Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5222 Rev. 1 (EN) 2
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.
USER/PATIENT SAFETY
• VERASENSE for Exactech Equinoxe and shim sets are supplied as single-use sterile. Do not reuse or re-sterilize.
• If VERASENSE for Exactech Equinoxe or shim set packaging is open or damaged, do not use and immediately return to
OrthoSensor.
• Do not use VERASENSE for Exactech Equinoxe after the expiration date on the package labeling.
• Do not use the VERASENSE for Exactech Equinoxe without a shim attached.
• The measurement load range of the VERASENSE for Exactech Equinoxe is 5 to 40 lbf, with a load accuracy of ±3.5 lbf.
• Maximum allowable load for the VERASENSE for Exactech Equinoxe is 70 lbf. 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.
• Do not impact / hit the VERASENSE for Exactech Equinoxe or any objects in contact with the device as this may result in damage
to its exterior casing.
• Do not use a prying device during surgical procedure while the VERASENSE for Exactech Equinoxe is in place as this may result
in damage to the exterior of the device.
• The VERASENSE for Exactech Equinoxe device contains non-sterile, non-medical grade internal components. If the device
housing is damaged or cracked during the procedure, take appropriate steps to promote patient safety.
• Do not disassemble or otherwise modify the VERASENSE for Exactech Equinoxe or shims.
• Do not use VERASENSE for Exactech Equinoxe device if it appears to be functioning improperly.
• Observe all warnings generated by the VERASENSE Software Application for Shoulder.
INSTRUCTIONS
1. Confirm the LinkStation MINI or LinkStation MINI Evaluation Kit is setup appropriately outside of the sterile field.
Refer to the VERASENSE for Exactech Equinoxe User Guide. The LinkStation MINI or LinkStation MINI Evaluation Kit is
located outside of the sterile field and the VERASENSE for Exactech Equinoxe device and shims are used within the
sterile field.
2. Determine the specific implant type and size VERASENSE for Exactech Equinoxe required. Remove pouched Shims
and device from the box. DO NOT OPEN THE POUCH SEAL.
a. Do not use if device or shim set packaging has been opened or damaged.
3. Record device serial number ( ) onto patient and hospital records as required.
4. To activate the VERASENSE for Exactech Equinoxe:
a. With the product still in the sealed pouches, place the device directly over the magnet on LinkStation MINI
or LinkStation MINI Evaluation Kit. An LED light will illuminate on the device. Do not move the device until
you observe the following:
i. LED turns off after approximately four (4) seconds.
ii. VERASENSE Software Application for Shoulder launches.
iii. Initialization progress bar appears and completes.
iv. Prompt to select left or right shoulder appears.
b. Device may now be removed from magnet.
5. The VERASENSE Software Application for Shoulder will automatically prompt selection of left or right shoulder. Select
the appropriate operative shoulder.
6. Zero Device
a. Follow on screen instructions to zero the device.
7. Upon completion of the device initiation process as prompted on the VERASENSE Software Application for Shoulder,
pass the sealed pouch to the nurses within the sterile field of the operating room.
8. Open double sealed pouch per hospital protocol (VERASENSE for Exactech Equinoxe and shim set).
9. With the VERASENSE for Exactech Equinoxe and shims removed from the pouch, apply designated shim to underside
of the device.
Note: The VERASENSE for Exactech Equinoxe shim attaches to the bottom of the device. Attach by inserting
the device’s distal end into the shim, matching the sensor base geometry, then engage the proximal end
snapping mechanism by squeezing the assembly together.