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1. Introduction
This is the manual for the C3+Holter Monitor (referred to as the “C3+” from here on). The C3+is an
ambulatory ECG recorder, which can record three channels of ECG for up to 7 days continuously.
The C3+is attached directly to a patient’s torso using three third-party ECG electrodes. This manual
contains all the information required to safely use the C3+.
1.1 Intended use
The C3+is an ambulatory ECG recorder, intended for recording three-channel ECG for up to 7 days.
The C3+is intended for use in both healthcare and home environments. During use, the C3+
continuously records and stores ECG signals and motion data directly in the internal memory.
Additionally, the C3+has a built in Bluetooth module for streaming live data to a mobile app in order
for the healthcare personnel to visually verify signal quality of the ECG.
Data recorded by the device can be analyzed by other processing software to provide reports.
This software can be either third party or designed, maintained and/or owned by Cortrium.
The C3+hardware has no capacity for automatic ECG analysis and consequently no capacity for
automatically generating alerts to potentially critical cardiac conditions.
Cortrium C3+is intended for adult and pediatric patients (above 10kg) who require ECG monitoring.
The C3+can be used on patients wearing an implanted pacemaker, but the C3+does not detect
pacemaker pulses (see Warnings section).
Final interpretation and diagnosis is the responsibility of a trained physician.
