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safety and performance information of Healthdot

Sep 11, 2026

intended use

The Healthdot is intended to measure motion signals using a chest-worn accelerometer to derive respiratory rate and heart rate for adult users requiring monitoring of vital parameters in low-to-medium acuity care settings. This single-use device periodically transfers health data wirelessly via mobile network regardless of the user's location.

This device is intended to be used by healthcare professionals within hospitals, nursing homes, and for home care, in combination with external (separate) clinical information management systems. These clinical information management systems present the Healthdot data for monitoring and shall not use these data as input to monitor situations where the patient is in immediate danger.


safety - general information

  • The Healthdot is only intended to be used on an adult population.
  • The Healthdot gives an average value of heart rate and respiratory rate over the last 5 minutes. This value may differ from the value you are measuring in real time.
  • As an alternative to the Healthdot, manual spot checks can be executed according to the procedure defined by your department/hospital.
  • Before using the Healthdot system users shall follow the training on how to use the device correctly, which is provided by the manufacturer upon first installation. Thereafter, training may be provided by a person from the hospital itself who is already trained.
  • For cleaning, wipe the device with a clean cloth and water.
  • After wearing the device for a prolonged time on the same body location, a mild form of skin redness or irritation can occur on the site the device has been worn.
  • Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.
  • If unexpected system behaviour, or other circumstances leading to believe that a security vulnerability was potentially exploited, this should be reported to the manufacturer.


safety - contraindications

  • Do not use the Healthdot if there are skin problems or wounds on the application site.
  • Do not use the Healthdot on persons known to be allergic to the Healthdot adhesive.
  • Do not use the Healthdot on patients who require continuous ECG monitoring as the Healthdot is not a substitute for an ECG monitor.
  • Do not use the Healthdot on patients for whom the nature of variations of the measured parameters respiratory rate and heart rate is such that it could result in immediate danger to the patient.
  • Do not use the Healthdot data in combination with external (separate) clinical information management systems as input to monitor situations where the patient is in immediate danger
  • Do not use the Healthdot nearby sensitive electromagnetic equipment like ECG electrodes as the signal quality of this equipment may degrade.
  • Do not use the Healthdot nearby equipment that generates large electromagnetic fields like high frequency or MRI equipment

The content presented above is aligned with the paper IFU, version 7.0.