L011-57
Rev.
D1
2018-11-09
Page
4
of
11
Indications for use:
The microTargeting™ Guideline 4000 LP+™ neuromodulation targeting system is intended to assist in functional
neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the
placement of depth electrodes.
Intended use:
The Guideline 4000 LP+™ neuromodulation targeting system is intended to be used by a neurosurgeon, neurologist or
clinical neurophysiologist to accurately position depth electrodes during functional neurosurgical procedures.
Applicable Standards:
General Standard: EN60601-1 General Electrical Safety; Collateral Standards: 60601-1-1, 60601-1-2, 60601-1-4, 60601-1-4, 60601-1-6;
Particular Standard: EN60601-2-26; The Guideline 4000 LP+™ is a Class 1 medical device with a type BF applied part.
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.
Medical device manufacturer, as defined
in EU Directives 90/385/EEC, 93/42/EEc
and 98/79/EC.
Telephone number
Indicates the catalog number so that the
medical device 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.
Temperature limitation: Storage conditions
are between 0°C - 40°C (32°F - 104°F)
Humidity limitation: Not to exceed 95%
Atmospheric pressure limitation:
between 500hPa and 1060hPa
Date when the medical device was
manufactured.
Rx only
Rx only
0%
95%
j
n
Warnings and Cautions:
WARNING: The Guideline 4000 LP+ does no analysis, diagnosis, or monitoring for undesirable or dangerous physiological conditions.
WARNING: The Guideline 4000 LP+ issues no alarms should undesirable or dangerous medical conditions arise.
WARNING: The Guideline 4000 LP+ must be operated by a person who has been trained by an FHC authorized representative and has
read and understood the directions for use (DFU).
WARNING: The Guideline 4000 LP+ must be installed by an FHC authorized representative.
WARNING: Do not use the Guideline 4000 LP+ system or any part of it as a diagnostic instrument.
WARNING: Potentially hazardous interactions between the Guideline 4000 LP+ and other patient connected equipment may occur.
Review the documentation associated with all such equipment for relevant warnings and restrictions prior to use with the Guideline
4000 LP+.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
microTargeting™ and Guideline 4000 LP+™ are trademarks of FHC, Inc.
500hPa
1060hPa
Guideline 4000 LP+
Breakout Box
Digital input
Analog input
Analog output
Guideline 4000 LP+
Stimulation Remote Control
Audio jack
Type BF Applied Part
Microphone
Instructions for end of life
disposal
0°C
32°F
+40°C
+104°F
Содержание 66-EL-LP
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