Indications, Safety, Warnings

The Barrx™ flex RFA energy generator is indicated for use for the coagulation of soft tissue. The Barrx™ flex system is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including but not limited to, the esophagus. Indications include esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Barrett’s esophagus, Dieulafoy’s lesions, and angiodysplasia.

• Do not operate the energy generator before thoroughly reading this user’s guide and the IFU for each disposable device.
• Do not remove the cover of the energy generator, as there is a potential for electrical shock. Refer to authorized personnel for service. Do not use the generator if significant damage to the cover or front panel is detected as there is a risk of electrical shock.
• Do not use this device in the presence of flammable anesthetics; other flammable gases, near flammable fluids such as skin prepping agents and tinctures, flammable objects, or with oxidizing agents. Observe appropriate fire precautions at all times.
• Do not use this device in oxygen-enriched atmospheres, nitrous oxide (N₂O) atmospheres, or in the presence of other oxidizing agents. While using this device during a procedure, the patient should not be allowed to come into direct contact with grounded metal objects, such as the surgical table frame, the instrument table, etc.
• It is necessary to use the supplied hydrophobic filter (included in all balloon catheter’s packaging), placed between the pneumatic connector located at the proximal end of both the sizing balloon and ablation catheter and the pneumatic connector line on the output cable to ensure fluids are not aspirated into the output cable in the event of a balloon leak. If the catheter is used without the filter and a balloon leak occurs, inspect the clear tubing portion of the connecting output cable for traces of fluid. If fluid is detected, discontinue the use of the output cable and order a replacement.
• Only inflate all balloon catheters using the inflation system incorporated into the energy generator.
• If the energy generator displays an E95 or C56 operational code, this is most likely caused by an air leak in the system. If the E95 or C56 operational codes are observed, under endoscopic visualization, manually deflate the balloon using a syringe via pneumatic connector at the proximal end of ablation catheter; remove and replace the catheter.
• Visual endoscopic confirmation of complete balloon deflation must be performed prior to attempting to reposition or remove a balloon-based ablation catheter, sizing balloon, or Barrx™ 360 express RFA balloon catheter.
• Do not deliver RF energy in areas containing surgical staples. The presence of metallic staples may disturb the treatment pattern and may lead to complications.
• Needle-monitoring electrodes are not recommended for use with this equipment.
• Patient-monitoring systems used with this equipment should incorporate high-frequency current limiting devices.
• The output cable should be placed as to avoid unnecessary contact with patient leads or leads from other patient-connected equipment. Do not use the output cable if the insulation is damaged to prevent the risk of electrical shock.
• Failure of the energy generator could result in an unintended power output increase.
• Place any monitoring electrodes as far as possible from the surgical electrodes when RF surgical equipment and physiological monitoring equipment are used simultaneously on the same patient.
• Electrosurgery should be used with caution in the presence of internal or external pacemakers. Interference produced with the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker entirely. Consult the pacemaker manufacturer or hospital cardiology department for further information when use of electrosurgical devices are planned to be used in patients with cardiac pacemakers.
• This equipment is intended to be used by healthcare professionals only.
• This equipment has been tested and complies with the limits for medical devices to the IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
• EMC testing ensured the energy generator’s immunity to interference was sufficient to maintain accurate power output (+/- 20%) and prevent unintended activation of power output. Testing also ensured reasonable protection against disruption of nearby equipment from the energy generator’s conducted and radiated emissions.
• When the energy generator is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment. The energy generator must be installed and put into service according to the EMC information provided in Guidance and Manufacturer’s Declaration—Electromagnetic Compatibility.
• Portable and mobile RF communications equipment can affect the energy generator function.
• The energy generator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the energy generator should be observed to verify normal operation in the configuration in which it will be used.
• Use of the energy generator with accessories or cables other than those supplied and manufactured by Covidien may result in increased emissions or decreased immunity of the energy generator.
• This equipment may cause radio interferences or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting, relocating the equipment or shielding the location. If this equipment does cause harmful interference to 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:
  • Reorient or relocate the receiving device.
    
  • Increase the separation between the equipment.
  • Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.
  • Consult the manufacturer or field service technician for help. The USB port connector on rear panel is for the manufacturer’s use only, do not attempt to connect anything to this port.
• The AC power cord is the mains disconnect device. Allow sufficient spacing in rear of generator to be able to disconnect the AC power cord.
• The generator contains a 3.3V lithium battery (Ref designator BTI) and a 5A 250V μ Fuse (Ref designator FI). These parts may only be replaced by Covidien-authorized service personnel. There are no user-serviceable parts in this device. Refer servicing to qualified Covidien personnel. For service information, please call 888-662-2779 or 408-328-7310, or refer to the Covidien website: www.barrx.com.

Precautions

• In order to avoid the potential of having to abort a patient procedure, specifically after the patient has undergone conscious sedation/anesthesia, the generator should be powered up and the front panel display should read, “ready connect catheter.” After this message is indicated on the display, the patient can be prepped, including conscious sedation/anesthesia, and the procedure can proceed.
• This system cannot be used at an elevation greater than 7000 feet (2134 meters) above sea level or lower than 300 feet (91 meters) below sea level.
• Do not activate the energy generator until the ablation catheter is properly positioned in the patient.
• The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the audible tone.
• Use only the provided flex footswitch model with the energy generator.
• The main power cord of the energy generator MUST be connected to a properly grounded receptacle. Extension cords and/or adapter plugs MUST NOT be used.
• Do not wrap the output cable around metal objects. Wrapping cables around metal objects may induce hazardous currents.
• Disconnect all cables after use.