A Medical Device for long-term ECG data recording for General Practitioners and Cardiologists

Intended use

The auxilECG is an ambulatory ECG holter monitor device manufactured by latest German technology for the continuous measurement and digital storage of ECG signals –while the patient goes through his daily activities –as part of a long-term ECG recording. The recorded data is used to diagnose cardiac arrhythmias.

The recorded data is downloaded from the auxilECG device on to a PC in a medical facility and evaluated using a suitable Holter-ECG analysis software. A physician evaluates the normal and abnormal ECG data for further therapeutic measures.

Contraindications – The auxilECG must not be applied on an open heart.

SEE SAMPLE DATA

Device setup

Device removal and reporting

Specs

The auxilECG is a medical device for long-term ECG data recording with the following features:

  • Recording of usual 24h – 48h Holter ECGs.
  • No cables necessary, high-wearing comfort for the patient and low-effort for cleaning and disinfection.
  • Continuous recording of three ECG signals up from 9 days without changing the battery
  • Recording of three ECG signals up to 60 days by changing batteries and ECG electrodes.
  • Secure and simple download of data via the integrated USB interface
  • Bluetooth interface for patient-specific initialization of an ECG recording.
  • Easy application and removal of the adhesive electrode(s) via three snap buttons.
  • Support for event marking by the patient (e.g.in case of symptoms or medication).
  • Support of standardized ECG data formats such as MIT, ISHNE, EDF+

Highlight & Advantages

By using decentralised single-use electrodes in combination with sophisticated hardware and software, the auxilECG enables permanent recording of long-term ECGs well over 24h with an extremely high signal quality along with maximum patient comfort.

By eliminating cables – that were previously common – and due to the integrated intelligence, auxilECG requires almost no operational steps and thus enables (especially for ambulant applications with elderly patients) ECG recordings without affecting patients in their usual living conditions and quality of life. For the first time, this enables practical, efficient, and safe “round the clock” long-term ECG recordings. By simply changing the single-use electrodes and the battery, the auxilECG can be used as a long-term recorder for ECG recordings up to 60 days.

Advantages for the physician

Simple configuration, commissioning, and application.

Safe recordings over long periods of time through wireless technology; (no loose cables, no loose electrodes, and strong electrode contact)

Modular concept enables ECG recordings over theoretically any length of time

High signal quality by elimination of cables and derivation of the vectors on a small area (low-artefact and low-noise ECG recordings).

Minimal effort for patient instruction for ambulatory recordings.

What are the Benefits for the patient

No impairment of quality of life and habits. After wearing it for a short period of time, the patient will not notice the auxilECG anymore

Simple operation / handling by patients even during longer recording periods (only the change of the electrodes and battery is necessary).

  • CE marking. The device complies with the requirements of the European Council Directive 93/42/EEC for medical equipment.
  • Device includes radio transmitter (Bluetooth module)
  • Battery operation Size of battery AAAA.
  • Suitable for ECG recordings in children with a body weight of < 10 kg
  • Product life cycle  is 5 years
  • Number of ECG channels are 3
  • Dimensions  approx. 71.5 x 46 x 14.7 mm
  • Weight approx. 30 g
  • Interfaces to the readout device  USB interface (USB 2.0)
  • Read data rates: approx. 15 MBytes/s
  • Write data rates: approx. 10 MBytes/s
  • Bluetooth interface
  • Bluetooth 4.0
  • Frequency band: 2400.0-2483.5 MHz
  • Type of modulation: JRCK (PI/4DQPSK, 8DPSK)
  • Maximum radiated power: 4 dBm (BT Class 2)

The auxilECG is compatible with following ECG analysis software:

  • PADSY-Holter (medset GmbH, Germany) 7.5.h
  • CubeHolter (Cardioline S.P.A., Italy) 3.20.12500.0
  • Cardiomatics-Software for ECG analysis (Cardiomatics Sp. z o.o., Poland)  

AuxilECG and Auxil Analysis A Short Instructions

Initialize the recording

  1. Open the auxilECG Init application on your computer.
  2. Put the battery in to the auxilECG and close it with the battery cover.
  3. Connect now the electrodes to the auxilECG.
  4. The auxilECG should be detected via the Bluetooth-Interface of your computer and visible in the auxilECG Init application
  5. Select your auxilECG and click on “Connect”.
  6. Delete the old recordings.
  7. Remove the protective foils of the electrodes and position the auxilECG with the electrodes on the prepared chest area of the patient.
  8. Enter the patient data in to auxilECG Init application and click “Apply”.
  9. The ECG-signal of the patient will now be displayed. If necessary, apply another. “AutoGain”.
  10. If you are satisfied with the quality of the ECG-signal click on “Start Recording”.
  11. The recording has now started. You can close the auxilECG Init application.

  1. Please log onto http://auxil.cardiomatics.com with your user-ID and password.
  2. Open the battery compartment and remove the battery if not already done. Connect the auxilECG with the provided USB-cable to your computer.
  3. Now you can upload the recording by clicking on “Add Signal”. Select the recording file (“Recording.edf”). You will find this file on the auxilECG (Drive: “AUXILECG_V2”).
  4. Add an ID to the uploaded recording. Please assure that this ID does not contain any personal details of the patient.
  5. Once the upload is completed, you can generate the report by clicking on “Generate”.
  6. After 5 hours the final report should be ready and available online.

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