MAESTRO 4000™ Cardiac Ablation System

INTENDED USE/INDICATIONS FOR USE
The Maestro 4000 Cardiac Ablation System is intended for use with BSC cardiac ablation catheters in cardiac ablation procedures.

Note: Refer to the individual catheter Directions for Use for catheter compatibility to the Maestro 4000 Cardiac Ablation System. It is also important to carefully review the specific indications, contraindications, warnings, precautions and adverse events included with each catheter, prior to use of the catheter with the Maestro 4000 Cardiac Ablation System.

CONTRAINDICATIONS
There are no specific contraindications for use of the Maestro 4000 Cardiac Ablation System itself. However, users should read and understand the specific indications, contraindications, warnings, and precautions included with any cardiac ablation catheter used in conjunction with the System.

Note: The contraindications listed in the catheter Directions For Use also apply to the use of the Maestro 4000 Cardiac Ablation System. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each catheter, prior to use of the catheter with the Maestro 4000 Cardiac Ablation System.

WARNINGS
• System must be installed, calibrated and serviced by BSC trained personnel.
• No modification of this equipment is allowed other than the specified fuses, as this may result in electrical shock and/or other unexpected consequences.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• A Hospital Grade power cord (such as those supplied with the Maestro) must be used to connect the RF Generator or Remote Mains Power Inlet to an AC wall outlet designated as “Hospital Grade” or “Hospital Only.”
• Do not use an extension cord with the System and do not connect the System’s power supply cord to an additional multiple portable socket.
• Equipment connected to the analog and digital interfaces of the System must be certified to the respective IEC standards (i.e. IEC 950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1 (or 60601-1 3rd edition). Any user who connects additional equipment to the signal input ports or signal output ports configures a medical system, and is therefore responsible for the compliance
of that system with the requirements of the system standard IEC 60601-1-1 (or 60601-1 3rd edition).
• Electromagnetic interference (EMI) produced by the RF Generator during delivery of RF power may adversely affect the performance of other equipment. 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 your local BSC field service technician for help. The use of accessories, transducers and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the System. EMC installation and service information is provided in the Maestro 4000™ Cardiac Ablation System Safety Specifications section.
• Components of the Maestro 4000 Cardiac Ablation System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Maestro 4000 Cardiac Ablation System should be observed to verify normal operation in the configuration in which it will be used.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Maestro 4000 Cardiac Ablation System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• When physiological monitoring equipment is used on the same patient, any monitoring electrodes should be placed as far as possible from the ablation electrodes. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high frequency current-limiting devices are recommended.
• The cables connecting the catheter to the System should be positioned in such a way that contact with the patient or other leads is avoided.
• During power delivery, the patient should not come into contact with metal parts which are electrically connected to earth ground or which have an appreciable capacitance to earth (such as operating table supports, etc.). The use of antistatic sheeting is recommended.
• Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.
• There is a possibility of skin burns to the patient during ablation therapy. The use of dispersive pads, which meet or exceed IEC 60601-2-2 requirements, is required. The entire area of the dispersive pad should be reliably attached to the patient’s body as close to operating field as possible. Refer to the manufacturer’s directions for use for proper application. When using BSC high-power catheters, it is required that two dispersive pads be used.
• The Pod cable is permanently attached to the Pod. Do not attempt to loosen or remove this cable from the Pod. Do not attempt to rotate or twist the connector itself.
• Refer to the Directions for Use (DFU) provided with individual catheters to determine if the catheters are compatible with the Maestro 4000 Cardiac Ablation System. Carefully review the specific indications, contraindications, warnings, precautions and adverse events included in a catheter’s DFU prior to using the catheter with the Maestro 4000 Cardiac Ablation System.
• Pacemakers, implantable cardioverter/defibrillators, and leads can be adversely affected by radiofrequency energy. It is important to refer to the manufacturer’s instruction for use prior to performing ablation procedures.
• The impedance display of the RF Generator should be continuously monitored during RF power delivery. If a sudden rise in impedance is noted, RF power delivery should be discontinued.
• Failure of the RF Generator could result in an unintended increase of output power.
• The risk of igniting flammable gases or other materials is inherent in the application of RF power and precautions must be taken accordingly. Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment.
• With non-irrigated catheters, start with a low temperature setting in temperature-control mode, and then slowly titrate the temperature setting up to achieve the desired effect. With irrigated catheters, select power-control mode with a temperature setting intended to ensure that adequate fluid is irrigating the tip of the catheter.
• To minimize the potential for thrombus formation, inadvertent damage to cardiac tissues, and collateral damage to adjacent tissue not intended for ablation, begin by using a low power setting and gradually increase the power output if necessary, especially in areas where low blood flow and correspondingly low convective cooling may be present.
• To minimize the potential for thrombus formation, inadvertent damage to cardiac tissues, and collateral damage to adjacent tissue not intended for ablation, begin by using a low temperature setting and gradually increase the power output if necessary, especially in areas where high blood flow and correspondingly high convective cooling may be present.
• The displayed temperature is not the maximum tissue temperature. The measured temperature may be influenced by the degree of tissue contact and variations in blood flow. The difference between the max tissue temperature and the displayed temperature increases when using irrigated catheters, and the correlation with lesion formation is greatly reduced. The temperature displayed with irrigated catheters is not intended to guide lesion formation. The temperature displayed with irrigated catheters is intended to verify that the tip is being sufficiently irrigated. This behavior will minimize the potential for thrombus formation and/or inadvertent damage to nearby tissue.
• Damage such as frayed cords or cables and cracks or dents on the equipment may result in electrical shock.
• Do not immerse the Generator, the Remote, or accessories in any liquid.
• Use of non-flammable cleaning and disinfection agents is recommended. If used, flammable agents or solvents should be allowed to evaporate before high-frequency surgery. 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 mopped up before HF SURGICAL EQUIPMENT is used.
• Apparent low power output or higher than typical impedance measurements may be indicative of faulty dispersive pad application or failure of an electrical lead. Check the application of the dispersive pad and all electrical connections before continuing or selecting higher power outputs.

CAUTIONS
• Portable and mobile RF communications equipment can affect the Maestro 4000™ Cardiac Ablation System. It is advised not to use this equipment in proximity to the Maestro 4000 Cardiac Ablation System.
• Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during RF power applications.
• BSC recommends that the RF Generator and Remote be powered off at the end of each procedure in order to ensure that the self-test is performed before the next procedure.
• The Generator, Pod, Remote, Footswitch, power cords, and communication cables are not intended to be sterilized and should remain outside of the sterile field.

ADVERSE EVENTS
Users should also read and understand the specific indications, contraindications, warnings, and precautions included with any catheter used in conjunction with the System.

Potential adverse events associated with the use of the Maestro 4000 Cardiac Ablation System are, but not limited to, the following:
• Additional intervention required
• Arrhythmia
• Burns
• Cardiac Arrest
• Cardiac Tamponade
• Cerebral Vascular Accident (CVA)
• Complete Heart Block
• Conduction Pathway Injury
• Congestive Heart Failure
• Death
• Discomfort
• Edema
• Electrical Shock
• Embolism
• Esophagitis
• Exposure to Biohazardous Material
• Fistula
• Hematoma
• Infection
• Injury (Not Otherwise Specified)
• Laceration
• Myocardial Infarction
• Myocardial Trauma
• Necrosis
• Nerve Injury
• Perforation
• Pericardial Effusion
• Pericarditis
• Pleural Effusion
• Prolonged Procedure
• Renal damage/failure
• Respiratory Distress/Insufficiency
• Swallowing Disorders
• Tissue Damage
• Transient Ischemic Attack (TIA)
• Vasospasm
• Vessel Occlusion
• Vessel Trauma
 

92292194 (Rev. B)