System Installation - Boston Scientific MAESTRO 4000 Manual De Instrucciones

SYSTEM INSTALLATION

This section provides installation instructions for the Maestro 4000™ Cardiac Ablation System.
• WARNING: No modification of this equipment is allowed other than the specified fuses, as this may result
in electrical shock and/or other unexpected consequences.
• WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• WARNING: 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."
• WARNING: 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.
• WARNING: 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).
• WARNING: 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.
• WARNING: 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.
• WARNING: 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.
• WARNING: 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.
• WARNING: 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.
• 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.
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Black (K) ∆E ≤5.0
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global