Cortrium C3+ Guide

Instructions for use
and technical documentation

Cortrium C3+Holter Monitor Instruction for use and technical documentation
Ver.: 1.0 Rev.: 02 EN, Issue date: 2019-10-14

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1. Introduction 5
1.1 Intended use 5
1.2 Intended users 6
1.3 Additional software 6
2. Safety information 7
2.1 Notes on proper C3+use 7
2.2 Warnings 7
3. Device description 9
3.1 Included components 9
3.2 Accessories 9
3.3 Device layout and light 9
3.4 Interfaces 11
3.5 Button presses 11
3.6 LED light notifications 12
3.7 Package and device symbols 13

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4. User Information 17
4.1 Installation of C3+Cortrium Data Transfer Tool 17
4.2 How to start a recording 17
4.3 After use 20
4.4 Charging 21
4.5 Cleaning 21
4.6 Frequently asked questions 22
5. Maintenance, storage and disposal 23
5.1 Maintenance 23
5.2 Storage 23
5.3 Warranty 23
5.4 Disposal 23
6. Technical and regulatory information 24
6.1 Technical specification 24
6.2 Regulatory information 26
6.3 Declaration of conformity 27

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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.

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1.2 Intended users
The C3+is not a consumer product. It is intended solely to be used by qualified health care
personnel and thoroughly instructed patients.
1.3 Additional software
The C3+is intended to be used with the Cortrium Data Transfer Tool software tool found at
www.cortrium.com
Cortrium Data Transfer Tool is required to prepare the C3+for use on patients and for extracting
recordings after use. Instructions for Cortrium Data Transfer Tool can be found at www.cortrium.com
Further, the C3+is compatible with the CE marked 3rd party software CUBE by Cardioline, and CE
marked software Cardiomatics. Additionally it is possible to export data as EDF using Cortrium Data
Transfer Tool.

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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 the Cortrium Data Transfer Tool 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.
• 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).
• ECG electrodes (not supplied by Cortrium) may cause a patient’s skin to react with irritation
or reddening. Consult information provided with the electrodes for more information.
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.

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• Do not allow patients to interact with the C3+, unless when directly instructed by a healthcare
professional.
• 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.

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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
• Instructions for Use and Technical Documentation (this document)
• Short manual
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 Cortrium Data Transfer Tool software 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 Data Transfer Tool
software. The C3+contains a non-replaceable, rechargeable Lithium battery.
The C3+is recharged via the device’s micro-USB-port.

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3.4 Interfaces
The C3+is intended to interface with a PC using the accompanying USB-cable and iOS mobile
devices using Bluetooth.
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)

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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

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3.7 Package and device symbols
The following symbols are found on the C3+package and device label.
Device label example

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Symbol Description
Manufacturer
Year of manufacture
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)

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Reference number
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
Recycle: Electronic equipment

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CE mark with notified body identification number
Company logo with name

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4. User instructions
The following section describes how to properly prepare and use the C3+.
4.1 Installation of C3+Cortrium Data Transfer Tool
Before using the C3+, download and install the Cortrium Data Transfer Tool from www.cortrium.com.
When the C3+is connected to a PC, the device will appear as a Mass Storage Device that can be
opened by Cortrium Data Transfer Tool.
4.2 How to start a recording
Before starting a new recording, make sure that the C3+is sufficiently charged as described in
section 4.5, and it has been setup for the intended recording using Cortrium Data Transfer Tool.

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1. Prepare Skin
- Shave all hair in the area where the
electrodes will be placed.
- Clean and abrade the skin with a cotton
swab and appropriate alcohol (denat.
80%).
2. Attach electrodes to each
electrode connector
3. Remove plastic from electrodes

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4 Attach device to patient
- Make sure the adhesive sticks properly to skin
- Make sure there is no air left between adhesive and skin
- Make sure that there is no hair underneath the electrode
- The dashed outline shows alternative placement of the C3+

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5 Start recording
- Press the button
- The green light will flash
- The C3+is now recording
4.3 After use
1. When recording has ended, remove the device from the patient
(patient may have done this already).
2. Detach ECG electrodes and dispose of them.
3. Connect the C3+to a PC via USB cable.
4. Extract recordings using Cortrium Data Transfer Tool.
5. Clean and store the C3+according to instructions in section 4.5 and 5.2.