Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
8
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The safety and effectiveness of the Acessa procedure has not been evaluated in women with uterine size >14 weeks.
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Uterine tissue may contain unsuspected cancer, particularly in patients who are peri- or post-menopausal. Insufficient
data exist on which to evaluate the safety and effectiveness of Acessa procedure for treatment of cancerous uterine
tissue. Thoroughly discuss the benefits and risks of all treatments with patients.
•
Do not substitute transabdominal or transvaginal ultrasound for laparoscopic ultrasound when performing the Acessa
procedure.
6.
Precautions
6.1.
General Precautions
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Do not use the Acessa ProVu System if any of the hardware components, cables, or connectors are damaged. Such
damage may affect system functionality.
•
If the system becomes unresponsive during a procedure, reboot the system. If the problem persists, call Acessa Health
Inc. customer service, refer to §1 for applicable contact information.
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Reusable accessory cables should be periodically inspected for damage to insulation and tested for function and safety
in accordance with the cable’s instructions for use.
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The Hospital-owned accessory video monitor (an IEC/EN/UL/CSA 60950 or 60601-1 certified monitor) must have at
least a 1920 x 1080 resolution and a DVI input. A 27” or larger diagonal screen is preferred.
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Position the Console to allow adequate ventilation during operation.
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Arrange cables to minimize trip hazard and avoid damage.
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Position the Console to allow easy access to the On/Standby power switch on front of Console.
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Dispose of used Handpieces, Pads, and Cables in accordance with local, state, and national bio-waste laws and
regulations.
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Always turn the Console power OFF before connecting or disconnecting the power cord and TTFG cable. Not doing so
may result in sparks being generated.
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The Console should not be used adjacent to or stacked with other equipment. The system should be observed to verify
normal operation in the configuration in which it will be used.
•
Portable and mobile radio frequency (RF) communications equipment can affect the Acessa ProVu System functionality.
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Do not expose the Handpiece or Transducer with Sensorto a high magnetic field such as a Magnetic Resonance Imaging
(MRI) scanner, as they may become magnetized and affect system functionality.
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Mains power quality should be that of a typical commercial or hospital environment. If the user of the Acessa ProVu
System requires continued operation during power mains interruptions, it is recommended that the Console be
powered from an uninterruptible power supply.
•
Do not use abrasives, caustics, or mineral spirits. Use of these agents to clean the Console or any of its accessories may
cause damage and voids the warranty. All electrical connection ports must be air-dried before use.
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The output power selected should be as low as possible for the intended purpose.
6.2.
Environmental and EMI Precautions
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Non-flammable agents should be used for cleaning and disinfection wherever possible. (See Cleaning and Disinfecting
instructions and precautions for the validated cleaning agent. (§17.3)
•
Interference produced by operation of high-frequency surgical equipment may adversely affect the operation of other
electronic medical equipment such as monitors and imaging systems. This can be minimized or resolved by rearranging
monitoring device cables so they do not overlap the Acessa ProVu System’s cables.
6.3.
Precautions During Electrosurgical Device Use
•
Due to the non-homogenous conduction that occurs near organ surfaces or vasculature, shapes of ablations performed
in these areas may be altered. Careful planning is needed for targets in these locations
•
Any application or procedure that alters tissue perfusion and affects temperature elevation should be monitored
carefully.
6.4.
Precautions Specific to the Acessa ProVu System
•
A USB flash memory device is the only device that should be inserted into the back panel USB port (USB port, Item T as
shown in §8.4). This port is for Acessa Health personnel only.
6.5.
Precautions Concerning Acessa ProVu System Guidance Accuracy
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The System’s guidance capability has ±10 mm accuracy.
6.6.
Precautions Specific to Uterine Fibroid Ablation
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Avoid excessive pressure (e.g. lateral pressure) on the Handpiece which could bend or damage the shaft and/or
electrode array.
