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Lifelines trackit T4 32 Скачать руководство пользователя страница 47

T4 EEG Amplifier User Manual

47

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.

Accessory name

Type

Length

Manufacturer

USB Interface Ca-

ble

USB

2.8 m

USB shielded ca-

ble

Input electrodes

EEG disc elec-

trodes

1 m

Unshielded EEG

disc electrodes

Nonin XPOD

Shielded

2 m

Nonin

Aux. Connector

cable

Shielded

1 m

Shielded cable

Patient Event

Switch

CM-5

2 m

Zygo

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.

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Содержание trackit T4 32

Страница 1: ...T4EEG Amplifier User Manual 32 channel version T432 68 channel version T468 Part no 51285 006 Issue 1 9 Created Checked Approved ...

Страница 2: ...nected to a supply mains with protective earth Removed drawing numbers in section 1 4 Amended section 2 4 Internal Li Ion 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 V 1 5 10 March 2017 Amended instructions concerning oximeter and Aux input sensors V 1 6 13...

Страница 3: ...T4 EEG Amplifier User Manual 3 Lifelines Ltd 7 Clarendon Court Over Wallop near Stockbridge Hampshire SO20 8HU UK Telephone 44 0 1264 782226 www LLines com sales LLines com 0086 ...

Страница 4: ... 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 ma...

Страница 5: ...partment 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 shoul...

Страница 6: ... 5 Use in the home environment 15 2 6 Use with other equipment 15 2 7 Interference 15 2 8 Maintenance and cleaning 16 2 9 Disposal of equipment 16 3 Connections and usage 16 3 1 Overview 16 3 2 Laptop installation and operation 17 3 3 Connecting the T4 System 17 3 4 Starting the system 19 3 5 Shutdown of the system 20 3 6 Battery replacement and charging 20 4 The setup and recording software 21 4 ...

Страница 7: ...24 Figure 11 Channel setup 24 Figure 12 Recording Channel editing 25 Figure 13 Trackit software toolbar 25 Figure 14 Trackit Control Panel 26 Figure 15 Ongoing trace display 27 Figure 16 Adjust display parameters 27 Figure 17 Impedance check 28 Figure 18 Online Event Viewer 28 Figure 19 Montage Editor 29 Figure 20 Photic Stimulation 34 Figure 21 Photic Stimulation control window 34 Figure 22 Photi...

Страница 8: ...ly 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 u...

Страница 9: ...ic 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 saf...

Страница 10: ...tronic 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 Bluetooth Pushbutton WLAN WiFi Manufacturer Nonin Xpod Pulse Oximeter Memory card read write Internal battery hazard refer to section 1 7 On Off and patient event switch Storage and transport...

Страница 11: ...art number 1327 Trackit tool part number 1115 Amplifier USB cable part number 1277 Lenovo ThinkPad laptop computer part number 1389 Medical grade power supply part number 1390 Mains cable UK part number 1066 Trackit software CD standard part number 1009 Part numbers may be preceded by L14 on labelling or packaging 1 5 Specifications and safety Refer to Appendix 1 for specifications The Amplifier h...

Страница 12: ...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 touchpro...

Страница 13: ... 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 ...

Страница 14: ...ty 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...

Страница 15: ...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 l...

Страница 16: ...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 en...

Страница 17: ...ct 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 ...

Страница 18: ...he 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...

Страница 19: ...art 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 0 8 1 7 L R 1 2 0 7 7 2 B...

Страница 20: ... 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 inpu...

Страница 21: ... recording session 4 1 Setting up a recording protocol Summary Step 1 Define the patient ID Step 2 Define the signals if required 1 Step 3 Define the inputs if required 2 Step 4 Define the recording channels if required 2 Step 5 Activate the recording control Step 6 Connect the T4 for setup Step 7 Check T4 status Step 8 Start a recording Step 9 View the ongoing EEG traces Notes 1 Defining signals ...

Страница 22: ...raphic recordings airflow respiration etc If 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 calibrat...

Страница 23: ...g 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 di...

Страница 24: ...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 us...

Страница 25: ...allow for manual connection Figure 13 Trackit software toolbar Key 1 New Patient 2 Setup Recording 3 Trackit Control Panel 4 Ongoings On 5 Ongoings Off 6 Impedance Check On 7 Calibration On 8 Calibration Off 9 Page Down 10 Page Up 11 Get Trackit Events 12 Email Events List 13 Notch Filter On Off 14 PC Record On 15 PC Record Off 16 Videometry optional 17 Photic Stimulation 18 Hyperventilation 19 Ve...

Страница 26: ...er the T4 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 2nd tab These parameters do not apply to the T4 Step 8 Start a recording Click on the Send Setup button Wait for the setu...

Страница 27: ...aying the traces Figure 15 Ongoing trace display 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 cha...

Страница 28: ... 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 t...

Страница 29: ...her 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...

Страница 30: ...nd 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 ...

Страница 31: ...raphy inputs 8 poly bipolar inputs 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 Vp p 0 2 u V rm s Gain 12 0 5 AC 4 0 5 DC Max Input Vdiff 750mVpp AC setting including DC 2 25Vpp DC setting Bandwidth 3dB DC to 4193Hz Quantisation 0 17uV bit Gain 12 and Bits 22 Max common mode input voltage 0 4Vpp Inpu...

Страница 32: ...ocol 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 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 Wireless LAN Type 2 4 ...

Страница 33: ... 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 T4 Amplifie...

Страница 34: ... Photic User Manual Figure 20 Photic Stimulation Click on the Photic Stimulation icon in the top toolbar to bring up the Photic Stimulation control panel shown below Figure 21 Photic Stimulation control window 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 P...

Страница 35: ...er 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 Figure 22 Photic trigger signal definition ...

Страница 36: ...ent Fixed Auto 1 16 Awake User config 16 x 16 256 F1 17 Asleep User config F2 18 Eyes open User config F3 19 Eyes closed User config F4 20 Lights on User config F5 21 Lights off User config F6 22 Drowsy User config F7 23 User config 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...

Страница 37: ...p 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 Figure 24 Events Template setup 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 ...

Страница 38: ... 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 Figure 26 Event List ...

Страница 39: ...39 Appendix 4 PC Setup Options Tab 1 The Options panel Tab 1 contains general settings which are self explanatory as shown below Figure 27 Options Tab 1 Options Tab 2 The second tab in Options is shown below Figure 28 Options Tab 2 ...

Страница 40: ... options are not applicable to the T4 except for XPOD channel name SPO2 otherwise SAO2 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 ...

Страница 41: ...uter 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 us...

Страница 42: ...evented 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 ...

Страница 43: ...ption 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 IE...

Страница 44: ... 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 a...

Страница 45: ...rface 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 in...

Страница 46: ...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 ...

Страница 47: ...he manufacturer of the equipment as replacement parts for internal components may result in increased emissions or decreased immunity of the equipment Accessory name Type Length Manufacturer USB Interface Ca ble USB 2 8 m USB shielded ca ble Input electrodes EEG disc elec trodes 1 m Unshielded EEG disc electrodes Nonin XPOD Shielded 2 m Nonin Aux Connector cable Shielded 1 m Shielded cable Patient...

Страница 48: ... 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 Compli...

Страница 49: ...ons Electromagnetic propagation is affected by absorption and reflection 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 broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF tran...

Страница 50: ...ter 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 P 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 12 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 f...

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