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WayPoint™ Implant and Surgical Kits
Directions For Use
L011-68 (Rev E0, 2018-07-18)
Contains directions for the following products:
66-WP-BKS, 66-WP-IKS, 66-WP-SKS
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
FHC Europe
(TERMOBIT PROD srl)
42A Barbu Vacarescu Str, 3rd Fl
Bucharest 020281 Sector 2
Romania
FHC Latin America
Calle 6 Sur Cra 43 A-200
Edificio LUGO Oficina 1406
Medellín-Colombia
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Related Manuals for FHC WayPoint 66-WP-BKS
Summary of Contents for FHC WayPoint 66-WP-BKS
- Page 1 L011-68 (Rev E0, 2018-07-18) Contains directions for the following products: 66-WP-BKS, 66-WP-IKS, 66-WP-SKS 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 L011-68 Rev. E0 2018-07-18 Page 2 of 11...
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Page 3: Table Of Contents
Table of Contents: Indications for use, Intended use, and Other devices required Symbol Key Storage Warnings and Cautions Inventory Illustrative Procedure: Implant Procedure Scanning Surgical Procedure Track Selection Track Offsetting Chart L011-68 Rev. E0 2018-70-18 Page 3 of 11... -
Page 4: Indications For Use, Intended Use, And Other Devices Required
MDD Directive 93/42/EEC hazards in all MR environments and legal responsibilities as a manufacturer In reference to “Rx only” symbol; this are with FHC, Inc., 1201 Main Street, applies MR Conditional-an item that has been Bowdoin, ME 04287 USA. -
Page 5: Warnings And Cautions
Warnings and Cautions: WARNING: Do not drill or install anchors in bone that is less than 4.5mm thick, or in bone that is weakened or diseased. WARNING: Do not use anchors that exhibit any sign of looseness. Replace anchors and rescan if necessary. WARNING: Do not allow WayPoint™... -
Page 6: Inventory
Inventory: WayPoint™ Implant Kit: 66-WP-IKS Removable Combo Driver 5mm Fiducial Anchors Combo Driver Bit Pilot Drill Driver Anchor Wrench WayPoint™ Surgical Kits: 66-WP-SKS & 66-WP-BKS 66-WP-SKS: Surgical Kit 66-WP-BKS: Simultaneous Bilateral Kit Burr Hole Offset Combo Burr Hole Center Offset Center Marker Bushing Positioner... -
Page 7: Illustrative Procedure
Illustrative Procedure: Implant Procedure Follow aseptic technique throughout. The implant procedure does not need to be done in an OR setting. Mark the intended anchor points on the patient’s scalp. • Proper placement of the fiducial anchors is important to generate optimal platform geometry. The Fiducial Placement Template DFU (L011-40-05) describes ideal anchor locations for each DBS platform model that can be easily measured using the disposable fiducial placement template. -
Page 8: Scanning
• Use the wrench to support the anchor while twisting the driver counterclockwise out of the anchor. • Inspect the attachment of the anchor to the skull. Anchors must be tight. Replace stripped anchors in a new location. Note that if anchors are not fully seated in the skull, they should be tightened by hand with the hex wrench. •... -
Page 9: Surgical Procedure
Surgical Procedure Attach and handtighten standoffs to anchors. Attach platform to standoffs with thumbknobs. WARNING: Do not overtighten thumbknobs. Only turn an additional 1/4 turn after contacting mating surface. Attach the center hub to the platform using 2 screws at 90 degrees apart. Make sure the hub is completely seated in the platform. - Page 10 Remove platform and drill burr hole. Reattach platform. Attach center drive positioner to center hub with tab oriented 45°, 90°, or 135° relative to screw. Make sure positioner is completely seated in the hub. Attach drive to positioner and secure following drive instructions. Perform MER and implant lead.
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Page 11: Track Selection
Track Selection: Center positioner (9 distinct tracks): Center track on target. Four parallel tracks with 2mm offset, ‘+’ configuration, using positions A, C, E and G. Four parallel tracks with 2mm offset, ‘x’ configuration, using positions B, D, F and H. Examples: Center Positioner, ‘+’...
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