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iMNS – USER MANUAL

1. csccssscoscccsccnsccssccnsccssccsscsccnsscnsscnsccnsccsscosscessoescees 116 22 7 INSTRUMENTS irruere ex oceuul enabacelatewscencuseasouecconcouatocecel en cuncelatacecou ee avnucnenesuswuanoceueleveraee 119 SYMBOLS Throughout the surgical technique you will find the following symbols _ The descriptions in the Option boxes are referred to first Mm generation GMK instruments The descriptions in the MSS boxes are referred to instruments Suitable for muscle sparing approaches MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 CAUTION BEFORE USING THE MEDACTA iMNS NAVIGATION SYSTEM CAREFULLY READ THROUGH THE MANUALS PROVIDED WITH THE SYSTEM AND THE SURGICAL TECHNIQUES RELATED TO THE SURGERY TO BE PERFORMED THE USER IS RESPONSIBLE FOR ANY DAMAGE OR MALFUNCTIONING CAUSED BY IMPROPER USE OF THE iMNS SYSTEM OR OF ANY OF ITS COMPONENTS This manual illustrates the operation of the navigation software produced by MEDACTA for the specific application described herein This manual applies only to the GMK Knee application This manual describes the Computer Assisted surgical technique of the GMK and describes the use of navigation related instruments The user is required to be familiar with the conventional GMK surgical technique The information contained in this manual and the product to which it refers may be modified by MEDACTA without giving prior notice Note Most of the numerical value
2. 78 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 16 6 MICROMETRIC ADJUSTMENTS USING THE 4IN1 MICROMETRIC POSITIONER The 4inl CAS positioner allows micrometric fine tuning of the anterior posterior cuts parameters Adjustments are performed by turning specific knobs under computer assistance as indicated in the figure below pins fixation option CAS 33 22 0137 H Cut height adjustment R External rotation adjustment 16 7 POSITIONING THE ASSEMBLY 4IN1 CUTTING BLOCK 4IN1 POSITIONER ON THE FEMORAL CLAMP Connect the 4in1 positioner on the 4in1 cutting block see par 16 4 Slide the 4in1 micrometric positioner on the micrometrical distal cutting block fixed on the femoral clamp and move the lever down to secure the connection green arrow Under computer guidance fine tune the 4in1 cutting block position as described in par 16 6 16 8 POSITIONING THE 4IN1 CUTTING BLOCK FREEHAND 02 07 10 0201 6 It is possible to navigate the freehand positioning of the 4inl cutting block To do so assemble the G array on the block as described in 16 1 Rest the block on the distal resection surface and under computer guidance fine tune the positioning 16 9 NAVIGATING THE 4IN1 FEMORAL RESECTION Before proceeding with the navigation of the resection block it Is advisable to perform a confidence test on T and F arrays Suggested prosthesis size is based on femoral A P dimensions If th
3. Fit the Easy CLIP on the pin already introduced in the bone orient the hinge so that the locking knob is facing opposite to the camera and use it as a guide to insert the second pin through the proper groove When fitting Easy CLIP hinge on the first pin it is advisable to use the groove closer to the knee joint see picture and leave the one farther from the joint to guide the insertion of the second pin Before inserting the pin make sure that the line connecting the two pin holes is parallel to the mechanical axis 19 Slide the hinge on the two pins to move it about 5 mm from the skin Once the second pin has been introduced insert the reference array in the dedicated hole rotate it around the axis of the hinge so that it is approximately parallel to the mechanical axis see figure and orient it towards the camera 4 Make sure that the T and F reference arrays are parallel to the M sagittal plane or slightly facing anteriorly 20 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Using the special Allen wrench tighten Easy CLIP to lock the entire assembly Make sure that the mechanical assemblies have been sufficiently tightened and that none of its parts are loose Should any of the reference arrays change position during the surgery it would invalidate the exactness of the data and it will be necessary to abort navigation or repeat the acquisition procedure from the start
4. ecceee 91 17 5 POSITIONING THE TIBIAL CUTTING BLOCK FREEHAND 0 cece ceccecceececeeeesecseeeeceeceeceeenes 91 17 6 NAVIGATING THE TIBIAL RESECTION tise Sacscare te avecss sac teasssansusnenceseesacaaeuatanesdeatatacteassacedeatecaaieaieaes 92 17 7 SECURING THE TIBIAL RESECTION BLOCKS ccccccicasicasnacnnecgacachads E A 94 17 8 HBALRESEC TON curone aa E she ddcaeoe eae pene O deus ees cee ane eestor 95 17 9 TIBIAL RESECTION VALIDATION Option c ccccccccessccccseccccesececescceceececeueceeeeeceeeeecetsuneeetees 95 17 10 JOINT LINE FINE TUNING only for tibia first technique ccccccesssseeecceeeeeeeeeeeeeeeeeeaeeees 96 17 11 IMPLANTATION ait oetsta rts serene E T S E AEA OE 98 17 11 1 TRIAL IMPLANTANALYS Soorinna oa EEEE AEA 98 17 11 2 FINAL IMPLANT ANALYSIS eeeeeeseeneneesesesesesreresesesesrerseseseseserrosesesesesrsrereeseseoeererereseseseseeeeee 100 17 12 REPORT CREA HON arere a a A A AIN 102 18 APPENDIX 1 OTHER DISTAL CUTTING BLOCKS eseessssesoesoscescesossescesossoscessesosoescesossosoesossossesoe 103 18 1 ASSEMBLING THE G ARRAY ON THE DISTAL CUTTING BLOCK cccccsecceceeeceeeeeeeeceeceees 103 18 2 NAVIGATING THE DISTAL CUTTING BLOCK ic scesinsasvssucnesiasaanvendltteves T E E 104 18 3 POSITIONING THE ASSEMBLY DT MICROMETRIC POSITIONER DISTAL CUTTING BLOCK ON FEMUR 104 18 4 SECURING THE DISTAL CUTTING BLOCKS seisiiscusatsieass ccitetincsausdisinracioctastcd
5. PROGRESSION Guides selection The Clamp distal femoral resection block 02 06 10 0004 will be used Tibia tool Distal tool STD 02 07 10 2145 6 _ STD 2 623 _ STD 02 07 10 0111 3 C STD 02 07 10 0127 _ Mis 2 622 _ Mis 2 618 MIS 02 07 10 0290 1 MIS 02 07 10 0065 C Clamp 02 06 10 0004 02 06 10 0014 4 in 1 tool _ STD 02 07 10 2101 6 _ Mis 2 631 6 _ 02 07 10 0201 6 _ CAS 2 637 _ CAS 33 22 0137 The following tools can be used to navigate the bone resections Tibia tools e STD 02 07 10 2145 6 MIS 02 07 10 0065 Clamp 02 06 10 0004 e STD 02 07 10 0111 3 e MIS 2 622 4 in 1 tools e MIS 02 07 10 0290 1 e STD 02 07 10 2101 6 Femur tools Distal Tools e STD 2 623 e STD 02 07 10 0127 e MIS 2 618 DELETE LOAD SAVE MIS 2 631 6 02 07 10 0201 6 both for STANDARD and MIS procedures CAS 2 637 CAS 33 22 0137 These controls are used to delete load or save an existing profile See MANAGING PROFILES section 42 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 12 6 SURGERY PLANNING This screen allows to modify the cuts default parameters in order to customize the positioning of the default target reference Move to the corresponding box using f3 then use f2 decrease or f4 increase to modify the value Surgery planning Set your resection parameters Delete i z GM came Tibial resection Distal resections 4 in 1 resec
6. 33 22 0001 33 22 0002 33 22 0072 33 22 0071 33 22 0073 33 22 0101 Pin D 3 2 L 100 I1S05835 L 25 meche 02 07 10 2299 triangle ee tenia Pin D 3 2 L 100 ISO5835 L 25 meche 02 07 10 2303 triangle 02 07 10 2046 33 22 0102 33 22 0103 02 07 10 2281 Navigation sword pin 33 22 0129 33 22 0130 33 22 0131 33 22 0141 33 22 0049 33 22 0050 Template for cuts control Tightening screw with OR for rigid body G on 75 36 302 adaptor 33 22 0003 33 22 0004 Assembly palpator 75 36 301 33 22 0052 33 22 0057 33 22 0053 33 22 0100 33 22 0107 33 22 0108 head for fixing rigid body CAS 4in1 Positioner 33 22 0137 33 22 0135 33 22 0136 02 06 10 0069 02 06 10 0070 02 06 10 0045 02 06 10 0014 02 06 10 0004 119 O2 06 10 0000 Medial jaw small right 02 06 10 0001 Medial jaw small left 02 06 10 0002 Large medial jaw right 02 06 10 0003 Large medial jaw left O2 26 10 0011 Universal hex head screwdriver 3 5 mm The following instruments are part of the GMK Instruments set and are mentioned or appeared in this document These instruments are part of different GMK instrumentation generations Some items may have the same description but different reference numbers Ref No Description _ 02 07 10 0105 Extramedullary superior guide asn UER 2 617 without pins 120 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 121
7. STD 02 07 10 0127 left knee Green parallel pins Red oblique pin Blue G array MIS BLOCK MIS 2 618 Left knee Green parallel pins Red oblique pin Blue G array It is advisable to insert the pins under power control to avoid pinning the block in malalignment Ensure low drilling speed to reduce heat generation 73 15 7 DISTAL FEMORAL RESECTION Before performing the distal resection tools that could interfere with the saw blade must be removed Check the final alignment of the block and gently remove the G array It is suggested to double check the cut by mean of the conventional sickle finger before cutting Insert the saw capture on the block to ensure a more accurate resection and using a 1 27 mm blade accurately resect the bone taking care protecting soft tissue from injury To help relaxing the quadriceps muscle and reduce tension on the cutting block it is advisable to perform the cut with the leg approximately 50 60 degrees flexed In case the CAS 4in1 positioner will be used to align the 4in1 cutting block it is recommended to keep the distal cutting block in position once resected 74 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 15 8 DISTAL FEMORAL RESECTION VALIDATION Option PROGRESSION Distal resection Acquire the distal resection surface using the verification template If the CONFIDENCE TEST was selected test it before the acquisition C C
8. 9 NAVIGATING THE 4IN1 FEMORAL RESECTION ccccccscscscsececscsescscscscsecscscsessscssecscscsssescacscsesacscees 80 16 10 SECURING THE 4in1 RESECTION BLOCKS c cccccccsssscscscscsecscscscscscscssecscscscscacassescscasscssacacavevees 82 16 11 ANTENORA R A ON O e 83 16 12 ANTERIOR FEMORAL RESECTION VALIDATION Option siessen 84 4 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 17 TIBIALIRESECT ION uinnean a T 85 17 1 ASSEMBLING THE G ARRAY ON THE TIBIAL CUTTING BLOCK ssnsnsnssssessssnsessesesessrsesessrsessese 85 ISTO 02 OYA TONON E EVE everest rtacerorer cess ses candarecatesescanstcmmassauats tocatdninesaeatsntesbamastuestasee ideas mewuneadomoaseeseass 85 IMIS 02 07 10 0290 1 ingoni T ON E T ial oa aa sonst auc A 85 17 2 ASSEMBLING THE TIBIAL CUTTING BLOCK ON THE EXTRAMEDULLARY ALIGNMENT JIG 86 17 3 POSITIONING THE TIBIAL CUTTING BLOCK EXTRAMEDULLARY JIG OPTION cc eee eeeeee 87 17 4 POSITIONING THE TIBIAL CUTTING BLOCK DT MICROMETRIC POSITIONER 000 88 17 4 1 ASSEMBLING THE DT MICROMETRIC POSTIONER ON THE DT MICROMETRIC SUPPORT 88 17 4 2 ASSEMBLING THE TIBIAL CUTTING BLOCK ON THE DT MICROMETRIC POSITIONER 89 17 4 3 POSITIONING THE ASSEMBLY TIBIAL RESECTION BLOCK DT MICROMETRIC POSITIONER ON THE TIBIA aaraa temeiataraetoa etna nee ce Satna uucerncea T O O O 90 17 4 4 MICROMETRIC ADJUSTMENTS USING THE DT MICROMETRIC POSITIONER
9. acquisitions and begin registering data A higher BUZZ sound will inform the user when the acquisition is ongoing a lower BUZZ sound will inform the user if one of the arrays is not visible during acquisition In this case the acquisition will be stopped until all the arrays are visible again Once the wished data have been registered press f4 again to stop registration A snapshot will be automatically taken and the cursor will move to the navigation box To acquire a new graph move the cursor to START STOP acquisitions and press f4 Please note that the previous graph will be deleted but any existing snapshot will be kept in memory 101 17 12 REPORT CREATION PRERESECTION ANATOMICAL pesecnon TRIALIMPLANT FINAL IMPLANT ANALYSIS LANDMARKS ANALYSIS ANALYSIS PROGRE A Create report Insert the remarks on the surgery Remarks Write a comment Create Report store on CD Create Report store on USB DRIVE At the end of the procedure the iMNS system can display a surgery report containing the pre surgery and post surgery data as well as the personal data of the patient if entered at the beginning of the procedure Prior to generating the report Create Report control the user can add annotations and remarks by typing text in the Remarks box as displayed in the picture above When Create Report is activated iMNS asks the user whether he she wishes to sav
10. be assembled on G shaped and P shaped arrays Using the G array or the pointer without the blue disks in place will lead to unpredictable results 17 8 2 Installing the reference arrays 8 2 1 Easy Clip option Ref no 33 22 0065 The side of the reference array bearing the passive markers must a face the camera For proper positioning of the F and T shaped reference arrays respectively on the femur and the tibia of the patient follow the instructions below Simulate the placement of the tools you will use during the surgery to make sure that they will not interfere with the reference arrays The pins holding the reference arrays can be positioned either percutaneously or inside the incision according to the needs and to the different surgical techniques Usually it is preferable to insert them in the antero medial aspect of the bone Having selected the appropriate location insert the first pin into the bone Secure the pins medially with respect to the anatomical axis of the tibia in order to prevent any conflicts with the alignment rod that can be used to control the tibial cutting guide positioning Threaded pins must be inserted until the second bone cortex is 5 reached in order to assure the maximum hold in the bone 18 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Open the Easy CLIP hinge by unscrewing it Carefully unscrew the Easy CLIP hinge without forcing it beyond the limit
11. check box registers the position of the template and validates the cut The navigator will then display the validated external rotation related to the posterior condyles line It is extremely important to position the reference array correctly and to acquire the real data the next steps depend on this acquisition and a deviation from the real values may lead to errors 84 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 17 TIBIAL RESECTION _ For the tibial cutting blocks ref no 02 07 10 2145 6 and 2 622 please refer to Appendix 3 17 1 ASSEMBLING THE G ARRAY ON THE TIBIAL CUTTING BLOCK STD 02 07 10 0111 3 Select the appropriate cutting block Left or Right according to the knee undergoing surgery and insert the G array in the two dedicated holes MIS 02 07 10 0290 1 Two blocks are available for a left or right knee Chose the correct block and insert the G array in the two dedicated holes as shown in the picture 85 17 2 ASSEMBLING THE fTIBIAL CUTTING BLOCK ON THE EXTRAMEDULLARY ALIGNMENT JIG STD 02 07 10 0111 3 MIS 02 07 10 0290 1 The standard and MIS tibial cutting blocks can be assembled on the extramedullary alignment jig The advantage of using this instrumentation in conjunction with navigation is a higher stability of the block during the positioning phase The stylus can optionally be used to estimate the depth of the resection see conventional surgical technique
12. must necessarily be available in the operating theatre As en electronic device iMNS system should not be put in direct contact with flammable materials such as anesthetics solvents detergents gases In addition avoid exposing the acquisition system to direct daylight Although the iMNS Navigation System has been tested and declared fully satisfying the electromagnetic compatibility requirements indicated in the standards EN 60601 1 2 2nd ed radio communication devices including portable ones may interfere with the iMNS system reducing its accuracy 2 INSTALLATION For proper installation and maintenance of the MEDACTA iMNS navigation system refer to the specific hardware user manual Use the iMNS system only with the equipment specifically supplied or approved by MEDACTA Prior to every surgery make sure that the instruments have been properly sterilized and that they are in such conditions as to adequately perform their function The instruments for non navigated surgery should also be available Clean and disinfect the instruments before sterilization Before sterilizing the reference arrays remove the markers from their supports THE MARKERS ARE MEANT FOR ONE TIME USE They are provided sterile Do not sterilize them do not reuse them Re sterilizing and re utilizing the passive markers may compromise the infrared reflective properties The user is responsible for damages to components caused
13. pins B in the figures above must be inserted on the verification template V in the figure on the side il f Of When assembling the G shaped array on the template and on the other specific tools make sure that the array is fully seated An incomplete insertion will lead to loss of accuracy and false information 9 ACQUISITIONS The acquisitions are extremely important for the proper functioning of the navigation process The quality of the information provided by the MEDACTA navigation system to the surgeon is in fact strictly related to the accuracy of the acquisitions performed using the pointer or markers fixed to bones and instruments At the beginning of each acquisition the tip of the pointer P shaped reference array must already be in contact with the bone surface and must absolutely not be lifted until the end of the acquisition If the user suspects that the pointer was not held in contact with the bone surface during the acquisition repeat the procedure to avoid providing the navigator with unreliable information 30 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Make sure that the cameras are perfectly still during the acquisitions Vibrations and small movements may compromise the accuracy of the results Between one acquisition and the next the camera can however be repositioned according to the needs without compromising system accuracy and reliability in any way 9 1 USAGE OF
14. the iIMNS navigation software manager To move the cursor on GMK v4 4 0 use the Tab key select the application by pressing Return 34 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Select the desired application and press f4 to start the navigation l l IMNS Software m C mn 12 1 PREVIOUS SESSION RECOVERING The navigation process is continuously stored in the hard drive of the computer In case of an improper termination of the navigation program e g due to a power failure it will be possible to restore the navigation process exactly as it was before the problem arose To do so Select the same application that you were using when you experienced the improper termination The following warning message will be displayed The previous session was unproperly closed All the data stored until now will be recovered To have a blank session please press the exit button in the next window and restart this application i Change selection F4 Confirm selected option To restore the previous session select OK and continue navigation Recovered data will be already registered In case the recovery of the previous session is not needed select OK and then EXIT to restart the software application 35 12 2 SURGERY DATA Surgery data Insert surgeon s ID Surgery data Surgeon Surgery date mm de__ _ veer Decode S O Patient data T Nme SSS Male Fema
15. ties mS aah ir SSS ee Rest the selected 4in1 cutting block on the performed distal cut and under computer assistance fine tune its position 19 3 ASSEMBLING THE 4IN1 CAS POSITIONER ON THE 41IN1 CUTTING BLOCK CAS 2 637 Insert the G array in the two holes as displayed in the picture on the left 107 MIS 2 631 6 Insert the centering pins on the CAS positioner see figure above left into the two holes located on the rib on the MIS 4in1 cutting blocks figure above right Apply pressure so that the block and the positioner are in full contact and secure the assembly by turning the knob highlighted in green in the picture above right The 4in1 cutting blocks ref no 02 07 10 2101 6 are not compatible with the fixation by means of the micrometric 4in1 positioner ref no 33 22 0137 108 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 19 4 POSITIONING THE ASSEMBLY CAS POSITIONER 4IN1 CUTTING BLOCK ON FEMUR TIP Before fixing the CAS positioner on distal block set the regulation screws in the middle position in order to have the possibility to fine tune the 4in1 block position in both directions The distal cutting block must be firmly in place in the same position it was when the distal resection was performed To allow the connection of the cutting block on the CAS positioner loosen the locking knob A in the figure above Pay attention to not reach the complete unsc
16. 4 0 and up ref no 99 36 12US rev 02 Saw blade exit locate the region of the anterior femoral cortex where you wish the blade to exit from the bone This acquisition may be multi point or single point depending on the selected option see 12 5 J This acquisition affects femoral size estimation and the position of the anterior femoral cut Should the data presented by iMNS be contradictory or a considered unreliable it is recommended to repeat the corresponding acquisitions 57 14 4 HIP CENTER ACQUISITION 14 4 1 STANDARD SEQUENCE PROGRESSION Hip centre Put the leg in adduction Patient s pelvis must be kept still during the acquisition process _ Abducted leg Adducted leg L Lifted leg Accuracy degrees Clear All A sequential abduction adduction and lift of patient s leg is required This maneuver has to be done twice in order to allow the navigation system to calculate acquisition accuracy displayed in the traffic light on the right In order to assure the accuracy of identification of the hip center it is essential that the femur is able to make movements even if modest with respect to the pelvis If these movements cannot be made it is impossible to identify the desired point thus precluding an accurate navigation In such a circumstance please abort navigation and continue with the traditional instrumentation Y Patient s pelvis must be kept still during the hip c
17. 4 4 0 and up ref no 99 36 12US rev 02 17 4 4 MICROMETRIC ADJUSTMENTS USING THE DT MICROMETRIC POSITIONER The DT micrometric positioner allows micrometric fine tuning of the cut position of the block Adjustments are performed by turning specific knobs under computer assistance as indicated in the figures below S slope V varus valgus H cut height 17 5 POSITIONING THE TIBIAL CUTTING BLOCK FREEHAND STD 02 07 10 0111 3 MIS 02 07 10 0290 1 It is possible to navigate the freehand positioning of the tibial cutting block To do so assemble the G array on the block as described in 17 1 Rest the block on the tibia and under computer guidance fine tune the positioning 91 17 6 NAVIGATING THE TIBIAL RESECTION RESECTION ANATOMICAL F2 F3 F4 ANALYSIS ANALYSIS Tibial resection Set the resection parameters and accordigly navigate the resection block Varus 3 0 2 0 Slope Cut Height 9 Varus 3 Slope 3 _ HKA Varus O 02 07 10 0291 33 22 0003 Before proceeding with the navigation of the resection block it is advisable to perform a confidence test on T and F arrays Assemble the G array on the tibial cutting block Standard resection parameters are displayed on the right They can be altered according to the surgeon s needs This operation will move the bone model displayed on screen so that its orientation with respect to the target blue lines is accordingly updated Real time n
18. 8 2 2 Pins locking clamp option ref no 33 22 0107 The T shaped and F shaped arrays can alternatively be secured on bones using the hinge in figure Insert the first pin mount the hinge on it pushing the lever red in figure taking care that the release button indicated in figure is facing the patient finally measure the distance where to insert the second pin using the hinge itself 21 After both pins have been inserted the locking screw see figure in green must be tightened to prevent any movements Insert the reference array into the ball socket orient it parallel to the bone diaphysis facing the camera and slightly anterior Once the positioning is satisfying tighten the screw see figure in red to fix the position 22 Insert the head for rigid body ref no 33 22 0108 into the dedicated slot on the clamp only one orientation is allowed by pressing the release button see figure in yellow Y Y bi MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 This fixation system allows the reference array to be removed during the surgery when not needed Do not remove the reference array when acquisitions are ongoing To release the reference array push the release button and extract it keeping it assembled with the support Do not directly pull the array when removing it After reconnecting a reference array on the clamp it is recommended to perform a confidence tes
19. 86 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 17 3 POSITIONING THE TIBIAL CUTTING BLOCK EXTRAMEDULLARY JIG OPTION STD 02 07 10 0111 3 MIS 02 07 10 0290 1 To navigate the positioning of the tibial cutting block when the extramedullary jig is used insert the G array on the cutting block and position the lower part of the jig taking care that the malleolary pincer is exactly facing the centre of the ankle joint Let the upper and lower part of the jig free to slide into each other Under computer guidance it will then be possible to fine tune the placement of the block 87 17 4 POSITIONING THE fTIBIAL CUTTING BLOCK ODT MICROMETRIC POSITIONER The DT micrometric positioner can be fixed on the tibia by mean of the DT micrometric support 17 4 1 ASSEMBLING THE DT MICROMETRIC POSTIONER ON THE DT MICROMETRIC SUPPORT The following components of the micrometric system must be assembled to navigate the tibial resection e DT Micrometric Positioner 33 22 0136 e DT Micrometric Support 33 22 0135 Assemble the micrometric support on the 3 hole socket on the micrometric positioner as indicated in the picture above on the left Secure the assembly by turning the knob highlighted in green in the picture above on the right 88 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 17 4 2 ASSEMBLING THE TIBIAL CUTTING BLOCK ON THE DT MICROMETRIC POSITIONER TIP Before
20. Acquire a single point on the medial malleolus Medial malleolus _ Lateral malleolus _ Tibia centre _ Femur centre Clear All The navigation system will use the malleolary references to calculate the distal extremity of the tibial mechanical axis and the tibia and femur centers to define a virtual hinge in the center of the knee 53 14 2 TIBIAL SURFACES ACQUISITION PROGRESSION Tibial plateaus Surfaces have been acquired V Medial tibial plateau a Lateral tibial plateau Clear Al O OE All Registration of the tibial plateaus allows the system to assess tibial resection level single point or surface acquisition The graphical representation can highlight any possible lifting of the pointer that occurred during acquisition In this case it is in fact possible to see a red segment coming out of the profile in the graphical representation on the left of the image Should this be the case and in any case if the surgeon doubts of having lifted the pointer from the articular surface the acquisition must be repeated 54 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 14 3 FEMORAL LANDMARKS ACQUISITION Femoral landmarks Acquire a single point on the anterior cortex This point will be the saw blade exit Medial post condyle Lateral post condyle Medial distal condyle Lateral distal condyle Medial epicondyle Lateral epicondyle Z Whiteside s line Sizing Med
21. F7 Camera positioning F8 F amp T Confidence test F9 Pre surgery analysis F11 screenshots slide show F12 Back to current step the navigation step in use when the shortcut was selected Shortcuts can be also activated in sequence Example F8 F6 CURRENT STABILITY NAV CAMERA OTEP TESI SETTINGS POSITIONING F12 Fiz 16 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 8 REFERENCE ARRAYS 8 1 Preparing the reference arrays The system works with four different reference arrays also known as rigid bodies h Paa A 7 i J i a J J Figure 1 T shaped Figure 2 F shaped Figure 3 G shaped Figure 4 P shaped reference array for reference array for reference array for reference array pointer the tibia the femur the cutting guides T T shaped reference array used to identify the position of the tibia of the patient F F shaped reference array used to identify the position of the femur of the patient P P shaped reference array pointer used to perform all the acquisitions of the anatomical references during navigated surgery G G shaped reference array used to identify the position of the different cutting guides The passive markers disposable IR reflecting balls must be assembled on the reference arrays before each surgery For the assembly maintenance and operating procedures see the appropriate paragraph in the hardware user manual Blue disks must
22. IMNS MEDACTA NAVIGATION SYSTEM SURGICAL TECHNIQUE GMK v 4 4 0 and up Ref 99 36 12US rev 02 CAUTION Federal law USA restricts this device to sale by or on the order of physician Distributed by MEDACTA USA Inc 4725 Calle Quetzal Unit B Camarillo CA 93012 1 800 901 7836 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 TABLE OF CONTENTS 1 INTENDED USE ice desancd Gacic dc Goceca Gesnwtic O E A ouuveatecenenetees 8 1 1 COME AIM GCIG ATION snaren one N T 10 1 2 COWIE AU ONG cei orca ere cae E T E A Sak aaivag valency O aslesacyenaenn es 10 2 INSTALLATION aariaa ett siseusttyasevaasy ins ucnsy acai uote teuensvansvuns O 11 3 CONTROLS cieta a A A E once raneuncuvecanacerswanesusmbenaseneseeasesebenecers 12 4 USER INTERFACE reaa assa E aE ENE aAA ENN aA 13 5 ICONS IN THE NAVIGATION BOX arcsin N A 15 5 1 CONTROL Een A E A EE EA AE EA ieee aeeontas 15 6 ACCURACY INDICATOR crota E 15 Ze SHORTCUTS cicirine nioena er a a On aaa 16 8 REFERENCE ARRAY Soinin E N E A 17 8 1 Prepannedherelerente aiT ays ogno tinaaa aa n a a a Ri 17 8 2 stalling the reference artaySrnsininrniiinin a a ea a a a ae 18 8 2 1 Easy Clip option Rer no 33 22 0065 aranui aE EO N E TA T A 18 8 2 2 Pins locking clamp option ref no 33 22 0107 ccccccssscccccssssecccccensecccccaesecceesaueccessaaeeeessanaees 21 82 3 Femoralholderoption ref no 33 22 0129 e seinan a a E 23 82A FEMOPAlClAND ODEON a h aa
23. ON BLOCKS Once the positioning of the block is deemed satisfactory it can be stabilized using parallel pins that still allow a correction of cut height an oblique pins to firmly hold the block in position The following diagrams display the layout of the pin holes 3 2 mm diameter pins are used STANDARD BLOCK STD 02 07 10 0111 3 left knee Green parallel pins Red oblique pin MIS BLOCK MIS 02 07 10 0290 1 left knee Green parallel pins Red oblique pin It is advisable to insert the pins under power control to avoid pinning the block in malalignment Ensure low drilling speed to reduce heat generation 94 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 17 8 TIBIAL RESECTION Before performing the resection tools that could interfere with the blade must be removed Check the final alignment of the block and gently remove the G array Insert the saw blade guide on the standard block for a more accurate resection and using a 1 27 mm blade accurately resect the bone taking care protecting soft tissue from injury 17 9 TIBIAL RESECTION VALIDATION Option Before validating the resection plane it is advisable to perform a confidence test on T and F arrays Assemble the G array on the verification template and rest it on the cut Surface Tibial resection Validate the tibial resection Please TEST markers stability before acquiring the cut surface Validate Tibial varus 0 0 3 0
24. Slope Real time varus valgus posterior slope and cut heights are displayed on screen 95 F4 on the validate check box registers the position of the template and validates the cut The navigator will then display the validated varus valgus and slope and the amount of bone resected from each plateau It is extremely important to position the reference array correctly and to acquire the real data the next steps depend on this acquisition and a deviation from the real values may lead to errors 17 10 JOINT LINE FINE TUNING only for tibia first technique Joint line Put the knee in extension and press F4 Make sure that the spacer is in contact with the tibia and both the femoral condyles C Extension spacer AND the tibi Flexion OR alternatively Clear Al This step refines the position of the joint line after the tibial resection Y The simulation of the 10 mm minimum gap is MANDATORY The spacer must be inserted into the joint before performing the acquisitions in extension and flexion 96 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 The 10 mm gap can be obtained by mean of two different combinations as Suggested on screen e 2mm tibial cover plate Ref no 02 07 10 2305 7 depending on tibial size IC reference spacer Ref no 02 07 10 2230 mounted on the dedicated handle Ref no 02 07 10 1027 e 10mm spacer Ref no 02 07 10 4710 or 02 07 10 4810 depending on tibial s
25. THE POINTER The pointer adopted with iMNS can be used in three different ways according to the kind of data being registered Single point acquisition rest the pointer on the appropriate anatomical reference point and press F4 or right pedal In order to perform an acquisition all the involved reference arrays must be visible A higher BEEP sound will inform the user when the acquisition have been done a lower BEEP sound will inform the user if one of the arrays is not visible during the acquisition In this case the acquisition will not start Surface acquisition rest the tip of the pointer on the appropriate landmark and press F4 An acoustic signal will confirm that the acquisition is ongoing Taking care not to lift the pointer paint the surface by gently moving the tip of the pointer in a spiral motion 31 In order to perform an acquisition all the involved reference arrays must be visible A higher BUZZ sound will inform the user when the acquisition is ongoing a lower BUZZ sound will inform the user if one of the arrays is not visible during the acquisition In this case the acquisition will not start or will be frozen until the needed arrays are visible 32 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 10 PREOPERATIVE PLANNING 10 1 RADIOLOGICAL PLANNING This is performed from the pangonogram hip knee angle film postero anterior and lateral knee ra
26. able width of the femoral component ADDITIONAL FEATURES Automatic screenshots Screenshots of key steps of the navigation process will be automatically stored G tool calibration The G reference array will be calibrated by mean of a specific tool T amp F confidence test Two references one on the tibia and one on the femur will be registered and used to test if F or T reference arrays moved during the surgical procedure By disabling the confidence test it will not be possible to test navigation accuracy It is strongly recommended that the confidence test is kept enabled to ensure the maximum safety 40 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Volume control By pressing f2 and f4 it is possible to set the volume of the sounds emitted by the iMNS from 0 minimum to 5 maximum Joint line fine tuning only for tibia first navigation By selecting this option an additional fine tuning of the distal and posterior femoral landmarks will be performed using a spacer block Auto forward By enabling this option after the last acquisition in the current screen if any warning message is shown the system will automatically proceed to the next screen 41 12 5 GUIDES SELECTION Cutting blocks and micrometric tools to navigate them can be individually selected To visualize the selected block move the cursor on the related box and confirm the choice by pressing f4
27. asscandeacsabatioaveusdees 105 19 APPENDIX 2 OTHER 4IN1 CUTTING BLOCKGS ccssccssccssccssccssccssccsscsscnscccsscesccsscosscosseesees 106 19 1 ASSEMBLING THE G ARRAY ON THE 4IN1 CUTTING BLOCK cccccccecccccssececeeeeceeeeeceeeeneeees 106 PST DOF 0710 210 126 ennn tects taicte vet teh A eased anata eas alae aa 106 19 2 NAVIGATING THE 4IN1 CUTTING BLOCK FREE HAND ccccccesseccceseceeeesececeeseeeeeeeceseeneeess 107 Rest the selected 4in1 cutting block on the performed distal cut and under computer assistance fine TUNIS IES DOSI OMen a E E E N E TG a 107 19 3 ASSEMBLING THE 4IN1 CAS POSITIONER ON THE 4IN1 CUTTING BLOCK ccecceseeeeeees 107 19 4 POSITIONING THE ASSEMBLY CAS POSITIONER 4IN1 CUTTING BLOCK ON FEMUR 109 19 5 SECURING THE 4IN1 CUTTING BLOCKS ON FEMUR norinni an a a 110 20 APPENDIX 3 OTHER TIBIAL CUTTING BLOCKS cssccssccssccssccssccssccsccnsccnsscnsccssccssccsscescoescees 111 20 1 ASSEMBLING THE G ARRAY ON THE TIBIAL CUTTING BLOCK ccccccceseccceseeeceeseceeeeseeeeees 111 20 2 ASSEMBLYING THE TIBIAL CUTTING BLOCK ON THE EXTRAMEDULLARY JIG cccceeeeeeeee 112 20 3 NAVIGATING THE TIBIAL CUTTING BLOCK FREE HAND cccccssccccssecceeesececeesseeeeeeceseeneeees 114 20 4 SECURING THE TIBIAL CUTTING BLOCK ON TIBIA cccccssecccessceccesececeeseceeeeeceseeeeceseueeesees 115 21 APPENDIX 4 ANATOMIC LANDMARKS
28. avavsssssacssssacavacsesasscasssavavaaseacacees 62 14 7 END OF REGISTRATION PHASE w ssscecscsecsccseesesecschsvaccsseeaesovaaddsduscbedadsdubceadhuedscsvtnddedvscbedacewebaate 63 15 DISTAL FEMORAL RESECTION ccccccsccosececcececcesscecsececcacsccessccesacessaceccassccesaceasacsccarsceasaceetacscsacece 64 15 1 ASSEMBLING THE G ARRAY ON THE DISTAL CUTTING BLOCK 64 15 2 THE MEDACTA DT MICROMETRIC POSITIONER cccscscsccscesscscscscsscecscscsescacscsecucscscsescacscsseecacees 65 15 2 1 ASSEMBLING THE DT MICROMETRIC POSTIONER ON THE DT MICROMETRIC SUPPORT 65 15 2 2 ASSEMBLING THE DISTAL RESECTION BLOCK ON THE DT MICROMETRIC POSITIONER 66 15 2 3 POSITIONING THE ASSEMBLY DISTAL RESECTION BLOCK DT MICROMETRIC POSITIONER IN TRE FU ETE E EAE E EE E EN EE 67 15 2 4 MICROMETRIC ADJUSTMENTS USING THE DT MICROMETRIC POSITIONER 68 15 3 THE MEDACTA FEMORAL CLAMP ccccscscscscscsssscscscscscscsscecscscsescscsvsscucacssssasavscsssssscasssacavscsueacacees 69 15 3 1 ASSEMBLING THE DISTAL RESECTION BLOCK ON THE DT MICROMETRIC POSITIONER 69 15 3 2 POSITIONING THE ASSEMBLY DISTAL RESECTION BLOCK MICROMETRIC POSITIONER ON THE FEMORAL CLAMP cccccccssccecscscscscssecscscscscssvsscucssscscscavavssessasasasssavavavsusssasacssavavavaseasacseseasavavaveeasacaes 69 15 3 3 MICROMETRIC ADJUSTMENTS USING THE FEMORAL CLAMP MICROMETRIC POSITIONER 70 15 4 POSITIONING THE DISTAL CUTTING BLOCK FREEHAND ccccccscscscsccececs
29. by incorrect sterilization 11 3 CONTROLS iMNS navigation system is controlled by means of 3 pedals the keyboard is used in some specific circumstances only Keys F2 F3 and F4 can always be used instead of left middle and right pedal respectively Up and down arrow keys can also be used to move the cursor red rectangle contouring the currently selected control up and down 12 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 4 USER INTERFACE ye d ama co eee B q Tibial axis Acquire a single point on the medial malleolus _ _ m m A WORKFLOW INDICATOR Indicates the overall navigation workflow and the position of the current step yellow B PROGRESSION BAR and INSTRUCTIONS The progression bar indicates whether the minimum necessary information to move to the next screen has been provided to the navigator if the operator has not yet entered any of the necessary information the bar is completely white It progressively changes to yellow as information is added When the bar is completely yellow it means that the information provided is sufficient and that it is possible to go to the next navigation step C REFERENCE ARRAYS Icons are green if the corresponding arrays are visible red if they are not visible and gray if they are not needed in the current step A number displaying the accuracy appears next to the F and T array icon when stability is being te
30. calibration plane and press F4 Flip the G array 180 degrees and again rest the template on the calibration plane to calibrate the other side of the tool Check the accuracy on both sides of the G array by observing the traffic light Symbol on screen If the accuracy is not acceptable yellow or red please repeat the acquisition Carefully check that all passive markers of G and F arrays are fully visible by the camera during all calibration process Firmly keep the template well in contact with the calibration plate during all acquisitions to obtain the correct accuracy 48 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 13 SURGERY START HKA PRE RESECTION ANATOMICAL RESECTION TRIAL IMPLANT ANAL IMPLANT REPORT F3 ANALYSIS LANDMARKS ANALYSIS ANALYSIS PROGRESSION Surgery start Secure the T and F arrays on patient s tibia and femur respectively From this step on reference arrays must be firmly attached to patient s bones Different solutions may be available to fix the T and F arrays on the bones see 8 2 49 13 1 CAMERA PLACEMENT F7 Camera placement The reference arrays should be in the green zone in both views Camera icon is green when the camera is properly working Move the camera so that the reference arrays are in the field of view of the camera green region on screen The camera has an effective range of approximately 2 5 metres The presence of infrared radiation emitte
31. csescscscsecscscsesescscscssescscees 71 15 5 NAVIGATING THE DISTAL FEMORAL RESECTION cccscscsecscssscscscscsececscscsescscssececscscsescsvscsesacscees 72 15 6 SECURING THE DISTAL RESECTION BLOCK secciceesccscecchusssece meseicitestaces akak an En a Enna a annarra 73 15 7 DISTAL FEMORAL RESECTION c cccsccscscscscscscscsececscscscscavsesecscsssssavavsssscacssssavavacsssasacasasacavacsueacacees 74 15 8 DISTAL FEMORAL RESECTION VALIDATION Option cccccccecscsssesecessesesessssescsesscsesesesssesesvsececeee 75 16 4IN1 FEMORAL RESECTIONS cccecceseccccececceseccesscecssceccscsccsssceessceesaceccassccasscasacsccacccasaceacaceaeacece 76 16 1 ASSEMBLING THE G ARRAY ON THE 4IN1 CUTTING BLOCK iieiea 76 TOD FOOL Uke tlt cats ses neha cette E E A ean inate are 76 16 2 THE CAS 4IN1 POSITIONER c cscccececoccssecsscsesececocscccscscsececocscsessssssseseceeseavacscsssececsusnsvecacserecseseacees 76 16 3 ASSEMBLING THE G ARRAY ON THE 4IN1 MICROMETRIC POSITIONER ireren 77 16 4 ASSEMBLING THE 4IN1 CUTTING BLOCK ON THE 4IN1 MICROMETRIC POSITIONER e 20 0 77 16 5 POSITIONING THE ASSEMBLY 4IN1 CUTTING BLOCK 4IN1 POSITIONER ON THE FEMUR 78 16 6 MICROMETRIC ADJUSTMENTS USING THE 4IN1 MICROMETRIC POSITIONER ie 79 16 7 POSITIONING THE ASSEMBLY 4IN1 CUTTING BLOCK 4IN1 POSITIONER ON THE FEMORAL CLAMP 79 16 8 POSITIONING THE 4IN1 CUTTING BLOCK FREEHAND ccccscscecscscsccececscsescscscssscscscsescscsesesscscees 80 16
32. cted tibial cutting block on the tibial anterior face and under computer assistance fine tune its position 114 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 20 4 SECURING THE TIBIAL CUTTING BLOCK ON TIBIA STANDARD BLOCK STD 02 07 10 2145 6 left knee Green parallel pins Red oblique pin Yellow optional pin Green parallel pins Red oblique pin Yellow optional pin After the block has been properly fixed perform the tibial resection see 17 8 and finally validate the cut see 17 9 115 21 APPENDIX 4 ANATOMIC LANDMARKS Landmark Picture Most protruding point Medial Malleolus of the medial malleolus Tibia Center center of the tibial eminence in the middle of the intercondylar notch the most distal point of the trochlea Femur center The most posterior point of the internal Medial posterior condyle in contact condyle with the tibia when the knee is flexed 90 The most posterior point of the external condyle in contact with the tibia when the knee is flexed 90 Lateral posterior condyle Most protruding point Lateral Malleolus of the lateral malleolus tip of the fibula 2mm anterior to the KI 116 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 The most distal point of the internal condyle in contact with the tibia when the knee is in full extension Medial distal condyle The most distal point of the external condyle i
33. dary to advanced destruction of ostheocondral structures or loss of integrity of the lateral ligament Anatomic abnormalities preventing accurate landmarks acquisition or kinematic registration Any condition of the tibia or the femur preventing a stable fixation of the necessary reference arrays Any condition of the tibia and the femur so that the insertion of bicortical pins holding the reference arrays represents an unacceptable risk of stress fracture Patient characteristics that in the opinion of the surgeon make the use of computer assisted total knee replacement inappropriate Mental or neuromuscular disorders may create an unacceptable risk to the patient and can be a source of postoperative complications It is the Surgeon s responsibility to ensure that the patient has no known allergy to the materials used 1 2 Complications If the MEDACTA iMNS system is improperly used the following complications may arise among others Infection Incorrect implant positioning Failed recovery of the articular functionality Refer to the respective package insert for the applicable implant for information about complications 10 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Like all electrical devices the iMNS MEDACTA navigation system may be subject to malfunction due to improper use or to technical reasons It is always possible to complete the surgery with the aid of the standard equipment which
34. degrees indicated by the colored squares Squares are initially red and become green once the corresponding varus valgus sample has been recorded C MAX VALUES Maximum and minimum flexion i e maximum extension are displayed here D PLOT AREA Kinematics of the knee joint are plotted using green dots real time x axis horizontal flexion angle Each unit of the grid corresponds to 30 degrees y axis vertical varus upper half and valgus lower half Each unit of the grid corresponds to 5 degrees Press f4 to activate START STOP acquisitions and begin registering data A higher BUZZ sound will inform the user when the acquisition is ongoing a lower BUZZ sound will inform the user if one of the arrays is not visible 62 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 during acquisition In this case the acquisition will be stopped until all the arrays are visible again Once the desired data are registered press f4 again to stop registration A Snapshot will be automatically taken and the cursor will move to the navigation box To acquire a new graph move the cursor to START STOP acquisitions using f3 then press f4 Please note that the previous graph will be deleted but any existing snapshot will be kept in memory 14 7 END OF REGISTRATION PHASE This step informs that the registration phase has been completed and displays the instruments needed in the following steps D
35. diographs the femoral patellar film and from the available templates set The goal is to determine the angle formed by the anatomical axis and the mechanical axis of the femur to be treated to determine the tibial slope to trace and measure bone resections to establish the intra medullary guide introduction points to assess the sizes of the femoral and tibial components the height of the tibial insert the thickness of patella to be resected to study the topography of the operative site localization of osteophytes and mainly posterior osteophytes 10 2 CLINICAL PLANNING The goal is to assess the range of motion of the joint and patellar centering and to assess whether deformities are established or not 11 SURGICAL APPROACH The most commonly used surgical approach is the internal para patellar approach The surgeon may however use other approaches in certain cases of revision surgery or in the case of severe valgus deformities Mini midvastus and Mini subvastus exposures can also be used provided that in the surgeon s opinion patient characteristics are appropriate for a muscle sparing approach 12 STARTING THE SOFTWARE Turn on the computer and wait a few seconds for the operating system to load and all the peripherals to be initialized The user login screen appears Select the user medacta with password medacta without quotations 33 The applications manager screen appears Just press Return to start
36. e Suggested femoral component is wider than the femoral M L landmarks acquired in FEMORAL LANDMARKS ACQUISITION the system will display a warning message WARNING The prosthesis could be too wide It is up to the user to decide to keep the suggested size or select a smaller prosthesis and remove greater amount of bone from the post condyles The size of the selected femoral component is displayed in shaded yellow centered on the point registered as femur center gt 80 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 DESE F2 F3 F4 PROGRESSION a y gt 4 in 1 resection Please TEST markers stability before navigating the resection block Estimated size 2 Cut height O Femoral rotation Post condyles ext 0 Whiteside line int 9 Epicondyles int 6 EP Ma9 TKA int 1 0 Fe 33 22 0003 Post ext 0 0 02 07 10 0201 0206 Up to four fixed reference lines are dislpayed on screen Blue planned anterior resection level White posterior condylar axis Whiteside s line Epicondylar axis TKA i e tibia knee axis depending on the previously acquired landmarks A moving line informs the user about the real time positioning of the anterior cut plane during navigation of the cutting block The arrow symbol and the numerical value inform the user about the current difference in cut height with respect to the planned resection level An arrow pointing down means that the curr
37. e a a E a saveneias oh eateueams veces ceaens 25 ire no 0206 10000 7O 06 10 OOO isaac ein ch oh wae sia A 25 8 3 Assembling the G shaped reference array occian aiaa N 29 8 4 Assembling the G shaped reference array on the verification template cccccsssececeeeeeeees 30 95 ACQUISITIONS voran asc anise Gey tain Scluyinnd a Seis eins Sa win onan Sarasota De a re E omen 30 9 1 USAGE OFTHE POUN TE Rists ccancsacieas siasi aa i AAA s duueassaeeseatacaaivareanesoutciaasante adueateiacteedieas 31 10 PREOPERATIVE PLANNING coniac aa EE E R 33 10 1 RADIOLOGICAL PLANNING eessesessseessssseresssreresssrevessrecesssreresssreressseeeessrecosssrerosssrerossseeressrecessseeee 33 10 2 CHNICAL PLANNIN G esane irena E aa eee ail crs ads aad aa ie del lle iat sles 33 Ii SURGICAL APPROAGH iirinn a E EN A O ES 33 12 STARTING THE SOFIWARE seg cesusiy haters r a N 33 T21 PREVIOUS SESSION RECOVERING aids sciransvascanencescenarnetndadis taceuspuiceindeu E 35 122 SURGERY DATA cicer a a E S NA 36 12 HMB SELECHON cierran E E O wuincbiuuicedsmauteheeat 37 124 NAVIGATION SETTINGS F6 iccse aai e a a A a aaia 38 T25 GUIDES SELECTION a A 42 126 SURGERY PANNING aroia a a a a eae T eee 43 27s MANAGING PROFILES msarisan E A 45 1283 POINTER CAL BRATION sessc cr sxwse deasaseriademanc at saceiede vnalewntananat dueduc T N 46 12 9 G TOOL CALIBRATION OU OW arnein anr A EA ENE EA ATT 47 13 SURGERY STAR Tiia a a Sonveivnapeselsent
38. e array push the release button and extract it keeping it assembled with the support Do not directly pull the array when removing it After reconnecting the F shaped array on the femoral holder it is recommended to perform a confidence test before proceeding with navigation 8 2 4 Femoral clamp option ref no 02 06 10 0069 02 06 10 0070 The femoral clamp allows to perform the femoral cuts without using any pin to fix the F array on the femoral bone Select the clamp version depending on the side operated left or right and chose the medial jaw version depending on the femur size large or small and leg side left or right Engage the medial jaw on the main body of the femoral clamp as shown in picture 25 Rotate the medial jaw and clip it on the main body of the clamp Open the bone plier unscrewing the corresponding screw picture right red arrow Engage the bone plier on the femoral clamp pic below left and rotate it on the clamp pic below right Lock the connection by turning the corresponding screw pic below right in red in the same sense as indicated by the marked arrow 26 The bone plier is then used to position the clamp on the femur Insert the Whiteside s reference rod into the corresponding hole located on the plier Two positions are available depending on the femur size small or large o Small femur Large femur The position of the clamp on the femur
39. e been acquired it will be possible to test during whatever stage of navigation if the reference arrays moved To do so simply rest the tip of the pointer on the corresponding reference point A number will be displayed next to the array icon If it is greater than 1 this means that the array has moved WARNING If F or T moved data from the navigation system are no longer reliable If the test confirms that F or T have moved one of the following actions is compulsory e Firmly secure the array and repeat the acquisitions performed so far to reinitialize the navigation process e Abort navigation Mark the points used as reference with an electrosurgical knife or by drilling a small hole in case of need it will be easier to locate them The test can be performed also on an array that is not currently in use grayed array icon The test will not display numbers greater than 20 If doing the test no error is displayed this means that the amplitude of motion of the reference array is absolutely unacceptable 52 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 14 ANATOMICAL LANDMARKS ACQUISITIONS NOTICE The screens workflow described in this manual follows the single point pointer on hand mode 14 1 TIBIAL MECHANICAL AXIS Touch with the pointer Medial Lateral malleoli gt Ankle center definition Tibia center Femur center gt Knee center definition PROGRESSION Tibial axis
40. e the data on CD or USB stick If the answer is positive insert the CD USB stick in the drive to automatically save the previously displayed Surgery report In case of negative answer the surgery is stored by default in the system memory and can be later retrieved The report is a multi page document after selecting the report pressing F4 will display next page on screen 102 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 18 APPENDIX 1 OTHER DISTAL CUTTING BLOCKS 18 1 ASSEMBLING THE G ARRAY ON THE DISTAL CUTTING BLOCK STD 2 623 The same block is used on a left or a right femur Insert the G array in the two holes marked with an L left knee or an R right knee MIS 02 07 10 0065 The same block is used on a left or a right femur Locate the upper face and insert the G array in the two dedicated holes 103 18 2 NAVIGATING THE DISTAL CUTTING BLOCK FREE HAND STD 2 623 MIS 02 07 10 0065 d A y 2 Rest the selected distal cutting block on the anterior condyles and under computer assistance fine tune its position 18 3 POSITIONING THE ASSEMBLY DT MICROMETRIC POSITIONER DISTAL CUTTING BLOCK ON FEMUR Assemble the DT micrometric positioner and the DT micrometric Support see 15 2 1 then mount the distal cutting block on the assembly see 15 2 2 Position the assembly on femur figure left and fine tune the position of the block by mean of the micrometr
41. ent positioning of the cutting block is more posterior than the planned resection level more bone will be resected from the anterior femur Below each condyle a numerical value informs the user in real time about the amount of bone going to be cut from each post condyle The real time rotation vs posterior condyles line Post transepicondylar axis EPI and Whiteside s line WS is also shown on screen It is advisable to always check the cut using the conventional instruments before resecting 81 M In case CAS Positioner was selected in the Navigation settings screen an additional optional verification feature is available Move the cursor to the picture icon the lower right corner of the screen press f4 to switch the instrument in use from the CAS Positioner to the corresponding 4in1 block and accordingly assemble the G array on the 4in1 block Check the alignment of the block by reading on screen values 16 10 SECURING THE 4in1 RESECTION BLOCKS Once the positioning of the block is deemed satisfactory it can be stabilized using parallel pins that still allow a correction of cut height and an oblique pin to firmly hold the block in position The following diagrams display the layout of the pin holes 3 2 mm diameter pins are used 4in1 BLOCK 02 07 10 0201 6 Green parallel pins Red oblique pin Yellow cancellous bone screws It is advisable to insert the pins under power control to avoid
42. enter acquisition 58 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 14 4 2 SIX IN ONE Option Hip centre Acquired points 5 6 Put patient s leg in abduction and press F4 Gently execute the following maneuver adduction lift abduction adduction lift An acoustic signal informs the user of the completion of each phase Check measurement accuracy and repeat the acquisition in case accuracy is not acceptable TIP During acquisition keep the F array parallel to the camera it is essential that the femur is able to make movements even if modest with respect to the pelvis If these movements cannot be made it is impossible to identify the desired point thus precluding an accurate navigation In such a circumstance please abort navigation and continue with the traditional instrumentation 7 In order to assure the accuracy of identification of the hip center Y Patient s pelvis must be kept still during the hip center acquisition 59 14 5 SAGITTAL PLANE ACQUISITION PROGRESSION Sagittal plane Put the leg in flexion Put patient s limb in extension first and then in flexion Acquire each stage Once the sagittal plane is calculated the system will be able to assess varus valgus FOR SINGLE POINT OPTION ONLY If any medial lateral acquisitions on the tibia or on the femur have been previously inverted a warning is now shown on screen In such a case go back to the acquisi
43. epending on the technique selected in the Navigation settings screen tibial or femoral instrumentation will be required first Resections start The landmarks needed to create the leg model have been acquired The system is now ready to navigate the resections 02 07 10 0291 02 07 10 0065 02 07 10 0201 0206 63 15 DISTAL FEMORAL RESECTION For distal cutting blocks ref no 2 623 and 0O2 07 10 0065 please refer to Appendix 1 15 1 ASSEMBLING THE G ARRAY ON THE DISTAL CUTTING BLOCK STD 02 07 10 0127 The same block is used on a left or a right femur Insert the G array in the two holes marked with an L left knee or an R right knee MIS 2 618 The same block is used on a left or a right femur Select the appropriate side of the cutting block according to the knee undergoing surgery and insert the G array in the two corresponding dedicated holes 64 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 15 2 THE MEDACTA DT MICROMETRIC POSITIONER The DT micrometric positioner allows the micrometric placement of the distal and tibial cutting blocks by adjusting cut height varus valgus and flexion or slope under computer assistance The DT micrometric positioner can be fixed on the femur by mean of the DT micrometric support 15 2 1 ASSEMBLING THE DT MICROMETRIC POSTIONER ON THE DT MICROMETRIC SUPPORT To navigate the distal resection by mean of the m
44. fixing the micrometric positioner on the distal block set the regulation screws in the middle position in order to have the possibility to fine tune the block position in both directions Locate the flat coupling surface on the DT micrometric positioner in green in figure above left and slide the selected tibial resection block on it Figures above display the assembling of a right MIS tibial resection block Once the block is fully inserted in position see figure above right secure the assembly by tightening the locking knob highlighted in green in the picture aside AN a E rT le SS a 89 17 4 3 POSITIONING THE ASSEMBLY TIBIAL RESECTION BLOCK DT MICROMETRIC POSITIONER ON THE TIBIA Assemble G shaped array on the selected tibial cutting block see 17 1 and make sure that the latter is firmly attached to the micrometric positioner Before navigating the block set the parameters see 17 4 4 close to the target position and finally fix the DT micrometric support to the tibial plateaus by inserting two 3 2 mm pins in the dedicated holes The following pin holes can be used Green tibial pins Under computer guidance it will then be possible to fine tune the placement of the block using the micrometric adjustments The following pictures illustrate the positioning on a right knee STD 02 07 10 0111 3 MIS 02 07 10 0290 1 90 MEDACTA iMNS GMK v
45. g to the knee undergoing surgery and insert the G array in the two dedicated holes see fig left MIS 2 622 The same block is used on a left or a right tibia Orient the block on the appropriate side and insert the G array in the two dedicated holes see fig left The tibial cutting blocks STD 02 07 10 2145 6 and MIS 2 622 are not compatible with the fixation by mean of the micrometric positioner 111 20 2 ASSEMBLYING THE TIBIAL CUTTING BLOCK ON THE EXTRAMEDULLARY JIG Assemble the tibial cutting blocks on the extramedullary alignment jig as shown in figures below STD 02 07 10 2145 6 MIS 2 622 112 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Connect the G array on the tibial cutting block and then position the assembly on tibia as shown in figures below STD 02 07 10 2145 6 MIS 2 622 ST BA PA ink mt SD A LIA i Eear T Wee eh i jer a _ rau I gt Ie wer By ra gt A hy wk Pirni SIETI on 5 3 f fai ane i E ATN J i f TPR J it EL EL Ti f d Af Ji it pi M 4 ie Th HEAT eo Ro g BOs oe D parran q The stylus can optionally be used to estimate the depth of the resection Under computer guidance it is then possible to fine tune the position of the block 113 20 3 NAVIGATING THE TIBIAL CUTTING BLOCK FREE HAND MIS 2 622 STD 02 07 10 2145 6 Sas OE Fg AO ee SS Place the sele
46. graph move the cursor to START STOP acquisitions and press f4 Please note that the previous graph will be deleted but any existing snapshot will be kept in memory 99 17 11 2 FINAL IMPLANT ANALYSIS This step allows performing kinematic analysis of the knee along the entire range of motion ROM as a result of the final components placement Current varus valgus values at different flexion angles are plotted on screen C MAX VALUES Maximum and minimum flexion i e maximum extension are displayed here Final implant Start stop varus amp valgus graph s drawing RT Flexion 2 0 RT Varus A 0 0 Max Flexion 89 5 Min Flexion C 0 5 Real time flexion and varus valgus are displayed and constantly updated A REAL TIME RT DATA B ROM INDICATOR The range of motion is segmented in sectors of 5 degrees indicated by the colored squares Squares are initially red and become green once the corresponding varus valgus sample has been recorded C MAX VALUES Maximum and minimum flexion i e maximum extension are displayed here 100 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 D PLOT AREA Kinematics of the knee joint are plotted using green dots real time x axis horizontal flexion angle Each unit of the grid corresponds to 30 degrees y axis vertical varus upper half and valgus lower half Each unit of the grid corresponds to 5 degrees Press f4 to activate START STOP
47. ial ref Sizing Lateral ref Saw blade exit DAAN ANN Clear All Acquisitions of references needed to navigate the external rotation and the femoral size Medial Lateral posterior condyle single point or surface acquisition locate the most posterior points of the M L condyles Medial Lateral distal condyle single point or surface acquisition locate the most distal points of the M L condyles Medial Lateral epicondyle single point acquisition only touch with the pointer the M L epicondyles This acquisition is optional Whiteside s line acquire some single points along the Whiteside line direction until the accuracy is deemed satisfactory by the system In case accuracy is not satisfactory a warning message appears on screen A minimum number of 4 points and a minimum distance of 17 mm between the first and the last point are required The Whiteside s line acquisition is optional It is strongly suggested to mark the Whiteside line with an electrocautery knife to facilitate its acquisition 55 PROGRESSION f Femoral landmarks Acquired points 8 10 M JANE M L sizing single point acquisition only touch with the pointer the medial and lateral reference points that will be used to define the limits of the M L size of the prosthesis This acquisition is optional medial lateral reference point reference point left knee left knee 56 MEDACTA iMNS GMK v 4
48. ibia Navigation settings Independent resections Dependent resections Hip center acquisition C Six in one Standard sequence Anatomic Landmarks Tibial cut height reference Higher tibial plateau Lower tibial plateau DELETE LOAD SAVE These controls are used to delete load or save an existing profile See Graph after cementation Enabled Disabled Optional femoral rotation references Whiteside s line C Epicondyles O Tibia Knee Axis Landmarks acquisitions C Single point Fast multi point Multi point Medial lateral femoral condyles acquisitions Enabled _ Disabled MANAGING PROFILES section MAIN SETTINGS Resection order Tibia femur distal femur 4 in 1 Femur distal tibia femur 4 in 1 Femur distal femur 4 in 1 tibia Navigation settings Independent resections the navigation system will act as a measuring instrument Dependent resections varus valgus resection angle to validated on distal or tibial cut 38 the navigation system will Additional features Automatic screenshots Enabled Disabled G tool calibration Enabled Disabled T amp F confidence test Enabled Disabled Volume control B Volume Joint line fine tuning Auto forward Enabled C Enabled Disabled Visabdied Suggest the compensate the varus valgus MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Hip center acquisition e Si
49. ic positioner regulations see 15 2 4 104 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 The distal cutting block ref no 02 07 10 0065 is not compatible with the fixation by mean of the micrometric positioner 18 4 SECURING THE DISTAL CUTTING BLOCKS After positioning the block under computer assistance see 15 4 secure it by mean of dedicated pins as shown in figures below STANDARD BLOCK STD 2 623 left knee Green parallel pins Red oblique pin Yellow optional parallel pins Blue G array MIS 02 07 10 0065 Green parallel pins Red oblique pin Blue optional parallel pins After the block has been properly fixed perform the distal resection see 15 6 and finally validate the cut see 15 7 105 19 APPENDIX 2 OTHER 4IN1 CUTTING BLOCKS 19 1 ASSEMBLING THE G ARRAY ON THE 4IN1 CUTTING BLOCK 106 STD 02 07 10 2101 6 The same block is used on a left or a right femur Insert the G array in the two dedicated holes located on the top of the block MIS 2 631 6 The same block is used on a left or a right femur Three holes are located on the top of the cutting block The G array must be inserted in the two medial ones in the picture on the left G array assembly for a LEFT knee is displayed MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 FREE HAND 4IN1 CUTTING BLOCK 19 2 NAVIGATING THE pots a ADY ARETAN ay a te
50. icrometric system the following components must be assembled e DT Micrometric Positioner Ref no 33 22 0136 e DT Micrometric Support Ref no 33 22 0135 Assemble the DT Micrometric Support on the 3 hole socket on the micrometric positioner as shown in the picture above on the left Fix the assembly by turning the knob highlighted in green in the picture above on the right Finally secure the connection by mean of a screwdriver 65 5 2 2 ASSEMBLING THE DISTAL RESECTION BLOCK ON THE DT MICROMETRIC POSITIONER TIP Before fixing the micrometric positioner on distal block set the regulation screws in the middle position in order to have the possibility to fine tune the block position in both directions Locate the flat coupling surface on the micrometric positioner highlighted in green in figure above left and slide the selected distal resection block on it Figure above right displays the assembling of a left MIS distal resection block Once the block is fully inserted in position secure the assembly by turning the locking screw A in the picture above right 66 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 15 2 3 POSITIONING THE ASSEMBLY DISTAL RESECTION BLOCK DT MICROMETRIC POSITIONER ON THE FEMUR Assemble the G shaped array on the selected cutting block see 15 1 and make sure that the latter is firmly attached to the micrometric system Before positioning the assembly on femur set
51. ion parameters and accordigly navigate the resection block Distal cut height 8 Valgus O Flexion fo 02 07 10 0065 Varus 0Q 0 1 5 Flexion 33 22 0003 Default resection parameters are displayed on the right They can be set according to the surgeon s preferences see Default cut parameters This operation will move the bone model displayed on screen so that its orientation is accordingly updated with respect to the target blue lines Real time values show varus valgus flexion and cut height on both condyles obtained during navigation of the cutting block The numerical value in the field HKA Hip Knee Ankle axis Varus Valgus is calculated as Validated Tibial V v Planned Distal V v HKA Varus Valgus equals O if the planned distal resection compensates the validated tibial resection 72 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 M The field HKA Varus Valgus will not be displayed in case a femur _ first procedure was selected It is advisable to always check the cut using the conventional instruments before resecting 15 6 SECURING THE DISTAL RESECTION BLOCK Once the positioning of the block is deemed satisfactory it can be stabilized using parallel pins that still allow a correction of cut height and an oblique pin to firmly hold the block in position The following diagrams display the layout of the pin holes 3 2 mm diameter pins are used STANDARD BLOCK
52. is determined depending on rotational alignment align the Whiteside s rod along the Whiteside s line direction pic below left proximal distal position put the Whiteside s rod in contact with the intercondylar notch pic below right 2 Lock the two plier jaws by screwing the corresponding screw on the plier Do not over tight the plier screw Over tightening may cause bone breakage Slighty unscrew the screw A see pic right then unlock the locking screw turn it in the opposite sense as previously done and finally remove the plier from the clamp 28 Fix the jaws position by turning the medial screw on the clamp MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Insert the Easy clip on the 2 spikes arm on the clamp main body position the F array and then lock the Easy clip hinge using the dedicated L shaped key OPTION As an alternative to the Easy clip the pins locking clamp ref no 33 22 0107 and 33 22 0108 may be used to fix the F array to the clamp 8 3 Assembling the G shaped reference array G G A B Place the adapter support B on the lower end of the reference array G stem aligning the pins and the centering holes Insert the screw A as shown in the figure on the right and tighten it with an Allen wrench 29 8 4 Assembling the G shaped reference array on the verification template To carry out the acquisition the support
53. ity and repeat the screenshot acquisition f4 44 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 12 7 MANAGING PROFILES Any setup in the options screen can be associated with a specific profile SAVE function and retrieved to be used in future surgeries ell C beee lt I load Save CES a ES Se l Are NETES ok ee The box highlighted in the picture above displays the name of the current profile Anew name can be typed in the box to create a new profile Pressing f2 or f4 will scroll the list of the profiles currently stored in the IMNS Once a name is displayed in the text box a profile can be loaded saved this will overwrite any existing configuration associated to the selected profile or deleted IMNS asks for confirmation of each of the actions above 45 fa ay i 12 8 POINTER CALIBRATION nS AA PROGRESSION Pointer calibration Flip the pointer make sure that the tip is still in the hole and press F4 to calibrate the other side of the pointer Repeat calibration l Accuracy mm F T or G array can be used interchangeably Locate the small hole on the edge of each array Rest the tip of the pointer in the hole and press F4 Flip the pointer 180 deg so that the other face of the tool is visible to the camera and press F4 again Check the accuracy on both sides of the pointer by observing the traffic light symbol on screen If the accuracy is not accep
54. ize IC reference spacer Ref no 02 07 10 2230 mounted on the dedicated handle Ref no 02 07 10 1027 Make sure that the distal posterior condyles as well as the tibia are firmly in contact with the spacer when acquiring If the joint line fine tuning is not properly done femoral resections will be adversely affected thus making navigation unreliable This step is NOT for ligament balancing purposes Even though the 10 mm spacer appears inadequate to correctly fill the joint gap DO NOT USE A THICKER SPACER when fine tuning the joint line Make sure to perform each acquisition at the required extension flexion green area on screen If the required extension flexion can t be reached the following message will be displayed on screen WARNING Data was not acquired Put the knee at the appropriate flexion green area when acquiring Otherwise disable Joint Line fine tuning in the options menu F3 Change selection F4 Confirm selected option 97 If it is impossible to reach the required extension flexion and no surgical modification of flexion extension gap is deemed necessary come back to the Navigation settings screen by pressing f6 and disable the Joint line fine tuning option 17 11 IMPLANTATION 17 11 1 TRIAL IMPLANT ANALYSIS This step allows performing kinematic analysis of the knee along the entire range of motion ROM as a result of the trial components placement Current varus valgu
55. lated by using dedicated knobs under computer guidance F Flexion adjustment H Cut height adjustment V Varus Valgus adjustment Flexion fine tuning can be obtained by turning the screw using a screwdriver Varus valgus pushed down the button by using a screwdriver and manually rotate the cutting block When the position is deemed satisfactory release the pressure on the button and give an additional turn to fix the position Cut height e macro tuning push the button and slide the distal cutting block release the button to fix the position e fine tuning turn the screw by using the screwdriver When the distal cutting guide position is deemed satisfactory remove the G array connect the saw capture to the block and perform the distal cut 70 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 15 4 POSITIONING THE DISTAL CUTTING BLOCK FREEHAND It is possible to navigate the freehand positioning of the distal cutting blocks To do so assemble the G array on the block as described in 15 1 Rest the block on the anterior condyles and under navigation guidance fine tune the positioning STD 02 07 10 0127 MIS 2 618 71 15 5 NAVIGATING THE DISTAL FEMORAL RESECTION Before proceeding with the navigation of the resection block it is advisable to perform a confidence test on T and F arrays Assemble the G array on the distal cutting block PROGRESSION Distal resection Set the resect
56. le Birth date Mmm dd _ year Metric USA Height m cm Weight 7Ke Here it is possible to specify the name of the surgeon and other data related to the surgery and the patient Although data in this screen are optional it is advisable to fill all the fields In order to guarantee patient s privacy the file containing the report of the surgery will record and display only the first letters of patient s name and surname After typing in the surgeon s name it is possible to load his profiles set by clicking on the LOAD button This option ts available only if Settings Planning and Guides profiles have been all previously associated to the surgeon 36 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 12 3 LIMB SELECTION Select the limb that will undergo the surgery and place the camera according aca PRERESECTION ANATOMICAL RESECTION TRIALIMPLANT FINAL IMPLANT REPORT F2 F3 F4 ANALYSIS LANDMARKS ANALYSIS ANALYSIS yr Limb selection LEFT knee surgery to the picture 37 12 4 NAVIGATION SETTINGS F6 It is always possible even when navigation is ongoing to return to this step and select different options F6 shortcuts PROGRESSION Navigation settings Press F2 or F4 to choose your profile Main settings Resection order Tibia femur distal femur 4 in 1 Femur distal tibia femur 4 in 1 _ Femur distal femur 4 in 1 t
57. lusively by suitably trained personnel Studying this manual is an integral part of the training process 8 procedures by providing Y MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 Should any part of the manual not be clear please contact the specialized MEDACTA staff for help The GMK v 4 4 0 application whose operating modes are described in this manual has been developed and produced to be used exclusively in conjunction with GMK equipment To properly use the instruments in association with the iMNS navigation system please refer also to the GMK Surgical Technique The iMNS system shall not be used to perform surgeries other than the ones indicated in the surgical techniques enclosed to this manual Do not use the iMNS system in the presence of sources or reflectors of intense infrared radiation as under these conditions the acquisition system is unable to work properly In addition avoid exposing the acquisition system to direct daylight In case of knee operations adequate mobility of the corresponding hip joint is an essential requirement for the effective use of the iMNS system It is essential to always bear in mind all the warnings related to the surgery to be performed 1 1 Contraindications Progressive local or systemic infection Muscular loss neuromuscular disease or vascular deficiency of the affected limb making the operation unjustifiable Severe instability secon
58. n contact with the tibia when the knee is in full extension Lateral distal condyle The middle of the Sulcus surgical epicondylar axis or the most prominent point anatomical epicondylar axis Medial epicondyle The most prominent point in Lateral epicondyle correspondence with the insertion of the collateral ligament The deepest line of the trochlear groove Whiteside s Line The surgical axis is usually 6 with respect to posterior condyles Yoshioka et al JBJS 1987 the anatomical axis is usually 3 5 with respect to the posterior condyles Berger et al Clin Orthop 1993 117 Medio lateral reference Saw blade blade to exit from the bone exit Second Metatarsus The two points will define the maximum acceptable width of the prosthesis If the selected femoral size of the implant is wider than the distance between the two points a warning message will be ispl displayed M The Navigation System will use the collected points to prevent notching the femoral anterior cortex Collect one or more points on the area you wish or expect the The landmark that is usually pointed at when checking the alignment of the tibial cutting block using the telescopic alignment rod 118 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 22 INSTRUMENTS The following instruments are part of the navigation instruments set Description
59. of the 4in1 cutting block by adjusting cut height and external rotation It is available in different versions depending on the 4in1 cutting block to be navigated 76 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 16 3 ASSEMBLING THE G ARRAY ON THE 4IN1 MICROMETRIC POSITIONER CAS 33 22 0137 Insert the G array in the two holes as displayed in the picture on the left 16 4 ASSEMBLING THE 4IN1 CUTTING BLOCK ON THE 4IN1 MICROMETRIC POSITIONER Slide the connection plate located on the bottom of the 4in1 positioner into the corresponding slot on the top of the 4in1 cutting block and turn the locking screw A in the picture above right to secure the connection 7 16 5 POSITIONING THE ASSEMBLY 4IN1 CUTTING BLOCK 4IN1 POSITIONER ON THE FEMUR The distal cutting block must be firmly in place in the same position it was when the distal resection was performed TIP Before fixing the 4in1 positioner on the distal block set the regulation screws in the middle position in order to have the possibility to fine tune the block position in both directions Slide the assembly on the connection plate located on the 4in1 positioner into the slot on the distal block and put the lever down in the figure above green to secure the connection Make sure that the G array is fully inserted in the appropriate position and using the data provided by the navigator fine tune the position of the block see 16 8
60. pinning the block in malalignment Ensure low drilling speed to reduce heat generation 82 hi MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 16 11 4IN1 FEMORAL RESECTIONS Before performing the resections tools that could interfere with the saw blade must be removed Check the final alignment of the block and gently remove the G array It is suggested to double check the cut by means of the conventional sickle finger before cutting Insert the saw blade guide on the standard block to ensure a more accurate resection and using a 1 27 mm blade accurately resect the bone taking care protecting soft tissue from injury The following cutting sequence is suggested Anterior cut Posterior cut Posterior chamfer cut Anterior chamfer cut Femoral resections using 4in1 cutting blocks ref no 02 07 0201 6 require 13 mm wide blades 83 16 12 ANTERIOR FEMORAL RESECTION VALIDATION Option PROGRESSION 4 in 1 resection Validate the anterior femoral resection Please TEST markers stability before acquiring the cut surface Cut plane External rotation 4 0 Actual external rotation 4 5 Before validating the resection plane it is advisable to perform a confidence test on T and F arrays Assemble the G array on the verification template see 8 4 and rest it on the cut surface Real time external rotation and posterior cuts height are displayed on screen F4 on the validate
61. rewing of that knob it is enough to make only few turns counter clockwise Slide the locking mechanism of the CAS positioner into the slot located on the distal cutting block B in the figure above Secure the assembly by turning the knob located on the top of the locking mechanism A in the figure above 109 Pay attention to not apply excessive torque when screwing the Ay knob A in the figure above Make sure that the G array is fully inserted in the appropriate position and using the data provided by the navigator fine tune the position of the block see 16 8 CAS 2 637 H Cut height adjustment R External rotation adjustment 19 5 SECURING THE 4IN1 CUTTING BLOCKS ON FEMUR After positioning the block under computer assistance see 17 6 secure it by mean of dedicated pins as shown in figures below STANDARD BLOCK STD 02 07 10 0201 6 Green parallel pins Red oblique pins Yellow optional pins MIS BLOCK MIS 2 631 6 left knee Green parallel pins Red oblique pins Yellow optional pin MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 After the block has been properly fixed perform the anterior posterior resections and the chamfers see 16 10 and finally validate the anterior cut see 16 11 20 APPENDIX 3 OTHER TIBIAL CUTTING BLOCKS 20 1 ASSEMBLING THE G ARRAY ON THE TIBIAL CUTTING BLOCK 02 07 10 2145 6 Select the appropriate cutting block Left or Right accordin
62. rs or reflectors in the field of view of the camera may hinder proper recognition of the reference arrays In particular should the system show recognition difficulties make sure that all unused reference arrays are removed from the field of view of the camera and if necessary gently wipe the markers with a soft and dry cloth 4 It is suggested to check that the reference arrays that are going A to be used during the surgery are recognized by the camera when placed in the field of view of the camera itself To do so move them in the field of view of the camera and verify that they are displayed on screen It is advisable detecting with the pointer the highest and the lowest points which could be touched during the surgery e Pointer perpendicular to the tibial plateau on a flexed knee highest point e Pointer touching the malleoli lowest points 50 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 13 2 CONFIDENCE TEST F8 Option PROGRESSION Confidence test Mark a point on the femoral bone and acquire check its position These acquisitions are extremely recommended to ensure the maximum Safety Two points will be acquired one on the femoral bone and one on the tibial bone iMNS will store their position relative to the corresponding reference array The selected points must not be resected or altered during the surgical procedure 51 iG 2a TESTING CONFIDENCE Once the two points hav
63. s in the navigation program are expressed in millimeters or degrees GENERAL DESCRIPTION The iMNS Medacta Navigation System is intended to be used to support the Surgeon during specific orthopaedic surgical information on bone resections instrument and implant positioning during 1 INTENDED USE joint replacement The iMNS Medacta Navigation System provides computer assistance to the Surgeon based on anatomical landmarks and other specific data obtained intra operatively that are used to place surgical instruments Examples of surgical procedures include but are not limited to This manual illustrates the software operating modes and provides the Total knee replacement Minimally invasive total knee replacement The MEDACTA iMNS system does not provide information of diagnostic nature Use the iMNS system only with the equipment specifically supplied or approved by MEDACTA The iMNS navigation system must be cleaned and disinfected immediately after use by qualified personnel Clean and disinfect the instruments supplied in trays to be used with the iMNS navigation system before sterilization following the Recommendations for the Decontamination and Sterilization of Medacta International SA Reusable Orthopaedic Devices available from the company s website www medacta com or by calling 1 800 901 7836 necessary instructions for their proper and safe use HI The system shall be used exc
64. s values at different flexion angles are plotted on screen Trial implant Start stop varus amp valgus graph s drawing PD ose Max Flexion 97 5 Min Flexion C 2 0 Real time flexion and varus valgus are displayed and constantly updated A REAL TIME RT DATA B ROM INDICATOR The range of motion is segmented in sectors of 5 degrees indicated by the colored squares Squares are initially red and become green once the corresponding varus valgus sample has been recorded C MAX VALUES Maximum and minimum flexion i e maximum extension are displayed here 98 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 D PLOT AREA Kinematics of the knee joint are plotted using green dots real time x axis horizontal flexion angle Each unit of the grid corresponds to 30 degrees y axis vertical varus upper half and valgus lower half Each unit of the grid corresponds to 5 degrees Press f4 to activate START STOP acquisitions and begin registering data A higher BUZZ sound will inform the user when the acquisition is ongoing a lower BUZZ sound will inform the user if one of the arrays is not visible during acquisition In this case the acquisition will be stopped until all the arrays are visible again Once the wished data have been registered press f4 again to stop registration A snapshot will be automatically taken and the cursor will move to the navigation box To acquire a new
65. sted 13 ai D CAMERA The icon is normally green It turns to red when the camera is off or not working properly yellow in case some problem with data transfer arises e g unplugged data connector E ACQUISITIONS The acquisition to be performed is highlighted by the cursor When an acquisition is done a tick M appears in the box F NAVIGATION BOX Indicates the operations performed by pressing each pedal When the Navigation box is selected it is possible to move to the previous F2 or the next F4 navigation step Items in E and F can be selected by the user A red contour highlights the currently selected item Keeping the central pedal pressed for more than 3 tenths 0 3 of a second moves the cursor back to the Navigation Box 14 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 5 ICONS IN THE NAVIGATION BOX 5 1 CONTROLS NAVIGATION BOX SELECTED LEFT PEDAL MIDDLE PEDAL RIGHT PEDAL Back to previous Scroll selection Go to next screen screen down ANOTHER BUTTON SELECTED LEFT PEDAL MIDDLE PEDAL RIGHT PEDAL Delete selected Scroll selection Confirm Perform data down operation 6 ACCURACY INDICATOR Accuracy IS not Satisfactory repeat the acquisition Accuracy is good Proceed to the next step 15 7 SHORTCUTS F1 Screen capture both an acoustic signal and a message on screen will confirm the operation F5 List of the shortcuts F6 Navigation settings
66. t before proceeding with navigation 8 2 3 Femoral holder option ref no 33 22 0129 The F shaped array can alternatively be secured on femur using the femoral holder as shown ref no 33 22 0129 Position the femoral holder on the medial distal anterior condyle pic aside left femur connect the screw guide ref no 33 22 0130 insert the sleeve for the 3 2 mm drill ref no 33 22 0131 and perform the hole for the fixing screw with the dedicated 3 2 mm drill Remove the 3 2 mm drill sleeve and insert into the screw guide the fixing screw red arrow in figure below left by mean of a dedicated screwdriver Two additional sword pins ref no 33 24 0096 can be used to further Stabilize the holder red arrows in figure below right 23 24 Insert the head for rigid body ref no 33 22 0108 into the dedicated slot on the femoral holder only one orientation is allowed by pressing the release button red arrow in fig left Insert the reference array into the ball socket orient it parallel to the bone diaphysis facing the camera and slightly anterior Once the positioning is satisfying tighten the screw green arrow in fig left to fix the position MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 This fixation system allows the F shaped array to be removed during the surgery when not needed l Do not remove the reference array when acquisitions are ongoing To release the referenc
67. table yellow or red please repeat the acquisition Pointer calibration can be done by an assistant during patient preparation When acquiring the pointer should be held perpendicular to the hole and parallel to the camera 46 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 12 9 G TOOL CALIBRATION Option The G tool G array calibration ensures the maximum accuracy in cutting blocks navigation and validation of the resection planes G calibration is a two stage process PROGRE SSION G plate acquisition Acquire a third point on the G array calibration plate First point Second point C Third point Clear All 1 Identification of the calibration plane Secure the F array on the calibration block and orient it as indicated in the picture on screen Make sure that the screw on the calibration block is tight enough to prevent any movement of the F array Using the pointer acquire three points on the calibration plane the system will store their position relative to the F array Make sure that the pointer s tip fits perfectly into the marked reference holes 47 PRE RESECTION ANATOMICAL RESECTION TRIAL IMPLANT FINAL IMPLANT REPORT oe ANALYSIS LANDMARKS ANALYSIS ANALYSIS PROGRESSION G Tool calibration The G array is calibrated Repeat calibration Accuracy J 2 G array calibration Assemble the verification template on the G array Rest the template on the
68. the parameters see 15 2 4 close to the target position and finally fix the DT micrometric support to the distal condyles by inserting two four 3 2 mm pins in the dedicated holes The following pin holes can be used Green femoral pins 67 15 2 4 MICROMETRIC ADJUSTMENTS USING THE DT MICROMETRIC POSITIONER The DT micrometric positioner allows micrometric fine tuning of the position of the block Adjustments are performed by turning specific knobs as indicated in the figure below F Flexion adjustment H Cut height adjustment V Varus Valgus adjustment 68 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 15 3 THE MEDACTA FEMORAL CLAMP 15 3 1 ASSEMBLING THE DISTAL RESECTION BLOCK ON THE DT MICROMETRIC POSITIONER Slide the distal cutting block on its Support and fix the connection screwing the screw A Push the button B and insert this support on the two holes located on the micrometrical positioner blue arrows Release the button A to fix the position of the distal cutting guide 15 3 2 POSITIONING THE ASSEMBLY DISTAL RESECTION BLOCK MICROMETRIC POSITIONER ON THE FEMORAL CLAMP Engage the micrometrical positioner and rotate it on the clamp pic below left Turn the screw to fix the connection as shown in the picture below right 69 15 3 3 MICROMETRIC ADJUSTMENTS USING THE FEMORAL CLAMP MICROMETRIC POSITIONER The distal cutting block position can be regu
69. tion step and repeat the wrong acquisitions PROGRESSION Sagittal plane Acquisitions have been completed planes have been computed 60 MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 If it is impossible to reach at least 60 degrees of flexion the accuracy of sagittal plane acquisition is at risk of being inadequate The iMNS system will therefore suggest to define the sagittal plane by acquiring an additional reference point on the second metatarsal bone Flexion lower than 60 degrees Acquire the second metatarsus to compute the sagittal plane C CSS lt p Change selection Fa Confirm selected option Select OK on the screen then move to the next screen to perform the acquisition of the second metatarsal bone landmark i AN F4 H y A v C Second metatarsus PROGRESSION Leg acquisitions Acquire a point on the second metatarsal bone Clear All 61 14 6 PRE RESECTION ANALYSIS This step allows performing a real time kinematic analysis of the knee along the entire range of motion ROM Current varus valgus values at different flexion angles are plotted on screen Pre resection Varus Valgus acquisition RT Flexion RT Valgus 30 60 esa a 00 eeeP Pag Max Flexion 91 0 Min Flexion 6 0 A REAL TIME RT DATA Real time flexion and varus valgus are displayed and constantly updated B ROM INDICATOR The range of motion is segmented in sectors of 5
70. tions Tibial cut height 9 Distal cut height Anterior cut height o from the higher plateau Femoral valgus o Ext rotation o Tibial valgus o Flexion 0 vs Post condyles Posterior slope Cut check Cut check Cut check Enable v Enable Enable Disable w Disable Disable Screenshot Screenshot Screenshot Enable Enable Enable Disable 5 Disable Disable LIN LIN LIN LIN DELETE LOAD SAVE These controls are used to delete load or save an existing profile See MANAGING PROFILES section Please note that the profile in the DEFAULT CUT PARAMETERS step is independent from the profiles set in NAVIGATION SETTINGS and GUIDE SELECTION steps Cut check By enabling this option the system will ask to validate the cut after every bone resection i e tibial distal and anterior cuts If this option is kept disabled the system will move directly to the next resection step without asking for validation of the last cut performed Screenshot By enabling this option the screenshot showing the cut parameters can be frozen f4 and remains available on screen after pinning the cutting guide 43 The situation shown on screen displays the resection planning not the validated cut In case any rigid array is not fully visible by the camera during the screenshot acquisition f4 the system shows the following message error In such a case please go back f2 check on screen the rigid arrays visibil
71. umerical values in the front view of the tibia indicate the current cut height relative to the deepest point of each plateau Real time values on top show varus valgus and slope of the cutting block L It is advisable to always check the cut using the conventional instruments before resecting 92 Y Y Y MEDACTA iMNS GMK v 4 4 0 and up ref no 99 36 12US rev 02 The numerical value in the field HKA Hip Knee Ankle axis Varus Valgus is calculated as Validated Distal V v Planned tibial V v HKA Varus Valgus equals O if the planned tibial resection compensates the validated distal resection The field HKA Varus Valgus will not be displayed in case a tibia first procedure was selected The number in the numerical box Cut height always indicates the cutting height with respect to the tibial plateau selected as reference see Navigation settings The tibial slope must be set up before setting the level of the cut Any degree of anterior slope must be avoided An excessive slope could damage the tibial insertion of the posterior cruciate ligament in case a STD INSERT is used STD INSERT To protect the PCL 1 or 2 x 2 7 mm diameters nails may be fixed in front of the tibial insertion of the PCL before proceeding with the tibial resection STD AND PS INSERTS In case of a tibial cut with slope ensure that there is no rotation of the tibial resection guide 93 17 7 SECURING THE TIBIAL RESECTI
72. ut plane Before validating the resection plane it is advisable to perform a confidence test on T and F arrays Assemble the G array on the verification template see 1 1 and rest it on the cut surface Real time varus valgus real time flexion and resected bone are displayed on screen F4 on the cut plane check box registers the position of the template and validates the cut The navigator will then display the validated varus valgus the validated flexion and the amount of bone resected from each condyle while keeping real time values active It is extremely important to position the reference array correctly and to acquire the real data the next steps depend on this acquisition and a deviation from the real values may lead to errors 75 16 4IN1 FEMORAL RESECTIONS For the 4in1 cutting blocks ref no 02 07 10 2101 6 and 2 631 6 and the 4in1 CAS positioner ref no 2 637 please refer to Appendix 2 16 1 ASSEMBLING THE G ARRAY ON THE 4IN1 CUTTING BLOCK 16 2 THE CAS 4IN1 POSITIONER 02 07 10 0201 6 The same block is used on a left or a right femur Five holes are located on the top of the cutting block The G array must be inserted in the two medial ones in the picture on the left G array assembly for a LEFT knee is displayed The cutting blocks ref no 02 07 10 0201 6 are suitable also for muscle sparing approaches The CAS 4in1 positioner allows the micrometric placement
73. wsiessesavennsesessnaunsesveivasnes 49 131 CAMERA PLACEMENT IFI nran ne na A aren A E N 50 13 2 CONFIDENCE TEST F8 Option c c cccccccssssscsececsesessecsescssucscsessucacsesesucasscscsusacsesesesacaescsesecaceee 51 13 2 1 TESTING CONFIDENCE ecessscscesessisseacoxcnccudesshevnassxdcesotdieecavsncaddetshevsactaxbeesotduslexeeacacsvdstciowsatieee 52 ANATOMICAL LANDMARKS cccccececcececcececeecsceccececcscsceassceessceccacsacacsccacacesacacacsccatsceaeacacaceccassceaeaceees 53 PAs PRCOUISITIONS enei ENN 53 14 1 TIBIAL MECHANICAL AXIS ccccccscscsececscscscscscsscecscscscscavsscscscssssscavavassscasssssavavscsusacacssasacavaceueacacees 53 14 2 TIBIAL SURFACES ACQUISITION cccccccsscssscscscsececscscscscscsvcscscssstscscsvsscecscssssasavscsesscacasssacavaaseacacees 54 14 3 FEMORAL LANDMARKS ACQUISITION cccccscsecsscscscscscsccecscsssescscsssucecscssseacavscsecscscassescavscsueecacees 55 14 4 HIP CENTER ACQUISITION ccccccscccsececscscscscscsucusscscscscsvsvsscscsssessavavassusasssssaavacsssacacasatacavsceueacacees 58 14 4 1 STANDARD SEQUENCE c ccccscscscsscecscscscscssecscscscscscsvsccucscscsesavavasescasasssasaacsusacacasssacavscseasacees 58 TAA DY SIXINONE lt Opiom esens ae an tinea loed e E A A T OS 59 14 5 SAGITTAL PLANE ACQUISITION ccccccssscssscscscsececscscscscscsucecscscssscscsvsccucacssssasavscsesacacasssacavscseacacees 60 14 6 PRE RESECTION ANALYSIS ccccscscscsececscssscscscsscucscscscscavsccucscssssss
74. x in one one single pressure of F4 e Standard sequence limb abduction adduction and lift each followed by F4 ANATOMIC LANDMARKS Tibial cut height reference e Higher tibial plateau the less worn plateau is set as tibial cut height reference e Lower tibial plateau the most consumed plateau is set as tibial cut height reference Select the tibial plateau that will be used to assess cut height Graph after cementation Analyze the Range Of Motion ROM after implantation of definitive components Optional femoral rotation references The system by default shows the femoral rotation vs the posterior condyles line Additional reference lines may be selected e Whiteside s line e Epicondyles e Tibia knee axis i e tibial mechanical axis Landmarks acquisition e Single point e Fast multi point e Multi point Femoral landmarks can be registered by acquiring a single point or by painting the surface of the bone multi point mode 39 he Single point option pointer on hand method and multi points option imply a different acquisitions workflow ACQUISITION STEPS WORKFLOW SINGLE POINT POINTER ON HAND FAST MULTI POINT pointer calibration pointer calibration Surgery start Surgery start camera placement camera placement Medial lateral femoral condyles acquisition Acquisition of two reference points one on the medial condyle and one on the lateral condyle to assess the maximum accept

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iMNS – USER MANUAL