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USER MANUAL

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Содержание trackit T4

Страница 1: ...USER MANUAL...

Страница 2: ...Road Dun Laoghaire Dublin A96 F8W5 Ireland Doc No 51285 006 Part No 51285 006 Issue 2 1 CCN CCN0152 Created Checked Approved Digitally signed by Geoff Salter Date 2021 12 07 18 38 44 Z Digitally signe...

Страница 3: ...ble from Lifelines Neuro The owner of this system has the sole responsibility for any malfunction resulting from improper use or maintenance or repair done by anyone other than a qualified Lifelines N...

Страница 4: ...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 cons...

Страница 5: ...d 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 wi...

Страница 6: ...eteness and integrity 15 2 2 Environmental parameters for operation 15 2 3 Power supply connections 16 2 4 Battery Operation Time 16 2 5 Use in the home environment 17 2 6 Use with other equipment 17...

Страница 7: ...ement 2 26 Figure 9 Photic Stimulation using Trackit Plus software 33 Figure 10 Photic Stimulation control window 33 Figure 11 Photic trigger signal definition 34 Figure 12 Bluetooth pairing 36 Figure...

Страница 8: ...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...

Страница 9: ...he USB Power Bank supplied or authorised by Lifelines To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Lifelines does not supply EEG el...

Страница 10: ...nal antennas should be used no closer than 30 cm 12 inches to any part of the Trackit T4 including cables specified by Lifelines Ltd Otherwise degradation of the performance of this equipment could re...

Страница 11: ...y 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 othe...

Страница 12: ...laptop and a medical grade power supply Refer to section 3 1 for details The PC or laptop must only be powered using the medical grade mains power supply as supplied or authorised by Lifelines The T4...

Страница 13: ...ations from IEC 60601 1 USA CAN CSA 22 2 No 601 1 M90 Canadian standard for medical electrical equipment general requirements IEC 60601 1 2 Standard for medical electrical equipment EMC requirements c...

Страница 14: ...fier 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...

Страница 15: ...latory applications The Amplifier plugs directly into the USB port on the Power Bank The Amplifier must only be used with the USB Power Bank supplied or authorised by Lifelines Micro SD memory card Th...

Страница 16: ...Remove the PCU 2 Remove the four screws from the underside of the T4 amplifier as well as the two screws from the front PCU end moulding and the two screws from the connector end moulding Remove the b...

Страница 17: ...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...

Страница 18: ...y Lifelines To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth 2 4 Battery Operation Time USB Powerbank When fully charged the battery pa...

Страница 19: ...ot 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 Oth...

Страница 20: ...ds to be installed 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 calibrati...

Страница 21: ...nt Isolation Zone Clinical Use Wireless or USB Connection Type BF Laptop PC Trackit T4 Amplifier Battery pack and bag optional To USB Port EEG Electrodes Patient Figure 1 Connecting the T4 Amplifier C...

Страница 22: ...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...

Страница 23: ...aptop PC is optional 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 NOTE For Home Use applications...

Страница 24: ...ent cabling to reduce the possibility of patient entanglement or strangulation The conductive part of electrodes and their connectors including the Neutral electrode should not contact other conductiv...

Страница 25: ...se some extra channels as well These are labelled EEG 1 22 EEG 2 23 etc Also provided are 3 bipolar channels Electrocap connector Electrode EEG channel No D25 pin No Electrode EEG channel No D25 pin N...

Страница 26: ...for the connection of the Sleepsense body position 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 Pati...

Страница 27: ...the Bluetooth option is not fitted nothing is displayed 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 i...

Страница 28: ...metal objects e g hair clips and keys y This device may get hot during use and this is normal Hold carefully y This unit is not user repairable y Do not heat this device or throw it into a fire y Do n...

Страница 29: ...e micro SD card is formatted using the SD formatting software supplied on the Lifelines CD y There should be no read only files on the card y There should be no folders directories on the card If thes...

Страница 30: ...files on the micro SD card The two files will have the same file name The EEG data is stored in a BDF and the events are stored in a TEV file The file name can be set in the software to use the Patien...

Страница 31: ...r 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 bein...

Страница 32: ...t bias current 0 3 nA Front end Calibration 8mVpp 5 at 0 98Hz Impedance Check current 24nA 20 at 7 8Hz Polygraphy inputs Number of polygraphy inputs 8 poly bipolar inputs ADC Resolution 24 bits Sampli...

Страница 33: ...ng Spread Spectrum FHSS Error correction Forward Error Correction FEC Automatic repeat request ARQ Security Authorization and authentication of devices proprietary Interface Protocol Type Approvals Eu...

Страница 34: ...es 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...

Страница 35: ...Manual and the Trackit Plus Software manual Figure 9 Photic Stimulation using Trackit Plus software Click on the Photic Stimulation icon in the top toolbar to bring up the Photic Stimulation control...

Страница 36: ...p a suitable Photic trigger signal definition open the Signal library as described in section 0 and define a signal with a name Photic set it to type DC units mV and Physical Signal Amplitude of 1000m...

Страница 37: ...d 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 1...

Страница 38: ...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 proc...

Страница 39: ...module the WAP SSID is entered together with its password as shown below Figure 13 WiFi setup If an attempt is made to connect to an unsecure network without a password this is prevented and an error...

Страница 40: ...t of the transmission range or when either antenna is adversely obscured or under the influence of interference It will be noticed that the wireless transmission will use its available bandwidth to tr...

Страница 41: ...ith 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 wirele...

Страница 42: ...s 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...

Страница 43: ...fier 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 artefac...

Страница 44: ...Recording setup have the same sample rate The T4 does not support multi sample rate An incorrect setup has been sent If an incompatible setup has been sent to the Trackit T4 the message unable to comp...

Страница 45: ...nd that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used Portable RF communications equipment...

Страница 46: ...nvironment Immunity Test EN 60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharges ESD IEC 61000 4 2 8 kV Contact 15kV Air 8 kV Contact 15kV Air Floors sho...

Страница 47: ...ction from structures objects and people a Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broa...

Страница 48: ...to the patient as the Trackit T4 is a non invasive recording device that does not modify or interact with the patient Rated maximum output power of transmitter Separation distance according to freque...

Страница 49: ...to section 3 3 details of battery replacement frequency V 1 5 10 March 2017 y Amended instructions concerning oximeter and Aux input sensors V 1 6 13 March 2017 y Further amendments to instructions co...

Страница 50: ...Lifelines Ltd 1 Tannery House Tannery Lane Woking Surrey GU23 7EF UK Telephone 44 0 1483 224 245 www lifelinesneuro com sales lifelinesneuro com...

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