Lifelines neuro R40 User manual

R40 EEG System User Manual
2
Version History
V1.0 (24th June 2014)
•Initial release
V1.1 (7th July 2014)
V1.2 (31st July 2014)
V1.3 (18th September 2014)
V1.4 (29th September 2014)
•Various amendments for IEC 60601-1 3rd edition
•Amended Appendix 5 compliance levels.
V1.5 (17th October 2014)
•Added statements and warnings concerning multiple socket outlets to section 2.4
•Added statement that assembly and modification require evaluation to IEC 60601-1 in section 2.
V1.6 (27th October 2014)
•Amended operating temperature for PC in section 2.2
V1.7 (24th November 2014)
•Added caution in section 1.2 ‘Do not touch simultaneously...’
•Updated picture on front page and minor corrections (5/2/2105)
V1.8 (19th November 2015)
•Added “CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician” on
page 8.
•Added “FDA cleared for use in USA” to EEG electrode warning on page 8.
•Amended “Indications for Use” statement on page 8 and deleted “Intended Use”.
•Added “Compliance is provided by the recommended PC equipment” to Electromagnetic Immunity ta-
bles in Appendix 5.
•Changed EN references to IEC.
•Amended sampling rate and bandwidth specifications.
•Electromagnetic immunity compliance level amended on pages 39 & 40.
V1.9 (27th February 2018)
•Added disinfection information in section 2.6.
•Added device lifetime in section 2.7.
•Change of N.B. to 0086 (BSI).
V1.10 (19 July 2019)
•Updated with new cart design and Lenovo PC
•Software section updated
•EMC warnings and information updated
V1.11 (14 Oct 2019)
•Notified Body change and EC Rep information added.
•Updated with new Cover page and images.

R40 EEG System User Manual
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Lifelines Ltd,
7 Clarendon Court,
Over Wallop, near Stockbridge,
Hampshire SO20 8HU, UK
Telephone [phone]
www.LLines.com
[e-mail]
Incereb Ltd.
3015 Lake Drive
Citywest
Dublin
D24 DKP4
Ireland
2797
Doc No: 1338
Part No: 1338
Issue: 1.11
CCN: CCN121
Created:
Checked:
Approved:
Digitally signed by Geoff
Salter
Date: 2019.11.20 11:13:07 Z
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2019.11.20 12:46:47 Z
Digitally signed by Geoff
Salter
Date: 2019.11.20 12:48:21 Z

R40 EEG System User Manual
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Disclaimers & Warranties
The information in this section is subject to change without notice.
Except as stated below, Lifelines Ltd makes no warranty of any kind with regard to this material, including, but
not limited to, the implied warranties of merchantability and fitness for a particular purpose. Lifelines shall not
be liable for errors contained herein or for incidental or consequential damages in connection with the furnish-
ing, performance or use of this material.
Lifelines shall warrant its products against all defects in material and workmanship for one year from the date
of delivery.
Misuse, accident, modification, unsuitable physical or operating environment, improper maintenance or dam-
age caused by a product for which Lifelines is not responsible will void the warranty.
Lifelines do not warrant uninterrupted or error-free operation of its products.
Lifelines or its authorised agents will repair or replace any products that prove to be defective during the war-
ranty period, provided that these products are used as prescribed in the operating instructions in the user’s
and service manuals.
No other party is authorised to make any warranty to assume liability for Lifelines products. Lifelines will not
recognise any other warranty, either implied or in writing. In addition, services performed by someone other
than Lifelines or its authorised agents or any technical modification or changes of products without Lifelines
prior, written consent may be cause for voiding this warranty.
Defective products or parts must be returned to Lifelines or its authorised agents, along with an explanation of
the failure. Shipping costs must be prepaid.
Lifelines Ltd. manufactures hardware and software to be used on or with standard PC-compatible computers
and operating software. Lifelines, however, assumes no responsibility for the use or reliability of its software or
hardware with equipment that is not furnished by third-party manufacturers accepted by Lifelines at the date
of purchase.
All warranties for third-party products used within the R-40 system are the responsibility of the relevant manu-
facturer. Please refer to the relevant documentation on each product for further details.
This document contains proprietary information that is protected by copyright. All rights are reserved. No part
of this document may be photocopied, reproduced in any other form or translated into another language with-
out the prior written consent of Lifelines.
Trademarks
Microsoft, Windows and Windows NT are registered trademarks of the Microsoft Corporation. All other trade-
marks and product names are the property of their relevant owners.
Responsibility of manufacturer
The manufacturer and distributor consider themselves responsible for the equipment’s safety, reliability and
performance only if:
•any peripheral equipment to be used with the R-40 system is supplied by third-party providers recom-
mended by the manufacturer;
•assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons
authorised by the manufacturer;
•the electrical installation of the relevant room complies with the appropriate requirements;
•the equipment is used by a health-care professional and in accordance with the instructions for use.
Note: the manufacturer has a policy of continual product improvement; hence the equipment specifications
are subject to change without notice.
Check with Lifelines or your distributor if a software update is available.
Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the Appendix.

R40 EEG System User Manual
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Software and Virus Protection
Lifelines takes all reasonable steps to ensure that its software is virus-free. In line with modern computing prac-
tice, it is advisable that continual protection against viruses, Trojans, malware, adware etc. is provided on the
PC used for installation and the surrounding systems. Please note the following recommendations which
should be supported by your internal IT/Computing department procedures and practices:
1. Virus protection software should be installed on every computer at risk of infection. This software
should have a resident (online) shield and provide email scanning if appropriate.
2. Virus scanning should be set to manual mode or automatic if desired but at a time when the system is
not being used.
3. All programs offering auto-update features, including Windows, should be set to manual or automatic if
desired but at a time when the system is not being used.
4. Adopt formal departmental or organisational procedures to ensure the integrity and safe operation of
the medical equipment and supporting systems.

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Contents
Version History 2
Disclaimers & Warranties 4
Trademarks 4
Responsibility of manufacturer 4
Software and Virus Protection 5
Contents 6
Illustrations 8
1System Overview and Technical Description 9
1.1 General description 9
1.2 Cautions and Warnings 9
1.3 Explanation of symbols 11
1.4 The system and its parts 12
1.5 Specifications and safety 12
1.6 Description of the components 13
1.7 Replaceable parts 14
2Installation and Maintenance 15
2.1 Checks for completeness and integrity 15
2.2 Environmental parameters for operation 15
2.3 Power supply connections 15
2.4 Use with other equipment 16
2.5 Interference 16
2.6 Maintenance and cleaning 17
2.7 Disposal of equipment 17
3Connections and usage 18
3.1 Overview 18
3.2 Connecting the R-40 System 19
3.3 Starting the system 21
3.4 Shutdown of the system 21
4Trackit Software - setup and recording software 22
4.1 Overview 22
4.2 Trackit Control Panel 23
4.3 Defining Input Signals 26
4.4 Setting up the Inputs and Recording channels 27
4.5 Starting a Recording 29
4.6 Recording Control Panel (Amplifier recording) 31
4.7 View EEG Signal Traces 33
4.8 Calibration Check 34
4.9 Impedance Check 34
4.10 Events 35
4.11 Montage Editor 36
4.12 Reading an EEG recording 37
4.13 Advanced Settings 38
Appendix 1: Specifications 42
R-40 Amplifier Specifications 42
Lenovo ThinkCentre All-in-One PC Specifications 44
Lifelines Photic Stimulator 44
Appendix 2: Photic Stimulator and Hyperventilation 45
Photic Stimulation 45
Hyperventilation 46
Appendix 3: Additional Events Information 47

R40 EEG System User Manual
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Appendix 4: PC Setup 50
Appendix 5: Manufacturer’s Declaration 52
EMC Compatibility 52

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Illustrations
Figure 1 Connecting the R-40 System 18
Figure 2 Connecting the R-40 Amplifier (top face) 20
Figure 3 Connecting the R-40 Amplifier (front face) 20
Figure 4: Trackit Software ‘File’ Toolbar 22
Figure 5: Trackit Software ‘Home’ Toolbar 22
Figure 6: Trackit Software "Settings Toolbar 23
Figure 7: Trackit Software 'Help' Toolbar 23
Figure 8: Trackit Control Panel 24
Figure 9: Connect Dialog Box 24
Figure 10: Trackit Control Panel "Status B" 26
Figure 11: Signal List 26
Figure 12: Signal Editing Tool 27
Figure 21: EEG setup 27
Figure 14: Setup Recording dialog 28
Figure 15: Channel setup 29
Figure 16: Recording Channel editing 29
Figure 25: New Patient dialog 30
Figure 18: New Patient database 30
Figure 19: Recording Control panel 32
Figure 20: EEG Signal trace display 33
Figure 21: Adjust display parameters 34
Figure 22: Impedance check 34
Figure 23: Continuous Impedance Check 35
Figure 24: Event Viewer 36
Figure 25: Montage Editor 37
Figure 26: Defaults Tab 1 39
Figure 27: Defaults | Tab 2 40
Figure 28 Photic Stimulation 45
Figure 29 Photic Stimulation control window 45
Figure 30 Hyperventilation 46
Figure 31 Hyperventilation control window 46
Figure 32 User Events 48
Figure 33 Events Template setup 48
Figure 34 Free-text Event 49
Figure 35 Event List 49
Figure 36 Options Tab 1 50
Figure 37 Options Tab 2 50
Figure 38 Options Tab 3 51

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1System Overview and Technical Description
1.1 General description
Indications for use
The R-40 EEG System is intended to measure and record EEG signals and is used as an aid in the diagnosis of
neurophysiological disorders.
General description
The R-40 EEG System is a multi-channel electroencephalograph designed for use in routine EEG and lab moni-
toring applications.
The system uses the compact R-40 USB 40-channel amplifier which incorporates 32 referential channels and 8
polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin XPOD interface
is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector.
The system includes a PC and monitor, for control and storage, powered by a medical-grade power supply and
an optional USB Photic Stimulator and arm. The system is mounted on a special wheeled cart, which houses all
components and allows convenient mobility.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with
other methods of patient diagnosis. The equipment does not sustain or support life.
Intended User
The intended user of the equipment is a healthcare professional who has the training and knowledge to
undertake EEG examinations and is familiar with EEG equipment and practice.
1.2 Cautions and Warnings
CONTRAINDICATIONS: Do not use the R-40 EEG System in an MRI environment, in an explosive atmosphere or
during defibrillation.
WARNING: This equipment is intended to be used by a healthcare professional and in accordance with these
instructions for use which must be read in their entirety before the device is used.
WARNING: This equipment in intended only as an adjunct device in patient assessment; it must be used in
conjunction with other methods of patient diagnosis. This equipment is not be used for the determination of
brain death.
WARNING: Lifelines does not supply EEG electrodes. The unit accepts standard 1.5 mm touchproof electrodes
using DIN 42802-style connectors. To ensure patient safety, the electrodes used must be approved to the
Medical Device Directive 93/42/EEC in Europe or FDA cleared for use in USA.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
WARNING: Lifelines does not supply the Nonin sensor. Only use the ‘PureLight’ sensors specified by Nonin to
be used with their Oximeters.
CAUTION: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in the Appendix.
CAUTION: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the R40 EEG System, including cables
specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
CAUTION: When in close proximity to the R40 EEG System, do not use mobile phones, transmitters, power
transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for more
information.
WARNING: The function or safety of the equipment could be impaired if it has been subjected to unfavourable
conditions in storage or in transit. If at any time function or safety is thought to be impaired, the instrument
should be taken out of operation and secured against unintended use.
WARNING: Do not open or modify the equipment without the authorization of the manufacturer.
CAUTION: Before transportation, the system should be put into its transportation position to reduce the risk of
overbalancing: disconnect mains supply cable; lower work top to lowest position; fully retract arms; release
brakes.
CAUTION: Do not exceed the Safe Additional Working Load of 4 kg on the work-top.

R40 EEG System User Manual
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CAUTION: Do not touch simultaneously any accessible USB or other contacts on the PC or monitor and the pa-
tient.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

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1.3 Explanation of symbols
Type BF equipment Follow operating instructions
Input/output connection Input connection
Special recycling required, do not dispose of in landfill. When this equipment has reached the
end of its useful life, it must be disposed of in an environmentally-friendly way. Waste
electrical and electronic equipment (WEEE) requires special procedures for recycling or
disposal. This includes batteries, printed circuit boards, electronic components, wiring and
other elements of electronic devices. Follow all of your respective local laws and regulations
for the proper disposal of such equipment. Contact your local distributor for information
concerning this.
Consult warnings in User Manual Bluetooth
Internal radio device WLAN WiFi
Sitting prohibited
Pushbutton Nonin Xpod Pulse Oximeter
Manufacturer European Representative
DC power Protective earth (ground)
Equipotentiality Electrocap
Internal battery hazard –
refer to section 1.7.
Storage and transport symbols
Temperature limits Fragile Keep dry
Relative humidity limits Barometric pressure limits
-10
+50
°C
10
95
%RH
500
1060
hPa
Pushing Prohibited
(When not in Transport Position)

R40 EEG System User Manual
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1.4 The system and its parts
The R-40 EEG System is a multi-channel electroencephalograph designed for use in routine EEG and lab moni-
toring applications.
The system uses the compact R-40 USB 40-channel amplifier which incorporates 32 referential channels and 8
polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin XPOD interface
is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector.
The system includes a PC for control and storage, a video monitor, a medical-grade power supply and an op-
tional USB Photic Stimulator and arm. The system is mounted on a special wheeled cart, which houses all com-
ponents and allows convenient mobility.
The system uses a specific PC and medical grade power supply. Refer section 3.1 for details.
Caution:
Only use the PC supplied or authorised by Lifelines
Only use the medical-grade mains power supply with it as supplied or authorised by Lifelines
The R-40 EEG System comprises the following components:
R-40 Amplifier part number 1326
Amplifier USB Cable part number 1277
EEG System (Full System) part number 1396
Cart, adjustable height part number 1296
Arm (for Photic or R-40 Amplifier) part number 1291
Photic Stimulator part number 1290
Photic USB Cable part number 1241
Xpod Pulse Oximeter Nonin part number 1327
Patient Event Pushbutton part number 1353
Note: The Oximeter sensor is a consumable and is not supplied by Lifelines. Only use the ‘PureLight’ sensors
specified by Nonin for use with their Oximeters.
Note: If using the Photic Stimulator refer to the User Manual supplied with it.
1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The system has been certified and complies with the following standards:
IEC 60601-1 and
IEC 60601-2-26
European standard for medical electrical equipment, general require-
ments and particular requirements for EEG systems.
ANSI/AAMI ES 60601-1
AAMI Deviations from IEC 60601-1 (USA).
CAN/CSA 22.2 No 601.1 M90
Canadian standard for medical electrical equipment, general require-
ments.
IEC 60601-1-2
European standard for medical electrical equipment, EMC requirements,
calling:
CISPR11
Conducted Emissions, Group 1, Class B
CISPR11
Radiated Emissions, Group 1, Class B
IEC61000-4-2
Electrostatic Discharges
IEC61000-4-3
Immunity - Radiated RF Field
*IEC61000-4-4
Immunity - Transients Bursts
*IEC61000-4-5
Immunity – Surges
IEC61000-4-6
Immunity – Conducted
IEC61000-4-8
Immunity – Power frequency fields
*IEC61000-4-11
Immunity – Voltage dips, interruptions
IEC61000-3-2
Harmonic Emissions
*IEC61000-3-3
Voltage Fluctuations/flicker
*Note: Compliance is provided by the PC

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Classification of system
Degree of protection against electrical shock Class I. Type BF applied parts
Type of protection against electrical shock Optically isolated USB amplifier
Mains isolated power supply for PC
Degree of protection against harmful ingress of water Ordinary (no protection)
Mode of operation Continuous
Degree of safety of application in the presence of a
flammable anaesthetic mixture with air or with oxygen
or nitrous oxide
Not suitable
1.6 Description of the components
The R-40 Amplifier
The R-40 USB 40-channel amplifier incorporates 32 referential channels and 8 polygraphic channels with built-
in calibration and electrode impedance measurement. A Nonin XPOD interface is provided, a Patient Event in-
put, 2 Aux DC inputs and an Electrocap connector. The Amplifier has built in type-BF patient isolation and has a
USB interface to the PC.
Applied parts
EEG Electrodes
The amplifier connects to standard 1.5mm touchproof EEG recording electrodes arranged in a standard 10-
20 pattern, attached to the patient’s head.
WARNING: Lifelines does not supply EEG electrodes. The Amplifier accepts standard 1.5 mm touchproof
electrodes using DIN 42802-style connectors. To ensure patient safety, the electrodes used must be ap-
proved to the Medical Device Directive 93/42/EEC in Europe or to the relevant local standards outside
Europe.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode,
should not contact other conductive parts including earth.
Oximeter Sensor
An optional oximeter sensor attaches to the patient’s finger.
Patient Event pushbutton
The Patient Event Pushbutton is used by the patient to record the instance of a significant event.
Aux DC Inputs
The Auxiliary DC inputs are intended for the connection of patient-attached transducers which are passive
or battery-powered such as sleep sensors. They must be insulated with no accessible conductive parts.
USB Cable
The Amplifier plugs directly into a USB port on the PC.
WARNING: The Amplifier must only be used with the USB cable provided with the unit.
Medical grade AC/DC mains power supply module for PC
Where EEG studies are conducted within the patient environment the leakage current must be controlled. The
PC power supply supplied by Lifelines is a special medical-grade type (with appropriate safety standards), which
limits the mains leakage current of the system. It is rated for 90V – 230V input voltage.
WARNING: The PC must only be connected to the medical-grade laptop power supply supplied or author-
ised by Lifelines. Do not use the standard, non-medical grade, power supply.
Only use the PC supplied or authorised by Lifelines.
The Setup and Recording Software
The R-40/Trackit setup software runs under Microsoft Windows 2000 (with SP2), Windows XP, Windows Vista,
Windows 7, Windows 8.1 or Windows 10 on the host PC and is used to setup and review the R-40 Amplifier and
to record on to the PC.

R40 EEG System User Manual
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Functions of the software:
Setup the input signals. See Section 4.3
Setup and download the recording template. This includes which electrodes are used and the recording
montage. See section 4.4.
Perform a calibration check of the Amplifier. See section 4.8.
Perform an Impedance check on the Amplifier. See Section 4.9.
Perform an EEG recording. See Section 4.5.
View on-going EEG traces. See Section 4.7.
Review an EEG Recording. See Section 4.12
1.7 Replaceable parts
Lifelines Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibration in-
structions, or other information that will assist service personnel to repair those parts that are designated by
Lifelines Ltd. as repairable by service personnel.
Internal battery replacement – service personnel only
The R-40 amplifier contains a replaceable lithium ion rechargeable coin cell, type LIR2450.
WARNING: Battery replacement by inadequately trained personnel could result in a hazard. It must
be replaced only with the correct type and it must be installed correctly with +ve uppermost.
1. Remove four screws from underside of instrument and remove bottom of case.
2. Un-clip the wrap-around screen to expose the battery beneath.
3. Grasp battery between thumb and forefinger and pull it from the socket.
4. Push replacement battery into the socket ensuring +ve is uppermost.
5. Re-clip the wrap-around screen and reassemble the case.
Battery safety instructions
Do not attempt to open, puncture, disassemble or modify the battery in any way.
Do not subject the battery to sudden shock or heat.
Do not dispose of battery in fire.

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2Installation and Maintenance
WARNING: The following section must be read and understood before the equipment is switched on.
Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the Appendix.
The function or safety of the equipment could be impaired if it has been subjected to unfavourable conditions
in storage or in transit. If at any time function or safety is thought to be impaired, the instrument should be
taken out of operation and secured against unintended use.
The manufacturer should be contacted (details on page 3) for assistance, if needed, in setting up, using or
maintaining the equipment; or to report unexpected operation or events.
The assembly of the system and any modifications during its service life require evaluation to the requirements
of IEC 60601-1.
2.1 Checks for completeness and integrity
1Remove the equipment from the packaging case(s).
2Use the parts list to check that all ordered items have been received.
3Assembly instructions for third-party products will be found in their packing cases. It is recommended
that these instructions be filed with the R-40 system technical reference materials.
4Check for signs of damage that may have occurred during transit or storage. If any damage is found, do
not use the instrument; contact your distributor.
2.2 Environmental parameters for operation
The operational and storage/transportation environmental conditions are as follows:
Operational: R-40 Amplifier and Photic
Temperature +10°C to +40°C
Relative humidity 25% to 95% non-condensing
Atmospheric pressure 700mB to 1060mB
Operational: All-in-one PC
Temperature +10°C to +40°C
Relative humidity 20% to 80% non-condensing
Atmospheric pressure 700mB to 1015mB
Consult the documentation supplied with the PC equipment for additional details.
WARNING:
Do not obstruct any cooling slots.
Position the equipment so that air flows freely.
Storage and transport: R-40 Amplifier and Photic
Temperature -10°C to +50°C
Relative humidity 10% to 95% non-condensing
Atmospheric pressure 500mB to 1060mB
Storage and transport: All-in-one PC
Temperature -40°C to +65°C
Relative humidity 5% to 95% non-condensing
Atmospheric pressure 238mB to 1015mB
2.3 Power supply connections
Power requirements
•Medical grade AC mains power supply module for PC / Laptop
oMains power input: 90 – 264 VAC, 47–63 Hz, 1.4 A @ 115 Vac, 0.7 A @ 230 Vac.
oOutput: 20 Vdc, 5.25 A.

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oMaximum power: 105 W
•R-40 Amplifier and Photic (USB)
o5VDC (USB Port)
oMaximum power: 2.5 W
Mains power connections
The system operates with a medical-grade mains power supply. The mains input accepts a standard IEC320
three pin mains connection cable.
When the mains plug is designed to hold a fuse, a 3A-rated fuse should be used.
WARNING:
1. This equipment must only be connected to a supply mains with protective earth.
2. Always use the power lead and connector supplied with the R-40 system, or a lead and connector of equiva-
lent standard.
3. Do not use adaptor plugs or extension leads unapproved by Lifelines.
4. Only appropriately trained and qualified personnel should adjust, maintain or repair this equipment.
5. Always disconnect the equipment from the main power supply before removing any covers.
2.4 Use with other equipment
Defibrillators and HF surgical equipment
The equipment is not defibrillator proof and should not be used in situations where a defibrillator is likely to be
used.
The equipment should not be used with high frequency surgical equipment.
Other patient-connected equipment
When used simultaneously with other patient-connected equipment, for example a cardiac pacemaker or
other electrical stimulator, it is unlikely that a safety hazard will arise. However always consult the documenta-
tion supplied with the other patient-connected equipment to ensure that all hazards, warnings and cautions
are considered before the equipment is used together.
Leakage current
This system is designed to comply with IEC 60601-1, the international standard for medical electronic equip-
ment, which specifies the permissible levels of leakage current. A potential hazard exists in the summation of
leakage currents caused by connecting several pieces of equipment together. Because this system can be used
in conjunction with standard electronic devices, the total leakage current should be tested whenever the sys-
tem is modified.
There should be no electrical connections between the system equipment, which is powered via the isolated,
medical grade power supply, and any other equipment powered from a non-isolated mains supply.
2.5 Interference
The R-40 will continue to operate in the presence of radio frequency magnetic fields (RF) and the effects of
electrostatic discharges (ESD) and other interference, in accordance with the requirements of IEC60601-1-2.
However, the R-40 amplifier records signals of very low amplitude, and these signals themselves are not im-
mune to the effects of RF, ESD and low-frequency magnetic field interference. Such interference may cause
signal artefacts.
The R-40 may have internal radios fitted. These are approved industry-standard Bluetooth and Wi-Fi types
which present minimal risk of reciprocal interference with other equipment.
Caution: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the R40, including cables specified by
Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
Caution: when in close proximity to the amplifier, do not use mobile phones, transmitters, power transformers,
motors, or other equipment that generates magnetic fields. Refer to the Appendix for more information.

R40 EEG System User Manual
17
Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the Appendix.
2.6 Maintenance and cleaning
The R-40 System requires no routine testing, calibration or maintenance procedures apart from occasional
cleaning and checking for wear and damage to all parts including the accessories.
Cleaning
All the outer surfaces of the individual pieces of equipment of the R-40 System may be cleaned using a soft
cloth moistened with water and a mild detergent. Each item may also be cleaned using a low-pressure air-line
or a vacuum cleaner.
Disinfection of the equipment can be carried out by the use of QAC-based disinfectants. Wipes are recom-
mended in order to prevent the ingress of any liquid into the equipment. Suitable products include Mikrozid
Sensitive Wipes (Schülke & Mayr GmbH), Microbac forte (Paul Hartmann AG), Distel Wipes (Tristel Ltd.), Mikro-
Kill disinfectant wipes (Medline Industries, Inc.), Sani-Cloth HB Germicidal Wipes (PD International, Inc).
Caution: Do not allow any liquid to enter the case of any instrument or connector. Do not use acetone on any
of the instruments.
2.7 Disposal of equipment
The expected service life of the equipment, parts and accessories is three years. When the equipment and its
parts and accessories has reached the end of its operating life, it should be disposed of in accordance with local
waste regulation authority that is typically within the local government office.

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3Connections and usage
3.1 Overview
Mains
power Medical grade
PC power
supply
All-in-
one PC
To
USB
port s
Patient
EEG
electrodes
Optional
Photic
Stimulator
and arm
Patient
isolation
zone
R-40 Amplifier
mounted on
bracket on Arm
Photic mounted
on Arm
All-in-one PC
System Cart
Cart workt op
height-adjust
lever
VESA mount
R-40 Amplifier
Figure 1 Connecting the R-40 System
The entire R-40 system including the PC can be used within the patient environment. The mains leakage cur-
rents and safety and regulatory requirements are met by the use of the medical power supply connected to the
PC. The current recommended PC is the Lenovo ThinkCentre Tiny All-In-One system.

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19
The PC
1. Fit the Lenovo Tiny PC into the Lenovo monitor in accordance with the installation instructions provided
with the PC.
2. Fit the monitor to the VESA mount. Route the DC Power cable from the power supply, up inside the VESA
mount to the monitor. Connect the DC power cable to the power input of the All-in one monitor.
3. Connect the mouse and keyboard to the rear of the PC in accordance with the installation instructions pro-
vided with the PC. These cables can be neatly routed through the VESA mount pole.
4. Connect the orange power cord to the medical-grade power supply.
5. Connect the country specific power cord to orange mains power cord.
WARNING: The PC must only be connected to the medical-grade laptop power supply supplied or authorised
by Lifelines. Do not use a standard laptop power supply.
Only use the PC supplied or authorised by Lifelines.
The Cart, Arm and Stand
This allows all the system components to be conveniently located on a custom cart. This cart has a height-ad-
justable worktop, large lockable wheels, a medi-rail, VESA display mount and an accessory tray.
Note: The cart is supplied flat-packed - refer to the enclosed instructions for assembly details.
A single mains input cable to the cart is provided, fitted with an earthed 3-pin IEC plug. A country-specific
power cord is provided for different territories. The connector on the cart’s mains cable is a locking type.
Note: The cart should be positioned in use so that disconnection of the mains plug from the supply socket can
be accomplished without difficulty.
The arm will mount on the cart and accommodates either the Photic or the R-40 on its bracket. The arm is also
supplied with a desk-clamp which allows it to be mounted on any convenient flat surface.
When the R40 EEG system is in operation, do not push the cart. Place the cart in the transportation
position before moving it.
CAUTION: Before transportation, the system should be put into its transportation position to reduce the risk of
overbalancing:
•Switch off and disconnect mains cable.
•Lower work top to lowest position.
•Fully retract arms.
•Release brakes.
•Push the cart using the handle on the worktop.
3.2 Connecting the R-40 System
The R-40 Amplifier is plugged into the PC USB port using the cable supplied, part number 1277 as shown below:

R40 EEG System User Manual
20
Figure 2 Connecting the R-40 Amplifier (top face)
The USB Cable is plugged into the bottom housing of the R-40 Amplifier as shown above using the RJ45 plug
and into any USB port on the PC.
The top face of the Amplifier is laid out in a standard 10-20 format, and accommodates standard touchproof
electrode leads fitted with DIN 42802 connectors.
WARNING: The Amplifier accepts standard 1.5 mm touchproof electrodes using DIN 42802-style connectors. To
ensure patient safety, the electrodes used must be approved to the Medical Device Directive 93/42/EEC in Eu-
rope or to the relevant local standards outside Europe.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
Also on the top face of the Amplifier are the electrode impedance check set-level pushbuttons. Adjacent to
each electrode is an LED indicating whether the impedance of the individual electrode is above the set-level.
The top edge of the Amplifier provides for several additional connections, as shown below.
Figure 3 Connecting the R-40 Amplifier (front face)
1. Nonin Xpod: the circular connector allows for the connection of a Nonin Xpod pulse oximeter for
measuring SpO2.
2. Electro-Cap: the 25-way D-type connector allows for the connection of a standard Electro-Cap.
3. Aux1 and Aux2: these two 3.5mm jack connectors allow for the connection of standard transducers
like Body Position, Respiration Belts etc.
4. Patient Event: this 3.5mm jack connector allows for the connection of a standard Patient Event Thumb
Switch.
CAUTION: All these connections are isolated. The conductive part of connectors and transducers should not
contact other conductive parts including earth. Always ensure that the transducer fitted is suitable for a con-
nection of this type.