OrthoSensor Verasense User Manual

VERASENSE USER GUIDE

12/2018 LB-5092 Rev. 2

VERASENSE OrthoSensor.com

12/2018 LB-5092 Rev. 2

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

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

Balance Soft-Tissue 2 1

VERASENSE OrthoSensor.com

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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 KEY PRODUCT FEATURES KEY CLINICAL BENEFITS

VERASENSE OVERVIEW

SENSOR-ASSISTED TKA

VERASENSE enables surgeons to

quantify ligament balance and

improves surgeon skill through

real-time, evidence-based data.

• 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

1 Gustke K A, Golladay GJ, Roche M, Elson L,

Anderson C. Primary TKA patients with Quantiﬁably Balanced Sof t-Tissue Achieve Signiﬁcant Clinical Gains S ooner than Unbalanced Patients. Adv Orthop. 2014:628 695.

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.

VERASENSE OrthoSensor.com

2 Gustke K A, Gollad ay GJ, Roche MW, Jerry GJ,

Elson LC , Anderson CR. In crease d satisfaction after total knee replacement using sensor-guided technology. Bon e Joint J 2014;96-B:1333–8.

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.

• 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 stability

• Enables reproducible, teachable surgical technique through quantifying surgeon “feel”

• Captures intraoperative data for inclusion in patient EMR, registries or comparative effectiveness studies

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.

7 Parratte S, Pagnano MW. Instability after total

knee arthroplasty. J Bone Joint Surg Am 2008; 90: 184-94.

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.

8 Rodriguez-Merchan, EC. Instability Following Total

Knee Arthroplasty. HSS J. Oct 2011: 7(3): 273-278.

*For Reference Only

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LINKSTATION MINI WITH INTEGRATED ANTENNA OPTION OVERVIEW

Antenna

LinkStation MINI Display Unit

Antenna

VERASENSE Activation Magnet

Transceiver

Easy Grip Transport Handle

VERASENSE Storage Basket

NOTE

The following accessories are necessary for the operation of the VERASENSE device:

VERASENSE Software Application

LinkStation MINI or LinkStation MINI Evaluation Kit

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.

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VERASENSE OrthoSensor.com

Antenna

LinkStation MINI Evaluation Kit Display Unit

LINKSTATION MINI EVALUATION KIT OVERVIEW

Transceiver

Transceiver Tripod

Medical Grade Power

Stand

Cord with Power Supply

(NOT DISPLAYED)

NOTE

The following accessories are necessary for the operation of the VERASENSE device:

VERASENSE Software Application

VERASENSE OrthoSensor.com

LinkStation MINI or LinkStation MINI Evaluation Kit

*Center of load and load values outside of the Green Zone are for reference only.

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VERASENSE SOFTWARE APPLICATION OVERVIEW

Medial/Lateral Indicators & Compartment Re-zero

Center of Load Indicators*

Load Values

LEFT

Center of load and load values outside of the Green Zone are for reference only.

• RF/Bluetooth Signal Strength/ Channel

VERASENSE Calibration

Indicators

EXIT

OPTIONS

TRACK

ZERO

Medial Lateral

Positional Data Capture Table

Exit VERASENSE Software Application

Options Menu

Kinetic Tracking*

Re-Zero

VERASENSE

•

VERASENSE Battery Life

• Tablet AC/DC

• Surgical Side Indicator

*Center of load and load values outside of the Green Zone are for reference only.

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VERASENSE OrthoSensor.com

POWERING ON THE LinkStation MINI

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

GETTING STARTED

DISPLAY UNIT POWER BUTTON

LINKSTATION MINI

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.

LINKSTATION MINI

EVALUATION KIT

CAUTION It is recommended to always plug in the Display Unit and

operate the system on AC power.

Please activate sensor by placing it on the magnet

(Keep sensor on the magnet until application starts)

Searching for sensors...

Physician Name

Turn OFF

Devices

NOTE

VERASENSE OrthoSensor.com

Place the LinkStation MINI or LinkStation MINI Evaluation Kit on contralateral side of the operating table for optimal surgeon visibility.

AC/DC POWER INDICATOR

RED = UNPLUGGED (DC)

GREEN = PLUGGED IN (AC)

Select

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TRANSCEIVER SETUP

NOTE The VERASENSE for Zimmer Biomet Persona communicates

with the LinkStation MINI via Bluetooth and the transceiver setup is not required.

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.

Please activate sensor by placing it on the magnet

(Keep sensor on the magnet until application starts)

Searching for sensors...

Physician Name

Turn OFF

Select

Devices

NOTES

1. LED (1) and LED (2) indicate communication between the

Transceiver and both LEDs are illuminated.

2. LED (3) and LED (4) indicate the Transceiver is powered on.

VERASENSE. Communication is optimal when

LED (1)

LED (2)

LED (3)

LED (4)

VERASENSE OrthoSensor.com

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TRANSCEIVER SETUP

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 WITH NON-INTEGRATED ANTENNA OPTION

STEP 1

See images for ideal Transceiver arm position.

TRANSCEIVER SETUP

LINE OF

SIGHT

>12”

>7”

LINKSTATION MINI

EVALUATION KIT

• Position antennas at 45° to the ﬂoor and at least 12”

(178 mm) out from the display unit.

(305 mm) above and 7”

• 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

LED (4)

1. LED (1) and LED (2) indicate communication between the Transceiver and

VERASENSE. Communication is optimal when both LEDs are illuminated.

VERASENSE OrthoSensor.com

2. LED (3) and LED (4) indicate the Transceiver is powered on.

LED (1)

LED (2)

LED (3)

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SELECT THE SURGEON

STEP 1

Prior to activating VERASENSE, select the surgeon performing the case.

SURGEON SELECTION

Please activate sensor by placing it on the magnet

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

(Keep sensor on the magnet until application starts)

Searching for sensors...

Physician Name

WIFI

Physician Name

Doe John MD Select Doe John MD Surgeon Not Listed

Surgeon Not Listed

POWER

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

VERASENSE OrthoSensor.com

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ACTIVATE VERASENSE

STEP 1

Select appropriate VERASENSE size and remove VERASENSE and shims from outer box.

• DO NOT remove from sterile pouch.

VERASENSE ACTIVATION

STEP 2

LINKSTATION MINI

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.

NOTE

VERASENSE OrthoSensor.com

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.

If channel switching is enabled, then the

ACTIVE VERASENSE FOUND dialog will display.

Select

OK after verifying serial number (

with package.

Active VERASENSE found

(

1234567890) Connect?

)

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OrthoSensor Verasense User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual