Blackrock Microsystems CerePlex E Series Manual de usuario

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

Revision 4.00 / LB-0545 – CerePlex E IFU – 2020/03

CerePlex E

PN: 7513, 10511 – E96

PN: 8010, 10510 – E128

PN: 10747 – E256

Instructions for Use

Revision 4.00 / LB-0545 – CerePlex E IFU

Table of Contents

What this Manual Covers ...................................................... 4

Intended Use and Indications for Use ................................... 4

Warnings and Cautions ......................................................... 4

Warnings ........................................................................................ 4

Precautions ..................................................................................... 5

Specifications ........................................................................ 6

Hardware ............................................................................... 7

Blackrock CerePlex E Setup ........................................................... 7

Instructions for Assembly ................................................................ 8

Description of Switches on the CerePlex E ..................................... 9

Impedance and Recording selector switch ................................... 9

Frequency Range Selector Wide & Norm ..................................... 9

Reference and Ground Selector ................................................. 10

R1 and R2 Reference selector ................................................... 10

Cleaning & Maintenance Instructions .................................. 10

Sterilization ................................................................................... 10

Cleaning and Maintenance ........................................................... 10

Filament Film Disassembly and Replacement .............................. 11

Disposal ........................................................................................ 12

Magnetic Resonance .......................................................... 12

Troubleshooting .................................................................. 12

Non-Green Indicator Light on CerePlex E ..................................... 12

Poor Signal to Noise Ratio / Noisy Signal ..................................... 13

Non-Green Light on Digital Hub Bank ........................................... 13

Return Merchandise Authorization ...................................... 13

Warranty .............................................................................. 14

Revision 4.00 / LB-0545 – CerePlex E IFU

Support ................................................................................ 14

Complaints .................................................................................... 14

Revision 4.00 / LB-0545 – CerePlex E IFU

What this Manual Covers

The CerePlex E is a Digital Headstage Accessory that provides a compact interface from

a Blackrock Utah Array to the Cerebus or CerePlex Direct data acquisition systems. The

CerePlex E converts analog signals to digital format at the recording site, which can

reduce noise introduced into the signal during transmission to the recording system.

This Instructions for Use will cover important information about the device including

warnings, hardware settings, and maintenance activities.

There are several CerePlex E models that are available in different channel counts.

These are outlined in the table below.

Intended Use and Indications for Use

The CerePlex E is intended to be used with the CerePort Electrode or CerePort

Electrode pedestal connector with third party electrodes.

The CerePlex E supports 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).

Warnings and Cautions

Warnings

 Only connect Cerebus 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 Cerebus System to an outlet controlled by a wall

switch.

 Do not use the CerePlex E 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.

Model Name

CerePlex E96

CerePlex E128

CerePlex E96

CerePlex E128

CerePlex E256

Model Number

7513 8010 10511 10510 10747

Channel Count

96 128 96 128 256

Revision 4.00 / LB-0545 – CerePlex E IFU

 Keep the CerePlex E away from liquids. Contact with water, shower

spray. or wet surfaces can lead to the subject receiving an electrical

shock.

 Connection of external instruments may compromise electrical safety

compliance with IEC 60601-1.

 The CerePlex E 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 CerePlex E is attached to the CerePort Electrode percutaneous

connector, force applied to the CerePlex E will be applied to this

connector. Avoid large impacts to the device when it is attached to the

subject.

 Using the ‘Wide-Band’ filter mode on the device may cause a reduced

signal to noise ratio.

Precautions

 Read this entire manual prior to using the device.

 Do not allow the digital data cable to be pulled and apply force to the

CerePlex E.

 Do not allow any object to impact the CerePlex E while in use.

 Do not drop the CerePlex E when handling.

 Do not use the CerePlex E with damaged data cables or data cables that

are not supplied by Blackrock, doing so may damage the device.

 When replacing the filament film of the device, avoid touching circuit

board components as these can be easily broken and cause damage to

the device.

 Do not attempt to use the CerePlex E with connectors other than the

CerePort pedestal connector.

 Do not plug the digital data cable into devices other than the Digital Hub

and Blackrock approved headstage accessories.

 Avoid spilling fluid onto or into the CerePlex E as doing so may cause

electrical damage to the device and loss of function or electrical shock.

Revision 4.00 / LB-0545 – CerePlex E IFU

Specifications

Model Name

CerePlex E

CerePlex E128

CerePlex

E256

Model Number

7513/10511 8010/10510 10757

Number of Channels

96 128 256

Power

Requirements

0-5 VDC, 150 mA maximum load 0-5 VDC, 300 mA maximum load

Resolution

16-bit, 250 nV per bit

Sampling Frequency

30,000 Samples per Second

Mode of Operation

Continuous

Input Hardware

Filter

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

Imp

edance

Measurement Range

5 kΩ – 1 MΩ

Maximum Input

Range

+/- 8.192 mV with Respect to Reference

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)

Revision 4.00 / LB-0545 – CerePlex E IFU

Hardware

Blackrock CerePlex E Setup

The image below demonstrates how the CerePlex E connects with the Digital

Cerebus System or the CerePlex Direct in a lower channel configuration.

Figure 1 - System Diagram of CerePlex E Connected to the Cerebus System or the CerePlex Direct. The

E256 requires two digital hubs.

Revision 4.00 / LB-0545 – CerePlex E IFU

Instructions for Assembly

The CerePlex E is designed to mate with the CerePort connector attached to

Blackrock Utah Arrays. The CerePlex E is equipped with three guide posts.

These guide posts must be aligned with the three available notches around the

edge of the CerePort connector to facilitate a correct connection between

CerePlex E and the CerePort array. For a detailed procedure on how to connect

the CerePlex E headstage to CerePort connector please refer to the following

instructions:

Connect the CerePlex E to the host device through an HDMI A-D cable. HDMI

Connector A is associated with banks A, B, C, and D of the LGA connector and

HDMI Connector B is associated with banks E, F, G, and H of the LGA

connector. The other end of the HDMI cable should be connected to the Digital

Hub or CerePlex Direct, with cable A occupying a lower slot and cable B

occupying a higher slot.

Power on the connected host device.

The LED on the CerePlex E should light up as blue.

Roughly align the guide pins with the pedestal before attaching to the pedestal.

Figure 3 - Connect CerePlex E to Pedestal

Hold the CerePlex E housing with one hand and gently rotate the wheel

clockwise with another hand.

While screwing down, slightly rotate the housing left or right until you feel the

guide posts slide into the notches.

Figure 2 – Insert HDMI A cable into CerePlex E

Revision 4.00 / LB-0545 – CerePlex E IFU

Once the CerePlex E is aligned with the pedestal, rotate the wheel until the

device is secured to the pedestal.

Figure 4 - Rotate wheel clockwise to connect CerePlex E to Pedestal

The blue LED will turn green when the device is connected correctly.

The instructions above are also detailed in one of the Blackrock training videos

which can be accessed online from the Blackrock Microsystems website under

How-to Videos.

Description of Switches on the CerePlex E

Figure 5 - Available switches on the CerePlex E96, E128, and E256

Impedance and Recording selector switch

When the selector is positioned on “Imp” the CerePlex E enters

impedance measurement mode. This mode enables users to measure

impedance of electrodes via Blackrock’s Central Suite. For information

regarding impedance measurement please refer to the document titled

“LB 0574 Central IFU,” which is available for download from the Blackrock

Microsystems website. To revert the CerePlex E headstage into the

recording mode, simply toggle the switch to “Rec” position (recording).

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

Revision 4.00 / LB-0545 – CerePlex E IFU

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 select between different sources to use as

the input reference. If the switch is toggled to “Gnd” mode, 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 can be selected by

another switch adjacent to reference and ground selector (see below).

R1 and R2 Reference selector

Use this switch to select which of the two available reference wires to use

as the input reference. A switch position to R1 selects reference wire

number 1 as the input reference. The R2 switch selects the reference

wire number 2 as shown in Figure 5. The Ref/Gnd switch must be in Ref

mode for this switch to be effective.

Cleaning & Maintenance Instructions

Sterilization

While not generally required, the device may be sterilized by both Vaporized

Hydrogen Peroxide and Ethylene Oxide Gas. Note that Vaporized Hydrogen

Peroxide may significantly discolor the case of the device. Newer models have a

new case that is immune to this discoloration.

Cleaning and Maintenance

The CerePlex E case may be wiped down with standard sanitizing wipes,

isopropyl alcohol (70%) or ethanol (96%). If necessary, the surfaces and

connection ports may be wiped with enzymatic detergent. Dust and debris on the

exterior connectors/ports may be removed with compressed air.

The collar assembly underneath the CerePlex E should be inspected before each

use and cleaned every time after use. To clean the collar and filament film, follow

the instructions below:

 Visually inspect the connector; remove any particles if present.

 Visually inspect the film. If the film is swollen or degraded, follow the

section titled “Filament Film Replacement” (see below) to replace the film.

 If necessary, clean the connector with a cotton swab and 70% isopropyl

alcohol. Do not let the cleaning solution pool. Allow the solution to dry

before use.

 The connector and the film must also be cleaned after use with a cotton

swab and 70% isopropyl alcohol. Do not allow the solution to pool. Allow

the solution to dry before storage.

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