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DM00003 Rev D

SYSTEM

MANUAL

12�9 Guidance and manufacturer's declaration

12�9�1 Electromagnetic emissions

Guidance and manufacturer's declaration - Electromagnetic Emissions

The Trackit M is intended for use in the electromagnetic environment specified below.

The customer or the user of the Trackit M should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The Trackit M 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

CISPR 11

Class A

The Trackit M is suitable for use in all establishments other

than domestic and those directly connected to the public low-

voltage power supply network that supplies buildings used for

domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies

Technical Description

Содержание PL00000

Страница 1: ...DM00003 Rev D SYSTEM MANUAL M is for Mobile ...

Страница 2: ...ndard 10 20 EEG Headbox 16 6 7 Understanding the Rendr Acquisition Software 17 7 Setting Up the Trackit M 18 7 1 Before You Begin 18 7 2 Setting Up the Trackit M Main Unit 19 7 3 Setting Up the Video and IR Illuminator Assembly 21 7 4 Setting Up the Photic Stimulator 22 7 5 Setting Up an External Monitor 24 8 Operating the Trackit M 25 8 1 Windows Login 25 8 2 Network Configuration 25 8 3 Opening ...

Страница 3: ...mplifier 36 11 3 Impedance Measurements 36 11 4 Degree of Accuracy of On Screen Measurements 37 11 5 Event Marker 37 11 6 Photic Stimulator 38 11 7 Video Assembly 39 12 Technical Description 40 12 1 Sensing Channels 40 12 2 Analog Circuit and Amplification 40 12 3 Analog to Digital Conversion 40 12 4 Differential Accessories 40 12 5 Common Mode Noise Rejection 41 12 6 Impedance Measurement 41 12 7...

Страница 4: ...tom Headbox and Cable left and Standard 10 20 Headbox and Cable right 20 Fig 6 Event Marker Cable 20 Fig 7 Video assembly 21 Fig 8 PTZ Camera Assembly 21 Fig 9 Photic Stimulator 22 Fig 10 Photic Stimulator Ports 22 Fig 11 Photic Stimulator Cable 23 Fig 12 Trackit M Main Unit Rear View 24 Fig 13 Custom EEG Headbox 26 Fig 14 Low Frequency Filter 42 Fig 15 High Frequency Filter 43 Fig 16 Notch Freque...

Страница 5: ... 6505 24 7 365 Normal Business hours 7 30 a m 5 00 p m CT Afterhours 5 00 p m 7 30 a m CT weekends and holidays E mail support LifelinesNeuro com During normal business hours you can expect a response within 2 hours Outside normal business hours or holidays please be advised that it may take up to 48 hours to respond For more information visit www lifelinesneuro com A digital copy of this manual c...

Страница 6: ...ir done by anyone other than a qualified Lifelines Neuro representative and for any malfunctions caused by any parts that have been damaged or modified by anyone other than a qualified Lifelines Neuro representative The owner of this system has the sole responsibility for the connection of this product to other systems not satisfying the electrical safety requirements class I type BF standards IEC...

Страница 7: ... examination by personnel who have fully familiarized themselves with the system and the processes and procedures contained in this manual including all warnings and caution statements The Photic Stimulator is classified as a Group 2 instrument under ISO 15004 2 In the event of an electrical failure that turns the Photic Stimulator on at full brightness and at continuous wave stimulation i e the p...

Страница 8: ...d cause shock hazards to the patient or operator or result in malfunction of the system Only use Lifelines Neuro approved power cords and power supplies Use of non approved cords could result in shock hazards to the patient or operator or malfunction of the system Power supplies are specified as part of ME equipment To avoid risk of electric shock this equipment must only be connected to a supply ...

Страница 9: ...f any differential sensor to any grounded connection as this could result in the electrical shock of the patient Ensure that the connector port dust cover is properly installed on the system whenever the connectors are not connected to prevent damage to the system Check the connector area for debris before connecting cables to ensure that they seat properly Unauthorized modification of the Trackit...

Страница 10: ...ystem may not function correctly Data collected during electrostatic discharge to the system may contain spike noise artifact Data collected within environments containing high frequency noise may be subject to such noise In such cases the traces may appear thicker Always disconnect all cables turn off the device and close the screen before transportation of the Trackit M to avoid injury and syste...

Страница 11: ...ent Power Stand by Do not dispose with other household wastes at the end of working life European Authorized Representative Consult instructions for use Caution To prevent possible harm to the environment or human health from uncontrolled waste disposal separate this product from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources Business users ...

Страница 12: ...isplaying digital filtering montage reformatting measuring and streaming data and video to the cloud The Trackit M hardware does not directly contact the patient Accessories that contact patients such as electrodes or sensors should comply with their respective requirements and be duly approved The Trackit M is not sterile The Trackit M is intended for use in clinical and research environments The...

Страница 13: ... 1 PL00016 Trackit M Connector Dust Cover 1 PL00003 Custom EEG Headbox 1 PL00005 Event Marker Cable 1 PL00001 Photic Stimulator 1 DP00851 Peripheral Power Supply and Interchangeable Plug 2 PL00006 Peripheral Cable 1 PL00015 Video and IR Illuminator Assembly 1 DP00282 Tripod Tilt Arm 1 DP00812 USB 2 0A to Mini B Cable 6 0 ft 1 DP00275 Tripod 2 PL00012 Carrying Case 1 PL00017 10 20 EEG Electrode Kit...

Страница 14: ...0 60 00 G Temporal Sensor Cable Gold Long Length Graduated Temporal Sensor Cable Gold Long Length Single Length 2 PL00011 60 00 W G Single Sensor Cable Gold Long Length White 1 PL00011 60 00 Gr G Single Sensor Cable Gold Long Length Green 1 PL00011 60 00 R G Single Sensor Cable Gold Long Length Red 2 Note Lead type delivered will be configured at sale 6 2 3 Optional Accessories Part Number Descrip...

Страница 15: ...Trackit M System Connections HDMI Cable USB Sensors and Sensor Leads Event Marker Video Assembly Power Isolation Unit Power Power Custom or Standard 10 20 EEG Headbox 802 11 Wifi Connection Peripheral Cable Photic Stimulator Power Isolation Device Rendr Platform Cloud EEG Electrodes AC Mains AC Mains Patient Optional External Monitor ...

Страница 16: ...r use Yellow Powered On Caution prompt response from operator required Yellow flashing System boot initial configuration Error if this state lasts for more than 2 seconds No Light Powered Off 6 4 3 Camera Indicator Light Color Status Green Powered On Initializing Green flashing Powered On Ready for use Yellow System boot Caution Camera not connected No Light Powered Off Understanding the Trackit M...

Страница 17: ...Rev D SYSTEM MANUAL Understanding the Trackit M System Connections 6 5 Understanding the Custom EEG Headbox R N F3 F7 T3 A1 A2 T5 T6 T4 F8 Fz C3 Cz C4 P3 Pz P4 O1 O2 F4 Fp1 Fp2 Fig 2 10 20 Sensor Positions on Head ...

Страница 18: ...Used for common mode sensing Should be placed between Cz and Pz along the midline Must be on the body for all measurements performed since all measurements are taken with respect to the Reference sensor Green Ground Neutral An active ground electrode that uses the Reference electrode to eliminate noise on the body and brings the Trackit M to a neutral potential with respect to the body Can be plac...

Страница 19: ... a respiratory belt or cannula temperature sensor See Connecting the Sensor Leads for more Sensors and sensor leads are important components of the EEG system All sensors and sensor leads should comply with Trackit M requirements Lifelines Neuro recommends using Lifelines Neuro branded sensors in order to achieve optimum results Recommendations for maintenance and disinfection of sensors should be...

Страница 20: ...ted from earth ground Must be on the body for all measurements performed X1 X8 Additional monopolar sensors that can be placed as needed and mapped in software Can be used for various bio potential signals and are all measured with respect to the Reference sensor D1 D2 Differential Pair channels that can be used for floating differential sensors such as the Ambu Sleepmate CannuTherm and Sleepmate ...

Страница 21: ...r Acquisition Software includes the following features y Data acquisition and graphing y Streaming data to Rendr Cloud y Photic stimulator controls controlled intervals synchronization y Video EEG with synchronization y Event markers y Notes and measurements y Patient data entry and synchronization with the Rendr Cloud y Data review and reporting y Montage filter selection and customization Refer ...

Страница 22: ...d to the power supply unit due to risk of electric shock Only Lifelines Neuro personnel should service the unit The operator should ensure that the Trackit M Main Unit is setup outside of the patient environment so as to prevent the patient from touching the main unit Failure to do so may result in risk of electric shock and decreased noise performance There are no parts internal to the Trackit M ...

Страница 23: ...arted with the Trackit M set up the Trackit M main unit and connect the EEG cable and event marker To set up the Trackit M main unit EEG cable and event marker 1 Remove the Trackit M main unit from the case 2 Connect the power cord to the unit and plug it into an electrical outlet 3 Open the Trackit M display then press the power button to turn it on 4 Remove the Trackit M dust cover from the left...

Страница 24: ...x and Cable right 5 Remove the EEG cable and Headbox from the case Connect the magnetized connector to the EEG cable port on the Trackit M Fig 6 Event Marker Cable 6 Remove the event marker from the case Connect the magnetized connector to the event marker port on the Trackit M Setting Up the Trackit M ...

Страница 25: ...connect the assembly to the USB port on the back of the Trackit M Connect the camera to power using the provided power supply To set up the PTZ camera 1 Unfold and assemble the video tripod 2 Remove the PTZ camera from the case Screw the camera to the tripod by rotating the camera base Ensure a secure fit 3 Use the network cable in combination with the Ethernet to USB adapter to connect the camera...

Страница 26: ...he photic stimulator tripod 2 Rotate the boom parallel to the ground by loosening the bolt pulling up then tightening the bolt 3 Remove the photic stimulator from the case and screw it to the end of the boom using the screw connector rotating the stimulator until it is tight Fig 10 Photic Stimulator Ports 4 Remove the photic stimulator cable from the case Connect the magnetized connector to the st...

Страница 27: ... electrical failure that turns the Photic Stimulator on at full brightness and at continuous wave stimulation i e the photic stimulator turns on and remains on for more than 16 seconds the light emitted from this instrument is potentially hazardous The longer the duration of exposure the greater the risk of ocular damage Exposure to light from this instrument when operated at maximum intensity wil...

Страница 28: ...s stated in the collateral standard IEC 60601 1 1 or the general standard IEC 60601 1 edition 3 clause 16 Any equipment not complying with the leakage current requirements in IEC 60601 1 shall be kept outside the patient environment i e at least 1 5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents Any person who connects external equipment...

Страница 29: ...Trackit M enter your Windows username and password 2 Double click the Rendr Acquisition Software desktop icon A new study may be initiated by clicking New selecting a patient profile and connecting to the amplifier hardware During a study you may run impedance measurement run calibration record EEG data control the photic stimulator run a hyperventilation sequence mark events and take notes and me...

Страница 30: ...tive paste inside each of the sensor cups 3 Connect the sensors on the patient s head as shown on page 13 4 If using the Custom EEG Headbox connect each sensor lead to the appropriate color coded jack on the custom EEG Headbox Begin with the shortest leads in the back of the head and work toward the front cables are sized to length using the following order a Midline yellow b Reference white c Gro...

Страница 31: ...sponding jack on the Headbox To Connect E Caps 1 Flip open the E cap connector cover on the Standard 10 20 EEG Headbox 2 Place the E Cap on the patient in accordance with the 10 20 system and manufacturer s instructions 3 Connect the E Cap to the Standard 10 20 EEG Headbox E Cap connector 25 pin d sub either directly or through the use of an adapter check with the manufacturer of the E Cap The pin...

Страница 32: ... long the light pulses during stimulation b Rest Duration Select the length for the rest period between pulses c Simulation Intensity Level The brightness of the photic stimulator light where 1 is the dimmest and 10 is the brightest d Pulse Width The duration for each photic stimulation pulse in milliseconds e Program Frequencies The stimulation frequencies to be used by the photic simulator Light...

Страница 33: ...se the component Contact the manufacturer for replacement parts Do not use limited life parts like sensor leads for longer than the specified number of uses or it may result in degraded performance due to regular wear and tear of the electrode cup plating 9 1 3 Dust Cover Installation Always install the dust cover to protect the connectors when cables are not connected to the Trackit M When removi...

Страница 34: ...tor sockets on the device using 70 Isopropyl Alcohol and lint free swabs to remove debris Ensure that all liquid has evaporated before connecting the cables Ensure that all debris is removed before connecting the cables Proper use of the dust cover will help protect the device from debris 9 2 3 Fan Vents The fan vents on both the bottom and rear of the device must not be blocked or obstructed Alwa...

Страница 35: ...of the recommended temperature ranges For long term storage ensure that the Trackit M battery is around 40 charged 9 5 Systems Check The Trackit M automatically performs a functional systems check when the device is powered on If there is a system fault detected the user will be notified in the Rendr Acquisition Software 9 6 Limited Use Items Do not use limited life parts like sensor leads for lon...

Страница 36: ...en to help identify the proper electrode positions and spacing Clean the patient s scalp where electrodes are placed Apply more conductive gel to electrodes Make sure the proper montage is selected in the Montage field at the top of the Graph screen An event marker label will be placed on the graph when the montage is changed Graph does not detect low or high frequency data Filter settings could b...

Страница 37: ...screen when the button is clicked Make sure the Video and IR Illuminator is plugged in via USB to the Trackit M Make sure the Video and IR Illuminator is powered Video and IR Illuminator will not record Make sure the Record button at the bottom of the Graph screen has been selected The video feed will show up in the window on the Graph screen however it will not begin recording until Record is cli...

Страница 38: ...aced on the graph when the recording has ended Data may still be scrolling on the graph until the electrodes are unhooked but that data will not be recorded Click Yes on the popup window that asks if you are sure that you want to stop recording Unable to locate an archived study On the Home screen select Open Existing Study Search for the study by patient name birth date ordering doctor patient ID...

Страница 39: ...ard Drive Capacity 512 GB or better RAM 8 GB Wireless Network Devices y Wi Fi 802 11 ac y Bluetooth Bluetooth 4 1 Nominal Power Input y Voltage Frequency Current 100 240 VAC 50 60 Hz 2 0 1 0 A Additional I O Connections y USB 1x USB 3 0 port y HDMI 1x HDMI port Ingress protection IP 2X Weight 7 7 lbs Dimensions 10 6 x 20 9 x 1 8 Operating Temperature 5 C 33 5 C Storage Temperature 5 C 43 C Relativ...

Страница 40: ...nnels 29 y Differential Channels 3 Custom EEG Headbox 2 Standard 10 20 EEG Headbox Analog to Digital Converter Resolution 24 bits Sampling Rate 500 Hz EEG Amplifier Noise 0 5 60Hz 2 5 µVp p 0 3 µVrms CMRR 100 dB Maximum DC Offset 300 mV 11 3 Impedance Measurements Category Specification Measurement Current Max 1 5 µA Measurement Voltage Max 0 3 V Measurement Frequency Nominal 27 Hz Impedance Range...

Страница 41: ...e values assume a resolution of 1920x1080 Category Specification Voltage Resolution uV px 0 114128 x Where x is sensitivity in uV mm Time Resolution sec px y 1830 Where y is timebase in seconds 11 4 2 Software Measurement Tool The built in software measurement tool reports measurement data based on the actual data array and is limited by the hardware resolution and sampling rate Category Specifica...

Страница 42: ...inal 3 000 lux y LVL 10 Setting Nominal 10 000 lux Stimulation Frequency y Minimum 1 Hz y Maximum 60 Hz y Resolution 1 Hz Stimulation Pulse Width y Minimum 0 1 ms y Maximum 12 8 ms y Resolution 0 1 ms Stimulation Duration Per Frequency y Minimum 1 second y Maximum 16 seconds y Resolution 1 second Rest Duration Between Frequencies y Minimum 1 second y Maximum 16 seconds y Resolution 1 second Techni...

Страница 43: ...econd Illumination Minimum 20 lux Power Requirements y Voltage 12 VDC y Current 2A Weight 1 8 lbs IR Sensitivity 850 nm Optional PTZ camera specs Manufacturer Amcrest Model IP4M 1051B Resolution Max 1280x720 Framerate Nominal 20 frames second Illumination Minimum 1 08lux F2 0 Power Requirements y Voltage 5 0 VDC y Current 2A Weight 0 77lbs IR sensitivity 850nm Technical Description ...

Страница 44: ... Circuit and Amplification The input circuit for each EEG channel consists of an RFI filter a buffer differential amplification and a low frequency filter Each EEG channel is initially measured with respect to the Reference sensor with montages calculated afterward in the Rendr Acquisition Software The input circuit also includes overcurrent and overvoltage protection as well as a multiplexor circ...

Страница 45: ... 5 kΩ y Yellow 5 to 10 kΩ y Red 10 kΩ At least three EEG sensors Fz Cz and Pz must be applied to the head before the impedance measurement can begin If the user begins the impedance measurement using the Rendr Acquisition Software before these sensors have been applied the software will cycle through these three sensors waiting for them to be applied If these sensors are removed from the head afte...

Страница 46: ...42 DM00003 Rev D SYSTEM MANUAL y High frequency filter y Notch filter The characteristics of each filter are shown below Fig 14 Low Frequency Filter Technical Description ...

Страница 47: ...43 DM00003 Rev D SYSTEM MANUAL Fig 15 High Frequency Filter Fig 16 Notch Frequency Filter Technical Description ...

Страница 48: ...T3 T5 C3 A1 C4 LE F3 C3 Fz F4 C3 Ref C3 Avg C3 Cz T5 O1 P3 A1 P3 LE C3 P3 F4 F8 P3 Ref P3 Avg P3 Cz O1 O2 O1 A1 P4 LE P3 O1 T3 C3 O1 Ref O1 Avg O1 Cz O2 T6 Fz A1 O1 LE Fz Cz C3 Cz Fz Ref Fz Avg Fz Cz T6 T4 Pz A2 O2 LE Cz Pz Cz C4 Cz Ref Cz Avg Cz Cz Fp1 F3 Fp2 A2 F7 LE Fp2 F4 C4 T4 Pz Ref Pz Avg Pz Cz F3 C3 F4 A2 F8 LE F4 C4 T5 P3 Fp2 Ref Fp2 Avg Fp2 Cz C3 O1 C4 A2 T3 LE C4 P4 P3 Pz F4 Ref F4 Avg ...

Страница 49: ...gnetic environment guidance RF emissions CISPR 11 Group 1 The Trackit M 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 CISPR 11 Class A The Trackit M is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power...

Страница 50: ...ironment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typica...

Страница 51: ...ed RF transmitters as determined by an electromagnetic site survey a 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 frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propogation is affected by absorption and r...

Страница 52: ...itter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 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 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the fr...

Страница 53: ...rademark of Ambu A S Lenovo and ThinkPad are trademarks of Lenovo Corporation Intel and Intel Core are trademarks of Intel Corporation All other product names and trademarks are the property of their respective owners 2020 Lifelines Neuro Company DM00003 Revision D ...

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