Lifelines neuro R40 User Manual
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Lifelines neuro R40 User Manual

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EEG System
USER MANUAL

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  • Page 1 EEG System USER MANUAL...
  • Page 2 Issue: CCN: CCN0153 Digitally signed by Geoff Created Salter Date: 2021.12.07 18:37:16 Z Digitally signed by David Hulin DN: cn=David Hulin, o=Lifelines Ltd, Checked ou=Development, email=david.hulin@llines.com, c=GB Date: 2021.12.08 10:39:22 Z Digitally signed by Geoff Salter Approved Date: 2021.12.08 15:24:15...
  • Page 3 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.

  • Page 4: 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.
  • Page 5 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.

  • Page 6: Table Of Contents

    USER EEG System MANUAL Contents Disclaimers & Warranties ..............................2 Overview and Technical Description ....................... 6 General description .....................................6 1.2 Warnings and Cautions .....................................7 1.3 Explanation of symbols .................................... 9 The system and its parts ..................................10 1.5 Specifications and safety..................................11 1.6 Description of the components ................................12 Replaceable parts.......................................
  • Page 7 USER EEG System MANUAL 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 Illustrations Figure 1: Connecting the R40 System ..............................19 Figure 2: Connecting the R40 and R40(24) Amplifier (front face) ...................

  • Page 8: Overview And Technical Description

    USER EEG System MANUAL Overview and Technical Description Overview and Technical Description 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).

  • Page 9: Warnings And Cautions

    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. 51335-006...
  • Page 10 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.

  • Page 11: Explanation Of Symbols

    USER EEG System MANUAL Overview and Technical Description Explanation of symbols Symbol Meaning Symbol Meaning Follow operating instructions Type BF applied part Input connection Input/output connection Bluetooth Special recycling required* WLAN WiFi Consult warnings in User Manual Nonin Xpod Pulse Oximeter On/Off and patient event switch Pushing Prohibited Sitting prohibited...

  • Page 12: The System And Its Parts

    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.

  • Page 13: Specifications And Safety

    USER EEG System MANUAL Overview and Technical Description 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 Standard for medical electrical equipment, general requirements and particular IEC 60601-2-26 requirements for EEG systems.

  • Page 14: Description Of The Components

    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.
  • Page 15 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.

  • Page 16: Replaceable Parts

    Overview and Technical Description 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.

  • Page 17: 1.8 Installation And Maintenance

    USER EEG System MANUAL 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.

  • Page 18: Power Supply Connections

    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.

  • Page 19: Use With Other Equipment

    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.

  • Page 20: Maintenance And Cleaning

    USER EEG System MANUAL Installation and Maintenance 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.

  • Page 21: Connections And Usage

    USER EEG System MANUAL Connections and Usage Connections and Usage Overview Patient Event Pushbutton* EEG Electrodes* AUX* Mains Power *Type BF Medical Grade Laptop Mains PSU All-in-one PC Optional Patient Photic Stimulator and arm To USB Ports R40 Amplifier Patient Isolation Zone System Cart 1.
  • Page 22 5. Connect the country specific power cord to orange mains power cord. The laptop 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 laptop supplied or authorised by Lifelines.

  • Page 23: Connecting The R40 System

    USER EEG System MANUAL Connections and Usage Connecting the R40 System The R40 Amplifier is plugged into the PC USB port using the cable supplied, part number 1277. The USB Cable is plugged into the bottom housing of the R40 Amplifier as shown below using the RJ45 plug and into any USB port on the PC.

  • Page 24: Starting The System

    USER EEG System MANUAL Connections and Usage The top edge of the Amplifier provides for several other connections, as shown below. Figure 3: Connecting the R40 Amplifier (top face) 1. Nonin Xpod: the circular connector allows for the connection of a Nonin Xpod pulse oximeter for measuring SpO2.

  • Page 25: Trackit Software - Overview

    Trackit Software - overview The Trackit software is available on the included CD/USB disk or on the Lifelines FTP site. A readme file describes installation. The Trackit Software version 2.8.0.0 (or later) supports the R40 EEG Amplifier. Check with your distributor or Lifelines if a newer version of software is available.

  • Page 26: Appendix 1: R40 Amplifier Specifications

    EEG System MANUAL Appendix 1 Appendix 1: R40 Amplifier Specifications Lifelines reserves the right to change product specifications at any time without notice. This is in line with the company’s policy of continual product development. R40 Amplifier Specifications EEG inputs...
  • Page 27 USER EEG System MANUAL Appendix 1 Connections, ports and controls Electrode Input connectors R40: 52 Touchproof 1.5mm R40 (24) 34 Touchproof 1.5mm E-cap connector 1 Standard 25-pin D socket Aux DC Inputs 2 Jack socket 3.5mm (Channels 39 and 40) Patient Event Input 1 Jack socket 3.5mm Front-panel push-buttons...
  • Page 28 EN55024/CISPR 24 EN61000-3-2 and EN61000-3-3 EN 62311 Input voltage 20VDC Power 90 W Size 385 x 539 x 251 mm Weight 6.8 kg Lifelines Photic Stimulator Refer to the Lifelines Photic Stimulator User Manual for specifications and operational details. 51335-006...

  • Page 29: Appendix 2: Photic Stimulator And Hyperventilation

    Hyperventilation Photic Stimulation An optional Lifelines Photic Stimulator is available which can be used with the R40 Amplifier to asses patient photosensitivity in EEG studies. For a detailed description of operation, connection and specifications please refer to the separate documentation Lifelines Photic User Manual and the Trackit Plus Software manual.

  • Page 30: Figure 6: Hyperventilation

    USER EEG System MANUAL Appendix 2 Hyperventilation A method of timing and marking a Hyperventilation and post-Hyperventilation activation sequence is provided. Figure 6: Hyperventilation This provides a digital timer, which is used as follows: y Click on HV Start to start the HV period and the timer starts running.

  • Page 31: Appendix 3: Additional Events Information

    USER EEG System MANUAL Appendix 3 Appendix 3: Additional Events Information For the R40 EEG Amplifier, events types are as shown below. y 56 Automatic events (hardware events, photic start/stop, video start/stop etc.) y 40 user-configurable events y Free-text events entered during acquisition Refer to the Trackit Plus software manual for more information Event No Contents...

  • Page 32: Appendix 4: Wireless

    USER EEG System MANUAL Appendix 4 Appendix 4: Wireless Introduction The R40 Amplifier has optional built-in Bluetooth and WiFi capabilities. Using the internal Bluetooth module in the R40, wireless connections can be established with it from a Bluetooth- enabled PC. Using the internal WiFi module in the R40 wireless connections can be established with it via a Wireless Access Point (WAP).

  • Page 33: Figure 9: Wifi Setup

    USER EEG System MANUAL Appendix 4 During the setup of the WiFi module, the WAP SSID is entered together with its password, as shown below. Figure 9: WiFi setup If an attempt is made to connect to an unsecure network without a password, this is prevented and an error displayed as shown below.

  • Page 34: Figure 11: Bluetooth Connection Quality Monitor

    USER EEG System MANUAL Appendix 4 When the Trackit application has established the Bluetooth connection, a connection quality monitor labelled “Comms.Q” is displayed in the status bar at the bottom left of the main screen, as shown below. Figure 11: Bluetooth connection quality monitor. This number given as a percentage is an approximate indication of the amount of data received as a ratio to that expected, calculated every second.
  • Page 35 USER EEG System MANUAL Appendix 4 Wireless Communication (general information) A wireless link can be subject to interference and disruption to communication. Bluetooth is a wireless technology designed for short-range wireless connections between devices in a wireless personal area network (WPAN). Bluetooth is compliant with the IEEE 802.15 standard and operates in the 2.4 GHz band.
  • Page 36 USER EEG System MANUAL Appendix 4 Quality of Service and Associated Risks 1. The risk of corrupt data due to interference is very small due to error detection, error correction and resend data packet mechanisms. In addition to this error detection and correction, the application provides time-stamped data packages, which enables the detection of corrupt, delayed or missing data.
  • Page 37 USER EEG System MANUAL Appendix 4 Specifications (taken from Appendix 1). Bluetooth Module Specifications: y Type: Bluetooth 4.0. y Output power: 11dBm max. y Output frequency: 2.402 - 2.480 GHz, ISM band. y Data rate: 1.3 Mbps max. y Protocols: Standard Bluetooth - SPP, GATT, DUN, PAN. y Modulation: GFSK, DQPSK.
  • Page 38 30 cm (12 inches) to any part of the Trackit R40, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result. When in close proximity to the amplifier, do not use mobile phones, transmitters, power transformers, motors, or other equipment that generates magnetic fields.

  • Page 39: Appendix 5: Troubleshooting Guide

    USER EEG System MANUAL Appendix 5 Appendix 5: Troubleshooting Guide COM port problems with Bluetooth communication to the R40 The COM port is available but is being used by another application. This could well be the case if an application such Microsoft Active Synch is installed and polling the COM port for a Windows CE device.

  • Page 40: Appendix 6: Manufacturer's Declaration

    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.
  • Page 41 USER EEG System MANUAL Appendix 6 Guidance and Manufacturer’s Declaration Electromagnetic Emissions IEC 60601-1-2 / EN 60601-1-2 The R40 is intended for use in the electromagnetic environment specified below. The customer or user of the R40 should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance...
  • Page 42 USER EEG System MANUAL Appendix 6 IEC 60601 Compliance Immunity Test Electromagnetic Environment Guidance Test Level Level Power frequency 3 A/m, 30A/m 3 A/m Power frequency magnetic fields should be at levels (50/60Hz) magnetic field See Note e. characteristic of a typical location in a typical com-mercial and/or hospital environment.
  • Page 43 USER EEG System MANUAL Appendix 6 Recommended separation distance between portable and mobile RF communications equipment and the R40 EEG System IEC 60601-1-2 / EN 60601-1-2 The R40 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 44: Version History

    USER EEG System MANUAL Version History Version History V1.0 (24th June 2014) V1.10 (19 July 2019) y Initial release y Updated with new cart design and Lenovo PC y Software section updated V1.1 (7th July 2014) y EMC warnings and information updated V1.2 (31st July 2014) V1.11 (14 Oct 2019) V1.3 (18th September 2014)
  • Page 45 EEG Amplifier Lifelines Ltd 1 Tannery House, Tannery Lane, Woking, Surrey, GU23 7EF UK Telephone +44 (0) 1483 224 245 www.lifelinesneuro.com sales@lifelinesneuro.com...

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