Tenex MicroTip TX1, Operator'S Manual

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CAUTION: For use on hard tissue, use multiple cortical penetrations using axial motion to
facilitate entry into bone. Attempting to breach cortical shell through a single insertion point will
not provide for adequate tip cooling and maneuverability of the tip and may result in damage to
the sheath of the device or tissue burns.
CAUTION:
DO NOT laterally load the MicroTip during use. Failure to follow appropriate technique
could result in potential hazard to adjacent tissue due to excessive heating or damage to the
MicroTip such as a broken needle and/or damage to irrigation sheath.
NOTE: When using the cutting function, there will be a 1 second delay between activation of
the foot pedal and delivery of ultrasonic cutting power. This is to allow for sufficient supply of
irrigation fluid at the ultrasonic tip.
NOTE: Keep the MicroTip moving to prevent occlusion. A triple beeping sound will be generated
by the console to indicate occlusion during use. Release and depress foot pedal to remove
occlusion.
NOTE: A user-controlled duty cycle of 15 seconds ON, 45 seconds OFF (15s/45s) is to be
followed when using HIGH CUTTING POWER. This is equal to a ratio of 1:3 of FOOT PEDAL
ON time to FOOT PEDAL OFF time with a maximum of 15 seconds of continuous FOOT PEDAL
ON time.
WARNING: Verify integrity of the MicroTip needle and irrigation sheath upon completion of
treatment. Failure to do so may result in device remnants left in the patient in the event of
device damage.
18. Upon completion of the procedure, prepare the patient using the TX Supply Kit and/or
other appropriate clinical supplies.
CAUTION: Minimal edema associated with the TX system occurs only occasionally and is
considered a routine response to treatment.
c. SHUT DOWN
WARNING: DO NOT recap the tip of the MicroTip.
WARNING: The MicroTip is single use. DO NOT resterilize/reuse. Reusing the device could
result in compromised device performance, cross-infection, and other safety hazards.
WARNING:
Surgical waste presents a biological hazard and must be handled and disposed of
properly. The MicroTip must be disposed of according to local regulations.
1. Select OFF for IRRIGATION, ASPIRATION, and CUTTING POWER.
2. Deflate the inflation cuff by disconnecting the air tube fitting from the AIR receptacle on
the console side panel OR by turning off the console by pressing the power switch on the
back panel to the OFF position.
3. Remove the saline irrigation bag from the inflation cuff. DO NOT discard the inflation cuff.
4. Remove the spike and discard the saline irrigation bag.
5. Disconnect the MicroTip electrical connector from the CUT receptacle on the console side
panel.
6. Depress the cartridge release button and remove the cartridge from side of console.
7. Dispose of the MicroTip in a receptacle designated for sharps/biohazard according to your
facility requirements.