Warnings And Cautions - Boston Scientific Vessix Generator Mode D'emploi

WarnInGs anD caUtIons

Warning: DO NOT perform the treatment using the Vessix™ Generator if it has been dropped from a height greater than
10 cm. Disconnect the system from the catheter, power down, and then restart. Contact Boston Scientific if there are any
anomalies.
Warning: Operate the Vessix™ System by or under the supervision of a trained physician skilled in angiography and
percutaneous interventional techniques in a fully equipped catheterization laboratory. Observe all contraindications.
Warning: Vessix Generator electronics are not user-maintainable or replaceable, aside from required cleaning after every
procedure. No modification of this equipment is allowed.
Warning: Immediately disconnect, deflate, and remove the catheter in the event of fluoroscopic failure or power surge.
Warning: Using the Vessix Generator near a pacemaker or other active medical devices can cause interference with or
damage to that device. See electromagnetic manufacturer's guidance in Table 2 for emissions/immunity details.
Warning: To reduce the potential for signal interference, place physiological monitoring electrodes as far away from the
treatment site as possible. Needle monitoring electrodes are not recommended.
Warning: To reduce the potential for signal interference or contamination, position non-sterile Vessix Generator cables to
avoid contact with the patient or clinical personnel.
Warning: To avoid the risk of electrical interference from the Vessix Generator with other electronic equipment, use
monitoring systems that incorporate high-frequency current-limiting or filtering.
Warning: Regularly inspect all Vessix Generator System cables and components, and immediately return any possibly-
damaged part to Boston Scientific for service or replacement.
Warning: To ensure proper operation, if generator power is removed or cycled at any time after power on, disconnect the
system from the catheter, power down, and then restart. Improper operation can cause patient injury.
Warning: To ensure proper operation, if a power fluctuation occurs at any time after power on, disconnect the system from
the catheter, power down, and then restart. Improper operation can cause patient injury.
Warning: To avoid the risk of patient injury due to improper storage, store Vessix Generator electronics in correct storage
conditions (see Environmental Specifications section).
Warning: The Vessix Generator is certified for electromagnetic immunity in the electromagnetic environment specified in
the manufacturer's guidance. See Table 2 for emissions/immunity details.
Warning: Use an uninterruptible power supply (UPS) or internal battery to power the Vessix Generator if mains power
interruptions are anticipated. The generator and power cable should be positioned with easy access to disconnect from
mains power.
Warning: Failure of the Vessix Generator could result in an unintended increase of output power.
Warning: The risk of igniting flammable gasses or other materials is inherent in the application of RF power. Precautions
must be taken to restrict flammable anesthetics or skin preparation agents from the ablation site.
Warning: Do not use an automated cleaning process for the patient extension cable. Use of an automated process may
cause damage to the cable and impair functionality.
Warning: The patient should not be allowed to come in contact with grounded metal parts or parts with appreciable
capacitance to ground (e.g., operating table supports, etc.). The use of antistatic sheeting is recommended.
Warning: Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by
insertion of dry gauze.
caution: DO NOT attempt to operate the Vessix Generator before thoroughly reading this manual and the Vessix Reduce™
Catheter Directions for Use (DFU). For future reference keep this manual in a convenient, readily accessible place.
caution: Changes or modifications not expressly approved by Boston Scientific could void the user's authority to operate
this equipment.
caution: DO NOT use Vessix Generator electronics within the sterile field without bagging them in the proper dressings.
caution: DO NOT use Vessix Generator electronics in the presence of condensing humidity (see Environmental
Specifications for correct operating conditions).
caution: To reduce the risk of electric shock, DO NOT touch Vessix Generator electronics and the patient at the same time.
caution: To avoid the risk of equipment damage or personal injury, use only supplied accessories and Vessix Reduce
Catheters. Use with any other catheters is prohibited.
caution: To avoid the risk of patient injury or catheter failure, do not deliver more than five (5) treatments per catheter. If
more treatments are needed, use additional catheters.
caution: To avoid the risk of patient injury due to unintentionally high output power, do not use the Vessix Generator near
high-frequency surgical equipment.
caution: Use only the supplied power supply with the Vessix Generator to assure proper system functionality.
caution: Do not stack other equipment on top of the Vessix Generator and/or Cart.
caution: If the battery is fully depleted, it should be charged for a minimum of one hour prior to treatment.
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Black (K) ∆E ≤5.0