Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
7
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Electric shock hazard. Do not saturate Console with liquids. Do not allow liquids to run inside the unit. Do not immerse
the Console in water. Shut off the Console and disconnect power before cleaning. Do not sterilize the Console or Pads.
5.3.
Warnings During Electrosurgical Device Use
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Pad temperatures normally remain within a few °C of their starting temperature but occasionally can rise further for
long ablations or higher than normal tissue impedance. The user is advised to have an external cooling system setup
nearby in standby for this contingency. Do not use dry ice.
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Cables connected to the device should not contact the patient or other electrical leads.
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Skin-to-skin contact, such as between the torso and the arms or between the legs of the patient should be avoided by
insulating these contacts with sheets or dry gauze.
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Keep the Handpiece active electrode arrays clean. Build-up of eschar may reduce the instrument’s effectiveness. Do
not activate the instrument while cleaning. Injury to operating room personnel may result.
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Do not touch the Handpiece tip and Pads at the same time especially when operating the Console, as capacitive coupling
may lead to burns.
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When using the device in situations where vision may be limited, burns may result if the device is activated outside the
field of view.
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Failure of high frequency surgical equipment could result in an unintended increase of output power.
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Ablation RF Output is active without continuous activation of the Foot Pedal. Care needs to be taken to avoid over-
exposure of RF energy which may result in tissue damage or adjacent tissue damage.
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When not in use, electrosurgical leads (active or return) should be positioned so that they cannot come into contact
with the patient, other leads or any metal objects.
5.4.
Warnings Specific to the Acessa ProVu System
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Apparent low power output or failure of the electrosurgical equipment to function correctly at normal settings may
indicate faulty application of the Pads or failure of an electrical lead.
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For monopolar surgery, effective contact between the patient and the Pads must be verified whenever the patient is
repositioned.
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The proper use and placement of the Pads are key elements in the safe and effective use of monopolar electrosurgery,
particularly in the prevention of burns. Follow directions and recommended practices for the preparation, placement,
surveillance, removal and use of the Pads. Use with the system in accordance with your facility’s standard operating
procedure, Acessa Health’s instructions, and AAMI standards.
5.5.
Warnings Concerning Acessa ProVu System Guidance Accuracy
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Do not use the Acessa ProVu System guidance system without the Table Top Field Generator (TTFG) and Pad Set (MS-
26-0022). The generator should be below the patient’s pelvis.
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Do not drop the Field Generator or subject it to impact. Physical damage to the Field Generator may alter its calibration
and contribute to inaccurate guidance.
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Do not place the Acessa ProVu System closer than 1m from the Field Generator. To do so may affect the tracking
accuracy.
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Only plastic or compatible metals may be in the magnetic field. The Acessa ProVu System guidance system works by
generating magnetic fields from its TTFG. Take care when using the system to not place ferromagnetic objects upon the
Field Generator or within the tracking volume, or accuracy may be affected. Those metals specifically known to cause
tracking disruptions are: mild steels such as DIN 1.4034 or DIN 1.4021, Aluminum alloys and 400 series stainless steel.
The following metal alloys do not affect the Acessa ProVu System: titanium (TiA16V4); and 300 series stainless steel.
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Do not coil the TTFG cable or place it inside the tracking volume or wrap it around the TTFG, as it may create magnetic
interference.
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Do not place the Handpiece cable within 30 mm of the TTFG cable.
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Do not wrap the Handpiece cable around the Transducer cable or Console cables.
5.6.
Warnings Specific to Uterine Fibroid Ablation
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Insufficient data exist on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future
pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy.
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To reduce the risk of injury to organs outside of the uterus, electrode tips must be deployed no closer than 1 cm from
the fibroid margin in all planes.
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Always verify that the electrode arrays are fully retracted before positioning, advancing, or withdrawing the Handpiece.
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The Handpiece tip should be allowed to cool for at least 60 seconds after the ablation has stopped, prior to removing
it from the target tissue.
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To reduce the risk of hematoma, identify the inferior epigastric arteries prior to percutaneous insertion of the
Handpiece.