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Acessa
ProVu System User's Guide
®
4.
Contraindications
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Patients who are not candidates for laparoscopic surgery (e.g. patients with known or suspected intra-abdominal
adhesions that would interfere with safe use of the Handpiece).
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Uterus adherent to pelvic tissue or viscera.
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Non-uterine pelvic mass.
•
Acessa ProVu System's guidance system is not intended for diagnostic use.
•
The Acessa ProVu System's guidance system may not be used to guide the tip of the Handpiece once the tip has
penetrated the uterine serosa. Ultrasound visualization must be used during fibroid penetration and treatment.
5.
Warnings
5.1. General Warnings
•
The safety of the electrosurgery will be greatly enhanced by a thorough knowledge of the medical literature on the
subject. Study of specific information on the hazards and complications of the procedure in question is especially
recommended.
Read all instructions for use of the Acessa ProVu System prior to its use. Safe and effective electrosurgery is dependent
•
not only on equipment design but also on factors under control of the operator. It is important that the instructions
supplied with this equipment be read, understood, and followed in order to enhance safety and effectiveness.
•
The safety and effectiveness of the Acessa ProVu System's electromagnetic tracking system to guide the tip of the
Handpiece has not been evaluated in clinical trials. Therefore, the electromagnetic tracking system should only be used
until the device has penetrated the uterine serosa.
The Acessa ProVu System should only be used by physicians and qualified medical personnel trained in the safe use of
•
electrosurgery and in the proper use of the Acessa ProVu System. After utilizing the Acessa ProVu System to determine
the desired entry location into the uterus, the physician must verify the final placement of the Handpiece shaft and
needles within the target tissue using ultrasound.
DO NOT USE with hybrid trocar systems, i.e. a combination of metal and plastic, when using monopolar active
•
components. This may result in alternate site burns due to capacitive coupling. Use only all-metal or all-plastic trocar
systems.
•
When not using instruments, place them in a clean, dry, highly visible area not in contact with the patient. Inadvertent
contact with the patient may result in burns.
•
Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke
plume and aerosols), protective eyewear, filtration masks, and effective smoke evacuation equipment should be used
in laparoscopic procedures.
•
DO NOT activate the Handpiece when not in contact with target tissue, as this may cause injuries due to capacitive
coupling with other surgical equipment.
•
The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated.
Re-use of the Handpiece or Transducer Sleeve may result in patient post-operative infection. These accessories are for
•
single use only.
•
When positioning the Handpiece, confirm proper placement prior to initiating treatment (RF energy activation).
Neuromuscular stimulation could cause injury due to unwanted muscle contractions.
•
Electric shock hazard. Acessa ProVu System Console must only be used with an IEC/EN/UL/CSA 60950 or 60601-1
certified monitor.
•
Electric shock hazard. Do not remove the cover of the Console. Refer all service to Acessa Health Inc. There are no
user-serviceable parts inside the Console.
•
Electric shock hazard. Do not saturate the Console with liquids. Do not allow liquids to run inside the unit. Do not
immerse the unit in water. Shut off the Console and disconnect power before cleaning. Do not sterilize the unit.
•
Electric shock hazard. Console must only be connected to a supply mains with protective earth.
•
When applying the Pads as described in this document or the Pad IFU (PL-01-0015), if it is found that the Pads will
overlap, the Acessa ProVu System cannot be used for that patient. SEVERE SKIN BURNS MAY RESULT.
•
FOR SINGLE USE ONLY! Re-use of the Pads may result in patient burn and/or infection.
•
FOR SINGLE USE ONLY! Re-use of the Handpiece may result in patient post-operative infection.
•
Treatment of children is limited due to the physical size and placement of Pads with respect to RF ablation site.
Treatment with the Acessa ProVu System is not recommended for nursing mothers or pregnant women.
•
•
Electrosurgery is not recommended for patients with metal implants near the ablation site or along the RF return path
to Pads.
•
Safety of using heat or cryo during or following the Acessa procedure has not been studied.
•
If the patient has a pacemaker, consult the patient's cardiologist prior to this procedure. Using the Acessa ProVu System
in the presence of an internal or external pacemaker may require special considerations.
CO 20-131 Revision: C
PL-01-0040
5
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