WayPoint Implant and Surgical Kits

Transcription

1 WayPoint Implant and Surgical Kits Directions For Use L (Rev C0, ) Contains directions for the following products: 66-WP-BKS, 66-WP-IKS, 66-WP-SKS FHC, Inc Main Street Bowdoin, ME USA Fax: FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest Sector 2 Romania FHC Latin America Calle 6 Sur Cra 43 A-200 Edificio LUGO Oficina 1406 Medellín-Colombia 24 hour technical service: (US & Can) L Rev. C Page 1 of 11

2 L Rev. C Page 2 of 11

3 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 L Rev. C Page 3 of 11

4 Indications for use: The WayPoint Implant and Surgical Kits are intended for use in neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system. 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 microtargeting stereotactic platform to previously implanted fiducial anchors, and provide fixtures to position a microtargeting drive or other stereotactic device along the planned trajectory or at fixed offsets. Other devices required: Compatible navigation software, such as WayPoint Navigator Patient specific microtargeting Platform built using fiducial anchor locations and desired trajectory Stereotactic device compatible with surgical kit positioners, such as microtargeting STar Drive Symbol Key Rx only j l WARNING / Caution, consult documents Read usage instructions 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. Catalog number Batch code Use by date 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 USA. Do not use if package is damaged Do not reuse Do not resterilize r Sterile Unsafe Safe- the item poses NO known hazards in all environments Conditional Manufacturer Telephone number Storage: Store the WayPoint Implant and Surgical Kits at normal room temperatures between 0 C (32 F) and 40 C (104 F). Do not exceed 104 F for long-term storage. Relative humidity should not exceed 95%. L Rev. C Page 4 of 11

5 Rx only r 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 Anchors to remain implanted for more than 28 days. WARNING: Do not overtighten screws or anchors as this could result in targeting errors. WARNING: Complete kit is labeled Unsafe because it contains some Unsafe components. Refer to inventory section for I status of individual components. CAUTION: Federal law (USA) restricts 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 structural integrity and/or function of the device.these devices are difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused. CAUTION: For the most secure fit of the WayPoint Anchors, advance drill and driver tools as perpendicular to the skull as possible, and do not permit them to wobble during advancement. CAUTION: Avoid over tightening anchors as this can strip bone, or otherwise damage components. CAUTION: Instruct the patient to avoid situations that could affect or disrupt the implanted anchors and to be cautious about infection. L Rev. C Page 5 of 11

6 Inventory: WayPoint Implant Kit: 66-WP-IKS Combo Driver 5mm Fiducial Anchors 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 Combo Driver Burr Hole Marker Burr Hole Marker Bushing Offset Positioner Center Positioner Offset Positioner Center Positioner Standoffs Anchor Wrench Thumbknobs Standoff Wrench Entry Offset Hub Center Hub Target Offset Hub Entry Offset Hub Center Hub Target Offset Hub L Rev. C Page 6 of 11

7 Illustrative Procedure: Implant Procedure 1. Follow aseptic technique throughout. The implant procedure does not need to be done in an OR setting. 2. 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 (L ) describes ideal anchor locations for each DBS platform model that can be easily measured using the disposable fiducial placement template. 3. Using local anesthesia, for 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. a b c Secure the combination driver to the anchor preloaded in the wrench. Install the anchor in the skull with a clockwise rotation of the wrench and combination driver. L Rev. C Page 7 of 11

8 Use the wrench to support the anchor while twisting the driver counterclockwise out of the anchor. a b c 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. Close each anchor wound over the anchor. Repeat this process for all remaining anchors. 4. Scan the patient (see next section). 5. Once scans have been checked to ensure that all anchors are displayed properly, patient may be released. Scanning WayPoint Anchors are CT visible. The patient s head must be kept immobile while being scanned. CT Scan 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 Conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions: Scan requirements: Static magnetic field of 3-Tesla or less Maximum spatial gradient magnetic field of 720-Gauss/cm or less Refer to WayPoint Anchor/Locator Implantation Kit DFU (L011-40) for detailed I safety information on the WayPoint Anchors image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the WayPoint Anchor. Therefore, optimization of imaging parameters to compensate for the presence of this device may be necessary. L Rev. C Page 8 of 11

9 Surgical Procedure 1. Attach and handtighten standoffs to anchors. a b 2. Attach platform to standoffs with thumbknobs. WARNING: Do not overtighten thumbknobs. Only turn an additional 1/4 turn after contacting mating surface. 3. Attach the center hub to the platform 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. a b 4. Use the burr hole entry marker with burr hole bushing and mark the skin and skull, then remove. a b c d L Rev. C Page 9 of 11

10 5. Remove platform and drill burr hole. 6. Reattach platform. 7. 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. a b c 8. Attach drive to positioner and secure following drive instructions. 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. a b c d 12. Use the anchor wrench to support the anchor while twisting the driver clockwise to secure it to the anchor. Turn anchor wrench counterclockwise to remove anchor. a b c d L Rev. C Page 10 of 11

11 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, + configuration, using any of positions A, C, E or G, indicated by the black dots in the offsetting chart below. Center Positioner, X configuration, using any of positions B, D, F or H, indicated by the red dots in the offsetting chart. 3mm offset positioner (40 distinct tracks): Five parallel tracks with 2mm offset, center track offset 3mm from origin, in eight configurations 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 area orthogonally offset 6mm from the original at the microelectrode tip depth when the physical drive reads 30mm. For platforms with T<>30, the offset of 0.69mm per 10mm of drive travel may be used to determine position at target depth. WARNING: The entry offset hub creates a new trajectory which is orthogonally offset 3mm from original at approximate entry depth, and coincides with the original at the microelectrode tip depth when the physical drive reads 30mm. For platforms with T<>30, the offset of 0.34mm per 10mm of drive travel may be used to determine position at target depth. L Rev. C Page 11 of 11