Lucid Robotic System - Neural Analytics › wp-content › uploads › 2020 › 04 › DC … · DC-01475 Rev B. Patient Set Up: Procedural Set • Use the probe pod covers to carefully

Lucid Robotic SystemIn-Service Presentation

The Lucid™ Robotic System (Lucid™ M1 System & NeuralBot™ System) Please refer to the NeuralBot™ System User Manual (60-00119) for detailed instructions 1

DC-01475 Rev B

Overview

1. Product Description2. Operating the NeuralBot System3. Equipment Care and Maintenance4. Software Features and Troubleshooting (Appendix)

For additional details refer to the NeuralBot System User Manual.

2

DC-01475 Rev BThe Lucid™ Robotic System (Lucid™ M1 System & NeuralBot™ System) Please refer to the NeuralBot™ System User Manual (60-00119) for detailed instructions

Product Description

3


The Lucid Robotic System

Product Description

Lucid M1 Transcranial Doppler DeviceNeuralBot System

4


Product DescriptionA. Lucid M1 System: Transcranial Doppler Ultrasound System

B. Patient Head mount Unit (PHU): The unit that consists of the head cradle, left and right probe pods and the head stabilizer

C. Accessory Control Unit (ACU): The touchscreen computer which is used to control the Lucid Robotic System

D. Robotic Control Unit (RCU): The unit that contains the electronics and embedded software

E. Cart: Medical grade cart with VESA mounts, work surface, probe pod storage and other storage shelves

F. Storage Bin: Container attached to the back of the cart that can be used to store the head mount base and head stabilizer

A.

B.

C.

D.

F.

E.

5


Product Description

A. Probe Pods (Left and Right): Detachable pods that contain the TCD transducers.

B. Registration Camera (Left and Right): Camera that registers the dots applied to the patient’s face to determine the search regions.

C. Transducer 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 Thumb Screws (Left and Right): Screws used to tighten or loosen the probe pods.

G. Head Stabilizer: A small brace to stabilize and hold the patient’s head in place.

A B

C

D

E

F

G

6


Cautions and Warnings

• US Federal Law restricts this device to use by or on the order of a physician.

• Minimize ultrasound exposure. Use the principle of As Low As Reasonably Achievable (ALARA).

• Do not place the NeuralBot System over other device electrodes, sensors or cables.

• Caution should be used when placing NeuralBot System over nasal cannula.

• Do not place the NeuralBot System over open wounds or abrasions.

• Inspect the system prior to use. Please contact Neural Analytics if any damage or deterioration is observed.

• Do not use if any part of the system is dropped as function may be compromised.

• 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.

• Avoid covering or blocking ventilation slots. This may cause the device to overheat during use.

• 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 different location or re-orient. 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.

• Use of this device in the presence of an ESU (electrosurgical generator) or electrocautery may cause distortion in the display.

• For the full list of cautions and warnings refer to the NeuralBot System User Manual.

7


Safety

ClinicalThere are no confirmed biological effects on patients or equipment operators caused by exposure from

existing ultrasound equipment in the market.

UltrasoundALARA When using NeuralBot System, the principles of ALARA should always be followed. ALARA is the

acronym for As Low As Reasonably Achievable. This principle simply states that the user should keep the ultrasound output levels and exposure times as low as possible while still obtaining the desired Cerebral

Blood Flow Velocity information.

8


Operating the DeviceSystem Pre-Checks

9


Cautions and Warnings• Do not apply a force greater than 20 lbs. at 1.5m or above to

the cart.• Do not lean on the cart.• Lower the cart to its lowest setting before moving.• Ensure wheels are unlocked before attempting to move the

cart.• Use caution and pull the cart over bumps or uneven surfaces.

Do not push the cart over thresholds, bumps or uneven surfaces.

Procedure• Move the cart to the intended area and connect the power to

a wall outlet.• If a wall outlet is not available, the system will run on

battery power for up to 30 minutes from fully charged. • The system will notify the user when 15% power is

remaining.

System Pre-Checks

10


• Confirm both Probe Pod connector cables are connected to the corresponding RCU connector receptacles.

• Position the system in such a way to minimize the stretch on the connector cables.

• Power ON the Robotic Control Unit by pressing the power switch.

• Confirm the RCU power light is green.

System Pre-Checks: RCU

11


• Set up the PHU on a flat surface (bed or gurney).• Carefully remove the left and right probe pods from the cart tray and attach to

the corresponding rails on the head cradle. When left and right probe pods are attached, ensure they are symmetrically positioned along their corresponding rails to enable the patient’s head to be symmetrically placed.

• Confirm that the left and right Probe Pod connector cables are firmly secured to the corresponding left and right Probe Pods.

System Pre-Checks: PHU

12


• Power On by pressing and holding the power button.

• Login to the Accessory Control unit.• Factory default password: password

• Following login, the ACU will open to the home screen.

System Pre-Check: ACU

13


System Pre-Check: Lucid M1

• Connect the left and right probe pod ultrasound connector cables into the corresponding left (GREEN) and right(ORANGE) channels on the Lucid M1 system.

• Power on the Lucid M1 and login

• Position the Lucid Robotic System in such a way to minimize the stretch on the ultrasound connector cables.

14


System Pre-Checks: Configuration & Initialization

ACU Home Screen

Press the flashing arrow on the bottom right of the screen to advance to the setup screen.

ACU Setup Screen demonstrating RCU “Connected”.

Shortly after transitioning to the setup screen, the RCU status will display a “Connected” message.

15


Probe Pod position confirmation notification

Click on the flashing Initialize button.

• Confirm the probe pods are not obstructed prior to initialization.• The system will perform a self test process.

A successful initialization will result in the left and right RCU channels displayingan “Initialized” message

System Pre-Checks: Configuration & Initialization

16


Operating the DevicePatient Set - Up

17


Patient Set Up: Lucid M1 – Run Exam

Lucid Home Screen

Select from• New Patient• Patient Search• Run

Lucid Exam Procedures Screen

Run the appropriate exam (ex: BUBBLE)• When running a Lucid exam, do not adjust

parameters aside from baseline, power and filter.

18


Patient Set Up: Patient Angle

• Prior to setting the patient up, ensure the gurney or bed is flat (0º)or in a reclined position no greater than 45º

• If the patient is unable to lie between these angles, do not attempt to scan using the NeuralBot system.

19


• Open the NeuralBot Procedural Set, which contains • (x2) Comfort Paddings • (x2) Probe Pod Covers• (x4) Registration Dots

• Firmly attach the larger comfort pad to the head cradle after peeling off the back layer. Ensure there are no air pockets between the larger comfort padding and the head cradle.

• If air pockets exist, carefully remove the pad and reapply.

• Firmly attach the smaller comfort pad to the head stabilizer after peeling off the back layer.

Patient Set Up: Procedural Set

20



• Use the probe pod covers to carefully cover each probe pod and insert the probes and registration cameras through the designated cut outs

• Camera = Corner Cut Out • Probe = Center Cut Out

• Use of the NeuralBot System without probe pod covers may result in harm to user or patient, or equipment damage

21



On each side of the patient’s head apply the registration dots to the mid-ear and outside the eye corner – a total of four registration dots. Ensure they are firmly affixed.

Quiz: Place the registration dots on this patient

22


Patient Set Up

Apply ample ultrasound gel to each side of the patient’s temporal region between the

registration dots.

23


Patient Set Up

• Rest the patient’s head into head cradle

• Ensure the head is symmetrical within the head cradle and the top of the head is in contact with the top of the head cradle

• Attach the head stabilizer

• Ensure the head stabilizer is firmly secured on the patient’s forehead

• Use the head stabilizer and the patient’s nose as landmarks to assess how symmetrical the patient’s head is within head cradle.

• Advance the probe pods to make contact with patient’s temporal region

Ensure the following: • Probes make firm contact with

the patient’s temporal regions

• The probe pods are centered in their rails

• Headmount thumb screws are secured once the pods are positioned

24


Registration

• On the ACU (NeuralBot software), click theflashing next arrow button on the bottom right of the setup screen to proceed

NeuralBot System Setup screen NeuralBot System Setup screen

• When on the registration screen, the left and right statuses will display “move probe pod closer until firm contact”.

• To advance the probe pods, untighten the thumb screws and slide the probe pod along the railing.

25


Registration

• When the probes are making appropriate contact with the patient, the status will display “Ready for registration” and the probe will become green.

• Tighten the thumb screws on each side to secure both probe pods in place.

• Press the flashing registration button on each channel.

NeuralBot System Registration screen

• After pressing the register button, the status will display “Registering…” for a few moments while the cameras are taking pictures of the temporal region


26


• The status for a successful registration will display “Ready for Review”.

• Press “accept” if the orange search area is within the blue good search range and the registration dots are correctly identified.

• Press “reject” if the registration dots are not correctly identified and if the orange search area is not within the blue good search range

• Press the flashing arrow to proceed to the signal search screen.


Probe Search Range Legend• The orange box is the search area - this is where the probes will search during

the scan, which is determined by both the position of the registration dots and the patient’s position within the head cradle.

• The blue box is the good search range - this is where the probes have access to most signal search positions and angles.

• The white area within the blue box is the optimal search range - this is where the probes have access to all signal search positions and angles.

Registration

27


Operating the DevicePerforming an Exam

28


Thermal Index

Read and acknowledge the ALARA message. Ensure an appropriate TIC is used for the duration of the scan. Continue with signal search by pressing confirm on the ACU.

The left and right TIC will be displayed on the Lucid M1 exam.

29


Signal Search

• Begin the scan by pressing the Start button on both channels.

• During the scan, ensure that the patient remains stillbecause movement within the head cradle can result in a sub-optimal search.

• Additional Signal Search Features or manual mode maybe used during or after signal search.

• The software will display “Finished” when the search is complete

• During the signal search, the system will search for signals on the Lucid M1 system between 45-60 mm and with flow towards the probe.

30


Operating the DevicePost Exam Procedure

31


Post Exam Procedure

• Push the home button at the bottom left of the ACU screen. The probes will retract from the patient’s temporal region and the software will return to the home screen.

• Carefully remove the head stabilizer.

• Unlock the head cradle screws, pull the probe pods to the edge of the rail and tighten the screws.

• Ensure that the screws are tightened to secure the probe pods to the rails of the headmount base to avoid accidental damage to the device.

32


Post Exam Procedure

• Carefully lift the patient’s head from head cradle. Slide the cradle away from the patient’s head. Remove gel.

• Clean the transducer probes and other external surfaces of PHU components using a clean damp cloth.• Do not use alcohol wipes as this may cause damage to the transducer probes.

• Remove patient comfort padding and probe pod covers and dispose of them. • Care should be taken while removing probe pod cover to avoid damage to probes.

33


Operating the DeviceQuick Release Procedure

34


Quick Release

Press the red STOP! button. Pressing STOP! will pause the search and retract the

probes.

• Loosen the headmount thumb screws and slide the probe pods along the railing away from the patient. Once the probe pods are away from the patient, tighten the screws on the head cradle.

• Remove head stabilizer.• Slide the Patient Headmount Unit away from the patient’s

head.

35


Operating the DeviceSystem Power Down

36


System Power DownAccessory Control Unit Press and hold the power button on the ACU for shutdown instructions.

Lucid System Press and hold the power button for at least three seconds, located on the left side of the system.

Robotic Control Unit Turn OFF the RCU using its power switch, located on the back of the cart.

37


Place the Probe Pods with the transducer probes face down and the cameras towards the center in the opening of the tray foam.

Device Storage

38


• Caution• Cleaning• Preventative Maintenance

Equipment Care and Maintenance

39


Caution

• Before cleaning the device, turn OFF power and disconnect 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 device should be stored in a location where it will not be damaged.

• Probe transducers are sensitive components of the ultrasound measurement equipment. Handle with care.

40


Cleaning

• Clean the exterior surfaces, transducers and cables using a clean damp cloth immediately after use. Avoid using liquids around the device’s electrical connections and ventilation openings.

• Follow the hospital or clinic guidelines for disinfection of equipment.

• Do not use alcohol for cleaning and disinfection.

• The transducers are not intended to be sterilized. Do not autoclave. Do not expose to ethylene oxide. Do not expose to gamma radiation. Do not expose to e-beam.

41


Preventative Maintenance

• Follow the policies and procedures of the hospital, clinic or health care facility regarding electrical safety test for equipment.

• Do not use if any part of the system is dropped as function may be compromised.

• 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.

42


• Software Features• Troubleshooting

Software Features and Troubleshooting

43


Software FeaturesStart(Pre-scan) Button that commands Probe Pod to begin automatedsignal search.

Pause (During scan) Button that commands that channels Probe Pod to temporarily halt signal search.

Resume(During scan)Button that commands the channel to “Resume” the automated signal search

STOP!(During scan) Button that commands right and left Probe Pods to retract away from patient and halt signal search.

Disable Channel(Pre-scan or during scan)De-activates the left or right channel on the NeuralBot software and retracts the transducer.

Finished(Post scan)will display when the search has reached the time limit and is tracking thebest located signal.

44


Software FeaturesLocated Signals(During and post scan) Displays a list of up to five signals found during the signal search and details regarding their depth, velocity and type (Manual and Auto).

At least two manually evaluated signals can be added to the located signal bar using the Evaluate Signal and Track Signal buttons.

Signal Quality Bar(During scan)A display bar of the quality of the signals found.

Status(Pre, during and post scan)A field that indicates the status of the signal search. Can display the following: Ready, Search, Evaluate signal, Track and No signal found

Force Level(Pre, during and post scan)Provides control over level of pressure applied by the probe pod transducer. Click on the force level and select low, medium or high from the drop down.

45


Software Features

Manual Mode(During and post scan)Press pause to activate-Allows user control over position and angle of probe pod transducer

Evaluate Signal(During and post scan)Press evaluate signal button so that the probe pod transducer will remain in a fixed position for the pre-defined signal evaluate time.

CursorBlack arrow within the search area that shows the position and angle of the transducer.

Local Search (During and post scan) Press pause button to activate. Then press local search. A fine search will be conducted at the current probe position for up to 4 minutes.

Track Signal(During and post scan) Commands the system to pause the signal search and track the signal at the current position. A local search is performed as needed to maintain the signal level.

Vertical SliderUse the slider on the right side of the workspace to angle the probes inferior or superior.

Horizontal SliderUse the slider on the bottom of the workspace to angle the probes posterior or anterior.

46


Software FeaturesSettingsProvides user with optional configuration for search time and data storage.•Set the search time (1 to 20 minutes, default 10 minutes).•Set the signal evaluation time (1 to 30 seconds, default 5 seconds).•Add an Exam Type by pressing the plus button.•Settings can only be changed on the Setup screen.

47


Troubleshooting: RCU Error

• Read the error message and perform the recommended actions.

• Power the RCU off and then power the RCU on.

• Retract the left and right probe pods away and ensure they are symmetrically oriented on their corresponding railings.

• Resume from System Pre-checks: configure and initialize the system

48


Troubleshooting: Registration

Troubleshooting for failed registration Process Correct Incorrect

Ensure the patient’s facial features are not distorting the registration dots. If so, push/pull down the skin close to the registration dots

during re-registration

Ensure that the probe pod covers are not obstructing the registration camera view of the registration dots. Gently fold the probe

pod covers away (do not tug) from the camera field of view to prevent this from

occurring

49


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. Indication: The NeuralBot™ when used with the Lucid M1 System (Lucid™ Robotic 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:This device is not intended to be used in fetal applications. This device is not intended to be used inside the sterile field. Copyright ©2019 Neural Analytics, Inc. All Rights Reserved.

50


Slide Number 1OverviewSlide Number 3Product DescriptionProduct DescriptionProduct DescriptionCautions and WarningsSafetySlide Number 9System Pre-ChecksSystem Pre-Checks: RCUSystem Pre-Checks: PHUSystem Pre-Check: ACUSystem Pre-Check: Lucid M1System Pre-Checks: Configuration & InitializationSystem Pre-Checks: Configuration & InitializationSlide Number 17Patient Set Up: Lucid M1 – Run ExamPatient Set Up: Patient AnglePatient Set Up: Procedural SetPatient Set Up: Procedural SetPatient Set Up: Procedural SetPatient Set UpPatient Set UpRegistrationRegistrationSlide Number 27Slide Number 28Thermal IndexSignal SearchSlide Number 31Post Exam ProcedurePost Exam ProcedureSlide Number 34Quick ReleaseSlide Number 36System Power DownDevice StorageEquipment Care and MaintenanceCautionCleaningPreventative MaintenanceSoftware Features and TroubleshootingSoftware FeaturesSoftware FeaturesSoftware FeaturesSoftware FeaturesTroubleshooting: RCU ErrorTroubleshooting: RegistrationSlide Number 50

Documents

Lucid Robotic System - Neural Analytics › wp-content › uploads › 2020 › 04 › DC … · DC-01475 Rev B. Patient Set Up: Procedural Set • Use the probe pod covers to carefully