lifelines Trackit Mk2 User manual

T4 EEG Am plifier

Use r M a n u a l

32 channel version: T432

68 channel version: T468

Part no. 51285-006

I ssue 1.9

Cr eat ed Checked Appr ov ed

Digitally signed by Michael

Hulin

Date: 2018.03.02 10:27:46 Z

Digitally signed by David Hulin

DN: cn=David Hulin, o=Lifelines Ltd,

ou=Development,

[email protected], c=GB

Date: 2018.03.02 11:01:33 Z

Digitally signed by Michael Hulin

Date: 2018.03.02 11:55:04 Z

T4 EEG Am plifier User Manual

Version History

V 1 ( 23 June 2016)

• I nit ial release

V 1.1 ( 09 Aug 2016)

• Am ended part num bers in sect ion 1.4.

V 1.2 ( 28 Sep 2016)

• Various am endm ent s for I EC 60601-1.

V 1.3 ( 13 Dec 2016)

• Am endm ent s t o Nonin and Aux I nput specificat ions in sect ion 1.6.

• Changed ‘Cont raindication’ t o ‘Warning’ in sect ion 1.2. There are no cont raindicat ions for this

device.

V 1.4 (08 February 2017)

• Added t o sect ion 1.2 “CONTRAI NDI CATI ONS: There are no known cont raindicat ions t o t he

use of this equipm ent ” .

• Added t o sect ion 1.2 and 2.3 “WARNI NG: To avoid t he risk of elect ric shock, this equipm ent

m ust only be connect ed t o a supply m ains with protective eart h” .

• Rem oved drawing num bers in section 1.4.

• Am ended sect ion 2.4: I nt ernal Li-I on backup bat t ery operation.

• Added t o Section 4.1: “Note: I f a Set up t hat uses great er t han 32 channels plus t he Nonin is

at tem pt ed. ..” .

• Added t o sect ion 3.3 det ails of bat tery replacement frequency.

V 1.5 ( 10 March 2017)

• Am ended inst ruct ions concer ning oxim et er and Aux. input sensors.

V 1.6 ( 13 March 2017)

• Furt her am endm ent s t o instruct ions concerning oxim et er and Aux. input sensors.

V 1.7 ( 22 March 2017)

• Added to Aux DC I nput instruct ions – “ for hospit al and clinic use. Not for hom e use” in

section 1.6 and 3.3.

V1.8 ( 18 August 2017)

• Photic operat ion added in Appendix 2.

• Wireless operation added in Appendix 5.

V1.9 ( 08 Novem ber 2017)

• Added disinfect ion inform at ion in sect ion 2.8.

• Change of N.B. t o 0086 ( BSI ) .

T4 EEG Am plifier User Manual

Lifelines Ltd, 7 Clarendon Court,

Over Wallop, near St ockbridge,

Ham pshire SO20 8HU, UK

Telephone + 44 ( 0) 1264 782226

www.LLines.com

sales@LLines.com

0 086

T4 EEG Am plifier User Manual

Disclaimers & Warranties

The inform ation in this sect ion is subject to 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 ited t o, t he im plied warrant ies of m erchant abilit 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 wit h the furnishing, perform ance or use of this m at erial.

Lifelines shall warr ant it s product s against all defect s in m aterial and workm anship for one year

from t he dat e of delivery.

Misuse, accident, m odification, unsuitable physical or operating environm ent , im proper m aint e-

nance or dam age caused by a product for which Lifelines is not responsible will void t he war rant y.

Lifelines do not warrant unint errupt ed or error-free operation of its product s.

Lifelines or its authorised agent s will repair or replace any products t hat prove to be defective dur-

ing the warrant y period, provided t hat t hese product s are used as prescribed in the operating in-

st ruct ions in t he user’s and service m anuals.

No other party is aut horised t o m ake any warranty t o assum e liabilit y for Lifelines product s. Life-

lines will not recognise any ot her warrant y, either im plied or in writ ing. I n addition, services per-

form ed by som eone ot her t han Lifelines or it s aut horised agent s or any t echnical m odificat ion or

changes of product s wit hout Lifelines prior, written consent m ay be cause for voiding this warranty.

Defect ive products or parts m ust be ret urned t o Lifelines or it s aut horised agents, along with an

explanat ion of the failure. Shipping cost s m ust be prepaid.

Lifelines Ltd. m anufact ures hardware and software t o be used on or with standard PC-com pat ible

com puters and operat ing soft ware. Lifelines, however, assum es no responsibility for t he use or reli-

abilit y of it s soft ware or hardware with equipm ent t hat is not furnished by third-part y m anufactur-

ers accept ed by Lifelines at t he dat e of purchase.

All warrant ies for third-part y product s used within t he T4 syst em are the responsibility of the rele-

vant m anufact urer. Please refer t o the relevant docum ent at ion on each product for furt her details.

This docum ent cont ains proprietary inform ation t hat is prot ect ed by copyright. All rights are re-

served. No part of t his docum ent m ay be photocopied, reproduced in any ot her form or t ranslated

into anot her language wit hout t he prior writt en consent of Lifelines.

Trademarks

Microsoft , Windows and Windows NT are regist ered t radem arks of the Microsoft Corporation. All

ot her t radem arks and product nam es are t he property of their relevant owners.

Responsibility of manufacturer

The m anufact urer and dist ribut or consider t hem selves responsible for the equipm ent ’s safet y, relia-

bilit y and perform ance only if:

 any peripheral equipm ent to be used wit h the T4 syst em is supplied by t hird-part y providers

recom m ended by t he m anufact urer;

 assem bly operations, ext ensions, readj ust m ent s, m odificat ions, or repairs are carried out by

persons aut horised by t he m anufact urer;

 the elect rical inst allation of t he relevant room com plies with t he appropriat e requirem ents;

 the equipm ent is used by a healt h-care professional and in accordance wit h the instruct ions for

use.

N ot e : t he m anufact urer has a policy of continual product im provem ent ; hence t he equipm ent

specifications are subj ect t o change wit hout not ice.

Check with Lifelines or your dist ribut or if a software updat e is available.

N ot e : Medical elect rical equipm ent needs special precautions regarding EMC and needs t o be in-

st alled and put into service according t o t he EMC inform at ion provided in t he Appendix.

T4 EEG Am plifier User Manual

Software and Virus Protection

Lifelines t akes all reasonable st eps to ensure t hat it s software is virus-free. I n line wit h m odern

com put ing practice, it is advisable t hat cont inual prot ection against viruses, tr ojans, m alware, ad-

ware et c. is provided on t he PC used for installat ion and the surr ounding syst em s. Please not e t he

following recom mendations which should be support ed by your int ernal I T/ Com put ing depart m ent

procedures and pract ices:

1. Virus prot ect ion software should be inst alled on every com puter at risk of infect ion. This

soft ware should have a resident ( online) shield and provide em ail scanning if appropriate.

2. Virus scanning should be set t o m anual m ode or aut om at ic if desired but at a tim e when

the system is not being used.

3. All program s offering aut o-update feat ures, including Windows, should be set t o m anual or

aut om at ic if desired but at a tim e when the system is not being used.

4. Adopt form al departm ental or organisational procedures t o ensure t he int egrit y and safe

operation of the m edical equipm ent and support ing system s.

T4 EEG Am plifier User Manual

Contents

Version Hist ory 2

Disclaim ers & Warrant ies 4

Tradem arks 4

Responsibilit y of m anufact urer 4

Soft ware and Virus Prot ection 5

Contents 6

I llust rat ions 7

1 Overview and Technical Descript ion 8

1.1 General description 8

1.2 Caut ions and War nings 8

1.3 Explanat ion of sym bols 10

1.4 The Am plifier and it s part s 11

1.5 Specificat ions and safet y 11

1.6 Description of the com ponent s 12

1.7 Replaceable part s 13

2 I nst allat ion and Maint enance 13

2.1 Checks for com pleteness and int egrit y 14

2.2 Environm ent al param eters for operat ion 14

2.3 Power supply connect ions 14

2.4 Batt ery Operat ion Tim e 14

2.5 Use in t he hom e environm ent 15

2.6 Use wit h ot her equipm ent 15

2.7 I nt erference 15

2.8 Maint enance and cleaning 16

2.9 Disposal of equipm ent 16

3 Connect ions and usage 16

3.1 Overview 16

3.2 Lapt op inst allation and operat ion 17

3.3 Connect ing t he T4 System 17

3.4 St art ing t he system 19

3.5 Shut down of t he syst em 20

3.6 Bat t ery replacement and charging 20

4 The setup and recording soft ware 21

4.1 Set t ing up a recording protocol 21

4.2 Configuring t he am plifier 25

4.3 Montage Editor 29

4.4 Reading an EEG recording 30

Appendix 1: Specificat ions 31

Appendix 2: Phot ic St im ulat ion 34

Appendix 3: Addit ional Events I nform ation 36

Appendix 4: PC Set up 39

Appendix 5: Wireless 41

I nt roduct ion 41

Syst em overview 41

Connect ion and use 41

Appendix 6: Troubleshooting Guide 46

Appendix 7: Manufacturer’s Declarat ion 47

EMC Com pat ibilit y 47

T4 EEG Am plifier User Manual

Illustrations

Figure 1 Connect ing t he T4 Am plifier – Clinical Use 16

Figure 2 Connect ing t he T4 Am plifier - Hom e Use 17

Figure 3 Connecting t he T4 Am plifier ( front face) 18

Figure 4 Connect ing t he T4 Am plifier ( back face) 18

Figure 5 New Patient dialog 21

Figure 6 New Patient dat abase 22

Figure 7 Signal List 22

Figure 8 Signal Edit ing Tool 23

Figure 9 EEG set up 23

Figure 10 Set up Recording dialog 24

Figure 11 Channel set up 24

Figure 12 Recording Channel edit ing 25

Figure 13 Trackit soft ware t oolbar 25

Figure 14 Trackit Cont rol Panel 26

Figure 15 Ongoing trace display 27

Figure 16 Adj ust display param eters 27

Figure 17 I m pedance check 28

Figure 18 Online Event Viewer 28

Figure 19 Mont age Editor 29

Figure 20 Phot ic St im ulation 34

Figure 21 Phot ic St im ulation cont rol window 34

Figure 22 Phot ic trigger signal definit ion 35

Figure 23 User Event s 37

Figure 24 Events Tem plat e set up 37

Figure 25 Free-t ext Event 37

Figure 26 Event List 38

Figure 27 Opt ions Tab 1 39

Figure 28 Opt ions Tab 2 39

Figure 29 Opt ions Tab 3 40

T4 EEG Am plifier User Manual

1 Overview and Technical Description

1. 1 General description

I ndica tion s for u se

The T4 EEG Am plifier is intended to be used as a front -end am plifier to acquire, st ore and t ransm it

elect rophysiological signals (wireless or cabled) .

CAUTI ON: Federal ( USA) law restricts t his device to sale by or on the order of a physician.

General descript ion

The Trackit T4 EEG Am plifier is a m ult i-channel electroencephalograph designed for use in rout ine

EEG and lab m onitoring applications and due to it s sm all size, can be used in am bulat ory

applications. I n t his sit uation, t he EEG electrodes are fitt ed to the patient by a trained clinician

prior to t he patient being sent hom e. No subsequent int ervent ion is required by the pat ient . Upon

com plet ion of t he recording, t he dat a which is stored on a m em ory car d is reviewed by a clinician

using review and analysis soft ware on a PC.

I t is a com pact USB am plifier which provides 32 channels (or 68 channels wit h int er nal expansion

option) wit h built -in calibrat ion and electrode im pedance m easurem ent . Also provided is a Nonin

pulse oxim et er int erface, a Pat ient Event input and an Aux DC input. Optional wireless

com m unicat ion is available ( Bluet oot h and WLAN WiFi).

There are two variants of t he Trackit T4 EEG Am plifier:

• Tr a ck it T4 -3 2 providing 24 referential + 8 poly channels.

• Tr a ck it T4 -6 8 providing 64 referent ial + 4 poly channels (using internal expansion board).

Plug-on Pat ient Connect ion Units ( PCUs) provide 32 channel touchproof input s ( m odel T4 -PCU

2 4 + 8 ) or 68 channels ( m odel T4 -PCU 6 4 + 4 ) .

The Am plifier is intended to be connected t o a USB port on a PC which is powered from a m edically

approved power supply. I n addition it can be batt ery powered in am bulat ory applicat ions.

This equipm ent is 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 patient diagnosis. The equipm ent does not sust ain or support

life.

I nt en de d U se r

The int ended user of the equipm ent is a healt hcare professional who has t he t r aining and

knowledge to undert ake EEG exam inations and is fam iliar wit h EEG equipm ent and pract ice.

1. 2 Cautions and Warnings

W ARN I N G: Do not use t he T4 EEG Am plifier in an MRI environm ent , in an oxygen rich

env ironm ent or during defibrillation.

W ARN I NG: This equipm ent is intended t o be used by a healthcare professional and in accordance

wit h t hese inst ruct ions for use which m ust be read in t heir ent iret y before t he device is used.

W ARN I NG: This equipm ent in intended 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

the det erm inat ion of brain death.

W ARN I NG: 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, this equipm ent m ust only be connected t o a supply

m ains wit h prot ect ive eart h.

W ARN I N G: Lifelines does not supply EEG elect rodes. The unit accepts standard 1.5 m m

touchproof elect rodes using DI N 42802-st yle connectors. To ensure pat ient safet y, t he elect rodes

used m ust be approved to the Medical Device Direct ive 93/ 42/ EEC in Europe or FDA cleared for use

in USA.

CAUTI ON : The conductive part of elect rodes and their connect ors, including the Neut ral electrode,

should not cont act other conduct ive part s including earth.

W ARN I N G: Do not plug the USB connect or into any device ot her t han the PC supplied or

aut horised by Lifelines. Do not connect any other equipm ent to t he PC.

T4 EEG Am plifier User Manual

CAUTI ON : Do not t ouch sim ult aneously any accessible USB or ot her cont acts on the PC and t he

pat ient .

W ARN I N G: St rangulation hazard due t o long cables. As with all m edical equipm ent, carefully

rout e patient cabling to reduce the possibilit y of patient entanglem ent or st rangulat ion.

CAUTI ON : Ensure t hat carrying bag and straps are worn over clothing t o prevent any possibility of

skin irrit at ion.

CAU TI ON : When in close proxim it y t o the Am plifier, do not use m obile phones, t ransm it t ers,

power t ransform ers, m otors, or ot her equipm ent t hat generat es m agnetic fields. Refer to t he

Appendix for m ore inform at ion. Medical elect rical equipm ent needs special precaut ions regarding

EMC and needs to be installed and put into service according t o t he EMC inform at ion provided in

the Appendix.

W ARN I N G: The funct ion or safet y of the equipm ent could be im paired if it has been subject ed t o

unfavourable condit ions in st orage or in t ransit. I f at any t im e funct ion or safety is t hought t o be

im paired, t he instrum ent should be t aken out of operation 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.

CAUTI ON : Federal ( USA) law restricts t his device t o sale by or on the order of a physician.

CON TRAI N D I CATI ON S: There are no known cont raindications t o t he use of this equipm ent .

T4 EEG Am plifier User Manual

1. 3 Explanation of symbols

Type BF applied part Follow operating instruct ions

I nput / output connect ion I nput connect ion

Special recycling required, do not dispose of in landfill. When t his equipm ent has

reached the end of its useful life, it m ust be disposed of in an environm ent ally-

friendly way. Wast e electrical and elect ronic equipm ent ( WEEE) requires special

procedures for recycling or disposal. This includes batt eries, printed circuit boards,

elect ronic com ponents, wiring and ot her elem ent s of elect ronic devices. Follow all

of your respect ive local laws and regulations for t he proper disposal of such

equipm ent . Cont act your local distribut or for inform at ion concerning t his.

Consult warnings in User Manual Bluet oot h

Pushbut t on WLAN WiFi

Manufact ur er Nonin Xpod Pulse Oxim et er

Mem ory car d read/ writ e I nt er nal bat tery hazard

- refer t o section 1.7

On/ Off and pat ient event swit ch

Storage and transport symbols

Tem perat ure limit s Fragile Keep dry

Relat ive hum idit y lim it s At m ospheric pressure lim its

I nt ernat ional protect ion code

Protected against ingress of solid obj ect 12.5 m m diam eter.

Prot ected against access t o hazardous part s wit h finger.

Protected against ingress of water dripping ( 15° t ilt ed) .

-25

+70

°C

%RH

500

1060

hPa

I P2 2

T4 EEG Am plifier User Manual

1. 4 The Amplifier and its parts

The T4 EEG Am plifier is a m ult i-channel elect roencephalograph designed for use in r out ine EEG and

lab m onitoring applicat ions.

I t is a com pact USB am plifier which provides 32 channels ( or 68 channels wit h int ernal expansion

option) wit h built -in calibrat ion and electrode im pedance m easurem ent . A Nonin XPOD int erface is

provided, a Pat ient Event input and an Aux DC input . Opt ional wireless com m unicat ion is available

(Bluet oot h and WLAN WiFi) .

The Am plifier is intended to be connected t o a specific PC and a m edical grade power supply. Refer

sect ion 3.1 for det ails.

Ca ut io n:

Only use t he PC supplied or authorised by Lifelines

Only use t he m edical-grade m ains power supply wit h it as supplied or aut horised by Lifelines

The T4 EEG Am plifier com prises the following com ponents:

T4-32 Am plifier part num ber 1505

T4-68 Am plifier part num ber 1501

T4-PCU 24+ 8 part num ber 1552

T4-PCU 64+ 4 part num ber 1553

USB Power Bank bat t ery part num ber 1560

Bat tery cable part num ber 1561

T4 bag and st raps part num ber 1562

Patient event swit ch part num ber 1353

Xpod Pulse Oxim et er Nonin part num ber 1327

Trackit tool part num ber 1115

Am plifier USB cable part num ber 1277

Lenovo ThinkPad lapt op com puter part num ber 1389

Medical grade power supply part num ber 1390

Mains cable, UK part num ber 1066

Trackit soft ware CD, standard part num ber 1009

Par t num bers m ay be preceded by ‘L14’ on labelling or packaging.

1. 5 Specifications and safety

Refer t o Appendix 1 for specifications.

The Am plifier has been certified and com plies wit h the following st andards:

I EC 60601-1 and

I EC 60601- 2- 26

European st andard for m edical elect rical equipm ent , general re-

quirem ent s and particular requirem ent s for EEG syst em s.

ANSI / AAMI ES 60601- 1

AAMI Deviat ions from I EC 60601-1 ( USA).

CAN/ CSA 22.2 No 601.1 M90 Canadian st andard for m edical elect rical equipm ent , general re-

quirem ent s.

I EC 60601- 1- 2 European standard for m edical elect rical equipm ent , EMC require-

m ent s, calling:

*CI SPR11

Conducted Em issions, Group 1, Class B

CI SPR11

Radiat ed Em issions, Group 1, Class B

I EC61000-4- 2

Elect rost 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 Burst s

I EC61000-4- 5

I m m unit y – Surges

I EC61000-4- 6

I m m unit y – Conduct ed

I EC61000-4- 8

I m m unit y – Power frequency fields

I EC61000- 4- 11

I m m unit y – Voltage dips, interruptions

I EC61000-3- 2

Harm onic Em issions

I EC61000-3- 3

Voltage Fluct uations/ flicker

Note: Com pliance is provided by t he PC.

T4 EEG Am plifier User Manual

Cla ssificat ion of syst em

Classificat ion Clinical use Hom e use

Degree of prot ect ion against

elect rical shock

I nt ernally powered; or it can

be connected to a PC which is

Class I power supply.

Type BF applied parts.

I nt ernally powered.

Type BF applied parts.

I f a PC is supplied, it has no

elect rical connection t o t he

Am plifier & has no applied part s.

Degree of prot ect ion against

harm ful ingress of wat er

Ordinary ( no prot ection) or

I P22 ( Am plifier in bag)

Mode of operat ion Cont inuous operat ion Cont inuou s operat ion

Suit abilit y for use in an

oxygen rich environm ent

Not suit able Not suit able

1. 6 Description of the components

The T4 Amplifier

The T4 USB am plifier provides 32 channels ( or 68 channels with int ernal expansion option) wit h

built-in calibrat ion and elect rode im pedance m easurem ent . A Nonin XPOD interface is provided, a

Patient Event input, an Aux DC input and an Elect rocap connect or. The Am plifier has built in type-

BF pat ient isolat ion and has a USB int erface t o the PC. Opt ional wireless com municat ion is available

(Bluet oot h and WLAN WiFi) .

The Pat ient Connect ion Unit (PCU) connect s t he st andard 1.5m m touchproof EEG recording elec-

trodes at t ached to the pat ient to t he T4 unit . I t is available either as a T4-PCU 24+ 8 (32 channel)

unit or a T4 PCU 64+ 4 ( 68 channel) . The PCU is plugged int o t he front of the unit and retained wit h

two screws operat ed by t he supplied special t ool.

Applied pa r t s, t ype BF

EEG Ele ct r ode s

The am plifier connect s to st andard 1.5m m touchproof EEG recording electrodes arranged in a

st andard 10-20 pattern ( T4 PCU 24+ 8) or t he grid layout ( T4 PCU 64+ 4), attached t o t he pa-

tient’s head.

W ARN I N G: Lifelines does not supply EEG electrodes. The Am plifier accepts st andard 1.5 m m

touchproof elect rodes using DI N 42802-st yle connect ors. To ensure pat ient safet y, t he elec-

trodes used m ust be approved t o the Medical Device Direct ive 93/ 42/ EEC in Europe or t o t he

relevant local standards outside Europe.

CAUTI ON : The conduct ive part of elect rodes and their connect ors, including the Neut ral elec-

trode, should not cont act ot her conduct ive parts including eart h.

Oxim e t e r Se nsor

The am plifier is approved for use wit h a Nonin 8000AA sensor which at t aches t o t he patient’s

finger.

Pat ie n t Eve n t pu sh but t on

The Pat ient Event Pushbut ton is used by t he pat ient t o record t he inst ance of a significant

event.

Aux DC I nput

The am plifier is approved for use wit h a SleepSense body posit ion sensor, t ype 1575, for

hospit al and clinic use. Not for hom e use.

CAUTI ON : Only use approved sensors as specified by Lifelines.

USB Cable

The Am plifier plugs directly into a USB port on t he PC.

W ARN I N G: The Am plifier m ust only be used wit h the USB cable provided with the unit .

USB Pow e r Ba n k ba tt ery pack f or am bula tor y a p pli ca t ion s

The Am plifier plugs directly int o t he USB port on the Power Bank.

W ARN I N G: The Am plifier m ust only be used wit h t he USB Power Bank supplied or authorised by

Lifelines.

T4 EEG Am plifier User Manual

Micro-SD M e m ory Ca r d

The m icro-SD card is used to st ore t he EEG dat a recorded by T4. St orage cards of var ying capacit y

are available in t he m icro-SD form at .

Ba gs a n d St ra ps f or am bula tory a pplica t ion s

The Bag houses t he Am plifier and batt ery.

Medical gr a de AC/ DC m a ins pow e r su pply m odu le for La pt op PC

Where EEG studies are conducted wit hin t he patient environm ent t he leakage current m ust be con-

trolled. The lapt op PC m ains power supply m ust be a special m edical-grade t ype with 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 conne ct ed t o t he m edica l-gr a de la pt op pow e r su pply

sup plie d or a ut horise d by Life lines. Do n ot u se a st a nda rd la pt op p ow e r sup ply .

Only use t he lapt op su pplie d or aut h or ise d by Lifelin e s.

The Se t u p a n d Re cordin g Sof t w are

The T4/Trackit set up soft ware runs under Microsoft Windows 2000 (with SP2) , Window s XP, Win-

dows Vista, Windows 7, 8 or 10 on the host PC and is used t o setup and review t he T4 Am plifier

and t o record on t o t he PC.

Funct ions of t he sof t ware:

 Download t he recording t em plat e. This includes which elect rodes are used and the recording

m ont age. See section 4.2, step 2.

 Perform a calibrat ion check of t he Am plifier. See section 4.2, st ep 8.

 Perform an EEG recording. See section 4.2, step 8.

 View on-going EEG traces. See sect ion 4.2, st ep 9.

1. 7 Replaceable parts

Lifelines Ltd. will m ake available on request circuit diagram s, com ponent part list s, descriptions,

calibration inst ruct ions, or other inform at ion t hat will assist service personnel to repair those part s

that are designat ed by Lifelines Ltd. as repairable by service personnel.

I nt er na l ba t te ry re pla ce m ent – service pe rsonnel only

The T4 am plifier cont ains a replaceable lithium ion rechargeable coin cell, t ype LI R2450.

W ARN I N G: Bat t ery replacem ent by inadequat ely t rained personnel could result in a haz-

ard. I t m ust be replaced only wit h the correct t ype and it m ust be inst alled correctly with

+ ve upperm ost .

1. Rem ove PCU and t he four screws from underside of inst rum ent , t wo from t he front and two

from t he rear m ouldings. Rem ove bottom of case.

2. Un-clip the wrap-around screen t o expose t he battery beneat h.

3. Grasp bat t ery bet ween thum b and forefinger and pull it from t he socket .

4. Push replacem ent batt ery int o t he socket ensuring + ve is upperm ost .

5. Re-clip t he wrap-around scr een and reassem ble t he case.

Bat t e r y safet y in st r uct ion s

Do not at tem pt t o open, puncture, disassem ble or m odify t he battery in any way.

Do not subject t he batt ery t o sudden shock or heat.

Do not dispose of battery in fire.

2 Installation and Maintenance

W ARN I N G: The following sect ion m ust be read and underst ood before t he equipm ent is swit ched ON.

N ot e : Medical elect rical equipm ent needs special precautions regarding EMC and needs t o be in-

st alled and put into service according to t he EMC inform at ion provided in the Appendix.

The funct ion or safety of t he equipm ent could be im paired if it has been subj ected t o unfavourable

condit ions in storage or in t ransit . I f at any t im e function or safet y is t hought t o be im paired, the

inst rum ent should be t aken out of operation and secured against unint ended use.

The m anufacturer should be contact ed ( details on page 3) for assist ance, if needed, in set t ing up,

using or m aint aining the equipm ent ; or to report unexpect ed operation or events.

T4 EEG Am plifier User Manual

The assem bly of t he syst em and any m odifications during its service life require evaluat ion to t he

requirem ent s of I EC 60601-1.

2. 1 Checks for complet eness and integrity

1 Rem ove the equipm ent from t he packaging case( s).

2 Use t he parts list t o check t hat all ordered it em s have been received.

3 Check for signs of dam age t hat m ay have occurred dur ing t r ansit or st or age. I f any dam age is

found, do not use t he inst rum ent ; cont act your dist ribut or.

2. 2 Environmental parameters for operation

The operat ional and st orage/ t r anspor t at ion environm ent al conditions are as follows:

Operational:

Tem per at ur e + 5° C t o + 40° C

Relat ive hum idit y 15% to 93% non-condensing

At m ospheric pressure 700 hPa t o 1060 hPa

W ARN I N G: Do not obstruct any cooling slots. Posit ion t he equipm ent so t hat air flows freely.

Storage and transport:

Tem per at ur e - 25° C to + 70° C

Relat ive hum idit y Up t o 93% non-condensing at + 70° C

At m ospheric pressure 500 hPa to 1060 hPa

2. 3 Power supply connections

Power requirements

St andard USB port.

Power consumption

Maxim um power from USB port : 2.5W.

Medical grade AC mains power supply module for Laptop PC

Where EEG studies are conducted wit hin t he patient environm ent t he leakage current m ust be con-

trolled. The m ains power supply m ust be a special m edical-grade type 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.

Output : 20 Vdc, 5.25 A.

W ARN I N G: The la pt op m ust only be conne ct ed t o t he m edica l-gr a de la pt op pow e r su pply

sup plie d or a u t hor ise d by Life lines. Do n ot u se a sta nda rd la pt op pow er su pply.

Only use t he lapt op su pplie d or aut h or ise d by Lifelin e s.

W ARN I N G: To a void t he risk of elect r ic shock , t his equipm e nt m u st only be con nect e d t o

a supply m ains w it h pr ot ective e ar t h.

W ARN I N G: The Am plifie r m ust only be used w it h t he USB ca ble pr ov ide d w it h t he un it .

2. 4 Battery Operation Time

USB Powerbank Li-Polymer battery pack

When fully charged the bat t ery pack will typically power t he unit for 36 hours depending on t he

num ber of channels, sam ple rate and wireless usage.

The t ypical service life is 2 years.

Internal Li-Ion backup batt ery

The int ernal backup battery will enable the unit t o cont inue operat ing for a short period of t im e ( 15

m ins approx.) to allow t he m ain bat t ery pack t o be replaced. I t is recharged aut om atically, when-

ever t he m ain bat t ery pack is connected, wit h acquir e off. The st at e of charge is displayed, as de-

scribed in section 3.4, whenever the unit is internally powered from t he backup battery. To charge

m anually, operate t he pushbut ton several t im es to act ivate the backlight and if t he reading drops

below approxim at ely 70% , charge t he batt ery for about 10 m inut es by connect ing the m ain bat t ery

pack or connect ing to a USB port .

The t ypical service life is 500 charge-discharge cycles.

T4 EEG Am plifier User Manual

2. 5 Use in the home environment

Where the equipm ent is int ended to be used in t he hom e, the unit and it s bat tery should be oper-

ated in it s bag where it is prot ect ed against ingress of solid obj ect s and wat er to a degree of I P22.

The lapt op PC is opt ional in t he hom e environm ent and m ay be used for video recordings. There is

no connect ion bet ween the PC and the T4 Am plifier unit , as all com m unicat ion is accom plished

wirelessly.

Keep t he equipm ent away from sources of heat .

Do not use m obile phones.

Do not allow pets or children t o interfere wit h t he sensor cables.

When t he equipm ent is operat ed with or wit hout it s Bluet oot h or WiFi on, ot her devices in t he vicin-

it y should be m oved away or t urned off t o reduce t he likelihood of interference to t he equipm ent or

by the equipm ent .

The T4 m ay have int ernal radios fitted. These are approved industry-standard Bluet oot h and Wi-Fi

types which present m inim al risk of reciprocal int erference with other equipm ent.

2. 6 Use with ot her equipment

Defibrillators and HF surgical equipment

The equipm ent is not defibrillator proof and should not be used in sit uations where a defibrillator is

likely t o be used.

The equipm ent should not be used wit h, or in the presence of, high frequency surgical equipm ent .

Other patient-connected equipment

When used sim ult aneously wit h ot her patient-connect ed equipm ent , for exam ple a cardiac pace-

m aker or ot her electrical st im ulator, it is unlikely that a safet y hazard will arise. However always

consult t he docum ent at ion supplied wit h t he ot her pat ient -connected equipm ent t o ensure t hat all

hazards, warnings and caut ions are considered before the equipm ent is used t ogether.

Leakage current

This syst em is designed t o com ply wit h I EC 60601-1, t he int ernat ional st andard for m edical elec-

tronic equipm ent , which specifies t he perm issible levels of leakage current . A potential hazard ex-

ist s in t he sum mat ion of leakage current s caused by connect ing several pieces of equipm ent t o-

get her. Because t his syst em can be used in conj unction with st andard elect ronic devices, t he tot al

leakage current should be test ed whenever t he system is m odified.

There should be no electrical connect ions between t he syst em equipm ent , which is powered via a

m edical grade power supply, and any ot her equipm ent powered from anot her m ains supply.

2. 7 Interference

The T4 will cont inue to operate in the presence of radio frequency m agnetic fields ( RF) and the ef-

fect s of elect rost at ic discharges ( ESD) and other int erference, in accordance wit h t he requirem ent s

of EN60601- 1 - 2. However, the T4 am plifier records signals of very low am plit ude, and t hese sig-

nals t hem selves are not im m une t o the effect s of RF, ESD and low-frequency m agnet ic field inter-

ference. Such int erference m ay cause signal artefacts.

The T4 m ay have int ernal radios fitted. These are approved in dust ry -st andard Bluet ooth and Wi-Fi

types which present m inim al risk of reciprocal int erference with ot her equipm ent.

However, w hen the equipm ent is operat ed with or wit hout it s Bluetooth or WiFi on, ot her devices in

the vicinity should be m oved away or t urned off t o reduce t he likelihood of int erference to t he

equipm ent or by t he equipm ent

Ca ut ion : When in close proxim ity to the am plifier, do not use m obile phones, t ransm itt ers, power

transform ers, m otors, or ot her equipm ent t hat generat es m agnetic fields. Refer t o t he Appendix for

m ore inform at ion.

N ot e : Medical elect rical equipm ent needs special precautions regarding EMC and needs t o be in-

st alled and put into service according t o t he EMC inform at ion provided in t he Appendix.

T4 EEG Am plifier User Manual

2. 8 Maintenance and cleaning

The T4 Am plifier and it s accessories require no rout ine t esting, calibrat ion or m aint enance proce-

dur es apart from occasional cleaning and checking for wear and dam age t o all part s including t he

accessories.

No servicing or m aint enance of t he equipm ent should t ake place while in use w ith a pat ient , except

for replacem ent of t he external bat t ery.

Clea ning

Prior t o each re-use of t he system , all the out er surfaces of t he T4 Am plifier, bag and power pack

m ay be cleaned, as required, wit h a clot h m oist ened wit h a m ild detergent solut ion.

Disinfection of t he equipm ent can be carried out by t he use of QAC-based disinfectant s. Wipes are

recom m ended in order t o prevent t he ingress of any liquid int o t he equipm ent . Suitable products

include Mikrozid Sensit ive Wipes ( Schülke & Mayr Gm bH) , Micr obac fort e ( Paul Hart m ann AG) , Dis-

tel Wipes (Tristel Ltd.) .

For cleaning inst ructions for the lapt op refer t o t he m anufact urer’s docum ent at ion.

Ca ut io n: Do not allow any liquid to ent er t he case of any inst rum ent or connect or. Do not use ace-

t one on any of t he inst rum ent s.

2. 9 Disposal of equipment

The expected service life of t he equipm ent , part s and accessories is t hree years, except for t he

USB Powerbank bat t ery pack w hich is two years. When t he device and it s part s and accessories has

reached the end of its operating life, it should be disposed of in accordance wit h local wast e regula-

tion authorit y t hat is t ypically wit hin the local governm ent office.

Ca ut io n: Do not dispose of bat t eries by incinerat ion.

3 Connections and usage

3. 1 Overview

Mains

power

Medical grade

laptop mains

PSU

Laptop PC

Patient

EEG

electrodes

T4 Amplifier

Battery pack & bag

optional

Patient

isolation

zone

To USB

port

Clinical use:

Wireless or USB cable connection

Type BF

AUX

SpO

Pushbutton

Figure 1 Con n e ct ing t he T4 Am plifie r – Clinical Use

Where t he ent ire T4 system including the PC is used within t he patient environm ent , t he m ains

leakage currents and safet y and regulat ory requirem ent s are m et by t he use of t he special m edi-

cal-grade lapt op power supply.

T4 EEG Am plifier User Manual

Mains

power

Medical grade

laptop mains

PSU

Laptop PC

optional for

home use

Patient

EEG

electrodes

T4 Amplifier

With battery pack

in bag

Patient

isolation

zone

Home use:

Wireless only (no electrical

connection to PC)

Type BF

AUX

SpO2

Pushbutton

Figure 2 Con n e ct ing t he T4 Am plif ie r - H om e Use

The lapt op PC is optional for hom e use where it m ay be used for video recordings. There is no con-

nection between t he PC and the T4 Am plifier unit, as all com m unicat ion is accom plished wirelessly.

3. 2 Laptop installation and operation

W ARN I N G: The lapt op m u st on ly be con nect e d t o t he m e dica l-gra de la pt op pow e r supply

sup plie d or a u t hor ise d by Life lines. Do n ot u se a sta nda rd la pt op pow er su pply.

Only use t he lapt op su pplie d or aut h or ise d by Lifelin e s.

1. Connect t he power cord t o t he m edical-grade power supply.

2. Connect t he power supply out put to t he power input connect or on the lapt op.

3. Connect t he power cord to m ains power outlet .

4. Not e t hat t he m ains power cord serves as a power disconnect device. I t should be inst alled

near the equipm ent and be easily accessible.

5. For laptop inst allation and operat ion refer t o the m anufacturer’s instruct ions supplied with it.

3. 3 Connecting the T4 System

Clinical Use

The T4 Am plifier is opt ionally housed inside it s bag with bat t ery or used st andalone. I t is plugged

into t he PC USB port using the cable supplied, part num ber 1277 as shown below, or a wireless

connect ion can be used inst ead. The USB Cable is plugged int o t he rear housing of t he T4 Am plifier

using t he RJ45 plug and int o any USB port on t he lapt op PC.

W arning: Do not plug the cable int o any ot her equipm ent ot her t han t he lapt op PC provided wit h

t he syst em .

Note: I n transport able, i.e. body-worn sit uat ions wit hin t he clinic, t he Am plifier m ust be housed in-

side it s bag aft er being disconnected from t he PC, for prot ection against spillage of liquids.

T4 EEG Am plifier User Manual

Hom e Use

The T4 Am plifier is bat tery powered and is housed inside its bag where it is prot ect ed against in-

gress of solid object s and wat er to a degree of I P22. The lapt op PC is opt ional and m ay be used for

video recordings. There is no connection between t he PC and t he T4 Am plifier unit , as all com m uni-

cat ion is accom plished wirelessly.

Note that for Hom e Use applications, the pat ient should be given a Patient I nst ruction Sheet, which

det ails essent ial usage and safet y inst ruct ions concerning t he equipm ent and battery replacem ent .

Refer to t he Pat ient I nst ruction Sheet for details.

Est im at ing the precise recording t im e of t he battery is difficult as it depends on the num ber of

channels, whet her Bluet ooth or Wi-Fi are enabled, oxim eter use, etc. For recordings over 24 hours

in lengt h it is recom m ended t hat t he pat ient is given instruct ions to replace t he bat tery every 24

hour s.

Connect ing t h e T4 Am plifie r

The t op face of t he T4 houses t he display and t he patient event pushbut t on. For display det ails re-

fer to sect ion 3.3 below. Pressing t he pushbut t on records a pat ient event and illum inat es the back-

light of the display.

Above t he pushbut t on is a circular apert ure which houses a light level sensor.

Figure 3 Con n e ct ing t h e T4 Am plifie r ( f r ont fa ce)

The front face of t he Am plifier’s PCU is laid out in a st andard 10-20 form at (T4 PCU 24+ 8) or a grid

layout ( T4 PCU 64+ 4). I t accom modates standard t ouchproof elect rode leads fit ted wit h DI N 42802

connect or s.

W ARN I N G: The Am plifier accepts standard 1.5 m m t ouchproof electrodes using DI N 42802-style

connect ors. To ensure pat ient safet y, t he electrodes used m ust be approved t o t he Medical Device

Directive 93/ 42/ EEC in Eur ope or to t he relevant local st andards out side Europe.

CAUTI ON : The conduct ive part of elect rodes and their connect ors, including the Neut ral elect rode,

should not cont act other conduct ive part s including earth.

W ARN I N G: Carefully rout e patient cabling t o reduce t he possibility of pat ient entanglem ent or

st rangulation.

The t op edge of t he Am plifier provides for several ot her connect ions, as shown below.

Figure 4 Con n e ct ing t h e T4 Am plifie r ( back f a ce )

T4 EEG Am plifier User Manual

1. Nonin Xpod: t he circular connect or allows for t he connect ion of a Nonin Xpod pulse oxim e-

ter for m easuring SpO2. This is plugged into t he circular connector and t he appropriat e sen-

sor plugged int o t he Xpod device. Not e t hat Lifelines does not supply sensors and t hese will

need t o be sourced separat ely.

Note: the Nonin Xpod should not be used if m ore t han 32 channels are on.

Refer t o t he m anufact urer’s inst ructions supplied with t he sensor w hen fitting it to t he pa-

tient.

The appropriate recording setup will need to be used as described in section 4.1.

2. Aux1: a 3.5m m m ono j ack connector allows for t he connect ion of t he Sleepsense body po-

sit ion sensor, t ype 1575, for hospital and clinic use. Not for hom e use.

3. Patient Event : t his 3.5m m j ack connector allows for the connection of a st andar d Patient

Event Thum b Swit ch.

CAUTI ON : All t hese connect ions ar e t ype BF isolated. The conductive part of connect ors

and t ransducers should not cont act ot her conduct ive part s including eart h. Always ensure

that the t ransducer fit ted is suit able for a connect ion of t his t ype.

4. Micro-SD m em ory car d slot .

5. Host connect ion RJ45 socket .

W ARN I N G: Cables m ust be rout ed carefully t o avoid risk t o the pat ient of ent anglem ent and

st rangulation.

3. 4 Starting the system

To st art the syst em proceed as follows:

• Plug t he PC int o the m ains supply.

• Swit ch on t he PC and wait for Windows t o load.

• Ensur e T4 Am plifier is connect ed via t he USB lead.

• Launch Trackit applicat ion and cont inue as det ailed in section 4.

• These procedures also apply following a m ains int errupt ion.

Indicators

The following indicat ors are shown on the display on the t op face of the T4:

















Where t he sym bols indicat e t he fields to t he right t o have the following m eanings:

 Current t im e, hh: m m

 Elapsed recording t im e, hh: m m (‘- - :- - ‘ if not recording)

 Battery capacity, % or ‘USB’ if ext ernal power applied

 Micro-SD card storage capacit y in Mbyt es, xxxx M ( rem aining capacit y if recording)

B If t he internal Bluet oot h option is fit t ed, t his indicat es t hat it is on. Pressing t he pushbutton 4

tim es wit hin 4 seconds t oggles t he setting t o off, indicated wit h a b. I f t he Bluet ooth opt ion is

not fitted, not hing is displayed.

W I f the int ernal WiFi option is fit t ed, t his indicates that it is on. Pressing t he pushbutton 5

tim es wit hin 4 seconds t oggles t he setting t o off, indicated wit h a w. I f t he WiFi option is not

fitted, not hing is displayed.

Ψ Whenever a wireless connection is made the ψ symbol is displayed.

L/ R Recording in progress

R Recording in progress

L Recording and Low m em ory card capacit y rem aining ( < 8 m inut es) during recording

( accom panied by audit ory beep every 30 seconds)

* When t he battery is low, t here is an audit ory beep at 1Hz rate. There is no addit ional

inform at ion displayed.

T4 EEG Am plifier User Manual

3. 5 Shutdown of the system

At t he com plet ion of a st udy proceed as follows t o shut down t he system :

• St op t he recording by pressing t he ‘PC Record Off’ but ton

• Exit the Trackit program .

• Shut down Windows.

• Swit ch off t he PC and disconnect t he m ains supply.

After t he recording is finished, t he Micro-SD m em ory card is rem oved for reading in a PC.

3. 6 Bat tery replacement and charging

For am bulatory, body-worn applications t he T4 is powered from a USB Power Bank. The T4 plugs

direct ly into t he USB port on t he Power Bank. Ensure that t his uses the 1A socket on t he Power

Bank. Aft er connect ion, press the green ‘ON’ pushbutton on t he side of t he bat tery.

1 2

Open zip at bot tom of bag to access bat tery I nsert charged batt ery into bag

Unplug cable from bat t ery Plug cable int o batt ery

Wit hdraw discharged bat tery from bag Turn bat t ery on using but t on on side

Do not connect cable to any ot her equipm ent Close zip

W ARN I N G: The Am plifie r m ust only be used w it h t he USB Pow e r Ban k supplie d or au-

t horise d by Life lin e s.

• Do not short circuit t his device. To avoid short circuit , keep the device away from any m et al

obj ect s (e.g., hair clips and keys).

• This device m ay get hot during use, and this is norm al. Hold carefully.

• This unit is not user repairable.

• Do not heat this device or t hrow it int o a fire.

• Do not drop or place t he unit under a heavy object .

• Keep t his device away from high tem perat ure, wet, or dusty environm ent s.

• During charging keep t he device out in t he open t o allow excess heat to dissipat e.

• Charge M5 for 4 hours / M10 for 8 hours before init ial use.

• Keep t he USB out put port and m icro-USB input port clean and free of obst ruction.

• For additional inst ructions, consult the docum ent at ion supplied wit h t he bat t ery.

To replace t he batt ery in the Bag, unzip t he bottom of t he Bag to gain access t o t he battery con-

nection. Unplug t he USB connection t o t he bat t ery and replace with a fully charged unit .

When not connect ed to t he T4 unit , t he bat t ery is charged by using t he m icro-USB socket and con-

nect ing to a standard USB port , using t he supplied cable.

Ba t t er y Char gin g

Connect the m icro-USB charging cable supplied to t he Bat t ery and use a USB connection for charg-

ing. The bat tery capacit y display will illum inat e to show how m uch of t he battery is charged. Once

all t he LEDs are lit , t he batt ery is fully charged and is ready for use.

For additional inst ructions, consult the docum ent at ion supplied wit h t he bat tery.

Do not charge t he bat t ery when used in the Hom e Environm ent .

W ARN I NG: Do n ot char ge t he ba t tery w h ilst it is con n e ct ed t o t he T4 u nit .

W ARN I NG: Do n ot char ge t he ba t tery w h e n t h e e quipm ent is in use .

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