Quick Guide - Stryker Neuro Spine.
Contents
1. Rotational Navigation Adapter 2 Assemble Disassemble instrumentation Assemble a navigation tracker 1 Press and hold the interface button D of the tracker interface j o O O lt X 2 Slide the tracker E on the tracker interface pin B of the Rotational Navigation Adapter 3 Release the interface button D and move the tracker E slightly until the interface button snaps back and the tracker is firmly attached to the interface B There are two tracker options available to interface with the Rotational Navigation Adapter gt nGenius Universal Tracker Ke pru O ag pa oO _ Q 14 Ke lt Rotational Navigation Adapter Assemble a handle 1 Pull back and hold the coupling ring G of the handle F 2 Slide the handle over the handle interface C of the Rotational Navi gation Adapter 3 Release the coupling ring G of the handle F and turn the handle until the coupling ring snaps back into its original position and the handle is firmly attached to the interface There are three handle options with the Rotational Navigation Adapter All handles are cannulated and ratcheting and can be used interchangeably with the Navigated Xia 3 and Navigated MANTIS instruments gt Navigated Round Handle _ a gt Navigated T Handle of gt Navigated T Handle Short Rotational Navigation Adapter Assemble a naviga2. Dilator in relation to the skin The dilators have depth markings laser etched which correlate to the blade lengths gt Choose a Blade or Redux Blade length based on where the top of the skin meets the Slim Dilator The markings on the dilators are intended to be a guide If it is desired to have a longer blade extend for manipula tion purposes you may select a blade one level higher than the measurement on the skin gt Slide the Navigated MANTIS Tap Sleeve over the Slim Dilator gt Remove the Slim Dilator making sure to leave the Navigated MANTIS Tap Sleeve in place gt The Navigated MANTIS Tap Sleeve will be the working channel during pedicle preparation Navigated MANTIS MANTIS Dilators can be used to dilate tissue if desired but must be removed before using Navigated Instrumentation because the MANTIS Hollow Dilator is too long to be used with Navigated MANTIS Instrumentation The MANTIS Hollow Dilator was designed to be used with MANTIS Blades up to Size 5 and would prevent use of the Navigated MANTIS Instruments which were designed to be used with blades up to Size 4 AEM ELGO MANTIS Navigated MANTIS 3 Prepare Pedicles Awl gt With the Navigated MANTIS Tap Sleeve still in place prepare the pedicle by placing the Cannulated Awl over the K Wire and impact into the pedicle with a twisting motion gt Use the cannulation of the Slap Hammer to impact the Awl gt Hold t
3. Ke O D gt ia Z Xia 3 Navigated MANTIS 1 Use of Navigated MANTIS Instrumentation The Navigated MANTIS Instruments are designed to be used with the Stryker MANTIS Spinal System The Navigated MANTIS Instruments include gt Cannulated Awl gt Cannulated Taps gt MANTIS Polyaxial Screwdriver gt Reduction Polyaxial Screwdriver gt Tap Sleeve The Navigated MANTIS Instrument Tips are assembled to the Rotational Naviga tion Adapter using the methodology described in the chapters before The MANTIS and MANTIS Reduction Polyaxial Screwdrivers have a marking on the long round shaped sides of the inter face This marking indicates the correct seating of the Polyaxial Screwdrivers when they meet the adapter interface NEE Wilefelicre MANTIS 2 Access Pedicles Incision gt Refer to MANTIS or MANTIS Redux Surgical Technique Calibrate Navigated Instrument gt Refer to Rotational Navigation Adapter Chapter in this document Vector Calibrate Navigated Jam Shidi gt Refer to SpineMap 3D User Manual Navigated MANTIS oo w A 27 gt 49 Z Navigated MANTIS Insert K Wire gt Insert the Navigated Jam Shidi through the skin incision to the inter section of the facet and transverse process gt Confirm that the appropriate pedicle starting place has been determined using Navigation The diameter of the MANTIS K Wire is 1 3 mm The Radius K Wire is not
4. compatible with the MANTIS Spinal System gt Use the Navigated Jam Shidi needle to gain access to the pedicle AEM ELGO MANTIS gt After placing the Navigated Jam Shidi at the intersection of the facet and the transverse process the needle may be advanced partially through the pedicle using the Slap Hammer gt Remove the inner trocar of the Navi gated Jam Shidi gt The removal of the Navigated Jam Shidi inner trocar allows the K Wire to be inserted into the pedicle gt Caution should be practiced with regard to the position of the K Wire in order to avoid the advancement of the K Wire gt Insert the K Wire impact to the desired depth using the Slap Hammer gt The K Wire Guide Tube can also be utilized to aid in K Wire Insertion Navigated MANTIS gt Once the K Wire is inserted remove the outer shaft of the Navigated Jam Shidi gt Hold the K Wire in position when removing the Navigated Jam Shidi AEM ELGO MANTIS Navigated MANTIS Dilation gt Insert the Slim Dilator through the incision and over the K Wire gt Advance the Slim Dilator through the tissue twisting clockwise while directing it toward the pedicle gt The Slim Dilator is advanced through the lumbodorsal fascia and docked on the junction of the facet and the transverse process gt Confirm the location of the Slim Dilator using imaging AEM ELGO MANTIS gt Note the depth marking of the Slim
5. Cancel Calibrate Universal Tracker dis 2 3 a 3 Touch the center of any of the PCD s validation discs with the tip of the v Validate navigated Spine Instrument and press min Calibration succeeded The tool can now be used SELECT on the PCD to confirm Valats a new teal tp by touching the vation disk onthe calibration device and by pressing SELECT If validation fails the new tool tip must not be used for gt If you change tools validate the new oas tool before usage Cancel Navigated Xia 3 Instrument Tips 1 Use of Navigated Xia 3 Instrument Tips The Navigated Xia 3 Instrument Tips are designed to be used with the Stryker Xia 3 Spinal System The Navigated Xia 3 Instrument Tips include gt Awl gt Straight Blunt Probe gt Straight Thoracic Pedicle Probe gt Modular Taps 12 2 DT gt z x lt zZ gt Polyaxial Screwdriver The Navigated Xia 3 Instrument Tips are assembled to the Rotational Navigation Adapter using the methodology described in the chapters before The Polyaxial Screwdriver has a marking on the long round shaped sides of the interface This marking indicates the cor rect seating of the Polyaxial Screwdriver when it meets the adapter interface 2 Prepare Pedicles Prepare the entry point with the Awl The Awl is designed with a stop at 13 mm to prevent overplunging Use the Straight Blunt Probe or the Straight Thoracic Pedicle Probe to create a path
6. IS Polyaxial Screwdriver et 18765330 Navigated MANTIS Reduction Polyaxial Screwdriver 48769300 Navigated Xia 3 Round Handle Ratchet Cannulated 48769200 Navigated XIA 3 T Handle i Ratchet Cannulated 48769210 Navigated MANTIS Short T Handle Ratchet Cannulated WWSSEEE 48761001 Navigated XIA 3 Tray s 48765001 Navigated MANTIS Tray A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treatinga particular patient Stryker does not dispense medical advice and recommends that surgeons be trained in the use ofany particular product before using it in surgery The information presented is intended to demonstrate the breadth of Stryker product offerings A surgeon must always refer to the package insert product label and or instructions for use before using any Stry ker product Products may not be available in all markets because pro duct availability is subject to the regulatory and or medical practices in individual markets Please contact your Stryker representative if you have questions about the availability of Stryker products in your area Stryker Corporation or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks Xia Stryker SpineMap nGenius MANTIS Literature Number 6002 050 750 Rev C 2012 06 22 Copyright 2012 Stryker Printed in Germany stryker Joint Repla
7. atent gt Initialize the Point Calibration Device PCD by pressing SELECT for three seconds Upon initialization an information box appears Track Instrumen t Track Patient Cancel Manage Tools Start C Arm 3 D scan Sele ct adapter ees gt Highlight and select Rotational Adapter by pressing SELECT on the PCD Calibrate Universal Tracker Universal Adapter Rotational Adapter Rotational Navigation Adapter Calibrate Rotational Adapter 1 Make sure that both the PCD and the tool tracker are visible and centered in the working space of the camera Calibrate Universal Tracker co 5 a o O O lt X 2 Touch the center of any of the PCD s validation discs with the tip of the Calibration Tip and press SELECT on the PCD to confirm 3 Touch the center of the validation x disc on the opposite side of the PCD with the tip of the calibration instru ment and press SELECT on the PCD to confirm gt After the calibration the Calibration cg ye Le Tip can be removed and replaced by one of the navigated Spine instru ment tips The tips must be validated according to the next step Validate Rotational Adapter calibration 1 Insert the required tip into the tip interface of the Rotational Naviga tion Adapter and check that the tip is firmly attached to the tip interface 2 Make sure that both the PCD and the tool tracker are visible and centered in the working space of the camera
8. cements Trauma Extremities amp Deformities Craniomaxillofacial Spine Biologics Surgical Products Neuro amp ENT Interventional Spine Navigation Endoscopy Communications Imaging Patient Care amp Handling Equipment EMS Equipment Manufactured and distributed Rotational Navigation Adapter Universal Tracker nGenius Universal Tracker by Stryker Leibinger GmbH amp Co KG Botzinger Stra e 41 D 79111 Freiburg Germany t 49 761 4512 0 f 49 761 4512 120 wil Manufactured all others by STRYKER Spine SAS ZI Marticot 33610 Cestas France t 33 05 57 97 06 30 f 33 05 57 97 06 31 www stryker com
9. crews With the pedicle pathway prepared and the proper screw diameter and length det emined using the SpineMap 3D software the screw can be Inserted into the pedicle using the Navigated Xia 3 Polyaxial Screw driver Navigated Xia 3 Polyaxial Screwdriver The Navigated Xia 3 Polyaxial Screwdriver Includes a locking feature that is designed to provide tactile visual and audible con firmation that the Polyaxial Screwdriver is securely locked To engage the Navigated Xia 3 Polyaxial Screwdriver 1 Pressthe UNLOCK button K 2 Hold the screw by the threads and engage the tabs on the screwdriver tip L into the saddle of the screw head M 3 Fully seat the screwdriver tip L into the screw head M 4 Turn the outer shaft N clockwise using the LOCK button J until the threads are fully engaged gt If the ratchet sound is not present confirm locking by pressing the LOCK button J gt LOCK button can be pressed at any time during or after the thread engagement action if ratchet sound is not desired To disengage the Navigated Xia 3 Polyaxial Screwdriver 1 Press and release the UNLOCK button K Navigated Xia 3 Instrument Tips 2 Rotate the outer shaft N counterclockwise while firmly hold ing the handle Once all of the screws have been placed refer to the Xia 3 Spinal System Surgical Technique for rod contouring rod link age final tightening and cross connector placement
10. he K Wire in position when removing the Awl The Awl has a stop at 13 0 mm Monitor the position of the K Wire to ensure that it is not advanced while awling oo w H az gt 4 LS Tap gt The appropriate Cannulated Tap may be used to prepare the pedicle screw canal gt The Cannulated Taps are designed to be used with the Navigated MANTIS Tap Sleeve and laser etched with 5 0 mm intervals to help indicate the depth at which the Tap has been inserted as well as to help determine proper screw length The length of the Tap thread is 25 mm p Asaninstrument advances Into the pedicle the proximal end of the Instrument will move relative to the markings on the K Wire If this does not occur during insertion the procedure should be stopped and fluoroscopy should be used to verify the position of the K Wire in relation to the Awl or Tap The 1 0 cm interval markings on the K Wire provide the cannulated instru ments change in depth in the pedicle Cantilevering the Awl and Taps while in the pedicle may damage the instrument Navigated MANTIS Monitor the position of the K Wire to ensure that it is not advanced while tap ping gt Check pedicle depth with either Navigation or read the depth from the Navigated MANTIS Tap Sleeve as it moves along the proximal edge of the sleeve There are markings at 30 40 and 50 mm The Navigated MANTIS Tap Sleeve is made of radiolucent material gt Hold the K Wi
11. re in position when removing the Cannulated Tap Ke oO G gt gt 14 ZA MANTIS Navigated MANTIS 4 Assemble Insert Screws Assemble Screw gt Refer to MANTIS or MANTIS Redux Surgical Technique Insert Screw gt With the pedicle pathway prepared the proper screw diameter and length determined using the SpineMap 3D software and the screw assembled the screw can be inserted into the pedicle using the Navigated MANTIS Polyaxial or Polyaxial Reduction Screwdriver Monitor the position of the K Wire to ensure that it is not advanced during screw insertion MANTIS Ke oO _ iq gt gt 14 Z Whenever a K Wire is being used during screw insertion the Short T Handle should be used with the Cannulated Awl and Cannulated Tap When using a Round Handle or T Handle the K Wire length may not be sufficient to pass through the entire instrument assembly gt The Navigated MANTIS Polyaxial and Polyaxial Reduction Screwdriv ers include a locking feature that is designed to provide tactile visual and audible confirmation that the Polyaxial Screwdriver is securely locked w v iv vl lv dele WWW Navigated MANTIS To engage the Navigated MANTIS Poly axial or Polyaxial Reduction Screwdriver 1 Press the UNLOCK button K 2 Hold the screw by the threads and engage the tabs on the screwdriver tip L into the saddle of the screw head M 3 Fully seat the screwdri
12. stryker N A3 gt G y aa SLLNVIN G31VSIAVN i i ki taratar ww l s ga Rotational Adapter 1 Introduction The Rotational Navigation Adapter provides a connection between dedicated Spine instrument tips and a Stryker Navi gation Tracker The instrument tips can be rotated within the adapter while being tracked by the Stryker Navigation System The Rotational Navigation Adapter pro vides three mechanical interfaces 1 Navigated tip interface with coupling ring A 2 Navigation tracker interface B 3 Handle interface C Rotational Navigation Adapter The Rotational Navigation Adapter shall only be used with application packages on the Stryker Navigation System which sup port the Rotational Navigation Adapter The part list of the respective application provides this information ieran Medical Professional Surgeons scrub nurses and employees P in the clinical processing department For the required safety information and contraindications please refer to the safety informations supplied with the software packages to the Instructions for use supplied with the system components tips and handles and to the surgical techniques brochures provided by Stryker Spine Refer to documentation As with any technical guide the surgeon should consider the particular condition of the patient and perform the necessary adjustments if required Safety and caution should always be utilized before proceeding
13. ted tip 1 Pull back and hold the coupling ring A of the Rotational Navigation Adapter Qe 72 SS o O O lt X 2 Insert the navigated tip interface H into the tip interface of the Rotational Navigation Adapter 3 Release the coupling ring A of the Rotational Navigation Adapter and fully insert the tip until the coupling ring snaps back to its original posi tion 4 Check that the tip is firmly attached to the tip interface The tip is cor rectly seated if the slope of the tip is aligned with the adapter interface as shown in the following Fully inserted Polyaxial Screwdriver Fully inserted Calibration Tip Rotational Navigation Adapter 3 Calibrate Rotational Navigation Adapter Prepare tools 1 For adapter calibration Navigated Xia 3 and Navigated MANTIS the navigated Calibration Tip must be used On Sg Oo o V O O lt X 2 Attach a tracker a handle and the Calibration Tip onto the Rotational Navigation Adapter Check that the Calibration Tip is firmly attached to the tip interface 3 Initialize the tracker by pressing SELECT for three seconds Upon initialization an information box appears 4 Highlight and select Track Instru ment An instrument calibration dialog starts System Setup y Patient Tracker Pointer Tool Calibration Tool Initialize calibration device i A tracker is switched on Do you want to use th rake for instrument or p
14. ver tip L into the screw head M 4 Turn the outer shaft N clockwise using the LOCK button J until the threads are fully engaged gt If the ratchet sound is not present confirm locking by pressing the LOCK button J AEM ELGO MANTIS gt LOCK button can be pressed at any time during or after the thread engagement action if ratchet sound is not desired To disengage the Navigated MANTIS Polyaxial and Polyaxial Reduction Screw driver 1 Press and release the UNLOCK button K 2 Rotate the outer shaft N counter clockwise while firmly holding the handle Once all of the screws have been placed refer to the MANTIS or MANTIS Redux Surgical Technique for the remainder of the procedure Part List 6002 050 000 Rotational Navigation Adapter 6000 014 000 nGenius Universal Tracker 6000 005 000 Universal Tracker 48761020 Navigated Xia 3 Calibration Tip m 48761111 Navigated Xia 3 Awl 48765111 Navigated MANTIS Cannulated Awl n 48761155 Navigated Xia 3 Thoracic Pedicle Probe 48761062 Navigated Xia 3 Blunt Probe 48765045 Navigated MANTIS Cannulated Tap 4 5 mm 48765055 Navigated MANTIS Cannulated Tap 5 5 mm 48765065 Navigated MANTIS Cannulated Tap 6 5 mm 48765075 Navigated MANTIS Cannulated Tap 7 5 mm 48765085 Navigated MANTIS Cannulated Tap 8 5 mm 48765300 Navigated MANTIS Tap Sleeve j 48761330 Navigated Xia 3 Polyaxial Screwdriver j 48765310 Navigated MANT
15. way into the pedicle The navigated insertion of the instru ment allows the probe tip to follow a path of least resistance without violating the pedicle walls In the case that resistance is met the entry point and trajectory should be reevaluated Probes There are two probe options available The primary differentiating feature of the Straight Blunt Probe and the Straight Thoracic Pedicle Probe is the distal end The Straight Blunt Probe has a flat distal end whereas the Straight Thoracic Pedicle Probe has a sharp pointy distal end designed to optimize its use in the thoracic region of the spine Navigated Xia 3 Instrument Tips The Straight Blunt Probe and the Straight Thoracic Pedicle Probe are laser marked in 10 mm intervals to help indicate the depth in which the probe tip has been inserted Next to the navigational infomation these depth indicators on the probe tips are also helpful in determining the appropriate pedicle screw length Se Straight Blunt Probe See Straight Thoracic Pedicle Probe xe oO Q gt gt 14 Xia 3 Navioateo Xia 3 Instrument Tips Modular Taps For increased bone purchase use the Modular Taps to prepare the pedicle canal Insert the Modular Tap into the pedicle and into the vertebral body The Modular Taps are laser marked with lines in 5 mm increments and numbers in 10 mm incre ments Xia 3 xe oO D gt Z 3 Insert S
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