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Doc #: 60-00118 Rev. A 

 

3 

 

 

Table of Contents 

Introduction ...................................................... 6

 

Device Description ............................................................................................. 6

 

Intended Users ................................................................................................... 7

 

Indications for Use ............................................................................................. 7

 

Contraindications .............................................................................................. 7

 

Compatibility ...................................................................................................... 7

 

How to Use this Manual ..................................................................................... 8

 

Conventions used in this Manual ..................................................................... 8

 

Symbols .............................................................................................................. 9

 

Overview ......................................................... 12

 

Physical Description ........................................................................................ 12

 

Remote Control ................................................................................................ 15

 

Cart .................................................................................................................... 16

 

Quick Start ...................................................... 18

 

Hardware Setup ................................................................................................ 18

 

Login ................................................................................................................. 18

 

Perform TCD Exam .......................................................................................... 18

 

System Setup .................................................. 20

 

Hardware ........................................................................................................... 20

 

Initial Login ....................................................................................................... 22

 

Display Options ................................................................................................ 22

 

Report Heading ................................................................................................ 22

 

Custom Protocols ............................................................................................ 22

 

PACS ................................................................................................................. 23

 

Turning Off the System ................................................................................... 23

 

Transport .......................................................................................................... 23

 

Users ............................................................... 25

 

New User ........................................................................................................... 25

 

Edit User ........................................................................................................... 25

 

Delete User ....................................................................................................... 25

 

Forgot Password .............................................................................................. 25

 

Содержание Lucid M1

Страница 1: ...Doc 60 00118 Rev A 1 Lucid M1 System User Manual Copyright 2019 By Neural Analytics Inc...

Страница 2: ...Neural Analytics Year of Authorization 2017 COMPANY DATA Neural Analytics Inc 2440 S Sepulveda Blvd Suite 115 Los Angeles CA 90064 USA Phone 877 638 7251 ext 733 Email support neuralanalytics com AUTH...

Страница 3: ...ntions used in this Manual 8 Symbols 9 Overview 12 Physical Description 12 Remote Control 15 Cart 16 Quick Start 18 Hardware Setup 18 Login 18 Perform TCD Exam 18 System Setup 20 Hardware 20 Initial L...

Страница 4: ...Scanning Controls 31 Acoustic Power 31 Gain 32 Filter 33 Sample Volume 33 Scale 34 Sweep Speed 34 Depth 35 Baseline 35 Vessel Label 36 Envelope 37 Baseline Shift 37 Snapshots 38 Screen Freeze 39 Scree...

Страница 5: ...ound Safety 58 ALARA 58 Managing Ultrasound Exposure 59 Electrical Safety Test 61 Troubleshooting 63 Software Version 63 Error Screen Messages 63 Export Log Files 68 Specifications 69 Technical Inform...

Страница 6: ...tem can be configured as a one or two channel ultrasound system with customizable application software It can be used as a portable standalone system or it can be mounted on an adjustable height TCD c...

Страница 7: ...e Lucid M1 System measures the occurrence of transient emboli signals within the blood stream The device is not intended to replace other means of evaluating vital patient physiological processes is n...

Страница 8: ...e device technical information and other important notes regarding the use of the device Conventions used in this Manual Throughout this manual the following conventions will be utilized Caution indic...

Страница 9: ...tion or Precaution WARNING CE Mark Direct current Alternating current Separate collection for electrical and electronic equipment WEEE Symbol Equipotential ground Headphone Manufacturer DC power conne...

Страница 10: ...plied Parts Catalog number Serial number Lot Number Authorized representative in the European Community Fragile handle with care Keep dry Temperature limit See Technical Information Humidity limits Se...

Страница 11: ...Doc 60 00118 Rev A 11 Symbol Description For indoor use only Cart Tipping Hazard Video Output HDMI...

Страница 12: ...Doc 60 00118 Rev A 12 Overview Physical Description Front View This Front View of the Lucid M1 System shows the following Touchscreen Display Transducer Connectors 1 2 Remote Connector...

Страница 13: ...Button Four USB ports One is labeled for connection to PACS One is labeled for connection to the NeuralBot System One audio output jack One HDMI port not available on all versions The Right Side View...

Страница 14: ...shows the following DC power input Equipotential Connection location Equipotential plug and cable assembly is not included with the Lucid M1 System and must be supplied separately VESA mounting locati...

Страница 15: ...essory NA ACC2 is an accessory device designed to replicate the touch screen interface for commonly used commands during the Lucid Transcranial Doppler Exam Remote Control Diagram Up Right 1 2 3 4 5 6...

Страница 16: ...e pole VESA Mount using the four 4 bolts from the previous step Verify the Lucid M1 System is firmly seated on the VESA mount and all four 4 bolts are securely installed Adjust the height of the adjus...

Страница 17: ...f the adaptor plate Verify the Lucid M1 System is firmly seated on the VESA mount and all four 4 bolts are securely installed Slide the system into the installed quick release plate Slide the Lucid M1...

Страница 18: ...m 2 From the Exam Procedures page select the desired exam 3 If the selected exam has protocol options select the desired protocol 4 Use the M mode display to locate the desired vessel 5 Adjust the dep...

Страница 19: ...h the exam 4 User events can be added for all other monitoring exams 5 The M mode can be toggled with a velocity trend plot for Monitoring and VMR exams 6 Snapshots can be taken to capture specific ev...

Страница 20: ...Connect the DC power cord from the AC adapter to the DC input of the Lucid M1 System Connect the AC cordset to the AC adapter and to a standard AC power outlet Use the AC adapter supplied with the Luc...

Страница 21: ...transducer s connector s into the front panel Plug the Remote Control into the port on the front panel Plug keyboard and mouse into the USB ports on the side panel Press the power button on the left...

Страница 22: ...option 1 Spectrogram on the top M mode on the bottom 2 M mode on the top spectrogram on the bottom 3 Spectrogram only or 4 M mode only Settings Exam Exam Layout Select the M mode preferred M mode opt...

Страница 23: ...s screen the Server Address Port ID Remote AE and Local AE can be entered Press Test Connection to ensure a proper connection Connection of the Lucid M1 System to an IT NETWORK that includes other equ...

Страница 24: ...Doc 60 00118 Rev A 24 4 The system can be carried or transported on a mobile cart to the desired destination 5 Follow the procedure described in the Setup section...

Страница 25: ...ppropriate information Press Update Delete User When it is desired to Delete a User perform the following steps Select the User to be deleted Press the Delete button Press Yes to confirm user deletion...

Страница 26: ...search fields can be corrected and the search results will be updated automatically To see all listings in a field simply delete all items entered in a field For Gender the Female or Male buttons can...

Страница 27: ...off Vessel and Depth Exam Type The icon indicates the type of exam Digital Streaming Home Page The icon returns the display to the Home Page Patient ID The patient name and MRN are shown here Clock Lo...

Страница 28: ...Indicator The probe icons indicate that the probe is active The icon will be greyed out if the probe is inactive Active Channel The active channel is highlighted and the TCD parameters for this channe...

Страница 29: ...w toward the insonating transducer probe Blue indicates blood flow velocity away from the insonating transducer probe Brighter colors indicate greater intensity of the signal The sample depth is displ...

Страница 30: ...s four velocity measurements and calculations are displayed During monitoring exams two are displayed for each channel The display order is configurable Click each box to display the options and selec...

Страница 31: ...f The Acoustic Power ON OFF control toggles the ultrasound energy ON or OFF When the ultrasound energy is ON the spectrogram and M mode will actively display data When the ultrasound energy if OFF the...

Страница 32: ...e the adjustment window can be closed by pressing the power icon again or by pressing the button Gain The Gain control adjusts the intensity of the spectrogram display The gain is adjustable from 0 to...

Страница 33: ...ter the filter adjustment is made the adjustment window can be closed by pressing the filter icon again or by pressing the button There is no Filter button on the remote Sample Volume The Sample Volum...

Страница 34: ...screen remote the vertical axis of the spectrogram display can be adjusted to capture the full velocity envelope and spectrogram on the display After the scale adjustment is made the adjustment windo...

Страница 35: ...ange the depth From the remote the depth is changed by using the depth button Baseline The Baseline adjustment is used to adjust the 0 cm s line baseline on the vertical axis This can be moved up or d...

Страница 36: ...ox Press the up down arrows on the screen or on the remote to advance to the next vessel in an exam protocol or to return to a previous label The entire list of vessels included in an exam protocol ca...

Страница 37: ...w for each vessel Press the envelope icon on the screen to change the envelope position Baseline Shift When the Envelope is set to Auto the spectrogram baseline will shift slightly down for vessels wh...

Страница 38: ...included on the first page of a diagnostic report The snapshot can be saved as a still image as well as an MP4 video If desired these images and videos can also be included in reports The last 9 snaps...

Страница 39: ...n the screen or press and hold the snapshot icon on the remote When the envelope is on the Mean Velocity is calculated by averaging the velocities from spectrogram data When the envelope is turned off...

Страница 40: ...hannel A Screenshot taken during a bilateral exam will show both channels A Screenshot differs from a Screen Freeze or Snapshot in that a Screenshot cannot be edited or annotated Screenshots can be in...

Страница 41: ...ecords screen by pressing New Exam If an exam is started from the Home Page the patient will be assigned after the exam is completed From the Patient Records page the patient is assigned to the exam f...

Страница 42: ...n be labeled using the vessel labelling controls 7 Vessels can be interrogated in 1 mm depth increments 8 An envelope will trace the spectrogram and the Maximum Peak Systolic and Minimum End Diastolic...

Страница 43: ...e been selected for the report press the Next button to advance to the Exam Review Reports page 18 The patient name medical record number date of birth exam date exam type and technologist s name are...

Страница 44: ...list will be displayed and the user must select the protocol to be used 4 A Complete report is generated from snapshots taken during the exam Lindegaard Ratio The Lindegaard Ratio is defined as the M...

Страница 45: ...tocol Graphs will be generated for the vessel pairs and the Basilar Artery 3 If additional vessel pairs are desired a custom protocol can be generated to plot velocity changes in other vessels 4 When...

Страница 46: ...ge all snapshots taken during the exam are listed on the left side of the page and the snapshot flyout will display the list 5 From this screen snapshots can be replayed marked for inclusion in the re...

Страница 47: ...rded exams that can be replayed in post processing Play Pause Fast Forward and Rewind buttons enable review of the recorded exam The snapshot icon can be used to take a snapshot from the recording Gre...

Страница 48: ...ressing the M mode Trend button 4 Trend lines for Mean Min and Max velocities as well as the Pulsatility Index PI can be plotted 5 Events can be included in the exam recording by clicking the User Eve...

Страница 49: ...olding 5 When the desired protocol is selected the exam screen will be displayed Vessels should be located in the usual manner and the exam started with the Start Exam button 6 When the exam is starte...

Страница 50: ...the recording for at least one minute after the injection Snapshots of representative bubble activity can be taken during the exam or after the exam in Exam Review 6 Click Exit Exam to stop the recor...

Страница 51: ...shots 5 Use the snapshot flyout to display the embolic events and view each embolus If the embolic event is determined to be artifact use the check box on the left of the snapshot and the delete butto...

Страница 52: ...ogin credentials for the AMQP server i User name in the User Name field ii Password in the Password field 3 Press Test Connection to test the configuration and network connection c If the system fails...

Страница 53: ...g Headframe NA MOUNT2 2 qty 2 MHz Monitoring Transducer NA PRB3 1 qty Monitoring Headframe Procedural Set NA DSP3 Packaged 1 qty Transducer 2 Mhz Handheld NA PRB1 Packaged 1 qty Monitoring 2 Mhz Trans...

Страница 54: ...from the main outlet There are no user serviceable parts Do not open the equipment or transducers This may damage the equipment When not in use the Transducers should be stored in a location where the...

Страница 55: ...taken since disinfection agents may contain chemical compounds that may damage the probe Do not immerse the base unit or accessories keyboard mouse or remote in water or any cleaning solution Permane...

Страница 56: ...use an accessory if the accessory body is damaged This may cause an electric shock hazard Do not use an accessory if the accessory cable or connector are damaged This may cause an electric shock hazar...

Страница 57: ...ause radio interference or may disrupt the operation of nearby equipment If necessary move the device to a difference location or re orientate Electromagnetic fields from other non compliant devices m...

Страница 58: ...and a thermal mechanism that causes heating Following ALARA mitigates the possibility of any of these mechanisms occurring ALARA When using the Neural Analytics Lucid M1 System the principles of ALARA...

Страница 59: ...3 dB cm MHz along the beam axis in the body TIB Bone Thermal Index thermal index in which ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone TIC Crania...

Страница 60: ...significant adverse biological effects observed due to temperature increases less than or equal to 1 5 C above normal Limitations of the indices The indices are calculated estimates and not actual tem...

Страница 61: ...ter Power on the safety tester and system Perform the tests listed below making sure the measured values met the test criteria listed below Make sure the for any leakage current test the current is me...

Страница 62: ...e collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environmen...

Страница 63: ...m Orange channel Reconnect probe Press Acoustic Power icon until data reappears on screen If error persists power cycle Lucid M1 System Both Probes Disconnected Probes were disconnected from Green and...

Страница 64: ...firm that a valid connection was established Unable to connect to 0 Please check your export network settings The provided network drive path is not valid The user is not connected to a valid network...

Страница 65: ...e Error Code 002 High temperature warning TCD board temperature too high Power off Lucid M1 and restart If the error appears again contact Neural Analytics Customer Support System fault detected Pleas...

Страница 66: ...or the following data type s Please review the User Manual Troubleshooting Guide Customer s PACS server is incorrectly configured Test the connection again Contact PACS Admin and consult the DICOM Con...

Страница 67: ...erent duration Error while creating audit trail file if the issue persists please contact Neural Analytics Customer Service No logs were found for given time period System error Re attempt to export t...

Страница 68: ...ered by following the steps below 1 Insert a USB drive minimum 8GB into one of the USB ports 2 From Home screen press Settings 3 Press on the Logging tab 4 Press the Export button for Lucid Error Logs...

Страница 69: ...perating Software Version 1 3 X X represents a number used for minor releases with no feature changes Environmental Conditions Operating Temperature 15C to 60C Storage Temperature 0 to 70C Ambient Pre...

Страница 70: ...s the reflected Doppler ultrasound signals from the transmitted beam The received Doppler signal is processed based upon the depth and sample volume set by the user The output of the processed signal...

Страница 71: ...ection feature When the embolus is a weak reflector then the signal may not appear on the spectrogram or M mode display It should be noted that gaseous emboli are easily detected due to the high refle...

Страница 72: ...the velocity envelope is designed to follow the instantaneous maximum velocity of the flow signal waveform in the spectrogram For complex blood flows the spectral edge of the waveform is subject to i...

Страница 73: ...lation 100 2 BHI Breath Holding Index 100 Mean Velocity When the envelope is tracking the spectrogram 125 spectral slices second 500 slices 4 seconds Sum of 500 velocities 500 Mean Velocity When manua...

Страница 74: ...with the relevant requirements of EN IEC 60601 1 2 Electrical Fast Transient Burst Immunity on power lines Complies with the relevant requirements of EN IEC 60601 1 2 WARNING This device is compliant...

Страница 75: ...ptibility Power Lines Complies with the relevant requirements of EN IEC 60601 1 2 Conducted Susceptibility Signal Lines Complies with the relevant requirements of EN IEC 60601 1 2 Power Frequency Comp...

Страница 76: ...40 00008 handheld 2MHz Transducer Operating Mode Pulse Doppler Index Label MI TIS TIB TIC Scan non scan non scan Aaprt 1 Aaprt 1 Global Maximum Index Value 0 29 1 73 Assoc Acoustic Parameter Pr 3 MPa...

Страница 77: ...99 Assoc Acoustic Parameter Pr 3 MPa 1 50 W mW 142 142 142 Min of W 3 z1 mW ITA 3 z1 142 z1 cm 4 6 Zbp cm 2 7 Zsp cm 4 5 z PII 3max cm 4 5 dep Zsp cm 0 52 fc MHz 2 0 2 0 2 0 2 0 2 0 Dim of Aaprt X cm...

Страница 78: ...or fawf 4MH z Where Pra is the attenuated peak rare factional pressure at the position of ISPPA 3 in MPa fawf is the center frequency acoustic working frequency in MHz and CMI is 1 MPa MHz 2 P zs The...

Страница 79: ...mum attenuated pulse average intensity in cm zb The depth for the bone at focus thermal index in cm zbp The break point depth in cm zs The depth for the soft tissue thermal index scanning and non scan...

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