3
CAUTION:
The console can only be disconnected from the supply mains by means of the power
cord. Position equipment so that power cord is easily accessible.
CAUTION:
Ensure successful priming cycle and presence of acoustic signal prior to incising
the patient.
CAUTION:
DO NOT activate the MicroTip with the tip in air as immediate damage may result.
CAUTION:
DO NOT rest the saline irrigation bag on the TX Console enclosure or touchscreen.
CAUTION:
Failure to align the Red Dot on the MicroTip connector with the Red Dot on the
console receptacle may damage the connector pins.
CAUTION:
Maximum tip temperature can approach 47 degrees C. This does not present a
hazard to the patient if the TX System is used according to the recommended duty cycle: 15
seconds on, 45 seconds off on HIGH cutting power.
CAUTION:
DO NOT use abrasive cleansers or solvents on the TX console, particularly the
touchscreen.
CAUTION:
DO NOT spray liquids directly onto the TX console or submerge the TX console or
foot pedal into liquids.
CAUTION:
Individual TX Supply Kit components (if present) are sterile if the package is
unopened and undamaged.
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.
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 use the TXB Microtip for a total cutting time exceeding 10-minutes on hard
tissue or 15-minutes cumulative (hard and soft tissue). Failure to limit use beyond the maximum
cutting time could result in device damage or failure.
CAUTION:
DO NOT use the TX1 or TX2 Microtip for a total cutting time exceeding 10-minutes.
Failure to limit use beyond the maximum cutting time could result in device damage or failure.
CAUTION:
The TX1 and TX2 MicroTips should not be used on hard tissue such as bone.
CAUTION:
The Tenex Health TX System should not be used on bone cement.
Summary of Contents for MicroTip TX1
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