lifelines Trackit Mk2 EEG Amplifier User Manual

T4 EEG Am plifier
User Manual
32 channel version: T432
68 channel version: T468 Part no. 51285- 006
Issue 1.9

Trackit Mk2 EEG Amplifier

Created

Digitally signed by Michael
Hulin
Date: 2018.03.02 10:27:46 Z| Checked

Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
email= [email protected], c=GB
Date: 2018.03.02 11:01:33 Z| Approved
Digitally signed by Michael Hulin
Date: 2018.03.02 11:55:04 Z
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Version History

V1 (23 June 2016)

• Initial release

V1.1 (09 Aug 2016)

• Amended part numbers in section 1.4.

V1.2 (28 Sep 2016)

• Various amendments for IEC 60601-1.

V1.3 (13 Dec 2016)

• Amendments to Nonin and Aux Input specifications in section 1.6.
• Changed ‘Contraindication’ to ‘Warning’ in section 1.2. There are no contraindications for this device.

V 1.4 (08 February 2017)

• Added to section 1.2 “CONTRAINDICATIONS: There are no known contraindications to the use of this equipment”.
• Added to section 1.2 and 2.3 “WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth”.
• Removed drawing numbers in section 1.4.
• Amended section 2.4: Internal Li-lon backup battery operation.
• Added to Section 4.1: “Note: If a Setup that uses greater than 32 channels plus the Nonin is attempted…”.
• Added to section 3.3 details of battery replacement frequency.

V1.5 (10 March 2017)

• Amended instructions concerning oximeter and Aux. input sensors.

V1.6 (13 March 2017)

• Further amendments to instructions concerning oximeter and Aux. input sensors.

V1.7 (22 March 2017)

• Added to Aux DC Input instructions — “for hospital and clinic use. Not for home use” in section 1.6 and 3.3.

V1.8 (18 August 2017)

• Photic operation added in Appendix 2.
• Wireless operation added in Appendix 5.

V1.9 (08 November 2017)

• Added disinfection information in section 2.8.
• Change of N.B. to 0086 (BSI).

Disclaimers & Warranties

The information in this section is subject to change without notice.
Except as stated below, Lifelines Ltd makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Lifelines shall not be liable for errors contained herein or for incidental or consequential damages in connection with the 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 mainte- nance 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 dur- ing the warranty period, provided that these products are used as prescribed in the operating in- structions in the user’s and service manuals.
No other party is authorised to make any warranty to assume liability for Lifelines products. Life- lines will not recognise any other warranty, either implied or in writing. In addition, services per- formed by someone other than Lifelines or its authorised agents or any technical modification or changes of products without Lifelines prior, written consent may be cause for voiding this warranty.
Defective products or parts must be returned to Lifelines or its authorised agents, along with an explanation of the failure. Shipping costs must be prepaid.
Lifelines Ltd. manufactures hardware and software to be used on or with standard PC-compatible computers and operating software. Lifelines, however, assumes no responsibility for the use or reli- ability of its software or hardware with equipment that is not furnished by third-party manufactur- ers accepted by Lifelines at the date of purchase.
All warranties for third-party products used within the T4 system are the responsibility of the rele- vant 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 re- served. 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.
Responsibility of manufacturer
The manufacturer and distributor consider themselves responsible for the equipment’s safety, relia- bility and performance only if:

• any peripheral equipment to be used with the T4 system is supplied by third-party providers recommended by the manufacturer;
• assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorised by the manufacturer;
• the electrical installation of the relevant room complies with the appropriate requirements;
• the equipment is used by a health-care professional and in accordance with the instructions for use.

Note: the manufacturer has a policy of continual product improvement; hence the equipment pecifications 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 in- stalled 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, ad- ware 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 |1T/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.

Illustrations

Overview and Technical Description

1.1 General description
Indications for use
The T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
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. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC.
It is a compact USB amplifier which provides 32 channels (or 68 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WIFI).
There are two variants of the Trackit T4 EEG Amplifier:

• Trackit T4-32 providing 24 referential + 8 poly channels.
• Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board).

Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. In addition it can be battery powered in ambulatory applications.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
Intended User
The intended user of the equipment is a healthcare professional who has the training and knowledge to undertake EEG examinations and is familiar with EEG equipment and practice.
1.2 Cautions and Warnings
WARNING: Do not use the T4 EEG Amplifier in an MRI environment, in an oxygen rich environment or during defibrillation.
WARNING: This equipment is intended to be used by a healthcare professional and in accordance with these instructions for use which must be read in their entirety before the device is used.
WARNING: This equipment in intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. This equipment is not be used for the determination of brain death.
WARNING: Only use the PC and the medical-grade power supply as supplied or authorised by Lifelines.
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.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode, should not contact other conductive parts including earth.
WARNING: 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.
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.
CAUTION: When in close proximity to the Amplifier, do not use mobile phones, transmitters, power transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for more information. 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.
WARNING: The function or safety of the equipment could be impaired if it has been subjected to unfavourable conditions in storage or in transit. If at any time function or safety is thought to be impaired, the instrument should be taken out of operation and secured against unintended use.
WARNING: Do not open or modify the equipment without the authorization of the manufacturer.
CAUTION: 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.
1.3 Explanation of symbols

equipment has reached the end of its useful life, it must be disposed of in an environmentally- friendly way. Waste electrical and electronic equipment (WEEE) requires special procedures for recycling or disposal. This includes batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all of your respective local laws and regulations for the proper disposal of such equipment. Contact your local distributor for information concerning this.
| Consult  warnings in User Manual
| Pushbut ton
| Manufact urer
| Memory card read/ write
| On/ Off and pat ient  event  swit ch
| Bluetooth
| WLAN WiFi
| Nonin Xpod Pulse Oximeter
| Internal battery hazard –  refer t o sect ion 1.7

Storage and transport symbols

| Temperature limits
---|---
| Relative humidit y limits
| International protection code
| Fragile
| Atmospheric pressure limits
|  Keep dry

Prot ected against ingress of solid object 12.5 mm diameter.
Prot ected against access to hazardous parts with finger.
Prot ected against ingress of water dripping (15° tilt ed) .
1.4 The Amplifier and its parts
The T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications.
It is acompact USB amplifier which provides 32 channels (or 68 channels with internal expansion option) with built-in calibration and electrode impedance measurement. A Nonin XPOD interface is provided, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Amplifier is intended to be connected to a specific PC and a medical grade power supply. Refer section 3.1 for details.
Caution:
Only use the PC supplied or authorised by Lifelines
Only use the medical-grade mains power supply with it as supplied or authorised by Lifelines
The T4 EEG Amplifier comprises the following components:

Part numbers may be preceded by ‘L14’ on labelling or packaging.
1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The Amplifier 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.
ANSI/AAMI ES 60601-1| AAMI Deviations from |EC 60601-1 (USA).
CAN/CSA 22.2 No 601.1 M90| Canadian standard for medical electrical equipment, general re- quirements.
IEC 60601-1-2| European standard for medical electrical equipment, EMC require- ments, 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.
Classification of system

be connected to a PC which is powered by a medical grade Class I power supply.
Type BF applied parts.| Internally powered. Type BF applied parts.
If a PC is supplied, it has no electrical connection to the Amplifier & has no applied parts.
Degree of protection against harmful ingress of water| Ordinary (no protection) or IP22 (Amplifier in bag)| IP22 (Amplifier in bag)
Mode of operation| Continuous operation| Continuous operation
Suitability for use in an oxygen rich environment| Not suitable| Not suitable

1.6 Description of the components
The T4 Amplifier
The T4 USB amplifier provides 32 channels (or 68 channels with internal expansion option) with built-in calibration and electrode impedance measurement. A Nonin XPOD interface is provided, a Patient Event input, an Aux DC input 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 Patient Connection Unit (PCU) connects the standard 1.5mm touchproof EEG recording elec- trodes attached to the patient to the T4 unit. It is available either as a T4-PCU 24+8 (32 channel) unit or a T4 PCU 64+4 (68 channel). The PCU is plugged into the  front of the unit and retained with two screws operated by the supplied special tool.
Applied parts, type BF
EEG Electrodes
The amplifier connects to standard 1.5mm touchproof EEG recording electrodes arranged in a standard 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.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral elec- trode, should not contact other conductive parts including earth.
Oximeter Sensor
The amplifier is approved for use with a Nonin 8000AA sensor which attaches to the patient’s finger.
Patient Event pushbutton
The Patient Event Pushbutton is used by the patient to record the instance of a significant event.
Aux DC Input
The amplifier is approved for use with a SleepSense body position sensor, type 1575, for hospital and clinic use. Not for home use.
CAUTION: Only use approved sensors as specified by Lifelines.
USB Cable
The Amplifier plugs directly into a USB port on the PC.
WARNING: The Amplifier must only be used with the USB cable provided with the unit.
USB Power Bank battery pack for ambulatory applications The Amplifier plugs directly into the USB port on the Power Bank.
WARNING: 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.
Bags and Straps for ambulatory applications
The Bag houses the Amplifier and battery.
Medical grade AC/ DC mains power supply module for Laptop PC
Where EEG studies are conducted within the patient environment the leakage current must be con- trolled. The laptop PC mains power supply must be a special medical-grade type with appropriate safety standards, supplied or authorised by 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.
The Setup and Recording Software
The T4/Trackit setup software runs under Microsoft Windows 2000 (with SP2), Windows XP, Win- dows Vista, Windows 7, 8 or 10 on the host PC and is used to setup and review the T4 Amplifier and to record on to the PC.
Functions of the software:

• Download the recording template. This includes which electrodes are used and the recording montage. See section 4.2, step 2.
• Perform a calibration check of the Amplifier. See section 4.2, step 8.
• Perform an EEG recording. See section 4.2, step 8.
• View on-going EEG traces. See section 4.2, step 9.

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 T4 amplifier contains a replaceable lithium ion rechargeable coin cell, type LIR2450.
WARNING: Battery replacement by inadequately trained personnel could result in a haz- ard. It must be replaced only with the correct type and it must be installed correctly with +ve uppermost.

1. Remove PCU and the four screws from underside of instrument, two from the front and two from the rear mouldings. Remove bottom of case.
2. Un-clip the wrap-around screen to expose the battery beneath.
3. Grasp battery between thumb and forefinger and pull it from the socket.
4. Push replacement battery into the socket ensuring +ve is uppermost.
5. Re-clip the wrap-around screen and reassemble the case.

Battery safety instructions
Do not attempt to open, puncture, disassemble or modify the battery in any way.
Do not subject the battery to sudden shock or heat.
Do not dispose of battery in fire.

Installation and Maintenance

WARNING: The following section must be read and understood before the equipment is switched ON.
Note: Medical electrical equipment needs special precautions regarding EMC and needs to be in- stalled and put into service according to the EMC information provided in the Appendix.
The function or safety of the equipment could be impaired if it has been subjected to unfavourable conditions in storage or in transit. If at any time function or safety is thought to be impaired, the instrument should be taken out of operation and secured against unintended use.
The manufacturer should be contacted (details on page 3) for assistance, if needed, in setting up, using or maintaining the equipment; or to report unexpected operation or events.
The assembly of the system and any modifications during its service life require evaluation to the requirements of IEC 60601-1.
2.1 Checks for completeness and integrity

1. Remove the equipment from the packaging case(s).
2. Use the parts list to check that all ordered items have been received.
3. 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.

2.2 Environmental parameters for operation
The operational and storage/transportation environmental conditions are as follows:
Operational:
Temperature: +5°C to +40°C
Relative humidity: 15% to 93% non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
WARNING: Do not obstruct any cooling slots. Position the equipment so that air flows freely.
Storage and transport:
Temperature: -25°C to + 70°C
Relative humidity: Up to 93% non-condensing at + 70°C
Atmospheric pressure: 500 hPa to 1060 hPa
2.3 Power supply connections
Power requirements
Standard USB port.
Power consumption
Maximum power from USB port: 2.5W.
Medical grade AC mains power supply module for Laptop PC
Where EEG studies are conducted within the patient environment the leakage current must be con- trolled. The mains power supply must be a special medical-grade type with appropriate safety standards, as supplied or authorised by Lifelines.
Mains power input: 100—240 Vac, 47-63 Hz, 1.4 A@115 Vac, 0.7 A @ 230 Vac.
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.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
WARNING: The Amplifier must only be used with the USB cable provided with the unit.
2.4 Battery Operation Time
USB Powerbank Li-Polymer battery pack
When fully charged the battery pack will typically power the unit for 36 hours depending on the number of channels, sample rate and wireless usage.
The typical service life is 2 years.
Internal Li-lon backup battery
The internal backup battery will enable the unit to continue operating for a short period of time (15 mins approx.) to allow the main battery pack to be replaced. It is recharged automatically, when- ever the main battery pack is connected, with acquire off. The state of charge is displayed, as de- scribed in section 3.4, whenever the unit is internally powered from the backup battery. To charge manually, operate the pushbutton several times to activate the backlight and if the reading drops below approximately 70%, charge the battery for about 10 minutes by connecting the main battery pack or connecting to a USB port.
The typical service life is 500 charge-discharge cycles.
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. There is no connection between the PC and the T4 Amplifier unit, as all communication is accomplished wirelessly.
Keep the equipment away from sources of heat.
Do not use mobile phones.
Do not allow pets or children to interfere with the sensor cables.
When the equipment is operated with or without its Bluetooth or WiFi on, other devices in the vicin- ity should be moved away or turned off to reduce the likelihood of interference to the equipment or by the equipment.
The T4 may have internal radios fitted. These are approved industry-standard Bluetooth and Wi-Fi types which present minimal risk of reciprocal interference with other equipment.
2.6 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 pace- maker 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.
Leakage current
This system is designed to comply with IEC 60601-1, the international standard for medical elec- tronic equipment, which specifies the permissible levels of leakage current. A potential hazard ex- ists in the summation of leakage currents caused by connecting several pieces of equipment to- gether. 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.
2.7 Interference
The T4 will continue to operate in the presence of radio frequency magnetic fields (RF) and the ef- fects of electrostatic discharges (ESD) and other interference, in accordance with the requirements of EN60601-1-2. However, the T4 amplifier records signals of very low amplitude, and these sig- nals themselves are not immune to the effects of RF, ESD and low-frequency magnetic field inter- ference. Such interference may cause signal artefacts.
The T4 may have internal radios fitted. These are approved industry-standard Bluetooth and Wi-Fi types which present minimal risk of reciprocal interference with other equipment.
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 off to reduce the likelihood of interference to the equipment or by the equipment
Caution: When in close proximity to the amplifier, do not use mobile phones, transmitters, power transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for more information.
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 in the Appendix.
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.
Cleaning
Prior to each re-use of the system, all the outer surfaces of the T4 Amplifier, bag and power pack may be cleaned, as required, with a cloth moistened with a mild detergent solution.
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 (Schulke & Mayr GmbH), Microbac forte (Paul Hartmann AG), Dis- tel Wipes (Tristel Ltd.).
For cleaning instructions for the laptop refer to the manufacturer’s documentation.
Caution: Do not allow any liquid to enter the case of any instrument or connector. Do not use ace- tone on any of the instruments.
2.9 Disposal of equipment
The expected service life of the equipment, parts and accessories is three years, except for the USB Powerbank battery pack which is two years. 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 regula- tion authority that is typically within the local government office.
Caution: Do not dispose of batteries by incineration.

Connections and usage

3.1 Overview Figure 1 Connecting the T4 Amplifier — Clinical Use
Where the entire T4 system including the PC is used within the patient environment, the mains leakage currents and safety and regulatory requirements are met by the use of the special medi- cal-grade laptop power supply.Figure 2 Connecting the T4 Amplifier – Home Use
The laptop PC is optional for home use where it may be used for video recordings. There is no con- nection between the PC and the T4 Amplifier unit, as all communication is accomplished wirelessly.
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.

1. Connect the power cord to the medical-grade power supply.
2. Connect the power supply output to the power input connector on the laptop.
3. Connect the power cord to mains power outlet.
4. Note that the mains power cord serves as a power disconnect device. It should be installed near the equipment and be easily accessible.
5. For laptop installation and operation refer to the manufacturer’s instructions supplied with it.

3.3 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 as shown below, 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.
Warning: Do not plug the cable into any other equipment other than the laptop PC provided with the system. 7 Note: In transportable, i.e. body- worn situations within the clinic, the Amplifier must be housed in- side its bag after being disconnected from the PC, for protection against spillage of liquids.
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 |P22. The laptop PC is optional and may be used for video recordings. There is no connection between the PC and the T4 Amplifier unit, as all communi- cation is accomplished wirelessly.
Note that for Home Use applications, the patient should be given a Patient Instruction Sheet, which details essential usage and safety instructions concerning the equipment and battery replacement. Refer to the Patient Instruction Sheet for details.
Estimating the precise recording time of the battery is difficult as it depends on the number of channels, whether Bluetooth or Wi-Fi are enabled, oximeter use, etc. For recordings over 24 hours in length it is recommended that the patient is given instructions to  replace the battery every 24 hours.
Connecting the T4 Amplifier
The top face of the T4 houses the display and the patient event pushbutton. For display details re- fer to section 3.3 below. Pressing the pushbutton records a patient event and illuminates the back- light of the display.
Above the pushbutton is a circular aperture which houses a light level sensor.Figure 3 Connecting the T4 Amplifier (front face)
The front face of the Amplifier’s PCU is laid out in a standard 10-20 format (T4 PCU 24+8) or a grid layout (T4 PCU 64+4). It accommodates standard touchproof electrode leads fitted with DIN 42802 connectors.
WARNING: The Amplifier accepts standard 1.5 mm touchproof electrodes using DIN 42802-style connectors. To ensure patient safety, the electrodes used must be approved to the Medical Device Directive 93/42/EEC in Europe or to the relevant local standards outside Europe.
CAUTION: The conductive part of electrodes and their connectors, including the Neutral electrode, should not contact other conductive parts including earth.
WARNING: Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
The top edge of the Amplifier provides for several other connections, as shown below.Figure 4 Connecting the T4 Amplifier (back face)

1. Nonin Xpod: the circular connector allows for the connection of a Nonin Xpod pulse oxime- ter for measuring SpOs. 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.
   Refer to the manufacturer’s instructions supplied with the sensor when fitting it to the pa- tient.
   The appropriate recording setup will need to be used as described in section 4.1.

2. Aux1: a3.5mm mono jack connector allows for the connection of the Sleepsense body po- sition sensor, type 1575, for hospital and clinic use. Not for home use.

3. Patient Event: this 3.5mm jack connector allows for the connection of a standard Patient Event Thumb Switch.
   CAUTION: All these connections are type BF isolated. The conductive part of connectors and transducers should not contact other conductive parts including earth. Always ensure that the transducer fitted is suitable for a connection of this type.

4. Micro-SD memory card slot.

5. Host connection RJ45 socket.

WARNING: Cables must be routed carefully to avoid risk to the patient of entanglement and strangulation.
3.4 Starting the system
To start the system proceed as follows:

• Plug the PC into the mains supply.
• Switch on the PC and wait for Windows to load.
• Ensure T4 Amplifier is connected via the USB lead.
• Launch Trackit application and continue as detailed in section 4.
• These procedures also apply following a mains interruption.

Indicators
The following indicators are shown on the display on the top face of the T4:Where the symbols indicate the fields to the right to have the following meanings:

| Current time, hh:mm
---|---
| Elapsed recording time, hh:mm (‘–:–‘ if not recording)
| Battery capacity, % or ‘USB’ if external power applied
| Micro-SD card storage capacity in Mbytes, xxxxM (remaining capacity if recording)
B| If the internal Bluetooth option is fitted, this indicates that it is on. Pressing the pushbutton 4 times within 4 seconds toggles the setting to off, indicated with a b. If the Bluetooth option is not fitted, nothing is displayed.
W| If the internal WiFi option is fitted, this indicates that it is on. Pressing the pushbutton 5 times within 4 seconds toggles the setting to off, indicated with a w. If the WiFi option is not fitted, nothing is displayed.
| Whenever a wireless connection is made the w symbol is displayed.
L/R| Recording in progress
R Recording in progress
L Recording and Low memory card capacity remaining (< 8 minutes) during recording (accompanied by auditory beep every 30 seconds)

• When the battery is low, there is an auditory beep at 1Hz rate. There is no additional information displayed.

3.5 Shutdown of the system
At the completion of a study proceed as follows to shut down the system:

• Stop the recording by pressing the ‘PC Record Off’ button
• Exit the Trackit program.
• Shut down Windows.
• Switch off the PC and disconnect the mains supply.

After the recording is finished, the Micro-SD memory card is removed for reading in a PC.
3.6 Battery replacement and charging
For ambulatory, body-worn applications the T4 is powered from a USB Power Bank. The T4 plugs directly into the USB port on the Power Bank. Ensure that this uses the 1A socket on the Power Bank. After connection, press the green ‘ON’ pushbutton on the side of the battery.1. Open zip at bottom of bag to access battery
Unplug cable from battery
Withdraw discharged battery from bag
Do not connect cable to any other equipment2 Insert charged battery into bag
Plug cable into battery
Turn battery on using button on side
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).
• This device may get hot during use, and this is normal. Hold carefully.
• This unit is not user repairable.
• Do not heat this device or throw it into a fire.
• Do not drop or place the unit under a heavy object.
• Keep this device away from high temperature, wet, or dusty environments.
• During charging keep the device out in the open to allow excess heat to dissipate.
• Charge M5 for 4 hours / M10 for 8 hours before initial use.
• Keep the USB output port and micro-USB input port clean and free of obstruction.
• For additional instructions, consult the documentation supplied with the battery.

To replace the battery in the Bag, unzip the bottom of the Bag to gain access to the battery con- nection. Unplug the USB connection to the battery and replace with a fully charged unit.
When not connected to the T4 unit, the battery is charged by using the micro- USB socket and con- necting to a standard USB port, using the supplied cable.
Battery Charging
Connect the micro-USB charging cable supplied to the Battery and use a USB connection for charg- ing. The battery capacity display will illuminate to show how much of the battery is charged. Once all the LEDs are lit, the battery is fully charged and is ready for use.
For additional instructions, consult the documentation supplied with the battery.
Do not charge the battery when used in the Home Environment.
WARNING: Do not charge the battery whilst it is connected to the T4 unit.
WARNING: Do not charge the battery when the equipment is in use.

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.
The software is supported on Microsoft Windows 2000 (with SP2), Windows XP, Windows Vista and Windows 7 and Windows 8.
The USB drivers will be found on the CD. After connecting the Amplifier to the PC for the first time, at the Windows prompt, browse to the folder CD Drive:\USB Drivers. From there Windows will find the correct drivers for the version of Windows being used.
The software has the following functions:

• Define signal types: create labels to attach to inputs
• Attach the desired signal type (label) to the recording input
• Create a recording montage and download it to the amplifier
• Perform a calibration of the inputs
• Start and stop a recording session

4.1 Setting up a recording protocol
Summary
Step 1 Define the patient ID
Step 2 Define the signals — if required ‘
Step 3 Define the inputs — if required °
Step 4 Define the recording channels — if required *
Step 5 Activate the recording control
Step 6 Connect the 74 for setup
Step 7 Check T4 status
Step 8 Start a recording
Step 9 View the ongoing EEG traces
Notes:

1. Defining signals is usually done once only or very occasionally. The T4 Amplifier arrives with a default set of signals that should suffice for most applications, hence it may only neces- sary to add signal types for polygraphic recordings (airflow, respiration etc).
2. Defining inputs, recording channels and montage is usually only done once per setup type. This entire setup can then be saved and recalled for future use.

Step 1 Define the patient ID

1. Select the New patient icon on the toolbar.
   New Patient icon

2. Enter the patent name and Recording ID into the New Patient di- alog.
   This information is saved with the recording setup for download to the recorder in a future recording.

It is possible to configure the system to use a patient database instead of the simple dialog shown above.Step 2 Define the signals —if required
Defining signals is usually done once only or very occasionally. The T4 Amplifier arrives with a de- fault set of signals that should suffice for most applications, hence it may only necessary to add signal types for polygraphic recordings (airflow, respiration etc). lf for any reason the signals have not been created, it is necessary to define all the signals (labels) that are to be used for montage creation in Step 3. The signal editor allows the creation of up to 64 distinct signals ranging from the standard 10/20 EEG signals such as FP1 O2, to Respiration, Pulse and other polygraphy inputs.
Step 3 explains how to calibrate an AUX input.
To define a signal:
1 Click the View all signals tab in the Signal editor dialog box.2 Double click on the signal you want to edit. This brings up the Signal editor tab), allowing you to create a relevant signal or label to be entered into the signal list.3 Type in the Signal name (e.g. Fo1). 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.
6 If the signal is not an EEG signal, it may be necessary to insert a display sensitivity value by un- checking the Master control check box.
Signals that have been defined with their own independent sensitivities appear in red in the trace display. Further editing and changes to these sensitivity values in the trace display will be saved back into the signal library.
Step 3 Define the inputs
Note that if a pre-saved setup is available then this can be opened directly from the Open menu item, and this section skipped. Other- wise, if a new setup is being created, proceed as follows:

1. Select the Spanner icon on the toolbar. This opens the tabbed Setup Recording dialog.
   Spanner icon

2. Under the Amplifier Channels tab select the signals (labels) to be attached to the physical inputs.
   For example, EEG input 1 may require the label Fo1 and so on according to the standard 10/20 nomenclature.
   Double click the channel name and select the relevant signal label from the Setup Hardware EEG channel 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. For most applications you need perform amplifier setup only once — when the system is first installed — since the amplifier setup is saved with the recording montage for future recall and usage. See Step 4 below.
If you want to use the recording channel order defined in amplifier setup, click on Auto Record Setup in the Setup Recording dialog box. You can then skip Step 4 (Define the recording channels). Poly and AUX inputs: these inputs can be set to either referential (EEG mode), bipolar AC or bi- polar DC. They are ideal for polygraphic signals such as respiration, airflow, EKG, body position (DC mode) etc.
To calibrate an AUX input to reflect a required unit of scale for a given voltage input use the signal editor — see Step 2). Select the appropriate units, e.g. %, or mm Hg, and enter the Physical Signal Amplitude required to generate the Amplifier Input Voltage.
Also in the Aux input section is the SaO2 channel for the Nonin Xpod unit. Select this channel if us- ing the Xpod. Note: If a Setup that uses greater than 32 channels plus the Nonin is attempted to be downloaded to the recorder, an error is displayed and the download prevented.
Step 4 Define the recording channels
Step 4 can usually be skipped, since the Auto Record Setup button will copy what you have defined under the inputs in Step 3 into the list of recording channels. ,
However, you can define and save recording montages for spe- cific recording needs, and recall them for future usage.
Creating a montage follows the same principle as the signal creation and input definition tool: click on the channel number to define the active and reference label of choice.
An example of a recording montage is shown below.

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. Otherwise, from the Trackit toolbar select the Trackit Control Panel (‘handshake’) icon which will allow for manual connection. Key

1 New Patient
4 Ongoings On
7 Calibration On
10 Page Up
13 Notch Filter On/Off
16 Videometry (optional)
19 Vertical sensitivity
22 Stop playback
25 Stop paging
28 Playback time
31 Hi-filter selection| 2 Setup Recording
5 Ongoings Off
8 Calibration Off
11 Get Trackit Events
14 PC Record On
17 Photic Stimulation
20 Chart speed
23 Start playback
26 Page forward
29 Montage selection| 3 Trackit Control Panel
6 Impedance Check On
9 Page Down
12 Email Events List
15 PC Record Off
18 Hyperventilation
21 Open files for playback
24 Page back
27 Paging speed
30 Lo-filter selection
---|---|---

Clicking on the ‘handshake’ icon brings up the Control Panel dialog box.
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.After a couple of seconds Status shows ‘T4 Online’.
Most of the parameters in the Status section do not apply to the T4 and the panel is disabled. How- ever the few that do apply are detailed in the next step.
Step 7 Check T4 status
Use the Control Panel to check that the T4 is correctly online. For the 14, the Status part of the Control Panel gives you the following information:
Acquire — on or off: Shows whether the 14 is acquiring or not.
Patient event: Shows that the external patient event marker is activated.
CF card: Shows whether a CF card is present.
Acquire ready: Shows that a valid recording setup has been loaded into the T4.
Note that further status information is available on the 2″ tab. These parameters do not apply to the 14.
Step 8 Start a recording
Click on the Send Setup button. Wait for the setup to upload to the Trackit recorder. This should take a few seconds.
Click on the Start Record icon on the main screen in the toolbar to start recording. Ongoing traces will be displayed on the PC. These can be turned on or off by clicking on this icon:
To perform an Impedance Check click on this icon: The channel LED will illuminate to indi- cate when the electrode impedance is greater than the set level. The set level can be set with the two push-buttons on the amplifier front panel.
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:

• Ifthe T4 is connected to the PC, and has been sent a valid recording setup, the traces appear wiping from left to right across the display.
• Ifthe T4 has not been sent a setup from the PC, the system asks for the recording setup held in the T4 before displaying the traces.

Sensitivity, Chart speed, Notch Filter and Hi/ Lo filters: as is often the case when viewing a live trace display, the sensitivity, chart speed and filters need be adjusted for optimal viewing. Use the drop down lists on the toolbar.
To adjust the display parameters for an individual channel, click on the channel label. This displays a dialog box for that channel, with a check- box for master control, trace On or Off, and Numeric. Click on Numeric if you want the numeric value displayed under the label. This can be useful when for displaying units such as mmHg or degrees C.
When a channel is under individual channel control the label is depicted in red. When display of that channel is turned off, the label is greyed Out. 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.
The impedance check works via pass/fail threshold selection. Impedance values above the selected threshold (fail) are displayed on a red background. Values below (pass) are displayed on a green back- groundNotch filter: to set a notch filter, use Other Options from the View Menu. Notch filters are either 50Hz or 60Hz depending on where the system is to be used (USA 60Hz; Europe 50Hz).
To activate the notch filter, click on the Notch Filter icon in the Trackit toolbar.
Trackit events: to view all recorded events in the recording online, click on the Get Trackit Events icon in the Trackit toolbar.
Events are displayed in the online event viewer with a description and time. Key:

1. Opens the list of event types
   Additional icons at Playback time:

2. Opens an event file for an older re- cording

3. Navigate forwards or backwards

4. Selects the best trace resolution

5. Selects the max. number of traces

6. Enter a ‘Go to’ time here

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. Or you can go to a par- ticular time in the recording by entering the time (as hrs, min, sec) in the recording time fields.
4.3 Montage Editor
This is available via the Setup | Montage menu on the main screen, and displays the Montage Edi- tor as shown below.
The Montage Editor allows the setting-up of 16 user montages and the As- recorded montage. Note that the As-recorded montage can only have its channel on/off and channel master/special control edited (and if special, the channel sensitivity and filters). All the other 16 user montages are fully definable and can have the following parameters set for each channel:

1. Active channel name. This is either chosen from the drop-down list representing the current Sig- nal Library signals, or typed in directly.

2. Ref. channel name. This is either chosen from the drop-down list representing the current Signal Library signals, plus Ref and Gnd, or typed in directly.

3. Channel On or Off. If off, the channel label is greyed-out and no trace is displayed.

4. Master or Special Control. If Special, then the Sensitivity, Low Filter and High Filter can be set.
   Additional controls are provided to allow:

5. Update. Copies the current settings into the currently selected channel.

6. Add. This adds a channel to the end of the Montage list.

7. Insert. This insert a channel above the currently selected channel.

8. Remove. This removes the currently selected channel.

9. Montage name.

If anything is changed, an option is presented to save all changes to disk or not. If not saved, changes are only temporary.
Note that some of the montage parameters can be changed outside the Montage Editor, by clicking on a channel label to bring up the Channel Information window. These changes are only temporary (although you can save them later by subsequently going into the Montage Editor). 4.4 Reading an EEG recording
Click the ‘Open all playback files’ button on the left hand side of the Trackit software toolbar to playback a recording and browse to the folder and file required. This will open the EDF file and any associated files.
If currently recording to the PC, it is possible to open this file for simultaneous playback. This will open the current EDF file and all video files and the current Events list. Playback occurs in the nor- mal way. The 2″ playback window can be set to tile horizontally or vertically.
As an alternative to the Trackit software which offers basic playback features, any EDF-compatible viewer can be used to read the standard EDF files recorded by the Trackit.
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
• Nihon Kohden 1100 and 1200 EEG
• Neurotronics Polysmith Sleep software
• Nicolet One EEG
• Natus Coherance EEG (formerly Deltamed/Itmed)
• Persyst Insight EEG

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| 32 referential (monopolar) inputs, expandable to 64 with expansion option
---|---
ADC Resolution| 24 bits
Sampling| 250 — 16000 Hz
Input impedance| >20 Mohms
Common mode rejection ratio| > 100dB @ 50 and 60 Hz
Equivalent input noise| <1.5 **** Vpp, <0.2uV rms
Gain| 12 ± 0.5%
Max Input Vaits| 750mVpp (including DC)
Quantisation| 0.17uV/bit @ Gain = 12 and Bits = 22
Bandwidth (-3dB)| DC to 4193Hz
Max common mode input voltage| 0.4Vpp
Input bias current| < +0.3 nA
Front-end Calibration| 8mVpp +5% at 0.98Hz
Impedance Check current| 24nA +20% at 7.8Hz

Polygraphy inputs

Aux. high-level DC Inputs

Connections, ports and con-trols

Patient Connection Unit| Plug-on unit with touchproof 1.5mm sockets. Variants:
24 referential channels + 8 bipolar (model T4-PCU 24+ 8)
64 referential channels + 4 bipolar (model T4-PCU 64+ 4)
---|---
Aux DC Inputs| 1 Jack socket 3.5mm
Patient Event Input| 1 Jack socket 3.5mm
Front-panel push-button| On/Off and Patient Event
Host PC Connector| 1 RJ45 socket providing USB port (isolated from patient) or power input from external battery
Nonin Xpod (SaQ2)| 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
Internal beeper|
LCD display| Displays time/date, recording time, battery life and disk space

Bluetooth Wireless

(ARQ).
Security| Authorization and authentication of devices, proprietary Inter- face Protocol
Type Approvals| Europe (ETSI R&TTE); US (FCC/CFR 47 part 15 unlicensed modular transmitter approval); Canada (IC RSS); Japan (MIC – formerly TELEC)
R&TTE Directive 1999/5/EC| Effective use of frequency spectrum:
Medical Electrical Equipment| EN 300 328
EMC: EN 301 489-1, EN 301 489-17,
EN 61000-6-2
Health and safety: EN 62479,
EN 60950-1, IEC 60950-1
IEC 60601-1-2
Bluetooth Qualification| V4.0

Wireless LAN

802.11g: OFDM
Error correction| Forward Error Correction (FEC)
Security| WEP-128, WPA-PSK (TKIP), WPA2-PSK (AES)
FCC| Part 15.247 FCC T9J-RN171
IC| RSS-210 low-power communication device
CE| ID# 0681
REG| U9M21103-4249-C
Radio| EN 300328 V1.7.1 (10/2006)
EMC| EN 301489-1 V1.8.1 (04/2008)
EN 301489-17 V2.1.1 (05/2009)
Safety| EN 60950-1:2006+A11:2010, EN 50371 2002-03

Physical characteristics

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.
ANSI/AAMI ES 60601-1| AAMI Deviations from |EC 60601-1 (USA).
CAN/CSA 22.2 No 601.1 M90| Canadian standard for medical electrical equipment, general re- quirements.
IEC 60601-1-2| European standard for medical electrical equipment, EMC require- ments, calling:
1EC55011| Conducted Emissions, Group 1, Class B
IEC55011| 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: Com pliance is provided by t he PC
T4 Am plifier

Degree of protection against electrical shock (when con- nected to host system)| Type BF
---|---
Type of protection against electrical shock (when con- nected to host system)| Opt ically isolat ed USB am plifier
Mains isolat ion t ransform er for PC
Degree of protection against harmful ingress of water| Ordinary ( no prot ect ion)
Mode of operation| Cont inuous
Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide| Not  suit able

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”.Click on the Photic Stimulation icon in the top toolbar to bring up the Photic Stimulation control panel, shown below.This window allows single, manual, sweep and complex sequences of Photic stimulation to be pro- duced. Photic start/stop events are recorded as shown above. By using the Trigger output from the Photic Stimulator and connecting to an Aux input on the T4, the actual Photic flash ‘ticks’ are pro- duced in the recording.
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. Set the sensitivity to non-master and 10mV/mm.

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 Key| Event No.| Contents| Type| Size| Total size| Mapping
---|---|---|---|---|---|---
0| 0| No event| Fixed| 16 x 16| 256| Auto
1| Stop recording| Fixed| Auto
2| Start recording| Fixed| Auto
3| Door Open| Fixed| Auto
4| Door Closed| Fixed| Auto
5| Host On| Fixed| Auto
6| Host Off| Fixed| Auto
7| Low Battery| Fixed| Auto
8| OK Battery| Fixed| Auto
9| Imp.Check- Mode| Fixed| Auto
10| Calibrate Mode| Fixed| Auto
11| Normal Mode| Fixed| Auto
12| Electrodes on| Fixed| Auto
13| Electrodes off| Fixed| Auto
14| Patient Event| Fixed| Auto
15| External Event| Fixed| Auto
1| 16| Awake”| User-config| 16 x 16| 256| Fl
17| Asleep”| User-con fig| F2
18| Eyes open”| User-config| F3
19| Eyes closed”| User-config| F4
20| Lights on”| User-con fig| F5
21| Lights off”| User-config| F6
22| Drowsy”| User-con fig| F7
23| I| User-con fig| F8
24| Photic start| Fixed| Auto
25| Photic stop| Fixed| Auto
26| HV start| Fixed| Auto
27| HV >>| Fixed| Auto
28| HV stop| Fixed| Auto
29| Post HV start| Fixed| Auto
30| Post HV >>| Fixed| Auto
31| Post HV stop| Fixed| Auto
2| 32| Video start| Fixed| 32 x 32| 1024| Auto
33| Video stop| Auto
34| Video move- ment| Auto
35| Trackit connect| Auto
36| Trackit discon- nect| Auto
37 – 63| Reserved| Auto
3| 64 —95| ?| User-config| 32 x 32| 1024| Shift F1-8 Ctrl+Shift Fl-8
4| 96 —159| ?| User-config (free-text)| 64 x 64| 4096| F12
| | | | | |

The user-configurable events are edited and setup before acquisition. These are automatically saved and restored by the program. For ease of entry during acquisition, 24 of these events are mapped to the keyboard F1- F8 keys, Shift F1 — F8 and Control + Shift Fi — F8 keys.
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.The Events icon also brings up an option to print an events template for overlaying on the key- board. Facilities are provided to scale the printout to fit different size keyboards. Free Text Events
During a recording, pressing the F12 keyboard key allow a free-text event to be created. The event is recorded at the time F12 is pressed and a window is displayed allowing the entry of descriptive text which can be entered at the user’s leisure. During this time all the other types of events can be activated.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.
The events may be sorted alphabetically by clicking on the ‘Event’ heading in the list. This is con- venient for grouping all event types together, e.g. Photic. Clicking on the ‘Time’ heading sorts the events back into chronological time.

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.![lifelines Trackit Mk2 EEG Amplifier

• Options Tab 1](https://manuals.plus/wp-content/uploads/2023/10/lifelines- Trackit-Mk2-EEG-Amplifier-Options-Tab-1.jpg)Most of these options are not applicable to the 14, 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.

Screen Size
This Slider Bar allows the screen size to be set so that the Chart Speed for the traces exactly matches the cm/s selected. To use, adjust the slider so that it is 30 mm from the left-hand end.
Options| Tab 3 Most of these options are not applicable to the 14, except for:

• XPOD channel name SPO2 (otherwise SAQ2). This option allows the XPOD channel name to be either SPO2 or SAO2. This is because some playback software requires a specific label to enable recognition.
• Screen Width Calibration. This allows the program to be calibrated to the screen width.
• Default folder for EEG and Video files. This allows the program to always record EEG and/or video files to the same default folder. Use Browse to find and/or create the default folder for recordings.
  • Automatically create patient folder here. If checked, the program will automati- cally create a patient folder in the default recording folder set above without any user intervention. If not set, the user choses where to save the recording using the standard save file dialogue window.
• Connect at program launch. If checked, the program will automatically connect to the T4 at launch.

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). This allows the T4 to be monitored remotely over a secure wireless link up to a range of about 100m or greater (dependent on hardware and environmental factors).
System overview
The Bluetooth module is Bluetooth Qualified v4.0. The WiFi module is IEEE 802.11 b/g certified. For full specifications, refer below.
Bluetooth is a device to computer wireless connection and will connect to any suitably certified Bluetooth host, like a PC or laptop. The connection process uses authentication and password pro- tection.
The WiFi (wireless LAN Module) is a device to network wireless connection and will connect to a designated network via a Wireless Access Point (WAP). The connection process uses authentication and password protection.
Connection and use
Both the Bluetooth and WiFi connections require secure passwords to be entered.
During the Bluetooth pairing process, the correct password must be entered to establish the con- nection. As shown below, a secure password authorization and authentication process takes place during the pairing procedure.Once established, the T4 acts as the server and provides the SPP service to the PC acting as a cli- ent.
During the setup of the WiFi module, the WAP SSID is entered together with its password, as shown below.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’” is displayed in the status bar at the bottom left of the main screen, as shown below.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. It will be noticed that the wireless transmission will use its availa- ble bandwidth to try to “catch-up” after a drop in signal quality and the indication can read more than 100% momentarily. A reading, therefore, of less than 100% does not necessarily mean a per- manent bad connection since data flow can increase shortly afterwards. A sustained low value over several seconds will cause the Trackit application to close the connection. If the Autoconnect fea- ture has been enabled in Options, the application will automatically attempt to reconnect to the T4 every 10 seconds.
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. Wi-Fi is a wireless technology designed to connect devices and an infrastructure in a wireless local area network (WLAN). Wi-Fi is compliant with various IEEE 802.11 standards such as 802.11a, 802.11b, 802.119, and 802.11n. 802.11b and 802.119 operate in the 2.4 GHz band, 802.11a operates in the 5 GHz band, and 802.11n can operate in both bands Both Wi-Fi and Bluetooth are based on spread spectrum signal structuring. With this radio trans- mission technique, a narrowband signal is expanded across a given portion of the radio frequency spectrum to result in a broader or wideband signal. Such a wideband signal provides a very strong immunity to interference compared to a narrowband signal.
Bluetooth uses Frequency Hopping Spread Spectrum (FHSS), whilst WiFi uses Direct Sequence Spread Spectrum (DSSS). Given that both technologies operate in the same frequency band, this use of differing techniques can result in interference issues. FHSS devices and DSSS devices per- ceive each other as noise.
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. Due to the robust error detection mecha- nisms, however, as the interference level increases, data continues to be delivered correctly, but the data rate decreases as the number of dropped packets increases.
In terms of security, both system use authentication with encryption and pin codes/pass words. In addition, the T4 itself uses a proprietary Interface Protocol thus preventing a non-authorised user from taking control of the device.
When transmitting wirelessly, data packages are time-stamped when acquired by the amplifier, be- fore being transmitted, and when received by the application they are recorded according to this timestamp. In this way, there is no risk associated with delayed communications or missing data packets over a wireless link since, if the recording software detects missing packages, an event is inserted into the recording to notify the operator. In the extreme case whereby the interference causes the wireless link to be dropped all together, the application automatically reconnects when the interference is removed.
Quality of Service and Associated Risks

1. The risk of corrupt data due to interference is very small due to error detection, error cor- rection and resend data packet mechanisms. In addition to this error detection and correc- tion, the application provides time-stamped data packages, which enables the detection of corrupt, delayed or missing data.
2. The risk of missing data due to interference is also very small, but at the extreme, the data rate decreases aS more and more data packets have to be dropped and resent. Ultimately, in the presence of extreme interference, the data rate will decrease to zero and the wire- less link will be dropped. This situation is also adequately handled with the provision of time-coded data packets, which enables the detection of corrupt, delayed or missing data. In the extreme case whereby the interference causes the wireless link to be dropped all to- gether, the application automatically reconnects when the interference is removed. This sit- uation is very similar to being out-of-range and the same mechanisms apply and, again, the application will automatically reconnect when the device comes back into range. In the presence of extreme and persistent interference, the cabled USB connection is, of course, available.
3. The risk of unauthorised users is very small due to the authentication requirements of the wireless link and the 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.
5. The radio modules are tested according to their own EMC emissions and immunity stand- ards: EN 300 328, EN 301 489-1, EN 301 489-17 and IEC 60601-1-2 (Bluetooth).
6. The radio modules are pre-certified and Type Approved.

Considering the medical system function, its indication for use and very low risk associated with a low level of concern, the analysis, evaluation and preventative measures undertaken reveal the low risk associated with wireless communication. In the presence of extreme interference, the rate of delivery of data packets will decrease until ultimately, the wireless link is dropped. Wireless communication problems are identified, prevented and mitigated, as described. The application identifies these wireless problems and automatically reinstates the wireless link if dropped in the presence of extreme interference. Alternatively, the cabled USB connection is available.
Pre-compliant Wireless Modules
The use of pre-compliant, certified and Type-approved optionally-fitted internal Bluetooth and WiFi wireless modules which comply with applicable national radio regulations ensures best perfor- mance, interoperability, coexistence and quality of service is achieved.
Specifications (taken from Appendix 1).
Bluetooth Module
Specifications:

• 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).
• Error Correction: Forward Error Correction (FEC), Automatic repeat request (ARQ).
• Security: authorization and authentication of devices, proprietary Interface Protocol.

Conformance:

• Type Approval: Europe (R&TTE), US (FCC/CFR 47 part 15), Canada (IC RSS).
• R&TTE Directive 1999/5/EC
• Effective use of frequency spectrum: EN 300 328
• EMC: EN 301 489-1, EN 301 489-17,EN 61000-6-2
• Health and safety: EN 62479, EN 60950-1, IEC 60950-1
• Medical Electrical Equipment IEC 60601-1-2
• Bluetooth Qualification v4.0.

WiFi Module
Specifications:

• Type: 2.4 GHz IEEE Std. 802.11 b/g Wireless LAN Module
• Output power: 12dBm max.
• Output frequency: 2.412 to 2.462 GHz, ISM band.
• Data rate: 230kbps max.
• Protocols: TCP, UDP, DHCP, DNS, ICMP, ARP, HTTP Client, and FTP Client.
• Modulation: 802.11b Compatibility: DSSS (CCK-11, CCK-5.5, DQPSK-2, DBPSK-1) – 802.11g: OFDM.
• Error Correction: Forward Error Correction (FEC).
• Security: WEP-128, WPA-PSK (TKIP), WPA2-PSK (AES), proprietary Interface Protocol.

Conformance:

• Type Approval: Europe (R&TTE), US (FCC/CFR 47 part 15), Canada (IC RSS).
• R&TTE Directive 1999/5/EC
• Effective use of frequency spectrum: EN 300 328
• EMC: EN 301 489-1, EN 301 489-17
• Health and safety: EN 60950-1, EN50371

Interference
The T4 Amplifier will continue to operate in the presence of radio frequency magnetic fields (RF) and the effects of electrostatic discharges (ESD) and other interference, in accordance with the requirements of |EC60601-1-2. However, the amplifier records signals of very low amplitude, and these signals themselves are not immune to the effects of RF, ESD and low-frequency magnetic field interference. Such interference may cause signal artefacts.
Caution: when in close proximity to the amplifier, do not use mobile phones, transmitters, power transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for more information.
Caution: when using the amplifier in close proximity to other devices using Bluetooth or WiFi communication, orientate or position these devices for least interference. If possible separate the devices or turn off their wireless communication.
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 Manufacturers Declaration in the Appendix.

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. Make sure Connection Mode for Active Synch is set to Only When Device is Connected, and not to Continuous.
Make sure other applications such as virus protection software and personal firewalls (ZoneAlarm) are not accessing the COM port while a connection to Trackit is being made.
Problems starting the recording
The setup has not been sent correctly
Under Trackit Status, in the Control Panel, check that Acquire Ready shows Yes. If it is not ready, acquisition cannot begin. This could be caused by incomplete transmission of the Trackit T4 setup. Try to adjust the transmission delay for serial communication in the Trackit software as described above.
An incorrect setup has been sent
If an incompatible setup has been sent to the Trackit T4 the message; “unable to comply” will indi- cate that. If an incorrect setup has been sent, the Trackit Control Panel will show ‘Acquire Ready: No’.
The card is not formatted correctly
If the card is not formatted with a correct 16-bit FAT, a recording cannot commence. Format the flash card using the inbuilt Trackit format utility under Get Card Info. See ‘Get Card Info’, in 5.5 Advanced Settings.
Caution: do not attempt to do a low-level format, or do a standard format using a SCSI or USB card reader.
The card is corrupted
Disk corruption can be caused when a flash card is removed from Trackit or the Card reader while data is being written or accessed.
Trackit T4: always stop a recording, or if hot swapping wait for the write LED to go out, before re- moving the card.
Card reader: make sure the device is stopped, in Card Services, before removing the Card. This is especially important in Win2000 systems using a USB card reader, where the activity LED stays on for several seconds after deleting an old file. If the card is removed when this LED is on, the card will be corrupted and a reformat will be necessary. Always stop and eject the card using the icon in the Windows system tray before physically ejecting it.
The card is not inserted correctly
If the flash card is not pushed in far enough, the card will not engage the pins on the card reader.
‘No CF card present’, in the Status section of the Trackit Control Panel, will evidence this.
File review problems
The card is not formatted in FAT16
When a recording is made on a card formatted in FAT32 it will appear to be severely truncated and most probably unreadable. If you Know a recording has a duration of >24 hours but it only shows up as several minutes in review, the most likely cause is that the card is not formatted in FAT16.
Notes:

1. This problem does not occur if the format has been performed using the inbuilt Trackit format utility.
2. Trackit software detects corrupted or incorrectly formatted cards prior to recording.

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 equipment.

WARNING: The equipment or system should not be used adjacent to or stacked with other equip- ment and that if adjacent or stacked use is necessary, the equipment or system should be ob- served to verify normal operation in the configuration in which it will be used.
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
---|---|---
RF em issions CISPR11/EN55011| Group 1| The T4 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR11/EN55011| Class B| The T4 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
Note: Only the recommended or supplied PC must be used in the system to ensure compliance.
Harmonic emissions EN 61000-3-2| Class A
Voltage fluctuations/Flicker emissions EN 61000-3-3| Complies

Electromagnetic Immunity
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.

Immunity  Test| EN 60601-1-2 Test Level| Compliance Level| Electromagnetic Environment Guid- ance
---|---|---|---
Electrostatic dis- charges (ESD) EN 61000-4-2| +/- 6 kV:Contact +/- 8 kV:Air| +/- 6 kV:Contact +/- 8 kV:Air| Floors should be wood. concrete or ceramic tile. If floors are covered with synthetic ma-terial. the relative humidity should be at least 30%
Electrical fast Transi- ents/burst
EN 61000-4-4| Compliance is provided by the recommended PC equipment.| Compliance is provided by the recommended PC equipment.| Mains power should be that of a typical cornmercial and/or hospital environment
Surge
EN 61000-4-5| Compliance is provided by the recommended PC equipment.| Compliance is provided by the recommended PC equipment.| Mains power should be that of a typical commercial and/or hospital environment
Voltage dips,short in- terruptions and volt- age variations on
power supply input lines
EN 61000-4-11| Compliance is provided by the recommended PC equipment.| Compliance is provided by the recommended PC equipment.| Mains power should be that of a typical cornmercial and/or hospital environment. If the user of the T4 requires continued operation during power mains interruptions. it is recom mended that the T4 be powered from an uninterruptible power supply or a battery
Power frequency
(50/60 Hz) magnetic field
EN 61000-4-8| 3 A/m| 3 A m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital en-vironment
Immunity Test| EN 60601 Test Level| Compliance Level| Electromagnetic Environment Guidance
---|---|---|---
| | | Portable and mobile RF communications equipment should be used no closer to any part of the T4, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recom mended separation distance
RF Common mode/ Conducted Susceptibility EN 61000-4-6| 3 Vrms
150 kHz to 80 MHz| 3 Vrms| d = 13.5/V) \’P = 1.2 ,;I:’
Note: using unshielded input leads
Radiated RF Elect romag – net ic Fields
EN 61000-4-3| 3 V/m
80 MHz to 2.5 GHz| 3 V/m| d = [3.5/E] ,:P : 80 MHz to 800 MHz = 1.17 ,d:,
d = [7/E] \’1″: 800 MHz to 2.5 GHz = 2.33 ,d:,
Note: using unshielded input leads”
| | | Where P is the maximum output power rating of the transmitter in watts (W) according to the manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey’, should be less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1. At 80 MHz and 800 MHz, the higher frequenc range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Fieid strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the T4 is used exceeds the applicable RF compliance level above, the T4 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the T4.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/ m.
c. The immunity levels for conducted RF are for unscreened input electrode leads 1 m in length and worse-case coupling, including any resonances across the frequency band. The interference is less when the coupling plane of the interference source is not in the same plane as the electrode leads.
d. The immunity levels for radiated RF are for unscreened input electrode leads 1 m in length and worse-case coupling, including any resonances across the frequency band. The interference is less when the polarisation plane of the interference source is not in the same plane as the electrode leads.

Recommended separation distance between portable and mobile RF communications equipment and the T4 EEG System
EN 60601-1-2
The 14 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.

Rated maximum out-
put power of trans-
mitter| Separation distance according to frequency of transmitter
m
---|---
W| 150 kHz to 80 MHz
d= 1.17√P| 80 MHz to 800 MHz
d= 1.17 √IP| 800 MHz to 2.5 GHz
d= 2.33√P
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 1.2| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Lifelines Ltd, 7 Clarendon Court,
Over Wallop, near Stockbridge,
Hampshire S020 8HU, UK
Telephone +44 (0)1264 782226
www.LLines.com
[email protected]
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Documents / Resources

| lifelines Trackit Mk2 EEG Amplifier [pdf] User Manual
Trackit Mk2 EEG Amplifier, Trackit Mk2, EEG Amplifier, Amplifier
---|---

References

• llines.com

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