TM
USER GUIDE
Device Activation and LinkStation™ Operation
LB-03000-003 Rev A
INTRODUCTION
The OrthoSensor™ Knee Balancer is an intelligent tibial trial that provides intraoperative data to help determine and
achieve optimal soft tissue balance and component position during total knee arthroplasty (TKA).
The Knee Balancer is capable of sensing dynamic loads and center of load* in the medial and lateral compartments of the
operated knee through a full range of motion with the patella reduced.
When utilized in the trialing phase of TKA the Knee Balancer will sense intercompartmental loads, center of load* as a
reference for tibial-femoral contact, tibial tray rotation and exion angle of the leg*. Data is displayed on a 27” monitor on the
OrthoSensor LinkStation™ depicted below.
The OrthoSensor Knee Balancer enables the surgeon to make evidence based decisions regarding soft tissue releases and
component position to achieve true balance and stability through a full range of motion.
Key Features
• Provides dynamic intraoperative loads and
center of load* in the medial and lateral
compartments through full range of motion
with the patella reduced.
•
Kinetic Tracking™
kinematic tracking in conjunction with load
data.
• Displays Tibial Tray Rotation and Knee Flexion
Angle*.
• Requires no change to surgical workow.
• Low cost, single use disposable device.
• Enables data capture in still images or video
that may be added to the patient record.
feature provides dynamic
Key Clinical Benets
• Addresses the leading causes of early
implant failure in TKA: instability,
malrotation and loosening
• Dynamic intercompartmental load data
and Kinetic Tracking enable evidence
based soft tissue releases to improve
stability.
• Provides intraoperative feedback on
tibial component rotation*, center of
load* and femoral articulation to
facilitate optimal component position.
• Enables reproducible, teachable surgical
technique.
• Captures intraoperative data for inclusion
in patient record and registries.
*For Reference Only
1
LINKSTATION SETUP
STEP 1
Activate LinkStation
Press and hold power button on back of computer to
activate.
Conrm surgeon visualization of LinkStation.
Position Transceiver
Ensure Transceiver is connected directly to USB port on
back of computer.
Power switch on back of computer
Transceiver CANNOT be connected through a peripheral
USB hub.
Transceiver should point toward the operating table
with antennae oriented in opposite directions at
approximately 45º to the Transceiver.
This position promotes optimal communication
between the Transceiver and the OrthoSensor Knee
Balancer.
Four (4) blue LED lights on the top of the transceiver
FIGURE I indicate power and communication link with
the OrthoSensor Knee Balancer.
LED #1 and LED #2 indicate communication link between
Transceiver and the OrthoSensor Knee Balancer. These
LEDs will illuminate only after device is activated.
LED #4 indicates that Transceiver is active.
Optimal Transceiver position with antennae at 45º
LED #1
LED #2
LED #3
LED #4
LED #3 is inactive and will not illuminate.
FIGURE I
2
DEVICE ACTIVATION
STEP 2
Launch Application
Double click the OrthoSensor icon to launch
application.
Activate Device
A. Remove appropriate size OrthoSensor Knee
Balancer and Shims from box.
Do not remove from sterile pack.
Remove outer box labels and ax to patient
documentation as required.
B. Place device directly over round silver magnet
on LinkStation with articulating surface facing up.
The LED will illuminate on the articulating surface of
the device after approximately one second.
DO NOT MOVE THE DEVICE until you observe the
following:
i) LED turns o after approximately four (4) seconds.
ii) Graphic User Interface (GUI) launches.
iii) Load Sensor initialization progress bar appears
and completes.
OrthoSensor Icon & Application Start Screen
LED illuminated
Initialization takes up to 10 seconds.
Device may now be removed from magnet.
3
Initialization in progress