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Related Manuals for Lifelines trackit T4
Summary of Contents for Lifelines trackit T4
- Page 1 USER MANUAL...
- Page 2 Issue: CCN: CCN0152 Digitally signed by Geoff Salter Created Date: 2021.12.07 18:38:44 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 10:35:02 Z Digitally signed by Geoff Salter Approved Date: 2021.12.08 15:20:05...
- 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 Neuro representative and for any malfunctions caused by any parts that have been damaged or modified by anyone other than a qualified Lifelines Neuro representative.
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Page 4: Disclaimers & Warranties
Disclaimers & Warranties 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 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.
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Page 6: Table Of Contents
USER 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 Amplifier and its parts .................................. 10 1.5 Specifications and safety..................................11 1.6 Description of the components ................................12 Replaceable parts....................................... - Page 7 USER MANUAL Appendices Appendix 1: Trackit T4 Amplifier Specifications ....................... 30 Appendix 2: Photic Stimulation ............................33 Appendix 3: Additional Events Information ........................ 35 Appendix 4: Wireless ................................36 Appendix 5: Troubleshooting Guide ..........................42 Appendix 6: Manufacturer’s Declaration ........................43 Illustrations Figure 1: Connecting the T4 Amplifier –...
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Page 8: Overview And Technical Description
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. General description The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. -
Page 9: Warnings And Cautions
The conductive part of electrodes and their connectors, including the Neutral electrode, should not contact other conductive parts including earth. Do not plug the USB connector into any device other than the PC supplied or authorised by Lifelines. Do not connect any other equipment to the PC. - 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 Trackit T4, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
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Page 11: Explanation Of Symbols
USER MANUAL Overview and Technical Description Explanation of symbols Symbol Meaning Symbol Meaning Follow operating instructions Type BF applied part Input connection Input/output connection Special recycling required* Bluetooth WLAN WiFi Consult warnings in User Manual Nonin Xpod Pulse Oximeter Remote event pushbutton Memory card read/write On/Off and patient event switch European Representative... -
Page 12: The Amplifier And Its Parts
The Amplifier is intended to be connected to a specific PC or laptop and a medical grade power supply. Refer to 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 T4 EEG Amplifier comprises the following components: Component... -
Page 13: Specifications And Safety
USER 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 USB Power Bank battery pack for ambulatory applications The Amplifier plugs directly into the USB port on the Power Bank. The Amplifier must only be used with the USB Power Bank supplied or authorised by Lifelines. Micro-SD memory card The micro-SD card is used to store the EEG data recorded by T4. Storage cards of varying capacity are available in the micro-SD format.
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Page 16: Replaceable Parts
Refer to the Trackit Plus software manual for more details. 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. -
Page 17: Installation And Maintenance
USER MANUAL Installation and Maintenance 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
20 Vdc, 5.25 A. 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. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. -
Page 19: Use In The Home Environment
USER MANUAL Installation and Maintenance Use in the home environment Where the equipment is intended to be used in the home, the unit should be operated in its bag where it is protected against ingress of solid objects and water to a degree of IP22. The laptop PC is optional in the home environment and may be used for video recordings. -
Page 20: Interference
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 Trackit T4, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result. -
Page 21: Connections And Usage
Medical Grade Laptop Mains PSU *Type BF Patient To USB Port Clinical Use: Wireless Trackit T4 Amplifier Battery pack and or USB Connection bag optional Patient Isolation Zone Figure 1: Connecting the T4 Amplifier – Clinical Use Clinical Use W h ¡ e h ¢... -
Page 22: Laptop Installation And Operation
Laptop installation and operation 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. 1. Connect the power cord to the medical-grade power supply. -
Page 23: Connecting The T4 System
USER MANUAL Connections and Usage Connecting the T4 System Clinical Use The T4 Amplifier is optionally housed inside its bag with battery or used standalone. It is plugged into the PC USB port using the cable supplied, part number 1277, or a wireless connection can be used instead. The USB Cable is plugged into the rear housing of the T4 Amplifier using the RJ45 plug and into any USB port on the laptop PC. -
Page 24: Figure 3: T4 Amplifiers And Pcus
USER MANUAL Connections and Usage Electrode connections The Amplifier accepts standard 1.5 mm touchproof electrodes using DIN 42802-style connec¬tors. 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. Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation The conductive part of electrodes and their connectors, including the Neutral electrode, should not contact other conductive parts including earth. -
Page 25: Figure 4: T4 Pcu 32+3
USER MANUAL Connections and Usage T4-PCU 32+3 Connections The T4-PCU 32+3 has a standard 25-way D-type Electrocap socket providing 21 EEG channels. It uses the standard mapping Fp1 – Pz mapped to EEG channels 1 – 21, plus Ref and Gnd. An additional 10 independent EEG channels are provided by individual touchproof connectors, mapped to EEG channels 22 –... -
Page 26: Starting The System
SpO2. This is plugged into the circular connector and the appropriate sensor plugged into the Xpod device. Note that Lifelines does not supply sensors and these will need to be sourced separately. NOTE: The Nonin Xpod should not be used if more than 32 channels are on. -
Page 27: Shutdown Of The System
USER MANUAL Connections and Usage Indicators The following indicators are shown on the display on the top face of the T4: ψ Figure 6: T4 Amplifier display indicators The symbols have the following meaning: Symbol Description Clock: Represents the time of day in HH:MM format. When the T4 is connected to the PC, the clock is synchronised to the PC’s clock. -
Page 28: Battery Replacement And Charging
Close zip The Amplifier must only be used with the USB Power Bank supplied or authorised by Lifelines. Do not short circuit this device. To avoid short circuit, keep the device away from any metal objects (e.g., hair clips and keys). -
Page 29: Micro-Sd Card
The T4 Amplifier supports micro SD and SDHC cards up to 32GB. The SD card needs to meet the following requirements: y Formatted to FAT32 (Lifelines recommends that the micro-SD card is formatted using the SD formatting software supplied on the Lifelines CD). - Page 30 USER MANUAL Connections and Usage To remove the card: 1. Gently push the micro-SD card with the T4/T4A tool. 2. Release the pressure on the card and it will eject out of the card slot. The micro-SD card can be inserted and removed while the T4 Amplifier is switched on. When the micro-SD card is inserted (and successfully read) or removed, an audible beep will sound.
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Page 31: 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 2.8.1.7 (or later) supports the Trackit T4. Check with your distributor or Lifelines if a newer version of software is available. -
Page 32: Appendix 1: Trackit T4 Amplifier Specifications
USER MANUAL Appendix 1 Appendix 1: Trackit T4 Amplifier Specifications v i felines 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. EEG inputs Number of EEG channels... - Page 33 USER MANUAL Appendix 1 t ient Connection Unit Plug-on unit with touchproof 1.5mm sockets. Variants: € 2 24 referential channels + 8 bipolar (model T4-PCU 24+8) 64 referential channels + 4 bipolar (model T4-PCU 64+4) 31 referential channels (21 on Ecap connector) + 3 bipolar (model T4-PCU 32+3) Aux DC Inputs 1 Jack socket 3.5mm Patient Event Input...
- Page 34 *Note: Compliance is provided by the PC Classification of system Classification Clinical use Home use Trackit T4 Amplifier: Internally powered. Type BF applied parts. Internally powered; or it can be Degree of protection against connected to a PC which is powered by electrical shock a medical grade Class I power supply.
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Page 35: Appendix 2: Photic Stimulation
3 4 5 6 3 n 7 8 9 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. Figure 9 Photic Stimulation (using Trackit Plus software) -
Page 36: Figure 11: Photic Trigger Signal Definition
USER MANUAL Appendix 2 h e T4, the actual Photic flash ‘ticks’ are produced in the recording. Note: to setup a suitable Photic trigger signal definition open the Signal library as described in section 0, and define a signal with a name “Photic”, set it to type DC, units mV and Physical Signal Amplitude of +- 1000mV/V. Set the sensitivity to non-master and 10mV/mm. -
Page 37: Appendix 3: Additional Events Information
USER MANUAL Appendix 3 Appendix 3: Additional Events Information For the T4 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 38: Appendix 4: Wireless
USER MANUAL Appendix 4 Appendix 4: Wireless Introduction T4 has optional built-in Bluetooth and WiFi capabilities. Using the internal Bluetooth module in the T4, wireless connections can be established with it from a Bluetooth- enabled PC. Using the internal WiFi module in the T4 wireless connections can be established with it via a Wireless Access Point (WAP). -
Page 39: Figure 13: Wifi Setup
USER MANUAL Appendix 4 O A B C C E F G H I P E Q C R , the T4 acts as the server and provides the SPP service to the PC acting as a client. During the setup of the WiFi module, the WAP SSID is entered together with its password, as shown below. Figure 13: 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 40: Figure 15: Bluetooth Connection Quality Monitor
USER 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 15: 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 41 USER MANUAL Appendix 4 Wireless Communication (general information) A wireless link can be subject to interference and disruption to communication. Bl S T U V V U W X Y ` a X i T b T Y Y U T ™ W c V b V g y designed for short-range wireless connections between devices in a wireless personal area network (WPAN).
- Page 42 USER MANUAL Appendix 4 fact that the T4 Interface Protocol is proprietary. 4. The medical system uses mature, industry-standard hardware and protocols: Bluetooth and WiFi. This ensures that the system utilises all the benefits associated with these mature standards, concerning the authentication, data integrity and interference performance as discussed in this document.
- Page 43 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 Trackit T4, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
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Page 44: Appendix 5: Troubleshooting Guide
An incorrect setup has been sent If an incompatible setup has been sent to the Trackit T4 the message; “unable to comply” will indicate that. If an incorrect setup has been sent, the Trackit Control Panel will show ‘ A cquire Ready: No’ . -
Page 45: Appendix 6: Manufacturer's Declaration
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 Trackit T4, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result. - Page 46 Guidance and Manufacturer’s Declaration Electromagnetic Emissions IEC 60601-1-2 / EN 60601-1-2 The Trackit T4 is intended for use in the electromagnetic environment specified below. The customer or user of the T4 should assure that it is used in such an environment. Emissions Test...
- Page 47 The Trackit T4 does not contain magnetic components and is not susceptible to power frequency magnetic field interference. f The conditions of intended use justify lower immunity test levels. The hazards and risk analysis associated with these lower limits have...
- Page 48 If any electromagnetic interference is encountered, the patient and equipment should move to an area without interference. In any case, the electromagnetic interference does not pose any risks to the patient, as the Trackit T4 is a non-invasive recording device that does not modify or interact with the patient.
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Page 49: Version History
USER MANUAL Version History Version History V 1 (23 June 2016) V1.9 (08 November 2017) y s h i i i q l r t l t q u t y Added disinfection information in section 2.8. y Change of N.B. to 0086 (BSI). V 1.1 (09 Aug 2016) y w m t h x t x y q r i h ... - Page 50 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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