L011-51-02 (Rev. B0, 2020-07-28)
4
microTargeting™ Electrodes Directions For Use
Indications for use
The FHC, Inc. microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal
activity or intra-operative stimulation of neural elements in the brain.
Intended use
The FHC microTargeting™ Electrodes are intended to be used by a neurosurgeon for intra-operative recording
of single unit neuronal activity or intra-operative stimulation of neural elements in the brain during stereotactic
functional neurosurgical procedures.
Symbol Key
WARNING:
• DO NOT attempt to sterilize the electrodes using this package. Remove microTargeting™ Electrodes from
the package prior to sterilization. FHC recommends use of the FHC sterilization tray.
• While transferring microTargeting™ Electrodes for sterilization, please maintain a record of the lot number.
• FHC has validated and recommends the following steam sterilization parameters:
Prevacuum wrapped
(in 2 layers of 1-ply polypropylene wrap
[1]
)
Preconditioning pulses: 3
Exposure time: 4 minutes at 132°C (270°F)
Minimum dry time: 30 minutes
[1]
Cycle was validated using Halyard Health H600 wrap
Safety Information
• For single patient use only
• Do not reuse; reusing single-use medical devices could lead to serious patient injury
• Not intended for implantation
• microTargeting™ Electrodes must only be used with a medically approved stereotactic system aligned
with a planned trajectory.
• microTargeting™ Electrodes must be used with a medically approved drive system capable of precise
depth control.
• microTargeting™ Electrodes must only be inserted through a rigid insertion tube having a
maximum inside diameter no more than 100 microns (0.004”) larger than the diameter of
the electrode.
• microTargeting™ Electrodes must only be used with medically approved (IEC60601 compliant)
recording/stimulating devices and patient leads that have been designed for use with high impedance
microelectrodes. This equipment must be capable of verifying electrode impedance and controlling the
amplitude of stimulation currents delivered through the electrode.
Non Sterile Electrodes
WARNING /Caution, consult instructions
for important cautionary information.
Medical device manufacturer, as defined
in EU Directives 90/385/EEC, 93/42/EEC,
and 98/79/EC.
Consult instructions for use.
Telephone number
Do not re-use; intended for one use
on a single patient, during a single
procedure.
Authorized Representative in the European
Community.
Medical device that is not to be
resterilized.
European Conformity. This device fully
complies with MDD Directive 93/42/EEC
and legal responsibilities as a manufacturer
are with FHC, Inc., 1201 Main Street,
Bowdoin, ME 04287 USA.
Fragile item, can be damaged if not
handled carefully.
Indicates the catalog number so that
the medical device can be identified.
Array configuration
Indicates the batch code so that the
batch or lot can be identified.
Single configuration
In reference to “Rx only” symbol; this
applies to USA audiences only.
0°C
+32°F
+40°C
+10 4°F
Indicates the temperature limits to which
the medical device can be safely exposed.
Caution- Federal law (USA) restricts
this device to sale by or on the order of
a physician.
95%
0%
Indicates the range of humidity to which
the medical device can be safely exposed.
Date after which the medical device is
not to be used.
Medical device that has not been
subjected to sterilization process.
To Next Page
Loading...