User's Manual

14 English SEEQ MCT Instructions for use
M958549A001 Rev B
Refer to doc # A73903 for Printing
Instructions.
M958549A_ch.fm 3/12/15 2:34 pm
4" x 8" (101 mm x 203 mm)
Medtronic Confidential
mdvtldct_R1.5
Indications for use, contraindications, and
precautions
Indications for use
The SEEQ Mobile Cardiac Telemetry (MCT) System is intended to
continuously measure, record, and periodically transmit physiological
data. The System is indicated for those patients who require
monitoring for the detection of non-lethal cardiac arrhythmias such
as, but not limited to, supraventricular tachycardias (for example,
atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy,
bradyarrhythmias, and conduction disorders. The SEEQ MCT
System monitors, derives, and displays the following: ECG, and Heart
Rate.
Description of the system
The SEEQ MCT System consists primarily of the Wearable Sensor
monitoring device and the Transmitter data transmission device.
Once activated, the Wearable Sensor continuously monitors the
heart and automatically collects ECGs. When rhythm abnormalities
are detected, data is automatically transmitted from the Wearable
Sensor to the Transmitter, which then automatically transmits the
data to the Medtronic Monitoring Center. Patients can also trigger
transmission of ECGs when they experience cardiac symptoms by
using the Patient Trigger Button. Certified cardiographic technicians
at the Medtronic Monitoring Center review received data and
document symptoms reported to the Medtronic Monitoring Center by
patients. Reports prepared by the Medtronic Monitoring Center are
delivered to the prescribing physician and made available to them at
www.medtronic.com to provide them with data for their diagnosis and
identification of various clinical conditions, events and/or trends.
Based on the indications, the SEEQ MCT System may be used
for the following:
▪ patients who require monitoring for suspected or known,
non-life threatening arrhythmias
▪ patients with symptoms such as chest pain, syncope, light-
headedness or near syncope, vertigo, dizziness, fall,
palpitations, transient ischemic episodes, and dyspnea
(shortness of breath) that might be due to cardiac arrhythmias
▪ patients with cardiac arrhythmias associated with co-morbid
conditions
▪ obtaining correlation of rhythm with symptoms when symptoms
have unknown etiology
▪ evaluating possible arrhythmias in a) patients recovering from
cardiovascular or thoracic surgery; b) survivors of myocardial
infarction; c) patients with diagnosed sleep disorder breathing
▪ evaluating benefits after initiating or discontinuing
pharmacological therapy (for example, anti-arrhythmic,
beta-blocker, anti-coagulation therapies).
▪ assessing the results of an ablation procedure for an
arrhythmia