Orthosensor ORTHOSNSR7 Users Manual

For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail

OrthoSensor , Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA

www.orthosensor.com

VERASENSE INSTRUCTIONS FOR USE

DESCRIPTION

VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral
compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI
Evaluation Kit with VERASENSE Software Application (VSA) installed for surgeon visualization. Individual VERASENSE 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 device:

• LinkStation MINI or LinkStation MINI Evaluation Kit

• VERASENSE Software Application (VSA)

The LinkStation MINI and LinkStation MINI Evaluation Kit displays the measured load data by providing a graphical and
numerical presentation of the loads in both the medial and lateral compartments of the knee.

VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the
following implant systems:

• VERASENSE for Biomet Vanguard

• VERASENSE for Stryker Triathlon

• VERASENSE for Zimmer NexGen

• VERASENSE for Smith & Nephew Legion

• VERASENSE for Smith & Nephew Journey II

• VERASENSE for Zimmer Biomet Persona

Please see Table 3 for the listing of Catalog Numbers for each compatible implant system and sizes.

INDICATIONS

VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be
indicated.

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. VERASENSE is
sterile, for single patient use.

CONTRAINDICATIONS

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

• Refer to Implant Knee 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 knee system IFU for additional precautions.

• Data from VERASENSE is for reference purposes only and should not be the sole basis for surgical decisions.

• The internal components of the VERASENSE device 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 device consists of sophisticated calibrated internal microelectronics. Do NOT directly impact with mallet or

other instruments at any time.

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06-2018

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VERASENSE for Biomet Vanguard

VERASENSE for Smith & Nephew Journey II

OrthoSensor , Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA

www.orthosensor.com

• Handle VERASENSE device with care when inserting, adjusting shim size or removing from tibial tray.

• Do not forcibly impact femoral implant trial onto the VERASENSE device placed in tibial tray.

• Do not attempt to use the VERASENSE device without selection and use of proper shim and appropriate sized tibial tray.

• When detaching a shim from the VERASENSE device, detach anterior lip first, do not pry off posterior edge.

o Note: For the VERASENSE for Zimmer Biomet Persona, detach shim by prying on the posterior edge.

• Federal law restricts this device to sale by or on the order of a licensed physician.

USER/PATIENT SAFETY

• VERASENSE device and shim sets are supplied as single-use sterile. Do not reuse or re-sterilize.

• If VERASENSE device or shim set packaging is open or damaged, do not use and immediately return to OrthoSensor.

• Do not use VERASENSE device after the expiration date 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.

• 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.

o Note: Load values between 41-70 lbf are displayed for reference only.

• Do not impact / hit the VERASENSE device 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 device is in place as this may result in damage to

the exterior of the device.

• The VERASENSE 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 device or shims.

• Do not use VERASENSE device if it appears to be functioning improperly.

• Observe all warnings generated by the VERASENSE Software Application.

Model Measurement Load Range Load Accuracy

VERASENSE for Stryker Triathlon

VERASENSE for Zimmer NexGen

VERASENSE for Smith & Nephew Legion

VERASENSE for Zimmer Biomet Persona

5-40 lbf per compartment

±3.5 lbf

INSTRUCTIONS

1. Confirm the LinkStation MINI or LinkStation MINI Evaluation Kit is setup appropriately outside of the sterile field.

Refer to the VERASENSE User Guide or VERASENSE Quick Reference Guides. The LinkStation MINI or LinkStation MINI
Evaluation Kit is located outside of the sterile field and the VERASENSE device and shims are used within the sterile
field.

2. Determine the specific implant type and size VERASENSE device required. Remove pouched Shims and device from

the box. DO NOT OPEN POUCH SEALS.

a. Do not use if device or shim set packaging has been opened or damaged.

3. Record VERASENSE device serial number ( ) onto patient and hospital records as required.

4. To activate the VERASENSE device:
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 launches.

iii. Initialization progress bar appears and completes.

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OrthoSensor , Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA

www.orthosensor.com

iv. Prompt to select left or right leg appears.

b. Device may now be removed from magnet.

5. The VERASENSE Software Application will automatically prompt selection of left or right leg. Select the appropriate

operative leg.

6. Zero Device
a. Follow on screen instructions to zero the VERASENSE

device.

7. Upon completion of the device initiation process as prompted on the VERASENSE Software Application, pass the

sealed pouches to the nurses within the sterile field of the operating room.

8. Open double sealed pouches per hospital protocol (VERASENSE device and shim set).

9. With the VERASENSE device and shims removed from the pouches, apply designated shim to underside of VERASENSE

device.

Note: The VERASENSE for Zimmer Biomet Persona device shim attaches to the top of the device. Attach by
inserting the devices anterior tab into the anterior loop on the shim, engage the posterior snapping
mechanism by squeezing the assembly together. Input the selected shim thickness within the VERASENSE
Software Application.
Note: Once the product is removed from the pouch, the application of the initial shim, if applicable, relates
to devices without mounted shims (VERASENSE for Stryker Triathlon Sizes 2 & 7, VERASENSE for Zimmer
NexGen, VERASENSE for Smith & Nephew Journey II, and VERASENSE for Smith & Nephew Legion). Apply
desired shim to all VERASENSE for Stryker Triathlon 3-6, VERASENSE for Biomet Vanguard, and VERASENSE
for Zimmer Biomet Persona devices prior to use.

10. To remove the shim, or exchange for another size, simply unsnap the anterior lip of the attached shim and replace.

Note: VERASENSE for Zimmer Biomet Persona shim is removed by distracting the posterior aspect of the
device from shim. This releases the posterior snapping mechanism.

11. With the VERASENSE device and shim attached, physician should manually compress / apply load to the device and

verify the response on the User Interface prior to placing VERASENSE device into the tibial tray.

12. Place VERASENSE within tibial tray.

13. Confirm that the VERASENSE device with shim is fully seated when placed in the tibial tray.

14. Flex the joint throughout its full range of motion to ensure appropriate response on the User Interface.

15. Proceed with TKA process per physician / hospital protocol.

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.

16. Upon completion of the procedure, deactivate the VERASENSE Software Application by pressing the Exit Button on

the User Interface.

17. Dispose of the VERASENSE device per institutional guidelines for biohazardous medical waste.

Note: 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.

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Table 1

Issue

Cause

Solution

Discard VERASENSE device and
replace

Move LinkStation MINI or LinkStation

VERASENSE device

Move LinkStation MINI or LinkStation

VERASENSE device field of use

Activate with LinkStation MINI or

magnet

Discard VERASENSE device and
replace

VERASENSE device internal

Discard device and replace.

Maintain knee position until data
settles (approximately 5 seconds)

OrthoSensor , Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA

www.orthosensor.com

VERASENSE TROUBLESHOOTING

VERASENSE device LED does not light up VERASENSE device batteries are dead

MINI Evaluation Kit closer to

VERASENSE device is out of wireless

range
VERASENSE Device not transmitting data
to LinkStation MINI or LinkStation MINI

MINI Evaluation Kit to achieve an
unobstructed line-of-sight to the

Evaluation Kit

VERASENSE device is powered off

LinkStation MINI Evaluation Kit

VERASENSE device batteries are low

VERASENSE device breakage

VERASENSE device applied load is

beyond limit

components are non-sterile and non­medical grade. Ensure patient safety.

Lag in reported data Software latency

Note: Should any of the issues above arise please contact OrthoSensor Customer service at + 1 954-577-7770 for return or
replacement assistance.

DECONTAMINATION OF PRODUCT RETURNED FOR COMPLAINT INVESTIGATION

This section applies to all VERASENSE devices intended to be returned for complaint investigations. Any device that has been
opened/removed from sterile packaging and exposed to biohazardous material must be sent to central processing within the
hospital for decontamination according to this procedure prior to transport to OrthoSensor. The following guidelines have been
proven effective for cleaning VERASENSE devices but are not guaranteed to result in a safe handling environment or sterilized
devices.

Note: Should a device be clearly marked as having been used on a patient with HIV or infectious disease of equivalent
risk, the device must not be decontaminated but rather documented and destroyed.

Decontamination Procedure:

1. Create cleaning solution in labeled cleaning container by combining 2 ounces (59 mL) of ENZOL Enzymatic detergent

(or equivalent*) per gallon (3.8 L) of warm water.

2. Soak device(s) for 5 minutes. If necessary, use brush to clean any dried-on material.

3. Thoroughly rinse device(s) with clean running water. Dry device(s) and place on clean absorbent pad.

4. Fill labeled disinfection container with enough Cidex OPA solution (or equivalent*) to cover device(s) completely.

5. Immerse device(s) in solution and soak for 15 minutes. Ensure that all devices are 100% covered by the solution.

6. Remove device(s) and rinse for at least one minute with a large volume of clean water. Dry device(s) and place

decontaminated parts on clean absorbent pad.

*If equivalent agent is used, it is recommended to follow manufacturer’s instructions for creating cleaning and
disinfectant solutions. Once this procedure has been carried out, devices may be packaged in the enclosed return
envelope and transported per instructions on return envelope.

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