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Laminar air flow for plastic and reconstructive surgery

Laminar air flow for plastic and reconstructive surgery

Laminar air flow for plastic and reconstructive surgery

Product catalog summary
Introduction
The document discusses the Operio laminar air flow system, a mobile unit designed to create ultraclean air environments in operating rooms, particularly for plastic and reconstructive surgery. It aims to prevent airborne bacterial contamination of surgical wounds by using positive pressure air currents filtered through HEPA filters.

Specifications
The Operio system provides ISO5 air quality, achieving up to 95% more sterility compared to conventional air supply systems. It is portable, easy to install, and can be used in small rooms. The system includes a removable instrument table available in various lengths and features electrical height adjustment.

Procedures and Benefits
The system creates a "germ-free zone" around the surgical site, protecting both the surgical team and the patient. It reduces bacterial load on instruments and surgical sites by more than 95% compared to conventional systems. The focused laminar flow is not impeded by surgical lights or staff, maintaining sterility during operations.

Technical Standards and Compliance
The Operio system complies with the Medical Device Directive 93/42 EEC and other relevant standards, including EN 60601-1 and EN ISO 13485. It meets the protective effect requirements according to DIN 1946-4.

Studies and Expert Opinions
Various studies confirm the effectiveness of the Operio system in reducing bacterial contamination. A study by the University of Greifswald showed a 1000-fold reduction in particles in the surgical field. The system's performance aligns with ISO class 5 standards, ensuring low germ levels.

Conclusion
The Operio laminar air flow system offers significant advantages in maintaining sterile conditions in operating rooms, particularly for surgeries involving implants. Its compliance with rigorous standards and proven effectiveness in reducing bacterial load make it a valuable tool in surgical environments.
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Catalog excerpts

Laminar air flow for plastic and reconstructive surgery-1

Laminar air flow for plastic and reconstructive surgery Operio laminar air flow is a mobile laminar air flow unit that creates ultraclean air for operating rooms and ambulatory rooms. The portable laminar air flow can be installed in any operating theatre or operating room in just a few minutes without any construction work. This operating theater ventilatory system have been developed to prevent direct airborne bacterial inoculation of the surgical wound. This laminar air flow uses a positive pressure air current through filtration with hepa filters which is directed to the operative field in order to create an ultraclean zone around the operative site. Ultraclean air with ISO5 air quality: the sterility of the surgical field and the instruments is not restricted by the horizontal laminar air flow Operio. Turbulence and germs are largely excluded. This principle achieves up to 95% more “sterility” than with conventional air supply ceilings in the operating theater and on the instruments (see studies). The Operio laminar air flow can be positioned in such a way that a “germ-free zone” is set up, which offers the greatest possible protection for both the surgical team and the patient.

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Laminar air flow for plastic and reconstructive surgery-2

Focus laminar air flow Conventional ventilation system Bacterial load after 60 min. Bacterial load after 60 min. 0,2- 0,52 CFU/m3 (*1) Focused laminar flow systems: the air is filtered through hepa filters free of microorganisms and then directed immediately onto the surgical instruments and surgical site. It is only then distributed throughout the operating theatre. This protects the critical area of the operating theatre, i.e. the instruments and the surgical site. With this system, the bacterial load on the instruments and surgical site is reduced by more than 95% compared with conventional...

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Laminar air flow for plastic and reconstructive surgery-3

Breast implants Operio reduces the risk of breast infections after surgery with a laminar air flow that is focused to reduce the bacterial load in the operating field up to 95 % in comparison to a conventional operating room. The ultraclean air is not disturbed by surgical light nor the heads of the surgical team as it is directly focused to the operating field. Instrument preparation: the opening of the implant can be done under aseptic conditions. During the preparation of the implant it is very important to keep sterile conditions as just a few bacteria can already be decisive for the outcome...

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Laminar air flow for plastic and reconstructive surgery-4

Technical specifications The Operio devices are extremely small and handy and can also be used in very small rooms. The removable instrument table from Operio is available in various lengths of 45 cm (for intravitreal injections), 60 cm (for ophthalmic operations and intravitreal injections) and 75 cm (for operations that require a lot of instruments). The electrical height adjustment can be carried out by the sterile OR staff (using a sterile covered display) as well as by the other OR staff using a separate display. There is no need to purchase a separate instrument table for storing the instruments....

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