Following intensive teamwork in cooperation with accredited Specialised Doctors, Professionals and Laboratories, we have obtained certification of an entire range of mattresses, anatomical supports and accessories as Class I Medical Devices.
All have CE marking, as they comply with European Regulation (EU) 2017/745, with documented ergonomic performance and anti-decubitus properties.
The certification process involved most of the Dorsal product range; in total, it involved 35 mattress models, 22 lines of bed bases, pillows and accessories. The quality of the distribution of body pressure was measured by accredited laboratories using the "Body Pressure Measurement System", in both supine and side positions and for the shoulder, pelvis/thigh, calf and foot areas, obtaining results well above the reference standards.
The laboratory tests involved a representative sample of users with different anthropometric characteristics, divided both by gender and body mass index. The tests were complemented by user trials, a panel of users who evaluated ergonomic comfort.
The results allow us to offer the market a range of Medical Devices with documented ergonomic performance and anti-decubitus properties, which contribute significantly to relieving body pressure, resulting in relaxation of the entire spinal structure. Analyses have been conducted to guarantee the safety of the user, for a highly reliable and safe product.
Use and Maintenance Manual
Dorsal® Medical Device mattresses, anatomic supports and pillows are provided with a specific user and maintenance manual, technical data, assembly, use and maintenance information and a declaration of conformity.
What is a Medical Device
Medical Device means "... any instrument, apparatus, implant, substance or other product, whether used alone or in combination, including computer software used for its proper functioning and intended by the manufacturer to be used in human beings for the purpose of diagnosis, prevention, control, therapy or alleviation of disease; [...] the principal intended action of which in or on the human body is not achieved by pharmacological or immunological means... "*.
19% Tax Deduction
Dorsal Medical Devices are deductible as a medical expense in the 730 and Unico tax returns. To be entitled to the deduction, the expense must be accompanied by a medical prescription or self-certification and substantiated by an invoice or tax receipt in the name of the person incurring the expense, plus a description of the Medical Device.
The EC declaration of conformity is included in the user and maintenance manual, together with the registration number; the details are also included in the Dorsal transport document. All Dorsal Medical Devices are accompanied by a user and maintenance manual and Declaration of Conformity.
Dorsal® Medical Device mattresses are:
Zefiro line → Gel, Memory, Mousse, Wind and Body
Grand Soleil line → Planet, Polaris, Soleil, Antares and Matrix Therapy
Elisir Line → 5000, 4000, 3000, 2000 and 1000
Suite Line → 480, 400, 360, 300, 280 and 150
Contemporanei Line → Greener, Issimo and Spa
Fitness line → Memory
Vitalay Line → Body Care, Paradise, Divine and Sublime
Upholstery → In all fabrics except Botanic upholstery
The anatomical Dorsal® Medical Device supports are:
XPoint → 400, 300 e 200
Experience 800, 600, 600 FRT
Superego → Superego Firm e Superego FXA
In single and double motor versions → R-4, RA, RT, FRA, MRA and with Bluetooth, in flat versions NA and FA
Dorsal® Medical Device pillows are:
The certified Dorsal® bed system
