Willem™

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Critical warnings

11 warnings recorded — scroll inside the panel to see all entries.

CW999
Warning: The device responsible for measuring cardiac electrical signals must be previously checked, verified and/or calibrated to ensure the accuracy and fidelity of the data. Willem™ cannot perform a validation precision and stability of the measurements. Therefore, the signals must comply with the requirements established by the applicable harmonised regulations, in relation to their own characteristics, IEC 60601-2-25, IEC 60601-2-27, or IEC 60601-2-47 and any others determined necessary by the manufacturer.
CW999
Warning: In case of malfunction, please contact the manufacturer by sending an email to willem@idoven.ai. Any serious incident should be reported to IDOVEN 1903 S.L. and the National Competent Authority of the country.
CW999
Warning: Features that do not meet the minimum acceptance criteria are temporarily disabled until the minimum acceptance criteria have been met. The manufacturer will notify the user when the feature has been activated. The output of the 2nd-degree AV block of this device is currently disabled and will be available in future releases of the product.
CW999
Contra-indication: Willem™ is not intended for real-time patient monitoring.
CW999
Contra-indication: Willem™ is not intended to be used for the assessment of paediatric patients or patients under the age of 18, due to different normal ranges for electrocardiographic measurements.
CW999
Contra-indication: Willem™ is not intended to be used for the assessment of pregnant and lactating women.
CW999
Contra-indication: Willem™ is not for use in life supporting or sustaining systems or ECG monitors and Alarm devices.
CW999
Contra-indication: Willem™ interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
CW011
Willem™ does not require calibration because it is not a medical device with a measuring function.
CW010
EUDAMED did not publish a description for this code.
CW999
Warning: Willem™ is a software health product. In accordance with its intended purpose, the information provided by the product must always be used, verified, and validated by physicians or qualified clinical professionals.

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