Corventis NUVANT Manual de instruções de utilização

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NUVANT

Mobile Cardiac Telemetry (MCT) System

Instructions for Use

Rx Only

FOLLOW THESE INSTRUCTIONS CAREFULLY AND WATCH YOUR

INSTRUCTIONAL VIDEO BEFORE USING NUVANT MCT

The NUVANT Mobile Cardiac Telemetry (MCT) System is a wearable, wire-

less arrhythmia detection system that is used to aid clinicians in diagnosing

suspected cardiac arrhythmias. It consists primarily of the PiiX

monitoring device, the zLink

Trigger Magnet to enable on-demand collection of ECGs (recordings of heart

rhythm). In combination with interpretation services provided by the Corventis

Monitoring Center, as well as secure online review of data (for prescribing phy-

sicians only), NUVANT MCT enables patient- and physician-friendly arrhythmia

detection for up to 30 days at a time.

How NUVANT MCT Works

Once activated, the wearable PiiX sensor continuously monitors the heart and

automatically collects ECGs when rhythm abnormalities are detected. Patients

can also drive collection of ECGs when they experience cardiac symptoms by

using the Patient Trigger Magnet. Data are automatically transmitted from the

PiiX to the zLink, which then automatically transmits the data to the Corventis

Monitoring Center. Certified cardiographic technicians at the Corventis

Monitoring Center review received data and document symptoms reported

by patients. Clinical reports, prepared by the Corventis Monitoring Center,

are delivered and made available at www.corventis.com to provide data to

prescribing physicians for the diagnosis and identification of various clinical

conditions, events and/or trends. Prescribing physicians may also be contacted

by the Corventis Monitoring Center directly when arrhythmias that meet pre-

defined criteria are detected.

IMPORTANT:

•

The NUVANT MCT System is not intended to be an alarm or to

alert patients or physicians, and will not summon emergency

response in the event help is needed.

•

The NUVANT MCT System is not intended to replace direct com-

munication with healthcare providers.

•

Data provided by the system should be used by physicians along

with all other clinical findings and exams to come to a diagnosis.

•

Patients should talk to their healthcare provider immediately if

there are any concerns or if their condition changes.

P01281-005 (05/13)

™

Customer Service:

USA: 1-877-247-PIIX(7449)

portable data transmission device and a Patient

wearable