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SO.X-VERSUS

RX protective clothing system

Servizi Ospedalieri SpA proposes a revolutionary new solution in the field of PPE against ionizing radiation: the X-Versus system.

The creation of a protective fabric, patented by Servizi Ospedalieri SpA and designed according to an innovative concept, has enabled the production of garments that can be sanitized with industrial processes and steam-sterilized with standard autoclave cycles used for surgical textiles.

The integrated service offered by Servizi Ospedalieri SpA provides for the rental, cleaning, sterilization (if required), maintenance and control of every radioprotective garment, relieving health facilities from the burden of having to purchase directly and making available all the advantages of the service.

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Advantages of the X-Versus system

The radiomitigating metals are antimony and bismuth incorporated into a thermosetting polyurethane resin.

All X-Versus products are leadfree, latex-free and PVC-free.

The X-Versus fabric is a product Made in Italy and is covered by industrial patent.

Product technical characteristics

The originality of the X-Versus fabric lies firstly in its structure, which is the result of the coupling of fabrics conforming with Standard UNI EN 13795, and a special radiopaque foil, resulting in an extremely malleable multilayer fabric (conventional lead garments are very rigid), sanitizable with industrial washing processes, sterilizable in steam autoclaves and impermeable to liquids and microorganisms.

The outside and the inside (in contact with the user) are in high-performance and highly breathable fabrics which ensure high comfort for the user.

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Standard colors

AZ01 – blue

GR01 – gray

VE01 – green

Extra colors

426 yellow | 16466 pink | 8804 red | 8810 violet | 22286 green | 14396 light blue | 8779 navy blue | 8776 lilac

Fancy patterns for pediatric wards

AZ01P1

AZ01P2

GR01P1

GR01P2

GR01P3

VE01P1

VE01P2

VE01P3

Packaging

The garments are delivered, with first supply, in white recyclable die-cut cardboard boxes (with bayonet closure), with X-Versus logo in the middle.

Two different package sizes are supplied depending on the size of the garment:

  • 595x395x50 mm (aprons, bodices, skirts, etc.)
  • 260x210x33 mm (thyroid shields, gonad shields, caps, etc.).

Conformity with current regulations

  • Directive 89/686 as amended, implemented by Leg. Decree 475/92 as amended;

  • Directive 93/42 as amended, implemented by Leg. Decree 46/97 as amended;

  • CEI EN 61331-1: Protective devices against diagnostic medical X-radiation-Part 1:Determination of attenuation properties of materials;

  • CEI EN 61331-3: Devices for protection from X-radiation for diagnostic medical use – Part 3: Protective garments and devices for gonads;

  • CE marking as PPE category III;

  • UNI EN 13795: Operating theater fabrics;

  • UNI EN 13688: Protective garments – General requirements;

  • UNI EN ISO 10993-1: Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process.

Certification for Personal Protective Equipment

CE Marking X-radiation protection devices for medical – diagnostic use
Apron Model IRX category III
Gown Model ARX Category III
Bodice Model CRX + Skirt Model GRX Category III
Accessories Model TRX Category III

Certification of medical devices for sterile radiation protection

Servizi Ospedalieri is also in possession of CE Marking Sterile Medical Devices, Sterile Procedure Packs of drapes, gowns and radioprotective cloths and surgical instruments.

cert_marcaturaceteleriaCE marking drapes

Production, inspection and testing of the finished product “Sterile Procedure Pack of drapes and hybrid sterile Procedure Pack with reusable and disposable material”.

The certification according to the ISO 13485 standard specifies the requirements for a quality management system in supplying medical devices and related services that meet customers’ requirements and meet the regulations regarding medical devices and related services.

cert_unieniso13485UNI EN ISO 13485
(Sterile procedure packs)

Design and supply of industrial laundry and linen, mattress and pillow rental services.

Management of linen for medical facilities. Design, packaging and sterilization of procedure packs for medical use.

Provision service for disinfection, assembly, packaging and steam sterilization of procedure packs of surgical instruments.

Integrated management

The integrated management of radioprotective PPE (such as gowns, aprons, collars, etc.), used in the operating theater and/or in departments where operators have to be protected from diffuse ionizing radiation) provides for its rental, sanitizing, sterilization and functional checking.

The periodic service for sanitizing, according to protocols of the healthcare facility, is carried out by means of specific and validated industrial processes.

Each garment has an RFID tag for its complete traceability.

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