DignaCare is not designed to be used as a standalone product. DignaCare is developed to be used together with, and to be mounted on the outside of an incontinenceincontinenceInvoluntary loss of control of the bladder and / or intestines. product. DignaCare can only operate, and have the intended effect, when an incontinence product is used correctly, either during day and night, part of the day, at night or as a temporary assistance over a limited period. DignaCare will not work as intended if multiple incontinence products are used in layers and not according to manufacturer specifications. DignaCare will monitor and make notifications and alarms when the incontinence product is defined to be ready to be changed.
The sensor device should never be:
Used inside an incontinence product
Mounted directly on underwear
Fixed directly to human skin
Be placed in any openings of the human body
DignaCare is designed to operate according to guidelines made by the Medical Device Coordination Group, Document MDCG 2021-24, The DignaCare Solution and the sensor device has been classified as a Medical Device class 1 product. The classification of medical devices is a risk-based system considering the vulnerability of the human body and the potential risks associated with a device. The ‘classification rules’ can be found in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR) established by Article 103 of Regulation (EU) 2017/745. They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:20121.
The DignaCare Solution is developed to be a supplement and improvement to existing routines and policies in institutions or environments run by trained and professional care personnel. The solution is simple to use and developed to be intuitive for the employee’s care personnel. However, all employees care personnel must be trained and educated to secure correct use.
To assist care personnel and institutions DignaCare has developed a comprehensive collection of educational platforms to educate health care works in correct use of DignaCare. Education is available through SensCom, SensCom web pages www.dignacare.com, our partners and on the DignaCare App. Additional training modules can be found at SkillAid. The SkillAid Application can be downloaded at Google Play Store or Apple App Store. To use the app a user must be created, and a QR-code scanned to get started:
DignaCare Solution and the sensor device has been classified as a Medical Device class 1 product. This classification means that data provided by the sensors should never be used to or used as bases for a diagnose, to start, stop or change any prescribed treatment or any other medical decision. The DignaCare Solution is not designed, classified, certified, or meant to treat any human condition. Any incidents or errors to the product or the service provided by SensCom should be reported to SensCom without delay.