Orthosensor ORTHOSNSR3 User Guide

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 workow.
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 Benets
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 SETUP
STEP 1
Activate LinkStation
Press and hold power button on back of computer to activate.
Conrm 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 ax 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
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