LinkStation MINI QUICK REFERENCE GUIDE

Transcription

1 B A LinkStation MINI QUICK REFERENCE GUIDE Catalog Number Description Qty LinkStation MINI Complete System 1 C Transceiver Assembly A 1 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 1 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) 1 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 1: 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 12 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 (1) LED (1) 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 10, 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: 1. 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. 1. 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: 1. 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: 1. Wipe the LinkStation MINI Transceiver down with 70% isopropyl alcohol wipes after each use. LinkStation MINI Operating & Storage Temperature: Operating Temperature: -10 C to 55 C Storage Temperature: -51 C to 71 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 Griffin Road, Suite A-310 Dania Beach, Florida USA OS-VS Rev 3