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14. Prepare the patient for procedure using the TX Supply Kit and/or other appropriate clinical
supplies.
CAUTION:
Individual TX Supply Kit components (if present) are sterile if the individual package
is unopened and undamaged.
15. Select desired settings for IRRIGATION, ASPIRATION, CUTTING POWER, and COAGULATION.
NOTE:
See Operations section of the TX Console Operator’s Manual for detailed information
regarding each function.
16. Remove the tip cap from the handpiece.
17. The Tenex Health TX System is now ready to use.
WARNING:
Monitor the location of the MicroTip during use. Failure to monitor the location of
the tip of the device may present a hazard to the user, result in damage to unintended tissue or
limit the ability to detect device malfunction or damage to the MicroTip related to use.
NOTE:
Identify the target pathology via ultrasound imaging, direct visualization and/or by
palpation, as appropriate.
CAUTION:
The TX1 and TX2 MicroTips should not be used on hard tissue such as bone.
CAUTION:
The MicroTip should not be used on bone cement.
CAUTION:
Use caution when removing potentially malignant or harmful tissues, to isolate
contamination from surrounding tissue.
CAUTION:
DO NOT activate the MicroTip with the tip in air as immediate damage may result.
CAUTION:
DO NOT use the device if the tip of the MicroTip is received bent or is bent during use.
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 hold MicroTip static. Keep the MicroTip moving using axial motion when
targeting and emulsifying tissue to prevent damage to the MicroTip and/or occlusion of the tip.
Due to friction related to ultrasonic vibration, appropriate technique is necessary for thermal
management at the treatment site and will minimize the potential for tissue burns.
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:
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:
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.
Summary of Contents for MicroTip TX1
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