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T4
EEG Amplifier
User Manual
32 channel version:
68 channel version:
Created
Digitally signed by Michael
Hulin
Date: 2018.03.02 10:27:46 Z
T4
T4
Checked
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
email=david.hulin@llines.com, c=GB
Date: 2018.03.02 11:01:33 Z
32
68
Approved
Part no. 51285-006
Issue 1.9
Digitally signed by Michael Hulin
Date: 2018.03.02 11:55:04 Z
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Summary of Contents for Lifelines trackit T4 32
- Page 1 Part no. 51285-006 Issue 1.9 Created Checked Approved Digitally signed by David Hulin Digitally signed by Michael DN: cn=David Hulin, o=Lifelines Ltd, Digitally signed by Michael Hulin Hulin ou=Development, Date: 2018.03.02 11:55:04 Z email=david.hulin@llines.com, c=GB Date: 2018.03.02 10:27:46 Z Date: 2018.03.02 11:01:33 Z...
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Page 2: Version History
T4 EEG Amplifier User Manual Version History V 1 (23 June 2016) • Initial release V 1.1 (09 Aug 2016) • Amended part numbers in section 1.4. V 1.2 (28 Sep 2016) • Various amendments for IEC 60601-1. V 1.3 (13 Dec 2016) •... - Page 3 T4 EEG Amplifier User Manual Lifelines Ltd, 7 Clarendon Court, Over Wallop, near Stockbridge, Hampshire SO20 8HU, UK Telephone +44 (0)1264 782226 www.LLines.com sales@LLines.com 0086...
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Page 4: 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. -
Page 5: Software And Virus Protection
T4 EEG Amplifier User Manual 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, ad- ware etc. is provided on the PC used for installation and the surrounding systems. Please note the... -
Page 6: Table Of Contents
T4 EEG Amplifier User Manual Contents Version History Disclaimers & Warranties Trademarks Responsibility of manufacturer Software and Virus Protection Contents Illustrations Overview and Technical Description General description Cautions and Warnings Explanation of symbols The Amplifier and its parts Specifications and safety Description of the components Replaceable parts Installation and Maintenance... -
Page 7: Illustrations
T4 EEG Amplifier User Manual Illustrations Figure 1 Connecting the T4 Amplifier – Clinical Use Figure 2 Connecting the T4 Amplifier - Home Use Figure 3 Connecting the T4 Amplifier (front face) Figure 4 Connecting the T4 Amplifier (back face) Figure 5 New Patient dialog Figure 6 New Patient database Figure 7 Signal List... -
Page 8: Overview And Technical Description
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 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. - Page 9 T4 EEG Amplifier User Manual CAUTION: Do not touch simultaneously any accessible USB or other contacts on the PC and the patient. WARNING: Strangulation hazard due to long cables. As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. CAUTION: Ensure that carrying bag and straps are worn over clothing to prevent any possibility of skin irritation.
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Page 10: Explanation Of Symbols
T4 EEG Amplifier User Manual 1.3 Explanation of symbols Type BF applied part 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. -
Page 11: The Amplifier And Its Parts
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 T4 EEG Amplifier comprises the following components: T4-32 Amplifier part number 1505... -
Page 12: Description Of The Components
10-20 pattern (T4 PCU 24+8) or the grid layout (T4 PCU 64+4), attached to the pa- tient’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 elec- trodes used must be approved to the Medical Device Directive 93/42/EEC in Europe or to the relevant local standards outside Europe. -
Page 13: Replaceable Parts
Lifelines. WARNING: 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 14: Checks For Completeness And Integrity
Output: 20 Vdc, 5.25 A. WARNING: 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 15: Use In The Home Environment
T4 EEG Amplifier User Manual 2.5 Use in the home environment Where the equipment is intended to be used in the home, the unit and its battery should be oper- ated 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 16: Maintenance And Cleaning
T4 EEG Amplifier User Manual 2.8 Maintenance and cleaning The T4 Amplifier and its accessories require no routine testing, calibration or maintenance proce- dures apart from occasional cleaning and checking for wear and damage to all parts including the accessories. No servicing or maintenance of the equipment should take place while in use with a patient, except for replacement of the external battery. -
Page 17: Laptop Installation And Operation
3.2 Laptop installation and operation WARNING: 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 18: Figure 3 Connecting The T4 Amplifier (Front Face)
T4 EEG Amplifier User Manual Home Use The T4 Amplifier is battery powered and is housed inside its bag where it is protected against in- gress of solid objects and water to a degree of IP22. The laptop PC is optional and may be used for video recordings. -
Page 19: Starting The System
SpO . This is plugged into the circular connector and the appropriate sen- sor 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 20: Shutdown Of The System
Close zip WARNING: The Amplifier must only be used with the USB Power Bank supplied or au- thorised 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 21: The Setup And Recording Software
The setup software is available on CD. A readme file describes installation. Check with your distrib- utor or Lifelines if a newer version of software is available. The Trackit software is designed to work with both the Trackit recorder and the T4 Amplifier and with the optional Photic Stimulator. -
Page 22: Figure 6 New Patient Database
T4 EEG Amplifier User Manual Figure 6 New Patient database The database allows you to enter more extensive information about the patient and recording, and save it for future reference. See the section entitled ‘Advanced options’. Step 2 Define the signals – if required Defining signals is usually done once only or very occasionally. -
Page 23: Figure 8 Signal Editing Tool
T4 EEG Amplifier User Manual Figure 8 Signal Editing Tool 3 Type in the Signal name (e.g. Fp1). Note that for EEG signals this must be case-sensitive. 4 Select a signal type (in this case EEG). 5 Click on the Change button. The signal is now entered into the list under the View all signals tab. -
Page 24: Figure 10 Setup Recording Dialog
T4 EEG Amplifier User Manual Figure 10 Setup Recording dialog The order of the signal labels in the pull down list is the same as the order of the signals in the sig- nal list defined using the signal-editing tool. Amplifier setup: amplifier setup activates the recording inputs in preparation for a recording. -
Page 25: Configuring The Amplifier
T4 EEG Amplifier User Manual Figure 12 Recording Channel editing 4.2 Configuring the amplifier When you have finished setting up the recording protocol, connect the T4 to the host computer. Steps 5 to 9 describe configuration and set-up of an EEG recording. Step 5 Activate the recording control The Trackit application software will normally connect automatically to the T4 Amplifier as soon as it is plugged in. -
Page 26: Figure 14 Trackit Control Panel
T4 EEG Amplifier User Manual Step 6 Connect T4 Check that the T4 is connected properly. The software will normally connect automatically, how- ever to do this manually, in the Control Panel select the USB option for the T4 and click on Con- nect. -
Page 27: Figure 15 Ongoing Trace Display
T4 EEG Amplifier User Manual To perform a Calibration check, click on this icon: . The waveforms will show a square wave of amplitude 8 mV pk-pk and frequency 1 Hz. Step 9 View the ongoing EEG traces To view the ongoing traces at any time, whether recording or not, click on the following icon: When you do this, one of the following things occur: If the T4 is connected to the PC, and has been sent a valid recording setup, the traces appear ... -
Page 28: Figure 17 Impedance Check
T4 EEG Amplifier User Manual Impedance check: to carry out an impedance check, click on the impedance check icon on the Trackit toolbar. If recording has started , the impedance check is displayed on the trace display with an impedance check event. -
Page 29: Montage Editor
T4 EEG Amplifier User Manual The event list allows the user not only to see when events took place, but to also view the data be- hind those events. To display a page of EEG around an event of interest, double click on the event in the list. To navi- gate forwards or backwards, press the forward or backward arrow buttons. -
Page 30: Reading An Eeg Recording
All Trackit recordings have a user-definable 8-character file name with ‘.edf’ extension. They are stored in EDF format, readable in all EDF-compatible EEG browsers. In an EDF-compatible browser, the patient’s name and recording ID are displayed in the test properties. Lifelines currently recommends: Lifelines iEEG ... -
Page 31: Appendix 1: Specifications
T4 EEG Amplifier User Manual Appendix 1: Specifications Note: 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. T4 Amplifier Specifications EEG inputs Number of EEG channels... - Page 32 T4 EEG Amplifier User Manual Host PC Connector 1 RJ45 socket providing USB port (isolated from patient) or power input from external battery Nonin Xpod (SaO2) 1 Binder 710 series 3-pin socket LED indicators LED for disk access Micro-SD card port 1 Micro-SD socket Internal Battery 1 type LIR2450 Lithium-ion rechargeable Coin cell...
- Page 33 T4 EEG Amplifier User Manual Physical characteristics Weight 270g Size 17cm x 9cm x 3cm Safety and EMC standards The system has been certified and complies with the following standards: IEC 60601-1 and European standard for medical electrical equipment, general re- IEC 60601-2-26 quirements and particular requirements for EEG systems.
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Page 34: Appendix 2: Photic Stimulation
T4 EEG Amplifier User Manual Appendix 2: Photic Stimulation An optional Lifelines Photic Stimulator is available which can be used with the T4 to asses patient photosensitivity in EEG studies. For a detailed description of operation, connection and specifica- tions please refer to the separate documentation “Lifelines Photic User Manual”. -
Page 35: Figure 22 Photic Trigger Signal Definition
T4 EEG Amplifier User Manual Note: to setup a suitable Photic trigger signal definition open the Signal library as described in sec- tion 4.1, and define a signal with a name “Photic”, set it to type DC, units mV and Physical Signal Amplitude of +- 1000mV/V. -
Page 36: Appendix 3: Additional Events Information
T4 EEG Amplifier User Manual Appendix 3: Additional Events Information For the T4 EEG system, events types are as shown below. • 56 Automatic events (hardware events, photic start/stop, video start/stop etc.) • 40 user-configurable events • Free-text events entered during acquisition Event List Event No. -
Page 37: Figure 23 User Events
T4 EEG Amplifier User Manual Clicking on the Events icon on the main program window allows these configurable events to be edited as shown below. If the system is recording, selecting an event marks it in the recording. If not recording, selecting an event allows it to be edited. Figure 23 User Events The Events icon also brings up an option to print an events template for overlaying on the key- board. -
Page 38: Figure 26 Event List
T4 EEG Amplifier User Manual During playback, all the events are displayed for the file by clicking on the Events icon. Double- clicking on an event in the list jumps to that point in the recording. All the events are also dis- played in their correct position in relation to the EEG along the bottom of the main window. -
Page 39: Appendix 4: Pc Setup
T4 EEG Amplifier User Manual Appendix 4: PC Setup Options | Tab 1 The Options panel Tab 1 contains general settings which are self-explanatory as shown below. Figure 27 Options Tab 1 Options | Tab 2 The second tab in Options is shown below. Figure 28 Options Tab 2... -
Page 40: Figure 29 Options Tab 3
T4 EEG Amplifier User Manual Most of these options are not applicable to the T4, except for: Use File Length instead of EDF Length. This a playback feature and if ticked, the file length • is used instead of the edf length parameter embedded in the edf header. Due to the fact that the T4’s memory card can be removed at any time, there can be a partial 1s data block at the end of the file and so the actual size may not be an exact multiple of 1s. -
Page 41: Appendix 5: Wireless
T4 EEG Amplifier User Manual Appendix 5: 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 es- tablished with it via a Wireless Access Point (WAP). - Page 42 T4 EEG Amplifier User Manual If an attempt is made to connect to an unsecure network without a password, this is prevented and an error displayed as shown below. For maximum security it is recommended that only WPA2 ac- cess is allowed. When the Trackit application has established the Bluetooth connection, a connection quality moni- tor labelled “Comms.Q”...
- Page 43 T4 EEG Amplifier User Manual 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. It is most likely to drop below 100% when either device is at the limit of the transmission range or when either antenna is adversely obscured or un- der the influence of interference.
- Page 44 T4 EEG Amplifier User Manual Both Bluetooth and WiFi technologies, however, use sophisticated error detection and error correc- tion techniques to deliver correct data. Additionally, if a transmission cannot be decoded due to in- terference, the transmission is resent. This interference will, of course, increase as the number of coexistent devices in proximity to each other increases.
- Page 45 T4 EEG Amplifier User Manual Type: Bluetooth 4.0. • • Output power: 11dBm max. Output frequency: 2.402 - 2.480 GHz, ISM band. • Data rate: 1.3 Mbps max. • • Protocols: Standard Bluetooth - SPP, GATT, DUN, PAN. Modulation: GFSK, DQPSK. Frequency Hopping Spread-Spectrum (FHSS). •...
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Page 46: Appendix 6: Troubleshooting Guide
T4 EEG Amplifier User Manual Appendix 6: Troubleshooting Guide COM port problems with Bluetooth communication to Trackit T4 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 47: Appendix 7: Manufacturer's Declaration
T4 EEG Amplifier User Manual Appendix 7: Manufacturer’s Declaration EMC Compatibility This section contains specific information regarding the device’s compliance with EN 60601-1-2. Note: Medical electrical equipment needs special precautions regarding EMC and needs to be in- stalled and put into service according to the EMC information provided here. WARNING: The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the equipment as replacement parts for internal components, may result in increased emissions or decreased immunity of the... - Page 48 T4 EEG Amplifier User Manual Guidance and Manufacturer’s Declaration Electromagnetic Emissions EN 60601-1-2 The 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 Compliance Electromagnetic Environment Guidance...
- Page 49 T4 EEG Amplifier User Manual Immunity Test EN 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable mobile communications equipment should be used no closer to any part of the T4, including cables than the rec- ommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 50 T4 EEG Amplifier User Manual Recommended separation distance between portable and mobile RF communications equipment and the T4 EEG System EN 60601-1-2 The T4 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the T4 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the T4 as recommended below, according to the maximum output power of the communications equipment.
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