LinkStation MINI QUICK REFERENCE GUIDE

Transcription

1 B A LinkStation MINI QUICK REFERENCE GUIDE Catalog Number Description Qty LinkStation MINI Complete System C Transceiver Assembly A D E 883-T Dual Telescoping B CCTV Mount 9 w/knob (Not Displayed) USB Cable (Not Displayed) LinkStation MINI Tablet C LinkStation MINI Tablet Mount with Hardware (Not Displayed) LinkStation MINI Roll Stand D FSND75N 0.75 x Magnet E Power Supply Holster (Not Displayed) LinkStation MINI Power Cord (Not Displayed) VRSE VERASENSE Software Application for LinkStation MINI (Not Displayed) Important Information: Only trained medical personnel should use the OrthoSensor VERASENSE and LinkStation MINI System. OrthoSensor as the manufacturer of this sensor does not practice medicine and does not recommend any particular surgical technique for use on a specific patient. The surgeon who performs total knee arthroplasty is responsible for determining and utilizing the appropriate techniques for implanting prosthesis in each individual patient. As with any guide, the surgeon should consider the particular condition of the patient and perform the necessary adjustments if required by his/her own surgical judgment. OrthoSensor is not responsible for selection of the appropriate surgical technique to be utilized on an individual patient. Safety and caution should always be utilized before use of any OrthoSensor product. For the required safety information, system device specifications, indications and contraindications for use, please refer to the product package insert for all warning and caution statements. For a detailed description of the LinkStation MINI, refer to the LinkStation MINI Technical Specifications. For information related to the use of conventional knee system instrumentation, please refer to the operative techniques and the user documentation supplied by each manufacturer for their respective implant systems. The information presented in this quick reference guide is intended to demonstrate effective use of an OrthoSensor product. Always refer to the package insert, product label and/or user instructions before using any OrthoSensor product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your OrthoSensor representative if you have any questions about the availability of OrthoSensor products in your area. This user guide and all the illustrations are the property of OrthoSensor, Inc. Reproduction of any of this material is prohibited without the prior written permission of OrthoSensor, Inc.

2 LinkStation MINI QUICK REFERENCE GUIDE Active Sensor found ( ). Connect? STEP : Activate LinkStation MINI Press the Power Button on the left side of the LinkStation MINI to activate. Ensure transceiver is connected directly to the USB port on the (right) side of the LinkStation MINI. The following diagram depicts ideal transceiver position. Antennas are approximately 45 to the floor (or to the horizontal plane of the bed) and the transceiver is no less than 2 above and 7 out from the tablet screen. STEP 2: VERASENSE Application and Selection of Surgeon Once the LinkStation MINI is powered on, the VERASENSE Knee Application will start automatically. Select the surgeon performing the case from the drop-down menu. If your LinkStation MINI is enabled with Channel Switching and the VERASENSE Knee Application detects an active sensor the above dialog box will appear with the active sensor serial number. STEP 4: Select Laterality Select the Left or Right Button. LED (3) LED (4) LED (2) LED () LED () and LED (2) indicate communication between the transceiver and the VERASENSE Sensor. Communication is optimal when both LED s are illuminated. LED (3) and LED (4) indicate the Transceiver has been powered ON. STEP 3: Activate Sensor Activate the VERASENSE Sensor by holding it stationary against the magnet that is located on the roll stand pole for the LinkStation MINI system. DO NOT REMOVE THE SENSOR FROM THE MAGNET UNTIL YOU OBSERVE THE FOLLOWING: A Light illuminates in the Sensor and turns off after approximately 4 seconds. B VERASENSE Knee Application displays the message Initialization Communication with Device. STEP 5: Verify Sensor Activation While in sterile pouch, apply pressure to the Sensor condylar surface to confirm that load displays on the VERASENSE Knee Application. The VERASENSE Sensor is now ready for use. STEP 6: Open Sterile Packaging Once activation is confirmed, open the VERASENSE Sensor and shims and pass into sterile field using standard sterile technique.

3 ADDITIONAL FEATURES Medial Lateral VERASENSE KNEE APPLICATION 5 Displays sensor communication status and channel Enables Kinetic Tracking feature STEP 7: Sensor Insertion Insert VERASENSE Sensor. The appropriate sized shim may be attached to replicate the thickness of the standard trial insert. Positional Load Capture The VERASENSE Knee Application can record Positional Load Data to display intercompartmental load values at various flexion angles. Displays laterality, may be switched intraoperatively for bilateral procedure. Enables the Positional Capture Table NOTE: DO NOT utilize excessive force or impact the sensor directly with a mallet. Excessive impaction force may damage or negatively impact function of the VERASENSE Sensor. STEP 8: Reference Tray Rotation* 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. Displays the panel with additional available options Opens/Closes ORTHOLOIQ Closes the Option Panel Resets the VERASENSE Sensor to zero lbs Opens Sensor Information Panel Exits the application to the VERASENSE Home Screen With the leg in extension, the surgeon may reference the tibial tray rotation. STEP 9: Kinetic Tracking PRESS the Track Button on the VERASENSE Knee 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. Re-Zero Load Sensors Feature The VERASENSE load sensors may be reset to zero lbs. of load (re-zero d). To activate the re-zero function:. Motion Control Re-Zero Hold the sensor with superior side (articulating surface) facing the floor for three (3) seconds Re-Zero Enabled will appear on the VERASENSE Knee Application, followed by: Re-Zero Complete indicating that the load sensors have been reset to zero 2. Re-Zero Button from LinkStation MINI Ensure the sensor is unloaded Press the Re-Zero button *For Reference Only Powers down the LinkStation MINI completely Tablet Plug-In (Green AC / Red DC) WARNINGS & DIALOG BOXES Sensor overload detected Sensor Overload Protection: Shuts sensor off without powering down the VERASENSE Knee Application Displays the VERASENSE Sensor battery life This message appears when the VERASENSE Knee Application detects the sensor condyle load exceeds 70lbs. Re-zeroing of the Sensor will remove the Sensor overload detected dialog box.

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

5 CLEANING & CARE LinkStation MINI Tablet: 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 LinkStation MINI.. Disconnect the LinkStation MINI Tablet from any external power sources. 2. Spray approved cleaner/disinfectant onto soft lint-free cloth. Do not spray cleaner/disinfectant directly onto equipment or at any openings. 3. Wipe surface until clean. 4. Cleaning of the LinkStation MINI tablet should be performed after each use. LinkStation MINI Roll Stand:. The LinkStation MINI roll stand mounting assembly 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 mounting assembly. Wipe any cleaning agents off the mounting assembly immediately using a water-dampened cloth. Dry all mounting assemblies thoroughly after cleaning. LinkStation MINI Transceiver:. Wipe the LinkStation MINI Transceiver down with 70% isopropyl alcohol wipes after each use. LinkStation MINI Operating & Storage Temperature: Operating Temperature: -0 C to 55 C Storage Temperature: -5 C to 7 C Relative Humidity: 5% to 95% noncondensing TROUBLESHOOTING VERASENSE Sensor: If Sensor Light Does Not Turn Off During Activation: Return the sensor to the activation magnet to complete the activation sequence If Sensor 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 Sensor LinkStation MINI Transceiver: If Intermittent RF communication: Verify USB cable for the transceiver is securely plugged into the LinkStation MINI tablet and to the USB port on the bottom of the transceiver assembly Ensure antennas on the transceiver are secure and that the line of sight between the transceiver and the sensor is clear Objects such as OR lights, table, mayo stands or people can potentially interfere with communication All four LED lights on the transceiver will be illuminated when the Sensor is communicating LinkStation MINI Tablet: If LinkStation MINI Tablet will not turn on, or shut down inadvertently: Ensure that power cord is properly attached to the LinkStation MINI Tablet and plugged into power outlet If LinkStation MINI Tablet power button is blinking but nothing is happening: The LinkStation MINI Tablet is in sleep mode. Press the power button to wake up the LinkStation MINI Tablet LinkStation MINI Roll Stand: If LinkStation MINI 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.

6 Tel ORTHO ( ) Tel Fax OrthoSensor, Inc. 855 Griffin Road, Suite A-30 Dania Beach, Florida USA OS-VS Rev 3

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. OS-VS-6-07 Rev. 2

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: 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 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 Transceiver: If Intermittent RF communication: Verify USB cable for the Transceiver is securely plugged into the Display Unit and to 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 Objects such as OR lights, table, mayo stands or people can potentially interfere with communication All four LED lights on the Transceiver will be illuminated when VERASENSE is communicating 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. OS-VS-6-07 Rev. 2

9 VERASENSE QUICK REFERENCE GUIDE Active VERASENSE found ( SN ). Connect? 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. 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. CAUTION: DO NOT utilize excessive force or impact VERASENSE directly with a mallet. Excessive impaction force may damage or negatively impact function of VERASENSE. OS-VS-6-07 Rev. 2

10 ADDITIONAL FEATURES MEDIAL LATERAL VERASENSE SOFTWARE APPLICATION 5 Displays VERASENSE communication status and channel Enables Kinetic Tracking feature STEP 8: Reference Tray Rotation* With the leg in extension, the surgeon may reference the tibial tray rotation. STEP 9: Kinetic Tracking 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 *For Reference Only Displays laterality, may be switched intraoperatively for bilateral procedure Displays the panel with additional available options Opens/Closes ORTHOLOGIQ Closes the Option Panel Powers down the LinkStation MINI Evaluation Kit completely Tablet Plug-In (Green AC / Red DC) Enables the Positional Capture Table Resets VERASENSE to zero lbs Opens VERASENSE Information Panel Exits to the VERASENSE Software Application Home Screen Shuts VERASENSE off without powering down the VERASENSE Software Application Displays the 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. OS-VS-6-07 Rev. 2

11 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? Active VERASENSE Found: 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 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 OK to reset. VERASENSE Search Error: This message appears when an error has ocurred while the VERASENSE Software Application is searching for active VERASENSE. Select OK 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. Try again? VERASENSE Shutdown Failed: This message will appear if an error has ocurred when trying to shutdown VERASENSE from the Active Monitoring Screen. If OK 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. 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. OS-VS-6-07 Rev. 2

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 OS-VS-6-07 Rev. 2