Revision 2.00 / LB-0889
– CerePlex Exilis: Instructions for Use
© 2019 Blackrock Microsystems, LLC
4
Warnings and Precautions
•
Do not touch any exposed metal plates or input contacts of the 36-pin Omnetics
connectors at the bottom of the CerePlex Exilis when in use. This may result in inducing
electric charge to the neural tissue. Irreversible damage may occur.
•
Note that this product contains an internal battery. Please refer to the Cleaning,
Maintenance, and Disposal section for disposal instructions.
•
Do not recharge the device with an uncertified charger, short circuit, crush, disassemble,
or heat above 100°C (212°F).
•
When plugging in the CerePlex Exilis device to its mating connector, please ensure the
orientations of the connectors are matched, then carefully align the pins, and plugin
gently. Excessive force during connection and disconnection can damage the
connectors and cause harm to the subject.
•
Use antistatic or ESD safe gloves when using the CerePlex Exilis or the wireless
receiver.
•
The CerePlex Exilis device and its receiver system are only approved for use with
Blackrock Microsystems data acquisition systems.
•
Do not use the CerePlex Exilis device with non-approved electrodes.
•
The CerePlex Exilis must be used with a Blackrock Omnetics array, or a Blackrock
adaptor approved for use with alternative arrays.
•
Use the CerePlex Exilis device in a clean and dry environment, do not use the CerePlex
Exilis device near liquids.
•
Do not drop or put excessive force on the CerePlex Exilis device. High mechanic force
can damage the device permanently.
•
Do not use the CerePlex Exilis with other RF radiator in the 3-4GHz frequency range,
which will cause interference to and from the CerePlex Exilis device.
•
For cleaning the device, please use water and gauze to gently wipe the surface, do not
use isopropanol (IPA) for cleaning, since it will dissolve the acrylic clear surface coating
on the case.
Symbols
BS EN 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.
5.1.3
Date of Manufacture
Indicates date of manufacture and
is accompanied by a date.
5.1.5
Batch Number
Indicates the manufacturer's batch
or lot code, for example on a
medical device or the
corresponding packaging. The
