VERASENSE QUICK REFERENCE GUIDE

Transcription

1 VERASENSE QUICK REFERENCE GUIDE Catalog Number Description Qty LinkStation MINI With Power cord for United States and Canada LinkStation MINI 2 With Power cord for Australia and New Zealand LinkStation MINI 3 With Power cord for Continental Europe LinkStation MINI 4 With Power cord for United Kingdom and Ireland LinkStation MINI 5 With Power cord for Italy LinkStation MINI 6 With Power cord for Switzerland LinkStation MINI 3 With Power cord for South Korea With power cord for United States and Canada PART NO With power cord for Australia and New Zealand PART NO With power cord for Continental Europe & South Korea PART NO With power cord for United Kingdom and Ireland PART NO With power cord for Italy PART NO With power cord for Switzerland PART NO NOTE The following accessories are necessary for the operation of the VERASENSE device: VERASENSE Software Application and LinkStation MINI. 0/207 LB-5084 Rev. 0

2 CLEANING & CARE Display Unit: Use only a soft, lint-free cloth. Please Note: Abrasive cloths, towels, paper towels or similar items should not be used as these may cause damage to the Display Unit:. Disconnect the Display Unit from any external power sources. 2. Spray approved cleaning solution onto soft lint-free cloth. Do not spray cleaning solution directly onto Display Unit or at any openings. 3. Wipe surface until clean. 4. Cleaning of the DIsplay Unit should be performed after each use. Roll Stand:. The roll stand may be cleaned with most mild, non-abrasive solutions commonly used in the hospital environment (e.g. diluted bleach, ammonia, or isopropyl alcohol). * Please Note: The surface finish will be permanently damaged by strong chemicals and solvents such as acetone and trichloroethylene; do not use steel wool or other abrasive material to clean the mounting assembly. Never submerge or allow liquids to enter the roll stand. Wipe any cleaning agents off the roll stand immediately using a water-dampened cloth. Dry roll stand thoroughly after cleaning. Transceiver:. Wipe the Transceiver down with 70% isopropyl alcohol wipes after each use. LinkStation MINI Operating & Storage Temperature: -30 C -30 C 5% 70 C 70 C 95% non-condensing Operating Temperature: 5 C to 23 C Storage Temperature: 5 C to 23 C Relative Humidity: 5% to 95% noncondensing TROUBLESHOOTING VERASENSE: If VERASENSE Light Does Not Turn Off During Activation: Return VERASENSE to the activation magnet to complete the activation sequence If VERASENSE is showing no load values in the knee, or load values are being shown when it has been removed from the knee and no load is being applied: Re-Zero VERASENSE Wireless Communication TRANSCEIVER: 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. Objects such as OR lights, metal tables and mayo stands, and people can potentially interfere with communication. RF COMMUNICATION: Verify USB cable for the Transceiver is securely plugged into the Display Unit and into the USB port on the bottom of the Transceiver. Ensure antennas on the Transceiver are secure and that the line of sight between the Transceiver and VERASENSE is clear. All four LED lights on the Transceiver will be illuminated when VERASENSE is communicating assembly. BLUETOOTH COMMUNICATION: (FOR ZIMMER BIOMET PERSONA ONLY) If communication is completely lost, complete a force restart of the LinkStation Mini or LinkStation Mini Eval Kit by holding the power button on the display unit down for 5 seconds. The system will reboot and automatically reconnect to the device. Display Unit: If Display Unit will not turn on, or shut down inadvertently: Ensure that power cord is properly attached to the Display Unit and plugged into power outlet If Display Unit power button is blinking but nothing is happening: The Display Unit is in sleep mode. Press the power button to wake up the Display Unit. Roll Stand: If Roll Stand will not roll: Check to ensure that the breaks on the casters are disengaged ROUTINE MAINTENANCE Periodically inspect all fasteners associated with the LinkStation MINI. Ensure to tighten as necessary for optimal operation and safety. 0/207 LB-5084 Rev. 0

3 Turn Off Devices Physician Name Select VERASENSE QUICK REFERENCE GUIDE STEP : Activate LinkStation MINI Press the Power Button on the left side of the Display Unit to activate. Ensure Transceiver is connected directly to the USB port on the (right) side of the Display Unit. LED (4) LED (3) LED (2) LED () LED () and LED (2) indicate communication between the Transceiver and VERASENSE. Communication is optimal when both LED s are illuminated. LED (3) and LED (4) indicate the Transceiver has been powered ON. NOTE: The VERASENSE for Zimmer Biomet Persona communicates with the LinkStation MINI via Bluetooth and the transceiver setup is not required. DO NOT REMOVE VERASENSE FROM THE MAGNET UNTIL YOU OBSERVE THE FOLLOWING: A Light illuminates in VERASENSE and turns off after approximately 4 seconds. B VERASENSE Software Application displays the message Initialization Communication with VERASENSE. Please select leg LEFT RIGHT Please activate sensor by placing it on the magnet (Keep sensor on the magnet until application starts) Searching for sensors... Active VERASENSE found ( ). Connect? STEP 4: Select Laterality Select the Left or Right Button. CANCEL For the integrated Transceiver antenna option, 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. Confirm both antenna cables are securely connected to the Transceiver and to the top and bottom mounted antennas. STEP 2: VERASENSE Software Application and Selection of Surgeon Once the LinkStation MINI is powered on, the VERASENSE Software Application will start automatically. Select the surgeon performing the case from the dropdown menu. If your LinkStation MINI is enabled with Channel Switching and the VERASENSE Software Application detects an active VERASENSE, the above dialog box will appear with the active VERASENSE serial number ( SN ). STEP 5: Verify VERASENSE Activation While in sterile pouch, apply pressure to the VERASENSE condylar surface to confirm that load displays on the VERASENSE Software Application. VERASENSE is now ready for use. For the LinkStation MINI with non-integrated Transceiver, position antennas at 45 to the floor and at least 2 (305 mm) above and 7 (78 mm) out from the display unit. STEP 3: Activate VERASENSE Activate VERASENSE by holding it stationary against the magnet that is located on the roll stand of the Link- Station MINI. STEP 6: Open Sterile Packaging Once activation is confirmed, open the sterile packaging that contains VERASENSEand shims and pass into sterile field using standard sterile technique. 0/207 LB-5084 Rev. 0

4 EXIT OPTIONS TRACK ZERO STEP 7: VERASENSE Insertion Insert VERASENSE. The appropriate sized shim may be attached to replicate the thickness of the standard trial insert. SHIM 6 NOTE: VERASENSE for Zimmer Biomet Persona requires the user to input the selected shim thickness within the VERASENSE Software Application prior to use. CAUTION: DO NOT utilize excessive force or impact VERASENSE directly with a mallet. Excessive impaction force may damage or negatively impact function of VERASENSE. ADDITIONAL FEATURES Medial Lateral Positional Load Capture The VERASENSE Software Application can record Positional Load Data to display intercompartmental load values at various flexion angles. To activate the Positional Load Data Capture if it is not displayed on the Active Monitoring Screen. Select the Options Menu and PRESS the Position Capture Button. To disable the Positional Load Data Capture PRESS the Options Button and Press the Position Capture Button to close positional capture table. To record load values at different flexion angles, holding the leg stationary at 0, 45 or 90 of flexion, allow several seconds for the data to stabilize and PRESS the corresponding Positional Capture Button. Data can be updated by pressing each positional capture button throughout the case. VERASENSE SOFTWARE APPLICATION 5 Displays VERASENSE communication status and channel LEFT Displays laterality, may be switched intraoperatively for bilateral procedure. OPTIONS Displays the panel with additional available options IQ Opens/Closes ORTHOLOGIQ CLOSE Closes the Option Panel TRACK Enables Kinetic Tracking feature POSITION CAPTURE Enables the Positional Capture Table ZERO Resets VERASENSE to zero lbs INFO Opens VERASENSE Information Panel EXIT Exits to the VERASENSE Software Application Home Screen STEP 8: Reference Tray Rotation* With the leg in extension, the surgeon may reference the tibial tray rotation. Contact Point Rotation External Center of load, angle indicators, and load values outside of the Green Zone are for reference only STEP 9: Kinetic Tracking Medial Lateral PRESS the Track Button on the VERASENSE Software Application to enable Kinetic Tracking. To deactivate Kinetic Tracking, select the Track Button once again. Internal - Indicates internal rotation* of the tibial tray position. External: Indicates external rotation* of the tibial tray position. VERASENSE Re-Zero Load Feature VERASENSE may be reset to zero lbs. of load (re-zero d). To activate the re-zero function:. Motion Control Re-Zero Hold VERASENSE with superior side (articulating surface) facing the floor for three (3) seconds Re-Zero Enabled will appear on the VERASENSE Software Application, followed by: Re-Zero Complete indicating that VERASENSE has been reset to zero 2. Re-Zero Button from LinkStation MINI Ensure VERASENSE is unloaded Press the Re-Zero button * Center of load, angle indicators, and load values outside of the Green Zone are for reference only POWER Powers down the LinkStation MINI completely Tablet Plug-In (Green AC / Red DC) Turn Off Devices Shuts VERASENSE off without powering down the VERASENSE Software Application Displays VERASENSE battery life WARNINGS & DIALOG BOXES VERASENSE Overload Detected, Re-Zero Recommended VERASENSE Overload Protection: This message appears when the VERASENSE Software Application detects the VERASENSE condyle load exceeds 70lbs. Loads beyond 70lbs are for reference only. Re-zeroing of VERASENSE will remove the overload detected dialog box. 0/207 LB-5084 Rev. 0

5 WARNINGS & DIALOG BOXES Transceiver is unplugged! Please plug it back into a USB port. Invalid Leg Selection. VERASENSE Calibration Timeout. Transceiver Is Unplugged: This message appears when the VERASENSE Software Application detects that the USB cable is unplugged from either the Transceiver or the Display Unit USB port. Please plug the USB cable back into the USB port. Active VERASENSE found ( SN ). Connect? CANCEL Active VERASENSE Found: This message appears when an active VERASENSE is found. If your LinkStation MINI is enabled with Channel Switching, and the VERASENSE Software Application detects an active VERASENSE, the above dialog box will appear with the active VERASENSE serial number. Serial Number ( SN ) of VERASENSE. (The serial number is located on both the VERASENSE box as well as the Tyvek Pouch that VERASENSE is in). Multiple VERASENSE found Please select a VERASENSE or CANCEL to wait for a different VERASENSE to become activated SN SN SELECT SELECT Incorrect Operative Side Warning: This message appears when the VERASENSE Software Application detects that when using a VERASENSE left-right specific the VERASENSE Software Application shall display a warning message if the incorrect operative side is selected. (e.g. Using a Left VERASENSE, and Right is selected.) Error during VERASENSE search. Select to reset. VERASENSE Search Error: This message appears when an error has ocurred while the VERASENSE Software Application is searching for active VERASENSE. Select and the VERASENSE Software Application will reset and reestablish the seach for all active VERASENSE. VERASENSE error. Unable to connect. VERASENES Error Unable to Connect: This message may appear when an error has ocurred during the initial connection after the identification of VERASENSE and the VERASENSE Software Application is unable to properly obtain VERASENSE EEPROM data. Typical causes are due to loss of VERASENSE power during activation or RF reception issues. VERASENSE Calibration Timeout: This message will appear if an error ocurrs or the VERASENSE calibration is taking longer than expected, resulting in the VERASENSE Software Application timing out. VERASENSE Data Transfer Timeout. VERASENSE Data Transfer Timeout: This message will appear if an error has ocurred when handling measured data that is being transferred from VERASENSE. VERASENSE shutdown failed. Try again? Exit Home Screen VERASENSE Shutdown Failed: This message will appear if an error has ocurred when trying to shutdown VERASENSE from the Active Monitoring Screen. If is selected, the VERASENSE Software Application will offer additional shutdown attempts. If CANCEL is selected, then the VERASENSE Software Application will close and return back to the VERASENSE Homepage. Transceiver error. Please unplug it, then plug it back into the USB port. Retry CANCEL Multiple VERASENSE Found: This message will appear when the VERASENSE Software Application detects multiple active VERASENSE. Serial Number ( SN ) of VERASENSE. (The serial number is located on both the VERASENSE box as well as the Tyvek Pouch that VERASENSE is in). VERASENSE Calibration Error. VERASENSE Calibration Error: This message will appear if a VERASENSE Software Application error has ocurred during the initial VERASENSE calibration, while on the Active Monitoring Screen. Transceiver Error: This message appears when a failure has ocurred during the connection/ reset of the Transceiver indicating it is unable to communicate properly. To establish Transceiver communication, unplug then plug the Transceiver back into the USB port. 0/207 LB-5084 Rev. 0

6 MANUFACTURER OrthoSensor, Inc. 855 Griffin Road, Suite A-30 Dania Beach, FL , USA CAUTION DOCUMENTATION Consult User Guide IDENTIFICATION SN Serial Number AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY EC REP Regulatory and Marketing Services-UK, LTD 28 Trinity Road, Nailsea, Somerset BS48 4NU United Kingdom CE MARK 0297 Important Information: 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. Information presented is intended to demonstrate the breadth of OrthoSensor product offerings. Surgeons must always refer to the package insert, product label and/or IFU before using any OrthoSensor product. OrthoSensor products may not be available in all markets because product availability is subject to the regulator and/or medical practices in individual markets. For additional product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the Instructions For Use and OrthoSensor website. All trademarks herein are property of OrthoSensor, Inc. or its subsidiaries unless otherwise indicated. Copyright 207 OrthoSensor, Inc. CustomerService@OrthoSensor.com U.S. Only ORTHO ( ) U.S. and International Fax OrthoSensor, Inc. 855 Griffin Road, Suite A-30 Dania Beach, Florida USA 0/207 LB-5084 Rev. 0

7 VERASENSE QUICK REFERENCE GUIDE Catalog Number Description Qty LinkStation MINI Evaluation Kit With Power cord for United States and Canada LinkStation MINI Evaluation Kit 2 With Power cord for Australia and New Zealand LinkStation MINI Evaluation Kit 3 With Power cord for Continental Europe LinkStation MINI Evaluation Kit 4 With Power cord for United Kingdom and Ireland LinkStation MINI Evaluation Kit 5 With Power cord for Italy LinkStation MINI Evaluation Kit 6 With Power cord for Switzerland LinkStation MINI Evaluation Kit 3 With Power cord for South Korea With power cord for United States and Canada PART NO With power cord for Australia and New Zealand PART NO With power cord for Continental Europe & South Korea PART NO With power cord for United Kingdom and Ireland PART NO With power cord for Italy PART NO With power cord for Switzerland PART NO NOTE The following accessories are necessary for the operation of the VERASENSE device: VERASENSE Software Application, and LinkStation MINI Evaluation Kit. 0/207 LB-5085 Rev. 0

8 CLEANING & CARE Display Unit: Use only a soft, lint-free cloth. Please Note: Abrasive cloths, towels, paper towels or similar items should not be used as these may cause damage to the Display Unit:. Disconnect the Display Unit from any external power sources. 2. Spray approved cleaning solution onto soft lint-free cloth. Do not spray cleaning solution directly onto Display Unit or at any openings. 3. Wipe surface until clean. 4. Cleaning of the DIsplay Unit should be performed after each use. Transceiver:. Wipe the Transceiver down with 70% isopropyl alcohol wipes after each use. LinkStation MINI Evaluation Kit Operating & Storage Temperature: TROUBLESHOOTING VERASENSE: If VERASENSE Light Does Not Turn Off During Activation: Return VERASENSE to the activation magnet to complete the activation sequence If VERASENSE is showing no load values in the knee, or load values are being shown when it has been removed from the knee and no load is being applied: Re-Zero VERASENSE Wireless Communication TRANSCEIVER: 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. Objects such as OR lights, metal tables and mayo stands, and people can potentially interfere with communication. Display Unit: If Display Unit will not turn on, or shut down inadvertently: Ensure that power cord is properly attached to the Display Unit and plugged into power outlet If Display Unit power button is blinking but nothing is happening: The Display Unit is in sleep mode. Press the power button to wake up the Display Unit. 5 C 5% 5 C 23 C 23 C 95% non-condensing Operating Temperature: 5 C to 23 C Storage Temperature: 5 C to 23 C Relative Humidity: 5% to 95% noncondensing RF COMMUNICATION: Verify USB cable for the Transceiver is securely plugged into the Display Unit and into the USB port on the bottom of the Transceiver. Ensure antennas on the Transceiver are secure and that the line of sight between the Transceiver and VERASENSE is clear. All four LED lights on the Transceiver will be illuminated when VERASENSE is communicating assembly. BLUETOOTH COMMUNICATION: (FOR ZIMMER BIOMET PERSONA ONLY) If communication is completely lost, complete a force restart of the LinkStation Mini or LinkStation Mini Eval Kit by holding the power button on the display unit down for 5 seconds. The system will reboot and automatically reconnect to the device. 0/207 LB-5085 Rev. 0

9 VERASENSE QUICK REFERENCE GUIDE Active VERASENSE found ( ). Connect? CANCEL STEP : Activate LinkStation MINI Press the Power Button on the left side of the Display Unit to activate. Ensure Transceiver is connected directly to the USB port on the (right) side of the Display Unit. The following diagram depicts ideal Transceiver position. Antennas are approximately 45 to the floor (or to the horizontal plane of the bed) Attach the Transceiver to the tripod and position at an appropriate distance to the sterile field. STEP 2: VERASENSE Software Application and Selection of Surgeon Once the LinkStation MINI Evaluation Kit is powered on, the VERASENSE Software Application will start automatically. Select the surgeon performing the case from the drop-down menu. If your LinkStation MINI Evaluation Kit is enabled with Channel Switching and the VERASENSE Software Application detects an active VERASENSE, the above dialog box will appear with the active VERASENSE serial number ( SN ). STEP 5: Verify VERASENSE Activation While in sterile pouch, apply pressure to the VERASENSE condylar surface to confirm that load displays on the VERASENSE Software Application. VERASENSE is now ready for use. LED () LED (2) LED (3) LED (4) STEP 3: Activate VERASENSE Activate VERASENSE by holding it stationary against the magnet. DO NOT REMOVE THE VERASENSE FROM THE MAGNET UNTIL YOU OBSERVE THE FOLLOWING: A Light illuminates in VERASENSE and turns off after approximately 4 seconds. B VERASENSE Software Application displays the message Initialization Communication with VERASENSE. STEP 6: Open Sterile Packaging Once activation is confirmed, open the sterile packaging that contains VERASENSE and shims and pass into sterile field using standard sterile technique. LED () and LED (2) indicate communication between the Transceiver and VERASENSE. Communication is optimal when both LED s are illuminated. LED (3) and LED (4) indicate the Transceiver has been powered ON. NOTE: The VERASENSE for Zimmer Biomet Persona communicates with the LinkStation MINI via Bluetooth and the transceiver setup is not required. Please select leg LEFT RIGHT STEP 4: Select Laterality Select the Left or Right Button. STEP 7: VERASENSE Insertion Insert VERASENSE. The appropriate sized shim may be attached to replicate the thickness of the standard trial insert. SHIM 6 NOTE: VERASENSE for Zimmer Biomet Persona requires the user to input the selected shim thickness within the VERASENSE Software Application prior to use. 0/207 LB-5085 Rev. 0

10 EXIT OPTIONS TRACK ZERO CAUTION: DO NOT utilize excessive force or impact VERASENSE directly with a mallet. Excessive impaction force may damage or negatively impact function of VERASENSE. ADDITIONAL FEATURES MEDIAL LATERAL VERASENSE SOFTWARE APPLICATION 5 Displays VERASENSE communication status and channel LEFT TRACK Enables Kinetic Tracking feature POSITION CAPTURE STEP 8: Reference Tray Rotation* With the leg in extension, the surgeon may reference the tibial tray rotation. Contact Point Rotation External Center of load, angle indicators, and load values outside of the Green Zone are for reference only STEP 9: Kinetic Tracking Medial Lateral PRESS the Track Button on the VERASENSE Software Application to enable Kinetic Tracking. To deactivate Kinetic Tracking, select the Track Button once again. Internal: Indicates internal rotation* of the tibial tray position. External: Indicates external rotation* of the tibial tray position. Positional Load Capture The VERASENSE Software Application can record Positional Load Data to display intercompartmental load values at various flexion angles. To activate the Positional Load Data Capture if it is not displayed on the Active Monitoring Screen. Select the Options Menu and PRESS the Position Capture Button. To disable the Positional Load Data Capture PRESS the Options Button and Press the Position Capture Button to close positional capture table. To record load values at different flexion angles, holding the leg stationary at 0, 45 or 90 of flexion, allow several seconds for the data to stabilize and PRESS the corresponding Positional Capture Button. Data can be updated by pressing each positional capture button throughout the case. VERASENSE Re-Zero Load Feature VERASENSE may be reset to zero lbs. of load (re-zero d). To activate the re-zero function:. Motion Control Re-Zero Hold VERASENSE with superior side (articulating surface) facing the floor for three (3) seconds Re-Zero Enabled will appear on the VERASENSE Software Application, followed by: Re-Zero Complete indicating that VERASENSE have been reset to zero 2. Re-Zero Button from LinkStation MINI Evaluation Kit Ensure VERASENSE is unloaded Press the Re-Zero button *Center of load, angle indicators, and load values outside of the Green Zone are for reference only Displays laterality, may be switched intraoperatively for bilateral procedure. OPTIONS Displays the panel with additional available options IQ Opens/Closes ORTHOLOGIQ CLOSE Closes the Option Panel POWER Powers down the LinkStation MINI completely Tablet Plug-In (Green AC / Red DC) Enables the Positional Capture Table ZERO Resets VERASENSE to zero lbs INFO Opens VERASENSE Information Panel EXIT Exits to the VERASENSE Software Application Home Screen Turn Off Devices Shuts VERASENSE off without powering down the VERASENSE Software Application Displays VERASENSE battery life WARNINGS & DIALOG BOXES VERASENSE OVERLOAD DETECTED, RE-ZERO RECOMMENDED VERASENSE Overload Protection: This message appears when the VERASENSE Software Application detects the VERASENSE condyle load exceeds 70lbs. Loads beyond 70lbs are for reference only. Re-zeroing of VERASENSE will remove the overload detected dialog box. 0/207 LB-5085 Rev. 0

11 WARNINGS & DIALOG BOXES Transceiver is unplugged! Please plug it back into a USB port. Invalid Leg Selection. VERASENSE Calibration Timeout. Transceiver Is Unplugged: Active VERASENSE Found: This message appears when the VERASENSE Software Application detects that the USB cable is unplugged from either the Transceiver or the Display Unit USB port. Please plug the USB cable back into the USB port. Active VERASENSE found ( SN ). Connect? CANCEL This message appears when an active VERASENSE is found. If your LinkStation MINI Evaluation Kit is enabled with Channel Switching, and the VERASENSE Software Application detects an active VERASENSE, the above dialog box will appear with the active VERASENSE serial number. Serial Number ( SN ) of VERASENSE. (The serial number is located on both the VERASENSE box as well as the Tyvek Pouch that VERASENSE is in). Multiple VERASENSE found Please select a VERASENSE or CANCEL to wait for a different VERASENSE to become activated SN SN SELECT SELECT Incorrect Operative Side Warning: This message appears when the VERASENSE Software Application detects that when using a VERASENSE left-right specific the VERASENSE Software Application shall display a warning message if the incorrect operative side is selected. (e.g. Using a Left VERASENSE, and Right is selected.) Error during VERASENSE search. Select to reset. VERASENSE Search Error: This message appears when an error has ocurred while the VERASENSE Software Application is searching for active VERASENSE. Select and the VERASENSE Software Application will reset and reestablish the seach for all active VERASENSE. VERASENSE error. Unable to connect. VERASENSE Error Unable to Connect: This message may appear when an error has ocurred during the initial connection after the identification of VERASENSE and the VERASENSE Software Application is unable to properly obtain VERASENSE EEPROM data. Typical causes are due to loss of VERASENSE power during activation or RF reception issues. VERASENSE Calibration Timeout: This message will appear if an error ocurrs or the VERASENSE calibration is taking longer than expected, resulting in the VERASENSE Software Application timing out. VERASENSE Data Transfer Timeout. VERASENSE Data Transfer Timeout: This message will appear if an error has ocurred when handling measured data that is being transferred from VERASENSE. VERASENSE Shutdown Failed: VERASENSE shutdown failed. Try again? Exit Home Screen This message will appear if an error has ocurred when trying to shutdown VERASENSE from the Active Monitoring Screen. If is selected, the VERASENSE Software Application will offer additional shutdown attempts. If CANCEL is selected, then the VERASENSE Software Application will close and return back to the VERASENSE Homepage. Transceiver error. Please unplug it, then plug it back into the USB port. Retry CANCEL Multiple VERASENSE Found: This message will appear when the VERASENSE Software Application detects multiple active VERASENSE. Serial Number ( SN ) of VERASENSE. (The serial number is located on both the VERASENSE box as well as the Tyvek Pouch that VERASENSE is in). VERASENSE Calibration Error. VERASENSE Calibration Error: This message will appear if a VERASENSE Software Application error has ocurred during the initial VERASENSE calibration, while on the Active Monitoring Screen. Transceiver Error: This message appears when a failure has ocurred during the connection/ reset of the Transceiver indicating it is unable to communicate properly. To establish Transceiver communication, unplug then plug the Transceiver back into the USB port. 0/207 LB-5085 Rev. 0

12 MANUFACTURER OrthoSensor, Inc. 855 Griffin Road, Suite A-30 Dania Beach, FL , USA CAUTION DOCUMENTATION Consult User Guide IDENTIFICATION SN Serial Number AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY EC REP Regulatory and Marketing Services-UK, LTD 28 Trinity Road, Nailsea, Somerset BS48 4NU United Kingdom CE MARK 0297 Important Information: 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. Information presented is intended to demonstrate the breadth of OrthoSensor product offerings. Surgeons must always refer to the package insert, product label and/or IFU before using any OrthoSensor product. OrthoSensor products may not be available in all markets because product availability is subject to the regulator and/or medical practices in individual markets. For additional product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the Instructions For Use and OrthoSensor website. All trademarks herein are property of OrthoSensor, Inc. or its subsidiaries unless otherwise indicated. Copyright 207 OrthoSensor, Inc. CustomerService@OrthoSensor.com U.S. Only ORTHO ( ) U.S. and International Fax OrthoSensor, Inc. 855 Griffin Road, Suite A-30 Dania Beach, Florida USA 0/207 LB-5085 Rev. 0