L011-68
Rev.
E0
2018-07-18
Page
4
of
11
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.
The date after which the medical
device is not to be used.
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.
medical device that should not be used if
the package has been damaged or opened.
Do not re-use; intended for one use on a
single patient, during a single procedure.
Medical device that is not to be resterilized.
Medical device that has been sterilized using
ethylene oxide.
Indications for use:
The WayPoint™ Implant and Surgical Kits are intended for use in neurosurgical procedures which require the accurate positioning of
microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
Intended use:
The WayPoint™ Implant Kit is intended for use by medical personnel under the direction of a neurosurgeon in a clinical or operating
room, to place WayPoint™ fiducial anchors used to build a microTargeting™ stereotactic platform for one or more trajectories of a
neurosurgical procedure.
The WayPoint™ Surgical Kits are intended for use by a neurosurgeon in an operating room to attach a microTargeting™ stereotactic
platform to previously implanted fiducial anchors, and provide fixtures to position a microTargeting™ drive or other stereotactic de-
vice along the planned trajectory or at fixed offsets.
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
Storage:
Store the WayPoint™ Implant and Surgical Kits at normal room temperatures between 0°C (32°F) and 40°C (104°F). Do not exceed
104°F for long-term storage. Relative humidity should not exceed 95%.
MR Unsafe- an item that is known to
pose hazards in all MRI enviroments.
MR Safe- the item poses NO known
hazards in all MR environments
MR Conditional-an item that has been
demonstrated to pose no known
hazard in specicied MRI enviroments
with specified conditions of use.
Medical device manufacturer, as
defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
Telephone number
MR
Содержание WayPoint 66-WP-BKS
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