Frequently Asked Questions

FAQs

Use & Application

CardioSecur Active is a clinical quality, mobile ECG system for private use. It serves not only to anaylse the rate and rhythm of the heart, but also to detect circulation disturbances such as infarctions (heart attacks). A 15-lead ECG is recorded using only 4 electrodes. Based upon the comparison of your ECG reading to your previously recorded reference ECG, you receive a personalised analysis and a recommendation to act.

CardioSecur Active provides you with immediate feedback about what to do when certainty of your heart is needed.

You also have the option to share your ECG report directly with your physician.

The entire sytem is composed of a 50g-light CardioSecur cable, the CardioSecur Active app, and your own smartphone or iPad.

Learn here if your device is compatible. 

Using CardioSecur is extremely easy. Receive an ECG analysis, with validity comparable to that from your physician, in just three steps.

To start, record a reference reading (reference ECG) at a point in time when you are free of symptoms. This personalizes your device. Each subsequent reading will be compared with this reference ECG. If changes are present between the two ECGs, you receive a recommendation to act. You also receive an ECG report for each recording, which is saved in your app.

Learn detailed information about the use of CardioSecur under “How it works.” 

Attach the CardioSecur Active electrodes as depicted:

  • White electrode: upper end of the sternum (on the bone)
  • Yellow electrode: lower end of the sternum (on the bone)
  • Red electrode: middle of the right axillae at the height of the lower end of the sternum (same height as the yellow electrode)
  • Green electrode: middle of the left axillae at the height of the lower end of the sternum (same height as the yellow electrode)

Please note: correction positioning of the electrodes is key to recording a meaningful ECG. 

Diagram of the adhesive electrode attachment sites
Four electrodes are attached to the upper body before starting a reading.

CardioSecur Active is mostly used for the quick and easy clarification of unclear symptoms and for prevention of life-threatening acute events.

In the setting of a known diagnosis, regular control readings can also detect non-symptomatic events and prevent damage to the heart (e.g. heart attack, stroke).

For more information about specific situations, visit our site “When to use“.

You have two options:

a.     You can link with your physician directly in the app if he has already created a free CardioSecur physician account.

b.     You can display your ECG on the screen of your smartphone when you are with your physician, or you can send or print your ECG.    

An ECG is as individual as a fingerprint and changes only when pathologic reasons for this are present. It is therefore possible to use the comparison between a reference reading and a future control reading to detect detailed changes of the heart early. It is also for this reason that the guidelines from cardiac societies recommend serial (comparison) ECG readings.

After each CardioSecur reading, one of three possible recommendations to act is derived and presented in the app:

a.  No changes: No action required. (neutral)

b.  Minor changes: Physician evaluation is recommended. (yellow)

c.  Significant changes: See a doctor instantly. (red)

If symptoms last longer than twenty minutes, cardiac guidelines recommend seeking medical attention, independent of of your CardioSecur recommendation to act. 

Depiction of the recommendations to act after a reading
Immediately seek medical attention or not? You receive a recommendation to act immediately after your reading.

 

Technical Details

CardioSecur Active is an approved class IIa medical product with the CE mark valid throughout Europe. CardioSecur is currently the only device worldwide that can record 15 leads with only 4 electrodes, thereby allowing for analysis of the posterior wall of the heart (which is recommended by the guidelines from European societies). CardioSecur’s ECG technology provides diagnostic results comparable with the ECG technology in hospitals, clinics, or physician’s practices. This has been shown in numerous studies. Therefore, in addition to many private users and physicians, clinics such as the Charité in Berlin, Uniklinik Hamburg, and Uniklinik Heidelberg all use CardioSecur.    

Apple:

CardioSecur Active is available for devices with iOS 8.0 or higher.

Compatible with:

iPad 3, iPad 4, iPad Air, iPad Mini 2, iPad Mini 3, iPad Mini 4, iPad Pro 1, iPad Pro 2

iPhone X, iPhone 8, iPhone 8 Plus, iPhone 7, iPhone 7 Plus, iPhone 6S, iPhone 6S Plus, iPhone SE, iPhone 6, iPhone 6 Plus, iPhone 5, iPhone 5S, iPhone, 5C, iPhone 4S

Android:

CardioSecur Active is available for devices with Android 4.0 or higher. CardioSecur Active requires support from OTG (USB On the Go). CardioSecur is not compatible with Android tablets.

Compatible with:

  • Samsung: Galaxy S8, Galaxy S8 Plus, Galaxy S7, Galaxy S7 Edge, Galaxy S6, Galaxy S6 Edge, Galaxy S5, Galaxy S5 NEO, A5 (2016, 2017), Galaxy S4, Galaxy S3 (NOT available for Samsung Galaxy Mini smartphones)
  • Huawei: P9, P9 Plus, Mate S
  • Vodafone: Smart platinum 7, Smart prime 7, Smart ultra 6
  • Sony: Xperia X, Xperia compact Z3, Xperia Z2
  • Google: Google Nexus 5, Pixel 1, Pixel 2
  • LG: LG G3
  • HTC: HTC One M8

The list is not all-inclusive, as we cannot regularly test every Android device available on the market.

If your device is not listed, please check if OTG is supported. With OTG support, your device should be compatible.

Given the possibility for reclamation for private users, you can easily and risk-free test the compatibility of your device. You can also send us an email inquiry to find out if your device is suitable: info@cardiosecur.com

Yes, CardioSecur can also be used offline. No matter where you are, you can record an ECG at any time and receive automatic feedback within the app.

A network connection is required to synchronise your user account. Readings that are recorded when offline will be synchronized as soon as you have an internet connection.

On your mobile device: your data is stored in your CardioSecur Active app. The number of ECGs that you can save is depenent upon the storage capacity of your smartphone, and is limited to 10,000 readings.

In your user account: when you are logged in to the app, your ECG readings are synchronized with your user account. The data are saved on secure, proprietary servers, which are physically located in Germany. The servers are regularly audited as part of CardioSecur’s approval as a medical system (according to DIN EN ISO 13485). The management of the data is subject to the strictest data protection regulations (according to the BDSG) and the new EU GDPR (General Data Protection Regulation) for data with special protections (e.g. medical data).

To ensure additional data security, your personal and health data are transmitted separately from each other during the encrypted transfer to the server. Matching your data to your identity is therefore not possible.

While a standard ECG records only 12 leads, with CardioSecur Active you receive a personalised ECG with 15 leads. It is through the extra leads that additional areas of the heart, such as the posterior wall, are also included when evaluating for infarctions and complex arrhythmias.

Leads I, II, III, aVR, aVL, aVF, V1-V6 and the additional V7-V9 are recorded.

Horizontal plane with the measured CardioSecur ECG leads
How CardioSecur records an ECG: The various ECG leads in the horizontal plane.

By synchronizing your account, your ECG data is backed up twice –once on your smartphone, and once in your user account on the server. If you lose your smartphone, you do not lose your data.

Synchronization also offers the possibility to connect with a registered physician through the app so that your ECG data are made available to him.

Please note: synchronization from iOS to Anroid is currently not possible.

 

Purchase and Delivery

You can orer CardioSecur easily from our online shop and we will deliver it to your desired address. Obtain CardioSecur for €99,- (once) + €9,95/month (monthly cancellable with a one month notification period).    

  • Credit card (VISA, MasterCard)
  • PayPal
  • Direct debit (only possible for German bank accounts) 

CardioSecur is approved as a medical device in all european countries. The app is currently available in the following languages:

  • German
  • English
  • French
  • Spanish
  • Italian
  • Dutch

According to law, as a consumer you have the option to revoke your online purchase up to 14 days after the date of delivery. You are responsible for paying the costs for the return of goods. In order to receive a refund, the goods must be functioning and in flawless condition. The original packaging does not need to be intact.    

Under the framework of an integrated care contract (ICC), health insurers will cover the costs of CardioSecur for certain conditions.  It is necessary that your physician (interventional cardiologist or internist) is also enrolled in the program, as CardioSecur can only be issued by physicians as specified by the ICC.

More information about current cooperations with health insurers and and physicians is available here.

 

Troubleshooting. What happens when…

  • Always use fresh, compatible electrodes (wet gel adhesive electrodes). Be sure to check the expiration date.
  • When possible, record a reading when undressed
  • Do not apply cream to the skin
  • Keep your distance from possible electronic disturbances (e.g. monitors, dimmers, kitchen devices, etc.)
  • Sit and breathe calmly and regularly
  • Do not speak or cough
  • Check the electrode positioning

CardioSecur complies with the standard for lectromagnetic compatibility (IEC60601-1-2.2001) for electronic devices in regard to immunity as well as emissions. Nevertheless, you should still take special precautions when using CardioSecur. Do not use devices near CardioSecur that generate strong electric or electromagnetic fields. It is recommended to keep a minimum distance of 2 meters. Distances of less than 2 meters may lead to device malfunction, which may result in distortion of the ECG line.    

CardioSecur Active differentiates between the reference and control reading. The reference reading, recorded when setting up the system, requires correct placement of the colored electrodes as shown in the app. For subsequent control readings it is possible to switch the colored electrodes. The CardioSecur technology recognizes switching of the electrodes and corrects this mistake in its analysis, without the need to reposition the electrodes. In an emergency, you save valuable time.    

Diagram of the adhesive electrode attachment sites
Four electrodes are attached to the upper body before starting a reading.

If your app is not working, please follow the steps below in the order listed. If your app is still not functioning after performing step 1, move on to step 2.

1.      Close the app and restart it. Merely „hiding“ the app is not sufficient.

2.      Turn your device off and restart it.

3.      Download the newest version of the CardioSecur Active app.

4.      Update the operating system of your smartphone.

If your app works to the point that you are able to view the main menu, please ensure that you are logged in with your user account and that your synchronization is activated (menu – settings – user account).

Typically, pacemakers function either below a minimum or above a maximum heart rate. This means that the pacemaker starts to pace the heart when it is beating outside of the normal range. ECG curves with or without a pacemaker look completely different. For CardioSecur, reference ECGs and control ECGs can be recorded with a pacemaker.  When interpreting results one must take into account if the reference ECG was being paced or not. If both ECGs are not the same (both paced or both not paced), false alarms can present.

The following decision tree can help to understand this:

1.      Reference ECG = normal ECG

Control ECG = normal ECG : normal comparison

Control ECG = pacemaker ECG : Red alarm

2.      Reference ECG = pacemaker ECG

Control ECG = normal ECG : red alarm

Control ECG = pacemaker ECG : normal comparison    

 

About the heart

In order to prevent damage to the heart from a heart attack, immediate treatment the moment symptoms arise is essential (the “golden hour”).

In the following video, Cardiologist Dr. Glenn van Langenhove explains how using CardioSecur Active can save lives.

 

Download the user handbook here.

 

 

Do you have questions?

Contact us via email:

info@cardiosecur.com

…or via Phone:

Monday-Friday
between 9:00 a.m. and 5:00 p.m.

 

Personal MedSystems GmbH
Wilhelm-Leuschner-Str. 41
60329 Frankfurt am Main

Here for you: the CardioSecur Customer Support team