Indications, Safety and Warnings

Heart Connect™ System for 3300 Programmer

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE
The Heart Connect System is an optional data-sharing system intended to display and share physiological and/or other medical data from the Model 3300 Programmer. The Heart Connect System provides health care providers and Boston Scientific personnel with means to establish an online meeting and share the display of the Model 3300 Programmer with individuals in a remote location.

CONTRAINDICATIONS
The Heart Connect System is contraindicated for use with medical equipment that is not compatible with system characteristics as defined in the manual.

WARNINGS
Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for additional Warnings. The use of any cables or accessories with the Heart Connect System, other than those included with the Heart Connect could result in increased electromagnetic emissions or decreased electromagnetic immunity, or electrical shock of the LATITUDE Programming System. The LATITUDE Programming System is MR unsafe and must remain outside the magnetic resonance imaging (MRI) site Zone III (and higher).

PRECAUTIONS
Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for additional Precautions. The Model 3300 Programmer transmits display content that may include patient data that are protected health information. Patient data should only be accessed by authorized healthcare providers and Boston Scientific personnel.

ADVERSE EFFECTS
Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for Adverse Effects.

92495688 (Rev. A)

Top