FCC ID: XNL-ORTHOSNSR3 Knee Balancer Transceiver

TM Device Activation and LinkStation Operation USER GUIDE LB-03000-003 Rev A INTRODUCTION The OrthoSensor Knee Balancer is an intelligent tibial trial that provides intraoperative data to help determine and achieve optimal soft tissue balance and component position during total knee arthroplasty (TKA). The Knee Balancer is capable of sensing dynamic loads and center of load* in the medial and lateral compartments of the operated knee through a full range of motion with the patella reduced. When utilized in the trialing phase of TKA the Knee Balancer will sense intercompartmental loads, center of load* as a reference for tibial-femoral contact, tibial tray rotation and flexion angle of the leg*. Data is displayed on a 27 monitor on the OrthoSensor LinkStation depicted below. The OrthoSensor Knee Balancer enables the surgeon to make evidence based decisions regarding soft tissue releases and component position to achieve true balance and stability through a full range of motion. Key Clinical Benefits Addresses the leading causes of early implant failure in TKA: instability, malrotation and loosening Dynamic intercompartmental load data and Kinetic Tracking enable evidence based soft tissue releases to improve stability. Provides intraoperative feedback on tibial component rotation*, center of load* and femoral articulation to facilitate optimal component position. Enables reproducible, teachable surgical technique. Captures intraoperative data for inclusion in patient record and registries. Key Features Provides dynamic intraoperative loads and center of load* in the medial and lateral compartments through full range of motion with the patella reduced. Kinetic Tracking feature provides dynamic kinematic tracking in conjunction with load data. Displays Tibial Tray Rotation and Knee Flexion Angle*. Requires no change to surgical workflow. Low cost, single use disposable device. Enables data capture in still images or video that may be added to the patient record.

*For Reference Only 1 LINKSTATION SET-UP STEP 1 Activate LinkStation Press and hold power button on back of computer to activate. Confirm surgeon visualization of LinkStation. Position Transceiver Ensure Transceiver is connected directly to USB port on back of computer. Transceiver CANNOT be connected through a peripheral USB hub. Transceiver should point toward the operating table with antennae oriented in opposite directions at approximately 45 to the Transceiver. This position promotes optimal communication between the Transceiver and the OrthoSensor Knee Balancer. Four (4) blue LED lights on the top of the transceiver

(FIGURE I) indicate power and communication link with the OrthoSensor Knee Balancer. LED #1 and LED #2 indicate communication link between Transceiver and the OrthoSensor Knee Balancer. These LEDs will illuminate only after device is activated. LED #4 indicates that Transceiver is active. LED #3 is inactive and will not illuminate. Power switch on back of computer Optimal Transceiver position with antennae at 45 LED #1 LED #2 LED #3 LED #4 2 FIGURE I DEVICE ACTIVATION STEP 2 Launch Application Double click the OrthoSensor application. icon to launch Activate Device A. Remove appropriate size OrthoSensor Knee Balancer and Shims from box. Do not remove from sterile pack. Remove outer box documentation as required. labels and affix to patient B. Place device directly over round silver magnet on LinkStation with articulating surface facing up. The LED will illuminate on the articulating surface of the device after approximately one second. DO NOT MOVE THE DEVICE until you observe the following:

i) LED turns off after approximately four (4) seconds. ii) Graphic User Interface (GUI) launches. iii) Load Sensor initialization progress bar appears and completes. Initialization takes up to 10 seconds. Device may now be removed from magnet. OrthoSensor Icon & Application Start Screen LED illuminated 3 Initialization in progress LEG SELECTION STEP 3 Select LEFT or RIGHT leg The GUI will automatically prompt leg selection. 4 ZERO DEVICE STEP 4 Zero Device The OrthoSensor Knee Balancer utilizes an accelerometer to assess component position* and leg flexion angle*. The zero process calibrates the accelerometers to enable these functions and is accomplished in three steps. Note that the GUI prompts user to execute each step in the Zero process. A. Horizontal Zero, step 1 Place sterile packed device flat on LinkStation shelf Gently secure medial and lateral edges to ensure device is flat. (FIGURE I) Click the Zero button (now flashing red) in the lower left corner of the GUI. Load Sensor initialization progress bar will appear and complete. Initialization takes up to 10 seconds B. Horizontal Zero, step 2 Rotate device 180 and repeat previous step. FIGURE I 180

*For Reference Only 5 ZERO DEVICE STEP 4 (continued) C. Vertical Zero, step 3 Place sterile packed device flat against LinkStation post. Underside (non-articulating surface) of device should be placed against post with posterior edge pointing toward floor. Hold device in place and click the Zero button. Device is Ready for Use will appear on the GUI indicating completion of the Zero process. NOTE: This step is instantaneous and has no progress bar. 6 DEVICE READY FOR USE STEP 5 The OrthoSensor Knee Balancer is now ready for use. Verify Device Activation While still in sterile packaging, apply pressure on the device to verify that loads are registering on the GUI. (FIGURE I) NOTE: If loads do not register then the device may not be fully active and the following steps are recommended:

i) Deactivate device by clicking the Power button in the lower right corner of the GUI. ii) If device does not shut down, click OK to exit or manually quit the GUI (hold Command key down and press the letter Q key). Unplug the transceiver USB cable and re-connect. Re-launch GUI and follow on-screen prompt to shut down active device (if necessary). Repeat device activation and zero process detailed steps 2-4 again to fully activate device. Open Sterile Packaging Once activation is confirmed, open sterile packed device and shims and pass into the operative field using standard sterile technique. (FIGURE II) 7 FIGURE I FIGURE II ATTACH SHIMS STEP 6 The OrthoSensor Knee Balancer is packaged with four (4) shims to enable use of trial inserts with 9mm, 11mm, 13mm and 16mm thickness. A shim must be affixed to the underside of the device prior to insertion into the tibial tray. Affix Shim Affix appropriate size shim to underside of device by sliding it posterior to anterior. (FIGURE I) Shim Exchange To exchange shim size, unsnap it from anterior portion of the device and replace with desired size. (FIGURE II) FIGURE I FIGURE II 8 SET TIBIAL ROTATION STEP 7 Select and position appropriate size Trial Tibial Tray to achieve maximum tibial plateau coverage. The tibial tubercle mid-middle 1/3 is marked and a single anterior pin is inserted to allow rotational adjustments and maintain medial-lateral position. Tibial trial with anterior medial pin inserted, PCL to medial 1/3 tibial tubercle is marked 9 DEVICE INSERTION STEP 8 The OrthoSensor Knee Balancer is inserted with appropriate sized shim affixed to replicate the thickness of the selected trial insert. In a tight knee it is often necessary to insert the tibial baseplate and the OrthoSensor Knee Balancer prior to insertion of the femoral trial. In this instance, reduce the tibia under the femur, then insert the femoral trial with minimal impaction force. NOTE: Excessive impaction force may damage or negatively impact function of the OrthoSensor Knee Balancer. Do not utilize excessive force or impact the Knee Balancer directly with a mallet. OrthoSensor Knee Balancer (size 5) inserted on the tibial plate with anterior pin inserted. Femoral trial inserted over tibial trial and OrthoSensor Knee Balancer, size 5. Anterior pin inserted. 10 ADDITIONAL FEATURES KINETIC TRACKING The Kinetic Tracking function displays dynamic kinematic motion of the knee with applied loads as well as maximum and minimum load values through the complete range of motion. To enable Kinetic Tracking click the Track button located on the bottom edge of the GUI. NOTE: Click the Clear button immediately after the Track button to reset max/min load values. Data Status Zero Kinetic Tracking Clear Left or Right Image Capture Power Button AUTO ZERO FEATURE The OrthoSensor Knee Balancer will automatically re-zero process if it detects residual load of greater than three (3) lbs. when resting idle outside of the knee to maintain accuracy for the duration of the procedure. The Knee Balancer detects that it is outside of the knee if it records a flexion angle of 180 (the equivalent of resting on a table or flat surface) for seven (7) seconds. BATTERY LIFE The OrthoSensor Knee Balancer has a battery life of 40 minutes. DEVICE DEACTIVATION The OrthoSensor Knee Balancer may be deactivated utilizing the Power button in the lower right corner of the GUI. IMAGE CAPTURE The Image Capture button (camera lens icon) will capture a screen shot and save to the desktop screen on the LinkStation computer . 11 OrthoSensor Customer Service Tel: 888-75-ORTHO

(888-756-7846) OrthoSensor (www.orthosensor.com) is the technology leader in development of intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor intelligent orthopedic devices utilize advanced sensor and communication technologies to improve healthcare outcomes and reduce the cost of treating musculoskeletal disease. 1560 Sawgrass Corporate Parkway 4th Floor Sunrise, FL 33323 United States of America 12

OrthoSensor, Inc 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise FL, 33323 www.orthosensor.com The OrthoSensor Knee Balancer provides a means to dynamically balance the knee during knee replacement surgery. The Knee Balancer is a smart tibial insert trial that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the OrthoSensor LinkStation for surgeon visualization. Individual OrthoSensor Knee Balancers are packaged sterile, for single patient use with a Shim Set for thickness adjustments. The OrthoSensor LinkStation is required for use of the Knee Balancer. The LinkStation contains a computer and all peripheral equipment required to display the measured load data by providing a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. Refer to the OrthoSensor Device Activation and LinkStation Operation User Guide for additional details on these components. The OrthoSensor Knee Balancer is a tool for the adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The Knee Balancer is sterile, for single patient use. Any active or suspected latent infection in or about the knee joint. Refer to Knee System IFU for additional contraindications. Read and follow instructions for proper use and interpretation of force data displayed. Strict adherence to the indications, contraindications, precautions and user/patient safety for this product is essential. Refer to appropriate Knee System IFU for additional precautions. Data from OrthoSensor Knee Balancer is for reference purpose only and should not be the sole basis for surgical decisions. OrthoSensor Knee Balancer internal components are non-sterile. Immediately discontinue use of device if any cracks, damage, or internal fluid is observed. Failure to observe these warnings may expose patient to non-sterile material. OrthoSensor Knee Balancer consists of sophisticated calibrated internal microelectronics. Avoid direct impact with mallet or other instruments when possible. Handle OrthoSensor Knee Balancer with care when inserting, adjusting shim size or removing from tibial tray. Do not forcibly impact femoral trial on to femur with Knee Balancer in place in tibial tray. Do not attempt to use OrthoSensor Knee Balancer without selection and use of proper shim and appropriate sized tibial tray. When attaching Shim to OrthoSensor Knee Balancer, take care and caution to properly slide shim onto Knee Balancer engaging/snapping components together. When detaching a Shim from the Knee Balancer, detach anterior lip first, do not pry off posterior edge. Knee Balancer and Shim Sets are supplied as single-use sterile devices. Do not reuse or re-sterilize. If Knee Balancer or Shim Set packaging is open or damaged, do not use and immediately return to OrthoSensor. Do not use Knee Balancer after the expiration date on the package labeling. Do not use the Knee Balancer in a tibial tray without a Shim attached. The measurement load range of the Knee Balancer is 5 to 40 pounds per condyle. Contact OrthoSensor for additional data regarding Knee Balancer accuracy. Maximum safe allowable load for the OrthoSensor Knee Balancer is 70 lbs per compartment. If maximum safe allowable load of 70 lbs is reached in either compartment, the Knee Balancer must be removed from the knee joint and placed on a flat surface to allow the device to re-zero to recalibrate the device load sensors. If the physician perceives a difference between the loads displayed on the screen and the physical feel, the physician should either replace the sensor or continue the procedure using their standard trial technique and best clinical judgment. Do not load the Knee Balancer at its edges. Do not subject Knee Balancer or Shims to loads beyond the maximum allowable load. Do not impact / hit the Knee Balancer or any objects in contact with the Knee Balancer as this may result in damage to the exterior of the device. LB-03000-001 Rev B Dec. 2012 For further information, contact the OrthoSensor Customer Service Center by phone at 954-577-7770 or by e-mail at customerservice@orthosensor.com or go to www.orthosensor.com. OrthoSensor, Inc 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise FL, 33323 www.orthosensor.com Do not use a prying device during surgical procedure while the Knee Balancer is in place as this may result in damage to the exterior of the device. The Knee Balancer contains non-sterile, non-medical grade internal components. If the Knee Balancer housing is damaged or cracked during the procedure, take appropriate steps to promote patient safety. Do not disassemble or otherwise modify the Knee Balancer or Shims. Do not use Knee Balancer if it appears to be functioning improperly. Observe all warnings and alarms generated by the OrthoSensor LinkStation. Federal law restricts this device to sale by or on the order of a licensed physician. 1. Determine the specific size Knee Balancer required. Remove pouched Shims and Knee Balancer from the box and put on the shelf of the OrthoSensor LinkStation. DO NOT OPEN POUCH SEALS. 2. Record Knee Balancer serial number (S/N) onto patient and hospital records as required. 3. To activate the Knee Balancer:

a. Locate the OrthoSensor Sensor Assisted Surgery (SAS) icon on the screen of the LinkStation and activate the SAS software. b. With the product still in the sealed pouches, place the device directly over the magnet on LinkStation shelf;

an orange LED light will illuminate on the articulating surface of the Knee Balancer. Do not move the device until you observe the following:

i. LED turns off after approximately four (4) seconds. ii. Graphic User Interface (GUI) launches. iii. Load Sensor initialization progress bar appears and completes. c. Device may now be removed from magnet. 4. The GUI will automatically prompt selection of left or right leg. Select appropriate leg. 5. Zero Device a. Horizontal Zero, Step One i. Place sterile packed device flat on LinkStation shelf. ii. Gently secure medial and lateral edges to ensure device is flat. iii. Click the Zero button on the GUI. iv. Progress bar will appear and complete. b. Horizontal Zero, Step Two i. Rotate the device 180. ii. Gently secure medial and lateral edges to ensure device is flat. iii. Click the Zero button on the GUI. iv. Progress bar will appear and complete. c. Vertical Zero, Step Three i. Place sterile packed device flat against LinkStation post. The flat non-articulating surface of the device should be against post with posterior edge oriented toward the floor. ii. Click the Zero button on the GUI. Note that this step is instantaneous and has no progress bar for this step. 6. With the Knee Balancer now activated, pass the sealed pouches to the nurses within the sterile field of the OR. 7. Open double sealed pouches per hospital protocol (Knee Balancer and Shim Set.) 8. With Knee Balancer and Shims removed from the pouches, apply designated Shim to bottom of Knee Balancer. 9. To remove the Shim, or exchange for another size, simply unsnap the anterior lip of the attached Shim and replace. 10. With the Knee Balancer and Shim attached, physician should manually compress / apply load to the Knee Balancer and verify the response on the LinkStation screen prior to placing Knee Balancer into the tibial tray. 11. Confirm that the Knee Balancer with Shim is fully seated when placed in the tibial tray. 12. Flex the joint throughout its full range of motion to ensure appropriate response on the LinkStation. 13. Proceed with total knee replacement process per physician / hospital protocol. 14. Upon completion of the procedure, deactivate the Knee Balancer by pressing the Power Button on the GUI. 15. Dispose of Knee Balancer per institutional guidelines for biohazardous medical waste. Issue Knee Balancer (KB) LED does not light up KB not transmitting data to LinkStation Cause KB batteries are dead KB is out of wireless range Solution Discard KB and replace Move LinkStation closer to KB LB-03000-001 Rev B Dec. 2012 For further information, contact the OrthoSensor Customer Service Center by phone at 954-577-7770 or by e-mail at customerservice@orthosensor.com or go to www.orthosensor.com. OrthoSensor, Inc 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise FL, 33323 www.orthosensor.com KB breakage KB is powered off KB batteries are low KB loaded beyond limit Lag in reported data Software latency Move LinkStation unobstructed line-of-sight to the KB Activate with LinkStation magnet to achieve an Discard KB and replace KB internal components are non-

sterile and non-medical grade. Ensure patient safety. Discard KB and replace Maintain knee position until data settles (approximately 5 seconds) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2.) These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving device Increase the separation between the equipment. Consult OrthoSensor for help. This device complies with Part 95 of the FCC rules. This device may not interfere with stations operating in the 400.150 406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. Modification of this device may void the users authority to operate the equipment under the FCC rules above. Model:

Load Balancing System Knee Balancer Quantity: 1 Type:

Single Procedure Only. Do not resterilize B Sterile: Ethylene Oxide Device Type:

Type BF FCC ID: XNL-ORTHOSNSR1 XNL-ORTHOSNSR2 Mode of Operation:

Operating Range: Y6.5 ft [2m] Unobstructed Temporary (single-use) D Internally powered at less than 3.3 VDC Power Supply:

yQ Battery Life: 40 minutes (approximate) Temperature:

Relative Humidity:

Operation 15l37 30% 100%, submersion Atm Pressure:

470-1060 hPa 0l50 Storage 10% 50%, non-condensing 360-1060 hPa Rx Only: U.S. Federal Law restricts this product to sale by or on the order of a physician LB-03000-001 Rev B Dec. 2012 For further information, contact the OrthoSensor Customer Service Center by phone at 954-577-7770 or by e-mail at customerservice@orthosensor.com or go to www.orthosensor.com.