Tenex TX Console - Chapter 2 Information for Safety; Contraindications; Adverse Effects; Warnings and Precautions

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Chapter 1 Indications for Use
TENEX HEALTH TX SYSTEM WITH TX1 / TX2 MICROTIP
The Tenex Health TX System with the TX1 / TX2 MicroTip is indicated for use in surgical proce-
dures where fragmentation, emulsication, and aspiration of soft tissue are desirable, including
General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive
Surgery.
TENEX HEALTH TX SYSTEM WITH TXB MICROTIP
The Tenex Health TX System with TXB MicroTip is indicated for use in surgical procedures
where fragmentation, emulsication, and aspiration of both soft and hard (e.g.: bone) tissue are
desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic
and Reconstructive Surgery.
The Tenex Health TX System with TXB MicroTip is also indicated for use in the debridement of
wounds, such as, but not limited to, diabetic ulcers, in applications in which, in the physician’s
judgement would require the use of an ultrasonic aspirator with sharp debridement.
Chapter 2 Information for Safety
CONTRAINDICATIONS:
This ultrasonic surgical aspirator device is not indicated for and should not be used for the
fragmentation, emulsication, and aspiration of uterine broids.
The Tenex Health TX System with the TXB MicroTip is also contraindicated for:
Active Infections
Weakness of the posterior muscle group with a calcaneal gait disorder
ADVERSE EFFECTS:
There is a possibility of a delay in the procedure from system issues. Other possible adverse
effects include edema at the treatment site, delayed healing, bone degradation, increased
morbidity or sub-optimal outcomes, sensitization and allergic reaction, infection, irritation, fever,
pain, tissue injury, foreign body reaction, electrical shock, and burns.
WARNINGS AND PRECAUTIONS:
Warnings and Cautions related to the MicroTip apply to the TX1, TX2, and TXB MicroTips
unless otherwise indicated.
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: DO NOT recap the tip of the MicroTip.
WARNING: Electrical shock hazard exists. No user serviceable parts within console. Call
manufacturer for service.
WARNING: No modication of this equipment is allowed.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
WARNING: DO NOT check function of MicroTip by placing hand or nger against tip or unintended
damage to healthy tissue may result.