The device label of each Kaiku Health installation displays the regulatory status of the device in the appropriate jurisdiction, and also includes the intended purpose of the product. Each installation is offered in the languages required by the locally applicable laws and regulations. No instructions for use are provided as the information contained within the application is considered to be sufficient for its safe and effective use.
Warnings and residual risks
Kaiku Health is not monitored in real-time by the clinical staff, it is intended only for non-urgent communication. In urgent situations, contact your care unit or emergency number by phone.
In some special cases the guidance and self-care instructions that Kaiku Health provides might not apply to you. If you have any questions regarding your care, or your symptoms and their management, we kindly ask you to contact your care team.
If you do not receive a response from your care unit within reasonable time, please contact the care unit via phone.
Risks related to confidentiality, integrity and availability of the personal data processed by Kaiku Health cannot be completely eliminated. If you suspect that your personal data has been compromised, please contact Kaiku Health support.
Contraindications
Any physical or cognitive condition that, according to clinical judgement, would prevent the patient from using Kaiku Health, e.g. dementia.
Undesirable side effects
No undesirable side effects concerning the safety of the users of Kaiku Health are expected to occur.
