C3+ IFU - 0723 01140 (70048) UK Page 3 of 18
5.1 Maintenance 14
5.2 Storage 14
5.3 Warranty 15
5.4 Disposal 15
6. Technical and Regulatory information 15
6.1 Technical specification 15
6.2 Regulatory information 16
6.3 Serious Incidents 17
6.4 Declaration of conformity 17
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 (Manual for Mobile
app can be found on www.cortrium.com).
Data recorded by the device can be analysed 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.
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