User's Manual
OrthoSensor, Inc
1560 Sawgrass Corporate Pkwy, 4
th
Floor
Sunrise FL, 33323
www.orthosensor.com
LB-03000-001 Rev B
Dec. 2012
For further information, contact the OrthoSensor Customer Service Center by phone at 954-577-7770 or by e-mail at
customerservice@orthosensor.com or go to www.orthosensor.com.
Do not use a prying device during surgical procedure while the Knee Balancer is in place as this may result in damage to the
exterior of the device.
The Knee Balancer contains non-sterile, non-medical grade internal components. If the Knee Balancer housing is damaged or
cracked during the procedure, take appropriate steps to promote patient safety.
Do not disassemble or otherwise modify the Knee Balancer or Shims.
Do not use Knee Balancer if it appears to be functioning improperly.
Observe all warnings and alarms generated by the OrthoSensor LinkStation.
Federal law restricts this device to sale by or on the order of a licensed physician.
1. Determine the specific size Knee Balancer required. Remove pouched Shims and Knee Balancer from the box and put
on the shelf of the OrthoSensor LinkStation. DO NOT OPEN POUCH SEALS.
2. Record Knee Balancer serial number (S/N) onto patient and hospital records as required.
3. To activate the Knee Balancer:
a. Locate the OrthoSensor Sensor Assisted Surgery (SAS) icon on the screen of the LinkStation and activate the
SAS software.
b. With the product still in the sealed pouches, place the device directly over the magnet on LinkStation shelf;
an orange LED light will illuminate on the articulating surface of the Knee Balancer. Do not move the device
until you observe the following:
i. LED turns off after approximately four (4) seconds.
ii. Graphic User Interface (GUI) launches.
iii. Load Sensor initialization progress bar appears and completes.
c. Device may now be removed from magnet.
4. The GUI will automatically prompt selection of left or right leg. Select appropriate leg.
5. Zero Device
a. Horizontal Zero, Step One
i. Place sterile packed device flat on LinkStation shelf.
ii. Gently secure medial and lateral edges to ensure device is flat.
iii. Click the “Zero” button on the GUI.
iv. Progress bar will appear and complete.
b. Horizontal Zero, Step Two
i. Rotate the device 180º.
ii. Gently secure medial and lateral edges to ensure device is flat.
iii. Click the “Zero” button on the GUI.
iv. Progress bar will appear and complete.
c. Vertical Zero, Step Three
i. Place sterile packed device flat against LinkStation post. The flat non-articulating surface of the
device should be against post with posterior edge oriented toward the floor.
ii. Click the “Zero” button on the GUI. Note that this step is instantaneous and has no progress bar
for this step.
6. With the Knee Balancer now activated, pass the sealed pouches to the nurses within the sterile field of the OR.
7. Open double sealed pouches per hospital protocol (Knee Balancer and Shim Set.)
8. With Knee Balancer and Shims removed from the pouches, apply designated Shim to bottom of Knee Balancer.
9. To remove the Shim, or exchange for another size, simply unsnap the anterior lip of the attached Shim and replace.
10. With the Knee Balancer and Shim attached, physician should manually compress / apply load to the Knee Balancer
and verify the response on the LinkStation screen prior to placing Knee Balancer into the tibial tray.
11. Confirm that the Knee Balancer with Shim is fully seated when placed in the tibial tray.
12. Flex the joint throughout its full range of motion to ensure appropriate response on the LinkStation.
13. Proceed with total knee replacement process per physician / hospital protocol.
14. Upon completion of the procedure, deactivate the Knee Balancer by pressing the Power Button on the GUI.
15. Dispose of Knee Balancer per institutional guidelines for biohazardous medical waste.
Issue
Cause
Solution
Knee Balancer (KB) LED does not light up
KB batteries are dead
Discard KB and replace
KB not transmitting data to LinkStation
KB is out of wireless range
Move LinkStation closer to KB