Intended Use/Indications For Use; Contraindications - Boston Scientific MAESTRO 4000 Manual De Instrucciones

User Profile
The Maestro 4000™ Cardiac Ablation System should be used only by physicians fully trained in cardiac
electrophysiology. EP lab staff members may prepare the Maestro 4000 Cardiac Ablation System for use and
assist with operation of the RF Generator.
Contents
The RF Generator and Pod are packaged separately as:
• (1) Maestro 4000 Controller
• (1) Maestro 4000 Pod, 100W or (1) Maestro Pod, 150W
Optional Accessories
The MetriQ™ Pump, Maestro 4000 Remote Control, Maestro 4000 Foot Switch, and communication cables
required for optional equipment such as the MetriQ Pump, Maestro 4000 Remote Control, or connection to an
EP recording system are packaged and sold separately.
• MetriQ Pump, Model 4100
• Maestro 4000 Remote Control, Model 4020
• Maestro 4000 Foot Switch, Model 21850
• Cable, Generator to Pump or Remote
• Model 661, 20 ft.
• Model 662, 25 ft.
• Model 663, 50 ft.
• Model 664, 75 ft.
• Pod to EGM Cable Model 653S

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.
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global 3
Black (K) ∆E ≤5.0