L011-44
Page 4 of 9
2019-05-13
Rev. E1
WARNING / Caution, consult instructions
for important cautionary information.
Consult the instructions for use.
In reference to “Rx only” symbol; this
applies to USA audiences only
Caution
- Federal law (USA) restricts this
device to sale by or on the order of a
physician.
Indicates the catalog number so that
the medical device can be identified.
Indicates the manufacturer’s batch
code so that the batch or lot can be
identified.
Indicates the serial number so that
a specific medical device can be
identified.
Indicates the use of Radio-Frequency
Identification (RFID).
Indications for use
STar™ Drive Platform Adapter Kit is intended to be used with commercially available stereotactic
systems for neurosurgical procedures which require the accurate positioning of micrelectrodes,
stimulation electrodes, or other instruments in the brain or nervous system.
Intended use
STar™ Drive Platform Adapter Kit is intended for use by a neurosurgeon in an operating room
environment to position and move devices relative to a planned stereotactic system trajectory and
target.
Other devices required:
• Compatible navigation software, such as WayPoint™ Navigator
• Patient specific microTargeting™ Platform built using fiducial anchor locations and desired
trajectory
• Stereotactic device compatible with surgical kit positioners, such as microTargeting™ STar™
Drive
Symbol Key
Medical device manufacturer, as
defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
Telephone number
Date when the medical device was
manufactured
Authorized Representative in the
European Community
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.
An item that is known to pose hazards
in all MRI environments.
Summary of Contents for STar 66-IT-VP-01
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