Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5190 Rev. 6 (EN) 2
08-2020
For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail
at [e-mail] or go to www.orthosensor.com.
• Do not attempt to use the VERASENSE device without selection and use of proper shim and appropriately sized tibial tray.
• If VERASENSE device or shim set packaging is open or damaged, do not use and immediately return to OrthoSensor.
• Maximum allowable load for the VERASENSE device is 70 lbf per compartment. If the physician perceives a difference
between the loads displayed on the screen and the physical feel, the physician should either replace the device or continue
the procedure using their standard instrumented trial technique and best clinical judgment.
Note: Load values between 41-70 lbf are displayed for reference only.
Note: If maximum allowable load of 70 lbf is reached in either compartment, the VERASENSE device must be
removed from the knee joint and “re-zeroed” by holding VERASENSE with superior side (articulating surface) facing
the floor for three (3) seconds, Re-Zero enabled will appear on the VERASENSE Software Application, followed by
Re-Zero Complete indicating that VERASENSE has been reset to zero; or Re-Zero button from the VERASENSE
Software Application by Pressing the Re-Zero button.
Compartment Re-Zero allows for a re-zero of the device without removing it from the joint. With VERASENSE in
the joint, apply a varus or valgus thrust to the knee to off-load the desired medial or lateral compartment. When
the VERASENSE surface is visually unloaded, select the laterality indicator of the unloaded side to initiate the Re-
Zero. Wait for Re-Zero Enabled and Re-Zero Completed messages to display. Repeat the steps on the opposite
compartment to complete the Re-Zero.
Note: Compartment Re-Zero is only available with VERASENSE devices that communicate with the LinkStation
MINI via Bluetooth. Check label on the front of the sensor box for the Bluetooth symbol .
• Do not use a prying device during surgical procedure while the VERASENSE device is in place as this may result in damage to
the exterior of the device.
• Perform load measurements without the patella everted to avoid altered compartmental loads.
• It is recommended to evaluate compartment loads and joint balance with the patella reduced and the capsule closed.
• Verify ligament balancing after final cementation to avoid altered joint balance.
• Clinician learning curve for the use of VERASENSE and accessories during surgery is estimated to possibly cause the following
complications to the patient.
• Prosthetic instability caused from incorrect reference of ligament tension, implant positioning and
varus/valgus angles.
• Patient infection caused from the delay in surgery.
• Only use the necessary accessories for the operation of the VERASENSE.
• Do not power the transceiver from any device other than the provided LinkStation MINI or LinkStation MINI Evaluation Kit.
• Do not connect any other devices to the display unit input/output ports other than those supplied with the VERASENSE.
• Do not modify this equipment.
• Observe all warnings generated by the VERASENSE Software Application.
• VERASENSE for Zimmer Biomet Persona contains lithium batteries, thus special disposal instructions should be taken in the
state of California, USA. The device cannot be incinerated.
• Modification of this device may void the user’s authority to operate the equipment under the FCC rules.
• Federal law restricts this device to sale by or on the order of a licensed physician.
PRECAUTIONS
• Read and follow instructions for proper use and interpretation of force data displayed.
• Refer to appropriate implant knee system IFU for additional precautions.
• The VERASENSE device and shim sets are supplied as single-use sterile. Do not reuse or re-sterilize.
• Do not use VERASENSE device after the expiration date printed next to symbol on the package labeling.
• Do not use the VERASENSE device without a shim attached in the tibial tray for the VERASENSE for Stryker Triathlon Sizes 3-6,
VERASENSE for Biomet Vanguard, or VERASENSE for Zimmer Biomet Persona devices.
• When detaching a shim from the VERASENSE device, detach anterior lip first, do not pry off posterior edge.
Note: For the VERASENSE for Zimmer Biomet Persona, detach shim by prying on the posterior edge.