Orthosoft Inc. R20S21A Manual Do Utilizador
SmartKnee Surgical Technique
5 of 58
Principal components
Description
[20-8011-049-00]
provide alignment information. This allows computing the
instrument orientations with respect to the bone.
instrument orientations with respect to the bone.
One Smart Tools Knee Pod Kit is required for each procedure.
Highlights:
• Single use, Disposable Pods x 4 (sterile use)
• Wireless communication radio
• Battery powered (up to 2 hours)
• Inertial Sensors
• Wireless communication radio
• Battery powered (up to 2 hours)
• Inertial Sensors
System Controller Kit
[
KT-8011-070-01]
The System Controller (non-sterile) is a computer system used to
controls the flow of the procedure via wireless communication
with the PODs.
controls the flow of the procedure via wireless communication
with the PODs.
The System Controller is intended to be used by nurse or Zimmer
Representative.
Representative.
The procedure is to be performed in an operating room with a temperature ranging from
18
18
o
C to 30
o
C (59
o
F to 86
o
F). Pods shall be stored at 20 deg minimum before being brought
in the OR.
After powering up the Pods, wait for at least 5 min before starting the intra-op calibration
In the following event occurs, the Navigation Application must be stopped and restarted
with a new Smart Tools Knee Pod Kit [20-8011-049-00], or the user may revert to
continuing the procedure with standard instrumentation:
with a new Smart Tools Knee Pod Kit [20-8011-049-00], or the user may revert to
continuing the procedure with standard instrumentation:
- If a Pod is dropped on the floor or is no longer sterile
,
- If a Pod battery reaches its end of life before the end of the procedure
Ensure that one Smart Tools Knee Pod Kit [20-8011-049-00] will be used per operated leg.
User must close and restart the application with another Smart Tools Knee Pod Kit [20-
8011-049-00] before operating another leg.
User must close and restart the application with another Smart Tools Knee Pod Kit [20-
8011-049-00] before operating another leg.
No modification of this “Smart Tools Knee System” equipment is allowed.
1.3 Implant indications
The knee implant, implanted with the Smart Tools Knee System, must be used in accordance with the
appropriate package insert labeling.
appropriate package insert labeling.