2
WARNING:
Use of a cutting handpiece other than the MicroTip may result in patient injury or
damage to the TX Console.
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.
WARNING:
DO NOT use the MicroTip after the expiration date indicated on the package.
WARNING:
The MicroTip is sterile if package is unopened and undamaged. DO NOT use if the
sterile package has been compromised.
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.
WARNING:
To prevent cross-infection, DO NOT use the device on multiple treatment sites.
WARNING:
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.
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.
WARNING:
Possible risk of fire or explosion. The Tenex Health TX System should never be
used in the presence of flammable anesthetics, oxidizing gases (i.e., nitrous oxide and oxygen),
endogenous gases, disinfecting agents, cleaning agents, or aerosol sprays.
WARNING:
Console Rear Panel Network and USB connections are for use by trained factory
personnel only.
CAUTION:
Minimal edema associated with the TX system occurs only occasionally and is
considered a routine response to treatment.
CAUTION:
Utilize Universal Precautions and Sterile Technique at all times. Failure to do so
can lead to increased risk of infection or aggravation of a recent infection.
CAUTION:
Use caution when removing potentially malignant or harmful tissues, to isolate
contamination from surrounding tissue.
CAUTION:
For TX1 and TX2 MicroTips, only use 500cc saline irrigation bag and cuff. Use of
an alternate volume irrigation bag in the inflation cuff may result in possible contamination of
the surgical environment, lack of irrigation flow during use, or electrical hazard.
CAUTION:
For TXB MicroTips, only use 1000cc saline irrigation bag and cuff. Use of an
alternate volume irrigation bag in the inflation cuff may result in possible contamination of the
surgical environment, lack of irrigation flow during use, or electrical hazard.
CAUTION:
Always check the saline irrigation bag for leaks prior to surgical procedures.
CAUTION:
DO NOT use the device if the tip of the MicroTip is received bent or is bent during use.
CAUTION:
The TX Console contains electrical circuit boards and must be returned to Tenex
Health for disposal.
CAUTION:
The foot pedal must be disposed of according to local regulations at the end of its
useful life.
CAUTION:
Pinch point hazard exists. Keep hands and fingers clear when lowering the display.
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