User Guide
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VeraSense System user guide ®
VeraSense system user guide | Table of contents
VeraSense system user guide Contents LinkStation MINI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 LinkStation MINI Evaluation Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 VeraSense Software Application (VSA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Getting started: Powering on the LinkStation MINI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Surgeon selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Channel selector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 VeraSense activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Calibration sequence and leg selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Active Monitoring Screen and communication status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 VeraSense shim assembly and insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Assessing loads and balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Image & data capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Calibration Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Understanding balance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Balance soft-tissue. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Re-zero load. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Kinetic tracking*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Load assessment during component placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Shutting down VeraSense. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Shutting down the LinkStation MINI and LinkStation MINI Evaluation Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
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VeraSense system user guide | Table of contents
Warning & dialog messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Cleaning and care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Additional features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Options menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Keyboard hot-keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
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VeraSense system user guide | LinkStation MINI
LinkStation MINI
LinkStation MINI Display Unit
VeraSense Activation Magnet
Easy Grip Transport Handle
VeraSense Storage Basket
Medical Grade Power Cord with Power Supply Holster Balanced Rolling Stand
*Center of load and load values outside of the green zone are for reference only.
Note The following accessories are necessary for the operation of the VeraSense device: • VeraSense Software Application • LinkStation MINI or LinkStation MINI Evaluation Kit 4
VeraSense system user guide | LinkStation MINI Evaluation Kit
LinkStation MINI Evaluation Kit
Display Unit
Medical Grade Power Cord with Power Supply (Not displayed)
*Center of load and load values outside of the green zone are for reference only.
Notes The following accessories are necessary for the operation of the VeraSense device: • VeraSense Software Application • LinkStation MINI or LinkStation MINI Evaluation Kit 5
VeraSense system user guide | VeraSense Software Application (VSA)
VeraSense Software Application (VSA) Load values Load measurement unit
Medial/Lateral Indicators & Compartment Re-zero
EXIT
Center of Load Indicators*
OPTIONS
Options menu
TRACK
Kinetic tracking*
ZERO
Initial Medial Lateral
LEFT
Exit VeraSense Software Application
Re-zero VeraSense
Final
Center of load and load values outside of the green zone are for reference only.
•B luetooth signal strength • VeraSense battery life • Display Unit power
VeraSense Calibration Indicators
Positional Data Capture Table
• Surgical side indicator
*Center of load and load values outside of the green zone are for reference only.
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VeraSense system user guide | Getting started
Powering on the LinkStation MINI Step 1 •
Display Unit power button
To turn on the LinkStation MINI or LinkStation MINI Evaluation Kit, press the power button located on the left side of the Display Unit.
Step 2 •
The VeraSense Software Application will automatically start once the Display Unit is powered on.
Step 3 •
LinkStation MINI
The plug-shaped Tablet Power Indicator on the bottom left of the screen shows whether the tablet is plugged in and running on AC power or if it is unplugged and running on DC battery power.
Caution: It is recommended to always plug in the LinkStation MINI and operate the system on AC power. LinkStation MINI Evaluation Kit
Please activate VeraSense device by placing it on the magnet (Keep VeraSense device on the magnet until application starts) Searching for VeraSense...
Physician Name
Select
POWER
Tablet Power Indicator Red = Unplugged (dc) Green = Plugged in (ac)
Notes Place the LinkStation MINI or LinkStation MINI Evaluation Kit on contralateral side of the operating table for optimal surgeon visibility. 7
VeraSense system user guide | Surgeon selection
Surgeon selection •
This feature is no longer in use.
Please activate VeraSense device by placing it on the magnet (Keep VeraSense device on the magnet until application starts) Searching for VeraSense...
Select
Physician Name POWER
Physician Name
Doe John MD Select
POWER
Doe John MD
Surgeon Not Listed
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VeraSense system user guide | Channel selector
Channel selector Channel assigned for communication between VeraSense Sensor and LinkStation MINI •
•
Channel 5 - Use for single-LinkStation MINI environments. VeraSense Software Application automatically connects to activated sensor. Channels 2/3/4 - Use for multi-LinkStation MINI environments. VeraSense Software Application asks user to confirm connection to activated sensor(s).
Please activate VeraSense device by placing it on the magnet (Keep VeraSense device on the magnet until application starts) Searching for VeraSense...
Physician Name
Select
POWER
Note If using multi-system setup, no individual system can be set to Channel 5 with autoconnection.
5 Channel selector 5= Auto-connect, 2/3/4= Multi-channel
Auto connection
RF signal will not be used and will appear in gray
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VeraSense system user guide | VeraSense activation
VeraSense activation Step 1 •
Select appropriate VeraSense size and remove sensor and shims from outer box. DO NOT remove from sterile pouch.
Step 2 •
Activate the sensor by holding it stationary up against the magnet. Note: For LinkStation MINI only, the magnet is mounted on the Roll Stand.
Step 3 •
LinkStation MINI
DO NOT remove the sensor from the magnet until each of the following activation steps occurs: • A n LED light will illuminate inside the sensor after approximately one (1) second. The light turns off after approximately four (4) seconds. •T he VeraSense Software Application will recognize the sensor and initialize communication.
Step 4 •
The LED inside the sensor will blink every few seconds to indicate the device is properly activated.
Active VeraSense found ( SN 1234567890) Connect? CANCEL
OK
Active VeraSense found dialog If channels 2, 3 or 4 are being used, the Active VeraSense found dialog will display. Select OK after verifying serial number ( SN ) with package.
Notes To optimize battery life, do not activate VeraSense until just before it is required in the surgical workflow. VeraSense has a 40 minute battery life. 10
VeraSense system user guide | Calibration sequence and leg selection
Select laterality Step 1 •
EXIT
Once the calibration sequence is complete, the select leg dialog will appear.
OPTIONS
TRACK
Step 2 •
ZERO
Press either left or right to match the surgery side.
Please wait... Calibrating VeraSense
Initial Lateral Medial
Final
Center of load and load values outside of the green zone are for reference only.
EXIT
OPTIONS
TRACK
ZERO
Please select the leg LEFT
Initial Lateral Medial
Final
RIGHT
Center of load and load values outside of the green zone are for reference only.
Center of load and load values outside of the green zone are for reference only. 11
VeraSense system user guide | Active Monitoring Screen and communication status
Active Monitoring Screen and communication status Step 1 •
EXIT
Once VeraSense is passed into the sterile field, it is ready for use during the procedure.
OPTIONS
TRACK
Step 2 •
ZERO
Position the LinkStation MINI or LinkStation MINI Evaluation Kit as close to the sterile boundary as possible and within direct view of the surgeon.
CAPTURE
LEFT
Center of load and load values outside of the green zone are for reference only.
Notes
1. The Active Monitoring Screen is the main screen of the VeraSense Software Application. 2. The Communication signal strength indicator is located at the bottom left of the Active Monitoring Screen. •R eposition the LinkStation MINI or LinkStation MINI Evaluation Kit to troubleshoot poor signal strength. * Center of load and load values outside of the green zone are for reference only. 12
VeraSense system user guide | VeraSense shim assembly and insertion
VeraSense insertion and shim assembly Step 1 •
Determine desired VeraSense thickness and attach the appropriate shim as needed.
Step 2 •
Insert VeraSense: In a tight knee, it may be necessary to insert the trial tibial baseplate and VeraSense prior to insertion of the femoral trial. In this instance, reduce the tibia under the femur, then insert the femoral trial.
Caution: DO NOT utilize excessive force or impact VeraSense directly with a mallet. Excessive impaction force may damage or negatively impact function of VeraSense.
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VeraSense system user guide | Assessing loads and balance
Assessing loads and balance Step 1 •
With VeraSense inserted, the VeraSense Software Application displays the center of load* and magnitude of the applied loads in the medial and lateral compartments.
Step 2 •
Data is displayed dynamically through a full range of motion.
EXIT
OPTIONS
TRACK
ZERO
Initial Medial Lateral
LEFT
Final
Center of load and load values outside of the green zone are for reference only.
Notes
It is recommended to evaluate compartmental loads and joint balance with the patella reduced and the capsule closed. * Center of load and load values outside of the green zone are for reference only. 14
VeraSense system user guide | Image & data capture
Image & data capture Two ways to capture screen images and data The VeraSense Software Application (VSA) shows either the simple capture button or the Position Capture Table
Simple capture
Position capture
•
Shown when Position Capture Table isn’t displayed.
•
aptures screenshot and records load data when C 10°, 45°, 90° buttons are selected.
•
Captures screenshot when selected.
•
Select initial and final tabs to store separate stages of positional range of motion data during case.
•
Positional Data Capture Table can be turned on/off in the options menu.
EXIT
OPTIONS
TRACK
ZERO
LEFT
EXIT
POSITION CAPTURE
lbf/N
INFO
OPTIONS
TRACK
Initial
Medial
Lateral
Final
10°
CAPTURE
ZERO
CLOSE
CAPTURE
45° 90°
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VeraSense system user guide | Calibration indicators
Calibration indicators What you need to know •
EXIT
Calibration indicators are the color bar displays beneath each M/L load value.
OPTIONS
- Indicate levels of VeraSense accuracy throughout loading range. •
Calibrated load range is within green zone from 22 – 180 N. Loads values outside of the green zone are for reference only.
•
VeraSense Software Application displays a VeraSense overload message when either side goes into the red zone.
TRACK
ZERO
CAPTURE
LEFT
Center of load and load values outside of the green zone are for reference only.
EXIT
OPTIONS
BLACK = 0 –21 N
TRACK
GREEN = 22–180 N
ZERO
CAPTURE
YELLOW = 181– 311 N RED = 311+ N LEFT
Center of load and load values outside of the green zone are for reference only.
EXIT
OPTIONS
TRACK
ZERO
CAPTURE
LEFT
Center of load and load values outside of the green zone are for reference only.
EXIT
OPTIONS
TRACK
ZERO
VERASENSE overload detected
LEFT
CAPTURE
Center of load and load values outside of the green zone are for reference only.
Notes Load values not displayed for loading < 22 N. * Center of load and load values outside of the green zone are for reference only. 16
VeraSense system user guide | Understanding balance
Understanding balance** Coronal balance •
EXIT
Clinical research suggests a load differential between the medial and lateral compartments of less than or equal to 67 N through the range of motion is indicative of coronal plane soft tissue balance.*
OPTIONS
TRACK
ZERO
Initial Final Medial Lateral
Sagittal balance (CR Components) •
This is typically determined by a stable end-point during a posterior drawer test, while not exhibiting gross PCL tension leading to excessive rollback or anterior lift-off of the tibial component. The femoral center of load points are in the mid-third of the tibial plateau.*
10° 45° LEFT
90°
Center of load and load values outside of the green zone are for reference only.
Unbalanced
EXIT
OPTIONS
TRACK
ZERO
Initial Final Medial Lateral
10° 45° LEFT
Center of load and load values outside of the green zone are for reference only.
90°
Balanced
* Center of load and load values outside of the green zone are for reference only. ** Roche MW, et al. Dynamic soft tissue balancing in total knee arthroplasty. Orthop Clin N Am. 2014; 45(2): 157-165 17
VeraSense system user guide | Balance soft-tissue
Balance soft-tissue Clinical experience combined with information displayed by the VeraSense Software Application (VSA) may be used to assist decision making regarding component placement and soft tissue releases to achieve compartmental balance.
MCL pie-crusting with an 18-gauge needle
EXIT
OPTIONS
TRACK
ZERO
VeraSense overload detected.
LEFT
CAPTURE
Center of load and load values outside of the green zone are for reference only.
Notes 1. If VeraSense indicates a compartmental load in excess of 311 N, reduce shim size if possible or perform initial adjustments to bring the load below 311 N. Before performing final release to achieve soft tissue balance, remove VeraSense and re-zero. 2. If VeraSense indicates a compartmental load of less than 22 N, increase shim size to generate condylar load. * Center of load and load values outside of the green zone are for reference only. 18
VeraSense system user guide | Re-zero load
Re-zero load If VeraSense experiences elevated loads, a re-zero may be required for accurate load readings. A user can perform a re-zero in three ways:
Compartment re-zero
Re-zero device
EXIT
OPTIONS
Motion-controlled re-zero •
Hold VeraSense with superior side (articular surface) facing the floor for three (3) seconds. Wait for re-zero enabled and re-zero completed messages to display.
Menu zero button •
TRACK
First, remove VeraSense from knee to unload sensor. Then press the zero button on the VeraSense Software Application. Wait for re-zero enabled and re-zero completed messages to display.
ZERO
VeraSense overload detected
LEFT
CAPTURE
Center of load and load values outside of the green zone are for reference only.
Re-Zero Enabled
Compartment specific re-zero •
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 rezero enabled and re-zero completed messages to display. Repeat the steps on the opposite compartment to complete the re-zero.
Center of load and load values outside of the green zone are for reference only.
Re-Zero Completed
Center of load and load values outside of the green zone are for reference only.
Notes
Do not re-load VeraSense until “Re-zero Completed” message is displayed. 19
VeraSense system user guide | Kinetic tracking*
Using the Kinetic tracking feature Press “track” to turn on/off Kinetic tracking
Displays dynamic motion of the knee through the full ROM to evaluate joint kinetics.
EXIT
• Extension to flexion roll back evaluation, AP drawer test, Int/Ext rotation laxity, etc.
OPTIONS
TRACK
Step 1 •
Select the track button on the VeraSense Software Application (VSA) to enable Kinetic tracking.
Step 2 •
ZERO
To clear and disable tracking, click the track button again.
Initial
Medial
Lateral
Final 10° 45°
LEFT
Center of load and load values outside of the green zone are for reference only.
90°
Kinetic tracks are displayed as green lines that trace center of load point movement*
* Center of load and load values outside of the green zone are for reference only. 20