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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

FHC, Inc.

1201 Main Street
Bowdoin, ME 04287 USA
Fax: +1-207-666-8292
www.fh-co.com

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

24 hour technical service:
1-800-326-2905 (US & Can)
+1-207-666-8190

www.fh-co.com

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Содержание WayPoint 66-WP-BKS

Страница 1: ... 66 WP SKS FHC Inc 1201 Main Street Bowdoin ME 04287 USA Fax 1 207 666 8292 www fh co com 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 24 hour technical service 1 800 326 2905 US Can 1 207 666 8190 www fh co com ...

Страница 2: ...L011 68 Rev E0 2018 07 18 Page 2 of 11 ...

Страница 3: ...ontents 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 4 4 4 5 6 7 7 8 9 11 11 ...

Страница 4: ...stem Intended use The WayPoint Implant Kit is intended for use by medical personnel under the direction of a neurosurgeon in a clinical or operating room to place WayPoint fiducial anchors used to build a microTargeting stereotactic platform for one or more trajectories of a neurosurgical procedure The WayPoint Surgical Kits are intended for use by a neurosurgeon in an operating room to attach a m...

Страница 5: ...tricts this device to sale by or on the order of a physician CAUTION Sterilized by ethylene oxide CAUTION Sterile Medical Device Do NOT resterilize CAUTION Do not use the contents if there is any evidence of damage to the package or package seal that could compromise sterility CAUTION WayPoint Implant and Surgical Kits are for single use only Do not reuse Cleaning or reuse may affect the structura...

Страница 6: ...ner Center Positioner Standoffs Anchor Wrench Thumb knobs Standoff Wrench Entry Offset Hub Center Hub Target Offset Hub 66 WP BKS Simultaneous Bilateral Kit Offset Positioner Center Positioner WayPoint Implant Kit 66 WP IKS MR WayPoint Surgical Kits 66 WP SKS 66 WP BKS Combo Driver MR MR MR MR MR MR MR MR MR MR MR Entry Offset Hub Center Hub Target Offset Hub MR MR MR Removable Combo Driver Bit ...

Страница 7: ...r each anchor installation Create a 10 15mm incision through scalp and muscle tissue and scrape the pericranium from the anchor site Use the Pilot Drill Driver to create a pilot hole particularly if the patient s bone is dense or if the surgeon encounters any difficulty fully seating the anchors Secure the combination driver to the anchor preloaded in the wrench Install the anchor in the skull wit...

Страница 8: ...an requirements Contiguous slices no gaps between slices No overlapping slices Slice thickness no greater than 1 25mm Pixel size less than 1mm 0 5 to 0 8mm for best results Gantry tilt angle of zero Non clinical testing demonstrated that the WayPoint Anchors are MR Conditional A patient with this device can be scanned safely immediately after placement under the following conditions MR Scan requir...

Страница 9: ...latform using 2 screws at 90 degrees apart Make sure the hub is completely seated in the platform The hub will sit approximately 1 8 above the top surface of the platform 4 Use the burr hole entry marker with burr hole bushing and mark the skin and skull then remove a b a b a b c d WARNING Do not overtighten thumbknobs Only turn an additional 1 4 turn after contacting mating surface ...

Страница 10: ...structions 9 Perform MER and implant lead 10 Remove drive from positioner then remove platform 11 Use the standoff wrench to support the standoff while twisting the driver clockwise to secure it to the standoff Turn standoff wrench counterclockwise to remove standoff 12 Use the anchor wrench to support the anchor while twisting the driver clockwise to secure it to the anchor Turn anchor wrench cou...

Страница 11: ... using positions A H Examples 3mm Offset Positioner in the G position indicated by the dark blue dots in the offsetting chart 3mm Offset Positioner in the B position indicated by the magenta dots in the offsetting chart Offsets beyond the 10mm range of the positioner may be reached with the target offset hub Track Offsetting Chart WARNING The target offset hub creates a new trajectory with target ...

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