OrthoSensor VERASENSE User manual

VERASENSE USER GUIDE
09/2016 OS-VS-16-5050 Rev. 1

09/2016 OS-VS-16-5050 Rev. 1

3
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
TABLE OF CONTENTS
VERASENSE USER GUIDE
VERASENSE Overview 4
LinkStation MINI & Transceiver Overview 5
LinkStation MINI Evaluation Kit 6
& Transceiver Overview
VERASENSE Software Application Overview 7
Getting Started 8
Transceiver Setup 9
Wifi Setup & Selection 10
Surgeon Selection 12
VERASENSE Activation 13
Calibration Sequence & Leg Selection 14
Verify VERASENSE Activation 15
Active Monitoring Screen 16
VERASENSE Insertion 17
Referencing Tibia Tray Rotation 18
Using Contact Points*
Assessing Loads 19
Calibration Indicators 20
Understanding Balance 21
Balance Soft-Tissue 22
VERASENSE Re-Zero Load 23
Kinetic Tracking* 24
Cementing 25
Shutting Down VERASENSE 26
Shutting Down the LinkStation MINI 27
Warning & Dialog Messages 28
Troubleshooting 30
Cleaning & Care 31
Additional Features 32
Options Menu 33
Display Available Menus 34
OrthoLogIQ Mode (“IQ Mode”) 35
Image & Data Capture 36
Keyboard Hot-Keys 37
Technical Specifications 38

4
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
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, tibiofemoral rotation* 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.
• 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
• Displays tibial tray rotation* data
• 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 enables surgeons to
quantify ligament balance and
improves surgeon skill through
real-time, evidence-based data.
SENSOR-ASSISTED TKA
VERASENSE OVERVIEW
*For Reference Only

5
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
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
NOTE
The following accessories are necessary for
the operation of the VERASENSE device:
VERASENSE Software Application
Transceiver
LinkStation MINI or LinkStation MINI
Evaluation Kit
LINKSTATION MINI & TRANSCEIVER OVERVIEW

6
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
LINKSTATION MINI EVALUATION KIT & TRANSCEIVER 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
Transceiver
LinkStation MINI or LinkStation MINI Evaluation Kit

7
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
VERASENSE SOFTWARE APPLICATION OVERVIEW
Exit VERASENSE
Software Application
Medial/Lateral Indicators
Contact Point
Rotation Indicator*
Center of Load
Indicators*
Load Values
Options Menu
Kinetic Tracking*
Re-Zero
VERASENSE
Positional Data
Capture Table
• RF Signal Strength/Channel
• VERASENSE Battery Life
• Tablet AC/DC
• Surgical Side Indicator
VERASENSE Calibration
Indicators

8
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
POWERING ON THE LinkStation MINI
GETTING STARTED
STEP 1
To turn on the LinkStation MINI, 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.
DISPLAY UNIT POWER BUTTON
AC/DC POWER INDICATOR
RED = UNPLUGGED (DC)
GREEN = PLUGGED IN (AC)
NOTE
Place the LinkStation MINI or LinkStation MINI Evaluation Kit on
contralateral side of the operating table for optimal surgeon visibility.
LINKSTATION MINI
LINKSTATION MINI
EVALUATION KIT

9
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
TRANSCEIVER SETUP
TRANSCEIVER SETUP
STEP 1
Ensure the Transceiver cable is connected to the USB port on the right of
the Display Unit.
STEP 2
See images for ideal Transceiver arm position.
• The antenna are ~45° to the floor.
• For the LinkStation MINI only, the Transceiver is at least 12” (305 mm)
above and 7” (178 mm) out from the Display Unit screen.
LED (1)
LED (2)
LED (3)
LED (4)
>12”
LINE OF
SIGHT
>7”
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.
LINKSTATION MINI
LINKSTATION MINI
EVALUATION KIT

10
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
WIFI CONNECTION SETUP
WIFI SETUP & SELECTION
The WIFI Button in the lower left-hand corner will indicate the
connection status of the VERASENSE Software Application:
GREEN = WIFI Connected
RED = WIFI Not Connected
STEP 1
Select the WIFI button to connect the VERASENSE Software
Application to a wireless network or to acknowledge a
network access policy for a connected (green) network.
• On the WIFI Network Configuration Screen, a list will
populate with the names of all available networks.
STEP 2
Use the UP and DOWN arrows to scroll through the list of
available networks.
NOTE: If desired network is not shown, please select the
RE-SCAN button to repopulate the network list.
STEP 3
Select the desired WIFI network by touching the appropriate
network box.

11
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
SELECTING THE OPEN NETWORK
WIFI SETUP & SELECTION
STEP 1
After selecting the appropriate WIFI network, enter the
Network Security Key:
• Press the KEYBOARD button to open the virtual keyboard.
• Select the Network Security Key field and enter key.
• Press the CONNECT button.
NOTE: If the WIFI network does not have a Network
Security Key, select the CONNECT button to proceed.
STEP 2
To confirm a successful WIFI network:
• The connect WIFI network will appear in GREEN.
• Is Connected = True
• On the right portion of the screen, the OrthoLogIQ login
page will appear.
NOTE
If the the selected network requires acceptance of a local
internet access policy , a pop-up window will appear in the
right-hand side of the WIFI Configuration Screen. Enter
the required policy information.
To exit to the Home Screen, select the CLOSE button in the
bottom left corner.

12
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
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

13
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
ACTIVATE VERASENSE
VERASENSE ACTIVATION
STEP 1
Select appropriate VERASENSE size and remove VERASENSE and shims
from outer box.
• DO NOT remove from sterile pouch.
STEP 2
Activate the 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.
Active VERASENSE found
(SN 1234567890) Connect?
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

14
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
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 wait... Calibrating Sensor
Please select the leg

15
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
VERIFY VERASENSE ACTIVATION
VERIFY VERASENSE ACTIVATION
STEP 1
While in sterile pouch, apply pressure to the VERASENSE condylar
surfaces and confirm that load displays 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.

16
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
ACTIVE MONITORING SCREEN AND COMMUNICATION STATUS
ACTIVE MONITORING SCREEN
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.

17
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
VERASENSE INSERTION
VERASENSE INSERTION
STEP 1
Insert VERASENSE. The appropriate sized shim may be
attached to replicate the thickness of the standard trial
insert.
STEP 2
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.

18
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
REFERENCING ROTATION/CONGRUENCY
REFERENCING TIBIA TRAY ROTATION USING CONTACT POINTS*
STEP 1
Tibiofemoral congruency may be referenced utilizing the
displayed “CONTACT POINTS”
• Depicted as ovals on the medial and lateral compartments
on the VERASENSE image.*
• Each position is derived from the center of load on the
tibia articular surface as calculated by each
compartment’s sensors.*
STEP 2
The CONTACT POINT ROTATION INDICATOR displays the
angle of the Contact Points relative to the M/L axis of
VERASENSE.*
• The Internal/External reading below the angle value
indicates the current position of the tibia relative to the
femoral contact.*
STEP 3
Once the desired position is determined, the surgeon can
mark/score the anterior tibial bone and pin the tibial plate.*
*For Reference Only

19
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
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.
*For Reference Only

20
VERASENSE OrthoSensor.com
09/2016 OS-VS-16-5050 Rev. 1
WHAT YOU NEED TO KNOW:
CALIBRATION INDICATORS
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.
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 = 71+ lbf