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Blackrock Microsystems NeuroPlex E Instructions For Use Manual

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Manufacturer
630 Komas Drive | Suite 200
Salt Lake City | UT 84108 | USA
P +1 (801) 582-5533 | F +1 (801) 582-1509
www.blackrockmicro.com
NeuroPlex
PN 10906, 10907, 10908, & 10909
Digital Data Cable: PN 11058 & 11404
Instructions for Use
Revision 1.00 / LB-0996 – NeuroPlex E IFU – 2021/06
© 2021 Blackrock Microsystems, LLC
E
TM

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Summary of Contents for Blackrock Microsystems NeuroPlex E

  • Page 1 P +1 (801) 582-5533 | F +1 (801) 582-1509 www.blackrockmicro.com NeuroPlex PN 10906, 10907, 10908, & 10909 Digital Data Cable: PN 11058 & 11404 Instructions for Use Revision 1.00 / LB-0996 – NeuroPlex E IFU – 2021/06 © 2021 Blackrock Microsystems, LLC...

  • Page 2: Table Of Contents

    Blackrock Microsystems NeuroPlex E Setup ........ 11 Blackrock Microsystems NeuroPlex E Pin-out ......12 Instructions for Assembly .............. 13 Description of Switches on the NeuroPlex E ......... 15 Impedance and Recording Selector Switch ........ 15 Frequency Range Selector: Wide & Norm ........15 Reference and Ground Selector ..........
  • Page 3 Non-Green Light on Digital Hub Bank ........... 19 Return Merchandise Authorization ........20 Warranty ................21 Support ................21 Complaints ..................21 Revision 1.00 / LB-0996 – NeuroPlex E IFU © 2021 Blackrock Microsystems, LLC...

  • Page 4: What This Manual Covers

    E is designed for high fidelity transmission and recording of extracellular spikes and local field potentials from the brain. Blackrock Microsystems’ NeuroPlex E converts analog signals to digital format at the recording site which can reduce noise introduced to the signal during transmission.

  • Page 5: Warnings And Precautions

    Avoid large impacts to the device when it is attached to the patient. Consequences can include tearing of bone screws from skull.  Do not use the NeuroPlex E (PN 10907, 10909) or Digital Data Cable (PN 11058) if the sterile barrier packaging is damaged. ...

  • Page 6: Precautions

    Precautions  Read this entire manual prior to using the device.  Do not allow any object to impact the NeuroPlex E while in use.  Do not drop the NeuroPlex E when handling.  Do not use the NeuroPlex E with damaged Digital Data Cables or Digital Data Cables that are not supplied by Blackrock Microsystems.

  • Page 7: Symbols

    Symbols The following symbols may apply to the NeuroPlex E even if they do not appear on the physical product. ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to Be Supplied Reference...
  • Page 8 Revision 1.00 / LB-0996 – NeuroPlex E IFU © 2021 Blackrock Microsystems, LLC...
  • Page 9 Certain Prescription Device Labeling Requirements 2000-01-21 Symbol Title Meaning Prescription Caution: Federal (U.S.A.) law restricts Only this device to sale by or on the order of a physician. Revision 1.00 / LB-0996 – NeuroPlex E IFU © 2021 Blackrock Microsystems, LLC...

  • Page 10: Specifications

    L 24.9 mm x W 17.7 mm x H 17.9 mm Operating 10˚ C to 40˚ C, 5 to 95% R.H. (non-condensing) Environment Storage Environment -20˚ C to 50˚ C, 5 to 100% R.H. (non-condensing) Revision 1.00 / LB-0996 – NeuroPlex E IFU © 2021 Blackrock Microsystems, LLC...

  • Page 11: Hardware

    Hardware Blackrock Microsystems NeuroPlex E Setup The image below demonstrates how the NeuroPlex E connects with the Digital NeuroPort Biopotential Signal Processing System. Figure 1–NeuroPlex E as part of the Digital NeuroPort Biopotential Signal Processing System Revision 1.00 / LB-0996 – NeuroPlex E IFU...

  • Page 12: Blackrock Microsystems Neuroplex E Pin-Out

    Figure 2–Pinout of NeuroPlex E128 (PN 10906, PN 10907) Figure 3–Pinout of NeuroPlex E96 (PN 10908, PN 10909) Figure 4–Bottom view of NeuroPlex E (128 & 96). Red box indicates one of three guide posts Revision 1.00 / LB-0996 – NeuroPlex E IFU...

  • Page 13: Instructions For Assembly

    Instructions for Assembly The NeuroPlex E is available in two configurations: either as a non-sterile device that may be reprocessed or an ethylene oxide sterilized, single-use device. If the device is delivered sterile, inspect the packaging for any punctures, damage, or defect prior to use.
  • Page 14 Precaution: Avoid overtightening the NeuroPlex E when attaching to the NeuroPort Electrode. Device damage may result. The blue LED will turn green when the NeuroPlex E is firmly mated with the NeuroPort Electrode and data should be visible in the Central software.

  • Page 15: Description Of Switches On The Neuroplex E

    Figure 8–Available switches on the NeuroPlex E Impedance and Recording Selector Switch When the selector is positioned on “Imp” the NeuroPlex E enters impedance measurement mode. The impedance of each recording channel is measured with a 1 kHz, 10 nA sine wave. Impedance values are displayed in the Impedance Tester application of the Central Suite.

  • Page 16: Cleaning, Disinfection, Sterilization, Maintenance, And Disposal

    Maintenance, and Disposal Sterilization The NeuroPlex E (PN 10907 and 10909) and Digital Data Cable (PN 11058) are delivered in sealed, labeled, sterile barrier packaging. The NeuroPlex E and Digital Data Cable are validated to achieve a sterility assurance level of 10 when sterilized with Ethylene Oxide by Blackrock Microsystems.

  • Page 17: Filament Film Disassembly And Replacement

    NeuroPort Electrode pedestal. The filament film is conductive in the vertical direction with respect to the film surface, connecting the contacts on the NeuroPlex E input and the pins on the NeuroPort Electrode pedestal connector, while being insulative horizontally, eliminating cross talk.

  • Page 18: Disposal

    NeuroPlex E. Magnetic Resonance The NeuroPlex E has not been evaluated for safety and compatibility in the MR environment. The NeuroPlex E has not been tested for heating, migration, or image artifact in the MR environment.

  • Page 19: Troubleshooting

    The pedestal is the ground contact for the NeuroPlex E. Check that the reference wires are exposed to tissue. Non-Green Light on Digital Hub Bank The indicator light on the Digital Hub for the bank that the NeuroPlex E is attached to should be green. ...

  • Page 20: Return Merchandise Authorization

    Return Merchandise Authorization In the unlikely event that your device needs to be returned to Blackrock Microsystems for repair or maintenance, do not send any equipment back without a Return Merchandise Authorization Number (RMA). An RMA number will be issued to you by a Blackrock representative.

  • Page 21: Warranty

    Warranty Blackrock Microsystems (“Blackrock”) warrants its products are free from defects in materials and manufacturing for a period of one-year from the date of shipment. At its option, Blackrock will repair or replace any product that does not comply with this warranty.

This manual is also suitable for:

10906109071090810909

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