Lifelines neuro R40 User manual

R40 EEG Am plifier
Use r M a nu a l
Part no. 51262-006
I ssue 1.4
Cr eat ed Checked Appr oved
Digitally signed by Michael
Hulin
Date: 2018.03.02 10:24:42 Z
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2018.03.02 11:00:57 Z
Digitally signed by Michael
Hulin
Date: 2018.03.02 11:54:15 Z

R40 EEG Am plifier User Manual
2
Version History
V1 .0 ( 4th March 2015)
•I nit ial release
V1 .1 ( 16t h April 2015)
•Added “ CAUTI ON: Feder al ( USA) law r est r ict s t his dev ice t o sale by or on t he order of a
physician” on page 8.
•Added “ FDA cleared for use in USA” t o EEG elect rode warning on page 8.
•Added “The Am plifier is int ended t o be connected to a PC which is powered from a m edically
approved power supply” on page 8.
•Am ended “ I ndicat ions for Use” st atem ent on page 8 and delet ed “ I nt ended Use” .
•Added “Com pliance is provided by the recom m ended PC equipm ent ” to Elect rom agnet ic I m -
m unit y tables in Appendix 5. Am ended Bluet oot h and WLAN specificat ions in Appendix 1.
V1.2 ( 20t h October 2015)
•Changed EN references t o I EC.
•Am ended sam pling rat e and bandwidt h specificat ions.
V1 .3 ( 26th October 2015)
•Elect rom agnet ic im m unit y com pliance level am ended on pages 39 & 40.
V1.4 ( 27 February 2018)
•Added disinfect ion inform at ion in sect ion 2.6.
•Added device lifetim e in sect ion 2.7.
•Change of N.B. t o 0086 ( BSI ) .

R40 EEG Am plifier User Manual
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Lifelines Ltd, 7 Clarendon Court ,
Over Wallop, near St ockbridge,
Ham pshire SO20 8HU, UK
Telephone + 44 ( 0) 1264 782226
www.LLines.com
[e-mail]
00 86

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Disclaimers & Warranties
The inform ation in t his section is subj ect to change wit hout not ice.
Except as st at ed below, Lifelines Ltd m akes no warrant y of any kind with regar d to t his m aterial,
including, but not lim ited t o, the im plied warrant ies of m erchantabilit y and fit ness for a particular
purpose. Lifelines shall not be liable for errors cont ained 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 it s products against all defect s in m aterial and workm anship for one year
from the dat e of delivery.
Misuse, accident , m odification, unsuitable physical or operating environm ent , im proper m ainte-
nance or dam age caused by a product for which Lifelines is not responsible will void t he warrant y.
Lifelines do not warrant unint errupt ed or error-free operation of it s product s.
Lifelines or its aut horised agent s will repair or replace any products t hat prove t o be defective dur-
ing the warrant y period, provided that t hese product s are used as prescribed in t he operating in-
st r uct ions in t he user ’s an d ser vice m anuals.
No ot her part y is aut horised t o m ake any warranty to assum e liability 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, serv ices per -
form ed by som eone ot her than Lifelines or it s aut horised agent s or any t echnical m odification or
changes of products without Lifelines prior, writ t en consent m ay be cause for voiding this warrant y.
Defective product s or parts m ust be ret urned t o Lifelines or it s authorised agents, along wit h an
explanat ion of t he failur e. Shipping cost s m ust be prepaid.
Lifelines Ltd. m anufactures hardware and soft ware t o be used on or with standard PC-com pat ible
com put ers and operating software. Lifelines, however, assum es no responsibilit y for t he use or reli-
abilit y of its soft ware or hardware wit h equipm ent t hat is not furnished by third-par t y m an ufact ur-
ers accept ed by Lifelines at t he dat e of purchase.
All warranties for third-part y product s used within t he R-40 syst em are t he responsibility of t he rel-
ev ant m anu fact ur er. Please refer to t he relevant docum entat ion on each product for further details.
This docum ent cont ains propriet ar y inform at ion t hat is prot ect ed by copyright . All right s are r e-
served. No part of t his docum ent m ay be phot ocopied, reproduced in any ot her form or translat ed
int o anot her language without t he prior writt en consent of Lifelines.
Trademarks
Microsoft , Windows and Windows NT are regist ered t radem arks of t he Microsoft Corporation. All
ot her tradem arks and product nam es are the property of t heir relevant owners.
Responsibility of manufacturer
The manufact urer and dist ribut or consider t hem selves responsible for t he equipm ent ’s safety, relia-
bilit y and perform ance only if:
any peripheral equipm ent to be used wit h t he R-40 system is supplied by third-part y providers
recom m ended by the m anufact ur er;
assem bly operat ions, ext ensions, readj ustm ent s, m odifications, or repairs are carried out by
person s aut hor ised by t he m anufact ur er ;
the electrical inst allation of t he relevant room com plies wit h t he appropriat e requirem ent s;
t he equipm ent is used by a healt h-care professional and in accordance wit h t he instruct ions for
use.
N ot e : t he m anu fact urer has a policy of cont inual product im pr ovem ent ; hence t he equipm ent
specificat ions are subj ect to change wit hout notice.
Check wit h Lifelines or your dist ributor if a soft ware updat e is available.

R40 EEG Am plifier User Manual
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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 the EMC inform at ion provided in t he Appendix.
Software and Virus Protection
Lifelines takes all reasonable st eps to ensure t hat it ’s soft ware is virus-free. I n line wit h m odern
com p ut ing p ract ice, it is advisable t hat continual protection against viruses, troj ans, m alwar e, ad-
ware et c. is provided on t he PC used for installation and t he sur rou nding sy st em s. Please note t he
following r ecom m endat ions which should be support ed by y our int ernal I T/ Com put ing depar t m ent
pr ocedur es and p ract ices:
1. Virus prot ect ion soft ware should be inst alled 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 t im e when t he
syst em 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 t he system is not being used.
4. Adopt form al depart m ent al or or ganisat ional procedures t o ensure t he int egr it y and safe op-
erat ion of t he m edical equipm ent and support ing syst em s.

R40 EEG Am plifier User Manual
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Contents
Version History 2
Disclaim er s & War rant ies 4
Tradem arks 4
Responsibilit y of m anufact urer 4
Soft ware and Virus Prot ection 5
Cont ent s 6
I llust rat ions 7
1Overview and Technical Description 8
1.1 General description 8
1.2 Caut ions and War ning s 8
1.3 Explanat ion of sym bols 9
1.4 The Am plifier an d it s par t s 10
1.5 Sp ecificat ions and safet y 10
1.6 Descr iption of t he com ponent s 11
1.7 Replaceable part s 12
2I nst allat ion and Maint enance 12
2.1 Checks for com plet eness and int egrit y 12
2.2 Environm ent al param et er s for operat ion 12
2.3 Power supply connect ions 13
2.4 Use wit h ot her equipm ent 13
2.5 I nt erference 13
2.6 Maint enance and cleanin g 14
2.7 Disposal of equipm ent 14
3Connect ions and usag e 14
3.1 Overview 14
3.2 Connect ing t he R-40 Syst em 15
3.3 St arting t he syst em 16
3.4 Shut d own of t he sy st em 16
4The setup and recording soft ware 17
4.1 Sett ing up a recording protocol 17
4.2 Configuring the am plifier 21
4.3 Montage Editor 25
4.4 Reading an EEG recording 26
Appendix 1: Specificat ions 27
R- 40 Am plifier Specificat ions 27
Appendix 3: Addit ional Event s I nform at ion 31
Appendix 4: PC Setup 34
Appendix 5: Manu fact u rer ’s Declarat ion 37
EMC Com pat ibilit y 37

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Illustrations
Figure 1 Connecting t he R-40 Am plifier 14
Figure 2 Connecting t he R-40 Am plifier ( top face) 15
Figure 3 Connecting t he R-40 Am plifier ( front face) 16
Figure 4 New Pat ient dialog 17
Figure 5 New Pat ient dat abase 18
Figure 6 Signal List 18
Figure 7 Signal Edit ing Tool 19
Figur e 8 EEG set up 19
Figure 9 Set up Recording dialog 20
Figure 10 Channel set up 20
Figure 11 Recording Channel edit ing 21
Figure 12 Trackit soft ware t oolbar 21
Figure 13 Trackit Control Panel 22
Figure 14 Ongoing t race display 23
Figur e 1 5 Adj ust display param et ers 23
Figur e 16 I m pedance check 24
Figure 17 Online Event Viewer 24
Figure 18 Mont age Edit or 25
Figure 19 User Event s 32
Figure 20 Event s Tem plat e set up 32
Figure 21 Free-t ext Event 33
Figure 22 Event List 33
Figure 23 Options Tab 1 34
Figure 24 Options Tab 2 35
Figure 25 Options Tab 3 36

R40 EEG Am plifier User Manual
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1Overview and Technical Description
1. 1 General description
I ndi ca t ion s f or u se
The R-40 EEG Am plifier is int ended t o be used as a fr ont -end am plifier to acquire, store and
t ransm it elect rophysiological signals ( wir eless or cabled) .
Ge n er a l d escr ip t ion
The R-40 EEG Am plifier is a m ult i-channel elect r oencephalograph designed for use in rout ine EEG
and lab m onit oring applicat ions.
I t is a com pact USB 40-channel am plifier which incor porat es 32 r eferent ial channels and 8 poly-
graphic channels wit h built -in calibr at ion and elect rode im pedance m easurem ent . A Nonin XPOD
int erface is provided, a Pat ient Event input , 2 Aux DC input s and an Elect rocap connect or. Opt ional
wireless com m unicat ion is available ( Bluet oot h and WLAN WiFi) .
The Am plifier is int ended t o be connect ed to a PC which is powered from a m edically approved
power supply.
This equipm ent is int ended only as an ad j un ct dev ice 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. The equipm ent does not sust ain or support
life.
I nt e nde d Use r
The int ended user of t he equipm ent is a healt hcare professional who has t he t raining and
knowledge to undert ake EEG exam inat ions and is fam iliar wit h EEG equipm ent and pr act ice.
1. 2 Cautions and Warnings
CON TRAI N D I CATI ON S: Do not use t he R- 40 EEG Am plifier in an MRI environm ent , in an
explosive at mosphere 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 t hese inst ruct ions for use which m ust be read in their ent irety before the device is used.
W ARN I N G: This equipm ent in int ended 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 er m inat ion of br ain deat h.
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-style connectors. To ensure pat ient safet y, the electrodes
used must be approved t o t he Medical Device Directive 93/ 42/ EEC in Europe or FDA cleared for use
in USA.
CAU TI ON : The conductive part of elect rodes and t heir connect ors, including the Neut ral elect rode,
should not cont act ot her conductive part s including eart h.
W ARN I N G: Lifelines does not supply the Nonin sensor. Only use t he ‘PureLight ’ sensors specified
by Nonin t o be used wit h their Oxim et ers.
CAU TI ON : When in close proxim it y t o t he Am plifier, do not use m obile phones, t ransm it ters,
power transform ers, m ot ors, or ot her equipm ent t hat gener at es m agnet ic fields. Refer t o t he
Appendix for m ore inform at ion. Medical elect rical equipm ent needs special precaut ions regarding
EMC and needs t o be inst alled and put int o service accor ding t o t he EMC inform at ion provided in
the Appendix.
W ARN I N G: The function or safet y of t he equipm ent could be im paired if it has been subj ect ed t o
unfavourable condit ions in st orage or in t ransit . I f at any tim e function or safet y is thought t o be
im paired, t he inst rum ent should be taken out of operat ion and secured against unint ended use.
W ARN I N G: Do not open or m odify t he equipm ent wit hout t he aut horizat ion of t he m anufact urer.
CAU TI ON : Do not t ouch sim ult aneously any accessible USB or ot her cont act s on t he PC or m onit or
and t he pat ient .
W ARN I N G: Do not plug the USB connector into any device ot her than t he PC supplied or
aut horised by Lifelines.
CAU TI ON : Federal ( USA) law rest rict s t his device t o sale by or on the order of a physician.

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1. 3 Explanation of symbols
Type BF equipm ent Follow operating inst ructions
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 w ay. Wast e elect rical and elect ronic equipm ent ( WEEE) requires special
procedures for recycling or disposal. This includes batt eries, print ed circuit boards,
elect ronic com ponent s, wiring and ot her elem ent s of electronic devices. Follow all
of your respect ive 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 Bluetoot h
I nt er nal radio device WLAN WiFi
Pushbut t on Nonin Xpod Pulse Oxim et er
Manu fact u rer DC power
I nt er nal bat t er y hazar d – r efer to sect ion 1.7 Elect r ocap
Storage and transport symbols
Tem per at ur e lim it s Fragile
Keep dry Relat ive hum idit y lim it s
Barom et ric pressur e lim it s
-10
+50
°C
10
95
%RH
500
1060
hPa

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1. 4 The Amplifier and its parts
The R- 40 EEG Am plifier is a m ult i-channel elect roencephalograph designed for use in r out in e EEG
and lab m onit oring applicat ions.
The Am plifier is a com pact USB 40-channel am plifier which incorporat es 32 referential channels
and 8 polygraphic channels wit h built -in calibrat ion and electrode im pedance measurem ent . A
Nonin XPOD interface is provided, a Pat ient Event input , 2 Aux DC input s and an Electrocap con-
nect or. Opt ional wir eless com m unicat ion is available ( Bluet oot h and WLAN WiFi) .
The Am plifier is int ended t o be connect ed to a specific PC and a m edical grade power supply. Refer
section 3.1 for det ails.
Ca ut ion :
Only use the 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 R-40 EEG Am plifier com pr ises t he following com ponent s:
R- 40 Am plifier part num ber 1326
Am plifier USB Cable part num ber 1277
Xpod Pulse Oxim et er Nonin part num ber 1327
N ot e : The Oxim et er sensor is a consum able and is not supplied by Lifelines. Only use t he ‘Pur e-
Light ’ sensors specified by Nonin for use wit h t heir Oxim et ers.
1. 5 Specifications and safety
Refer to Appendix 1 for specificat ions.
The Am plifier has been cert ified and com plies with t he following standards:
I EC 60601-1 and
I EC 60601- 2- 26
European st andard for m edical electrical equipm ent , general re-
quir em ent s and part icular requirem ent s for EEG syst em s.
ANSI / AAMI ES 6060 1- 1
AAMI Deviat ions from I EC 60601-1 ( USA) .
CAN/ CSA 22.2 No 601.1 M90 Canadian st andar d for m edical elect rical equipm ent , gener al re-
quir em ent s.
I EC 60601- 1- 2 European st andard for m edical electrical equipm ent , EMC require-
m 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
Electrost at ic Discharges
I EC61000- 4- 3
I m m unit y - Radiat ed RF Field
*
I EC61000- 4- 4
I m m unit y - Transient s Bur st s
*
I EC61000- 4- 5
I m m unit y – Surges
I EC61000- 4- 6
I m m unit y – Condu ct ed
I EC61000- 4- 8
I m m unit y – Power frequency fields
*
I EC61000- 4- 11
I m m unit y – Voltage dips, int errupt ions
I EC61000- 3- 2
Har m onic Em issions
*
I EC61000- 3- 3
Volt age Fluct uations/ flicker
*
Not e: Com pliance is provided by the PC.
Cla ssif ica t ion of sy st e m
Degree of prot ection against electrical shock Class I . Type BF applied part s
Type of protection ag ainst elect rical shock Opt ically isolat ed USB am plifier
Mains isolat ion t ransform er for PC
Degree of protect ion against h ar m ful ing ress of water Ordinary (no prot ect ion)
Mode of operat ion Cont inuous
Degree of safet y of application in t he presence of a flam -
m able anaest het ic m ixt ure wit h air or wit h oxygen or ni-
trous oxide
Not suit able