Specifications

Blackrock CerePlex M - Instruction for Use
Page 3 of 8
LB-0398 1.00
1 Symbols of Contraindications, Warnings, Cautions, and Specifications
IEC60101-0102
Danger of Electrostatic Discharge (ESD)
EN-980
Caution
IEC60417-5036
Dangerous voltage
IEC60417-5019
Protective earth (ground)
IEC60417-5021
Equipotentiality Connector
IEC606417-5335
Type of CF Applied Part
1.1 Contraindications
• The CerePlex M is part of a recording system and should not be used in applications involving
stimulation.
• Do not plug in devices to the CerePlex M that are not approved by Blackrock Microsystems.
1.2 Warnings
• Do not touch any exposed electrical conductors when the CerePlex M connector is attached to
devices on subject’s head as this may result in inducing electric charge to the neural tissue.
Irreversible damage may occur.
• The CerePlex M is NOT to be used for stimulation.
• The patient/subject should not attempt to remove the connections themselves.
• Use caution when connecting and disconnecting the Cable to the CerePlex M to minimize the
risk of the cable being accidently pulled or tugged.
• Do not use the CerePlex M in the presence of flammable anesthetic agents or any other
reagents.
• Avoid strong static discharges from sources like television or computer monitors because it can
damage the electrical components of the system.
• Keep the CerePlex M away from liquids. Contact with water, shower spray, or wet surfaces can
lead to the patient receiving an electrical shock.
• Connection of external instruments to the CerePlex M may compromise electrical safety.
• Always use antistatic or electrostatic discharge (ESD) safe gloves when connecting the
CerePlex M.
• Use only the supplied Blackrock Microsystems components (Cerebus™ system, Digital Hub128,
CerePlex M Cable). Substitution of components not supplied by Blackrock Microsystems may
affect system performance and patient/ subject safety.
• Do not leave the patient/subject connected to the CerePlex M when the NeuroPort™ System is
not in use.
• Use caution when placing cables and other connectors to minimize the likelihood of tripping or
accidentally pulling on cables. Pulled cables may cause damage to the CerePlex M or any other
connected devices.
1.3 Cautions
• Read this entire manual prior to using the device.