OrthoSensor.com VERASENSE SHOULDER USER GUIDE 1 06/2019 06/2019LB-5200 LB-5200Rev. Rev.
06/2019 LB-5200 Rev.
TABLE OF CONTENTS 4 Motion Capture 19 Linkstation MINI With Integrated Antenna Option Overview 5 Assessing Stability 20 Linkstation MINI Evaluation Kit Overview 6 Shutting Down VERASENSE for Exactech Equinoxe 21 VERASENSE Software Application for Shoulder Overview 7 Shutting Down the Linkstation MINI and Linkstation MINI Evaluation Kit 22 Getting Started 8 Warning & Dialog Messages 23 Surgeon Selection 9 Troubleshooting 25 VERASENSE for Exactech Equinoxe Activation 10 Cleaning & Ca
VERASENSE FOR EXACTECH EQUINOXE OVERVIEW OrthoSensor’s VERASENSE for Exactech Equinoxe delivers data wirelessly to an intra-operative monitor that enables surgeons to make informed decisions on joint tension and implant position in real time. VERASENSE for Exactech Equinoxe utilizes proprietary sensor technologies to transmit load data wirelessly.
L I N K S TAT I O N M I N I WITH INTEGRATED ANTENNA OPTION OVERVIEW Antenna LinkStation MINI Display Unit Antenna VERASENSE for Exactech Equinoxe Activation Magnet Easy Grip Transport Handle VERASENSE for Exactech Equinoxe Storage Basket OrthoSensor.
LINKSTATION MINI EVALUATION KIT OVERVIEW Antenna** Transceiver** Antenna** LinkStation MINI Evaluation Kit Display Unit Transceiver Tripod VERASENSE OrthoSensor.
VERASENSE SOFTWARE APPLICATION FOR SHOULDER OVERVIEW Load Value EXIT Center of Load Indicator* OPTIONS TRACK ZERO VERASENSE for Exactech Equinoxe Calibration Indicators MOTIONS Exit VERASENSE Software Application for Shoulder Options Menu Kinetic Tracking* Re-Zero VERASENSE for Exactech Equinoxe Capture motions for 0, 45 and 90 degree adbuction and Forward Elevation Center of load and load values outside of the Green Zone are for reference only.
GETTING STARTED DISPLAY UNIT POWER BUTTON LINKSTATION MINI 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 for Shoulder will automatically startup once the Display Unit is powered on.
SURGEON SELECTION SELECT THE SURGEON STEP 1 Prior to activating VERASENSE for Exactech Equinoxe, select the surgeon performing the case. Please activate sensor by placing it on the magnet (Keep sensor on the magnet until application starts) STEP 2 Searching for sensors... Touch the text box to open a drop down menu of surgeon names. OTE: The first name to appear is the surgeon who was N selected for the last use of the VERASENSE Software Application for Shoulder.
VERASENSE FOR EXACTECH EQUINOXE ACTIVATION ACTIVATE VERASENSE FOR EXACTECH EQUINOXE STEP 1 Select appropriate VERASENSE for Exactech Equinoxe size and remove VERASENSE for Exactech Equinoxe and shims from outer box. • DO NOT remove from sterile pouch. STEP 2 LINKSTATION MINI Activate VERASENSE for Exactech Equinoxe by holding it stationary up against the magnet. NOTE: For the LinkStation MINI only, the magnet is mounted on the roll stand.
CALIBRATION SEQUENCE & SHOULDER SELECTION SELECT LATERALITY STEP 1 Once the calibration sequence is complete, the SELECT SHOULDER dialog will appear. STEP 2 Press either LEFT or RIGHT to match the surgery side. OrthoSensor.com Center of load and load values outside of the Green Zone are for reference only. VERASENSE Center of load and load values outside of the Green Zone are for reference only. * C enter of load and load values outside of the Green Zone are for reference only.
VERIFY VERASENSE FOR EXACTECH EQUINOXE ACTIVATION VERIFY VERASENSE FOR EXACTECH EQUINOXE ACTIVATION STEP 1 EXIT While in sterile pouch, apply pressure to the VERASENSE for Exactech Equinoxe articular surface on the sensor nodes and confirm that loads display. OPTIONS TRACK ZERO STEP 2 CAPTURE MOTIONS Once activation is confirmed, open the sterile packaging that contains VERASENSE for Exactech Equinoxe and shims and pass into sterile field using standard sterile technique by hospital personnel.
ACTIVE MONITORING SCREEN ACTIVE MONITORING SCREEN AND COMMUNICATION STATUS STEP 1 EXIT Once VERASENSE for Exactech Equinoxe is passed into the sterile field, it is ready for use during the procedure. OPTIONS TRACK ZERO STEP 2 CAPTURE Position the LinkStation MINI or LinkStation MINI Evaluation Kit as close to the sterile boundary as possible and within direct view of the surgeon. MOTIONS RIGHT Center of load, and load values outside of the Green Zone are for reference only. OrthoSensor.
VERASENSE FOR EXACTECH EQUINOXE INSERTION VERASENSE FOR EXACTECH EQUINOXE INSERTION & SHIM ASSEMBLY STEP 1 Determine desired VERASENSE for Exactech Equinoxe thickness and attach the appropriate shim as needed. STEP 2 Insert VERASENSE for Exactech Equinoxe VERASENSE OrthoSensor.
ASSESSING LOADS ASSESSING LOADS AND TENSION STEP 1 EXIT With VERASENSE for Exactech Equinoxe inserted, the VERASENSE Software Application for Shoulder will display the position (contact point*) and magnitude of the compressive loads in the glenohumeral joint. OPTIONS TRACK ZERO CAPTURE STEP 2 MOTIONS Data is displayed dynamically through a full range of motion. It is recommended to evaluate glenohumeral load with retractors and other surgical instruments removed and the capsule closed.
IMAGE & DATA CAPTURE IMAGE & DATA CAPTURE TWO WAYS TO CAPTURE SCREEN IMAGES AND DATA The VERASENSE Software Application for Shoulder shows EITHER the Simple Capture Button OR the Position Capture Table SIMPLE CAPTURE POSITION CAPTURE EXIT LEFT OPTIONS POSITION CAPTURE TRACK IQ ZERO INFO CAPTURE MANUALS EXIT OPTIONS Load Overhead TRACK Behind Back VERASENSE OrthoSensor.com ZERO Cross Body CLOSE CAPTURE • Shown when Position Capture Table isn’t displayed.
CALIBRATION INDICATORS EXIT OPTIONS TRACK WHAT YOU NEED TO KNOW: ZERO CAPTURE MOTIONS Calibration Indicators are the color bar displays beneath the shoulder load range. LEFT Center of load and load values outside of the Green Zone are for reference only. • I ndicate levels of VERASENSE for Exactech Equinoxe accuracy throughout loading range. EXIT OPTIONS TRACK ZERO Center of Load reference points are a consistent color throughout all loading ranges.
VERASENSE FOR EXACTECH EQUINOXE RE-ZERO LOAD RE-ZEROING If VERASENSE for Exactech Equinoxe experiences elevated loads, a re-zero calibration may be required for accurate load readings. A user can perform a re-zero as follows: VERASENSE overload detected MENU ZERO BUTTON Remove loaded VERASENSE for Exactech Equinoxe and then press the Zero Button on the VERASENSE Software Application for Shoulder. Center of load and load values outside of the Green Zone are for reference only.
MOTION CAPTURE USING THE MOTION TRACKING FEATURE Press Track to turn on/off kinetic tracking Displays dynamic motion of the shoulder through the full ROM to evaluate joint kinetics EXIT OPTIONS STEP 1 TRACK Select the Track Button on the VERASENSE Software Application for Shoulder to enable Kinetic Tracking. ZERO CAPTURE MOTIONS STEP 2 To clear and disable tracking, click the Track Button again. LEFT Center of load and load range outside the Green Zone are for reference only.
ASSESSING STABILITY ASSESSING STABILITY VERASENSE for Exactech Equinoxe quantifies the stability of the shoulder by measuring and recording the trace of the Center of Load and Maximum Load during prescribed motions. Motion traces are recorded for internal/external rotation of the humerus at 0, 45, & 90 degrees of abduction (elbow at 90 degrees flexion) as well as shoulder forward elevation.
SHUTTING DOWN VERASENSE FOR EXACTECH EQUINOXE VERASENSE FOR EXACTECH EQUINOXE SHUT DOWN EXIT STEP 1 To turn off VERASENSE for Exactech Equinoxe when the procedure is complete, press the EXIT button in the top right corner of the Active Monitoring screen. OPTIONS VERASENSE connected. Are you sure you want to exit? CANCEL TRACK OK ZERO Center of load and load values outside of the Green Zone are for reference only. STEP 2 Confirm exit on the pop-up window by pressing OK .
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 for Exactech Equinoxe has been shut down successfully, shut down the Display Unit by pressing the POWER BUTTON and then selecting OK . • This will power the entire Display Unit down.
WARNING & DIALOG MESSAGES VERASENSE ERROR UNABLE TO CONNECT VERASENSE CALIBRATION TIMEOUT Error during the initial connection with starting VERASENSE for Exactech Equinoxe. Typically due to VERASENSE power loss during connection. This message will appear if a calibration error occurs during Activation of VERASENSE for Exactech Equinoxe.
WARNING & DIALOG MESSAGES VERASENSE SEARCH - ERROR VERASENSE DATA TIMEOUT VERASENSE SHUTDOWN FAILED This message appears when an error has occurred while the VERASENSE Software Application for Shoulder is searching for active VERASENSE for Exactech Equinoxe. Select OK and the VERASENSE Software Application for Shoulder will reset and re-establish the search for all active VERASENSE for Exactech Equinoxe.
TROUBLESHOOTING TROUBLESHOOTING VERASENSE WIRELESS COMMUNICATION If VERASENSE for Exactech Equinoxe light does not turn off during activation: • Return the VERASENSE for Exactech Equinoxe to the activation magnet to complete the activation sequence. If Communication is intermittent: • Reposition the LinkStation MINI or LinkStation MINI Evaluation Kit as close to the sterile boundary as possible and within direct view of the surgeon.
CLEANING & CARE CLEANING AND CARE SOLUTIONS TRANSCEIVER The following is a list of chemical cleaning solutions that have been successfully tested on the Display Unit & Roll Stand: Wipe the Transceiver down with 70% isopropyl alcohol wipes after each use. • • • • • • • • SANI-CLOTH HB SANI-CLOTH PLUS SUPER SANI-CLOTH Cavi Wipes Cloro-Wipe Towelette 70% Isopropyl Alcohol Alcohol Prep Pads Tuffie Wipes DISPLAY UNIT Use only a soft, lint-free cloth.
OrthoSensor.com VERASENSE V E RAS E N S E A DDI T I O NAL F E AT URE S *Center of load and load values outside of the Green Zone are for reference only. 27 06/2019 LB-5200 Rev.
ADDITIONAL FEATURES OPTIONS MENU EXIT LEFT OPTIONS POSITION CAPTURE TRACK IQ ZERO INFO CAPTURE MANUALS Left/Right Shoulder Selection Open/Close the 0/45/90 Position Capture Table Open OrthoLogIQ* Web Portal Open VERASENSE for Exactech Equinoxe Information Panel Open VERASENSE for Exactech Equinoxe User Manuals VERASENSE OrthoSensor.
ADDITIONAL FEATURES DISPLAY AVAILABLE MANUALS EXIT LEFT OPTIONS POSITION CAPTURE TRACK IQ ZERO INFO CAPTURE MANUALS IFU User Guide SHOULDER USER GUIDE CLOSE 1 Page Up / Page Down Buttons Opens & Displays the appropriate manual when selected. OrthoSensor.com 01/2019 01/2019LB-5200 LB-5200Rev Rev00 VERASENSE Exit to VERASENSE Active Monitoring Screen VERASENSE OrthoSensor.com CLOSE 29 06/2019 LB-5200 Rev.
ADDITIONAL FEATURES ORTHOLOGIQ MODE (“IQ MODE”) EXIT LEFT OPTIONS POSITION CAPTURE TRACK IQ ZERO INFO CAPTURE MANUALS VERASENSE OrthoSensor.com CLOSE Browser Controls ack/Forward B Home Open/Close Digital Keyboard Exit to VERASENSE Software Application for Shoulder If user exits IQ mode, browser will minimize and can be reopened with IQ button. * O rthoLogIQ is only available to those end-users who purchase it pursuant to a separate agreement with OrthoSensor, Inc.
WIFI CONNECTION SETUP WIFI CONNECTION SETUP The WIFI Button in the lower left-hand corner will indicate the connection status of the VERASENSE Software Application for Shoulder: Please activate sensor by placing it on the magnet GREEN = WIFI Connected (Keep sensor on the magnet until application starts) RED = WIFI Not Connected Searching for sensors...
WIFI CONNECTION SETUP SELECTING THE OPEN NETWORK 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: VERASENSE OrthoSensor.com • The connect WIFI network will appear in GREEN.
ADDITIONAL FEATURES KEYBOARD HOT KEYS STEP 1 Press the top left corner of the screen to open the digital keyboard. • Works on both the VERASENSE Software Application for Shoulder Activation and Active Monitoring screens. STEP 2 “Hot-keys” have been designated for added features: • U – Initiate the utilization data upload to cloud. Select OK once the upload is complete. Center of load and load values outside of the Green Zone are for reference only.
VERASENSE OrthoSensor.com NOTES 34 06/2019 LB-5200 Rev.
VERASENSE OrthoSensor.com NOTES 35 06/2019 LB-5200 Rev.
OrthoSensor is the technology leader in the development of intelligent orthopaedic solutions that provide real-time intraoperative data to surgeons and hospitals. OrthoSensor intelligent orthopaedic solutions utilize proprietary sensor technologies with the goal of improving healthcare outcomes and potentially reducing the cost of treating musculoskeletal disease. OrthoSensor, Inc.