MIR Cardionica User manual

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USER MANUAL
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English
USER MANUAL
Thank you for choosing
a MIR - Medical International Research - product
Keep the original packaging!
If your product has a problem, use the original packaging to ship it back to your local distributor
or the manufacturer.
Follow the rules below to return the product for repair:
•ship the product in its original packaging;
•shipping costs are borne by the sender.

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Manufacturer’s address:
MIR–Medical International Research S.p.A.:
Viale Luigi Schiavonetti 270
00173 ROMA (ITALY)
Tel ++ 39 0622754777
Fax ++ 39 0622754785
Website: www.spirometry.com
Email: [email protected]
MIR pursues an improvement policy to continuously evolve the technology of its products.
That’s why MIR reserves to update these user instructions if needed. Please email any suggestions
to: [email protected].
MIR cannot be held responsible for any damage caused by users failing to follow these instructions
and/or the warnings contained in this manual.
Please note that, due to printing limitations, the images contained in this manual may differ from
the actual device. It is prohibited to copy this manual in whole or in part.
TERMINOLOGY USED IN THIS MANUAL
WARNING: Indicates a potentially hazardous situation that could result in severe injury
if not prevented.
CAUTION: Indicates a potentially hazardous situation that could result in minor or moderate
injury if not prevented.
ATTENTION: Indicates caution when using and servicing the device to prevent failures.

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SUMMARY
1. CONTENT DESCRIPTION ............................................................................................................4
2. INDICATIONS FOR USE ..............................................................................................................5
3. COUNTERINDICATIONS .............................................................................................................6
4. SAFETY PRECAUTIONS ..............................................................................................................6
5. CLEANING, STORING, AND SERVICING THE DEVICE....................................................................7
5.1 REPLACING THE BATTERY..................................................................................................8
6. WARNINGS ...............................................................................................................................9
7. USING CARDIONICA ................................................................................................................10
8. USING CARDIONICA VIA APP...................................................................................................16
9. POSITIONING CARDIONICA ON THE CHEST..............................................................................19
10. INDICATORS (ATRIAL FIBRILLATION, NORMAL HEART RATE, NON-INTERPRETABLE
RECORDING).................................................................................................................................20
11. WHAT TO DO IF CARDIONICA DETECTS ATRIAL FIBRILLATION .................................................22
12. DATA SECURITY WARNINGS....................................................................................................22
13. DISPOSAL................................................................................................................................23
14. TROUBLESHOOTING................................................................................................................23
15. TECHNICAL SPECIFICATIONS....................................................................................................24
16. APPLICABLE REGULATIONS .....................................................................................................25
17. SYMBOLS USED.......................................................................................................................26

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1. CONTENT DESCRIPTION
1 device, 1 CR2032 battery, 2 reusable electrodes, 1 user manual.
Description of product
Cardionica is a device for detecting atrial
fibrillation from a single-lead
electrocardiogram (ECG). Cardionica uses
a CR2032 battery
Cardionica is placed on the chest through
an adhesive electrode.
A. Device
B. Reusable electrode for personal use
C. Green light indicator: presence of sinus
rhythm (normal)
D. Orange heart indicator: presence
of bradycardia or tachycardia
E. Red light indicator:
presence of atrial fibrillation
F. Orange light indicator (repeat):
impossible to make a diagnosis.
Repeat the measurement
G. Power switch
H. Battery hatch

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Cardionica records a 1-minute single-lead electrocardiogram. At the end of the recording, it provides
the results through the light indicators.
When the green indicator lights up, it means that Cardionica has not detected
atrial fibrillation.
When the red broken heart indicator lights up, it means that Cardionica has
detected atrial fibrillation
When the orange indicator (repeat) lights up, it means that the electrocardiogram
cannot be done. Repeat the measurement
The orange heart indicator lights up when the device has not detected atrial
fibrillation but the heart rate is below 50 beats per minute or above 100 beats per
minute.
Cardionica can be used by adults as a screening method for atrial fibrillation, people with an atrial
fibrillation history, or people with symptoms like palpitations and tachycardia to periodically check
the presence of atrial fibrillation.
WARNING:
Cardionica detects only atrial fibrillation. It does not detect other life-threatening arrhythmias.
The atrial fibrillation detector checks the presence of fibrillation only during the recording. It does
not monitor the heart activity continuously. Therefore, it cannot warn you if you experienced atrial
fibrillation in the past or will do in the future.
2. INDICATIONS FOR USE
Cardionica records, stores and transfers a single-channel electrocardiographic (ECG) trace. Cardionica
also displays the result of ECG analysis, detecting the presence of normal sinus rhythm, atrial

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fibrillation, bradycardia, tachycardia and more. Cardionica can also display the ECG when used in
conjunction with a smartphone/tablet. Cardionica is intended for use by healthcare professionals,
patients with known or suspected heart disease and health-conscious individuals. The device has not
been tested and is not intended for paediatric use.
3. COUNTERINDICATIONS
Cardionica must not be used in the following cases:
•children and pregnant women.
•patients with implanted pacemakers or defibrillators.
The electrode must not be used in the following cases:
•patients with known allergies to adhesive materials or hydrogels.
•In the presence of wounds, injury, or irritated skin on the application area.
4. SAFETY PRECAUTIONS
WARNING:
•This device must not be used near water or in a humid environment
•Do not use this device in places where temperature and humidity do not fall within
the range indicated in the product’s label.
•Do not sterilise the device.
•Audio, video, and similar electronic equipment can interfere with Cardionica’s operation.
Stay away from this equipment during the recording.
•Do not record in places where the device is exposed to intense electromagnetic fields,
e.g., near arc welders, high-power radio transmitters, etc.
•Do not make sudden movements or record from moving vehicles.
•Do not expose the device to strong impact or vibrations.
•Do not dismantle, repair, or modify the device.
•Do not record if the electrodes are dirty or have lost adhesion.
•Do not use the device for purposes other than those indicated in this manual.
•The recordings may fail if the electrode is applied to an area with a large amount
of fat, hair, or dry skin.
•Use the device only on intact skin.

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5. CLEANING, STORING, AND SERVICING THE DEVICE
Cardionica doesn’t need to be disinfected. Clean Cardionica when needed using a damp cloth and
soap.
WARNING: do not use the same electrodes on different persons to prevent cross-infection
and disease transmission between users
Store Cardionica and its accessories in its case, avoiding:
•Places exposed to direct sunlight
•Places subject to high temperature or humidity
•Next to fire or naked flame
•Places exposed to strong vibrations
•Places exposed to intense electromagnetic fields.
WARNING
This system doesn’t need maintenance. However:
Before every use, check the condition of the electrodes. Replace the electrode if dirty or has lost
adherence.
Do not use the same electrodes on different persons to prevent cross infection and disease
transmission between users.

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5.1 REPLACING THE BATTERY
Replace the battery when you hear the low battery signal upon activation:
1. Remove the battery hatch by rotating it anticlockwise while pressing it firmly
2. Remove the battery and replace it with a new cr2032 3v button battery.
3. Face the positive terminal upwards so you can read the code. Remove the protective adhesive
from the battery (if present)

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4. Close the hatch. Remember that the battery hatch can be inserted only from one side and must
be rotated.
6. WARNINGS
•Cardionica does not provide a complete diagnosis of cardiac conditions. It must never be
used as a base for starting or modifying the therapy without consulting the physician.
•This device does not analyse all heart rate and cardiac waveform aspects, especially
if related to ischemic conditions.
•Do not make a diagnosis or prescribe or change a therapy based only on the analysis results.
Self-diagnosis and self-treatment can compromise health.
•Users can always consult their physician if they notice health changes.
•Do not use the device in the presence of flammable anaesthetics, medicines, or pressurised
oxygen (e.g., in a hyperbaric chamber, ultraviolet steriliser, or an oxygen tent).
•Do not use this device during MRI exams, medical or aesthetic treatments involving
electromagnetic fields.
•Keep the device out of reach of children and persons unable to use it properly.
•This device has not been tested and it is not intended for pediatric use.
•Do not use defibrillators on patients wearing a sensor. The sensor is not protected from
defib discharges. Defibrillators can cause sensor malfunction and injure the patient.
•Communication devices, such as mobile phones, WIFI systems, or portable radio
transmitters can interfere with Cardionica’s operation. These devices must stay at least
30 cm away from Cardionica when in use.

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WARNING:
Cardionica cannot ensure that no arrhythmias or other health problems occur when an ECG
is labelled as normal. Immediately inform the physician about your possible health changes.
WARNING:
Report any serious accident involving the device to the manufacturer and the competent authority
where the user/patient is established;
7. USING CARDIONICA
1. Open the box and check its content.
Contact MIR if the content differs from
the list in section 1.
2. Apply one of the supplied electrodes
to Cardionica without removing
its protective film.

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3. Remove the protective film only after having
applied the electrode to Cardionica.
4. Sit down and apply Cardionica to the chest.

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5. Make sure that the electrode adheres
to the skin.
6. If necessary, clean the skin using a cloth
dampened with ethyl alcohol.
7. To ensure correct positioning, follow the instructions provided in section “Positioning
Cardionica on the chest”.

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8. Press the button and wait for the exam
to be complete.

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9. Remove Cardionica from the chest when
you hear the buzzer. Watch the light
indicators .
10. Apply the protective film on the electrode
and and place Cardionica back into its case.
It is not necessary to remove the electrode
from Cardionica
WARNING:
Use only the electrodes indicated in this manual (see section 14. Technical Specifications).
Using electrodes other than those supplied or indicated in this manual can be a source of danger.
Contact the manufacturer if in doubt.

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ATTENTION: Always sit down when using Cardionica. Cardionica does not start the test if you
are lying down.
ATTENTION: if you always apply the protective film to the electrodes and use them correctly, they can
be used for 30 applications or stored for 6 months. Before every application, clean the skin with water
and soap. Before and after each use, Apply some water (not much) to the electrode’s adhesive part.
ATTENTION: replace the battery if you hear a sound that gradually fades when you press the button.
WARNING:
Do not use Cardionica in the presence of signs of damage. It can cause electrical discharges or
reduce the quality of the acoustic signals.

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8. USING CARDIONICA VIA APP
You can also use Cardionica on your smartphone or tablet.
Download the Cardionica app (developed by MIR)
from Play Store (Android 5.0 onwards), or Apple
Store (iOS 9.0 onwards). You cannot install the app
on incompatible devices.
Start the app, press Cardionica’s power switch and
make sure that it’s connected to your smartphone.
Use the ECG start tab on the app or Cardionica’s
power switch
During the test, you can see the ECG tracing, heart
rate, and the remaining seconds

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The app also allows you to stop the test by scrolling
upwards and clicking the “Stop Test” button
Once the ECG recording is complete, the app
displays the result with the same indicators
described in section 8. The test result is also
displayed on the device. The app shows the heart
rate in beats per minute (bpm). It also allows you
to add symptoms (if any) and notes
Furthermore, you can view the list of tests made
by clicking the “Results” tab
By clicking a test, you can view the tracing

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Another option is to associate a name to the
tracings by clicking the settings icon .
WARNING
If the device is used on different persons,
it’s important to associate its name to the exam
to prevent identification errors.
If the device has a low battery, the app displays the
“low battery” message

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9. POSITIONING CARDIONICA ON THE CHEST
Correctly position Cardionica on the chest to have reliable measurements. Refer to the positions
shown below:
WARNING:
Using Cardionica in different positions from those indicated can affect the test result.

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10.INDICATORS (ATRIAL FIBRILLATION, NORMAL HEART RATE,
NON-INTERPRETABLE RECORDING)
Cardionica provides an interpretation of the heart rate through a code and a buzzer, as described
below:
The red heart indicator lights up if Cardionica detects atrial fibrillation in the ECG
tracing (irregular heart rate and no P waves)
The orange heart indicator lights up when the Cardionica has not detected atrial
fibrillation in the ECG tracing but has measured a heart rate lower than 50 bpm
or higher than 100 bpm.
The orange indicator (repeat) lights up when Cardionica fails to interpret the ECG
tracing.
This problem could be due to:
•Poor contact between the electrodes and skin.
The most common causes are:
oHair abundance.
oDirty electrode or no longer adherent.
•Incorrect position of Cardionica on the chest
•The person has moved while using Cardionica
•Presence of other arrhythmias.