OrthoSensor VERASENSE User manual

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VERASENSE OrthoSensor.com
VERASENSE USER GUIDE
12/2018 LB-5092 Rev. 2

12/2018 LB-5092 Rev. 2

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VERASENSE OrthoSensor.com
VERASENSE USER GUIDE
TABLE OF CONTENTS
VERASENSE Overview 4
Linkstation Mini With 5
Integrated Antenna Option Overview
Linkstation Mini Evaluation Kit Overview 6
VERASENSE Software Application Overview 7
Getting Started 8
Transceiver Setup 9
Surgeon Selection 1 1
VERASENSE Activation 12
Calibration Sequence & Leg Selection 13
Verify VERASENSE Activation 14
Active Monitoring Screen 15
VERASENSE Insertion 16
Assessing Loads 17
Image & Data Capture 18
Calibration Indicators 19
Understanding Balance 20
Balance Soft-Tissue 2 1
VERASENSE Re-Zero Load 22
Kinetic Tracking* 23
Cementing 24
Shutting Down VERASENSE 25
Shutting Down the Linkstation Mini 26
and Linkstation Mini Evaluation Kit
Warning & Dialog Messages 27
Troubleshooting 29
Cleaning & Care 30
Additional Features 3 1
Options Menu 32
Display Available Menus 33
OrthoLogIQ Mode (“IQ Mode”) 34
WiFi Connection Setup 35
Selecting the Open Network 36
Keyboard Hot-Keys 37

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VERASENSE OrthoSensor.com
OrthoSensor’s VERASENSE delivers evidence-based data wirelessly to
an intra-operative monitor that enables surgeons to make informed
decisions on soft tissue balance and implant position in real time.
VERASENSE utilizes proprietary sensor technologies to transmit compartmental
load data wirelessly. This enables surgeons to make informed decisions regarding
soft tissue balance, and implant position with the goal of improving joint
performance, knee kinetics and patient satisfaction.1-3
As a result, patients whose knees have been balanced through the use of
VERASENSE show statistically significant improvements in joint function, pain,
activity level and patient satisfaction.
VERASENSE enables surgeons to
quantify ligament balance and
improves surgeon skill through
real-time, evidence-based data.
SENSOR-ASSISTED TKA
*For Reference Only
• Provides dynamic intercompartmental loads in the medial
and lateral compartments through full ROM with the capsule
closed and patella reduced
• Kinetic Tracking* feature displays dynamic kinematic tracking
in conjunction with load data to visualize tibiofemoral
articulation through full ROM
• Requires no change in surgical workflow
• Low-cost, single-use disposable sensor
• Compatible with multiple knee implant systems
• Enables intraoperative data capture
• Intended to address leading causes of premature implant
failure in TKA: mal-alignment and soft-tissue balance
related complications
4-8
• Dynamic compartmental load data and Kinetic Tracking*
enables evidence-based soft tissue releases to improve
stability4
• Enables reproducible, teachable surgical technique through
quantifying surgeon “feel”
• Captures intraoperative data for inclusion in patient EMR,
registries or comparative effectiveness studies
VERASENSE KEY PRODUCT FEATURES KEY CLINICAL BENEFITS
1 Gustke KA, Golladay GJ, Roche M, Elson L,
Anderson C. Primary TKA patients with Quantifiably
Balanced Soft-Tissue Achieve Significant Clinical
Gains Sooner than Unbalanced Patients. Adv
Orthop. 2014:628695.
2 Gustke KA, Golladay GJ, Roche MW, Jerry GJ,
Elson LC, Anderson CR. Increased satisfaction
after total knee replacement using sensor-guided
technology. Bone Joint J 2014;96-B:1333–8.
3 Gustke, Golladay, et al. A New Method for Defining
Balance: Promising Short-Term Clinical Outcomes
of Sensor-Guided TKA. J Arthroplasty. 2014
May:29(5):955-60.
4 Bozic K, Kurtz S, Lau E, et al. The epidemiology of
revision total knee arthroplasty in the united
states. Clin Orthop Relat Res. 2010. 468: 45-51.
5 Lombardi AV, Berend KR, Adams JB. Why knee
replacements fail in 2013: patient, surgeon, or
implant? Bone Joint J. 2014;96-B(11 Supple A):
101-104.
6 Schroer WC, Berend KR, Lombardi AV, et al. Why
are total knees failing today? Etiology of total
knee revision in 2010 and 2011. J Arthroplasty
2013;28(8 Suppl):116–119.
7 Parratte S, Pagnano MW. Instability after total
knee arthroplasty. J Bone Joint Surg Am 2008; 90:
184-94.
8 Rodriguez-Merchan, EC. Instability Following Total
Knee Arthroplasty. HSS J. Oct 2011: 7(3): 273-278.
VERASENSE OVERVIEW

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LINKSTATION MINI WITH INTEGRATED ANTENNA OPTION OVERVIEW
NOTE
The following accessories are necessary for
the operation of the VERASENSE device:
VERASENSE Software Application
LinkStation MINI or LinkStation MINI
Evaluation Kit
Transceiver
VERASENSE Activation Magnet
Easy Grip Transport Handle
VERASENSE Storage Basket
Balanced Rolling Stand
Medical Grade Power Cord
with Power Supply Holster
LinkStation MINI Display Unit
Antenna
Antenna
*Center of load and load values outside of
the Green Zone are for reference only.

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LINKSTATION MINI EVALUATION KIT OVERVIEW
Transceiver
Transceiver Tripod
Medical Grade Power
Cord with Power Supply
(NOT DISPLAYED)
LinkStation MINI
Evaluation Kit
Display Unit
Stand
NOTE
The following accessories are necessary for the
operation of the VERASENSE device:
VERASENSE Software Application
LinkStation MINI or LinkStation MINI Evaluation Kit
Antenna
Antenna
*Center of load and load values outside of the Green Zone are for reference only.

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VERASENSE SOFTWARE APPLICATION OVERVIEW
*Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
TRACK
Exit VERASENSE
Software Application
Medial/Lateral Indicators
& Compartment Re-zero
Center of Load
Indicators*
Load Values
Options Menu
Kinetic Tracking*
Re-Zero
VERASENSE
Positional Data
Capture Table
• RF/Bluetooth Signal Strength/
Channel
• VERASENSE Battery Life
• Tablet AC/DC
• Surgical Side Indicator
VERASENSE Calibration
Indicators
Medial Lateral
LEFT Center of load and load values outside of the Green Zone are for reference only.

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POWERING ON THE LinkStation MINI
GETTING STARTED
LINKSTATION MINI
LINKSTATION MINI
EVALUATION KIT
Turn OFF
Devices
Please activate sensor by placing it on the magnet
(Keep sensor on the magnet until application starts)
Searching for sensors...
Physician Name
Select
DISPLAY UNIT POWER BUTTON
AC/DC POWER INDICATOR
RED = UNPLUGGED (DC)
GREEN = PLUGGED IN (AC)
STEP 1
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 startup
once the Display Unit is powered on.
STEP 3
The plug-shaped AC/DC Power indicator on the bottom left of the screen
will show 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 Display Unit and
operate the system on AC power.
NOTE
Place the LinkStation MINI or LinkStation MINI Evaluation Kit on
contralateral side of the operating table for optimal surgeon visibility.

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TRANSCEIVER SETUP
TRANSCEIVER SETUP
LINKSTATION MINI WITH INTEGRATED ANTENNA OPTION
STEP 1
Ensure the Transceiver Antenna mounting brackets are securely fixed to the
back mounting plate of the Display Unit. Also ensure the Transceiver
housing is properly fixed to the top mounting bracket.
STEP 2
Ensure the Transceiver cable is connected to the USB port on the right of
the Display Unit and firmly connected to the Transceiver. Also confirm both
antenna cables are securely connected to the Transceiver and the top and
bottom mounted Antennas.
NOTES
1. LED (1) and LED (2) indicate communication between the
Transceiver and VERASENSE. Communication is optimal when
both LEDs are illuminated.
2. LED (3) and LED (4) indicate the Transceiver is powered on.
NOTE The VERASENSE for Zimmer Biomet Persona communicates
with the LinkStation MINI via Bluetooth and the transceiver setup is
not required.
LED (1)
LED (2)
LED (3)
LED (4)
Turn OFF
Devices
Please activate sensor by placing it on the magnet
(Keep sensor on the magnet until application starts)
Searching for sensors...
Physician Name
Select

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TRANSCEIVER SETUP
TRANSCEIVER SETUP
LINKSTATION MINI WITH NON-INTEGRATED ANTENNA
OPTION
STEP 1
See images for ideal Transceiver arm position.
• Position antennas at 45° to the floor and at least 12” (305 mm) above and 7”
(178 mm) out from the display unit.
• Ensure the Transceiver cable is connected to the USB port on the right of
the Display Unit.
LINKSTATION MINI EVALUATION KIT
STEP 1
Attach antennas to Transceiver and mount to tripod. Fully extend tripod
legs prior to use.
STEP 2
Ensure the Transceiver cable is connected to the USB port on the right of
the Display Unit.
NOTES
1. LED (1) and LED (2) indicate communication between the Transceiver and
VERASENSE. Communication is optimal when both LEDs are illuminated.
2. LED (3) and LED (4) indicate the Transceiver is powered on.
NOTE The VERASENSE for Zimmer Biomet Persona communicates
with the LinkStation MINI or LinkStation MINI Evaluation Kit via
Bluetooth and the transceiver setup is not required.
LINKSTATION MINI
EVALUATION KIT
LINKSTATION MINI
LED (1)
LED (2)
LED (3)
LED (4)
>12”
LINE OF
SIGHT
>7”

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SELECT THE SURGEON
SURGEON SELECTION
STEP 1
Prior to activating VERASENSE, select the surgeon
performing the case.
STEP 2
Touch the text box to open a drop down menu of surgeon
names.
NOTE: The first name to appear is the surgeon who
was selected for the last use of the VERASENSE Software
Application.
STEP 3
If the surgeon performing the case does not appear, then
select “Surgeon Not Listed” from the drop down menu.
NOTE
Please contact OrthoSensor Customer Service
to add a new surgeon to the list.
US ONLY 888.75.ORTHO (888. 756.7846)
US AND INTERNATIONAL +1 954.577.7700
POWER
WIFI
Please activate sensor by placing it on the magnet
(Keep sensor on the magnet until application starts)
Searching for sensors...
Physician Name
Surgeon Not Listed
Physician Name
Doe John MD
Select
Doe John MD
Surgeon Not Listed
POWER

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VERASENSE ACTIVATION
ACTIVATE VERASENSE
STEP 1
Select appropriate VERASENSE size and remove VERASENSE and shims
from outer box.
• DO NOT remove from sterile pouch.
STEP 2
Activate VERASENSE by holding it stationary up against the magnet.
NOTE: For the LinkStation MINI only, the magnet is mounted on the roll stand.
STEP 3
DO NOT REMOVE VERASENSE FROM THE MAGNET UNTIL EACH OF THE
FOLLOWING ACTIVATION STEPS OCCURS:
• An LED light will illuminate in VERASENSE after approximately one (1)
second. The light turns off after approximately four (4) seconds.
• The VERASENSE Software Application will recognize VERASENSE and
initializes communication.
If channel switching is enabled, then the
ACTIVE VERASENSE FOUND dialog will display.
Select OK after verifying serial number (
SN
)
with package.
NOTE
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.
LINKSTATION MINI
Active VERASENSE found
(SN 1234567890) Connect?

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SELECT LATERALITY
CALIBRATION SEQUENCE & LEG SELECTION
STEP 1
Once the calibration sequence is complete, the SELECT LEG
dialog will appear.
STEP 2
Press either LEFT or RIGHT to match the surgery side.
Please select leg
LEFT RIGHT
* Center of load and load values outside of the Green Zone are for reference only.
Please wait... Calibrating Sensor
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
TRACK
Medial Lateral

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VERIFY VERASENSE ACTIVATION
VERIFY VERASENSE ACTIVATION
STEP 1
While in sterile pouch, apply pressure to the VERASENSE
condylar surfaces and confirm that loads display on the
VERASENSE Software Application.
STEP 2
Once activation is confirmed, open the sterile packaging that
contains VERASENSE and shims and pass into sterile field using
standard sterile technique by hospital personnel.
* 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.
EXIT
OPTIONS
ZERO
CAPTURE
TRACK
LEFT

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ACTIVE MONITORING SCREEN
ACTIVE MONITORING SCREEN AND COMMUNICATION STATUS
STEP 1
Once VERASENSE is passed into the sterile field, it is ready
for use during the procedure.
STEP 2
Position the LinkStation MINI or LinkStation MINI Evaluation
Kit as close to the sterile boundary as possible and within
direct view of the surgeon.
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 screen VERASENSE
Software Application.
•
Reposition the LinkStation MINI or 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.
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
TRACK
LEFT
Medial Lateral

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VERASENSE INSERTION & SHIM ASSEMBLY
VERASENSE INSERTION
STEP 1
Determine desired VERASENSE thickness and attach the
appropriate shim as needed.
• NOTE: VERASENSE for Zimmer Biomet
Persona requires the user to input the
selected shim thickness within the
VERASENSE Software Application prior to use.
STEP 2
Insert VERASENSE.
• In a tight knee capsule, 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.
SHIM
16

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ASSESSING LOADS AND BALANCE
ASSESSING LOADS
STEP 1
With VERASENSE inserted, the VERASENSE Software
Application will display the position (Contact Points*) and
magnitude of the applied loads in the medial and lateral
compartments.
STEP 2
Data is displayed dynamically through a full range of motion.
NOTE
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.
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
TRACK
RIGHT
Lateral Medial

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IMAGE & DATA CAPTURE
IMAGE & DATA CAPTURE
TWO WAYS TO CAPTURE SCREEN IMAGES AND DATA
The VERASENSE Software Application shows EITHER the Simple Capture Button OR the Position Capture Table
SIMPLE CAPTURE POSITION CAPTURE
• Shown when Position Capture Table isn’t displayed.
• Captures screenshot when selected.
CLOSE
LEFT
POSITION
CAPTURE
IQ
INFO
MANUALS
EXIT
OPTIONS
TRACK
ZERO
CAPTURE
EXIT
OPTIONS
TRACK
ZERO
CAPTURE
• Captures screenshot and records load data when 10°, 45°, 90°
BUTTONS are selected.
Lateral Medial

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WHAT YOU NEED TO KNOW:
CALIBRATION INDICATORS
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
CAPTURE
TRACK
LEFT
VERASENSE overload detected,
re-zero recommended.
Calibration Indicators are the color bar displays beneath each M/L load value.
• Indicate levels of VERASENSE accuracy throughout loading range.
Center of Load reference points are a consistent color throughout all
loading ranges.
Calibrated load range is within GREEN ZONE FROM 5 – 40 LBF. 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.
BLACK = 0-4 lbf
GREEN = 5-40 lbf
YELLOW = 41-70 lbf
RED = 70+ lbf
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
CAPTURE
TRACK
LEFT
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
CAPTURE
TRACK
LEFT
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
CAPTURE
TRACK
LEFT
* Center of load and load values outside of the Green Zone are for reference only.

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UNDERSTANDING BALANCE
UNDERSTANDING BALANCE
CORONAL BALANCE
Clinical research suggests a load differential between the
medial and lateral compartments of less than or equal to 15 LBF
through the range of motion is indicative of coronal plane soft
tissue balance.*
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 contact points are in the mid-third of
the tibial plateau.*
Roche MW, et al. Dynamic soft tissue balancing in total knee
arthroplasty. Orthop Clin N Am. 2014; 45(2): 157-165
* Center of load and load values outside of the Green Zone are for reference only.
UNBALANCED
(Load Difference = 29 - 4 = 25lbf)
BALANCED
(Load Difference = 15 - 14 = 1lbf)
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
TRACK
RIGHT
Lateral Medial
Center of load and load values outside of the Green Zone are for reference only.
EXIT
OPTIONS
ZERO
TRACK
RIGHT
Lateral Medial