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VE R ASE N SE U SE R GUIDE
1
12/2018 LB-5092 Rev. 2
12/2018 LB-5092 Rev. 2

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Summary of Contents for OrthoSensor Verasense

  • Page 1 VE R ASE N SE U SE R GUIDE 12/2018 LB-5092 Rev. 2 12/2018 LB-5092 Rev. 2...
  • Page 2 12/2018 LB-5092 Rev. 2...
  • Page 3: Table Of Contents

    Linkstation Mini With Kinetic Tracking* Integrated Antenna Option Overview Cementing Linkstation Mini Evaluation Kit Overview Shutting Down VERASENSE VERASENSE Software Application Overview Shutting Down the Linkstation Mini Getting Started and Linkstation Mini Evaluation Kit Transceiver Setup Warning & Dialog Messages...
  • Page 4: Verasense Overview

    VERASENSE enables surgeons to As a result, patients whose knees have been balanced through the use of quantify ligament balance and VERASENSE show statistically significant improvements in joint function, pain, improves surgeon skill through activity level and patient satisfaction. real-time, evidence-based data.
  • Page 5: Linkstation Mini With

    VERASENSE Medical Grade Power Cord with Power Supply Holster NOTE The following accessories are necessary for the operation of the VERASENSE device: Balanced Rolling Stand VERASENSE Software Application LinkStation MINI or LinkStation MINI Evaluation Kit *Center of load and load values outside of the Green Zone are for reference only.
  • Page 6: Linkstation Mini Evaluation Kit Overview

    (NOT DISPLAYED) NOTE The following accessories are necessary for the operation of the VERASENSE device: VERASENSE Software Application LinkStation MINI or LinkStation MINI Evaluation Kit *Center of load and load values outside of the Green Zone are for reference only.
  • Page 7: Verasense Software Application Overview

    V E RAS E N S E S OF T WA RE AP PLIC AT ION OV ERVI EW Medial/Lateral Indicators & Compartment Re-zero Exit VERASENSE EXIT Software Application OPTIONS Options Menu Center of Load TRACK Kinetic Tracking* Indicators* ZERO...
  • Page 8: Getting Started

    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...
  • Page 9: Transceiver Setup

    T R AN S C EI VER S ET UP TRANSCEIVER SETUP NOTE The VERASENSE for Zimmer Biomet Persona communicates with the LinkStation MINI via Bluetooth and the transceiver setup is Please activate sensor by placing it on the magnet (Keep sensor on the magnet until application starts) not required.
  • Page 10 T R AN S C EI VER S ET UP LINE OF TRANSCEIVER SETUP SIGHT >12” 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. >7” LINKSTATION MINI WITH NON-INTEGRATED ANTENNA OPTION...
  • Page 11: Surgeon Selection 1

    Touch the text box to open a drop down menu of surgeon names. NOTE: The first name to appear is the surgeon who Physician Name was selected for the last use of the VERASENSE Software Surgeon Not Listed POWER WIFI Application.
  • Page 12: Verasense Activation

    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 Active VERASENSE found initializes communication.
  • Page 13: Calibration Sequence & Leg Selection

    C A L I B RAT ION S EQU EN CE & LEG S ELEC T ION SELECT LATERALITY STEP 1 EXIT Once the calibration sequence is complete, the SELECT LEG OPTIONS dialog will appear. TRACK ZERO STEP 2 Press either LEFT or RIGHT to match the surgery side. Medial Lateral Please wait...
  • Page 14: Verify Verasense Activation

    VERASENSE Software Application. STEP 2 EXIT OPTIONS Once activation is confirmed, open the sterile packaging that contains VERASENSE and shims and pass into sterile field using TRACK standard sterile technique by hospital personnel. ZERO CAPTURE LEFT Center of load and load values outside of the Green Zone are for reference only.
  • Page 15: Active Monitoring Screen

    ACT IVE MON ITOR IN G SC REEN ACTIVE MONITORING SCREEN AND COMMUNICATION STATUS STEP 1 EXIT Once VERASENSE is passed into the sterile field, it is ready OPTIONS for use during the procedure. TRACK ZERO STEP 2 Position the LinkStation MINI or LinkStation MINI Evaluation...
  • Page 16: Verasense Insertion

    • In a tight knee capsule, it may be necessary to insert the CAUTION trial tibial baseplate and VERASENSE prior to insertion of the femoral trial. In this instance, reduce the tibia under the DO NOT utilize excessive force or impact VERASENSE femur, then insert the femoral trial.
  • Page 17: Assessing Loads

    ASS ESS IN G LOADS ASSESSING LOADS AND BALANCE 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.
  • Page 18: Image & Data Capture 1

    IM AG E & DATA CA P T URE 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...
  • Page 19: Calibration Indicators

    ZERO CAPTURE Calibration Indicators are the color bar displays beneath each M/L load value. • Indicate levels of VERASENSE accuracy throughout loading range. LEFT Center of load and load values outside of the Green Zone are for reference only. EXIT...
  • Page 20: Understanding Balance

    UND ERSTA N D IN G B ALA N C E UNDERSTANDING BALANCE UNBALANCED (Load Difference = 29 - 4 = 25lbf) CORONAL BALANCE EXIT Clinical research suggests a load differential between the OPTIONS medial and lateral compartments of less than or equal to 15 LBF TRACK through the range of motion is indicative of coronal plane soft tissue balance.*...
  • Page 21: Balance Soft-Tissue

    B A LA N C E S OF T-T I SSU E BALANCE SOFT-TISSUE MCL pie-crusting with an 18-gauge needle Clinical experience combined with information displayed by the VERASENSE Software Application may be used to assist decision making regarding component placement and soft tissue releases to achieve compartmental balance. EXIT...
  • Page 22: Verasense Re-Zero Load

    Button on the VERASENSE Software Application. COMPARTMENT SPECIFIC RE-ZERO With the VERASENSE in the joint, apply a varus or valgus Center of load and load values outside of the Green Zone are for reference only. thrust to the knee in order to off-load the desired medial or lateral compartment.
  • Page 23: Kinetic Tracking

    • Extension to flexion roll back evaluation, AP drawer test, Int/Ext rotation laxity, etc. TRACK ZERO STEP 1 Select the Track Button on the VERASENSE Software Lateral Medial Application to enable Kinetic Tracking. STEP 2 RIGHT Center of load and load values outside of the Green Zone are for reference only.
  • Page 24: Cementing

    C EMENT IN G USE OF VERASENSE DURING CEMENTATION VERASENSE can be used during the final cementation EXIT process to ensure balance achieved during component trialing is maintained through the end of the procedure. OPTIONS • Ensure proper seating of the components, as even a small TRACK amount of residual cement mantle can affect joint balance.
  • Page 25: Shutting Down Verasense

    EXIT VERASENSE connected. Are you sure you want to exit? STEP 1 OPTIONS To turn off VERASENSE when the procedure is complete, press the CANCEL TRACK EXIT button in the top right corner of the Active Monitoring screen. ZERO STEP 2 Center of load and load values outside of the Green Zone are for reference only.
  • Page 26: Shutting Down The Linkstation Mini

    SHUTTING DOWN THE LINKSTATION MINI AND LINKSTATION MINI EVALUATION KIT LINKSTATION MINI AND LINKSTATION MINI EVALUATION KIT SHUTDOWN After the procedure is complete and VERASENSE has been shut down successfully, shut down the Display Unit by pressing the POWER BUTTON and then selecting OK .
  • Page 27: Warning & Dialog Messages

    Transceiver cable disconnected during active monitoring. VERASENSE Error during the initial connection with This message will appear if a VERASENSE starting VERASENSE. Typically due to Software Application error has occurred VERASENSE power loss during Transceiver is unplugged! during the initial VERASENSE calibration Please plug it back into a USB port.
  • Page 28 Multiple VERASENSE found will appear with the active VERASENSE VERASENSE EEPROM data. Typical causes Please select VERASENSE or ‘CANCEL’ to wait for serial number. are due to loss of VERASENSE power a different VERASENSE to become activated.
  • Page 29: Troubleshooting

    Evaluation Kit as close to the sterile boundary as possible and within direct view of the surgeon. If VERASENSE is showing no load values in the knee, or load • Objects such as OR lights, metal tables and mayo stands, values are being shown when it has been removed from the and people can potentially interfere with communication.
  • Page 30: Cleaning & Care

    C LEA NIN G & CA R E CLEANING AND CARE SOLUTIONS TRANSCEIVER The following is a list of chemical cleaning solutions that have Wipe the Transceiver down with 70% isopropyl alcohol wipes been successfully tested on the Display Unit & Roll Stand: after each use.
  • Page 31 V E RASE NS E ADDI TI O N AL FE ATURE S *Center of load and load values outside of the Green Zone are for reference only. 12/2018 LB-5092 Rev. 2...
  • Page 32: Additional Features 3

    Device ID: 512193013 Device Type: OrthoSensor VERASENSE CLOSE Exit Options Panel * OrthoLogIQ is only available to those end-users who purchase it pursuant to a separate agreement with OrthoSensor, Inc. OrthoLogIQ is only available in the United States. 12/2018 LB-5092 Rev. 2...
  • Page 33: Display Available Menus

    PART NO. 05000-413 6 With power cord for Switzerland PART NO. 05000-414 CLOSE NOTE The following accessories are necessary for the operation of the VERASENSE device: VERASENSE Software Application, Transceiver, and LinkStation MINI. CLOSE OS-VS-16-0162 Rev. 4 Exit to VERASENSE Page Up / Opens &...
  • Page 34: Orthologiq Mode ("Iq Mode")

    IQ button. * OrthoLogIQ is only available to those end-users who purchase it pursuant to a separate agreement with OrthoSensor, Inc. OrthoLogIQ is only available in the United States. 12/2018 LB-5092 Rev. 2...
  • Page 35: Wifi Connection Setup

    (Keep sensor on the magnet until application starts) STEP 1 Searching for sensors... 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. Physician Name...
  • Page 36: Selecting The Open Network

    To exit to the Home Screen, select the CLOSE button in the bottom left corner. * OrthoLogIQ is only available to those end-users who purchase it pursuant to a separate agreement with OrthoSensor, Inc. OrthoLogIQ is only available in the United States. 12/2018 LB-5092 Rev. 2...
  • Page 37: Keyboard Hot-Keys

    * Center of load and load values outside of the Green Zone are for reference only. * OrthoLogIQ is only available to those end-users who purchase it pursuant to a separate agreement with OrthoSensor, Inc. OrthoLogIQ is only available in the United States.
  • Page 38 N OT ES 12/2018 LB-5092 Rev. 2...
  • Page 39 N OT ES 12/2018 LB-5092 Rev. 2...
  • Page 40 VERASENSE Surgeons must always rely on one’s own professional clinical judgment when deciding on whether to use a particular product for patient care. OrthoSensor does not provide medical advice and recommends that surgeons be trained in the use of any particular product before surgical use. No portion of this should be redistributed, duplicated or disclosed without the express written consent of OrthoSensor, Inc.

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