Revision 1.00 / LB-0996 – NeuroPlex E IFU
© 2021 Blackrock Microsystems, LLC 5
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.
