NovaSignal NovaGuide Intelligent Ultrasound User manual

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
1
The NovaGuide™ Intelligent
Ultrasound
Comprised of NovaBot™Automated Headset and Lucid™
TCD 2.0 Transcranial Doppler Ultrasound
User Manual
Copyright © 2020 By NovaSignal™ Corp.

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
2
NovaSignal, Corp. All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any
form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of
NovaSignal.
Year of Authorization: 2018
COMPANY DATA NovaSignal™, Corp.
2440 S. Sepulveda Blvd, Suite 115
Los Angeles, CA 90064, USA
Phone: [phone] ext. 3 or [phone] ext. 3
Email: [e-mail]
AUTHORIZED REPRESENTATIVE
Emergo Europe B.V.
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Phone: (31) (0) 70 345-8570
Email: EmergoVig[email protected]
PRODUCT INFORMATION The NovaGuide™Intelligent Ultrasound
MODEL NA-RBTSYS1 (The NovaGuide™)
Includes:
NA-RBT1 (The NovaBot™)
NA-LUCM1 (The Lucid™ TCD 2.0)

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
3
Table of Contents
Introduction ..................................................... 7
How to Use this Manual ...................................................................................7
Indications for Use ...........................................................................................7
Intended Use.....................................................................................................8
Contraindications.............................................................................................8
Intended Use Environment..............................................................................8
Compatibility.....................................................................................................8
Conventions used in this Manual....................................................................8
Symbols.............................................................................................................9
Product Description....................................... 11
Overview of the NovaGuide™ ........................................................................11
Remote Control...............................................................................................16
Warnings and Precautions ............................................................................17
Clinical Safety.................................................................................................20
Ultrasound Safety...........................................................................................20
Managing Ultrasound Exposure....................................................................20
Operating the NovaGuide™ ........................... 23
Overview of the NovaGuide™ procedure .....................................................23
System Pre-Checks........................................................................................23
Setup and Initialize NovaGuide™..................................................................25
Perform Exam.................................................................................................33
Post Exam Procedure ....................................................................................34
Quick Release Procedure ..............................................................................35
System Power Down ......................................................................................35
Transport.........................................................................................................35
Device Storage................................................................................................35
Export Log Files for NovaBot™ ....................................................................36
Export Log Files for Lucid™ TCD .................................................................37
Overview of the Lucid™ TCD ......................... 38
Hardware Setup ..............................................................................................38
Initial Login .....................................................................................................38
Perform TCD Exam (Without Worklist).........................................................38
Perform TCD Exam (With Worklist)...............................................................39
Diagnostic Exams (Complete & Limited)......................................................40

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
4
Monitoring Exams (Monitoring, VMR, Bubble & Emboli)............................42
Display Options ..............................................................................................43
Report Heading...............................................................................................44
Custom Protocols...........................................................................................44
PACS ...............................................................................................................45
Worklist ...........................................................................................................46
NovaView (Cloud Application).......................................................................47
New User.........................................................................................................48
Edit User..........................................................................................................48
Delete User......................................................................................................48
Forgot Password ............................................................................................49
Patient Information........................................ 50
Patient Search.................................................................................................50
New Patient.....................................................................................................50
Delete Patient..................................................................................................50
Exam Screens ................................................ 51
Unilateral Exam Screen..................................................................................51
Bilateral Exam Screen....................................................................................52
M-Mode Display..............................................................................................53
Spectrogram Display......................................................................................53
Velocity Displays............................................................................................54
Scanning Controls ......................................... 55
Acoustic Power...............................................................................................55
Power On/Off...................................................................................................55
Power Adjustment..........................................................................................55
Gain .................................................................................................................56
Filter.................................................................................................................57
Sample Volume...............................................................................................57
Scale................................................................................................................58
Sweep Speed ..................................................................................................59
Depth ...............................................................................................................59
Baseline...........................................................................................................60
Vessel Label....................................................................................................60
Envelope..........................................................................................................61
Baseline Shift..................................................................................................62
Snapshots.......................................................................................................63
Screen Freeze.................................................................................................64

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
5
Screenshots....................................................................................................67
Exams and Reports........................................ 68
Diagnostic Exams...........................................................................................70
Complete Exam...............................................................................................72
Limited Exam..................................................................................................74
Monitoring Exams ..........................................................................................76
Exam Replay...................................................................................................77
Monitoring Exam ............................................................................................79
Vaso-Motor Reactivity Exam .........................................................................81
Bubble Study ..................................................................................................83
Emboli Study...................................................................................................85
Software Upgrade.......................................... 87
Hardware Setup ..............................................................................................87
Upgrade Steps................................................................................................87
Digital Streaming ........................................... 89
Hardware Setup ..............................................................................................89
Digital Streaming Setup.................................................................................89
Digital Streaming............................................................................................89
Equipment Care and Maintenance ................ 91
Cleaning ..........................................................................................................91
Preventative Maintenance..............................................................................92
Electrical Safety Test .....................................................................................92
Regulatory Statements.................................. 93
Instructions on Disposal................................................................................93
Electro-Magnetic Compatibility (EMC)..........................................................94
Potential Equalization ....................................................................................95
Service and Ordering Information ................. 96
Product Reference Numbers.........................................................................97
Appendix A..................................................... 98
Quick Start Guide ...........................................................................................98
Appendix B................................................... 100

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
6
Troubleshooting Guide: NovaBot™............................................................100
Troubleshooting Guide: Lucid™ TCD.........................................................106
Lucid™ TCD Software Version....................................................................106
Lucid™ TCD Error Screen Messages .........................................................106
Appendix C................................................... 111
Technical Information ..................................................................................111
Measurements ..............................................................................................112
Calculations..................................................................................................115
Appendix D................................................... 116
ACU Display Descriptions ...........................................................................116
Basic Features in the ACU Interface...........................................................117
Advanced Features in the ACU interface ...................................................119
Appendix E ................................................... 121
Acoustic Output............................................................................................121

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
7
Introduction
How to Use this Manual
This manual is a reference for the use of NovaSignal’s NovaGuide™ Intelligent Ultrasound, which
is comprised of NovaBot™ and Lucid™ TCD. The manual 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.
Indications for Use
The Lucid™TCD 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 and veins of the head and neck. Additionally, the Lucid™TCD measures the
occurrence of transient emboli signals within the bloodstream.
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.
The NovaBot™when used with the Lucid™TCD is a medical ultrasound device which assists the
user in the setup and acquisition of cerebral blood flow velocity via the patient’s temporal
windows. It is intended for use as an adjunct to standard clinical practices for measuring and
displaying cerebral blood flow velocity and the occurrence of transient emboli within the
bloodstream.
The NovaBot™is intended to be used by healthcare professionals qualified by training in its safe
and effective use. 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.
The NovaGuide™consists of the NovaBot™and the Lucid™TCD. It is intended for use as an
adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity
and the occurrence of transient emboli within the bloodstream. The NovaGuide™is intended to
be used by healthcare professionals qualified by training in its safe and effective use. 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.

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
8
CAUTION: Federal (USA) law restricts this device to sale, distribution by or on the order of a
physician. Indications, contraindications, warnings and instructions for use can be found in the
product labeling supplied with each device.
Intended Use
The Lucid™ TCD is intended to be used during diagnostic exams and surgical interventions 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. Cerebral blood flow velocity
within these arteries is visualized using non-invasive pulsed transcranial Doppler ultrasound
(TCD). This includes, but is not limited to, insonation of the middle, anterior and posterior
cerebral arteries via the temporal windows, the vertebral and basilar arteries via the foramen
magnum, and the ophthalmic arteries and internal carotid artery siphons via the patient’s
transorbital windows.
TCD is a common tool for the visualization of cerebral blood flow velocity and the detection
of emboli which present as High-Intensity Transient Signals (HITS) in the display of the TCD
blood flow.
The Lucid™ TCD is not indicated for the diagnosis of COVID-19. However, it is intended to
be used as a diagnostic tool in the screening of patients both affected and not affected by
the disease. The Lucid™ TCD does not predict the outcome and/or response to treatment for
COVID-19 patients nor does the use of the device confer a specific benefit to them.
Contraindications
The NovaGuide™ is not intended to be used in persons younger than 18 years of age.
The NovaGuide™ is not intended to be used in fetal applications.
The NovaGuide™ is not intended to be used inside the sterile field.
Intended Use Environment
The NovaGuide™ is intended to be used on patients in the supine or reclined position up to 45
degrees on a bed or a gurney in a clinical setting. The device is NOT intended to be used
simultaneously with head imaging equipment such as MRI and CT.
Compatibility
The NovaGuide™ is compatible with the following:
•NovaKit Exam Pack (Single Use –Pack 10) (NA-DSP2PK)
•Remote Control, Lucid™ TCD (NA-ACC2)
Conventions used in this Manual
Throughout this manual, the following conventions are utilized:

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
9
Caution indicates a potentially hazardous situation that may result in minor or moderate
injury to the patient or user or damage to the system.
Precaution indicates an action that a patient or user can initiate to prevent injury to a
patient or user or damage to the system.
WARNING indicates a significant problem that may lead to serious injury or death to the
patient or user.
Symbols
Symbol
Description
Symbol
Description
Caution or Precaution
WARNING
Serial number
Lot Number
Direct current
Fragile, handle with care
Alternating current
Keep dry
Equipotential ground
Temperature limits
(See Technical
Information)
Humidity limits (See
Technical Information)
Atmospheric pressure
limits (See Technical
Information)
Manufacturer
On/Off Push button or
switch

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
10
Symbol
Description
Symbol
Description
DC power connection
Catalog number
Consult instructions for use
Protective Earth
Terminals
Refer to instruction manual
For indoor use only
USB 2.0 or USB 3.0 that is
backwards-compatible to
USB 2.0
Cart Tipping Hazard
B-type Applied Parts
Prescription Only
CE Marking
Separate collection for
electrical and electronic
equipment (WEEE
Symbol)
Remote Control
Headphone
European authorized
representative
Video Output (HDMI)

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
11
Product Description
Overview of the NovaGuide™
The NovaGuide™ (REF: NA-RBTSYS1) is a combination of the Lucid™ TCD (REF: NA-LUCM1)
Transcranial Doppler Ultrasound system and NovaBot™(REF: NA-RBT1), a robotic probe
positioning device.
Lucid™ TCD is a non-invasive, non-ionizing radiation, 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.
NovaBot™ is designed to assist in the acquisition of cerebral blood flow velocity data from the
arteries and veins of the head via the patient’s temporal windows. The NovaBot™ uses two
reusable, non-sterile 2-MHz probes that are controlled by robotic actuators. The NovaGuide™ is
a cart mounted system and contains the following components.
Figure 1: NovaGuide™ Components
A. Patient Headmount Unit (PHU): The unit that
consists of the head cradle, headmount base, the
left and right probe pods and the head stabilizer.
B. Lucid™TCD: The TCD ultrasound system (see
Overview of the Lucid™ TCD for more details).
C. Accessory Control Unit (ACU): The touchscreen
computer in which the NovaBot™ is operated.
D. Robotic Control Unit (RCU): The control unit that
contains the electronics and embedded software
for NovaBot™.
E. Cart: Medical grade cart with VESA mounts and a
flat work surface and storage shelves.
F. Storage Bin: Container attached to the back of
the cart that can be used to store the headmount
base and head stabilizer.
G. Cable Hooks: Hooks that are attached to each side
of the cart’s storage bin that can be used to manage
and store the power cord and probe pod cables.

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
12
Figure 2: Patient Headmount Unit
A. Probe Pod (Left and Right): Detachable pods
that contain the TCD probes and robotic
actuators.
B. Registration Camera (Left and Right): Camera
that registers the dots applied to the patient’s
face to determine the search range area.
C. Probes (Left and Right): Probes used to gather
TCD signals.
D. Head Cradle: The support structure in which the
patient’s head is placed.
E. Headmount Base: The support structure of the
patient headmount unit.
F. Headmount Screws (Left and Right): Screws
used to tighten or loosen the probe pods.
G. Head Stabilizer: A detachable brace on the head
cradle. Used to stabilize and hold the patient’s
head in place. The position of the stabilizer and
firmness applied to the head are adjustable.
G.

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
13
Figure 3: Accessory Control Unit (ACU)
Figure 4: (Top) Frontal view of Robotic Control Unit (RCU); (Bottom) Rear of the RCU showing
locations of (A) Probe Pod receptacles –left and right sides; (B) Power Switch
Figure 5: Probe Pod Storage Tray is used to store the Probe Pods when not in use

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
14
Figure 6: The Front View of the Lucid™ TCD
The Front View of the Lucid™ TCD shows the following:
•Front panel contains the 2 ports for the transducer connectors (orange).
•Front panel contains the port to connect the remote control to Lucid TCD (blue).
Figure 7: The Right-Side and Left-Side Views of the Lucid™ TCD (respectively)
The Left-Side View of the Lucid™ TCD shows the following:
•Power Button
•Four USB ports
•One is labeled for connection to PACS
•One is labeled for connection to NovaBot™
•One audio output jack

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
15
•One HDMI port (not available on all versions)
The Right-Side View of the Lucid™ TCD does not have any connecting ports.
Figure 8: The Rear View of the Lucid™ TCD
This Rear View of the Lucid™ TCD shows the following:
•DC power input
•Equipotential Connection location (Equipotential plug and cable assembly
is not included with the Lucid™ TCD and must be supplied separately)
•VESA mounting location
DC power input
Equipotential
Connection
VESA
Mounting
Location

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
16
Remote Control
The NovaSignal Lucid™ TCD Remote Accessory (NA-ACC2) is an accessory device designed to
replicate the touch screen interface for commonly used commands during Lucid™ TCD exams.
Figure 9: 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

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
17
Warnings and Precautions
WARNING
US Federal Law restricts this device to use by or on the order of a physician.
Read User Manual before using system.
Use only approved accessories with this device. See Compatibility section for list of approved accessories.
Minimize ultrasound exposure and use the principle of As Low As Reasonably Achievable (ALARA).
Do not place The NovaBot™ over other device electrodes, sensors or cables.
Caution should be used when placing The NovaBot™ over nasal cannula.
Do not place The NovaBot™ over open wounds or abrasions.
Do not push the probe pods with excessive pressure against the patient’s head.
Do not insert objects, gel or liquids into the probe pod cavities.
Do not use device in a nitrous oxide, oxygen-rich or explosive atmosphere or in the presence of explosive anesthetics.
Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in
the diagnostic range.
Inspect the system prior to use. Please contact NovaSignal if any damage or deterioration is observed for the system,
including the transducer probes, cart and cables.
Do not use transducer probes if the transducer probe face, body or cables are damaged as this may cause patient
discomfort when used.
Do not use if any of the probe pods or the whole PHU is dropped.
Do not use if any part of the system is dropped as function may be compromised. It is recommended to contact
NovaSignal Customer Service.
If any part of the system is dropped, please use caution in handling. Broken enclosure/glass or chipped/abraded
surface may have occurred.
Avoid installing accessories during an Exam or when the Exam screen is open.
Do not modify the system. Modifications may degrade the measurements, impact the service life of the product or
cause hazardous situations such as electric shock.
To avoid risk of electric shock:
The equipment must only be connected to supply mains with protective earth.
Do not use an accessory if the accessory body is damaged.
Do not use an accessory if the accessory cable or connector are damaged.
Keep liquids and gels away from The NovaBot™ openings and electrical connections.
Place covers on the left and right probe pods prior to use.
Do not open the device enclosure.
Disconnect device from AC Adapter prior to cleaning.
Inspect the AC Adapter and AC cord set for damage prior to use.
Connect to "Hospital Only" or "Hospital Grade" or equivalent receptacles.
Use only the specified AC Adapter with the device. Electric shock, fire or explosion may occur if the incorrect AC
adapter is used.
Inspect the AC Adapter and AC cord set for damage prior to use. Using a damaged AC Adapter or worn or damaged

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
18
AC cord set may result in electric shock or fire hazard.
Check the audio volume to avoid hearing loss or damage especially when using headphones.
This device contains both a lithium-ion battery and a lithium polymer battery. It must be disposed of properly. Follow
your clinic or hospital disposal or recycling procedures.
This device meets EMI/EMC standards.
However, this device may cause 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 may cause degradation of the device display. If
necessary, move the source of interference to a different location.
This device contains a multiple socket-outlet (MSO). Connecting electrical equipment to the MSO effectively leads to
creating a medical electrical system and can result in a reduced level of safety. Do not connect any other electrical
equipment to the MSO.
Additionally, do not connect an MSO or extension cord to the system. Connect to “Hospital Only” or “Hospital Grade”
or equivalent receptacles.
Use of this device in the presence of an ESU (electrosurgical generator) or electrocautery may cause distortion in the
display.
Read and follow all cleaning and disinfection instructions. Patient contact material must be properly cleaned to
prevent transmission of infectious diseases.
Patient contact materials are only intended for limited duration (less than 24 hours) skin contact.
Reference the Equipment Care and Maintenance section of this manual for additional cleaning instructions.
To avoid risk of tipping the cart:
Do not apply a force greater than 20 lbs. at 1.5m or above to the cart.
Do not lean on the cart.
Ensure wheels are disengaged before attempting to move the cart.
Lower the cart to its lowest setting before moving.
Make sure wheels are unlocked before attempting to move the cart.
To avoid tip over, pull cart over thresholds.
Use caution while pulling the cart over thresholds, bumps, or uneven surfaces.
Do not push the cart over thresholds, bumps, or uneven surfaces.
Lock all four cart wheels after moving.
Only push the cart using the handles.
To avoid tripping over cables during use or transportation, store cables as far away from the ground as
possible.

The NovaGuide™ Intelligent Ultrasound User Manual (60-00153, Rev. C)
19
Precaution
Avoid placing objects on the touchscreen. Permanent damage to the touchscreen may occur.
To avoid risk of damage to the device:
Connect only to the correct rated mains outlet.
Always use the provided probe pod covers prior to operating the system. Do not perform scans without
using the provided probe pod covers.
Do not operate in outdoor lighting conditions.
Do not use alcohol for cleaning and disinfection as it may damage the probe transducer; wipe the probe
transducer with a clean damp cloth immediately after use.
Use only the specified AC Adapter with the device. Danger of permanent damage may occur if the incorrect AC
adapter is used.
Do not submerge the device in liquid. This will damage the device.
Do not submerge any accessories (keyboard, mouse or remote) in liquid. This may damage the accessories.
When disconnecting any electrical connection from the device, pull from the plug and not the cable.
When disconnecting any accessory from the device, pull from the plug and not the cable.
Avoid covering or blocking ventilation slots. This may cause the device to overheat during use.
Do not block or cover vents. This may cause the device to overheat during use.
When not using the device, store in a location to minimize accidental damage to the equipment. Store the
transducers in a location to minimize accidental damage. Reference the Technical Information section of this manual
for additional storage conditions.
When shipping the device, use only NovaSignal’s approved shipping package.
Shipping the device in an unapproved container may damage the equipment. Call NovaSignal’s Customer Service for
assistance in shipping a NovaSignal device.
Read and follow all cleaning and disinfection instructions. Improper cleaning or disinfection may also cause damage
to the system.