NeuralGlider 102 Inserter Neuro Nexus Instruction Manual

NeuralGlider 102 Inserter Neuro Nexus Instruction Manual

1.0 Intended Use

1.1) Indications for Use

The NeuralGlider Inserter is a device for assisting qualified personnel in performing insertions of neural implants for the study of neural function in animal models.

1.2) Contraindications

DO NOT use the NeuralGlider Inserter if:
– You are performing neural implant insertions on a human.
– You are not qualified to perform neural implant procedures in animal models.
– The animal is showing signs of illness or injury.
– The site you desire to insert the neural implant contains abnormalities.

2.0 Cautions

Due to the diverse landscape of neural implants, Actuated Medical, Inc. cannot gaurantee improved insertion for all implant types. Use of the NeuralGlider Inserter is at the Operator’s discretion, and Actuated Medical, Inc. is not responsible for any damage to implants.

3.0 Operator Profile

The NeuralGlider Inserter is intended for use by Laboratory Technicians, Laboratory Supervisors and Managers, and Research Scientists. Read the Operator’s Manual for training.
For more information, contact Actuated Medical’s Customer Service Department at 814-355-0003 ext. 117 or visit the website NeuralGlider.com.

4.0 Device Description

The NeuralGlider Inserter is a device for assisting qualified personnel in performing insertions of neural implants for the study of neural function in animal models.
The NeuralGlider Inserter consists of a reusable Actuator that is connected to a reusable Motor. The Actuator is powered by a reusable Control Box and the Motor is powered by a reusable Motor Controller.
Refer to Figure 1a and Figure 1b for an illustration of the assembled device.
The NeuralGlider Inserter includes an Actuator (12) that ultrasonically vibrates a Coupler (21) that is connected to a neural implant, sold separately. This Operator’s Manual depicts an Array Clamp, the Coupler used for a standard A79038-001 Omnetics connector style microwire neural implant, however, many types of Couplers and neural implants may be used. The vibration decreases the amount of force necessary for the implant to penetrate brain tissue, thereby reducing tissue compression. This reduction in trauma can be associated with less glial scarring and increased recording yield. The Coupler is designed to connect to a neural implant during implantation and to disconnect from the neural implant after the neural implant is fixed to the skull. The Torque Screwdriver (18) allows the screws on the Coupler to be reliably tightened to a pre-set torque to ensure vibration transfer. The provided Torque Screwdriver is used to attach the neural implant to the Coupler. The Actuator interfaces with the Coupler through a Male to Female Luer (20) that allows for 360° rotation when mated with the Luer Connector (19).
The driving electronics for the Actuator are housed in the Control Box (16). The Control Box is connected to power via the Control Box Power Cord (24) and the Jack (26). The Control Box allows for interfacing with a PC and Motor via the various USB Connections (6, 22, 23, 25). The NeuralGlider Inserter Software is used to control and set operating parameters. The Actuator is connected to the Control Box at the Control Box Receptacle (15) via the Actuator Cable (14).

The Actuator is connected to the Motor (4) so that the position of the neural implant can be adjusted relative to the insertion target. The Motor uses the Stereotactic Mounting Bar (2) and Stereotactic Mounting Bracket (1) to mount to a standard stereotactic frame, sold separately. This Operator’s Manual depicts Model 102 (26 mm Motor). The Motor is sent commands via the Motor Controller (5), which is connected through the Motor Cable (13). The Motor Controller is powered through the Motor Control Power Supply (8), which is attached through the Motor Controller Power Cord (9) and the Motor Controller Power Supply Cord (7).
The Actuator and Motor are controlled using the NeuralGlider Inserter Software. The software allows the user to specify position, velocity, actuation on/off, and power. A Microscopic Pen Camera (10) mounts next to the Actuator to view the neural implant and insertion site. The Stereotactic Mount (11) has three axes of rotation to allow for a greater range of adjustment. There are two thumbscrews on the Stereotactic Mount. One allows the Stereotactic Mount to be moved about the Stereotactic Mounting Bar, while the other allows for rotation of the camera relative to the neural implant.

5.0 Setup Instructions

5.1) Plug one end of the Control Box Power Cord into a standard wall outlet and the other end into the Jack on the Control Box.

5.2) Plug the USB Jumper Cable into the USB Type B port on the Control Box.

5.3) Plug the free end of the USB Jumper Cable into the USB Extension Cable. Plug the other end of the USB Extension Cable to a port on the USB Hub (not shown). Plug the USB Hub into a USB port on the computer that will run the NeuralGlider Inserter Software.

5.4) Attach the Actuator to the Motor by sliding the bracket on the Actuator into the receiver on the Motor. Then secure the Actuator in place by tightening the knob on the side of the receiver.
NOTE: The Actuator must be fully inserted into the receiver before tightening the knob or the Actuator will not be held securely in place.

5.5) Attach the Stereotactic Mounting Bracket to the stereotactic frame.

5.6) Firmly tighten the Male to Female Luer onto the Luer Connector at the end of the Actuator.

5.7) Plug the Actuator Cable into the Control Box Receptacle.

5.8) Attach the camera by sliding the Stereotactic Mount onto the Stereotactic Mounting Bar and tighten the thumbscrew to secure in place.

5.9) Plug the camera into the USB Hub.
5.10) Plug one end of the Motor Controller Power Supply Cord into the Motor Controller.

5.11) Plug one end of the Motor Controller Power Cord into the Motor Controller Power Supply if needed and the other end into a standard wall outlet (if needed).![NeuralGlider 102 Inserter Neuro Nexus Instruction Manual

• Plug one end of the Motor Controller](https://manuals.plus/wp- content/uploads/2024/03/NeuralGlider-102-Inserter-Neuro-Nexus-Instruction- Manual-Plug-one-end-of-the-Motor-Controller-2.jpg)

5.12) Plug the Motor Cable into the Motor Controller.

5.13) Plug the USB Type A to Mini B Cable into the Motor Controller.

5.14) Plug the USB Type A to Mini B Cable into the USB Hub.

5.15) Turn on the Control Box by flipping the ON/OFF Power Switch to the ON ( I ) position. The power and fault lights should flash, and then the power light should remain green. Within 30 seconds, the fault light will start blinking indicating that the Control Box is not connected to software. Connection to the software is performed during operation (Section 7.0).

5.16) Loosen the two screws on the top of the Coupler with the Torque Screwdriver. Place an Omnetics connector based neural implant in the groove. Make sure that the Omnetics connector is cantered and sitting flush within the groove of the Coupler. Tighten the two screws using the Torque Screwdriver until you feel the clutch break and then the Torque Screwdriver will turn without any resistance.
NOTE: If there is excess epoxy on the Omnetics connector, make sure that the epoxy is not preventing the Coupler from coming in full contact with the faces of the Omnetics connector.
NOTE: For information about other Coupler types, visit neuralglider.com/support.

5.17) Firmly tighten the Coupler onto the Male to Female Luer located at the end of the Actuator by using a clockwise motion so that the Male to Female Luer is not loosened.
NOTE: If adjustments to the angle of the neural implant are needed, always make adjustments by turning in a clockwise motion to assure that the Male to Female Luer and Coupler stay firmly tightened to the Luer Connector.

6.0 Software

Software Installation: 6.1) Plug the provided USB flash drive into a USB port on the computer.
See Table 2 for minimum or recommended PC specifications.
6.2) Navigate to USBDIR/Installer and run the Setup Application as an administrator. If you do not have administrator privileges, contact your facility’s IT department to proceed with the software installation.
6.3) If prompted that the installer may be unsafe, click the OK or Yes button to continue installation.
6.4) Follow the steps in the Installation Wizard and read any licensing agreements.
NOTE: You may need to restart the computer after installing the .NET Framework required for the program. If this happens you must restart the installation process after restarting the computer.
6.5) After finishing the main application installation, you will be prompted with a second Installation Wizard to install device USB drivers. Follow the steps in the Installation Wizard.
6.6) Restart the computer after the drivers are installed.
6.7) The integrated camera may be operated with a third-party video software. You may use a preferred video recording software that is already downloaded to your computer, or you may download a recommended software to the local drive on your computer.
Recommended Video Recording Software: ­ Plugable Digital Viewer
http://plugable.com/pages/microscope-drivers
­ Bandicam
http://www.bandicam.com/downloads/

Software Overview:
The software has two main modes of operation: Automated Insertion Mode and Manual Insertion Mode. The user may switch between these modes by clicking either the Auto or Manual button. The current active mode is indicated with an illuminated green light. The Manual Insertion Mode gives the user direct control of both the Actuator and the Motor. The Automated Insertion Mode automates control of the Actuator and the Motor based on user settings to perform controlled and consistent neural implant insertions.

7.0 Operating Instructions

7.1) Set up the NeuralGlider Inserter software and hardware as directed in Sections 5.0 and 6.0.
7.2) Ensure the Control Box and Motor Controller are both connected to your computer with the provided USB Extension Cable and powered ON. It is important that the Control Box is connected via USB cables before the ON/OFF Power Switch is turned to the ON ( l ) position.
NOTE: If not done in the proper order USB communication will be interrupted and the software will not function properly.
7.3) Run the NeuralGlider Inserter Software.
7.4) The Initialization window will open and indicate if the communication port for the Motor was found.
7.5) A pop up window will ask if you would like to use relative position or zero the Motor.
NOTE: If you select the Current Position button the Motor will not move. If you select the Zero button, the Motor will move up to the zero position at the top and show absolute position. If not, the Motor will show relative position.
7.6) The Set Home window will open to set the Motor home position. Set a desired home position by entering a numerical value from 0 to 26 and hit the Go to Home button.
NOTE: A home position that is at least 2 mm more than the neural implant length is recommended.

7.7) Once the program has finished the Initialization sequence, press the OK button within the Initialization window, and the NeuralGlider window will be enabled.

7.8) Ensure that the LED indicator lights within the software next to both “Control Box” and “Motor” are bright green. If either is not, click the Reconnect button.

7.9) In the Save info tab at the top of the window, set the Data File Folder to a valid location and enter the File Rootname and File Suffix #.

7.10) In the Insertion Information tab, fill in the Operator ID, Test ID, and Comments text boxes if desired. This information will be saved in the data log files.

7.11) Position the stereotactic frame such that it is above the desired implant site. Use the dials on the stereotactic frame to get the neural implant as close to the surface of the implant site as possible in Z travel.

7.12) Open the third-party video recording software. The camera migh need to be changed to the “Supereyes” within the setting of the third-party video recording software if other integrated webcams are present.

7.13) Position and focus the camera so that the tip of the neural implant is in clear view. The camera position can be adjusted in two ways Loosening the thumbscrews allows the Stereotactic Mount to be moved up and down on the Stereotactic Mounting Bar and the camera angle to be rotated. Secure both thumbscrews when finished. Pushing the camera through the ring allows for view and focal length adjustment. To focus the camera, turn the ribbed knob on the back of the camera clockwise or counter-clockwise.

7.14) In the MOTOR POSITION area of the window, set the Move textbox to 0.050 mm and the Velocity textbox to 0.050 mm/s if they are not already.
NOTE: Refer to Table 4 for Recommended Software Settings.

7.15) Using the Move arrow buttons, move the neural implant down until it is clearly touching the insertion site.

7.16) Click the ZERO button. The Relative Position textbox should indicate 0.000 mm.

7.17) Set the desired power level. The range of permitted power levels is 0.50 – 1.50 Watts.

7.18) Verify the Actuator is functional by first clicking the Enable Actuation button in the INSERTION CONTROL area of the window to indicate “ON”.
NOTE: The Enable Actuation Button will indicate “OFF” before pressed. After pressed it will indicate “ON”. This will enable actuation of the neural implant.
NOTE: The indicator light next to “Actuation” turns yellow momentarily before it turns green. The yellow light signifies that the power level has not yet ramped up to the specified power level.

Then use one or more of the following methods to confirm actuation:
– Rub a small-gauge (25G or less) needle across the Coupler. A vibration sound
should be heard.
– Place a couple drops of saline on the surface of the insertion site, touch the shanks
to the saline, and turn on actuation. Movement of the saline should be seen.

7.19) Turn off the Actuator by clicking the Enable Actuation button to indicate “OFF”.
7.20) Click the Auto button to go to automatic insertion mode. The indicator light above Auto should turn bright green.

7.21) Enter the target depth of insertion in the Target Depth textbox.
NOTE: The depth set here is the actual depth from the surface of the insertion site, or ZERO point.

7.22) If data logging is desired, press the Data Log button to indicate “ON”, and select automatic or manual save mode by using the Data Log Mode checkbox.
NOTE: When the Data Log Mode checkbox is unchecked (Manual Mode), data will continue to log until the Log Data button is pressed again. When the Data Log Mode checkbox is checked (automatic mode), data will stop recording 15 seconds after the target depth is reached and the Save button must be pressed to save the data.

7.23) Click Select Motor to indicate “26 mm Motor” above the postion graph.

7.24) Click the Enable Actuation button to indicate “ON”.
NOTE: While in automatic mode, the Actuation indicator light will not turn ON until the auto insertion sequence is enabled after clicking GO. Insertions can be performed using the NeuralGlider Inserter with actuation OFF if desired by leaving the Enable Actuation button to indicate “OFF”.

7.25) Set an actuation delay if desired. An actuation delay of 0 to 1 second is recommended.

7.26) Click GO to perform automatic insertion using the previously set parameters.
NOTE: If you would like to save video of the insertion, it must be done manually in the third-party software.

7.27) Once the neural implant has been implanted to the target depth, the Motor will stop and the Actuator will turn off.

7.28) If Data Log indicates “ON” and Data Log Mode is set to automatic, data recording will terminate 15 seconds after the target depth is reached. If the Data Log Mode is set to manual, then the Log Data button must be pressed to stop recording and to save data. Once data logging is complete, the Data Waiting indicator light will change to a bright green. Press SAVE to save the data.

7.29) Fix the neural implant to the skull according to your institution’s protocols.

7.30) After the neural implant is securely fixed in place, use your hand to provide some support to the Coupler and loosen the two screws that are holding the neural implant in place. Make sure the neural implant is fully free from the Coupler before moving to the next step.

7.31) Switch back to Manual Mode in the INSERTION CONTROL area.
7.32) Use the Move arrows to retract the Coupler up, leaving the neural implant in place.
7.33) Finish the procedure according to institution protocol.
7.34) When finished using the NeuralGlider Inserter, turn the ON/OFF Power Switch to the OFF ( O ) position, unplug the USB connections from the computer.

8.0 Cleaning and Sterilization Instructions

Turn the ON/OFF Power Switch to the OFF ( O ) position and unplug the NeuralGlider Inserter prior to cleaning.

Thoroughly clean the NeuralGlider Inserter after each use.

Clean the Control Box, Actuator, Motor, Motor Controller, and camera by wiping all exterior surfaces with either (1) a cloth dampened with 70% isopropyl alcohol or with (2) disinfectant wipes. Clean the Coupler by immersing in 70% isopropyl alcohol for two minutes. DO NOT submerge the Control Box, Actuator, Motor, Motor Controller, or Camera in liquid.

Use ethylene oxide sterilization to sterilize the Coupler and neural implant according to your institution’s protocols. DO NOT subject to autoclave sterilization.

A Sterilization Kit is included with the NeuralGlider Inserter when the Coupler being used is an Array Clamp or similar version. For instructions on how to use the Sterilization Kit, visit neuralglider.com/support.

9.0 Maintenance

Use compressed air to periodically clean the lead screw on the Motor.

10.0 Storage

Store the NeuralGlider Inserter in a clean, dry area. It is recommended that the NeuralGlider Inserter be stored at temperatures between -20°C (-4°F) and 60°C (140°F) and relative humidity between 25% and 80%. DO NOT exceed temperatures below -20°C (-4°F) or above 60°C (140°F) or relative humidity of 25% and 80%.

11.0 Return Policy

Actuated Medical takes pride in the quality of our products. If the device is found to be defective, contact our Customer Service Department at +1 814-355-0003 ext. 117 for prompt replacement. You will be provided with a Return Material Authorization (RMA) number and return shipping information. All returns must be accompanied by an RMA number and reason(s) for return.

12.0 Disposal

The NeuralGlider Inserter is classified as Waste Electrical and Electronic Equipment (WEEE). Do not dispose of the device with normal domestic waste at the end of its life. Please take it to an official recycling point to be properly disposed.

NeuralGlider Inserter Model 102 Operator’s Manual

13.0 Troubleshooting Guide

14.0 Technical Data

14.1) Environmental Conditions that Affect Use

­ Operating Conditions: From 0°C (32°F) to 35°C (95°F)
Relative Humidity from 30% to 75% ­ Transportation and Storage Conditions: From -20°C(-4°F) to 60°C
(140°F). Relative humidity from 25% to 80%.

14.2) Device and/or Packaging Symbols

14.3) Electrical Specifications ­ Control Box

– Control Box
90-264V ~ 1.4A 47-63 Hz, Conforms to IEC 60601-1-2 ed 4.0 (2014- 02) “Medical Electrical Equipment – Part 1-2: General Requirements For Basic Safety And Essential Performance – Collateral Standard:
Electromagnetic Disturbances – Requirements And Tests”
– Control Box Power Cord
IEC320 Connector, RoHS Compliant.
– USB Extension Cable
Shielded, USB 3.0 Cable A Female to A Male 6.00’ (1.83m), RoHS Compliant.
– Motor Controller Power Cord
Unshielded, 10A 125V MAX, CEE 7/16 To IEC320-C8 6.00’ (1.83m), RoHS Compliant.
– Motor Controller Power Supply
100-240 Volts DC 50-60Hz 1.2A MAX, IEC320-C8 Connector, RoHS Compliant.
– USB Type A to Mini B Cable
USB Cables / IEEE 1394 Cables USB A-B 28/28 BLACK .16 M, RoHS Compliant.

⚠ Use of Power Supplies and Power Cords other than those specified in Section 14.3 may result in improper functioning of the NeuralGlider Inserter.

15.0 Limited Warranty

Actuated Medical, Inc. (“Manufacturer”) makes certain limited warranties set forth in this Limited Warranty regarding the following products (the “Products” and each a “Product”): NeuralGlider Inserter Model 102.

Manufacturer warrants to the purchaser of the Products (“Customer”) that the Products will be free from defects in material and workmanship per Actuated Medical, Inc. Product specifications for a period of 13 months from the date of purchase (the “Warranty Period”). The foregoing limited warranties are solely to and for the Customer’s benefit.

Limited Warranties do not apply where any Product (a) has been subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper installation, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions or use contrary to any instructions issued by Manufacturer; or (b) has been reconstructed, repaired or altered by persons other than Manufacturer or its authorized representative.

During the Warranty Period, regarding any defective Product deemed defective by the Manufacturer, Manufacturer’s liability under any Limited Warranty is discharged, in Manufacturer’s sole discretion and at its expense, by (i) repairing or replacing the defective Product; or (ii) crediting or refunding the price of the defective Product, less any applicable discounts, rebates or credits.

All claims for breach of a Limited Warranty must be received by Manufacturer no later than fifteen (15) calendar days after the expiration of the Warranty Period.

This limited warranty sets forth customer’s sole remedy and manufacturer’s entire liability for any breach of any warranty relating to the products. Except for the express limited warranties described in this limited warranty, neither manufacturer nor any person on manufacturer’s behalf has made or makes any express or implied representation or warranty whatsoever, including any warranties of: (i) merchantability; (ii) fitness for a particular purpose; (iii) title; (iv) non-infringement; or (v) performance of products to standards specific to the country of import, whether arising by law, course of dealing, course of performance, usage of trade or otherwise, all of which are expressly disclaimed.

Operator Assistance Information
If you have questions regarding the use of NeuralGlider, please contact: Customer Service Department at Actuated Medical, Inc. 320 Rolling Ridge Drive, Bellefonte, PA 16823 Phone +1 814-355-0003 ext. 117 / Fax +1 814-355-1532 Monday through Friday 8:00 am – 5:00 pm U.S.A. Eastern Standard Time

NeuralGlider.com

1100794414-001 Pat. actuatedmedical.com/ip

©2022 Actuated Medical, Inc. + 320 Rolling Ridge Drive + Bellefonte, PA 16823 USA

References

• Intellectual Property (legal) - Actuated Medical, Inc.
• NeuralGlider | Neural Implant Inserter
• Support | NeuralGlider
• Support | NeuralGlider
• USB Microscope Drivers and Software – Plugable Technologies
• Screen Recorder Download - Best Screen Recording Software, Bandicam

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