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Acessa
ProVu System User's Guide
®
In the case of a pacemaker, a possible hazard exists because interference with the action of the pacemaker may occur,
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and the pacemaker may become damaged. Questions should be directed to the attending Cardiologist, or to the
pacemaker manufacturer.
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Do not use the Acessa ProVu System during cardiac defibrillation.
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The Transducer should not be used to manipulate the bowel during the procedure due to the risk of bowel injury.
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ONLY Acessa Health Inc. accessories may be attached to and used with the Acessa ProVu System. The Acessa ProVu
System is not compatible with any other RF devices or electro-magnetic guidance devices.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
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equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
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For surgical procedures where the RF current could flow through parts of the body having a relatively small cross
sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.
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The device should not be used on patients with bleeding disorder or an anticoagulant therapy.
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No modification of this equipment is allowed.
The connector of the TTFG must be positioned on the side of the patient opposite the physician.
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The Acessa ProVu System is sensitive to strong radiated and conducted electromagnetic interference. In the event of
such interference, the Console will cease displaying guidance information and will display an alert message. The user
should discontinue use of the Acessa ProVu System until the source of the interference can be determined and
removed.
5.2. Environmental and EMI Warnings
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In the case of a pacemaker, a possible hazard exists because interference with the action of the pacemaker may occur,
and the pacemaker may become damaged. Questions should be directed to the attending Cardiologist, or to the
pacemaker manufacturer.
•
Any additional monitoring electrodes should be placed as far as possible from the Handpiece and should incorporate
high-frequency current limiting devices. Needle monitoring electrodes are not recommended.
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Do not use flammable anesthetics, gases, or liquids while the system is in use. The risk of igniting flammable gases or
other materials is inherent in electrosurgery and cannot be eliminated by device design. Precautions must be taken to
avoid contact of flammable materials and substances with electrosurgical electrodes, whether they are in the form of
an anesthetic or skin preparation agent, or produced by natural processes within body cavities, or originate in surgical
drapes, tracheal tubes or other materials.
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ASPIRATE fluid from the area before activating the instrument. Conductive fluids (e.g. blood or saline) in direct contact
with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which
may cause unintended burns to the patient.
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There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in
body cavities such as the vagina. Any fluid pooled in these areas should be removed before RF surgical equipment is
used.
The presence of endogenous gases may create an ignition hazard. Ensure that the operating room is well ventilated.
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Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced
in normal use of the RF surgical equipment.
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This equipment has been tested and found to comply with the EMC limits for the Medical Device (CISPR 11 Class A and
IEC 60601-1-2). These limits are designed to provide reasonable protection against harmful interference in a typical
medical installation, however, in some cases of input power fluctuations or transients (electrical fast transient,
conducted immunity, and voltage dips/interrupts), compliance is achieved by safe shutdown into standby mode. If the
unit responds to an EMI event by shutting down, then it will be necessary to manually reboot the system by use of the
Standby pushbutton on the front of the Console. The equipment generates, uses, and can radiate radio frequency
energy, and if not installed and used in accordance with these instructions, may cause harmful interference to other
devices in the vicinity. Per the IEC 60601-2-2 standard, compliance to radiated emissions is only tested in the Ready
Mode; however, during ablation or coagulation known interference will be generated which degrades nearby AM radio
receivers and other equipment sensitive to harmonics of the 460 kHz RF Generator operating frequency. There is no
guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference
with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
o
Reorient or relocate the receiving device.
o
Increase the separation between the equipment.
o
Connect the equipment into an outlet on a circuit different from that to which the other device(s) is/are connected.
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Consult the manufacturer or field service technician for help.
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The use of Pads, Handpiece, Cables, and accessories other than specified, with the exception of those devices sold by
Acessa Health Inc. for the system as replacement parts for components may result in increased emissions or decreased
immunity of the Acessa ProVu System.
CO 20-131 Revision: C
PL-01-0040
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