C3+ IFU - 0723 01140 (70048) UK Page 4 of 18
1.2 Patient target group
Cortrium C3+ is intended for adult and paediatric 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 are the responsibility of a trained physician.
1.3 Intended users
The C3+ is not a consumer product. It is intended solely to be used by qualified healthcare personnel
and thoroughly instructed patients.
1.4 Additional software
The C3+ is intended to be used with the software tools found at www.cortrium.com
These software tools are required to prepare the C3+ for use on patients and for extracting
recordings after use. Instructions for the software can also be found at www.cortrium.com
Further, the C3+ is compatible with other approved CE marked 3rd party software. And it is
possible to export data as EDF using Cortriums’ software tools.
1.5 Additional hardware
The C3+ is intended to be used with 3rd party electrodes. These must be CE marked ECG
electrodes with a 4 mm snap connector, adhereing to IEC 60601-1 and ISO 10993
2. Safety information
The following is important information on how to use the C3+ properly and safely. Carefully read
this section before operating the C3+.
2.1 Notes on proper C3+ use
● The C3+ and Cortriums’ software contain no capacity for analysing the contents of ECG
recordings or providing diagnoses.
● The C3+ light patterns only reflect battery status and operation mode. The lights do not
reflect cardiac health in any way and should never be interpreted as an indication of patient
health.
● The C3+ is built to be operable by a healthcare professional. The patient should always be
walked through all required instructions before wearing the device.
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