User's Manual

OrthoSensor, Inc
1560 Sawgrass Corporate Pkwy, 4
th
Floor
Sunrise FL, 33326
www.orthosensor.com
07562-X1
TM
ORTHOSENSOR
ORTHOSENSOR ORTHOSENSOR
ORTHOSENSOR LOAD BALANCING SYSTE
LOAD BALANCING SYSTELOAD BALANCING SYSTE
LOAD BALANCING SYSTEM
MM
M
LOAD SENSOR
LOAD SENSOR LOAD SENSOR
LOAD SENSOR INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USEINSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
DESCRIPTION
DESCRIPTIONDESCRIPTION
DESCRIPTION
The OrthoSensor Load Balancing System (LBS) provides a means to dynamically balance the knee during knee replacement
surgery intra-operatively.
The OrthoSensor Load Sensor (LS) is made exclusively for use with the Stryker Orthopaedics Knee Trial for Triathlon™ system
with special authorization from OrthoSensor. The device is approved for early validation testing only. Therefore, the
information reported by the OrthoSensor System shall not be used to affect patient outcome.
The Load Sensor measures the forces between the tibia and the femur. It wirelessly transmits measured force data to the Link
Station positioned outside the sterile field. The Load Sensor replaces the standard trial tibial insert, it is provided sterile, for
single patient use. A Shim Set is included for thickness adjustments.
Additional Load Balancing System components include:
• Link Station: The Link Station houses a computer and all peripheral equipment required to interpret and display the
force data. The Link Station provides a graphical and numerical presentation of the forces in one or both of the knee
compartments.
• Receiver: The Receiver is incorporated into the Link Station; it receives the wireless transmissions from the Load
Sensor and communicates the data to the computer.
Refer to the OrthoSensor Link Station Instructions for Use for additional details on these components.
INDICATIONS
INDICATIONSINDICATIONS
INDICATIONS
The OrthoSensor Load Balancing System (LBS) is a tool for the adjustment of the femoral knee implant to reduce instability
from flexion gap asymmetry.
CONTRAINDICATIONS
CONTRAINDICATIONSCONTRAINDICATIONS
CONTRAINDICATIONS
• Any active or suspected latent infection in or about the knee joint.
• Refer to Stryker Orthopaedics Triathlon Knee System IFU for additional contraindications.
PRECAUTIONS
PRECAUTIONSPRECAUTIONS
PRECAUTIONS
• Read and follow instructions for proper use and interpretation of force data displayed.
• Strict adherence to the indications, contraindications, precautions and warnings for this product is essential.
• Refer to Stryker Orthopaedics Triathlon Knee System IFU for additional precautions.
USER/PATIENT SAFETY
USER/PATIENT SAFETYUSER/PATIENT SAFETY
USER/PATIENT SAFETY
• The Load Sensor and Shim Set are supplied as single-use sterile devices. If Load Sensor or Shim Set packaging are open or
damaged, do not use and immediately return to OrthoSensor.
• Impact or excessive loading of the Load Sensor may result in a failure of the Load Sensor housing, exposing the patient to
non-sterile and non-biocompatible internal components.
• Load Sensor and Shim Sets are single use only. Do not reuse or resterilze.
• Load range of the Load Sensor is 5 to 40 pounds per condyle.
• Maximum safe allowable load for the OrthoSensor Load Sensor is 70 lbs per condyle.
• Refer to the Device History File for Load Sensor accuracy data.
• Do not load the Load Sensor at its edges.