Assembly Instructions

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36 | iASSIST 2-Pod Version Surgical Technique

9. Attach the Tibial Positioner and the Tibial

Adjustment Mechanism assembly onto the

proximal part of the Tibial Alignment Guide

by aligning the arrows laser-marked on the

instruments.

10. Slide the Tibial Positioner towards the bone until

the Tibial Adjustment Mechanism sits on the

anterior cortex of the tibia.

Warning: Ensure that the Tibial Positioner is

well seated on the horizontal shaft of the Tibial

Alignment Guide.

Warning: For a small size tibia, the Tibial

Adjustment Mechanism should be placed

on the tubercle. In this case, care must be

taken when securing the Tibial Adjustment

Mechanism to the bone using the 3.5 x 38 mm

Hex Head Screw to avoid potential interference

between the screws and the spikes of the Tibial

Alignment Guide.

3.6.1 Tibial Positioner Technique (cont)

Workow Selection (cont)

Warning: Impact the Tibial Alignment Guide in-

line with the spikes of the instrument. O-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.

Warning: Do not pull on the distal part of the

Tibial Alignment Guide until both spikes have

been fully removed from the tibia. Doing so

might result in bending of the spikes.

8. Lock the blue knob on the distal Tibial Alignment

Guide.

Figure 3.6.1

Tibial Positioner Technique- Workow Selection (cont)

Summary of content (15 pages)

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36 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.1 Tibial Positioner Technique- Workflow Selection (cont) 3.6.1 Tibial Positioner Technique (cont) Workflow Selection (cont) Warning: Impact theTibial Alignment Guide inline with the 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.
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37 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.1 Tibial Positioner Technique - Workflow Selection (cont) 3.6.1 Tibial Positioner Technique (cont) Workflow Selection (cont) 11. Use three 3.5 x 38 mm Hex Head Screw to secure the Tibial Adjustment Mechanism to the bone. 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 lateral lower hole. 12.
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8 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.2 Tibial Aligner Technique - Instruments Assembly 3.6.2 Tibial Aligner Technique The following section describes an alternate technique for positioning the Tibial Adjustment Mechanism on the tibia using the Tibial Aligner rather than the Tibial Positioner. Warning: After wrapping/preparing the ankle, the surgeon should still be able to palpate the malleoli. Instruments Assembly 1.
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39 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.2 Tibial Aligner Technique- Tibial Workflow Selection Tibial Workflow Selection 1. Place the pegs of theTibial Aligner on the proximal tibial plateau and sit the Tibial Adjustment Mechanism on the anterior cortex of the tibia. 2. Preset the height of the Tibial Adjustment Mechanism by moving the lower part of the Tibial Aligner up or down. Note: Each position represents 6 mm increments. 3.
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40 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.2 Tibial Aligner Technique- Tibial Workflow Selection Tibial Workflow Selection (cont) 5. Use three 3.5 x 38 mm Hex Head Screw to 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.
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41 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.2 Tibial Aligner Technique- Tibial Workflow Selection Tibial Workflow Selection (cont) 9. Install 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: If the medial third of the tubercle was previously marked with a surgical marking pen, the instrument shaft can be aligned with this reference.
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42 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.2 Tibial Aligner Technique- Tibial Workflow Selection Tibial Workflow Selection (cont) 13. Ensure the distal clamps of the Tibial Alignment Guide remain securely positioned on the malleoli. If a re-adjustment is necessary, ensure the shaft of the guide remains immobile and in proper alignment. Adjust by rotating the distal part of the guide and re-secure the clamps around the malleoli.
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43 | iASSIST 2-Pod Version Surgical Technique Figure 3.7 Bilateral Procedure 3.7 Surgical Technique for Bilateral Procedure Note: The same iASSIST Knee Pod Kit can be used only if the application was not closed. Intraoperative calibration does not have to be repeated if the same iASSIST Knee Pod Kit is used. To perform a bilateral procedure, perform the following steps: 1.
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44 | iASSIST 2-Pod Version Surgical Technique Figure 3.8 Stop Panel 3.8 Surgical Transition (Stop Button) To stop and exit the application at the end of the surgery, click on the “Stop” button on the bottom right side of the iASSIST V2 Tablet screen. The Menu Panel will then be displayed with three different options. 3.8.1 Cancel If the “Stop” button was clicked accidentally, it is possible to go back to the previous panel by clicking the “Cancel” button on the left of the screen. 3.8.
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45 | iASSIST 2-Pod Version Surgical Technique 4. Postoperative Guide All the operations described in this section must be performed from the Tablet home screen. 1) The iASSIST V2 Tablet is not connected to the Internet or the Internet is deactivated 2) The iASSIST V2 Tablet is trying to connect to the Wi-Fi 3) The iASSIST V2 Tablet is connected to the Internet via Wi-Fi 4) The iASSIST V2 Tablet is connected to the Internet via Ethernet cable Figure 4.1 Internet Connection 4.
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46 | iASSIST 2-Pod Version Surgical Technique Figure 4.2 Case Data Manager 4.2 Case Data Manager The Case Data manager is used to store, access, archive and upload surgery related information on cases treated with the system. 4.2.1 Starting the Case Data Manager 1. After turning on the system, click the “Gear” icon (1) on the left bottom of the screen to open the System Utilities menu. 2. Click on the “Case Data Manager” icon (2). 4.2.
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47 | iASSIST 2-Pod Version Surgical Technique Figure 4.2 Case Data Manager (cont) 4.2 Case Data Manager (cont) 4.2.4 Uploading cases on the Zimmer Biomet Case Database 4.2.5 Deleting cases To upload cases on the Zimmer Biomet case database, when reporting an incident or to collect information related to a PER when filing a complaint: 1. Select all cases to delete by clicking their checkboxes. 1. Ensure that the system has an active Internet connection. 2.
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48 | iASSIST 2-Pod Version Surgical Technique Figure 4.3 Updating the System 4.3 Updating the System System updates must be performed by sales representatives. 4.3.1 Update via Internet Connection 1. Before starting the installation process, ensure that the system has an active Internet connection, and that the system is connected to an AC outlet. Note: Public networks using captive portals to enable Internet connection are not supported. 2.
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49 | iASSIST 2-Pod Version Surgical Technique Figure 4.3 Updating the System (cont) 4.3 Updating the System (cont) 4.3.2 Update via USB Key (cont) 3. To update the application, click on “Accept” and enter the installation license key in the dialog box that opens. Warning: When prompted to install an application update, it is important to review the associated release report to determine if the changes are understood well enough to continue using the system.
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50 | iASSIST 2-Pod Version Surgical Technique Figure 4.4 Date, Time and Regulatory Region 4.4 Date, Time and Regulatory Region 4.5 Shutdown of the iASSIST V2 Tablet The system is configured for a specific regulatory region. If it changes, the region should be updated through the regulatory region button in the maintenance mode. 1. Exit all applications in use, if any. It is also possible to change the date and time of the Tablet through the maintenance mode button.