Summary of Contents for Xpand Ortho XO1
- Page 1 Caution: Federal (United States) law restricts this device to sale, distribution and use by or on the order of a physician. 1 of 11...
- Page 2 Description: The XpandOrtho XO knee balancing system provides the surgeon with a method for assessing ligament balance during Total Knee Arthroplasty. The XpandOrtho XO knee balancing system consists of a controller with an attached tibiofemoral distractor (XO Device) and the XpandOrtho Graphic User Interface (GUI). The XO Device is supplied as a sterile, single use disposable device that employs a wireless communication link to the GUI to display information regarding the tibiofemoral gap.
- Page 3 The XpandOrtho XO knee balancing system is contraindicated in partial knee replacements such as unicompartmental arthroplasty. The XpandOrtho XO knee balancing system may not be used in cases with severe deformity: for example; a residual varus or valgus greater than 5° even after making bone cuts and ligament releases.
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Page 4: Airplane Mode
1.6. From the XpandOrtho Calibration Data CD: 1.6.1. Download the file "TrialCalData.xml" 1.6.2. Save the file "TrialCalData.xml" in the directory C:\Xpand Ortho\Calibration Data. 1.6.3. Once the Calibration Data is saved on the PC, eject the CD and remove it from the external CD drive. - Page 5 2.2. Prepare a surface within the sterile field to receive the XO device and components. 2.3. Using sterile technique, open the leg strap pouch and place the leg strap onto the prepared surface within the sterile field. 2.4. Using sterile technique, open the syringe pouch and place the syringe onto the prepared surface within the sterile field.
- Page 6 5.1. If a tourniquet is being applied, ensure that there will be at least 127mm (5inches) of space between the inferior margin of the tourniquet and the proximal extent of the incision. Cover the patie t’s lo er thigh ith a sterile arrier fil or drape. Wrap the leg strap around the patie t’s thigh, o top of the sterile arrier fil or drape, a d tighte fir l .
- Page 7 7. Pressurize the XO device: 7.1. Pump the piston of the 20mL syringe to pressurize the tibiofemoral distractor to 20psi (approximately 5 to 6 full strokes). The pressure will be displayed on the GUI. If the pressure is greater than 25psi, disengage the extension line from the dual check valve on the end of the syringe and allow the XO device to deflate.
- Page 8 8. Calibrate knee flexion: 8.1. To confirm proper positioning of the XO device controller relative to the tibiofemoral distractor, hold the knee in 0° flexion and at 90° flexion and monitor the flexion reading on the display. If the GUI display is different from the knee position, use the Calibrate tab on the GUI and follow the instructions on the GUI to calibrate knee flexion.
- Page 9 10. GUI Data Display: 10.1. There are two display tabs available on the GUI. 10.2. View 1: View 1 displays a live axial image of the tibiofemoral distractor with a cross-hair in the center. The location of the cross-hair provides a visual indication of the tilt between the top and bottom surfaces of the tibiofemoral distractor.
- Page 10 11.2. This process can be repeated as many times as needed. If the surgeon desires to recut the bones or reposition the components, tibiofemoral distractor can be deflated and removed. 11.3. If the surgeon desires to perform soft-tissue releases and there is adequate surgical access, the surgeon can perform the soft-tissue releases with the tibiofemoral distractor in place and monitor the tibiofemoral gap in real-time on the Tibiofemoral Gap Graph.
- Page 11 View 2 12. Measure Dynamic Knee Balance: The GUI will display the net gap between the tibial and femoral surfaces in real time as well as record the gap and show a plot of the tibiofemoral gap against knee flexion. The information may be referenced from either the View 1 or View 2 tabs. 12.1.
- Page 12 2. A wireless USB integrated radio receiver assembly is connected to the computer display. The assembly connects an A2500R24A-EZ4E Anaren Integrated Radio to a USB interface. 3. Total output power output is 1.5 mW maximum, and range is a maximum of 10m. 4.
- Page 13 3. Device does not communicate with the computer. Remove and re-insert the USB of the Wireless Receiver. If this does ’t ork, restart the PC. If this does ’t ork, repla e the U“B receiver. If this does not work replace the device. 4.