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iASSIST 2-Pod Version

Surgical Technique

Preoperative Guide

The surgical procedure must take place in an
operating room theater with temperatures ranging
from 15°C to 30°C (59°F to 86°F). Ensure that the
pods are maintained in this temperature range before
being used in a surgical procedure. Otherwise, the
system may indicate that the pods are outside their
operational temperature range and the pods cannot
be used until they reach an adequate temperature.

Ensure that one iASSIST Knee Pod Kit will be used per
surgical procedure. The user must exit and restart
the application with a new pod kit to begin another
surgical procedure. A bilateral knee procedure is
considered as one procedure.

The system controller computer should remain in the
system controller carrying case during transportation
and in use.

Figure 2.1

Operationg Room Setup

Warning:

A full set of the implant system’s standard

instrumentation is needed to perform a surgery in
conjunction with the iASSIST System and in case
the iASSIST Components cannot be used. Effects
that may prevent use of the iASSIST System include
the unlikely possibility of unresolvable interference
effects with the wireless communication of the
system.

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Содержание iASSIST Knee

Страница 1: ...iASSIST Knee 2 Pod Version Surgical Technique ...

Страница 2: ......

Страница 3: ...chnique for Bilateral Procedures 30 Freehand Positioning of the Tibial Adjustment Mechanism 31 Tibial Aligner Technique 36 Postoperative Guide 41 Exit the iASSIST Application 41 Retrieve Surgical Procedures Archives 41 Activate the Field Issue Recorder 42 Shut Down the System Controller Computer 42 Equipment Inventory and Cleaning Sterilization Methods 43 Sterilization Parameters 43 iASSIST Knee M...

Страница 4: ...mplant Warning The system should only be used with the instruments provided by Zimmer CAS or by the distributor for the given application Contraindications Clinical The system should not be used In cases of hip pathology severely limiting range of motion e g arthrodesis severe contractures chronic severe dislocation In cases of hip joint pathology or knee pathology with significant bone loss e g a...

Страница 5: ... will be used per surgical procedure The user must exit and restart the application with a new pod kit to begin another surgical procedure A bilateral knee procedure is considered as one procedure The system controller computer should remain in the system controller carrying case during transportation and in use Figure 2 1 Operationg Room Setup Warning Afullsetoftheimplantsystem sstandard instrume...

Страница 6: ...be connected to an AC outlet during the entire procedure The system controller computer must not be placed in a sterile bag as it might overheat 2 Secure the inside flap in place to maintain the appropriate angle for the system controller computer 3 Position the system controller computer on the angled flap 4 Connect the power cord to the power supply and computer port Plug it in to an AC outlet 5...

Страница 7: ...ll trigger and the application will launch Warning After having scanned the barcode and powered on the pods do not exit the application unless the surgical procedure has ended When exiting the application the pods will be permanently deactivated Once deactivated the pods cannot be restarted Figure 2 3 Application Launch 4 The Patient Side view will be displayed Click the L icon for a left knee or ...

Страница 8: ...ed in the snapshot directory found in the surgery folder of the Copy Logs feature Figure 2 5 Patient Side Icon Right Undetermined Left Side Button Click the Side button located at the bottom of the system controller computer screen to change the patient side The Patient Side view will be displayed and the user will be able to click on the L icon for the left knee or the R icon for the right knee W...

Страница 9: ...Bar The Pod Status bar is displayed at the bottom of the system controller computer screen The bar displays the status of each pod connected to the system controller computer showing its user interface A pod that has not joined the network will be displayed in red A pod that has joined the network but has not been connected to an instrument will be displayed in yellow A pod that has joined the net...

Страница 10: ...econd iASSIST Knee Pod Kit should be brought in the operating room theater as a backup The pods should be powered on five minutes before performing the intraoperative calibration Powering On Pods and Intraoperative Calibration 1 Open an iASSIST Knee Pod Kit and remove the pods from the pod tray Place them on the sterile instrument table Warning Verify that the packaging is not damaged A damaged pa...

Страница 11: ...ion jig upwards on a sterile table Keep the jig steady until a sound is triggered Continue the sequence by positioning the jig in its remaining five positions 2 through 6 When the calibration is completed the green status LED of each pod will blink Note The green LEDs on the flexion extension axis of the cut guide pod indicate the expected position 1 through 6 of the pod calibration jig during cal...

Страница 12: ...ngages The system will automatically monitor any improper physical connections between the pods and the instruments Figure 3 2 Assembling a Pod to an Instrument 3 To unclip the pod press on the locking lever and pull on the pod to disengage the spring holder Note There are no locking levers on the pod calibration jig Warning Throughout the surgery always ensure that the pods are properly assembled...

Страница 13: ... at the 0 position on the femoral distal cut guide resects 10 mm off the most distal condyle 2 Assemble the femoral A P slider to the distal femoral cut guide by tightening the blue screw 3 Clip the cut guide pod to the distal femoral cut guide 4 Clip the reference pod to the femoral reference Note The A P slider and the distal femoral cut guide are also available to fit high BMI patients Refer to...

Страница 14: ...lidation the instruments must remain stable and properly fixated to the bone to ensure the accuracy of the system Femoral Registration 1 Break the cortex at the mechanical axis entry point with a cortex breaker or a 3 2 mm drill bit 2 Impact the femoral spike or the CAS 7 9 mm Small Spike into the distal femur 2 5 3 5 cm Warning The spike should be aligned within 15 degrees of the mechanical axis ...

Страница 15: ... procedure 7 Acquire 13 stable positions by accelerating and stopping the leg to create a star shaped or circle pattern An audio feedback will be generated from the system controller computer after each acquisition until completion The LEDs on the pod will blink sequentially until completion of the acquisition Note To restart the femoral registration press the Z button on the pod attached to the f...

Страница 16: ...e femoral reference by aligning the arrows 2 Insert the two long pegs of the femoral A P slider into the femoral adjustment mechanism 3 Slide the femoral adjustment mechanism down towards the distal condyles to the half way mark 4 Follow the feedback red and green LEDs on the pod attached to the femoral distal cut guide and adjust flexion extension and varus valgus using the gold and green screws ...

Страница 17: ...ee 3 2 mm headless trocar drill pins in the base of the distal femoral cut guide using both parallel holes and one diagonal hole in the body of the guide x3 Figure 3 5 Distal Femur Cut 7 With the knee stable and flexed between 45 and 80 degrees and the leg in neutral abduction unlock the femoral A P slider using the blue screw and remove it from the assembly Hold the knee steady until the confirma...

Страница 18: ...mm headless trocar drill pin used to secure the femoral distal cut guide and the femoral saw slot to the bone has to be inserted carefully to avoid perforating the second cortex Figure 3 5 Distal Femur Cut Continued Distal Femoral Cut cont 8 Slide the femoral adjustment mechanism away from the distal femur so both arrows are aligned and pull it off the assembly 9 Remove the 3 5 X 38 mm hex head sc...

Страница 19: ...at the arm of the alignment arch is aligned with the A P plane of the femur Then slide a drop rod in the body of the alignment arch Note Thealignmentrodwithcoupler provided by Zimmer can be used to verify the cut Note Alternatively the Natural Knee II Axial Alignment Rod provided by Zimmer can be used to verify the cut Figure 3 5 Distal Femur Cut Continued 14 Resect the distal femur Warning The fe...

Страница 20: ... slot If interference is felt the validation tool should be shifted mediolaterally by 10 mm Figure 3 6 Distal Femur Cut Validation For steps four through six follow the feedback on the pod attached to the validation tool Ensure adequate stability of the validation tool on the distal femoral cut by manually holding it in place 4 Bring the leg into abduction Once the green LED stops blinking hold th...

Страница 21: ...one straight away from the cut plane 8 A drop rod can be inserted in the handle of the validation tool to check the varus valgus orientation of the cut Make sure that the arm of the validation tool is aligned with the A P plane of the femur Figure 3 6 Distal Femur Cut Validation 9 Remove the validation tool the 3 2 mm headless trocar drill pins the femoral saw slot and the distal femoral cut guide...

Страница 22: ...tween their pegs The tibial adjustment mechanisms are side specific Depending on the patient side 1 Pull out the handle of the tibial positioner Figure 3 7 Proximal Tibia Cut Instrument Assembly 2 Connect the tibial positioner to the tibial adjustment mechanism Note The left right tibial positioners are side specific and must be used with the corresponding left right tibial adjustment mechanism 3 ...

Страница 23: ...around the malleoli until both spikes are fully inserted into the tibia Note The tibial alignment guide is designed to be self centered when placed around the malleoli Warning After wrapping preparing the ankle the surgeon should still be able to palpate the malleoli 4 While continuing to firmly grip the distal clamps around the malleoli partially insert 2 3 mm the longer spike of the proximal par...

Страница 24: ...d carefully in order to avoid loosening 7 Ensure the distal clamps of the tibial alignment guide remain securely positioned on the malleoli If a readjustment is necessary ensure the shaft of the guide remains immobile and in proper alignment Adjust by rotating the distal part of the guide and resecure the clamps around the malleoli Warning Do not pull on the distal part of the tibial alignment gui...

Страница 25: ...5 X 38 mm hex head screws to secure the tibial adjustment mechanism to the bone Note Secure the tibial adjustment mechanism to the bone by first securing screws in the medial hole secondly in the upper lateral hole and finally in the lower lateral hole Warning Control the speed of the power tool or finish fixating the screws manually to avoid stripping the cortex of the tibia The 500 RPM adaptor o...

Страница 26: ...te To restart the tibial registration press the Z button on the pod attached to the tibial aligment guide Figure 3 8 Proximal Tibia Cut Tibial Registration Continued Abduction Adduction Neutral 16 Loosen the blue knob on the distal end of the tibial alignment guide 17 Unspike the proximal part of the tibial alignment guide from the tibia using a slaphammer Note The Persona Slaphammer provided by Z...

Страница 27: ...llow feedback red and green LEDs on the pod attached to the tibial adjustment mechanism and adjust flexion extension and varus valgus using the gold and green screws respectively Warning The knee should be flexed between 45 and 80 degrees in order for the system to be able to compute angle values Whenusingthe3 5mmhexheadknob remove the knob before performing the cut Figure 3 9 Proximal Tibial Cut ...

Страница 28: ...resection The stylus must be screwed on top of the tibial cut guide instead of being inserted in its slot 4 Insert the tibial cut guide elevator rod into the tibial adjustment mechanism Note The left right tibial cut guides are side specific and must be used per the corresponding left right tibial adjustment mechanism Note Each line increment on the rod measures 2 mm 5 Set the resection level in a...

Страница 29: ...he medial hole instead of the 3 2 mm headless trocar drill pin When using a 3 5 X 38 mm hex head screw the screw must only be inserted halfway as to avoid movement of the tibial cut guide x1 Warning The fasteners used to secure the tibial cut guide to the bone must be inserted carefully to avoid perforating the second cortex and to avoid potential interference with the screws used to secure the ti...

Страница 30: ...he tibial cut guide If interference is felt the validation tool should be shifted 10 mm mediolaterally Figure 3 10 Proximal Tibial Cut Validation Proximal Tibial Cut Validation 11 A drop rod can optionally be used to check the varus valgus orientation of the cut before performing the resection Insert the paddle section of the alignment arch in the tibial cut guide Make sure that the arm of the ali...

Страница 31: ...heard 7 Bring the leg into neutral position Once the green LED stops blinking hold the knee steady until the acquisition sound is heard 8 The proximal tibia cut values are displayed on the pod attached to the validation tool Note Torestarttheproximaltibiacutvalidation press the Z button on the pod attached to the validation tool 9 Optionally a drop rod be inserted in the handle of the validation t...

Страница 32: ...escribed in the Distal Femoral Resection Instrument Assembly section when performing the femur first approach or Proximal Tibial Cut Instrument Assembly section when performing the tibia first approach Proximal Tibial Cut Validation cont 11 Proceed with the femoral registration if continuing with the distal femoral cut Note If the proximal tibial cut needs to be corrected it is possible to navigat...

Страница 33: ... four new 3 2 mm headless trocar drill pins and four new 3 5 X 38 mm hex head screws for the second leg since they are single use Freehand Positioning of the Tibial Adjustment Mechanism The following section describes an alternate technique for positioning the tibial adjustment mechanism on the tibia without using the tibial positioner Instrument Assembly 1 Follow steps four and five of Proximal T...

Страница 34: ...rresponding left right tibial adjustment mechanism 4 Lock the tibial cut guide by hand tightening the blue screw on the tibial adjustment mechanism Tibial Registration 1 Position the tibial adjustment mechanism so that the concave shape at the rear of the instrument hugs the convex ridge of the tibial tubercle Ensure the position is low enough for the tibial cut guide to attain the desired level o...

Страница 35: ...justment Mechanism cont 3 Use three 3 5 X 38 mm hex head screw to secure the tibial adjustment mechanism to the bone Note Secure the tibial adjustment mechanism to the bone by first securing screws in the upper lateral hole secondly in the lower lateral hole and finally in the medial hole Warning Control the speed of the power tool or finish fixating the screws manually to avoid stripping the cort...

Страница 36: ...nt Mechanism cont 6 Place the distal part of the tibial alignment guide on the ankle by firmly gripping the distal clamps around the malleoli until both spikes are fully inserted into the tibia Note The tibial alignment guide is designed to be self centered when placed around the malleoli Warning After wrapping preparing the ankle the surgeon should still be able to palpate the malleoli 7 While co...

Страница 37: ... spikes of the instrument Off axis impaction may result in bending of the spikes The two spikes of the tibial alignment guide must be positioned and inserted carefully in order to avoid loosening Figure 3 12 Tibial Registration Continued 10 Ensure the distal clamps of the tibial alignment guide remain securely positioned on the malleoli If a readjustment is necessary ensure the shaft of the guide ...

Страница 38: ...s of the tibial aligner upper assembly and the tibial aligner lower assembly Note If desired the tibial aligner can be used without the upper assembly 3 Connect the tibial aligner to the tibial adjustment mechanism Figure 3 13 Instrument Assembly Figure 3 14 Tibia Registration Freehand Positioning of the Tibial Adjustment Mechanism cont 11 Lock the blue knob on the tibial alignment guide 12 Press ...

Страница 39: ...e As the tubercle may be obscured by the tibial adjustment mechanism the medial third of the tubercle can be marked with a surgical marking pen in order to ease the rotational alignment of the tibia alignment guide later on Figure 3 14 Tibia Registration Continued x3 4 Visually align the tibial adjustment mechanism in varus valgus and in flexion extension by aligning the rod of the tibial aligner ...

Страница 40: ... firmly gripping the distal clamps around the malleoli until both spikes are fully inserted into the tibia Figure 3 14 Tibial Registration Continued Tibial Registration cont 5 Use three 3 5 X 38 mm hex head screw to secure the tibial adjustment mechanism to the bone Note Secure the tibial adjustment mechanism to the bone by first securing screws in the upper lateral hole secondly in the lower late...

Страница 41: ... distal clamps around the malleoli set rotation using the tibial alignment guide Orient the instrument shaft to align with the medial third of the tubercle Note If the medial third of the tubercle was previously marked with a surgical marking pen the instrument shaft can be aligned with this reference Figure 3 14 Tibial Registration Continued 12 While continuing to firmly grip the distal clamps ar...

Страница 42: ...stal part of the guide and resecure the clamps around the malleoli Warning Do not pull on the distal part of the tibial alignment guide once both spikes have been inserted into the tibia Doing so may result in bending of the spikes 14 Lock the blue knob on the distal tibial alignment guide 15 Press the Z button on the pod attached to the tibial alignment guide to initiate the registration procedur...

Страница 43: ...n will not be available until a valid USB key is connected to the system 4 The system will copy the logs on the USB key and will inform the user when the archiving is successful Postoperative Guide Exit the iASSIST Application At the end of the procedure quit the application before starting another procedure with another pod kit To do so 1 Click on the Stop button at the bottom right of the screen...

Страница 44: ... may resultinlossofdataorcausehardwaredamage The proper way to turn off the computer requires exiting all applications in use before initiating the shutdown task Activate the Field Issue Recorder The field issue recorder is a utility that extracts useful data for the investigation of anomalies 1 On the main screen of the system controller computer click on the System Utilities tab 2 Click on the S...

Страница 45: ...eased to 134 C 3 C 273 2 F 5 4 F and 18 minutes according to local requirements outside of the United States such as in the European Union 2 Drying times vary according to load size and should be increased for larger loads 3 Cooling times vary according to the type of sterilizer used device design temperature and humidity of ambient environment and type of packaging used Cooling process should com...

Страница 46: ...quires a minimum 10 minutes ultrasonic cleaning cycle in an enzymatic solution E Screw mechanism should be checked and lubricated with a medical grade surgical lubricant normally after each cleaning as determined upon inspection Description Product ID Qty Sterilization and Specific Cleaning Instructions Additional Notes CAS Small Spike 7 9 mm 20 8000 010 27 1 Autoclave Manuf No 108 108 Femoral Spi...

Страница 47: ...isplayed 20 8011 017 00 20 8011 018 00 1 Autoclave Additional specific cleaning requirements Tibial Left Cut Guide Tibial Right Cut Guide Left instrument displayed 20 8011 019 00 20 8011 020 00 1 Autoclave Cut guides are compatible with saw blades of 1 27 mm 0 05 thickness Validation Tool 20 8011 021 00 1 Autoclave Additional specific cleaning requirements B D Alignment Arch 20 8011 022 00 1 Autoc...

Страница 48: ...djustment Mechanism 20 8011 025 00 1 Autoclave Additional specific cleaning requirements B C D E Femoral Reference 20 8011 026 00 1 Autoclave Additional specific cleaning requirements B D Femoral Distal Cut Guide HBMI Femoral Distal Cut Guide 20 8011 027 00 20 8011 027 50 1 Autoclave Additional specific cleaning requirements B C D E C C B B B C B ...

Страница 49: ...breakage Description Product ID Qty Sterilization and specific cleaning instructions Additional Notes Pod Calibration Jig 20 8011 048 00 1 Autoclave Additional specific cleaning requirements B D Femoral A P Slider HBMI Femoral A P Slider 20 8011 028 00 20 8011 028 50 1 Autoclave Additional specific cleaning requirements B B B ...

Страница 50: ...roduct ID Qty Sterilization and specific cleaning instructions Additional Notes Tibial Left Positioner Tibial Right Positioner Left instrument displayed 20 8011 040 00 20 8011 041 00 1 Autoclave Additional specific cleaning requirements A B C D E B B B B B B ...

Страница 51: ... 8011 042 00 1 Autoclave Saw slot is compatible with saw blades of 1 27 mm 0 05 thickness 3 5 mm Hex Head Knob 20 8011 050 00 1 Autoclave Optional Tibial Aligner Upper Assembly 20 8011 056 51 1 Autoclave Additional specific cleaning requirements B D Tibial Aligner Lower Assembly 20 8011 056 52 1 Autoclave Additional specific cleaning requirements B D B B B ...

Страница 52: ...e 3 5 mm Hex Head Screw x 38mm 20 8000 000 18 4 Autoclave for first use Single use Provided non sterile 3 2 mm Headless Trocar Drill Pin x 1 a 20 8000 000 16 4 Autoclave for first use Single use Provided non sterile Headless trocar drill pin 75 mm a Note This pin is manufactured by Zimmer not Zimmer CAS It should be ordered directly from Zimmer 00 5901 020 00 4 See package insert for re sterilizat...

Страница 53: ...e following situations arises have the equipment verified by a qualified service personnel a The equipment is not functioning properly nor functioning as per instructions b The system controller computer or the instruments have obvious visible signs of breakage or fatigue c The system controller computer or the instruments have been dropped and are damaged d Liquid has entered the system controlle...

Страница 54: ...figuration in which it will be used For safety reasons the system controller computer must be sent for repair if the battery capacity is significantly reduced Becauseofrisksrelatedtolithiumbatteryexplosion the system controller computer should not be exposed to extreme heat Do not use or store the system controller computer near a source of heat or dust Do not use another power supply or cables ot...

Страница 55: ...computer Pod Battery Battery life indication is visible on the pod and in the Pod Status bar on the system controller computer screen Cut Guide Pod 20 8011 000 02 Reference Pod 20 8011 000 01 Figure 5 1 Pods User Interface Model 20 8011 000 02 FCC ID CVOR20S20A IC 10254A R20S20A Model 20 8011 000 02 FCC ID CVOR20S20A IC 10254A R20S20A Model 20 8011 000 01 FCC ID CVOR20S21A IC 10254A R20S21A Pods U...

Страница 56: ...or the calibration process Proceed with surgery N A Solid green Indicates the expected calibration jig position for the intraoperative calibration Position the calibration jig so that the face marked with that number is directed upward and wait for the acquisition to be completed Registration and Validation N A Blinking green Manipulations are needed to complete the registration validation acquisi...

Страница 57: ... not attempt to remove the batteries from the waste Disposal of small amounts of portable batteries to landfills and incinerations are allowed under the Batteries Directive 2006 66 EC and Member State regulations Prior to sending electronic waste for recycling the pods are required to go through a complete cleaning and disinfection cycle The following steps are recommended 1 The pod s outer surfac...

Страница 58: ... iASSIST Knee System Turning off 2 4GHz band Radio Frequency RF devices around the system such as Bluetooth Wi Fi can improve communication performance between the pods and the system controller computer FCC Notice This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable prot...

Страница 59: ...t guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concreteorceramictile Iffloors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power ...

Страница 60: ...meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation ...

Страница 61: ...equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be est...

Страница 62: ...es may cause performance degradation Portable and mobile RF communications equipment can affect the iASSIST Knee System Turning off 2 4GHz band Radio Frequency RF devices around the system such as Bluetooth Wi Fi can improve communication performance between the pods and the system controller computer FCC Notice This equipment has been tested and found to comply with the limits for a Class B digit...

Страница 63: ...entification Guidance and Manufacturer s Declarations Table 5 5 Guidance and Manufacturer s Declaration Electromagnetic Emissions The pods are intended for use in the electromagnetic environment specified below The customer or the user of the pods should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The po...

Страница 64: ...al input output parts 100 kHz repetition frequency Not applicable Not applicable Surge IEC 61000 4 5 0 5 kV 1 kV line to line for input power port AC and DC 0 5 kV 1 kV 2 kV line to ground for input power port AC and DC 2 kV line to ground for signal input output parts Not applicable Not applicable Voltage dips on power supply lines IEC 61000 4 11 0 U_T 0 5 cycle At 0 45 90 135 180 225 270 and 315...

Страница 65: ...8 WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the iASSIST Pod including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Table 5 8 Guidance and Manufacturer s Declaration Electromagnetic Immunity The pods are in...

Страница 66: ...rk Symbol for Temperature Range Symbol for UL Classification Mark Symbol for Authorized EC Representative Symbol for ETL Classification Mark Symbol for Humidity Range Certifies that the electromagnetic interference from the device is under limits approved by the Federal Communications Commission Symbol for Caution Federal U S law restricts this device to sale by or on the order of a physician Symb...

Страница 67: ...65 iASSIST 2 Pod Version Surgical Technique ...

Страница 68: ... Each surgeon should exercise his or her own independent judgment in the diagnosis and treatment of an individual patient and this information does not purport to replace the comprehensive training surgeons have received As with all surgical procedures the technique used in each case will depend on the surgeon s medical judgment as the best treatment for each patient Results will vary based on hea...

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