Distance Expert Neurophysiology Suite System Setup

Transcription

1 Distance Expert Neurophysiology Suite System Setup Directions for Use L (Rev B0, February 2015) FHC, Inc Main Street Bowdoin, ME Fax: hour technical service: (US & Can) FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest Sector 2 Romania FHC Latin America Calle 6 Sur Cra 43 A-200 Edificio LUGO Oficina 1406 Medellín-Colombia

2 Indications for use: The Distance Expert Neurophysiology Suite System is intended to assist in functional neurosurgical procedures in which recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes. Intended Use: The Distance Expert Neurophysiology Suite System is intended for use by neurosurgeons, neurologists and clinical neurophysiologists to accurately position depth electrodes during functional neurosurgical procedures. WARNINGS AND CAUTIONS WARNING: For important safety precautions, warnings and instructions on proper use of the microtargeting Guideline 4000 LP+, refer to its Directions for Use (L011-57: included with the Guideline 4000 LP+, and L : included with the Breakout Box). CAUTION: Incorrect setup may impair performance of the Distance Expert Neurophysiology Suite System. WARNING: A trained, FHC authorized representative must set up the Distance Expert Neurophysiology Suite System. On completion of setup, an FHC-authorized remote Distance Expert assumes control of the Distance Expert Neurophysiology Suite System. CAUTION: Verify that backup modes of communication with the remote Distance Expert (e.g., telephone, cell phone) are in place in the event of loss of Internet connection or other lapses. ORDERING INFORMATION 65-GNC-DE-PHYS 66-GNC-DE-SW1.02 Distance Expert Neurophysiology Distance Expert Neurophysiology Software and DAQ This document contains Directions for Use of the Distance Expert Neurophysiology Suite System including the setup and verification of the Cable Management System (CMS), audiovisual equipment, the Distance Expert Neurophysiology laptop PC and supporting software. The CMS simplifies the system connections by routing analog electrophysiology data acquired from microelectrode recordings, motion sensors and drive position to the remote Distance Expert through the laptop PC. Audiovisual communication is achieved through wireless headsets and HD webcam. Connection to the remote Distance Expert workstation is established through Internet-based TeamViewer. L (Rev B0, Feb 2015) 2

3 INVENTORY OF COMPONENTS 1. E Carry bag 2. E6-63 Distance Expert Neurophysiology laptop PC including power brick DES-PHYS-01 Cable Management System (CMS) including Type A-Type B USB cable and D-Link power supply 4. E7-12 Logitech HD webcam 5. E7-08 Jabra Pro Base Station with headsets (2) and charging station 6. N Multicolored BNC analog input to HD15 cable 7. E7-11-SET Motion sensors (2) and charging pad 8. N male:female serial cable 9. N female:female serial cable and E USB-to-serial adapter (attached) QuickWave 11. E7-06 Power strip Other Items (sold separately) 12. MT-LPP-BOX 5-channel Breakout Box 13. N HD15 extension cable (optional) Not Shown (sold separately) 14. Guideline 4000 LP+ (or other compatible MER system) 15. microtargeting Controller (or other compatible depth reporting device) Figure 1. Distance Expert Neurophysiology Suite System components L (Rev B0, Feb 2015) 3

4 HARDWARE CONNECTIONS Figure 2. Wiring diagram for Distance Expert Neurophysiology Suite System hardware (with conceptual link to remote Distance Expert ) 1. Connect the Distance Expert Neurophysiology laptop PC to the CMS 1.1. Plug the power strip directly into a designated outlet. Avoid outlet trees and additional power strips Connect the laptop PC to its power cable and route the power cable to the power strip Connect the CMS D-Link power adapter to its rear panel and route the power adapter to the power strip Connect the Type A-Type B USB cable to the rear of the CMS and to the laptop PC Verify that the green indicator light on the front of the CMS is flashing. *Note: This is a directional LED and must be viewed horizontally Connect the multicolored analog input cable to the CMS via the HD15 port on the front of the CMS. *Note: Use an extension cable only if the need arises. L (Rev B0, Feb 2015) 4

5 1.7. Connect all the BNC connectors on the multicolored HD15 analog input cable to the BNC ports on the Guideline 4000 LP+ Breakout Box in the order shown in Table 1. Step BNC Connector RED GRN BLU BLK GRY Table 1. CMS to Guideline 4000 LP+ Breakout Box analog signal routing WARNING: Unterminated analog input connections may impair system performance. Verify that all five BNC connections have been made. 1.8.Connect the Guideline 4000 LP+ Breakout Box to the Guideline 4000 LP+ (see DFU L ). 2. Connect the microtargeting Controller 2.1. Connect the male:female serial cable to the rear of the CMS and to the microtargeting Controller Connect the female:female serial cable with attached USB-to-serial adapter to the CMS. Connect the USB end to the Guideline 4000 LP+ laptop PC. *Note: Avoid connecting the USB end to the Distance Expert Neurophysiology laptop PC. L (Rev B0, Feb 2015) 5

6 3. Connect the audiovisual equipment 3.1. Connect the HD webcam to the USB port on the Distance Expert Neurophysiology laptop PC Connect the Jabra headset base to its power cable and route the power cable to the power strip Connect the Jabra headset base to its USB cable. Connect the USB cable to the Distance Expert Neurophysiology laptop PC Place the primary Jabra headset on the headset base Connect the motion sensor charging pad to the front of the CMS via USB Place one of the motion sensors on the charging pad. SYSTEM CONNECTIONS 4. Launch all systems 4.1. Verify all Guideline 4000 LP+, CMS and Distance Expert Neurophysiology laptop PC links Power up the Guideline 4000 LP+, login and launch the software (see DFU L011-57) Perform pre-use checkout on the Guideline 4000 LP Power up the Distance Expert Neurophysiology laptop PC and login to Windows using the password distanceexpert (case sensitive). 5. Verify analog electrophysiology connections 5.1. Plug the QuickWave into the Distance Expert Neurophysiology laptop PC and allow it to enumerate Open the QuickWave application. Set the waveform parameters as follows: sine wave 300Hz, 1Vpp, zero offset. Enable output Connect channel 1 (red) of the multicolored BNC input cable to the QuickWave Terminate (short) all unused BNC inputs on the multicolored BNC input cable by keeping all other cable inputs connected to the Breakout Box. (Other MER systems: Terminate by connecting the BNC inner and outer conductors.) 5.5. Launch the Distance Expert Neurophysiology Software On the first setup form, Application Options, select the Channels tab Set the Total Channel Number to 5 (this may be preset). Click OK Click OK on the Patient and Trajectory Information form Click the green Start/stop Data Recording button in the upper left-hand corner to begin signal acquisition. Confirm that the 300Hz sine wave appears in the Neural Signal Amplitude (Volt) area Click Alt+2 in the Distance Expert Neurophysiology Software to select channel 2. Confirm that the sine wave disappears and that only a flat line appears. L (Rev B0, Feb 2015) 6

7 5.11. Disconnect channel 1 (red) and connect channel 2 (green) to QuickWave Terminate unused channel Confirm that the 300Hz sine wave from channel 2 appears in the Neural Signal Amplitude (Volt) area Repeat steps for each of the three remaining channels. 6. Verify motion sensor connections 6.1. Confirm that the motion sensors are in sleep mode (the LED will be unlit) Activate the motion sensors by briefly touching each one to the charging pad (the LED will light up). Confirm that the Distance Expert Neurophysiology laptop PC has detected them by selecting Start, then Devices and Printers. Two Kinesia devices should be displayed Place and leave one of the sensors on the charging pad to disable it Open the Motion Sensor drop-down menu in the Distance Expert Neurophysiology Software and select Search Sensors (or shortcut Alt+S ) Pause seconds to allow both sensors to populate the Select Sensor list Open the Motion Sensor drop-down menu and select Start/Stop Sensor. If the warning Sensor on charging pad appears, open the Motion Sensor drop-down, click Select Sensor, and click on the unchecked sensor Wiggle the active sensor to confirm that the waveform deflection appears in the Motion Sensor data (Vector Magnitude) area Open the Motion Sensor drop-down menu and select Start/Stop Sensor to stop acquisition Exchange the active motion sensor with the inactive sensor on the charging pad Open the Motion Sensor drop-down menu. Open Select Sensor and choose the next sensor Repeat steps for the next sensor Be sure to fully charge both sensors well in advance of surgery. L (Rev B0, Feb 2015) 7

8 7. Verify depth reading connection 7.1. Verify microtargeting Controller connectivity to the Guideline 4000 LP+ (see DFU L011-57) Verify Distance Expert Neurophysiology Software connectivity by selecting View, and then Depth. A depth display window will appear. Confirm that the value appearing in the depth display window equals the value displayed on the Guideline 4000 LP+. *Note: If the microtargeting Controller has not been reset to zero, its depth display will read NaN. 8. Verify Internet connection 8.1. Launch the Internet from the Distance Expert Neurophysiology laptop PC. (Availability of a wired or wireless connection must be arranged well in advance of the day of surgery.) 8.2. Check Internet connection speed by navigating the browser to and following site instructions Examine the site-generated report which includes ping (in ms), download speed (in Mbps) and upload speed (in Mbps). The connection must meet the speeds listed in Table 2. Minimum download / upload speed Recommended download / upload speed Mbps / Mbps Mbps / Mbps or higher Table 2. Video calling / Screen sharing speeds 9. Verify audiovisual connection 9.1. Open TeamViewer on the Distance Expert Neurophysiology laptop PC From the Extras tab, select Options Select Video in the opened window Ensure that HD Videocam is selected as the video source and that the webcam is on Verify that the displayed video belongs to the camera in use Check the Jabra wireless headset function by opening Options, then Audio Conferencing. Ensure that Mute is unchecked. L (Rev B0, Feb 2015) 8

9 10. Verify backup communication Establish and verify backup modes of communication with the remote Distance Expert (e.g., telephone, cell phone) in the event of loss of Internet connection or other lapses. 11. Restart the Distance Expert Neurophysiology Software At this point, the Distance Expert Neurophysiology Suite System is ready. Follow the Distance Expert -Neurophysiology Software Directions for Use (L011-76). 9