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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4
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

R40 EEG Am plifier User Manual
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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.

R40 EEG Am plifier User Manual
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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

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1. 6 Description of the components
The R-40 Amplifier
The R-40 USB 40-channel am plifier incorporat es 32 referent ial channels and 8 polygraphic channels
wit h built-in calibrat ion and elect rode im pedance m easurem ent . A Nonin XPOD int erface is pro-
vided, a Patient Event input , 2 Aux DC input s and an Elect rocap connect or. The Am plifier has built
in t ype-BF pat ient isolat ion and has a USB int erface t o t he PC. Opt ional wireless com m unicat ion is
av ailab le ( Blu et oot h and WLAN WiFi) .
Applie d pa rt s
EEG Ele ct r od es
The am plifier connect s t o st andard 1.5m m t ouchproof EEG recording elect rodes arranged in a
st andard 10-20 patt ern, at tached t o t he pat ient ’s head.
W ARN I N G: Lifelines does not supply EEG elect rodes. The Am plifier accep t s st an dar d 1.5 m m
t ouchproof elect rodes using DI N 42802-style connect ors. To ensure pat ient safet y, t he elec-
trodes used m ust be approved t o t he Medical Device Direct ive 93/ 42/ EEC in Europe or to t he
relevant local st andards out side Europe.
CAU TI ON : The conduct ive part of electrodes and their connect ors, including the Neutral elec-
trode, should not cont act ot her conductive part s including eart h.
Oxim e te r Se nsor
An opt ional oxim et er sensor at t aches t o t he pat ient ’s finger.
Pa t ie n t Ev e nt p ush bu t t on
The Pat ient Event Pushbut t on is used by t he pat ient to record t he inst ance of a significant
event .
Au x DC I npu t s
The Auxiliary DC input s are int ended for the connection of patient -at t ach ed t ransdu cer s wh ich
are passive or bat tery-powered such as sleep sensors. They m ust be insulat ed wit h no accessi-
ble conduct ive part s.
USB Ca ble
The Am plifier plugs directly int o a USB port on t he PC.
W ARN I N G: The Am plifier m ust only be used with t he USB cable provided with t he unit.
Medical grade AC/ DC mains power supply module for Laptop PC
Where EEG st udies are conducted wit hin the pat ient environm ent the 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 st an dar ds, supplied or aut horised by Lifelines.
W ARN I N G: The la pt op m u st on ly be con n ect e d t o t h e m e dica l-gr a de la pt op pow e r supply
supplie d or a ut horise d by Lif e lin e s. D o not u se a st a nda rd la pt op p ow e r su p ply.
Only use t h e lapt op supplie d or a ut h orised by Lif e lin e s.
The Setup and Recording Software
The R- 40/Tr ack it set up soft w ar e r uns under Microsoft Windows 2000 (wit h SP2), Windows XP, Win-
dows Vist a, Windows 7 or Windows 8 on t he host PC and is used t o setup and review t he R- 40 Am -
plifier and t o record on t o the PC.
Funct ions of t he sof t w are:
Download t he r ecording t em plat e. This includes w hich elect r odes are used and the recording
m ont age. See sect ion 4.2, step 2.
Perform a calibrat ion check of t he Am plifier . See sect ion 4.2, st ep 8.
Perform an EEG r ecording. See sect ion 4.2, st ep 8.
View on-going EEG t races. See sect ion 4.2, st ep 9.

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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 infor m at ion t hat will assist service personnel t o r epair t hose par t s
that are designat ed by Lifelines Lt d. as repairable by service personnel.
I n t e r na l b at t e r y r e pla ce m e nt – se rvice personn el only
The R-40 am plifier cont ains a replaceable lit hium ion rechargeable coin cell, t ype LI R2450.
W ARN I N G: Bat t ery replacem ent by inadequat ely trained personnel could result in a haz-
ard. I t m ust be replaced only wit h t he correct t ype and it m ust be installed correctly with
+ ve upper m ost .
1. Rem ove four screws from underside of instrum ent and rem ove bot tom of case.
2. Un-clip t he wrap-around screen to expose t he batt ery beneat h.
3. Grasp batt ery bet ween t hum b and forefinger and pull it from t he socket .
4. Push r eplacem ent bat t ery int o t h e socket ensuring + ve is upper m ost .
5. Re-clip t he wrap-around screen and reassem ble t he case.
Ba t t e ry safe ty in st r uct ion s
Do not at t em pt to open, puncture, disassem ble or m odify t he bat t ery in any way.
Do not subj ect t he batt ery to sudden shock or heat.
Do not dispose of bat tery in fire.
2Installation and Maintenance
W ARN I N G: The following sect ion m ust be read and underst ood before the equipm ent is swit ched
ON.
N ot e : Medical elect rical equipm ent needs special precaut ions regarding EMC and needs to be in-
st alled and put int o service according t o the EMC inform at ion provided in t he Appendix.
The funct ion 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 t im e funct ion or safet y is t hought t o be im paired, t he
instrum ent should be t aken out of operation and secured against unintended use.
The m anufact urer should be cont act ed ( details on page 3) for assistance, if needed, in set t ing up,
using or m aint aining t he equipm ent ; or to report unexpected operation or event s.
The assem bly of t he syst em and any m odificat ions during it s service life require evaluation t o t he
requir em ent s of I EC 60601-1.
2. 1 Checks for completeness and integrit y
1 Rem ove t he equipm ent from the packaging case( s) .
2 Use t he part s list to check that all ordered it em s have been received.
3 Check for sig ns of dam age t hat m ay hav e occu rr ed 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 dist ribut or.
2. 2 Environmental parameters for operation
The oper at ional and st or age/ t ranspor t ation environm ent al conditions are as follows:
Operat ional:
Tem perat ur e + 10° C t o + 40° C
Relat ive hum idit y 25% to 95% non-condensing
At m ospher ic pr essur e 700m B t o 1060m B
W ARN I N G: D o not obst r u ct any coolin g slot s. Po sit ion t h e e qu ip m e n t so t h a t a ir f low s
fr eely.
Storage and transport :
Tem per at u re - 10° C t o + 50° C
Relat ive hum idit y 10% to 95% non-condensing
At m ospher ic pr essur e 500m B t o 1060m B

R40 EEG Am plifier User Manual
13
2. 3 Power supply connections
Power requirement s
St andard USB port .
Power consumption
Maxim um pow er fr om USB port : 2.5W.
Medical grade AC/ DC mains power supply module for Laptop PC
Where EEG st udies are conducted wit hin the pat ient environm ent the leakage current m ust be con-
t rolled. The m ains power supply m ust be a special m edical-grade t ype wit h appropriate safet y
st andards, supplied or aut horised by Lifelines.
W ARN I N G: The la pt op m u st on ly be con n ect e d t o t h e m e dica l-gr a de la pt op pow e r supply
supplie d or a ut horise d by Lif e lin e s. D o not u se a st a nda rd la pt op p ow e r su p ply.
Only use t h e lapt op supplie d or a ut h orised by Lif e lin e s.
W ARN I N G: The Am plifie r m u st only b e use d w it h t h e USB ca bl e pr ov id e d w it h t he u nit .
2. 4 Use with other equipment
Defibrillators and HF surgical equipment
The equipm ent is not defibrillat or proof and should not be used in sit uat ions where a defibrillator is
likely to be used.
The equipm ent should not be used wit h 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 exam ple a cardiac pace-
m aker or ot her electrical st im ulat or, it is unlikely that a safety hazard will arise. However always
consult t he docum ent at ion supplied wit h t he other pat ient-connect ed equipm ent t o ensure t hat all
hazards, warnings and cautions are considered before t he equipm ent is used t ogether.
W ARN I N G: Non-m edical equipm ent , w hen used wit h t he sy st em , should com ply wit h I EC/ I SO
safet y st andar ds relevant t o t hat equipm ent . I T equipm ent should com ply wit h I EC 60950.
Leakage current
This syst em is designed t o com ply with I EC 60601-1, t he int ernat ional st andard for m edical elec-
t ronic equipm ent , which specifies the perm issible levels of leakage current . A potential hazard ex-
ist s in t he sum m at ion of leakage current s caused by connect ing sever al pieces of equipm ent t o-
get her. Because this syst em can be used in conj unct ion wit h st andard elect ronic devices, the tot al
leakage current should be t ested whenever the system is m odified.
There should be no electrical connect ions bet ween the syst em equipm ent , which is powered via t he
isolat ion t ransform er, and any ot her equipm ent power ed fr om a non-isolat ed m ains supply.
2. 5 Interference
The R-40 will cont inue to operat e in t he presence of radio frequency magnet ic fields (RF) and t he
effects of elect rostat ic discharges ( ESD) and other int erference, in accordance w it h t he require-
m ent s of EN60601- 1- 2. However , t h e R- 40 am plifier recor ds signals of very low am plit ude, and
these signals them selves are not im m une t o t he effect s of RF, ESD and low-frequency m ag net ic
field int erference. Such int er fer en ce m ay cause sign al art efact s.
The R-40 m ay have int ernal r adios fit t ed. These are approved indust r y-st andard Bluet oot h and Wi-
Fi types which present m inim al risk of reciprocal int erference wit h ot her equipm ent .
Ca ut ion : when in close proxim it y to t he am plifier, do not use m obile phones, t ransm it ters, power
t ransfor m er s, m ot ors, or other equipm ent that generates m agnet ic fields. Refer to the Appendix for
m ore infor m at ion.
N ot e : Medical elect rical equipm ent needs special precaut ions regarding EMC and needs to be in-
st alled and put int o service according t o the EMC inform at ion provided in t he Appendix.

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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 to all part s including t he accessories.
Cle an ing
All t he out er surfaces of t he R- 40 Am plifier m ay be cleaned using a soft clot h m oist ened wit h wat er
and a m ild det ergent solut ion. A low-pressure air-line or a vacuum cleaner can also be used.
Disinfection of t he equipm ent can be carried out by the use of QAC-based disinfectant s. Wipes ar e
recom m ended in order to prevent t he ingress of any liquid int o t he equipm ent . Suit able products
include Mikrozid Sensit ive Wipes (Schülke & Mayr Gm bH), Microbac forte ( Paul Hartm ann AG) , Dis-
tel Wipes ( Tristel Ltd.) .
Ca ut ion : Do not allow any liquid t o ent er the case of any inst rum ent or connector. Do not use ace-
t one on any of t he inst r um ent s.
2. 7 Disposal of equipment
The expect ed service life of t he equipm ent , par t s an d accessor ies is three years. When the device
and it s par t s and accessor ies has reached t he end of its operat ing life, it should be disposed of in
accordance with local wast e regulat ion authorit y t hat is typically within t he local governm ent office.
3Connections and usage
3. 1 Overview
Mains
power
Medical grade
laptop mains
PSU
Laptop
PC To
USB p ort
Patient
EEG
electrodes
R-40
Amplifier
Patient isolation
zone
Figur e 1 Con n ect in g t h e R-4 0 Am plifier
Where t h e ent ir e R- 40 syst em including t he PC is used within t he pat ient env ir onm ent , t he m ains
leakage current s and safet y and regulat ory requirem ents are m et by the use of the special m edi-
cal-grade lapt op power supply.

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15
W ARN I N G: The la pt op m u st on ly be con n ect e d t o t h e m e dica l-gr a de la pt op pow e r supply
supplie d or a ut horise d by Lif e lin e s. D o not u se a st a nda rd la pt op p ow e r su p ply.
Only use t h e lapt op supplie d or a ut h orised by Lif e lin e s.
3. 2 Connecting the R-40 System
The R- 40 Am plifier is plugged int o t he PC USB port using t he cable supplied, part num ber 1277 as
shown below:
Figur e 2 Con n ect in g t h e R-4 0 Am p lifie r ( t op fa ce )
The USB Cable is plugged int o t he bot t om housing of t he R-40 Am plifier as shown above using t he
RJ45 plug and int o any USB port on t he PC.
The t op face of t he Am plifier is laid ou t in a st andar d 1 0-20 form at , and accom m odates st andar d
t ouchproof elect rode leads fit t ed wit h DI N 42802 connect ors.
W ARN I N G: The Am plifier accept s st andard 1.5 m m t ouchproof elect rodes using DI N 42802-st yle
connectors. To ensure pat ient safet y, t he elect rodes used m ust be appr oved t o t he Medical Device
Direct ive 93/ 42/ EEC in Europe or to t he relevant local st andards out side Europe.
CAU TI ON : The conduct ive part of electrodes and t heir connect ors, including the Neutral electrode,
should not cont act ot her conductive part s including eart h.
Also on the t op face of t he Am plifier are the elect rode im pedance check set -level pushbutt ons. Ad-
j acent t o each electrode is an LED indicat ing whet her the im pedance of t he individual elect rode is
above t he set-level.
The t op edge of t he Am plifier provides for sever al ot her connect ions, as show n below.

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16
Figur e 3 Con n ect in g t h e R-4 0 Am plif ier ( front fa ce )
1. Nonin Xpod: t he circular connect or allows for the connection of a Nonin Xpod pulse oxim e-
t er for m easuring SpO2.
2. Electro-Cap: t he 25-way D-t ype connect or allows for t he connection of a st andard Elect ro-
Cap.
3. Aux1 and Aux2: t hese t wo 3.5m m jack connect ors allow for the connection of standard
transducers like Body Posit ion, Respirat ion Belt s etc.
4. Pat ient Event: t his 3.5m m j ack connect or allows for t he connection of a st andard Patient
Event Thum b Sw it ch.
CAU TI ON : All t hese connect ions are isolated. The conduct ive part of connect ors and t r ansducer s
should not cont act ot her conductive part s including eart h. Always ensure t hat t he transducer fit t ed
is suit able for a connection of this t ype.
3. 3 Starting the system
To start t he system proceed as follows:
•Plug t he PC int o t he m ains supply.
•Swit ch on t he PC and wait for Windows t o load.
•Ensure R-40 Am plifier is connect ed via t he USB lead.
•Launch Trackit applicat ion and cont inue as det ailed in section 4.
•These pr ocedures also apply following a m ains int err upt ion.
3. 4 Shutdown of the system
At t he com plet ion of a st udy proceed as follows to shut down t he system :
•St op t he recording by pressing t he ‘PC Record Off’ butt on
•Exit the Trackit program .
•Shut down Windows.
•Sw it ch off t he PC an d disconnect t he m ains supply .

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17
4The setup and recording software
The set up software is available on CD. A readm e file describes inst allation. Check with your distrib-
utor or Lifelines if a newer version of soft ware is available.
The Trackit soft ware is designed t o work with 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 .
The soft w ar e is support ed on Microsoft Windows 2000 (wit h SP2), Windows XP, Window s Vist a and
Windows 7 and Windows 8 .
The USB drivers will be found on t he CD. Aft er connect ing t he Am plifier to t he PC for the first t im e,
at t he Windows prom pt , browse t o t he folder CD Dr iv e: \ USB Drivers. From ther e Windows will find
t he correct dr ivers for the version of Windows being used.
The soft ware has t he following functions:
Define signal t ypes: creat e labels t o at t ach t o inputs
At tach t he desired signal t ype ( label) t o t he r ecor din g input
Creat e a recording m ont age and download it t o the am plifier
Perform a calibrat ion of t he input s
St art and st op a recording session
4. 1 Setting up a recording protocol
Summary
St ep 1 Define t he pat ient I D
St ep 2 Define t he signals – if required 1
St ep 3 Define t he input s – if required 2
St ep 4 Define t he recording channels – if required 2
St ep 5 Act ivat e the recording cont rol
St ep 6 Connect t he R-40 for set up
St ep 7 Check R- 40 st at us
St ep 8 Start a recording
St ep 9 View the ongoing EEG traces
Not es:
1. Defining signals is usually done once only or very occasionally. The R-40 Am plifier ar rives
wit h a default set of signals t hat should suffice for m ost applicat ions, hence it m ay only
necessary to add signal t ypes for polygraphic recordings ( airflow, respirat ion etc).
2. Defining input s, recording channels and m ont age is usually only done once per set up t ype.
This ent ir e set up can t hen be saved and recalled for future use.
Step 1 Define the patient ID
1 Select t he New patient icon on the t oolbar.
New Pat ient icon
2 Ent er t he pat ent n am e and Recor ding I D int o t he New Pat ient di-
alog.
This inform at ion is saved wit h t he r ecording set up for download
to t he recorder in a fut ure recording.
I t is possible to configure t he system t o use a patient dat abase inst ead of the sim ple dialog shown
above.
Figur e 4 N e w Pa t ie n t dia -
log

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Figur e 5 N e w Pa t ie n t da t a ba se
The database allows you t o ent er more extensive inform at ion about t he pat ient and recording, and
save it for fut ure reference. See the sect ion ent itled ‘Advanced opt ions’.
Step 2 Define the signals – if required
Defining signals is usually done once only or very occasionally. The R- 40 Am plifier ar riv es w it h a
default set of signals t hat should suffice for most applications, hence it m ay only necessary t o add
signal types for polygr aphic r ecor dings ( air flow , r espirat ion et c) .
I f for any reason the signals have not been creat ed, it is necessary to define all t he signals (labels)
that are t o be used for m ont age creat ion in St ep 3. The signal editor allows t he creat ion of up t o 64
distinct signals ranging from t he st andard 10/ 20 EEG signals such as FP1 O2, to Respirat ion, Pulse
and ot her polygraphy input s.
St ep 3 explains how to calibrat e an AUX input .
To define a signal:
1 Click the View all signals tab in the Signal edit or dialog box.
Figur e 6 Signal List
2 Double click on t he signal you want t o edit . This brings up t he Signal edit or tab) , allowing you t o
creat e a relevant signal or label t o be ent ered int o the signal list.

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19
Figur e 7 Sig na l Ed it in g 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.
4 Select a signal t y pe ( in t his case EEG) .
5 Click on t he Change but ton. The signal is now ent ered int o t he list under the View all signals
t ab.
6 I f the signal is not an EEG signal, it m ay be necessary to insert a display sensit ivit y value by un-
checking t he Mast er cont rol check box.
Signals t hat have been defined wit h t heir own independent sensit ivities appear in red in t he
trace display. Furt her edit ing and changes t o t hese sensit ivit y values in t he t race display will be
saved back int o t he signal library.
Step 3 Define the inputs
Not e that if a pre-saved set up is available t h en t his can be opened
direct ly from the Open m enu it em , and this sect ion skipped. Ot her-
wise, if a new set up is being creat ed, proceed as follows:
1 Select the Spanner icon on t he t oolbar. This opens the t abbed
Set up Recording dialog.
Spanner icon
2 Under t he Am plifier Channels t ab select t he signals ( labels) t o be
att ached t o t he physical input s.
For exam ple, EEG input 1 may require t he label Fp1 and so on
accor ding t o t he st andar d 10/ 20 nom enclat ure.
Double click t he channel nam e and select the relevant signal label
from the Set up Hardware EEG channel dialog.
Figur e 8 EEG se t up

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Figur e 9 Se t u p Re cor ding dia log
The order of t he signal labels in t he pull down list is the sam e as the order of t he signals in t he sig-
nal list defined using t he signal-edit ing t ool.
Am plifie r set up: am plifier set up act ivat es the recording input s in preparat ion for a recording. For
m ost applications you need per for m am plifier set up only once – w hen the sy st em is fir st inst alled –
since t he am plifier setup is saved wit h t he recording m ont age for fut ure recall and usage. See St ep
4 below.
I f you want t o use t he recording channel order defined in am plifier set up, click on Aut o Record
Set up in t he Set up Recording dialog box. You can t hen skip St ep 4 ( Define t he recording channels) .
Poly and AUX input s: t hese input s can be set t o either referent ial ( EEG m ode) , bipolar AC or bi-
polar DC. They are ideal for polygraphic signals such as respirat ion, airflow, EKG, body posit ion (DC
m ode) et c.
To calibrate an AUX input to reflect a required unit of scale for a given volt age input use t he signal
editor - see Err or! Re fe re nce sou rce n ot foun d.) . Select t he appropriate units, e.g. % , or m m
Hg, and en t er t he Physical Signal Am plit ude required t o generate t he Am plifier Input Voltage.
Step 4 Define the recording channels
St ep 4 can usually be skipped, since t he Aut o Record Setup but ton will copy what you have defined
und er t he inp ut s in St ep 3 int o t he list of recording channels.
However, you can define and save recording m ontages for spe-
cific recording needs, and recall t hem for fut ure usage.
Creating a m ontage follows the sam e principle as the signal
creat ion and input definit ion t ool: click on t he chan nel num ber
to define t he active and reference label of choice.
An exam ple of a r ecording m ont age is shown below.
Figur e 1 0 Ch a nn e l se t u p