Cortrium C3+ User manual

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Instructions for Use
and Technical Documentation

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Instructions for Use and Technical Documentation 1
1. Introduction 3
1.1 Intended use 3
1.2 Patient target group 4
1.3 Intended users 4
1.4 Additional software 4
1.5 Additional hardware 4
2. Safety information 4
2.1 Notes on proper C3+ use 4
2.2 Warnings 5
2.3 Contra indications and undesirable side effects 5
3. Device description 6
3.1 Included components 6
3.2 Accessories 6
3.3 Device layout and light 6
3.4 Interfaces 7
3.5 Button presses 8
3.6 LED light notifications 8
3.7 Package and device symbols 8
4. User instructions 10
4.1 Installation of C3+ Cortrium software 11
4.2 How to start a recording 11
4.3 After Use 13
4.4 Charging 13
4.5 Cleaning 13
4.6 Frequently asked questions 14
5. Maintenance, Storage and Disposal 14

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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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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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●The data recorded by the C3+ can only be used to diagnose heart-related diseases such as
atrial fibrillation and arrhythmias when reviewed by a properly trained healthcare
professional (e.g. a cardiologist).
2.2 Warnings
●Do not use C3+ before reading this manual and manual for ECG electrodes.
●Do not use C3+ without cleaning it according to instructions between patient uses.
●Do not use C3+ without preparing device as described in this document between patient
uses.
●Do not allow patients to interact with the C3+, unless when directly instructed by a
healthcare professional.
●Do not wear the C3+ in the shower.
●Do not touch the electrode connections while the USB cover is removed.
●Do not give the C3+ to a user or patient, without the USB cover being properly closed.
●Do not touch patient and C3+ simultaneously while C3+ is charging.
●Do not use the C3+ during MRI scans.
●Do not use the C3+ with a defibrillator.
●The C3+ cannot detect pacemaker pulses.
●Do not expose the device to strong sources of static electricity or electromagnetic fields.
●Do not leave C3+ on top of or next to other electrical equipment.
●Do not use C3+ with cables different than the one provided by Cortrium.
●Do not submerge the C3+ in liquid.
●Do not clean the C3+ with agents other than those listed in the cleaning instructions in this
manual.
●Do not damage the C3+ through drops, violent shaking or crushing.
●Do not use the C3+ on patients with highly sensitive skin or known skin-related allergies.
●Do not use the C3+ on breached skin.
●Do not use the C3+ on patients below 10 kilos of body weight.
●The C3+ is not a toy. Usage on children should be under strict supervision of adults.
●Do not put C3+ into mouth under any circumstances.
●Do not alter the C3+. Any modification of the C3+ is strictly prohibited.
2.3 Contra indications and undesirable side effects
●The C3+ device should not be used for patients that have, life-threatening conditions that
could result in immediate danger.
●The C3+ should not be used on breached skin.
●ECG electrodes may cause a patient’s skin to react with irritation or reddening. Consult
information provided with the electrodes for more information.
●As an end user, in case of side effects please consult your physician.

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3. Device description
The following section describes the features of the C3+, accessories and accompanying information.
3.1 Included components
The C3+ comes with the following included in the package:
●The Cortrium C3+ Holter Monitor
●A micro-USB cable for charging and data extraction
●Short manual with reference to Instruction for Use and Technical Documentation (this
document) also found on www.cortrium.com/manuals/
3.2 Accessories
The C3+ requires the following to function as intended:
●Three third-party ECG electrodes per patient use (not supplied with device)
●The software tools found on www.cortrium.com
3.3 Device layout and light
The C3+ has three connectors for ECG electrodes, a single button at the center as well as an LED
indicator. A USB port can be found on the back of the device.
The button is used to start recordings and to log patient events in the C3+’s internal memory as well
as connect the device via Bluetooth and turn the device off.

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Front
Back
The C3+ Holter Monitor front.
Button and light location shown.
USB-port cover location shown.
The device has three electrode connectors.
C3+ Recordings are stored in an internal memory. Recordings can be transferred and removed from
the device via the device’s micro-USB port, when interfaced with the Cortrium software tools. The
C3+ contains a non-replaceable, rechargeable Lithium battery.
The C3+ is recharged via the device’s micro-USB-port.
3.4 Interfaces
The C3+ is intended to interface with a PC using the accompanying USB-cable, and iOS mobile
devices using Bluetooth.

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3.5 Button presses
Press
pattern
Meaning
Single press
Turn on / Mark event
Double press
Activate Bluetooth
Long press
(3 seconds)
Turn off
(Note: Device must not have connection to body)
3.6 LED light notifications
Color
Light
pattern
Meaning
Green
Slow:
Fast:
Constant:
Recording in progress
Turning ON / Event button pressed
Fully charged
Blue
Slow:
Fast:
Streaming Bluetooth
Pairing with Bluetooth
Yellow
Slow:
Fast:
Constant:
Memory full
Low battery / Turning off
Charging
White
Fast:
Constant:
Lead OFF detected, C3+ does not have proper contact
to body.
Error. Contact Cortrium or supplier
3.7 Package and device symbols
The following symbols are found on the C3+ package and device label.

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Device label example
Symbol
Description
Manufacturer and Year of production
Temperature limitation / temperature range
5°- 40°degrees Celsius (while operating)
-25°- 70°degrees Celsius (while stored)
Pressure limitation
700 - 1060 mBar
Humidity limitation
10% - 95%
Serial number (Device ID)
Reference number

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Refer to instructions for use
General warning sign
Refer to warning section
Protected against solid foreign objects
(degree 5-dust protected)
Protected against ingress of water
(degree 4-protected against splashing water from any
direction)
Type BF applied part
Medical Device
Recycle: Electronic equipment
CE mark with notified body identification number
Company logo with name
4. User instructions
The following section describes how to properly prepare and use the C3+.