Introduction; Intended Use And Indications For Use - ZOLL CMCT Monitoring System Instructions For Use Manual

1 INTRODUCTION

The CMCT System is a wearable, wireless system that is used to aid clinicians in the
diagnosis and identification of various clinical conditions, events and/or trends. It consists
of the CMCT wearable Sensor and Patch, a portable data transmission device (Gateway),
and a Charger. The Sensor unit continuously records and transmits ECG data to the data
transmission device, and from there to the ZOLL monitoring center. Other physiological
parameters such as thoracic impedance, heart rate, respiration rate, activity and posture
are recorded periodically and are also transmitted, via the data transmission device to the
monitoring center. Certified technicians at the ZOLL Monitoring Center review received
data and prepare clinical reports to the prescribing physician. The CMCT System is designed
for use in outpatient clinic and home settings for up to 30 days.
2 INDICATIONS FOR USE
The CMCT System is intended to continuously record, store, and transmit ECG, Heart Rate,
Activity, and Posture to medical professionals. The CMCT System also periodically records,
stores, and transmits Respiration Rate and Thoracic Impedance to medical professionals.
The CMCT System is indicated for patients who are 21 years of age or older:
i. Who require monitoring for the detection of non-lethal cardiac arrhythmias, such
as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial
flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction
disorders
ii. with fluid-management problems;
iii. taking diuretic medication;
iv. living with heart failure;
v. living with end-stage renal disease;
vi. recovering from a coronary artery disease-related event; and/or suffering from
recurrent dehydration.
CMCT Monitoring System
Instructions for Use
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