User's Manual

OrthoSensor, Inc
1560 Sawgrass Corporate Pkwy, 4
th
Floor
Sunrise FL, 33326
www.orthosensor.com
07562-X1
TM
• The Load Sensor contains non-sterile, non-medical grade internal components. If the Load Sensor housing is damaged or
cracked during procedure, take appropriate steps to promote patient safety.
• Do not disassemble the Load Sensor.
• Do not use Load Sensor if it appears not to be functioning properly.
• Observe all warnings and alarms generated by the OrthoSensor Link Station.
• Do not subject Load Sensor or Shims to sudden impact.
• Federal law restricts this device to sale by or on the order of a licensed physician
IN
ININ
INSTRUCT
STRUCTSTRUCT
STRUCTIONS
IONSIONS
IONS
1. Prior to start of procedure, turn Orthosensor Link Station on. Ensure that the station is plugged into a standard 110V
outlet. Then locate the power button, which is located along the left lower rear side of the monitor and press the
button. Upon startup, the system will upload to the main screen.
2. Determine specific size load sensor. Remove pouched shims and load sensor from the box and set atop of the shelf
on the Orthosensor Link Station. DO NOT OPEN POUCH SEALS.
3. Record Load Sensor serial number (S/N) onto patient and hospital records as required.
4. To activate the Load Sensor:
a. Locate the magnet on the right rear side of the retractable keyboard / mouse tray.
b. With the product still in the sealed pouches, place the center rear section of the device over the magnet; a
red light will illuminate; continue to hold in place until the red light turns off.
5. Once the unit is activated, locate the TKA load balancing icon on the screen of the smart system and activate the
software.
6. Upon activation of software scan the label barcode attached to the Load Sensor outer pouch.
7. The software will now enter the active display mode.
8. Open double sealed pouches per hospital protocol (Load Sensor and Shim Set).
9. If required, snap a shim onto the base of the Load Sensor before implanting into the Tibia tray. Shim size to be
determined by the physician.
a. To remove the shim or exchange for another size, simply unsnap the installed shim and replace.
10. The physician should manually compress / apply load to the device and verify it’s response on the Link Station screen
prior to placing Load Sensor into the tibia tray.
11. Confirm that the load sensor module is fully seated when installed onto the tibial tray.
12. Flex the joint throughout its full range of motion five times (5X) to ensure appropriate response on the Link Station.
13. Perform knee surgery with the Load Sensor in conjunction with the instructions displayed on the Link Station, and per
the requirements of the Stryker Orthopaedics Triathlon Knee System. Due to the early verification status of the Load
Sensor do not use the data to affect patient outcome.
a. The load range of the Load Sensor is 5 to 40 pounds per condyle.
b. The maximum safe allowable load for the OrthoSensor Load Sensor is 70 lbs per condyle.
14. Dispose of Load Sensor per institutional guidelines for biohazardous medical waste.
LOAD SENSOR
LOAD SENSOR LOAD SENSOR
LOAD SENSOR (LS)
(LS) (LS)
(LS) TROUBLESHOOTING
TROUBLESHOOTINGTROUBLESHOOTING
TROUBLESHOOTING
Issue
Cause
Solution
Load Sensor (LS) LED does not light up
LS batteries are dead
Discard LS and replace
LS not transmitting data to Link Station
LS is out of wireless range
Move Link Station closer to LS
Move Link Station to achieve an
unobstructed line-of-sight to the LS
LS is powered off
Activate with Link Station magnet
LS batteries are low
Discard LS and replace
LS breakage
LS loaded beyond
limit
LS internal components are non
-
sterile
and non-medical grade. Ensure
patient safety. Discard LS and replace
Lag in reported data
Software latency
Maintain knee position until data
settles (approximately 5 seconds)