Normeditec

Ventilation system for ultraclean air in plastic surgery  operating rooms and Operating theatre  for Plastic and Reconstructive Surgery

Operio creates an asepsis for the instruments and operating area (and that’s what matters!) that is up to 100 times higher than in a conventional  operating theatre, because the sterile air flow protects directly  the instruments and the operating area without obstructions – such as the operating light  or the operating team.

It creates a physical barrier, therefore preventing micro-organisms from settling in the surgical wound or on the instruments. The bacterial count on the operating field or on the instruments is reduced up to 95%, without any time restraints.

The Operio Sterile Air Flow unit filters the ambient air through a highly purifying H 14 Hepa filter with an efficiency of over 99.9%, which eliminates bacteria and micro-organisms (including coronavirus covid 19) by over 99.9%! These units can be positioned to produce a “bacteria-free zone” that offers the greatest possible protection for both the surgical team and the patient, in that they filter 400 m3 of air per hour, thus reducing microorganisms in the entire room. The entirety of a 40 m3 space will be completely filtered every 6 minutes. The units provide, without any obstructions, extremely efficient protection from bacteria and microorganisms of exactly the recommended operating area and instruments.

Operio Sterile Air Flow requires only a standard power outlet to operate and is ready for use in just a few minutes. The units are mobile and are easily transported.

Breast implant infections: prevent surgical site infections in cosmetic surgery

Breast implant infections tend to arise from bacteria that enter the patient especially  during   breast implant surgery. The use of prosthetic materials is linked to an increased possibility of surgical site infection. Implant infection is the main complication related to breast aesthetic and reconstructive surgery. Once bacteria come in contact with an implant, the body’s own defenses cannot easily fight off an infection.  Even with the use of antibiotics, infections cannot always be prevented, or if already present, always cured.  It is very important that a patient undergo surgery in a sterile environment. Frequently, breast implant surgery is performed in the back room of a doctor’s office, which sometimes can lead to less than ideal sterile conditions. The rate of surgical site infection after post-mastectomy breast reconstruction is ranging from 1% to 53%.  (Infections in breast implants: a review with a focus on developing countries J Infect Dev Ctries 2014; 8(9):1089-1095. doi:10.3855/jidc.3898)

Operio enables implant surgery under highly aseptic conditions, ensuring the safety of the doctor and patient. The extremely aseptic conditions enable avoidance of periprosthetic infections during breast implants.

Operio: The unit creates a laminar flow of ultra-clean air that reduces bacterial contamination of the surgical area and/or instrument table by up to 95%.

The horizontal flow means that the sterility of the operating area and instruments is not obstructed by the operating lights or surgical team. This results in the greatest possible elimination of turbulence and bacteria contamination. This operating principle achieves up to 95% more “sterility” for the operating area and instruments than conventional air supply via ceilings (see studies). Operations with implants require the greatest possible degree of asepsis, in that the consequences of an infection are serious and often very cost-intensive. The mobility of the Operio units and their affordable price also make it possible to upgrade existing operating and minor procedures rooms quickly and cost-effectively. In the outpatient area, implant surgery, plastic surgery, reconstructive and aesthetic surgery, hand surgery and many other operations and minor procedures can be performed under highly aseptic conditions – conditions that were previously only possible in a very expensive operating theatre.

The units utilise 2-stage filtering (F7 and H14 Hepa filters). ISO 5 is achieved for the instrument and operating areas, i.e., a higher level of safety is achieved than with ISO 7. (Data on the Infectiological significance of room ventilation systems in operating and minor procedures rooms, 2010 Kramer1, R. Külpmann2, F.Wille3, B. Christiansen4, M. Exner5, and Koll. Zentralblatt Chirurgie 2010; 135(1): 11-17.

Studies

Prof. Dr. med. B. Wille Bionovis Hygieneinstitut 11/2019, Investigation report of an outpatient operating theatre for breast implantations

Infectiological significance of room ventilation systems in operating and minor procedures rooms, 2010 Kramer1, R. Külpmann2, F.Wille3, B. Christiansen4, M. Exner5, and Koll. Zentralbl Chir 2010; 135(1): 11-17 A reduction of particles in the operating area by a factor of 1000 was demonstrated in a study by the University of Greifswald. The colony-forming units in the operating area were reduced by a factor of 250 during a simulated operation (Prof. Dr. med. Axel Kramer, Institute for Hygiene and Environmental Medicine, Greifswald).

Free State of Thuringia from 1/7/2009:
Particle counts: The supply air meets the conditions of purity class ISO 5 and is accordingly low in bacteria, corresponding to less than 1 CFU/m3.

Sedimentation plates: Very low bacterial counts were detected in the protected area both during a simulated operation (0.2 CFU) and after an operating theatre operation (0.3 CFU). That means that the exemplary guideline values in accordance with DIN 1946 /4 for room class ISO 5 (under 1 colony-forming units) were complied with.