The product is intended to be used in humans for the purpose of treating or alleviating a disease, as well as for the treatment, alleviation or compensation of an injury or a deficiency, according to the current Spanish regulations on medical devices. According to the UNE-EN 60601-2-52 standard for medical beds, it can be used for two different application environments (EA):
•EA3.- long-term care provided in a medical area where medical supervision is required and monitoring is provided if necessary and the bed is used in medical procedures that can be provided to help maintain or improve the patient's condition.
•EA4.- care provided in a domestic area where the bed is used to alleviate or compensate an injury, disability or illness.
The bed is considered a class 1 medical device according to the European Regulation 2017/745 on Medical Devices (MDR). Reference rules:
* UNE-EN 60601-2-52 “Electrical medical equipment. Particular requirements for the basic safety and essential function of medical beds.
MATTRESS BASE External frame in 50x20x1.5mm steel tube and internal joints in 25x25x1.5mm steel tube curved at corners (manufactured according to UNE 10305-5). Safety distance of 30 mm all around the bed between the joints and the outer frame to avoid entrapment. Beige epoxy-polyester paint (consult other options). Provided with squares in the head area for anchoring drip support and/or incorporator. Possibility of mounting metallic or wooden side safety railings. Metal mattress holder on the footboard of the inner articulation and injected thermoplastic mattress holder (PP with fiberglass) on the sides.