Blackrock Microsystems NeuroPlex E User manual

Manufacturer
630 Komas Drive | Suite 200
Salt Lake City | UT 84108 | USA
P [phone] | F [phone]
www.blackrockmicro.com
Revision 1.00 / LB-0996 – NeuroPlex E IFU – 2021/06
© 2021 Blackrock Microsystems, LLC
NeuroPlexTM E
PN 10906, 10907, 10908, & 10909
Digital Data Cable: PN 11058 & 11404
Instructions for Use

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Table of Contents
What This Manual Covers ..................................................... 4
Intended Use and Indications for Use ................................... 4
Warnings and Precautions .................................................... 5
Warnings ........................................................................................ 5
Precautions ..................................................................................... 6
Symbols ................................................................................ 7
Specifications ...................................................................... 10
Hardware ............................................................................. 11
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 ................................................. 15
R1 and R2 Reference Selector ................................................... 15
Cleaning, Disinfection, Sterilization, Maintenance, and
Disposal .............................................................................. 16
Sterilization ................................................................................... 16
Cleaning, Disinfection, and Maintenance ...................................... 16
Filament Film Disassembly and Replacement .............................. 17
Disposal ........................................................................................ 18
Magnetic Resonance .......................................................... 18
Troubleshooting .................................................................. 19
Non-Green Indicator Light on NeuroPlex E ................................... 19
Poor Signal to Noise Ratio / Noisy Signal ..................................... 19

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Non-Green Light on Digital Hub Bank ........................................... 19
Return Merchandise Authorization ...................................... 20
Warranty .............................................................................. 21
Support ................................................................................ 21
Complaints .................................................................................... 21

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What This Manual Covers
Blackrock Microsystems’ NeuroPlexTM E provides a compact interface from a
NeuroPortTM Electrode to Blackrock’s NeuroPort Bio-Potential Signal Processing
Systems for up to 128 channels on the E128 or 96 channels on the E96. The NeuroPlex
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.
This manual covers the intended use, warnings, precautions, technical specifications,
pinout, cleaning, disinfection, sterilization, and maintenance instructions, and warranty of
the NeuroPlex E digital headstage manufactured by Blackrock Microsystems.
Intended Use and Indications for Use
The NeuroPlex E supports recording, processing, and display of biopotential signals
from user-supplied electrodes. Biopotential signals include, but are not limited to:
Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG),
electrocardiography (ECG), electrooculography (EOG), and Evoked Potential (EP).

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Warnings and Precautions
The NeuroPlex E, as part of the NeuroPort BioPotential Signal Processing System, has
the following warnings and precautions:
Warnings
 Only connect NeuroPort System components to properly tested,
grounded and dedicated AC outlets to reduce the risk of electrical shock.
Do not use an adapter for ungrounded wall outlets.
 Do not connect the NeuroPort System to an outlet controlled by a wall
switch.
 Do not use the NeuroPort System in the presence of flammable
anesthetic agents.
 Avoid strong static discharges from sources like televisions or computer
monitors because it can damage the electrical parts of the system.
 Keep the NeuroPort System away from liquids. Contact with water,
shower spray, or wet surfaces can lead to the patient receiving an
electrical shock.
 Connection of external instruments may compromise electrical safety
compliance with IEC 60601-1.
 The Digital Data Cable is long and may snag on equipment in the room.
Secure equipment in place and avoid placing in walkways or other traffic
areas.
 The NeuroPlex E is attached to the NeuroPort Electrode percutaneous
connector, force applied to the NeuroPlex E will be applied to this
connector. 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.
 Only sterile NeuroPlex Es and Digital Data Cables should be used in the
intraoperative environment. Non-sterile NeuroPlex Es and Digital Data
Cables should only be used in the postoperative environment.
 Do not allow the Digital Data Cable to be pulled in such a way that it can
apply force to the NeuroPlex E.
 Avoid spilling fluid onto or into the NeuroPlex E as doing so may cause
electrical damage to the device and loss of function or electrical shock.

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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. Doing so
may damage the device.
 When replacing the filament film of the device, avoid touching circuit
board components as electrostatic discharge can cause damage to the
device.
 When replacing the filament film, do not overtighten the screws.
Overtightening the screws may cause poor connection between the
device and the pedestal.
 Do not attempt to use the NeuroPlex E with connectors other than the
NeuroPort pedestal connector.
 Do not plug the Digital Data Cable into devices other than the Digital Hub
and Blackrock Microsystems approved headstage accessories.
 Avoid overtightening the NeuroPlex E when attaching to the NeuroPort
Electrode. Device damage may result.
 Using the ‘Wide-Band’ filter mode on the device may cause a reduced
signal to noise ratio.
 Swollen or degraded filament film may result in loss of signals.
 Do not immerse devices in liquid.
 Do not use a washing machine or an automated washing process (such
as an automated washer/disinfector). Doing so may damage the devices.
 Do not allow contaminated devices to dry. All subsequent cleaning and
steps are facilitated by not allowing blood, body fluids, bone and tissue
debris, saline, or disinfectants to dry on used devices.

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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 Symbol Title Meaning
5.1.1 Manufacturer Indicates the medical device
manufacturer.
5.1.4 Use-by Date Indicates the date after which the
medical device is not to be used.
5.1.5 Batch Code Indicates the manufacturer’s batch
code so that the batch or lot can be
identified.
5.1.6 Catalog
Number
Indicates the manufacturer’s catalog
number so that the device may be
identified. For Blackrock Microsystems
it is called the Part Number (PN).
5.1.7 Serial Number Indicates the manufacturer’s serial
number so that a specific medical
device can be identified.
5.2.3
Sterilized Using
Ethylene Oxide
Indicates that the device has been
sterilized using ethylene oxide.
5.2.6 Do Not
Resterilize
Indicates a medical device that is not
to be resterilized.

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ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels,
Labeling, and Information to Be Supplied
Reference Symbol Title Meaning
5.2.7 Non-Sterile To indicate that the device that is
normally provided sterile in the same
or similar packaging has not been
sterilized.
5.2.8 Do Not Use if
Package is
Damaged
Indicates that a medical device should
not be used if the package has been
damaged or opened.
5.4.2 Do Not Reuse Indicates a medical device that is
intended for one use, or for use on a
single patient during a single
procedure.
5.4.3
Consult
Instructions for
Use
Indicates the need for the user to
consult the instructions for use, which
you are currently reading.
5.4.4 Caution Indicates the need for the user to
consult the instructions for use for
important cautionary information such
as warning and precautions that
cannot, for a variety of reasons, be
presented on the medical device itself.

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IEC 60601-1, Edition 3.1 Medical Electrical Equipment – Part 1: General Requirements for
Basic Safety and Essential Performance
Reference Symbol Title Meaning
ISO 7010-
M002
Follow
Instructions for
Use
Indicates the need for the user to
consult the instructions for use for
important cautionary information such
as warning and precautions that
cannot, for a variety of reasons, be
presented on the medical device itself.
IEC 60417:2002 DB Graphical Symbols for Use on Equipment
Reference Symbol Title Meaning
5333
Type BF
Applied Part
To identify a type BF applied part
complying with IEC 60601-1.
5334 Electrostatic
Sensitive
Devices
To indicate packages containing
electrostatic sensitive devices, or to
identify a device or a connector that
has not been tested for immunity to
electrostatic discharge.
21 CFR 801. 109 (b) (1), 81 FR 38911 2016-09-13, U.S.A. FDA Guidance: Alternative to
Certain Prescription Device Labeling Requirements 2000-01-21
Symbol Title Meaning
Prescription
Only
Caution: Federal (U.S.A.) law restricts
this device to sale by or on the order
of a physician.

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Specifications
Model Name
Blackrock NeuroPlex
E128 Non-Sterile
Blackrock NeuroPlex
E128 Sterile
Blackrock NeuroPlex
E96 Non-Sterile
Blackrock NeuroPlex
E96 Sterile
Model Number
10906 10907 10908 10909
Sterility Non-Sterile
Ethylene Oxide
Sterilized
Non-Sterile Ethylene Oxide
Sterilized
Number of Channels
128 128 96 96
Power Requirements
0 to 5 VDC, 150 mA maximum load
Resolution
16-bit, at 250 nV per bit resolution
Sampling Frequency
30 ksps
Mode of Operation
Continuous
Input Hardware Filter
(User selectable)
Normal mode:
0.3 Hz (1st order) – 7.5 kHz (3rd order)
Wide-band mode:
0.02 Hz (1st order) – 10 kHz (3rd order)
Input Filter Type
Butterworth
Input Impedance
1300 MΩ @ 10 Hz, 13 MΩ @ 1 kHz
Auto
Impedance
Measurement Range
5 kΩ – 1 MΩ
Maximum Input
Range
± 8.192 mV with respect to reference
Ingress Protection
Ordinary Equipment, not fluid resistant, IP20
Dimensions
L 24.9 mm x W 17.7 mm x H 17.9 mm
Operating
Environment
10˚ C to 40˚ C, 5 to 95% R.H. (non-condensing)
Storage Environment
-20˚ C to 50˚ C, 5 to 100% R.H. (non-condensing)

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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

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Blackrock Microsystems NeuroPlex E Pin-
out
Figure 4–Bottom view of NeuroPlex E (128 & 96).
Red box indicates one of three guide posts
Figure 2–Pinout of NeuroPlex E128 (PN 10906, PN 10907)
Figure 3–Pinout of NeuroPlex E96 (PN 10908, PN 10909)

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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. Peel open the sterile pouch only when ready for use. Note
that the NeuroPlex E has double pouch layers to facilitate sterile transfer.
The NeuroPlex E is designed to mate with the pedestal connector of the
NeuroPort Electrode (PN 6248, 6249, 4383, and 4382) or other electrodes that
use the same connector. The NeuroPlex E is equipped with three guide posts
that are visible in center pane of Figure 4. These guide posts must be aligned
with the three available notches around the edge of the NeuroPort connector to
facilitate a correct connection between NeuroPlex E and the NeuroPort
Electrode. For a detailed procedure on how to connect the NeuroPlex E
headstage to NeuroPort Electrode please refer to the following instructions:
1. Connect the NeuroPlex E to the Digital Hub (PN 10480) and Digital Data
Cable (PN 11058 and 11404). See below Figure 5. Only one NeuroPlex
E should be plugged into each Digital Hub of the Digital NeuroPort
System.
2. Power on the Digital Hub.
 The LED on the NeuroPlex E should light up as blue.
 The LED on the Digital Hub corresponding to the Digital Data bank
connected to the NeuroPlex E should light up green.
3. Roughly align the guide pins with the pedestal before attaching to the
pedestal. See Figure 6 below.
Figure 5–NeuroPlex E and cable
Figure 6–NeuroPlex E and pedestal alignment

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4. Hold the NeuroPlex E housing with one hand and gently rotate the wheel
clockwise with another hand. See below Figure 7.
5. While screwing down, slightly rotate the housing left or right until you feel
the guide posts slide into the notches.
6. Once the NeuroPlex E is aligned with the pedestal, rotate the wheel until
two fingers are no longer able to move the wheel any further.
Precaution: Avoid overtightening the NeuroPlex E when attaching to the
NeuroPort Electrode. Device damage may result.
7. 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.
Figure 7–Instructions on connecting the NeuroPlex E to the NeuroPort Electrode

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Description of 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.
To revert the NeuroPlex E headstage into the recording mode, simply
toggle the switch to “Rec” position.
Frequency Range Selector: Wide & Norm
This switch toggles between two different hardware-based filter input
settings. The “Wide” filter setting corresponds to an input frequency range
from 0.02 Hz to 10 kHz. “Norm” (Normal) filter setting is between 0.3 Hz
to 7.5 kHz.
Reference and Ground Selector
This switch allows the user to toggle the reference used in the monopolar
recordings. If the switch is toggled to “Gnd”, subject ground will be used
as the input reference to the amplifier. Setting the switch position on “Ref”
(Reference) will use one of the implanted reference wires (R1 or R2) as
input reference.
R1 and R2 Reference Selector
Use this switch to select which of the two available reference wires to use
as the input reference when the Reference and Ground switch is set to
“Ref”. A switch position set to R1 selects reference wire number 1 as the
input reference. The R2 position selects the reference wire number 2.
Figure 8–Available switches on the NeuroPlex E

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Cleaning, Disinfection, Sterilization,
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 10-6
when sterilized with Ethylene Oxide by Blackrock Microsystems.
When the NeuroPlex E (PN 10906 and 10908) and Digital Data Cable (PN
11404) are provided non-sterile, the device should be cleaned and disinfected
according to the below Cleaning, Disinfection, and Maintenance section.
Warning: Only sterile NeuroPlex Es and Digital Data Cables should be used in
the intraoperative environment. Non-sterile NeuroPlex Es and Digital Data
Cables should only be used in the postoperative environment.
Cleaning, Disinfection, and Maintenance
The NeuroPlex E and Digital Data Cable should be disinfected and cleaned with
CaviWipes and CaviCide. Dust and debris on the exterior connectors/ports may
be removed with compressed air. Cleaning and disinfection should be done as
soon as possible after the device use to help facilitate ease of soil removal and
prevent continued microbial growth.
The collar assembly underneath the NeuroPlex E should be inspected before
each use and cleaned every time after use. To clean and disinfect the collar and
filament film, follow the instructions below. To clean and disinfect the Digital Data
Cable, follow steps 1 through 3 below.
1. Using CaviWipes and CaviCide, wipe and spray the articles to remove
visible soil for a minimum of 10 minutes.
2. Use additional CaviWipes and CaviCide spray as necessary to ensure
visible soil is removed.
3. Pay special attention to crevices, mated surfaces, connectors, and hard-
to-reach places. Use a soft-bristled brush to aid in the removal of soil from
these locations for a minimum of 2 minutes.
4. Visually inspect the connector. Remove any particles if present.
5. Visually inspect the film. If the film is swollen or degraded, follow the
section titled “Filament Film Disassembly and Replacement” (see below)
to replace the film.
6. Clean the connector. Do not let the cleaning solution pool. Allow the
solution to dry before use.
7. The connector and the film must also be cleaned after use. Do not allow
the solution to pool. Allow the solution to dry before storage.

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Filament Film Disassembly and
Replacement
The filament film which is visible from under the NeuroPlex E, provides a
conductive and uniform medium in between the input pins of the NeuroPlex E
and the connectors on top of the 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.
After repeated usage, dust or biological matter can accumulate on the filament
film which can affect the signal quality on the NeuroPlex E.
It is recommended to regularly check the condition of the filament film before use
and replace it at least once a year or whenever there is a degradation in signal
quality. Follow the procedures below to replace the filament film.
1. Loosen the four screws on the NeuroPlex E by turning them
counterclockwise with a flathead screwdriver.
2. Hold the bottom three plates together and lift them away from the cover.
3. Remove the old filament film and clean the nearby area on the plate and
the PCB.
4. Place a new filament film onto the plate. Make sure the holes on the film
are aligned with the pins on the plate. You may use a pair of flat-mating or
rubber-tipped tweezers to manipulate the film.
5. Replace the assembly.
6. Hold the three plates together as you lower them onto the NeuroPlex E
body.
7. Fasten the four corner screws clockwise.
8. Visually inspect the film placement and cleanliness. Confirm that the four
corner screws are fastened securely.

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Disposal
The NeuroPlex E may have incidental contact with bodily fluids. Follow
institutional procedures for disposing potentially infectious or biohazardous
devices when disposing of the 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.
Figure 9–Replacing the Filament Film

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Troubleshooting
Non-Green Indicator Light on NeuroPlex E
The indicator light on the NeuroPlex E should be illuminated green if the
headstage is receiving power and connected to a NeuroPort Electrode.
 If the light is not illuminated: check that the Digital Hub is powered on and
that the digital data cable is firmly connected to the Hub and NeuroPlex E.
 If the light is illumined blue, the headstage is receiving power, but is not
connected to the NeuroPort Electrode: Verify that the guide pins of the
NeuroPlex E are aligned with the guide holes of the NeuroPort Electrode,
that the wheel is tightened firmly with two fingers, and that the filament
film and pedestal LGA surface are both clean and free of debris.
Poor Signal to Noise Ratio / Noisy Signal
A typical high-passed noise band is less than +/- 30 microvolts or approximately
60 microvolts peak to peak (roughly 10 root mean squared). If the signal that you
are receiving is noisier than this, it could be due to a number of factors:
 Poor reference configuration: Try changing the reference setting of the
device.
 Poor contact between device and pedestal connector: Try the
troubleshooting steps above for ‘Non-Green Indicator Light on NeuroPlex
E’.
 Wideband configuration: Try changing the filter range to standard instead
of wideband.
 Electrode connections: Ensure the electrode has good ground contact
with the patient. 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.
 If it is not green, it could mean that your NeuroPlex E device is damaged
or malfunctioning or it could mean that you are using an unapproved or
damaged Digital Data Cable between the Digital Hub and the NeuroPlex
E. Try changing the Digital Data Cable to a Blackrock Microsystems’
Digital Data Cable. Finally, it could mean that the Digital Hub is
malfunctioning. Try changing which bank that the NeuroPlex E is
connected to. If the problem persists, contact Blackrock Microsystems
Support for assistance.

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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. If you need to obtain an RMA number, you may contact a product
support representative at [phone] or by emailing
[e-mail].
Once an RMA number has been issued, it is important to safely pack the returned item
for shipping back to Blackrock. It is preferred that you save the original boxes and
packing materials that your system arrived in for return shipment. Please address the
package as follows:
Blackrock Microsystems, LLC
ATTN: RMA#
630 S. Komas Dr., Suite 200
Salt Lake City, UT 84108 USA
Tel: [phone]