L011-61
Page 4 of 25
2019-08-08
Rev. F0
Indications for use
The WayPoint™ Inserter System is intended to be used with commercially available stereotactic systems for neurosurgical
procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the
brain or nervous system.
Intended use
The WayPoint™ Inserter System is intended for use with the microTargeting™ Platform by a neurosurgeon in a standard
operating room environment or a MRI suite.
Symbol Key
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 catalogue 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.
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.
Indicates the temperature limits to
which the medical device can be safely
exposed.
Indicates the range of humidity to
which the medical device can be safely
exposed.
MR Safe- the item poses NO known
hazards in all MR environments
Medical device manufacturer, as
defined in EU directives 90/385/
EEC, 93/42/EEC and 98/79/EC.
Telephone number
Do not re-use; intended for one
use on a single patient, during a
single procedure.
Indicates a medical device that is
not to be resterilized.
Indicates a medical device that
has not been subjected to a
sterilization process.
For use with microTargeting™
Platform
-34°C
-29°F
+57°C
+135°F
0%
95%
Warnings and Cautions
WARNING: Handle all components with extreme care. They may be damaged if excessive force or incorrect handling
occurs.
WARNING: User must examine unit prior to use to ensure it has no shipping damage.
CAUTION: SLS components are for single patient use only. Do not reuse any single use components.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Specifications
Array spacing: 2.00 mm from center
Array guide hole diameter: 1.88mm
Bushing configuration: center hole on stereotactic axis with 4 holes offset by 2.00 mm on center and orthogonal to the center
hole.
STar™ SteriSuite:
Material: Electropolished Stainless Steel
Insert: Nylabond coated Stainless Steel
