User's Manual

ManualsBrandsOrthosensor ManualsElectronicsKnee Balancer Transceiver

OrthoSensor, Inc

1560 Sawgrass Corporate Pkwy, 4

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.

The OrthoSensor Knee Balancer provides a means to dynamically balance the knee during knee replacement surgery.

The Knee Balancer is a “smart” tibial insert trial that measures dynamic loads in the medial and lateral compartments of the

knee and wirelessly transmits the measured load data to the OrthoSensor LinkStation for surgeon visualization. Individual

OrthoSensor Knee Balancers are packaged sterile, for single patient use with a Shim Set for thickness adjustments.

The OrthoSensor LinkStation is required for use of the Knee Balancer. The LinkStation contains a computer and all peripheral

equipment required to display the measured load data by providing a graphical and numerical presentation of the loads in both

the medial and lateral compartments of the knee. Refer to the OrthoSensor Device Activation and LinkStation Operation User

Guide for additional details on these components.

The OrthoSensor Knee Balancer is a tool for the adjustment of the femoral knee implant to reduce instability from flexion gap

asymmetry. The Knee Balancer is sterile, for single patient use.

 Any active or suspected latent infection in or about the knee joint.

 Refer to Knee System IFU for additional contraindications.

 Read and follow instructions for proper use and interpretation of force data displayed.

 Strict adherence to the indications, contraindications, precautions and user/patient safety for this product is essential.

 Refer to appropriate Knee System IFU for additional precautions.

 Data from OrthoSensor Knee Balancer is for reference purpose only and should not be the sole basis for surgical decisions.

 OrthoSensor Knee Balancer internal components are non-sterile. Immediately discontinue use of device if any cracks,

damage, or internal fluid is observed. Failure to observe these warnings may expose patient to non-sterile material.

 OrthoSensor Knee Balancer consists of sophisticated calibrated internal microelectronics. Avoid direct impact with mallet or

other instruments when possible.

 Handle OrthoSensor Knee Balancer with care when inserting, adjusting shim size or removing from tibial tray.

 Do not forcibly impact femoral trial on to femur with Knee Balancer in place in tibial tray.

 Do not attempt to use OrthoSensor Knee Balancer without selection and use of proper shim and appropriate sized tibial tray.

 When attaching Shim to OrthoSensor Knee Balancer, take care and caution to properly slide shim onto Knee Balancer

engaging/snapping components together. When detaching a Shim from the Knee Balancer, detach anterior lip first, do not

pry off posterior edge.

 Knee Balancer and Shim Sets are supplied as single-use sterile devices. Do not reuse or re-sterilize.

 If Knee Balancer or Shim Set packaging is open or damaged, do not use and immediately return to OrthoSensor.

 Do not use Knee Balancer after the expiration date on the package labeling.

 Do not use the Knee Balancer in a tibial tray without a Shim attached.

 The measurement load range of the Knee Balancer is 5 to 40 pounds per condyle. Contact OrthoSensor for additional data

regarding Knee Balancer accuracy.

 Maximum safe allowable load for the OrthoSensor Knee Balancer is 70 lbs per compartment.

 If maximum safe allowable load of 70 lbs is reached in either compartment, the Knee Balancer must be removed from the

knee joint and placed on a flat surface to allow the device to “re-zero” to recalibrate the device load sensors.

 If the physician perceives a difference between the loads displayed on the screen and the physical feel, the physician should

either replace the sensor or continue the procedure using their standard trial technique and best clinical judgment.

 Do not load the Knee Balancer at its edges.

 Do not subject Knee Balancer or Shims to loads beyond the maximum allowable load.

 Do not impact / hit the Knee Balancer or any objects in contact with the Knee Balancer as this may result in damage to the

exterior of the device.

Summary of content (3 pages)

PAGE 1
OrthoSensor, Inc 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise FL, 33323 www.orthosensor.com The OrthoSensor Knee Balancer provides a means to dynamically balance the knee during knee replacement surgery. The Knee Balancer is a “smart” tibial insert trial that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the OrthoSensor LinkStation for surgeon visualization.
PAGE 2
OrthoSensor, Inc 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise FL, 33323 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.
PAGE 3
OrthoSensor, Inc 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise FL, 33323 www.orthosensor.com KB breakage KB is powered off KB batteries are low KB loaded beyond limit Lag in reported data Software latency Move LinkStation to achieve an unobstructed line-of-sight to the KB Activate with LinkStation magnet Discard KB and replace KB internal components are nonsterile and non-medical grade. Ensure patient safety.