Page 4 of 17
L011-80
Rev.
C0
2020-11-05
Indications for use:
The microTargeting™ Drive System is intended to be used with commercially available stereotactic systems for neurosurgical
procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS electrodes, or other instruments
in the brain or nervous system.
Contraindications: Follow the general guidelines concerning the suitability of neurosurgery involving the insertion of electrodes,
instruments or devices.
Intended use:
The microTargeting™ Controller Power Assist System is intended to be used by a neurosurgeon, neurologist or clinical
neurophysiologist to manipulate the position of depth electrodes, such that they may identify functional targets in the brain.
The device is expected to be used on patients undergoing stereotactic and functional neurosurgical procedures.
Symbol Key
Classifications:
The controller is an IEC 60601 Class 2 medical device with two applied parts:
• The drive motor, shrouded in a sterile drape sleeve is applied to the micropositioner which is itself attached to a
stereotactic frame which is attached to the patient. The drive motor is a type BF applied part.
• The hand-held remote control is intended to be held by the operator of the controller who may come into contact with
the patient. The remote control is a type BF applied part.
Note: The system does not directly interface with tissue or other parts of the body. It interfaces with the micropositioner
responsible for positioning a microelectrode in the brain.
WARNING / Caution, consult instructions for important
cautionary information.
Medical device manufacturer, as defined in EU Directives 90/385/
EEC, 93/42/EEC and 98/79/EC.
Consult the instructions for use.
Telephone number
Caution
- Federal law (USA) restricts this device to sale by or
on the order of a physician.
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.
In reference to “Rx only” symbol; this applies to USA
audiences only.
Authorized Representative in the European Community.
Indicates the catalog number so that the medical device
can be identified.
Sterilized using ethylene oxide.
Indicates the serial number so that a specific medical
device can be identified.
A medical device that has not been subject to a
sterilizationprocess.
A medical device that should not be used if the package
has been damaged or opened.
A medical device that is not to be resterilized.
Instructions for end of life disposal.
Do not re-use; Intended for one use on a single patient, during a
single procedure.
+70
°C
+158°F
-40
°
C
-40
°
F
The temperature limits to which the medical device can be
safely exposed.
1060
hPa
500
hPa
The range of atmospheric pressure to which the medical device
can be exposed.
100%
10%
The range of humidity to which the medical device can be
exposed.
Not made with natural rubber latex.
Unit Symbols
Type BF applied part
Auto retract
Motor unit
Advance drive
Remote control
Retract drive
USB interface
Zero or origin
Содержание microTargeting 66-DA-ME
Страница 2: ...Page 2 of 17 L011 80 Rev C0 2020 11 05...
