Blackrock Microsystems NeuroPlex E Bedienungsanleitung

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 1.00 / LB-0996 – NeuroPlex E IFU – 2021/06

NeuroPlexTM E

PN 10906, 10907, 10908, & 10909

Digital Data Cable: PN 11058 & 11404

Instructions for Use

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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

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).

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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.

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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.

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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.

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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.

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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

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.

Revision 1.00 / LB-0996 – NeuroPlex E IFU

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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