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WayPoint™ Inserter System
Directions For Use
L011-61 (Rev F0, 2019-08-08)
Contains directions for the following products:
66-IT-MR1, 66-IT-MR3, 66-WP-ID, 66-WP-ID-01,
66-WP-ID-02, 66-WP-MR
www.fh-co.com
FHC, Inc.
1201 Main Street
Bowdoin, ME 04287 USA
Fax: +1-207-666-8292
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 020281Sector 2
Romania
FHC Latin America
Calle 6 Sur Cra 43 A-200
Edifi cio LUGO Ofi cina 1406
Medellín-Colombia
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Related Manuals for FHC Waypoint 66-IT-MR1
Summary of Contents for FHC Waypoint 66-IT-MR1
- Page 1 Directions For Use L011-61 (Rev F0, 2019-08-08) Contains directions for the following products: 66-IT-MR1, 66-IT-MR3, 66-WP-ID, 66-WP-ID-01, 66-WP-ID-02, 66-WP-MR www.fh-co.com FHC Latin America 24 hour technical service: FHC, Inc. FHC Europe Calle 6 Sur Cra 43 A-200 1-800-326-2905 (US & Can)
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Page 3: Table Of Contents
Table of Contents Indications for use and Intended use Symbol Key Warnings and Cautions Specifications Inventory Storage Cleaning Sterilization Height Chart - 120mm & 130mm Inserter Height Chart - 120mm Inserter extended clearance Pre-Use Check Illustrative Procedure: MRI implantation of Lead In the MRI Environment In the non-MRI Environment L011-61... -
Page 4: Indications For Use And Intended Use
MDD Directive 93/42/ Telephone number EEC and legal responsibilities as a In reference to “Rx only” symbol; this manufacturer are with FHC, Inc., 1201 applies to USA audiences only. Do not re-use; intended for one Main Street, Bowdoin, Me 04287 USA. -
Page 5: Inventory
Inventory SLS Components (part numbers 66-WP-ID, 66-WP-MR includes: WARNING: Do not reuse single use 66-WP-ID-01, and 66-WP-ID-02) include: items. Burr Hole Marker Inserter Standoff Wrench WARNING: Metal items should not be Lead Holder used in the MRI environment or in the Hex Wrench presence of an MRI magnet. -
Page 6: Cleaning
115°C Listed are the detergents and cycles that FHC has validated. Detergents listed are from Ecolab. If other neutral or alkaline detergents are used, testing should be done by the hospital to ensure product is not damaged. Detergents should be prepared per manufacturers recommendations. -
Page 7: Sterilization
The components of this system are not validated for use with alternative sterilization protocols, and FHC does not recommend or endorse their use. Users with questions regarding this safety issue should contact FHC’s Technical Service Department at 1-207-666-8190. -
Page 8: Height Chart - 120Mm & 130Mm Inserter
L011-61 Rev. F0 2019-08-08 Page 8 of 25... -
Page 9: Height Chart - 120Mm Inserter Extended Clearance
L011-61 Rev. F0 2019-08-08 Page 9 of 25... -
Page 10: Pre-Use Check
Pre-Use Check Confirm that there are no contaminants or debris on any of the parts. Confirm all thumbknobs are present. Note that a sterile marking pen may be used to mark the screw heads prior to use, making it easier to differentiate between them during the surgical procedure. 25mm 15mm 15mm... - Page 11 Place the two 8mm thumbknobs in the free indexing ring tapped holes and thread them in lightly. Mount the drape support as shown, tightening the thumbknobs until the drape support is held securely. Secure the center positioner to the inserter. Install the insertion tube with stylet into the inserter.
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Page 12: Illustrative Procedure: Mri Implantation Of Lead
Procedure for MRI Implantation of Lead Attach and hand tighten standoffs to anchors. Mount platform on standoffs using thumbknobs. WARNING: Delicate insertion tubes should always be carefully inspected before use because damage to them can cause targeting errors and impact patient safety. Handle insertion tubes carefully to prevent bending. Install center hub in indexing ring (built into platform). - Page 13 Insert burr hole marker bushing into center hub. Insert the burr hole marking tool down through the bushing. Create indentation in skin/skull for location of burr hole and remove marking tool. L011-61 Rev. F0 2019-08-08 Page 13 of 25...
- Page 14 Remove burr hole marker bushing. Remove platform and create burr hole. Reattach platform. L011-61 Rev. F0 2019-08-08 Page 14 of 25...
- Page 15 10. Install center positioner in center hub. The tab on the center positioner should be positioned opposite the hub thumbknob. Examine burr hole to ensure entry area is clear. If necessary, remove the center hub and install the entry offset hub. WARNING: Incorrect thumbknob orientation may affect targeting accuracy.
- Page 16 13. Place the two 8mm thumbknobs in the unused indexing ring tapped holes and thread them in lightly. 14. Mount the drape support as shown. Front View Back View 15. Tighten the 8mm thumbknobs until the drape support is held securely. The thumbknobs should be flush with the outer edge of the drape support.
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Page 17: In The Mri Environment
In the MRI Environment 16. Take MRI image to confirm location for DBS implant. 17. In WayPoint™ Navigator, load MRI image and merge with platform plan. 18. If the position is not correct, reposition using offset positioner and/or hub. Alternately, use one of the four available tracks in the ben-gun array. -
Page 18: In The Non-Mri Environment
In the non-MRI Environment 19. Secure lead holder to the DBS measurement fixture. 20. Pinch the tabs of the LeadLoc together slightly and slide the distal end of the lead through the top of the LeadLoc to approximately 25 mm from the lead stylet handle, making sure the lead is in the center notch of the LeadLoc. WARNING: Do NOT over-pinch the tabs. - Page 19 22. Insert the lead and the LeadLoc into the lead holder making sure the tabs of the LeadLoc are aligned with the thumbknob on the lead holder. Gently tighten the thumbknob to secure the LeadLoc into the holder then loosen slightly, ensuring that the LeadLoc cannot move vertically.
- Page 20 26. Remove the LeadLoc with lead from lead holder. 27. Remove drape support by removing the two 8mm thumbknobs and then lifting the drape support straight up. 28. Remove stylet. Be sure to hold the collar of the insertion tube down to prevent movement. L011-61 Rev.
- Page 21 29. Secure the lead holder to the inserter. 30. Insert the lead through the insertion tube and into the brain. If the center track is not being used, the lead should be placed down through the selected track. WARNING: Observe the exposed segment of the lead while advancing the inserter and ensure it advances into the insertion tube without binding or bending.
- Page 22 32. Confirm the lead location. 33. Loosen and raise the lead insertion tube out of the skull. 34. Secure the lead next to the skull with smooth tweezers or the selected securing device like Medtronic Navigus cap. 35. Remove the stylet from the lead. 36.
- Page 23 39. Remove the standoffs using the standoff wrench. 40. Insert the combination driver into the manual handle. 41. Place the hex wrench over the first anchor to be removed. Drop the combination driver down into the hex wrench until it engages with the anchor.
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