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L011-85-05
Rev B0
2019-06-26
Indications for use
The microTargeting™ Guideline 4000™ 5.0 is intended to record and stimulate electrophysiological
activity, as well as aid in the accurate placement of electrodes and other instruments.
Intended use
The Guideline 5 System is intended to be used by a neurosurgeon, neurologist or clinical
neurophysiologist to accurately position depth electrodes during functional neurosurgical
procedures.
WARNING/Caution, Consult instructions for
important cautionary information
Consult 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 order of a physician
Indicates catalog number
Indicates the batch code
Indicates the date after which the medical device is
not to be used
Medical device that should not be used if the
package has been damaged or opened
Indicates a medical device that is not to be
resterilized
Do not re-use; intended for one use on a single
patient, during a single procedure
Medical device manufacturer, as defined in EU
Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Telephone number
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 a medical device that has been sterilized
using ethylene oxide.
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
Symbol Key
Warnings and Cautions
Rx only CAUTION:
Federal law (USA) restricts this device to sale by or on the order of a
physician.
WARNING:
Sterile Medical Device – Do NOT resterilize.
WARNING:
Do not reuse; reusing single-use medical devices could lead to serious patient
injury.
WARNING:
Do not use the contents if there is any evidence of damage to the package or
package seal that could compromise sterility.
WARNING:
Remove patient leads if engaging defibrillation
WARNING:
Disconnect all patient connections when performing system self-test
WARNING:
Do not connect the electrode cables to earth.
WARNING:
Electrodes and electrode cables should be connected one at a time. Be careful to
assign electrode tracks and electrode contacts correctly. See L011-85-01 for more information
regarding track assignments.
WARNING:
Route electrode lead cables carefully to avoid a tripping hazard or possible
contamination of the sterile field.
0
°
C
(32
°
F)
40
°
C
(104
°
F)
0%
95%
