Neural Analytics NeuralBot NA-RBT1 Manuel utilisateur

NeuralBot™ System User Manual (60-00119, Rev. A)

NeuralBot™System

For use with the Lucid™M1 System

User Manual

NeuralBot™ System User Manual (60-00119, Rev. A)

form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of

Neural Analytics.

Year of Authorization: 2018

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

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: complaints@HealthlinkEurope.com

PRODUCT INFORMATION NeuralBot™™

MODEL NA-RBT1 (NeuralBot™)

 
 
NeuralBot™ System User Manual (60-00119, Rev. A) 
3 
Table of Contents 
Introduction ..................................................... 5 
How to Use this Manual ...................................................................................5 
Indications for Use ...........................................................................................5 
Contraindications.............................................................................................5 
Intended Use Environment..............................................................................5 
Compatibility.....................................................................................................5 
Conventions used in this Manual....................................................................6 
Symbols.............................................................................................................7 
Product Description......................................... 8 
Overview of the NeuralBot™ System .............................................................8 
Package Contents ..........................................................................................10 
Cautions and Warnings..................................................................................11 
Clinical Safety.................................................................................................13 
Ultrasound Safety...........................................................................................13
Operating NeuralBot™ ................................... 14 
Overview of the NeuralBot™ procedure.......................................................14 
System Pre-Checks........................................................................................14 
Patient Setup...................................................................................................17 
Registration: ...................................................................................................21 
Perform Exam.................................................................................................24 
Post Exam Procedure ....................................................................................25 
Quick Release Procedure ..............................................................................26 
System Power Down ......................................................................................26
Device Storage................................................................................................26 
Export Log Files .............................................................................................27 
Equipment Care and Maintenance ................ 28 
Cleaning ..........................................................................................................28 
Preventative Maintenance..............................................................................29 
Regulatory Statements.................................. 30 
Instructions on Disposal................................................................................30 
Electro-Magnetic Compatibility (EMC)..........................................................30 
Potential Equalization ....................................................................................31 

NeuralBot™ System User Manual (60-00119, Rev. A)

Service and Ordering Information ................. 32

Product Reference Numbers.........................................................................33

Appendix A..................................................... 34

Quick Start Guide ...........................................................................................34

Appendix B..................................................... 36

Troubleshooting Guide..................................................................................36

Appendix C..................................................... 42

Technical Information ....................................................................................42

Appendix D..................................................... 43

ACU Display Descriptions .............................................................................43

Basic Features in the ACU Interface.............................................................44

Advanced Features in the ACU interface .....................................................46

Appendix E ..................................................... 48

Acoustic Output..............................................................................................48

NeuralBot™ System User Manual (60-00119, Rev. A)

Introduction

How to Use this Manual

This manual is a reference for the use of Neural Analytics’ NeuralBot™ System for the Lucid™

M1 Transcranial Doppler ultrasound system. 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.

Indications for Use

The NeuralBot™when used with the Lucid™M1 System 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 blood stream.

The NeuralBot™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.

Contraindications

The NeuralBot™System is not intended to be used in persons younger than 18 years of age.

The NeuralBot™System is not intended to be used in fetal applications.

The NeuralBot™System is not intended to be used inside the sterile field.

Intended Use Environment

The NeuralBot™System 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 NeuralBot™System is compatible with the following:

1. Lucid™M1 System, Software revision 1.3.4 or higher.

2. NeuralBot™Procedural Set (NA-DSP2).

NeuralBot™ System User Manual (60-00119, Rev. A)

Conventions used in this Manual

Throughout this manual, the following conventions are utilized:

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 or may damage the NeuralBot™system.

NeuralBot™ System User Manual (60-00119, Rev. A)

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

DC power connection

Catalog number

Consult instructions for

use

Protective Earth

Terminals

Refer to instruction

manual

For indoor use only

USB2.0 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)

European authorized

representative

NeuralBot™ System User Manual (60-00119, Rev. A)

Product Description

Overview of the NeuralBot™System

The NeuralBot™System is a robotic probe positioning device that is paired with the Lucid™M1

System. It 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 NeuralBot™ System

uses two reusable, non-sterile 2-MHz probes that are controlled by robotic actuators. The

NeuralBot™System is a cart mounted system and contains the following components.

Figure 1: NeuralBot™System 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™M1 System: The TCD ultrasound system

(for reference only).

C. Accessory Control Unit (ACU): The touchscreen

computer in which the NeuralBot™system is

operated.

D. Robotic Control Unit (RCU): The control unit that

contains the electronics and embedded software.

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.

NeuralBot™ System User Manual (60-00119, Rev. A)

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.

Figure 3: Accessory Control Unit (ACU)

NeuralBot™ System User Manual (60-00119, Rev. A)

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

Package Contents

The NeuralBot™System is shipped in four separate packages

1. Robotic control unit (NA-RCU1) and Patient headmount unit (NA-PHU1)

2. Accessory Control Unit (NA-ACU1)

3. System cart configuration (NA-ACC10)

4. The NeuralBot™Procedural Set which includes:

•4 registration dots

•1 padding for the head cradle

•1 padding for the forehead mount

•2 probe pod covers

oThe NeuralBot™Procedural Set is shipped in packages of 10 (NA-

DSP2PK).

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