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+.

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4.1 Installation of C3+ Cortrium software
Before using the C3+, download and install the software 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 the
software.
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 the downloaded software.
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+
5. Start Recording

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-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 Cortriums’ software tools.
5. Clean and store the C3+ according to instructions in section 4.5 and 5.2.
4.4 Charging
The C3+ automatically charges when connected to a standard USB charger or a PC via the USB cable.
The C3+ may charge slower when connected to a PC. NB DC supply voltage 4.75V - 5.5V. Any
charger used must be a certified charger complying with IEC 60601-1.
To charge, perform the following actions:
1. Remove any ECG electrodes attached to the C3+.
2. Connect the C3+ to a charger or PC with the USB cable. Never do this while user or
patient is in contact with the electrode connectors.
3. Maintain USB connection to the charger or PC until the light indicator turns continuously
green.
4.5 Cleaning
In order to protect patients against risk of cross-contamination, the C3+ should be cleaned and
disinfected in preparation for a new patient (sterilisation is not required).
To Clean
1. Apply a non-abrasive liquid soap to a clean soft cloth.
2. Wipe the C3+ thoroughly.
To Disinfect
3. Apply 70 % isopropyl alcohol to a clean soft cloth.
4. Wipe the C3+ thoroughly.

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DO NOT use abrasive cleaners or solvents such as acetone.
4.6 Frequently asked questions
1.1. How do I know that the battery of the device is fully charged?
The LED will be continuously green when C3+ is connected to a power source and fully charged.
1.2. Time and date of my measurement were wrong. How can I fix this problem?
The C3+ has an internal clock which compares itself to the clock on the PC, when preparing for a
new patient. If the time is incorrect, just setup the device for a new patient, and the device will
automatically set the clock to the same time as the PC.
1.3. Do I need software for downloading measurement data from the C3+?
Yes, as a minimum you need the intended software which can be downloaded from
www.cortrium.com.
1.4. My C3+ does not start, what might cause this problem?
If the battery is empty, the C3+ will not be able to start. Charge the device using the USB cable and
wait for the LED to turn green.
5. Maintenance, Storage and Disposal
5.1 Maintenance
The C3+ device contains no user serviceable parts, cannot be opened, and does not require routine
maintenance. If a problem with the C3+ is experienced, contact Cortrium or your local supplier.
Cortrium service contact:
Cortrium ApS - Erik Husfeldts Vej 7 - DK-2630 Taastrup - Denmark
email: [e-mail] - Website: www.cortrium.com
5.2 Storage
Do not store the C3+ in locations in which the device would be exposed to:
●Temperatures lower than -25° or greater than 70 ° Celsius
●Air humidity outside 10 - 95 %
●Heavy contamination from dirt or other foreign agents

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●Running water
●Strong electromagnetic forces
5.3 Warranty
The C3+ has a warranty of 2 years from the date of purchase.
5.4 Disposal
The C3+ should be decommissioned when it reaches the end of its service life. The C3+ should be
disposed of in accordance with the EU WEEE directive for electronic waste.1
6. Technical and Regulatory information
6.1 Technical specification
Technical
Type of ECG Recorder
Holter, ambulatory ECG
No. of Channels
3
Wear Time
Up to 7 days
Recording Format
Continuous
Power Requirement
Lithium Polymer, 3.7V, 520 mAh
Dimensions
85 x 80 x 15 mm
Weight
32 grams
Sampling Rate
256 Hz
Input Impedance
10 Mohm
Resolution
24 bit
Performance Standard
Design verification IEC 60601-2-47
Safety
Safety Standard
IEC 60601-1 Basic Safety & Essential
Performance IEC 60601-2-47
Biological
Medicinal Substances
N/A
Tissue
N/A
Body fluids contacted by device
N/A
Type of contact to intact skin
Non-invasive
Duration of skin contact
Up to 7days continued contact
Mucosal membrane contact
N/A
Sterile or non-sterile
Non-sterile
Biological compatibility
ISO 10993-5
ISO 10993-10
Clinical
Medical purpose
Ambulatory ECG
1DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on waste
electrical and electronic equipment (WEEE).

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Single use / reusable
Reusable/Rechargeable Monitor
Recording standard
Holter
Recording format
Continuous
Intended placement
Midsternal line
Recording period
Up to 7 days on a single charge
6.2 Regulatory information
The C3+ is a class IIa medical device according to 93/42/EEC. The C3+ complies with the following
product standards:
DS/EN 60601-1-1
Safety Requirements for Medical Electrical Systems
DS/EN 60601-1-2
Electromagnetic Disturbances
DS/EN 60601-1-6
Medical Electrical Usability
DS/EN 60601-1-11
Home Healthcare Environment
DS/EN 60601-2-47
Particular requirements for the basic safety and essential
performance of ambulatory electrocardiographic systems
DS/EN 62366-1
Application of usability engineering to medical devices
DS/EN ISO 10993-1
Biological evaluation of medical devices
DS/EN ISO 15223-1
Symbols to be used with medical device labels, labelling and
information supplied
DS/EN 1041
Information supplied by the manufacturer of medical devices
DS/EN 62304
Medical device software – software life cycle processes
DS/EN ISO 14971
Application of risk management to medical devices
EN 301 489-17 V3.1.1
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17
EN 300 328 V2.1.1
Wideband transmission systems; Data transmission equipment
operating in the 2,4 GHz ISM band

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6.3 Serious Incidents
In case of serious incidents in relation to the device, please contact your local competent authority as
well as Cortrium [email protected] without undue delay.
6.4 Declaration of conformity
The C3+ is in conformity with the essential requirements and provisions of the EU Medical Device
Regulation (MDR).2
2REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017.

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Cortrium ApS
•
Erik Husfeldts Vej 7
•
DK-2630 Taastrup
•
Denmark
Email: [e-mail] • Website: www.cortrium.com
Cortrium C3+ UDI 05745000379002