LATITUDE ™ NXT LATITUDE NXT Patient Management System - IFU 51556790

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE

The LATITUDE NXT System is intended to remotely communicate with a compatible Boston Scientific implanted device and transfer data to a central database. The LATITUDE NXT System provides patient data that can be used as part of the clinical evaluation of the patient. 

CONTRAINDICATIONS

The LATITUDE NXT System 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 NXT System. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.

WARNINGS 

None Known.

PRECAUTIONS

The clinician needs to log onto the LATITUDE NXT website in order to receive Alerts. Alerts may appear on the LATITUDE NXT website as often as daily. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. Although secondary notifications through email and Short Message Service (SMS) text messages are available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the LATITUDE NXT website. 

Implanted device data and Alerts are typically available for review on the LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to 14 days may elapse before the LATITUDE NXT server detects these conditions and the LATITUDE NXT website informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following: 

• There may be system limitations. (See "System Limitations" on page 1-3.)
  
• The Communicator is unplugged.
• The Communicator is not able to connect to the LATITUDE NXT server through the configured method of connection.
• The implanted device and the Communicator cannot establish and complete a telemetry session.
• The Communicator is damaged or malfunctions.
• The patient is not compliant with prescribed use or is not using the LATITUDE NXT System as described in the Patient Manual.
  

The clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List page. (See Figure 2–4 View Patient List Page on page 2-8.)  

CAUTION

Ensure that each patient's alert configuration settings are appropriate when the patient is enrolled and, if applicable, after the implanted device is replaced.  

CAUTION

The maximum weighing capacity of the optional weight scale is 200 kg (450 lb). Do not place anything on the scale that is beyond the weighing capacity 

POTENTIAL ADVERSE EFFECTS

Patients may also experience psychological effects of anxiety related to remote patient monitoring. 

SYSTEM LIMITATIONS

The LATITUDE NXT System is not intended to assist with medical emergencies. Patients who are not feeling well should call their physician or emergency services number.Do not utilize remote monitoring to replace in-person, non-device clinical evaluation. Changes in patient condition may be missed as a result of reduced patient contact.LATITUDE provides limited information about the patient and should not be relied upon to confirm the overall health of the patient. The LATITUDE NXT System does not provide continuous monitoring. As a remote monitoring system, the LATITUDE NXT System provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of implanted device, sensor, and patient information as intended by the clinician. These factors include:implanted device clock; patient environment; cellular data service; telephone system; communicator memory capacity; clinic environment; schedule/configuration changes; or data processing.

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