Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5222 Rev. 1 (EN) 1
10-2019
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.
VERASENSE FOR EXACTECH EQUINOXE
INSTRUCTIONS FOR USE
DESCRIPTION
VERASENSE for Exactech Equinoxe provides orthopedic surgeons a tool to measure load and location for adjustment of humeral
shoulder implants during total shoulder arthroplasty (rTSA). This device does not make a diagnosis and is not intended to replace
a surgeon’s clinical judgment.
The VERASENSE for Exactech Equinoxe device is an intelligent disposable humeral insert trial that measures dynamic loads on the
humoral shoulder and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit
with VERASENSE Software Application for Shoulder (VSA-S) installed for surgeon visualization. Individual VERASENSE for Exactech
Equinoxe devices are packaged sterile, for single patient use with a shim set for thickness adjustments.
NOTE: The following accessories are necessary for the operation of the VERASENSE for Exactech Equinoxe device:
• LinkStation MINI or LinkStation MINI Evaluation Kit
• VERASENSE Software Application for Shoulder (VSA-S)
The LinkStation MINI and LinkStation MINI Evaluation Kit displays the measured load data by providing a graphical and numerical
presentation of the loads on the humoral insert.
INDICATIONS
The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be
indicated.
For use as a tool for measuring load magnitude and location for adjustment of the humeral shoulder implant. The device does
not make a diagnosis and is not intended to replace a surgeon’s clinical judgement. The VERASENSE for Exactech Equinoxe is
sterile, for single patient use.
CONTRAINDICATIONS
• Any active or suspected latent infection in or about the shoulder joint.
• Refer to Implant Shoulder System IFU for additional contraindications.
PRECAUTIONS
• 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 implant shoulder system IFU for additional precautions.
• Data from VERASENSE for Exactech Equinoxe is for reference purposes only and should not be the sole basis for surgical
decisions.
• The internal components of the VERASENSE for Exactech Equinoxe 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.
• The VERASENSE for Exactech Equinoxe consists of sophisticated calibrated internal microelectronics. Do NOT directly impact
with mallet or other instruments at any time.
• Handle VERASENSE for Exactech Equinoxe with care when inserting, adjusting shim size or removing from humeral trial tray.
• Do not forcibly impact implant trial onto the VERASENSE for Exactech Equinoxe placed in the humeral tray.
• Do not attempt to use the VERASENSE for Exactech Equinoxe without selection and use of proper shim and appropriate sized
humeral tray.
• When detaching a shim from the VERASENSE for Exactech Equinoxe, detach proximal lip first, do not pry off distal edge.
• Federal law restricts this device to sale by or on the order of a licensed physician.