Lifelines neuro R40 User manual

USER MANUAL
EEG System
®

Lifelines Ltd
1 Tannery House, Tannery Lane,
Woking, Surrey, GU23 7EF UK
Telephone [phone]
www.lifelinesneuro.com
[email protected]
Incereb Ltd.
6 Charlemont Terrace, Crofton Road,
Dun Laoghaire, Dublin, A96 F8W5. Ireland.
Doc No: 51335-006
Part No: 1338
Issue: 2.1
CCN: CCN0153
Created
Checked
Approved
Digitally signed by Geoff
Salter
Date: 2021.12.07 18:37:16 Z
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
[email protected], c=GB
Date: 2021.12.08 10:39:22 Z
Digitally signed by Geoff
Salter
Date: 2021.12.08 15:24:15
Z

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Customer Responsibility
The R40 EEG System is reliable only when operated and maintained in accordance with the instructions contained
in this manual, accompanying labels, and inserts. A defective system should not be used. Parts that may be broken
or missing or those that are clearly worn or contaminated should be replaced immediately with new original
replacement parts that have been manufactured by or are available from Lifelines.
The owner of this system has the sole responsibility for any malfunction resulting from improper use or
maintenance, or repair done by anyone other than a qualified Lifelines representative and for any malfunctions
caused by any parts that have been damaged or modified by anyone other than a qualified Lifelines Neuro
representative.
The owner of this system has the sole responsibility for the connection of this product to other systems not
satisfying the electrical safety requirements class I, type BF, standards IEC 60601-1, IEC 60601-2-26, IEC 60601-1-2
for medical devices.
Customer Responsibility

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Disclaimers & Warranties
The information in this section is subject to change without notice.
Except as stated below, Lifelines 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 furnishing,
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 damage
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 warranty
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 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 R40 system are the responsibility of the relevant
manufacturer. 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 without the
prior written consent of Lifelines.
Trademarks
Microsoft, Windows and Windows NT are registered trademarks of the Microsoft Corporation. All other trademarks
and product names are the property of their relevant owners.
Safety
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Responsibility of manufacturer
The manufacturer and distributor consider themselves responsible for the equipment’s safety, reliability and
performance only if:
yany peripheral equipment to be used with the R40 system is supplied by third-party providers recommended by
the manufacturer;
yassembly operations, extensions, readjustments, modifications, or repairs are carried out by person authorised
by the manufacturer;
ythe electrical installation of the relevant room complies with the appropriate requirements;
ythe equipment is used by a healthcare 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.
Software and Virus Protection
Lifelines takes all reasonable steps to ensure that its software is virus-free. In line with modern computing practice,
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
Disclaimers & Warranties.................................................................................................................................................2
1 Overview and Technical Description............................................................................................................... 6
1.1 General description..................................................................................................................................................................................... 6
1.2 Warnings and Cautions.............................................................................................................................................................................7
1.3 Explanation of symbols ............................................................................................................................................................................9
1.4 The system and its parts....................................................................................................................................................................... 10
1.5 Specifications and safety........................................................................................................................................................................11
1.6 Description of the components ........................................................................................................................................................12
1.7 Replaceable parts....................................................................................................................................................................................... 14
2 Installation and Maintenance .............................................................................................................................15
2.1 Checks for completeness and integrity .................................................................................................................................... 15
2.2 Environmental parameters for operation................................................................................................................................. 15
2.3 Power supply connections.................................................................................................................................................................. 16
2.4 Use with other equipment ....................................................................................................................................................................17
2.5 Interference......................................................................................................................................................................................................17
2.6 Maintenance and cleaning.................................................................................................................................................................. 18
2.7 Disposal of equipment............................................................................................................................................................................ 18
3 Connections and Usage.........................................................................................................................................19
3.1 Overview............................................................................................................................................................................................................ 19
3.2 Connecting the R40 System .............................................................................................................................................................. 21
3.3 Starting the system .................................................................................................................................................................................. 22
3.4 Shutdown of the system....................................................................................................................................................................... 22
4 Trackit Software - overview ................................................................................................................................23
Version History ....................................................................................................................................................................42

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Illustrations
Figure 1: Connecting the R40 System ..................................................................................................................................................19
Figure 2: Connecting the R40 and R40(24) Amplifier (front face) ...................................................................................21
Figure 3: Connecting the R40 Amplifier (top face)..................................................................................................................... 22
Figure 4: Photic Stimulation (using Trackit Plus software)................................................................................................... 27
Figure 5: Photic Stimulation control window.................................................................................................................................. 27
Figure 6: Hyperventilation..............................................................................................................................................................................28
Figure 7: Hyperventilation control window.......................................................................................................................................28
Figure 8: Bluetooth pairing............................................................................................................................................................................30
Figure 9: WiFi setup.............................................................................................................................................................................................31
Figure 10: Unsecure network error message...................................................................................................................................31
Figure 11: Bluetooth connection quality monitor...........................................................................................................................32
Appendices
Appendix 1: R40 Amplifier Specifications.................................................................................................................... 24
Appendix 2: Photic Stimulator and Hyperventilation.............................................................................................27
Appendix 3: Additional Events Information................................................................................................................ 29
Appendix 4: Wireless...............................................................................................................................................................30
Appendix 5: Troubleshooting Guide ................................................................................................................................37
Appendix 6: Manufacturer’s Declaration.....................................................................................................................38

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1 Overview and Technical Description
1.1 General description
Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications for use
The R40 EEG System is intended to be used as a front-end amplifier to acquire, store and transmit
electrophysiological signals (wireless or cabled).
General description
The R40 EEG System is a multi-channel electroencephalograph system designed for use in routine EEG and lab
monitoring applications.
The R40 system uses either the R40 EEG amplifier or the R40 (24) EEG amplifier. The R40 EEG amplifier is a
compact 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 R40 (24) EEG Amplifier is a reduced channel variant of the R40 amplifier. The R40 (24) provides 24 referential
channels and 4 polygraphic channels. In all other respects the R40 (24) amplifier is identical to the R40.
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.
NOTE: Unless otherwise specified, throughout this manual the term "R40" refers to both the R40 EEG Amplifier
and R40 (24) EEG Amplifier
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.
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1.2 Warnings and Cautions
Warning sign indicates a situation or
procedures that may be dangerous for
the patient and/or user.
Caution sign indicates a situation or
procedures that may cause equipment
damage or its improper usage.
Do not use the R40 EEG System in an MRI environment, in an explosive atmosphere or during
defibrillation.
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.
This equipment is 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.
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.
The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
Lifelines does not supply the Nonin sensor. Only use the ‘PureLight’ sensors specified by Nonin to be
used with their Oximeters.
The cart should be positioned in use so that disconnection of the mains plug from the supply socket
can be accomplished without diiculty.
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.
Do not open or modify the equipment without the authorization of the manufacturer.
Do not touch simultaneously any accessible USB or other contacts on the PC and the patient.
Only use the PC and the medical-grade power supply as supplied or authorised by Lifelines.
Do not plug the USB connector into any device other than the PC supplied or authorised by Lifelines.
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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 connection of type BF
Isolation.
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.
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.
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.
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.
Do not exceed the Safe Additional Working Load of 4 kg on the worktop.
Only use approved sensors as specified by Lifelines.
The Amplifier must only be used with the USB cable provided with the unit.
Do not allow any liquid to enter the case of the instrument or connector. Do not use acetone on any
of the instruments.
Federal (USA) law restricts this device to sale by or on the order of a physician.
CONTRAINDICATIONS: There are no known contraindications to the use of this equipment.
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1.3 Explanation of symbols
Symbol Meaning
Type BF applied part
Input/output connection
Special recycling required*
Consult warnings in User Manual
On/O and patient event switch
Pushing Prohibited
(When not in Transport Position)
Remote event pushbutton
Manufacturer
Equipotentiality
Internal battery hazard
- refer to section 1.7
Symbol Meaning
Follow operating instructions
Input connection
Bluetooth
WLAN WiFi
Nonin Xpod Pulse Oximeter
Sitting prohibited
DC power
Protective earth (ground)
Electrocap
European Representative
* 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.
Storage and transport symbols
Symbol Meaning Symbol Meaning Symbol Meaning
Temperature limits Fragile Keep dry
Relative humidity
limits
Atmospheric
pressure limits
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1.4 The system and its parts
The R40 EEG System is a multi-channel electroencephalograph designed for use in routine EEG and lab
monitoring applications.
The system uses either the R40 EEG amplifier or the R40 (24) EEG amplifier.
The R40 EEG amplifier is a compact 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 R40 (24) EEG Amplifier is a reduced channel variant of the R40 amplifier and incorporates 24 referential
channels and 4 polygraphic channels. In all other respects the R40 (24) Amplifier is identical to the R40.
The system includes a PC for control and storage, a video monitor, 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.
The system uses a specific PC and medical grade power supply. Refer section 3.1 for details
The PC or laptop must only be powered using the medical-grade mains power supply, as supplied
or authorised by Lifelines.
The R40 EEG System comprises the following components:
Component Part Number
R40 Amplifier 1326
R40 (24) Amplifier 1411
Amplifier USB Cable 1277
Cart, adjustable height 1296
Arm (for Photic or R40 Amplifier) 1291
Photic Stimulator 1290
Photic USB Cable 1241
Xpod Pulse Oximeter Nonin 1327
Patient Event Pushbutton 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.
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1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The amplifier has been certified and complies with the following standards:
Standard Description
IEC 60601-1 and
IEC 60601-2-26
Standard for medical electrical equipment, general requirements and particular
requirements for EEG systems.
IEC 60601-1-6 Collateral standard for usability.
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 requirements.
IEC 60601-1-2 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
Classification Clinical use
Degree of protection against electrical shock Class I. Type BF applied parts
Type of protection against electrical shock Optically isolated USB amplifier
Mains isolation transformer 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 R40 Amplifier
The R40 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 input,
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. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The R40 (24) EEG Amplifier is a reduced channel variant of the R40 amplifier. The R40 (24) provides 24 referential
channels and 4 polygraphic channels. In all other respects this amplifier is identical to the R40.
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.
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
approved to the Medical Device Directive 93/42/EEC in Europe or to the relevant local standards
outside Europe.
The conductive part of electrodes and their connectors, including the Neutral electrode, should not
contact other conductive parts including earth.
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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 mark 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.
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.
Only use the laptop and the medical-grade power supply as supplied or authorised by Lifelines.
Do not use the standard laptop power supply
The Setup and Recording Software
The R40/Trackit setup software runs under Microsoft Windows XP, Windows Vista, Windows 7, 8 or 10 on the host
PC and is used to setup and review the R40 Amplifier and to record on to the PC.
Functions of the software:
ySetup the input signals.
ySetup and download the recording template.
This includes which electrodes are used and the recording montage.
yPerform a calibration check of the Amplifier.
yPerform an Impedance check on the Amplifier.
yPerform an EEG recording.
yView on-going EEG traces.
yReview an EEG Recording.
Refer to the Trackit Plus software manual for more details.
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1.7 Replaceable parts
Lifelines Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, 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 R40 amplifier contains a replaceable lithium ion rechargeable coin cell, type LIR2450.
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 the underside of the R40 and remove the bottom of the case.
2. Unclip the wraparound screen to expose the battery beneath.
3. Using a NON-CONDUCTIVE tool (for example, a spudger, plastic card or pen lid) place the tool under the coin
cell battery and, without exerting any stress on the holder itself, gently prise out the battery at the negative
terminal end. The battery should release from the battery holder.
4. Remove the battery from the battery holder.
5. Locate the replacement battery, positive side up, against the POSITIVE terminal of the battery holder.
6. Gently push the battery, at the negative terminal end, into the battery holder. The battery will click into place.
NOTE: The positive terminal of the battery holder has a metal tab.
The battery must be located UNDER the tab. Take care not to bend
the tabs when inserting the battery. The image (right) shows the
metal tab.
7. Gently push the battery, at the negative terminal end,
into the battery holder. The battery will click into place.
8. Re-clip the wraparound 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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Installation and Maintenance
1.8 Installation and Maintenance
The following section must be read and understood before the equipment is switched ON.
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 ii) 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.
1.9 Checks for completeness and integrity
1 Remove the equipment from the packaging case(s).
2 Use the parts list to check that all ordered items have been received.
3 Assembly instructions for third-party products will be found in their packing cases. It is recommended that
these instructions be filed with the R40 system technical reference materials.
4 Check 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.
1.10 Environmental parameters for operation
The operational and storage/transportation environmental conditions are as follows:
Operational: R40 Amplifier and Photic Storage and transport: R40 Amplifier and Photic
Temperature +10°C to +40°C
(+50°F to +104°F) Temperature -10°C to +50°C (14°F to +122°F)
Relative humidity 25% to 95%
non-condensing Relative humidity 10% to 95% non-condensing
Atmospheric pressure 700 hPa to 1060 hPa Atmospheric pressure 500 hPa to 1060 hPa
Operational: All-in-one PC Storage and transport: All-in-one PC
Temperature +10°C to +40°C
(+50°F to +104°F) Temperature -40°C to +65°C (-40°F to +149°F)
Relative humidity 20% to 80%
non-condensing Relative humidity 5% to 95% non-condensing
Atmospheric pressure 700 hPa to 1015 hPa Atmospheric pressure 238 hPa to 1015 hPa
NOTE: Consult the documentation supplied with the PC equipment for additional details.
Do not obstruct any cooling slots.
Position the equipment so that air flows freely.

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1.11 Power supply connections
R40 Amplifier and Photic (USB)
Power requirements 5VDC (USB Port)
Power consumption Maximum power: 2.5W
Medical grade AC mains power supply module for Laptop PC
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.
Medical grade AC mains power supply module for Laptop PC
Mains Power input: 90 – 264 VAC, 47–63 Hz, 1.4 A @ 115 Vac, 0.7 A @ 230 Vac
Output: 20 Vdc, 5.25 A
The computer must only be connected to the medical-grade laptop power supply supplied or
authorised by Lifelines. Do not use the standard computer power supply.
Only use the computer supplied or authorised by Lifelines.
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 R40 system, or a lead and connector
of equivalent 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.
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1.12 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, or in the presence of, 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 documentation
supplied with the other patient-connected equipment to ensure that all hazards, warnings and cautions are
considered before the equipment is used together.
Non-medical equipment, when used with the system, should comply with IEC/ISO safety standards
relevant to that equipment. IT equipment should comply with IEC 60950.
Leakage current
This system is designed to comply with IEC 60601-1, the international standard for medical electronic equipment, 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 system is modified.
There should be no electrical connections between the system equipment, which is powered via a medical grade
power supply, and any other equipment powered from another mains supply.
1.13 Interference
The R40 will continue to operate in the presence of radio frequency magnetic fields (RF) and the eects of electrostatic
discharges (ESD) and other interference, in accordance with the requirements of EN60601-1-2. However, the R40
amplifier records signals of very low amplitude, and these signals themselves are not immune to the eects of RF, ESD
and low-frequency magnetic field interference. Such interference may cause signal artefacts.
The R40 may have internal radios fitted. These are approved industry-standard Bluetooth and WiFi types which present
minimal risk of reciprocal interference with other equipment.
However, when the equipment is operated with or without its Bluetooth or WiFi on, other devices in the vicinity should be
moved away or turned o to reduce the likelihood of interference to the equipment or by the equipment
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.
When in close proximity to the R40 Amplifier, do not use mobile phones, transmitters, power
transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for
more information.
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.
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1.14 Maintenance and cleaning
The R40 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 R40 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 recommended
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).
For cleaning instructions for the computer refer to the manufacturer’s documentation.
Do not allow any liquid to enter the case of the instrument or connector. Do not use acetone on any
of the instruments.
1.15 Disposal of equipment
When the device 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 oice.
Installation and Maintenance