Neural Analytics Lucid M1 User manual

Doc #: 60-00118 Rev. A 1
Lucid™M1 System
User Manual
Copyright © 2019 By Neural Analytics, Inc.

Doc #: 60-00118 Rev. A 2
NeuralAnalytics,Inc.All rights reserved. No part of this manualmaybereproduced,storedinaretrievalsystem,or transmitted, in
any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of
Neural Analytics.
Year of Authorization: 2017
COMPANY DATA Neural Analytics, Inc.
2440 S. Sepulveda Blvd, Suite 115
Los Angeles, CA 90064, USA
Phone: [phone] ext. 733
Email: [e-mail]
AUTHORIZED REPRESENTATIVE
Healthlink Europe Services BV
De Tweeling 20-22
5215 MC’s-Hertogenbosch
The Netherlands
Tel Nr: +31.13.5479300
Fax Nr: +31.13.5479301
E-mail: [e-mail]
PRODUCT INFORMATION Lucid™M1 System
Transcranial Doppler Ultrasound
MODEL NA-LUCM1

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

Doc #: 60-00118 Rev. A 4
Patient Information......................................... 26
Patient Search.................................................................................................. 26
New Patient....................................................................................................... 26
Delete Patient ................................................................................................... 26
Exam Screens ................................................. 27
Unilateral Exam Screen................................................................................... 27
Bilateral Exam Screen ..................................................................................... 28
M-Mode Display................................................................................................ 29
Spectrogram Display....................................................................................... 29
Velocity Displays ............................................................................................. 30
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
Screenshots ..................................................................................................... 40
Exams and Reports......................................... 41
Diagnostic Exams............................................................................................ 42
Monitoring Exams............................................................................................ 46
Digital Streaming ............................................ 52
Hardware Setup................................................................................................ 52
Digital Streaming Setup................................................................................... 52
Digital Streaming ............................................................................................. 52
Peripherals...................................................... 53
List of System Components & Compatible Accessories.............................. 53

Doc #: 60-00118 Rev. A 5
Equipment Care and Maintenance ................. 54
Safety .............................................................. 56
Cautions and Warnings................................................................................... 56
Clinical Safety .................................................................................................. 58
Potential Equalization...................................................................................... 58
Ultrasound 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 Information...................................................................................... 69
Measurements.................................................................................................. 70
Calculations...................................................................................................... 73
Electro-Magnetic Compatibility (EMC)........................................................... 74
Appendix 1 –Acoustic Output ........................ 76
Appendix 2 –Glossary of Terms..................... 78

Doc #: 60-00118 Rev. A 6
Introduction
Device Description
The Neural Analytics’ Lucid™ M1 System (REF: NA-LUCM1) is an adjunctive portable, non-
invasive, non-ionizing radiation, point-of-care Transcranial Doppler (TCD) ultrasound system. It is
designed to non-invasively measure and display cerebral blood flow velocities and detect emboli
within the arteries of the head and neck.
Reusable, non-sterile, 2-MHz probes can be configured as a handheld probe for unilateral
applications or as monitoring probes in a headframe for bilateral monitoring.
Lucid™M1 System
The Lucid™M1 System 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 cart.
Power M-mode provides a unique method of detecting emboli and is used to reliably define the
location of cerebral arteries. The velocity spectrogram incorporates artifact filtering to provide an
accurate velocity display with exceptional envelope tracking.
TCD reports can be saved as PDF files with the unique feature of including embedded MP4 video
segments. Reports can also be DICOM encrypted and sent to a PACS. The Lucid™M1 System
has been designed to provide technologists and physicians with an intuitive, easy to use TCD
system for all TCD applications.

Doc #: 60-00118 Rev. A 7
Intended Users
The Lucid™M1 System is intended to be used by technologists or physicians qualified by
education or training in the use of Doppler ultrasound. It is intended to be used in hospitals,
clinics or physician offices by prescription or by order of a physician trained in the use and
interpretation of TCD Ultrasound.
US Federal Law restricts this device to use by or on the order of a physician.
Indications for Use
The Lucid™M1 System is a medical ultrasound system intended for use as an adjunct to the
standard clinical practices for measuring and displaying cerebral blood flow velocity within the
major conducting arteries of the head and neck. Additionally, the 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 not intended to be used in fetal applications, and is not intended to be used inside
the sterile field.
Contraindications
This device is not intended to be used in fetal applications.
This device is not intended to be used inside the sterile field.
Compatibility
The Lucid™M1 System is compatible with the following accessories:
•Neural Analytics 2-MHz Transducer, Handheld (NA-PRB1)
•Neural Analytics 2-MHz Monitoring Transducer (NA-PRB2)
•Neural Analytics Monitoring Headframe (NA-MOUNT1)
•AC Power Adapter (NA-ACC1)
•Neural Analytics Remote Control (NA-ACC2)
•Ergotron TCD Cart –Model: SV43-1310-0 (NA-ACC3)
•Mouse and Keyboard (NA-ACC6)
•HP Laser Jet Pro M452dn Printer
•External Monitor - (NA-ACC9)
•NeuralBot™System (NA-RBT1)

Doc #: 60-00118 Rev. A 8
How to Use this Manual
This manual is intended to be a user reference for the use of the Lucid™M1 System. It is
intended to help the user operate the system. To avoid any operating errors please read these
instructions carefully before using the device.
The user manual should always be kept near the device so that the user can reference it quickly
whenever required.
This manual provides a description of the 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 indicates a potentially hazardous situation that may result in minor or moderate
injury to the patient or operator or damage to the system.
Precaution indicates action(s) that a patient or operator can initiate in order to prevent
injury to a patient or operator or damage to the system.
WARNING indicates a significant problem that may lead to serious injury or death
to the patient or user or may cause damage to the Lucid™M1 System.

Doc #: 60-00118 Rev. A 9
Symbols
Symbol
Description
Caution or Precaution
WARNING
CE Mark
Direct current
Alternating current
Separate collection for electrical and
electronic equipment (WEEE Symbol)
Equipotential ground
Headphone
Manufacturer
DC power connection
Refer to instruction manual
Prescription Only

Doc #: 60-00118 Rev. A 10
Symbol
Description
Remote Control
USB 2.0 or USB 3.0 that is backwards-
compatible to USB 2.0
B-type Applied 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 (See Technical Information)
Atmospheric pressure limits (See Technical
Information)
On/Off Push button
Protective Earth Terminals

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

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

Doc #: 60-00118 Rev. A 13
This Left Side View of the Lucid™M1 System shows the following:
•Power 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 of the Lucid™M1 System does not have any connecting ports.
Right Side View
Left Side View

Doc #: 60-00118 Rev. A 14
Rear View
This Rear View of the Lucid™M1 System 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 location
This Rear View shows the rear stand in
the fully collapsed position.

Doc #: 60-00118 Rev. A 15
Remote Control
The Neural Analytics’ Lucid™ M1 System Remote Accessory 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
1. Depth
2. Gain
3. Baseline
4. Power
5. Sample Volume
6. Scale
Down
Left
Volume
Capture

Doc #: 60-00118 Rev. A 16
Cart
The Cart accessory (NA-ACC3) can be configured to mount either the Neural Analytics’ Lucid™
M1 System or an External Monitor on the adjustable pole VESA mount. If the External Monitor is
mounted on the adjustable pole, the Mounting Accessories Kit (NA-ACC9) should be used to
mount the Lucid™M1 System to the back of the cart.
Mounting instructions: Lucid™System
only
Remove the four (4) bolts from the Lucid™M1 System
VESA cover; place the four (4) bolts aside. Leaving the
VESA cover in place, mount the Lucid™M1 System
onto the Cart’s adjustable 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 adjustable pole as needed. Reference the
manufacturer’s instructions that come with the Cart.
Connect the transducers, remote and AC adapter as instructed in this manual. The keyboard and
mouse may be installed by connecting them to the USB ports located on the side of the system.
Place the keyboard and mouse on the Cart tray. Adjust the height as needed.
Mounting instructions: External Monitor + Lucid™
Mount the monitor on the adjustable pole by aligning the External Monitor
mounting holes with the VESA mount holes. Install using four M4x10mm
bolts (provided with cart).

Doc #: 60-00118 Rev. A 17
To mount the Lucid™TCD system on the back of the cart pole, install the Rear VESA Mount Kit
approximately 5 inches below the top cap. Reference the manufacturer’s instructions (included in
the Rear VESA Mount Kit). Install the quick release plate on the Rear VESA mount using 4 x M4
(6mm) bolts.
Remove the four (4) bolts from the Lucid™M1 System VESA cover; place the four (4) bolts
aside. Leaving the VESA cover in place, use the four (4) bolts to mount the quick release adaptor
plate (30-00321) to the back of the Lucid™M1 System. Use the four (4) M4 x 6mm bolts to
install the quick release mount to the back of 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 System on to the Quick Release Plate
Connect the transducers, remote and AC adapter as instructed in this manual. The keyboard and
mouse may be installed by connecting them to the USB ports located on the side of the system.
Place the keyboard and mouse on the Cart tray. Adjust the height as needed. Connect the
external monitor to the Lucid™M1 system using the HDMI cable provided in the Lucid™Cart
Mounting Accessories Box (NA-ACC9).
The External Monitor and Lucid™M1 System are only compatible with the HDMI cable
provided in the Lucid™Cart Mounting Accessories Box. Other HDMI cables should not be used
with the system.

Doc #: 60-00118 Rev. A 18
Quick Start
Hardware Setup
1-A Option 1: Lucid™M1 System has an internal battery.
1-B Option 2: Connect the AC cord to the AC adapter and connect to Lucid™M1 System.
2. Connect the remote control, probe(s), keyboard and mouse.
3. Power on System.
Login
Log in as either a user or an administrator.
Perform TCD Exam
1. From the Home Page, Select New Patient or Patient Search.
a. For New Patient, enter all information on the Patient Setup screen and press
‘Save/Next’.
b. For Patient Search, enter information to search for patient, highlight patient name,
press ‘Open’. On Patient Records screen, press ‘New Exam’.
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 depth in the M-mode to display the velocity spectrogram.
Diagnostic Exams
1. Take snapshots to capture velocities at different depths.
2. Use the vessel arrow on the screen or the up/down arrows on the remote to change
vessels.
3. After all desired vessels are interrogated and snapshots of the highest velocities taken,
press Exit Exam.
4. The display will advance to Exam Review: Snapshots.
5. Use the snapshot fly out to display the list of snapshots.
6. Select the desired snapshots and videos to be included in the report.
7. Click Next to advance to the Exam Review: Report page.
8. Enter the Accession # and Blood Pressure.

Doc #: 60-00118 Rev. A 19
9. Enter the Referring Physician, Indication, and Technique/Description.
10. Add report notes.
11. Click Generate Report to preview the report.
12. Print, save or send report.
Monitoring Exams
1. After the vessels to be monitored are located, press Start Exam.
2. Touch/click the desired channel on the screen or press the side arrows on the remote to
adjust TCD parameters for each channel.
3. If performing a VMR exam, select the predefined events to step through 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 events in Monitoring and Bubble exams.
7. When the exam is completed, press Exit Exam. The display will advance to Exam
Review: Snapshots.
8. Use the snapshot flyout to select any snapshots, user events or videos to be included in
the report.
9. Use “Replay Exam” to display the recording of the exam.
10. Press the back arrow to return to the Exam Review: Snapshots page.
11. Select “Next” to enter report data.
12. Select “Generate Report” to preview the report.
13. Print, save or send report.

Doc #: 60-00118 Rev. A 20
System Setup
Hardware
•Unfold the rear stand. Position in a comfortable viewing position.
•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 Lucid™M1 System. For AC adapter information,
please refer to the Technical Information section of this user manual.