Patient Journey App

Nom de l'organisation

Interactive Studios BV

SRN

NL-MF-000017251

Statut du fabricant

Actif

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Contraindication, do not use for: Monitoring of hospitalized patients: monitoring of individuals who have been admitted to a hospital and are receiving medical care and treatment within the hospital setting;

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• Contraindication, do not use for: Emergency care: individuals experiencing sudden and severe medical condition or injury that poses an immediate threat to their life, health, or well-being

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• Contraindication, do not use for: Time critical monitoring of vital parameters: individuals continuously assessed and measured for key physiological indicators that reflect the functioning of essential bodily systems, where deviations in the indicators can lead to serious deterioration of health.

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• warnings/precautions for healthcare professionals: - **Do not rely solely on automated alerts.** Threshold alerts support but do not replace clinical judgment. Review the patient dashboard regularly, independent of alert notifications. - **Verify patient-entered data.** Patient-reported entries may be incomplete or ambiguous. For any clinically relevant decision, verify patient-entered data (e.g., by contacting the patient or reviewing context in the app). Do not rely solely on free-text entries without clarification. - **Verify data completeness.** If patient data appears incomplete or inconsistent, contact the patient directly before making clinical decisions. - **Threshold configuration requires clinical expertise.** Ensure threshold values are appropriate for the specific patient and clinical context. Incorrect thresholds may result in missed alerts or alert fatigue. - **Clinical content accuracy.** The healthcare organization is responsible for the accuracy of clinical content, decision trees, and calculations configured in patient journeys. - Periodically review patient data and intervene as necessary.

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• Warnings/precautions for patients: - **Complete your assigned tasks.** Completing questionnaires and other assigned tasks helps your healthcare professional monitor your health status. If you are unable to complete a task, inform your healthcare professional. - Follow the instructions and guidance provided by your healthcare professional and do not rely solely on the app for medical advice or decision-making. - Contact your healthcare professional if you have questions about your health or treatment.

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Marché principal en Pays-Bas ; disponible dans 3 pays au total.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Dispositifs médicaux de Classe IIa dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.