Trackit Mk2 and Mk3 User Manual Issue 2.4

Trackit User Manual

Version History V2.4 (August 2012) • Combo-EEG system details added in 3.1 • Print Electrode Hookup added in 4.1 • Simultaneous playback of current recording file added in 5.7 • Dual recording mode added in Appendix 4, Section 1 • Mini-wizard recording menu items added in Appendix 4, Section 1 • Expanded events detail added in Appendix 4, Section 1 • Additional specifications for mains power supplies added to Appendix 1 • Auto start video with EEG added in Appendix 5, Application PC Setup, Options | Tab 2 • Stop & Exit and Stop & Shutdown added in Appendix 4, Section 3 Video, Tab Options 2 • FAT16 and FAT32 CF card formatting section inserted at Appendix 8 • Releasing unused com ports details added in Appendix 9 V2.3 (December 2011) • Latest 4th Generation internal Bluetooth details added in Appendix 5 • Bluetooth recording times and range details added • Latest version low-power XPOD Pulse Oximeter details added in Appendix 2 V2.2 (September 2011) • Trackit Mk3 introduced: USB Interface detail added to Sections 1.2, 1.3, 3.1, 3.2 and 4.2. • Large memory cards (FAT32) added in Section 5.6. • Aux Box 2 added in Appendix 2. • More Setup parameters added to Appendix 5. • Quick Setup Guide adjusted in Appendix 6. • Troubleshooting adjusted in Appendix 8. V2.1 (June 2010) • Added Bluetooth indicator to Figure 6 • Added ‘Internal Bluetooth’ paragraph to Appendix 5 • Minor amendments to section 5.7 ‘Reading an ambulatory recording’ • Minor amendments to Appendix 4 ‘Network Connection’ V2.0 (April 2010) • Reformatted to A4 page size • Added full documentation to Appendix 4: o Section 1 Record to PC o Section 2 Network Connection o Section 3 Video • Added full documentation to Appendix 5: Bluetooth Wireless • Appendix 7: Troubleshooting guide moved to Appendix 8 • Appendix 8: Manufacturer’s Declaration moved to Appendix 9 • Added Appendix 7: Trackit Setup Wizard V1.8 (28 January 2010) • Virus protection recommendations added, Page 5. • Lifelines logo adjusted, Page 3. • References to Windows 98 and ME removed, Sections 1.4 and 4. • Check with distributor for later software version added, Section 4. • Picture of latest main Toolbar updated, Figure 16, and table below updated. • Picture of main ongoing display window updated, Figure 23. • Appendix 3 added, Photic and Hyperventilation. Photic refers to separate documentation. Old Appendix 3 now Appendix 4. • Appendix 4 added, Trackit Plus and Plus with Video Software. Both refer to separate documentation. Old Appendix 4 now Appendix 5. • Appendix 5 added, Bluetooth Wireless. Refer to separate documentation. Old Appendix 5 now Appendix 6.

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Trackit designed and distributed by: Lifelines Ltd, 7 Clarendon Court, Over Wallop, near Stockbridge, Hampshire SO20 8HU, UK Telephone +44 (0)1264 782226 www.LLines.com [email protected]

Trackit manufactured by: G & B Electronic Designs Ltd, 54 Woolmer Industrial Estate Bordon Hampshire GU35 9QF, UK Telephone +44 (0)1420 474188 [email protected]

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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 maintenance or damage caused by a product for which Lifelines is not responsible will void the warranty. Lifelines do not warrant uninterrupted or error-free operation of its products. Lifelines or its authorised agents will repair or replace any products that prove to be defective during the warranty period, provided that these products are used as prescribed in the operating instructions in the user’s and service manuals. No other party is authorised to make any warranty to assume liability for Lifelines products. Lifelines will not recognise any other warranty, either implied or in writing. In addition, services performed by someone other than Lifelines or its authorised agents or any technical modification or changes of products without Lifelines prior, written consent may be cause for voiding this warranty. Defective products or parts must be returned to Lifelines or its authorised agents, along with an explanation of the failure. Shipping costs must be prepaid. Lifelines 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 reliability of its software or hardware with equipment that is not furnished by third-party manufacturers accepted by Lifelines at the date of purchase. All warranties for third-party products used within the Trackit system are the responsibility of the relevant manufacturer. Please refer to the relevant documentation on each product for further details. This document contains proprietary information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced in any other form or translated into another language without the prior written consent of Lifelines.

Trademarks Microsoft, Windows and Windows NT are registered trademarks of the Microsoft Corporation. All other trademarks and product names are the property of their relevant owners.

Responsibility of manufacturer The manufacturer and distributor consider themselves responsible for the equipment’s safety, reliability and performance only if: z any peripheral equipment to be used with Trackit is supplied by third-party providers recommended by the manufacturer; z assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorised by the manufacturer; z the electrical installation of the relevant room complies with the appropriate requirements; z 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 specifications are subject to change without notice. Check with Lifelines or your distributor if a software update is available.

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Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Appendix.

Software and Virus Protection Lifelines takes all reasonable steps to ensure that it’s software is virus-free. In line with modern computing practice, it is advisable that continual protection against viruses, trojans, malware, adware etc. is provided on the PC used for installation and the surrounding systems. Please note the following recommendations which should be supported by your internal IT/Computing department procedures and practices: 1. Virus protection software should be installed on every computer at risk of infection. This software should have a resident (online) shield and provide email scanning if appropriate. 2. Virus scanning should be set to manual mode or automatic if desired but at a time when the system is not being used. 3. All programs offering auto-update features, including Windows, should be set to manual or automatic if desired but at a time when the system is not being used. 4. Adopt formal departmental or organisational procedures to ensure the integrity and safe operation of the medical equipment and supporting systems.

Combo-EEG system The Combo-EEG system allows the Trackit to be used not only as an Ambulatory Recorder but also as an amplifier for routine EEG examinations including Photic stimulation. The routine EEG system uses a Laptop or desktop computer with a special medical-grade mains power supply. This allows the system to be used within the patient environment. Refer section 3.1 for details. Caution: Only use the laptop or desktop computer supplied or authorised by Lifelines Only use the medical-grade mains power supply with it as supplied or authorised by Lifelines

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Trackit User Manual Contents Version History

2

Disclaimers & Warranties Trademarks Responsibility of manufacturer Software and Virus Protection Combo-EEG system

4 4 4 5 5

Illustrations

8

1

System Overview 1.1 Explanation of symbols 1.2 The system and its parts 1.3 Specifications and safety Description of the components

10 10 10 12 12

2

Installation and Maintenance 2.1 Checks for completeness and integrity 2.2 Environmental parameters for operation 2.3 Power supply connections 2.4 Use with other equipment 2.5 Interference 2.6 Maintenance and cleaning 2.7 Disposal of equipment

15 15 15 15 16 16 16 17

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Connections for Trackit setup 3.1 Overview 3.2 Connecting the Trackit 3.3 Switching on 3.4 Warning symbols on the display

18 18 22 24 25

4

The setup software 4.1 Setting up a recording protocol 4.2 Configuring the recorder 4.3 Montage Editor

26 26 31 38

5

The ambulatory recording 5.1 Changing batteries and cards 5.2 Fitting the Clickon PCU 5.3 Event marking 5.4 Ending a recording 5.5 Identifying a recording 5.6 Advanced Settings 5.7 Reading an ambulatory recording

40 40 44 45 45 46 46 50

Appendix 1: Specifications

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1

Trackit Specifications EEG inputs Polygraphy inputs Aux. high-level DC Inputs Modes of operation Connections, ports and controls Back-light display Recording format Physical characteristics Safety and EMC standards

51 51 51 52 52 52 52 52 53 53

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Reomed Mains Isolation Transformer Specifications

53

3

Lind Medical Dell Laptop Mains Power Supply Specifications

54

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Trackit User Manual Appendix 2: Trackit options Nonin XPOD pulse oximeter Auxiliary Input Box

55 55 57

Appendix 3: Photic Stimulator and Hyperventilation Photic Stimulation Hyperventilation

59 59 60

Appendix 4: Trackit Plus and Plus with Video Software

62

1

Record to PC

62

2

Network Connection

66

3

Video

70

Appendix 5: Bluetooth Wireless Introduction System overview Connection and use Application PC Setup Trackit and Bluetooth Module Setup Trackit Bluetooth Module Specifications Parameter Data Regulatory FCC Statement IC Compliance Guidelines for Efficient and Safe Use Trackit Bluetooth Battery Power Consumption Bluetooth Range Bluetooth Knowledge Base

75 75 76 77 80 83 93 93 94 95 95 96 98 99 101

Appendix 6: Trackit quick setup and operation guide

102

Appendix 7: Trackit Setup Wizard

103

Appendix 8: Memory card formatting

104

Appendix 9: Troubleshooting guide Problems with serial communication to Trackit Problems starting the recording File review problems

105 105 107 107

Appendix 10: Manufacturer’s Declaration EMC Compatibility

108 108

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Illustrations Figure 1 Connecting the Trackit for recorder set-up Figure 2 Connecting Combo-EEG system for routine EEG (Laptop) Figure 3 Connecting Combo-EEG system for routine EEG (Desktop) Figure 4 Connecting the medical-grade power supply Figure 5 Connecting to the PC Figure 6 Connecting to the Trackit recorder Figure 7 Trackit recorder: front panel Figure 8 The Trackit display Figure 9 New Patient dialog Figure 10 New Patient database Figure 11 Signal list Figure 12 Signal editing tool Figure 13 EEG setup Figure 14 Setup Recording dialog Figure 15 View Hookup Figure 16 Channel setup Figure 17 Recording Channel editing Figure 18 Trackit software toolbar Figure 19 Trackit Control Panel Figure 20 Trackit status 'B' Figure 21 Recording Control Figure 22 Ongoing trace display Figure 23 Adjust display parameters Figure 24 Impedance check Figure 25 The online event viewer Figure 26 Montage Editor Figure 27 Opening the rear battery box/door Figure 28 Removing and replacing PP3 batteries Figure 29 Removing and replacing Lithium rechargeable battery Figure 30 Closing the rear Battery box/door Figure 31 Removing and replacing the flash card Figure 32 Removing the flash card Figure 33 Clickon PCU Retaining screw location Figure 34 Detach the PCU Figure 35 Lift the PCU away from the Trackit Figure 36 Locating the PCU Figure 37 Trackit Defaults Tab 1 Figure 38 Trackit Defaults | Tab 2 Figure 39 Pulse oximeter and oximeter probe Figure 40 Connecting the oximeter to Trackit or the AUX box Figure 41 Connecting the oximeter to the oximeter probe Figure 42 Attaching the oximeter probe to the finger Figure 43 Display of SaO2 Figure 44 Auxiliary Input Box Type 1 (left) and Type 2 (right) Figure 45 Connecting Trackit to the AUX Input Box Figure 46 Photic Stimulation Figure 47 Photic Stimulation control window Figure 48 Photic trigger signal definition Figure 49 Hyperventilation Figure 50 Hyperventilation control window Figure 51 Menu items for different recording modes Figure 52 Trackit video preview Figure 53 Trackit with External Bluetooth Module (L) and Internal Module (R) Figure 54 The Trackit Control Panel Figure 55 A typical Bluetooth Places view

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18 19 21 23 24 24 25 25 26 27 27 28 28 29 29 31 31 31 32 33 33 36 36 37 38 39 40 41 41 42 43 43 44 44 45 45 47 48 55 56 56 56 57 57 58 59 59 60 60 61 63 72 76 77 78

Trackit User Manual Figure 56 Trackit Main Screen Figure 57 Options Tab 1 Figure 58 Options Tab 2 Figure 59 Options Tab 3 Figure 60 Trackit Defaults Tab1 Figure 61 Trackit Defaults Tab2 Figure 62 Trackit Defaults Tab 3 Figure 63 Trackit Defaults Tab 4 Figure 64 Trackit Defaults | Bluetooth Setup Tab 1 (General) Figure 65 Trackit Defaults | Bluetooth Setup Tab 2 (Profile) Figure 66 Trackit Defaults | Bluetooth Setup Tab 3 (Serial) Figure 67 Trackit Defaults | Bluetooth Setup Tab 4 (Version) Figure 68 Trackit Defaults | Bluetooth Setup Tab 5 (Misc) Figure 69 Trackit Defaults | Bluetooth Setup Tab 6 (Pairing) Figure 70 Tx Delay factor

79 80 81 83 84 85 85 87 88 89 90 91 91 92 105

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1 System Overview 1.1 Explanation of symbols Type BF equipment

Attention, consult accompanying documents

Input and 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 environmentallyfriendly 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.

1.2 The system and its parts The Trackit recorder is a multi-channel1 ambulatory electroencephalograph designed for use in a variety of monitoring applications, including those concerned with neurological and sleep disorders. The earlier Mk2 Trackit (in a silver anodised case) uses a serial interface whilst the later Mk3 Trackit (in a red anodised case) uses a USB interface. Note 1 : Trackit is available in a number of versions, including a 32-channel (Trackit-32/0 or Trackit-24/8), a 24-channel (Trackit 24/0) and a 12-channel (Trackit-24/0). The version is displayed on the Trackit LCD at switch-on. This manual applies to all versions, the only difference being the number of channels. The Combo-EEG system allows the Trackit to be used not only as an Ambulatory Recorder but also as an amplifier for routine EEG examinations including Photic stimulation. The routine EEG system uses a special Desktop or Laptop computer with a special medical-grade mains power supply. This allows the system to be used within the patient environment. The Trackit recorder comprises the following components: Recorder Trackit-32/0 (32 EEG) Trackit-24/0 (24 EEG) Trackit-12/0 (12 EEG) Trackit-20/4 (20 EEG, 4 POLYGRAPHIC) Trackit-18/8 (18 EEG, 8 POLYGRAPHIC)

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part number 1102 or 11863 part number 1103 or 11873 part number 1131 or 11893 part number 1100 or 11843 part number 1101 or 11853

Trackit User Manual Trackit-24/8 (24 EEG, 8 POLYGRAPHIC) part number 1123 or 11883 Recorder with internally fitted wireless Bluetooth option Trackit-32/0 (32 EEG) part number 1171 Trackit-24/0 (24 EEG) part number 1172 Trackit-12/0 (12 EEG) part number 1174 Trackit-20/4 (20 EEG, 4 POLYGRAPHIC) part number 1169 Trackit-18/8 (18 EEG, 8 POLYGRAPHIC) part number 1170 Trackit-24/8 (24 EEG, 8 POLYGRAPHIC) part number 1173 Patient connection unit (PCU) Clickon PCU-clickon 32/0 part number 1109 PCU-clickon 24/0 part number 1110 PCU-clickon 20/4 part number 1107 PCU-clickon 18/8 part number 1108 PCU-clickon Short part number 1181 PCU-clickon Sleep part number 1219 PCU-clickon Sleep with SaO2 part number 1220 Patient connection unit (PCU) Leaded PCU-leaded 24/0 part number 1104 PCU-leaded-Extended 32/0 (universal) part number 1136 Cable, PCU 32ch 1m part number 1106 Cable, PCU 32ch 0.5m part number 1105 RJ45/D9 Converter part number 1122 Cable, RJ45 part number 1113 Cable, Trackit USB 3m part number 1277 Power supply, medical grade Class 2 part number 10492 Power supply, medical grade Class 1 part number 1180 Mains cable US, 2pin Class 2 part number 1031 Mains cable Europe, 2 pin Class 2 part number 1030 Mains cable UK, 3 pin Class 2 part number 1029 Mains cable US, 3pin Class 1 part number 1068 Mains cable Europe, 3 pin Class 1 part number 1067 Mains cable UK, 3 pin Class 1 part number 1066 Trackit bag part number 1116 Trackit strap, adult part number 1117 Trackit strap, child part number 1118 Trackit bag with PCU-clickon part number 1142 Trackit set up software part number 1009 Trackit User manual part number 1114 Battery Box PP3 part number 1111 Battery Box PP3-Small part number 1140 Battery Box Li part number 1112 Note 2 : The Medical Grade power supply (for Mk2 only) may be supplied either as Class 2 (unearthed) or Class 1 (earthed). The appropriate mains cable must be used with each type. Note 3 : The 2nd of the two part numbers is for the later wireless Bluetooth-enabled units. Combo-EEG system (additional parts) Cart, adjustable height Lind Medical PSU Dell Laptop (135W AC/DC) Reomed mains isolation transformer, 600VA • 230V Input/230V Output • 115V Input/115V Output Trackit Mounting Cradle kit Photic or Trackit Arm Stand for Arm Photic Stimulator Photic Cables & other accessories

part number 1296 part number 1287 part number 1288 part number 1289 part number 1292 part number 1291 part number 1245 part number 1290 refer Photic User Manual 11

Trackit User Manual

Note: if using the Photic Stimulator refer to the User Manual supplied with it.

1.3 Specifications and safety The system has been certified and complies with the following standards: EN60601-1 and European standard for medical electrical equipment, general reEN60601-2-26 quirements and EEG systems. UL60601-1:2003 USA standard for medical electrical equipment, general requirements. CAN/CSA 22.2 No 601.1 M90 Canadian standard for medical electrical equipment, general requirements. EN60601-1-2:2001 European standard for medical electrical equipment, EMC requirements, calling: EN55011 Conducted Emissions, Group 1, Class B EN55011 Radiated Emissions, Group 1, Class B EN61000-4-2 Electrostatic Discharges EN61000-4-3 Immunity - Radiated RF Field EN61000-4-4 Immunity - Transients Bursts EN61000-4-5 Immunity – Surges EN61000-4-6 Immunity – Conducted EN61000-4-8 Immunity – Power frequency fields EN61000-4-11 Immunity – Voltage dips, interruptions EN61000-3-2 Harmonic Emissions EN61000-3-3 Voltage Fluctuations/flicker

Degree of protection against electrical shock (when connected to host system)

Type BF

Type of protection against electrical shock (when connected to host system)

Internally powered or Mains powered Class 1 or 2 (Mk2) or USB powered (Mk3) Ordinary (no protection)

Degree of protection against harmful ingress of water Mode of operation

Continuous

Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide

Not suitable

Description of the components The Trackit recorder The Trackit Recorder is a multi-channel recording device designed for use in recording a patient’s EEG signals. It comprises a 24-channel EEG (monopolar) amplifier acquisition board, an 8-channel polygraphic acquisition board and control board with all the I/O interface for serial, wireless, USB and patient communication. When connected to a host PC, the device has built-in isolation for patient safety. The device may be powered either by its own batteries, a PC USB port (Mk3) or from a medical-grade mains power supply (Mk2). EEG data is stored on an internal CF card. The data format is native European Data Format (EDF), allowing the EEG files to be reviewed by any EDFcompatible EEG reader.

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Patient Connection Unit The Patient Connection Unit (PCU) connects the standard 1.5mm touchproof EEG recording electrodes attached to the patient to the Trackit unit. It is available either as a ‘Leaded’ type which is connected via a screened cable or a ‘Clickon’ type which fits on the Trackit directly without needing a cable. WARNING: Lifelines does not supply EEG electrodes. The PCU 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.

PC Connection Cable This is either a serial connection, or on later Mk 3 units, a USB connection. Serial (Mk2): An RJ45 cable connects from the Trackit recorder to an RJ45/D9 Converter. This Converter plugs directly into the serial port connection on the PC. The connection is used to setup and review the Trackit recorder for an ambulatory recording session. USB (Mk3): The Trackit plugs directly into a USB port on the PC.

Trackit Medical grade AC/DC mains power supply module (Mk2) On later Mk3 units, this is not required since external power comes from the PC USB port. On Mk2 units, the medical grade mains DC power supply provides DC power to the Trackit recorder when connected to a host PC during system set up, using the serial connection. It is connected to the RJ45/D9 Converter. When connected, it supplies power to the Trackit itself and acts as a battery eliminator if no batteries are in the unit. It also charges the internal backup batteries. WARNING: The Trackit Mk 2 must only be connected to the medical-grade power supply provided with the unit. It must not be used with any other power supply. If the specific medical-grade power supply is not used, Trackit may not perform as intended, and the safety of personnel may be at risk. The Trackit Mk3 must only be used with the USB cable provided with the unit. Note: when Trackit is connected to the PC during setup, the PC is powered from its own power supply.

Lind Laptop Medical grade AC/DC mains power supply module for Laptop PC This is for the Combo-EEG system where EEG studies are conducted within the patient environment and the leakage current must be limited. The mains power supply is a special medical-grade type supplied by Lifelines with appropriate safety standards. Refer to Section 3 for this situation. WARNING: The laptop must only be connected to the medical-grade laptop power supply supplied by Lifelines. Do not use the standard power supply supplied with the laptop. Only use the laptop supplied or authorised by Lifelines.

Reomed mains Isolation Transformer for Desktop PC This is for the Combo-EEG system where EEG studies are conducted within the patient environment and the leakage current must be limited. The mains power supply is a special medical-grade isolation type supplied by Lifelines with appropriate safety standards. It is rated at 600VA and available as 230V input/output or 115V input/output. Refer to Section 3 for this situation. WARNING: The desktop PC, its monitor and any other mains-powered equipment in the vicinity must only be connected to the medical-grade mains isolation transformer supplied by or authorised by Lifelines. Ensure that the voltage rating of the isolation transformer matches the local mains supply voltage and do not exceed the maximum power output rating of 600VA.

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Batteries 3 PP3 disposable alkaline batteries are optionally supplied with the Trackit recorder. Alternatively, a rechargeable Lithium battery option is available and a small (single) PP3 option.

CF flash card A Compact Flash (‘CF’) card is used to store the EEG data recorded by Trackit. Storage cards of varying capacity are available in the CF format.

Trackit setup software The Trackit setup software runs under Microsoft Windows 2000 (with SP2), Windows XP, Windows Vista or Windows 7 on the host PC and is used to setup and review the Trackit recorder for an ambulatory recording session and for the Combo-EEG system allows routine EEG examinations to be done. The Trackit recorder is connected to the PC via the connection cable or wirelessly with Bluetooth. The recording setup/montage, and patient information/ID is downloaded to the device, and a short review is made to verify that all the electrodes have been attached correctly. The recorder is then disconnected from the PC and the ambulatory recording is started.

Functions of the setup software: z

z z z z

Download the recording template. This includes: which electrodes are turned on or off; the recording montage; any timed recording modes. Download the unique patient identifier onto the card so that no confusion can arise as to whom the recording belongs to. Perform a calibration of the Trackit device Synchronise the Trackit’s time and date to that of the host. Perform a routine EEG recording prior to the patient’s ambulatory EEG recording.

What does a recording consist of? 2–36 channels of recorded EEG/polygraphic signals z Signals recorded over a period usually not less than 24 hours z Patient event markers correlated in time with the real time clock displayed on Trackit’s LCD display z Data and results stored to card for future evaluation z Data review post-recording using any compatible EDF review program z

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2 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 installed and put into service according to the EMC information provided in the Appendix. The function or safety of the equipment could be impaired if it has been subjected to unfavourable conditions in storage or in transit. If at any time function or safety is thought to be impaired, the instrument should be taken out of operation and secured against unintended use.

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 Assembly instructions for third-party products will be found in their packing cases. It is recommended that these instructions be filed with Trackit technical reference materials. 4 Check for signs of damage that may have occurred during transit or storage. If any damage is found, do not use the instrument; contact your distributor.

2.2 Environmental parameters for operation Operation The instrument is designed to operate within the following ranges: Temperature +10°C to +40°C Relative humidity 25% to 95% non-condensing Atmospheric pressure 700mB to 1060mB Do not obstruct any cooling slots. Position the instrument so that air flows freely.

Storage and transport When the instrument is in store or being transported, the following ranges are tolerated: Temperature -10°C to +50°C Relative humidity 10% to 95% non-condensing Atmospheric pressure 500mB to 1060mB

2.3 Power supply connections Power requirements 100-240 Vac, 50/60 Hz when using the external mains power supply.

Power consumption Maximum peak power consumption for medical grade power supply: approximately 15W Maximum power from USB port: 2.5W Maximum power for Reomed mains isolation transformer: 600W Maximum power for Lind Laptop mains power supply: 135W

Mains power connections Instruments are supplied with a medical-grade mains power supply. The mains input accepts a standard IEC 320-C8 two pin or C5 three pin mains connection cable. When the mains plug is designed to hold a fuse, a 3A-rated fuse should be used. WARNING:

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Trackit User Manual 1 Always use the power lead and connector supplied with Trackit, or a lead and connector of equivalent standard. 2 Do not use adaptor plugs or extension leads unapproved by Lifelines. 3 Only appropriately trained and qualified personnel should adjust, maintain or repair an instrument. 4 Always disconnect the instrument from the main power supply before removing any covers.

Leakage current This instrument is designed to comply with IEC 601-1, the international standard for medical electronic equipment, which specifies the permissible levels of leakage current from individual products. A potential hazard exists in the summation of leakage currents caused by connecting several pieces of equipment together. Because this instrument can be used in conjunction with standard electronic devices, the total leakage current should be tested at regular intervals. For situations where the equipment is used within the patient environment, suitable mains isolation must be used to limit the leakage current. A special medical-grade laptop PSU or mains Isolation Transformer as described above, is used to achieve this.

2.4 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 high frequency surgical equipment.

Other patient-connected equipment When used simultaneously with other patient-connected equipment, for example a cardiac pacemaker or other electrical stimulator, it is unlikely that a safety hazard will arise. However always consult the documentation supplied with the other patient-connected equipment to ensure that all hazards, warnings and cautions are considered before the equipment is used together.

2.5 Interference Trackit 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 EN60601-1-2. However, Trackit 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 recorder, 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 installed and put into service according to the EMC information provided in the Appendix.

2.6 Maintenance and cleaning The Trackit contains no user-serviceable parts (apart from replaceable batteries). The system uses solid-state components and requires no routine testing or maintenance procedures apart from occasional cleaning and checking for wear and damage to all parts including the accessories. All the outer surfaces of the individual pieces of equipment of the Trackit system may be cleaned using a soft cloth moistened with water and detergent. Each item may also be cleaned using a lowpressure air-line or a vacuum cleaner. Caution: Do not allow any liquid to enter the case of any instrument or connector. Do not use acetone on any of the instruments.

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2.7 Disposal of equipment When the device has reached the end of its operating life, it should be disposed of in accordance with local waste regulation authority that is typically within the local government office. Caution: do not dispose of batteries by incineration.

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3 Connections for Trackit setup 3.1 Overview Below in Figure 1 is an overview diagram showing the principal components when connected to a PC during system set up of an ambulatory recording. Figures 2 and 3 show the Combo-EEG system used for routine EEG studies and ambulatory recordings.

Figure 1 Connecting the Trackit for recorder set-up In this configuration, the PC and its mains power supply are used outside the patient environment.

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Figure 2 Connecting Combo-EEG system for routine EEG (Laptop) This configuration allows the entire system including the PC to be used within the patient environment. The leakage currents and safety and regulatory requirements are met by the use of the special Lind medical-grade laptop mains PSU connected to a Dell laptop. The current range of recommended Dell laptops includes the Inspiron 15 and 17, and the XPS 15 and 17. WARNING: The laptop must only be connected to the medical-grade laptop power supply supplied by Lifelines. Do not use the standard power supply supplied with the laptop. Only use the laptop supplied or authorised by Lifelines. The Cart, Arm and Stand

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Trackit User Manual This allows all the system components to be conveniently located on a custom cart. This cart has a height-adjustable worktop, large lockable wheels, dual arm-mounting holes, lockable drawer, Vesa mount and Laptop secure bracket. It also houses a medical mains isolation transformer or laptop medical PSU and the mains input power cord. The laptop medical PSU is mounted on an internal shelf inside the drawer unit. A mains input connector is provided here for it. In this situation where the Reomed mains isolation transformer is not required in the lower housing, the mains input and output connectors located here are simply plugged together. In situations where more mains-powered equipment is required, e.g. printer, large monitor etc., it may be preferable to use the Reomed isolation transformer to power everything on the cart. The Reomed provides 600VA of power and has multiple output connectors. A single mains input cable to the Cart is provided, fitted with an earthed Schuko Europe plug. A Euro-US and Euro-UK adapter plug is provided for different territories. These are firmly screwed onto the Euro plug. The Arm will mount on the Cart or on the Stand and accommodates either the Photic or the Trackit in its Cradle. The Stand accommodates a Photic on an Arm or a Trackit in its Cradle on an Arm. The Trackit in its Cradle can also be mounted directly on the Stand without an Arm. Note: the Cart is supplied flat-packed - refer the enclosed instructions for assembly details.

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