Boston Scientific MAESTRO 4000 Manual De Instrucciones página 11

• WARNING: 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.
• WARNING: 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.
• Caution: Pins of connectors identified with the ESD warning symbol should not be touched and
connections should not be made to these connectors unless ESD precautionary procedures are
used. It is recommended that all staff involved in the assembly and/or installation of the Maestro 4000™
Cardiac Ablation System receive an explanation of the ESD warning symbol and training in ESD
precautionary procedures.
• Caution: 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.
• Caution: Adequate filtering must be used to allow continuous monitoring of the surface
electrocardiogram (ECG) during RF power applications.
• Note: The RF Generator, Pod, and if used, the Remote Control and Foot Switch, are intended for
installation within the Patient Environment.
Note: The Patient Environment is described per IEC 60601-1 as any volume in which intentional or
unintentional contact can occur between Patients and parts of the System, or between Patient and other
persons touching parts of the System.
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global 11
Black (K) ∆E ≤5.0