Surgical Technique Personal Fit. Renewed Life™

Table of Contents Page 2.1 System Controller Computer Setup 5 2.3 Settings, Snapshot, Patient Side and Pod Status Bar 6 3.1 Powering-On Pods and Intra-Operative Calibration 7 4.1 Retrieve Surgical Procedures Archives 20 4.2 Activate the Field Issue Recorder 20 4.3 Shut Down the System Controller Computer 20 5. Equipment Inventory and Cleaning/Sterilization Methods 21 5.2 iASSIST Knee Master Instruments Kit 22 5.5 General Equipment Information 28 5.6 Product Specifications and Regulatory Notices 32 6. General & Contact Information 41

1. Overview 1.1 Indication for Use The iASSIST™ Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes. The present iASSIST Knee System is designed for Total Knee Arthroplasty. 1.4 Contraindications 1.4.1 Clinical The system should not be used: a.  In cases of hip pathology...

Pre-Operative Guide 2. Pre-Operative Guide WARNINGS 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 use 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. User must exit and restart the application with a new pod kit to begin another...

Pre-Operative Guide 2.2 Application Launch 1.  Press and hold the barcode scanner button (orange button) located at the right of the System Controller Computer. 2.  Scan the 2D barcode located on the iASSIST Knee Pod Kit. 3.  A confirmation sound will 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. Note: If the 2D barcode cannot be read, the user can...

Intra-Operative Guide 3. Intra-Operative Guide 3.1 Powering-On Pods and Intra-Operative 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 package may affect the sterility of the Pods. If damage to the sterile packaging is observed, open another iASSIST Knee Pod Kit. 2.  Power-on each of the four Pods by depressing the power button until it is flush with the Pods surface. The green status LED (Light Emitting Diode) of each Pod will blink quickly. WARNINGS Make...

Intra-Operative Guide 5.  Begin by placing face 1 of the Pod Calibration 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” Pods indicate the expected position (1 through 6) of the Pod Calibration Jig during calibration. WARNING The Pods need to be calibrated on a flat, approximately horizontal surface to ensure optimal performance....

Intra-Operative Guide 3.3 Distal Femur Cut 3.3.1 Instrument Assembly The Tibial Adjustment Mechanisms are side specific and are used to correctly determine the patient side. One “Cut Guide” Pod must be attached to the corresponding Tibial Adjustment Mechanism. This is required even when performing the distal femur cut. 1.  Depending on the patient side: For a left knee procedure, clip one “Cut Guide” Pod marked with a on the back face to the Tibial Left Adjustment Mechanism. For a right knee procedure, clip one “Cut Guide” Pod marked with a on the back face to the Tibial Right Adjustment Mechanism....

Intra-Operative Guide 3.3.2 Femur 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 Small Spike 7.9 mm into the distal femur (2.5-3.5 cm). WARNING The spike should be aligned within 15° of the mechanical axis of the femur and be within 15° perpendicular to the final required orientation of the cut. This alignment is required because of the mechanical adjustment limit of the Femoral Adjustment Mechanism. 3.  Slide the Femoral Reference onto the spike. 4.  Align the Femoral Reference in a neutral...

Intra-Operative Guide WARNINGS The pelvis must remain immobile during the femoral registration. Do not perform the femoral registration by moving the leg in a uniaxial direction, i.e. only in a flexion/extension, abduction/adduction and/or combination of both motions (e.g. T-shape). 3.3.3 Distal Femur Cut 1.  Install the Femoral Adjustment Mechanism on the anterior side of the Femoral Reference by aligning the arrows. 2.  Insert the two long pegs of the Femoral AP Slider into the Femoral Adjustment Mechanism. 3.  Slide the Femoral Adjustment Mechanism down towards the distal condyles to the half...

Intra-Operative Guide 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 mm Hex Head Screw x 38 mm and the Femoral Reference. 10.  Remove the spike using a slaphammer. Note: As provided by Zimmer, the PersonaTM Slaphammer (425099-037-00) can be used to remove the Femoral Spike. Note: As provided by Zimmer, the NexGen® Slaphammer Extractor (00-5785-097-00) can be used to remove the Femoral Spike or the CAS Small Spike 7.9 mm. 11.  Manually adjust the resection level if desired. Loosen the screw on the...