Indications, Safety and Warnings
LATITUDE Consult™ System
The Programmer is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems.
LATITUDE Consult is intended to read data from a compatible Boston Scientific implanted device and transfer data to a central server. LATITUDE Consult can provide implanted device data that may be used as part of the clinical evaluation of the patient.
CONTRAINDICATIONS
There are no known contraindications for LATITUDE Consult.
WARNINGS
Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for warnings.
PRECAUTIONS
Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for additional precautions.
Ensuring a review. In order to ensure a review by Boston Scientific of the patient’s implanted device data, the clinician must call Boston Scientific at 1-800-CARDIAC (227-3422) or contact a local Boston Scientific representative after sending the data to request a LATITUDE Consult review. At all times the institution (clinic) is responsible for the clinical and technical interpretation of LATITUDE Consult reports. The institution acknowledges that if a technical consultation on the data is desired, an institution employee may call 1-800-CARDIAC (227-3422) or contact a local Boston Scientific representative to request a technical review by Boston Scientific. A local Boston Scientific representative may also be notified to assist with technical support of the device. If the institution requests reports to be sent automatically and does not receive a report within 15 minutes of a LATITUDE Consult transmission to Boston Scientific, the institution should call 1-800-CARDIAC (227-3422) or contact a local Boston Scientific representative to receive LATITUDE Consult System status; it is the institution’s responsibility, and not Boston Scientific’s, to ensure that the report is received by the institution.
ADVERSE EFFECTS
None known.
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.
92793836 (Rev A)
The LATITUDE Consult™ System is intended to read data from a compatible Boston Scientific implanted device and transfer it to a central server. The LATITUDE Consult™ System can provide implanted device data that may be used as part of the clinical evaluation of the patient.
CONTRAINDICATIONS
The LATITUDE Consult Communicator is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE Consult system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being read.
WARNINGS
The Communicator is MR (Magnetic Resonance) Unsafe. The Communicator is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices. Under no circumstances should the Communicator be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
PRECAUTIONS
In order to ensure a review by Boston Scientific of the patient’s implanted device data, the clinician must call Boston Scientific at 1-800-CARDIAC (227-3422) after sending the data and request a LATITUDE Consult review.
ADVERSE EFFECTS
None known.
92436257 (Rev. A)