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Guideline 4000 LP+™
neuromodulation targeting system
Directions For Use
L011-57 (Rev D1, 2018-11-09)
Contains directions for the following products:
MT-LPP, MT-LPP-APM, 66-EL-LP
www.fh-co.com
FHC, Inc.
1201 Main Street
Bowdoin, ME 04287 USA
Fax: +1-207-666-8292
www.fh-co.com
24 hour technical service:
1-800-326-2905 (US & Can)
+1-207-666-8190
L011-57
FHC Europe
(TERMOBIT PROD srl)
42A Barbu Vacarescu Str, 3rd Fl
Bucharest 020281 Sector 2
Romania
Rev. D1
2018-11-09
FHC Latin America
Calle 6 Sur Cra 43 A-200
Edificio LUGO Oficina 1406
Medellín-Colombia
Page 1 of 11
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Related Manuals for FHC Guideline 4000 LP+
Summary of Contents for FHC Guideline 4000 LP+
- Page 1 L011-57 (Rev D1, 2018-11-09) Contains directions for the following products: MT-LPP, MT-LPP-APM, 66-EL-LP www.fh-co.com FHC, Inc. FHC Europe FHC Latin America 1201 Main Street (TERMOBIT PROD srl) Calle 6 Sur Cra 43 A-200 Bowdoin, ME 04287 USA 42A Barbu Vacarescu Str, 3rd Fl...
- Page 2 L011-57 Rev. D1 2018-11-09 Page 2 of 11...
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Page 3: Table Of Contents
Table of Contents: Indications for use, Intended use, Applicable Standards Symbol Key Warnings and Cautions System Maintenance and Repair Handling Considerations Maintenance Repair System Disposal System Specifications - Performance & Accuracy Microelectrode Recording Stimulation Impedance Check Analog Inputs Inventory Ordering Information System Set-up and Pre-Use Checkout L011-57 Rev. -
Page 4: Indications For Use, Intended Use, Applicable Standards
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). -
Page 5: System Maintenance And Repair
WARNING: Do not allow any liquid to contact any Guideline 4000 LP+ component. Maintenance • The Guideline 4000 LP+ must be inspected and recalibrated each year by an FHC authorized representative. Contact FHC for more information on Service Agreements and Preventive Maintenance Programs. •... -
Page 6: Stimulation
Stimulation Mode: Constant Current, Compliance Voltage: ±50V Microstimulation: Stimulus Parameters Macrostimulation: Stimulate from microelectrode to common From macro-contact to common or between • Monophasic or biphasic, cathode or macro contacts • Range: 0 to 100μA, Display Resolution: 1 μA, anode leading or user defined Accuracy: ±5%, see performance graphs •... -
Page 7: Ordering Information
CAUTION: If using a shipping case with a lock, do not lose the key for the lock. WARNING: Packing foam can not be sterilized. If contamination of the foam is suspected, contact FHC for disposal instructions. CAUTION: Sharp edges, use caution. - Page 8 WARNING: Do not enable the wireless capabilities of the notebook computer in the hospital environment unless you are authorized to do so. WARNING: Do not install third party software onto the Guideline 4000 LP+ notebook computer unless authorized to do so by an FHC factory authorized representative.
- Page 9 16. Verify the impedance check and stimulation functionality of each available channel (by repeating step 3B) before every surgery. WARNING: If an error occurs during the pre-use checkout procedure (step 3), discontinue use of the system. Contact an FHC factory authorized representative for further instructions.
- Page 10 If using the microTargeting Controller and motor or encoder, connect the microTargeting motor or encoder assembly as shown and perform the following steps: Zero the microTargeting Controller by pressing the small black button on the front panel of the Controller. The depth readout of the microTargeting Controller should appear on the computer screen.
- Page 11 WARNING: Operation of the Guideline 4000 LP+TM in proximity of short wave or microwave therapy equipment may produce instability in the electrical stimulator output. WARNING: Do not arrange electrodes and equipment in such a way that stimulation current may pass through the heart.