12
11. Spike saline irrigation bag.
12. With the tip cap on, hold the MicroTip handpiece in a vertical position (needle pointing
upward) and press the PRIME key on the TX Console.
13. After successful priming, leave the tip cap on. Select IRRIGATION to ON, ASPIRATION
to MEDIUM or HIGH, and CUTTING POWER to MEDIUM or HIGH, then depress foot
pedal to test for acoustic signal.
CAUTION: Ensure successful priming cycle and presence of acoustic signal prior to incising
the patient.
WARNING: DO NOT check function of the MicroTip by placing hand or nger against the tip or
unintended damage to healthy tissue may result.
NOTE: For a description of setup related error messages, consult the Troubleshooting and
Factory Default Settings sections of the TX Console Operator’s Manual.
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, and CUTTING POWER.
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.
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