor

    R40 EEG Am plifier User Manual 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. To display a page of EEG around an event of int erest , double click on t he event in t he list . To navi- gat e forwards or backwards, press t he forward or backward arrow but t ons.

  • Page 26: Reading An Eeg Recording

    R40 EEG Am plifier User Manual 4. 4 Reading an EEG recording Click t he ‘Open all playback files’ but t on on t he left hand side of t he Trackit soft ware t oolbar t o playback a recording and browse t o t he folder and file required. This will open t he EDF file and any associat ed files.

  • Page 27: Appendix 1: Specifications

    Appendix 1: 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 28 R40 EEG Am plifier User Manual Aux . high- le ve l D C I nput s Num ber of Aux channels 2 ( channels 39 and 40) ADC Resolut ion 24 bit s Sam pling 250 - 16000 Hz...
  • Page 29 R40 EEG Am plifier User Manual W ir e le ss LAN Type 2.4 GHz I EEE St d. 802.11 b/ g Wireless LAN Module Out put power 12dBm m ax. Out put frequency 2.412 t o 2.462 GHz, I SM band Dat a rat e 230kbps m ax.
  • Page 30 R40 EEG Am plifier User Manual Degree of prot ect ion against harm ful ingress Ordinary ( no prot ect ion) of wat er Mode of operat ion Cont inuous Degree of safet y of applicat ion in t he presence of a...

  • Page 31: Appendix 3: Additional Events Information

    R40 EEG Am plifier User Manual Appendix 3: Additional Events Information For t he R- 40 EEG syst em , 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 32 R40 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 33 R40 EEG Am plifier User Manual Figur e 2 1 Fr e e - t e x t Eve nt 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.

  • Page 34: Appendix 4: Pc Setup

    R40 EEG Am plifier User Manual Appendix 4: PC Setup 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 2 3 Opt ion s Ta b 1 Options | Tab 2 The second t ab in Opt ions is shown below.
  • Page 35 R40 EEG Am plifier User Manual Figur e 2 4 Opt ion s Ta b 2 Most of t hese opt ions are not applicable t o t he R- 40, except for: • Use File Le ngt h inst e a d of ED F Le ngt h. This a playback feat ure and if t icked, t he file lengt h is used inst ead of t he edf lengt h param et er em bedded in t he edf header.
  • Page 36 R40 EEG Am plifier User Manual Figur e 2 5 Opt ion s Ta b 3 Most of t hese opt ions are not applicable t o t he R- 40, except for: • XPOD cha nne l na m e SPO2 ( ot he r w ise SAO2 ) . This opt ion allows t he XPOD channel nam e t o be eit her SPO2 or SAO2.

  • Page 37: Appendix 5: Manufacturer's Declaration

    R40 EEG Am plifier User Manual Appendix 5: 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 38 R40 EEG Am plifier User Manual Guidance and Manufacturer’ s Declaration Electromagnetic Emissions EN 60601-1-2 The R- 40 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 R- 40 should assure t hat it is used in such an environm ent .
  • Page 39 R40 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...
  • Page 40 R40 EEG Am plifier User Manual Recommended separation distance between portable and mobile RF communications equipment and t he R-40 EEG System EN 60601-1-2 The R- 40 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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