microTargeting™ Epilepsy Platform Incorporating STarFix™ Guidance Directions For Use L011-70 (Rev C1, 2017-05-19) Contains directions for the following products: MP-KIT-P-EP, MP-KIT-A-LG, MP-KIT-A-SG 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
Indications for use:The WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, simulating electrodes, or other instruments in the brain or nervous systems.
Intended use:The microTargeting™ Epilepsy Platform is intended for use by neurosurgeons in a standard operating room environment to position compatible tools orthogonally to the mid-sagittal plane within a 63mm radius around mid-commissure point, and in a 12mm radius around two additional surgeon specified trajectories.
Symbol Key
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
Serial number
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 -34°C and 57°C (-29°F and 135°F)
Humidity limitation: Not to exceed 100%
Rx only
Handling and Storage:Storage: Store the mechanical components of the microTargeting™ Epilepsy Platform at normal room temperatures between –34°C (-29°F) and 57°C (135°F). Do not expose to temperatures below –34°C (-29°F ) or greater than +70°C (158°F), or a relative humidity of less than 10% or more than 100%, including condensation.
Handling and use: Handle the microTargeting™ Epilepsy Platform and its accessories with extreme care. These components may be damaged if excessive force or incorrect handling occurs. Do not force engagement during pre-operative assembly or when positioning the implantation tools through microTargeting™ Epilepsy Platform. Follow the assembly and use instructions carefully.
Component failures: While a high degree of reliability is designed into the system, unexpected failure of components is always possible if improper storage or handling occurs.
Rx only
-34°C -29°F
+57°C +135°F
10%
100%
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n
Manufacturer
Telephone number
Reuse is not allowed
MR Unsafe
Warnings and Cautions:WARNING: A patient with this device cannot be scanned safely.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
CAUTION: WayPoint™ Anchors, microTargeting™ Platforms and standoffs are all single use items.
These are the tools and parts needed for the anchor implantation and scanning procedures. See the WayPoint™ Anchor/Locator Implantation Kit Directions For Use (L011-40) for details.
MP-KIT-MD: WayPoint™ Stainless Steel Standoff and Thumbknob
Hardware to attach one platform leg to WayPoint™ anchor.
Contact FHC for current licensing options availability. DICOM 3.0+ compatible scanning (CT and MR) required for use.Includes: microTargeting™ Platform Planning and Design software (WayPoint™ Planner or WayPoint™ Navigator); Software Guide;Portable PC with high resolution display, external mouse, network interface and modem, CDRW Drive; and Nylon carrying case.
Also required:• DICOM 3.0+ compatible scanner capability (CT and MR)• Image transfer facility by removable media or network• Internet Access
Optional Accessories::• MP-KIT-A-LG: additional Large Orthogonal Double Grid with associated mounting hardware • MP-KIT-A-SG: additional Small Oblique Double Grid with associated mounting hardware
microTargeting™ Epilepsy Platform
A unique platform is designed for each surgical procedure. It is held to a skull based anchor mount set using standoffs and thumbscrews which pass through the hollow cylindrical platform feet.
Single Large Lateral Double Grid
The large lateral double grids allow the implantation of electrodes that are orthogonal to the mid-sagittal plane and centered on the mid-commissure point. The double grids are placed at a fixed distance from the mid-sagittal plane; the individual distance to target may vary. On each grid surface, there are labels indicating the correct positioning of the grid on each side of the head, as well as protrusions preventing incorrect placement. The grids are secured to the Platform with 4 thumbscrews.
Single Small Oblique Double Grid
The small grids allow the implantation of oblique electrodes. They are aligned with the trajectories defined by the surgeon during pre-operative planning. The distance between grid and target is determined by the platform scale height selected during planning phase, plus the grid thickness. Normally, only the center hole is used, but the other holes allow intra-operative small adjustments to the trajectory. They are secured to the oblique Platform hubs with three hex cap screws.
Additional Parts
The following additional parts are included with the Epilepsy Platform Kit: • Large grid attachment screws - four 20mm M3x.5 stainless steel thumbknobs• Small grid attachment screws - three 20mm M3x.5 stainless steel thumbknobs• Drill - #39 (2.53mm) 14cm long, paraboliic
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Specifications:Grid Tracks: 2.55mm holes; 3.00mm spacing; 50.00mm spacing between grids
Large Grid: Overall: 149.35 ± .1mm; Tracks: 63 mm (21 track) radius
Attachment and Registration: WayPoint™ Fiducial Anchors (66-WP-AN5)
Planning/Configuration: WayPoint™ Planner or WayPoint™ Navigator
Target Accuracy: Within 2.0 mm of planned at a target depth of 160 mm
Large Grid
Small Grid
4x M3 x .5 Clearance hole
Indexing Ledge
63.00mm
63.00mm
Ø149.35mm
3.00mm
3.00mm 50.00mm
Ø2.55mm
50.00mm
12.00mm
Ø41.15mm12.00mm
3.00mm
3.00mm
Ø2.55mm3x M3 x .5 Clearance hole
L011-70 Rev. C1 2017-05-19 Page 7 of 10
Cleaning and Sterilization:
Platforms should be placed in a suitably sized container and sterilized as described below. Note that platforms have only been validated for a single sterilization cycle.
WARNING: Platforms and hardware are single use devices and shot NOT be cleaned prior to sterilization.
WARNING: The platform is shipped non-sterile and must be sterilized before use. Follow sterilization protocols described below.
WARNING: Components should be examined after each sterilization cycle for damage and function. Users should be aware that the effects of unvalidated sterilization protocols could result in damage to the components and affect their functioning or performance.
WARNING: The grids and platform must be sterilized separately.
Platform Sterilization Instructions:
(MP-KIT-P-EP, MP-KIT-A-LG, MP-KIT-A-SG)
Platforms should be placed in a suitably sized container and sterilized as described below. Note that platforms have only been validated for a single sterilization cycle.
Method
Steam
Protocol
Sterrad™ Sterrad™ 100S full cycle
Gravity wrapped:(in 2 layers of 1-ply polypropylene wrap [1])Exposure time: 10 minutes at 132°C (270°F)
[1] Cycle was validated using Halyard Health H600 wrap
[2] Cycle was validated using Halyard Health H200 wrap
Procedure:
Anchor Implantation and Scanning
Implant anchors following the WayPoint™ Anchor/Locator Implantation Kit DFU (L011-40). Two anchors should be placed in an anterior position, just above the hairline at about the same level in a normal adult individual, about 45-60 mm laterally from the mid-sagittal plane, such that the anchor separation is 90-120 mm. The other two anchors should be placed in a posterior position, approximately 20-30 mm above the external occipital protuberance (inion) at about the same level.
WARNING: Avoid placing anchors in sutures or areas of bone that may not provide sufficient solid bone to hold them in place during the pre-operative wait. Always inspect the anchors for solid implantation both after the scan and just before surgery. Anchors should not be used when bone thickness is less than 4.5 mm or where the possibility of skull penetration above blood vessels is present.
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Pre-operative Planning
1. Load the patient scan data into the microTargeting™ Platform Planning workstation.
2. Following the procedures in the software guide, process the scans to create one or more data sets. A CT dataset is required as the primary dataset.
3. Perform any desired preliminary functions such as image co-registration, segmentations, or threshold adjustments.
4. Locate and register the anchor points in the scanned images.
5. Set patient anatomy by identifying the anterior commissure (AC) and posterior commissure (PC). The orientation of the mid-sagittal plane will be given by AC, PC and a third point typically selected on the superior region of the mid-sagittal plane, near the sagittal suture.
6. Create two oblique trajectories by selecting the target and entry points. If no actual oblique trajectories are required, two dummy trajectories will have to be planned.
7. Verify the points and inspect the planned trajectories. A surgeon’s eye view display mode and multiple trajectories view options may be used in the inspection of the planned trajectories.
8. After the points are verified and the oblique trajectories inspected, select the anchor set, platform type and the height parameter, then select the platform creation menu. The virtual platform will appear in the 2D and 3D images, in place, on the anchors.
9. Inspect the position and shape of the displayed platform, check for trajectory issues relative to the entry or target point locations and adjust and regenerate the platform as necessary.
10. When satisfied with the trajectories check the distance between the bottom surface of the oblique rings and the patient. If more or less clearance is required adjust the height parameter accordingly.
11. Export the microTargeting™ Platform Model Files and transmit them to FHC’s fabrication facility by direct internet connection. A delivery confirmation will be sent back immediately.
12. A validated microTargeting™ Platform will be sent by expedited carrier within 24-72 hours.
13. Additional orthogonal trajectories can be planned by selecting target and entry points that have the same set of anterior-posterior and superior-inferior coordinates, in MC (mid-commissure) coordinate system. This can be accomplished with maximum accuracy by typing the actual coordinates into the coordinate box in the upper right corner of the microTargeting™ WayPoint™ Planning workstation, as illustrated below. The process includes the steps described below.
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14. In the coordinate box, select as reference the mid-commissure point, on which the lateral grids are centered, by clicking on the MC tab. To insure that any coordinates that are entered in the corresponding boxes are synchronized with the current trajectory coordinates, check the Update Coordinates box.
15. Click on the button that adds trajectories and select your target point.
16. At this point, one has to take into account the grid spacing of the orthogonal grids, which is 3 mm for MP-KIT-P-EP platform. The anterior-posterior and superior-inferior coordinates have to be rounded to a multiple of 3, as illustrated in the figure 3. After rounding the coordinates, click on the Go button to make sure that the changes are applied to the current trajectory point.
17. Write down the AP and SI coordinates of the target, to be used for marking the hole on the double grid corresponding to the current trajectory.
18. Confirm target coordinates and proceed with selecting the entry point. The initial entry point is selected by clicking on a point located on the outer cortical surface, which has approximately the same AP and SI coordinates. Then, in order to insure perfect orthogonality of the trajectory to the mid-sagittal plane, in the coordinates box manually adjust the AP and SI coordinates for the entry point such that they match the corresponding values for the target (as illustrated by the two horizontal arrows in figure 3). Click the Go button and confirm entry point selection.
19. Calculate the distance between the double-grid surface and the target by subtracting the target’s Right/Left coordinate value from the distance between the double grid surface and the mid-sagittal plane, which is 160 mm for MP-KIT-P-EP. Using as an example the coordinates shown in figure 3, the distance to target is going to be d = 160 mm - 11.6992 mm =148.3008 mm. Write down this value, for use according to the specific instructions for the implantation of the depth electrodes, provided by the manufacturer of the electrodes, tools and accessories.
20. Plan additional orthogonal trajectories by repeating steps 15-19 above.
21. When the platform has been received from the manufacturing facility, unpack the large lateral grids and using a ruler, first mark with a permanent color marker the hole corresponding to the center of the grid. Then mark the holes to be used, according to the AP and SI coordinates for each trajectory. Please make sure that you follow the left/right, anterior-posterior and superior/inferior markings on each surface of the grid. The marked holes have to be checked for ease of insertion with the 2.5 mm drill included as an accessory with the kit and enlarged as required. The lateral double grid can be used for sequential left and right implantations. The trajectories for the left hemisphere have to be marked on the surface labeled LEFT and the ones for the right hemisphere have to be marked on the surface labeled RIGHT.
22. The platform (including the grids and other accessories) should be sterilized by steam or EtO Sterrad™ methods. Refer to the chart on page 2. Other system components are sterilized in the WayPoint™ Anchor/Locator Implantation Kit tray (ordered separately).
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WARNING: Use only devices of an appropriate diameter for the platform grid to avoid targeting errors.
Surgery
Dimensions Box
For the large orthogonal grid:
• The grid will have an outer diameter of 149.35 mm +/- .1mm
• There will be 43 rows and 43 columns of holes, that would allow insertion of electrodes 63mm (21 grid steps) away from the center hole in any of the ANT/POS/SUP/INF directions
For the small oblique grid:
• The grid will have an outer diameter of 41.15 mm +/- .1mm
• There will be 9 rows and 9 colums of holes, that would allow insertion of electrodes 12mm (4 grid steps) away from the center hole in any of the directions
WARNING: The large orthogonal grid permits implanting electrodes within a 63 mm radius of the center hole (aligned with the mid-commissural point). Do not plan electrode trajectories outside of this radius.
WARNING: The small oblique grid permits implanting electrodes within a 12 mm radius of the center hole (aligned with the mid-commissural point). Do not plan electrode trajectories outside of this radius.
CAUTION: Trajectory coordinates must align with the grid spacing (3 mm by default) to ensure accurate targeting.
1. Place the patient on the table in a comfortable position. A noninvasive restraint system or tape should be used to prevent sudden or uncontrolled movements of the head. Drape the sterile field appropriately.
2. Apply local anesthetic, expose the anchors.
3. Attach the double grids to the rings using thumbscrews for the large lateral grids (orthogonal trajectories) or hex cap screws for the small grids (oblique trajectories). Make sure that the double grid lays flat against the rings. Use the provided hex driver for tightening the hex cap screws for the oblique small grids. When attaching the large lateral grids, follow the LEFT/RIGHT marks on each surface, such that the outer grid surface marks match the current implanted hemisphere. Incorrect positioning of the grids is prevented through built in locators that prevent placing the grid on the wrong side or with incorrect A/P or S/I orientations.
4. Follow the steps specified by the manufacturer of the depth electrodes and implantation tools to implant the depth electrodes. For each trajectory, use the appropriate distance to target calculated according markings adjacent to the appropriate hub plus 50mm(for oblique trajectories) and step 19 (for orthogonal trajectories).
5. If bilateral implantations are required, the oblique and orthogonal grids may be detached, moved to the alternate location, and reattached following step 3.
6. When the depth electrode implantation procedure is complete, remove the microTargeting™ Epilepsy Platform. The WayPoint™ Anchors may be left in the patient for post-operative scanning and may remain in place for up to 28 days if re-attachment of a new platform or rescanning is necessary.
Removal of Components: When the depth electrode implantation procedure has been completed, the platform can then be removed from the anchor standoffs by removing the thumbscrews securing it. WayPoint™ Anchors may remain in the skull for up to 28 days for post operative scanning or to allow additional surgical procedure(s). Remove the anchors from the skull using the WayPoint™ Hex Wrench tool and combination bit installed in the driver handle.
System Disposal: The single use items of the microTargeting™ Platform kit, including the patient and procedure customized platform itself, contain no hazardous materials requiring special handling, and may be disposed of using normal precautions for biohazardous materials.
