Intended Use; Safety Information - FHC microTargeting 66-PT Series Directions For Use Manual

microTargeting™ Insertion Tubes Directions For Use
Indications for use:
Insertion Tubes are components of the microTargeting™ Drive and STar™ Drive Systems. The Drive Systems
are intended to be used with commercially available stereotactic positioning 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 FHC microTargeting™ insertion tubes are intended to accurately guide a microelectrode or instrument
in the brain during stereotactic functional neurosurgical procedures.
Contraindications:
microTargeting™ Insertion Tubes are not suited for chronic implantation. They have been validated
for intracranial placement for 1 hour or less.

Safety Information:

Not intended for implantation
Symbol Key:
WARNING / Caution, consult
instructions for important
cautionary information
Consult instructions for use
Do not use if package is
damaged or opened
Do not re-use; intended for
one use on a single patient,
during a single procedure
Do not resterilize
Non-pyrogenic
j Catalog number
l
Batch code
f
Use-by date
In reference to "Rx only"
symbol; this applies to
USA audiences only
Rx only
Caution- Federal law (USA)
restricts this device to sale by
or on the order of a physician
Non Sterile Insertion Tubes:
• If your microTargeting™ Insertion Tubes were shipped in a standard plastic box, DO NOT
attempt to sterilize the tubes using this package. Remove microTargeting™ Insertion Tubes
from the package prior to sterilization. FHC recommends use of the FHC sterilization tray
(holds seven components).
• FHC has validated and recommends the following steam sterilization parameters:
Prevacuum wrapped
(in 2 layers of 1-ply polypropylene wrap
Preconditioning pulses: 3
Exposure time: 4 minutes at 132°C (270°F)
Minimum dry time: 30 minutes
Cycle was validated using Halyard Health H600 wrap
[1]
Prevacuum wrapped
(in 2 layers of 1-ply polypropylene wrap
Preconditioning pulses: 3
Exposure time: 18 minutes at 134°C (273°F)
Minimum dry time: 30 minutes
Cycle was validated using Halyard Health H300 wrap
[2]
• FHC has validated and recommends the following manual cleaning protocol:
1. Immediately following use, thoroughly rinse each tube and other components separately
under tap water. Repeatedly insert the stylet or spacer tube cleaning tool in and out of the
tube under running water to dislodge any debris or coagulated fluid.
2. Immerse all components in enzymatic wash solution for 1 minute. After soaking and while
immersed in wash solution, insert the stylet in and out of the devices. Remove from the
wash solution and repeat under tap water, then distilled water.
3. Dry devices using a clean soft cloth.
4. Insertion tubes, spacer tubes, and stylets MUST be steam sterilized as separate items
(not assembeled).
• Insertion tubes may be re-used for up to three years, providing user performs pre-use check.
4
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 manufac-
turer are with FHC, Inc., 1201 Main Street,
Bowdoin, ME 04287 USA.
Array configuration
Single configuration
Temperature limits to which the medical
device can be safely exposed:
0°C - 40°C (32°F - 104°F)
95%
Range of humidity to which the medical
device can be safely exposed: not to
exceed 95%
0%
)
[1]
)
[2]
Sterilized using ethylene oxide
Medical device has not been
sterilized
Gravity unwrapped
Exposure time: 10 minutes
at 132°C (270°F)