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MEDICAL DEVICE CLASS I
1. Description of products with Medical Device
We produce pillows that prevent and reduce all the normal back and neck pains thanks to their ability to adapt to the profile and position of the part they support, ensuring uniform pressure distribution over the entire contact surface, creating an ideal anatomic support.
When the pillows are subjected to stresses of the body weight they react with an upward thrust that supports the part generating an adequate relaxing counter-pressure. Moreover, the parts (head, neck and shoulders) are always supported in proportion to their weight, offering characteristics of posture that guarantee the right support for the cervical vertebrae, to ensure an adequate response to the needs of this important part of the body.
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MODEL |
DESCRIPTION |
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SAPONETTA MEMORY (BUGNATO)
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Pillow in ergonomic memory foam that relaxes the neck and supports the head depending on weight and pressure exerted naturally: the pillow adapts to the shape of the skull and vertebrae, preventing them from being burdened by excessive weight, and favours the de-contraction and relaxation, eliminating the annoying neck pains. Viscoelastic pillow made of water-filled polyurethane foam, free of C.F.C., anti-mite, hypoallergenic, breathable and non-deformable. |
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DOPPIA ONDA (GRECATO)
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Memory foam pillow with anatomical shape suitable for those suffering from cervical pains promoting relaxation and de-contraction of the muscles.
Viscoelastic pillow made of water-filled polyurethane foam, free of C.F.C., anti-mite, hypoallergenic, breathable and non-deformable.
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BABY LETTINO
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Memory foam pillow shaped to accommodate the head of a child, sized with regular shape and height 4.5 cm to ensure the correct position of the neck in any position taken.
Drilling also designed to ensure sufficient breathing even when the child is placed in a supine position on the pillow.
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BABY CULLA
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A pillow in memory foam of reduced dimensions for the cradle of new-born babies or in the first two or three years of growth. The reduced height, the regular shape with constant height guarantee the correct position of the infant's neck without causing tension or stretching.
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ANATOMICO BIANCO
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Memory foam pillow that supports the head depending on weight and pressure exerted naturally: it adapts to the shape of the skull and vertebrae, preventing them from being burdened by excessive weight, and promotes de-contraction and relaxation, eliminating the annoying cervical pains. The pillow prevents the body from assuming unnatural postures thanks to its ergonomics and its sensitivity to body heat, which allows it to adapt perfectly to the forms it supports.
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ANATOMICO ALOE
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Memory foam pillow that supports the head depending on weight and pressure exerted naturally: it adapts to the shape of the skull and vertebrae, preventing them from being burdened by excessive weight, and promotes de-contraction and relaxation, eliminating the annoying cervical pains. The pillow prevents the body from assuming unnatural postures thanks to its ergonomics and its sensitivity to body heat, which allows it to adapt perfectly to the forms it supports. It is made with new mixtures obtained from plant extracts.
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SAPONETTA ALOE
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Memory foam pillow that supports the head depending on weight and pressure exerted naturally: it adapts to the shape of the skull and vertebrae, preventing them from being burdened by excessive weight, and promotes de-contraction and relaxation, eliminating the annoying cervical pains. The pillow prevents the body from assuming unnatural postures thanks to its ergonomics and its sensitivity to body heat, which allows it to adapt perfectly to the forms it supports. It is made with new mixtures obtained from plant extracts.
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Over the years, several studies have been conducted in the use of ergonomic pillows as devices to reduce and prevent back or neck pain and several mattresses with this destination have been available on the market for years.
The properties of the pillows have been compared with the other products on the market and no contraindications or particular dangers have been noted for the health and safety of users different from what is already known.
The production of raw materials is entrusted to Qualified Suppliers who follow established procedures and in full compliance with the product technical specifications, which have contributed to define and respect to which they have committed production commitments.
All plates are individually checked in reception and packaged.
The packaging and the shipping packaging are made of heat-shrink and cardboard box ensures delivery to the customer in conditions of full integrity and functionality.
All models of pillow are made of the highest quality materials and the level of comfort guaranteed by the geometric study and the distribution of ventilation holes is destined to last over time.
The high production standards allow the pillows to be hypoallergenic, all breathable and for the careful study of the geometries and heights are all ideal for supporting the cervical vertebrae. The "Double Wave" models have been designed to eliminate the typical discomfort due to poor posture in sleep (dizziness, headaches, neck pains, etc.) because the shaping allows to accommodate the head slightly reclined backwards and to support it in correspondence of the first cervical vertebrae, preventing the annoyances of sleep and helping the user to maintain a correct position.
The models "Baby Cot" and "Baby Cradle” are all sized for the weight and pressure exerted by the head of a child or a new-born. The reduced heights, the constant geometry, the forced ventilation by a homogeneous distribution of through holes guarantee adequate postural properties and prevent the involuntary suffocation phenomena of the child.
1.3 Indications for use
The simplicity of use has confirmed that there are no problems in the continuous use of the product for all the expected useful life years.
On the contrary, there are evident therapeutic benefits (for example the reduction of pain) thanks to the ergonomic / anatomic applied to the discipline of posturology (scientific discipline that studies the position of the body in space (posture) both in static and dynamic conditions).
The product is subject to developing yellowing areas for direct exposure to air and sunlight. The physical and mechanical characteristics are not impaired.
1.4 Warning for the consumer
a) The pillow in memory foam adapt itself of the head and neck, helping the muscles to relax and guaranteeing a best sleep. It is able nevertheless a period to be necessary of adaptation before getting used to this type of material and to it characteristics.
b) The material could have a characteristic odour due to the packing. The odour naturally fades away opening the wrapping and airing the pillow before using it.
c) The pillow is not washable: it is sufficient for have care to regularly to put to the air to maintain it fresh. The use of a pillowcase and a cover pillow effectively protects from stains and dirt, prolonging the duration.
d) The product is subject to develop areas of yellowing for direct exposure to the air and to the solar light. The mechanical and physics characteristics of the product are note jeopardized.
1.5 Billing
The pillows described above are Medical Device Class 1 EC Complies with European Directive 93/42 / CEE can be deducted 19% from taxes (IRPEF) as health care.
At the time of purchase, you can request an invoice indicating the billing information.
The invoice will include, in addition to the data, the words "Medical Device Class 1 CE Compliant with European Directive 93/42 / CEE" guarantee the certification of the product and the lot number that identifies the product.