Lucid System In-Service Training DC-00172
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 and veins 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.
Hardware Set Up 1. Unfold the kickstand. Position in a comfortable viewing position. 2. Connect the DC power cord between the Lucid M1 System ( System ) console and the AC adapter 3. Connect the AC cordset to the AC adapter and a standard AC power outlet. 4. Plug the transducer connector/s into the front panel. 5. Plug in the remote control, keyboard or mouse if desired. 6. Turn on the System 7. Press the power button on the left side of the system. Transducer Plugs Remote Plug USB Ports Power Plug Power Button
System Set Up System Setup 1. At the login screen, enter username and password When this is the first time the device is used, enter the default username and password (without the quotes) i. default username: admin ii. default password: password The user will be asked to change the password
Start the Patient Exam 1. Login by entering username and password 2. Select Run 3. Make sure a probe is plugged into the system prior to starting an exam. 4. Choose an exam by selecting the appropriate button The System will display the exam screen with the pre-defined settings for the test procedure selected The pre-defined settings are set for convenience; the user is strongly encouraged to thoroughly review the settings and make the appropriate adjustments for safe and effective measurements.
Performing an Exam 1. Adjust Power to desired level. 2. Adjust depth into the desired vessel. 3. Adjust sample volume for the desired vessel. 4. Adjust gain to desired level. 5. Adjust scale for the desired vessel. 6. Adjust baseline for the desired vessel. Next, position the transducer and optimize blood flow velocity in the Spectrogram Screen and M-mode. Adjust the depth for the desired signal.
Performing an Exam Power The Power controls sets the acoustic power. The power is adjustable from 0 to 100% in increments of 1, 2, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100%. Adjust the acoustic power to the minimal setting that allows effective measurement. Pressing the Up arrow increments power. Pressing the Down arrow decrements power.
Performing an Exam Depth The Depth setting adjusts the depth (in mm) at which the velocity spectrogram is produced within a specific vessel. Pressing the Up arrow increments the depth setting. (the measurement is deeper with reference to the transducer) Pressing the Down arrow decrements the depth setting (the measurement is shallower with reference to the transducer)
Performing an Exam Sample Volume The Sample Volume adjusts the volume of space centered at the Depth setting where the Spectrogram is produced. Pressing the Up arrow increments the sample volume setting. (the measurement volume is larger) Pressing the Down arrow decrements the sample volume setting (the measurement volume is smaller)
Performing an Exam Display Controls Velocity Scale and Baseline The Velocity Scale is used to adjust the vertical axis of the Spectrogram display and can be used to capture the full velocity envelope and spectrum on the display. The Baseline adjustment is used to adjust the 0 cm/s line on the vertical axis. Pressing the Up arrow increases the Velocity Scale setting allowing higher velocities to be displayed on the scale. Pressing the Down arrow decreases the Velocity Scale setting allowing smaller velocity signals to be magnified.
Performing an Exam Sweep Speed The Sweep Speed is used to adjust the horizontal axis of the Spectrogram and M- mode display and can be used to capture the desired Spectrogram waveforms.
Performing an Exam Gain The Gain control adjusts the intensity of the Spectrogram display. Pressing the Up arrow increases the intensity of the display. Signals that are faint will increase in brightness and be more visible. Pressing the Down arrow decreases the intensity of the display. Signals that are faint will decrease in brightness and be less visible.
Performing an Exam Filter The Filter controls adjusts the low pass filter frequency. For signals that have low frequency noise, the filter can be adjusted to screen out that noise. PRF -3dB Frequency Cutoff Step Size Range 5Khz, 6.25Khz, 8Khz 25 to 600 Hz 25Hz 10Khz, 12.5Khz 100 to 2400 Hz 100Hz Pressing the Up arrow increases the filter frequency Pressing the Down arrow decreases the filter frequency.
Performing an Exam Vessel Selection The Vessel control allows the labeling of the snapshot with a vessel name The Vessel control lists the vessels and the depths for each vessel for a Complete Study. For any Monitoring Study, only the vessel name is displayed. The vessel name indicates the side of the head. Press the Up/Down arrows to increment up or down the list of vessels.
Performing an Exam Record The Record control toggles the record feature ON / OFF. When the Record control is toggled ON, the Spectrogram and M-mode display are recorded under the Patient Exam. The Snapshot feature is enabled. When the Record control is toggled OFF, the recording stops.
Performing an Exam Taking Snapshots 1. A Snapshot captures the Spectrogram, M-mode, control settings and measurements as well as a video of the previous sweep. 2. Perform a Snapshot by pressing the Snapshot button when the desired signal is in view in the Spectrogram.
Performing an Exam M-Mode Display The M-Mode display shows the direction and intensity of the blood flow velocity in a given depth range. Red indicates blood flow in the direction of the insonating transducer. Blue indicates blood flow velocity away from the insonating transducer. Brighter colors indicate greater intensity of the signal. The sample depth is displayed as a bar on the M-Mode graph.
Performing an Exam Spectrogram Display The Spectrogram display shows the Doppler spectral waveform of the blood flow velocity at the sampled depth. The Doppler gain can be adjusted by pressing the Gain button and adjusting the value. The gain adjusts the Doppler Spectrogram color scale. The Spectrogram gain does not adjust the ultrasound power or receiver gain.
Performing a Limited/Full Exam Locate the Blood Vessel Turn the acoustic power ON by selecting the acoustic power ON button. Start the study by selecting the vessel and depth that will be insonated. Position the transducer and optimize blood flow velocity in the Spectrogram Screen and M-mode. Adjust the depth for the desired signal. Save the Blood Flow Velocity Data To take a snapshot press the Snapshot button. Note that a check mark will appear next to vessels where Snapshots have been taken. Select the Next Vessel After a snapshot, the exam will automatically advance to the next vessel and depth setting. Press the Down arrow button to select the desired vessel. Press the Up or Down arrow buttons or select a different label in order to change the current vessel and depth. Multiple Snapshots may be taken for a vessel and depth. Review the Blood Flow Velocity Data In the Exam Review feature individual snapshots may be selected for inclusion in the exam report.
Performing a Monitoring Exam The Monitoring screen displays selected waveforms over the full course of the monitoring exam. Several different trending plots can be selected for display on the Monitoring Screen: Left and Right Mean Velocity Left and Right PI Left and Right Minimum Velocity Left and Right Maximum Velocity
Performing a CVR Exam 1. Select Patient to enter the patient information screen. Enter patient or select previous patient information. 2. Select New Exam. 3. Select the CVR exam from the Test Protocol screen. 4. Set up the rest of the exam as described in Performing a Monitoring Exam 5. Complete CVR protocol 6. From the Exam Review screen, select the CVR button to review the CVR calculation. 7. The Maximum Velocity, Minimum Velocity, and Mean Velocity may be individually adjusted, resulting in an updated CVR value.
Performing Emboli Detection Emboli Detection When an emboli event is detected, the system will increment the counter and save a snapshot of the display for inclusion into the patient report. Select Patient to enter the patient information screen. Enter patient or select previous patient information. Select New Exam. Select the Emboli Detection from the Exam Procedure screen. Set up the rest of the exam as described in Performing a Monitoring Exam The system will separate emboli signals from artifact or noise signals and will count the emboli events at all depths between 30mm and 81mm. Cumulative emboli count will be displayed on the screen When ready, press Record and start the study. The Emboli study will count emboli when the depth ranges of both the active channels (channels with transducers installed) are between 23 and 87 mm.
Generating a Report 1. When the exam is complete, press the Exit Exam button 2. Navigate to the Exam Review screen 3. Review and select the Snapshots and videos that are chosen for the Report 4. Adjust the vessel labels and spectrogram parameters as necessary 5. When completed, navigate to the Exam Report: Conclusion screen and add any desired notes into the Diagnosis and/or Conclusion entry fields. 6. Press Generate Report 7. The report can be printed or exported in PDF or DICOM format. 8. To export the report, navigate to the Patient Record screen and select the exam to export 9. Then press the Export button. 10. When complete and no additional exams are needed, disconnect the transducers, clean and store them away. Power down the system and place into storage.
Snapshot Editing 1. Snapshot spectrograms can be edited on the Exam Report Screen 2. Select the snapshot to be edited and press the edit button. 3. Once in the editing screen you can change the maximum and minimum velocities, which will also automatically update the mean velocities and PI for the snapshot, add or remove the spectrogram envelope and save or discard any changes made.
Video Review 1. Videos can be reviewed on the Exam Report Screen 2. View the video of a snapshot by pressing the play button next to the desired selection. 3. The system will replay a 4sec snippet of video corresponding to the snapshot taken: 1. 2sec before and after for embolic signals 2. 4sec beforehand for manual snapshots 4. Videos can be replayed using the controls on the bottom of the video playback screen.
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 in hospitals, clinics or physician offices by prescription or by order of a physician trained in the use and interpretation of Trans Cranial Doppler Ultrasound. US Federal Law restricts this device to use by or on the order of a physician.
Contraindications This device is not intended to be used in fetal applications. This device is not intended to be used inside the sterile field.
Precautions & Warnings Before performing an exam, thoroughly review the power settings on an exam screen to ensure safe and effective measurements. When setting the ultrasound power setting for a measurement, follow the ALARA principle (As Low As Reasonably Achievable) For ophthalmic, burr-holes, fontanels or foramen magnum measurements, it is recommended to always use 10% or lower power levels. The is device is not intended to be used in fetal applications. Warning: Do not exceed 10% power through the eye or foramen magnum.
August 15, 2017 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. The Lucid M1 Trans Cranial Doppler Ultrasound System is indicated 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 M1 System measures the occurrence of transient emboli signals within the blood stream. Neural Analytics, Neural Analytics Logo and Lucid are trademarks of Neural Analytics. 2017 Neural Analytics. DC-00172