The Operio Sterile Air Flow unit filters the ambient air through a highly purifying H 14 Hepa filter with an efficiency of over 99.995%, 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 standard practice area of 40 m3 will be completely filtered every 6 minutes.
These units can also be used for personal protection during the coronavirus pandemic. It is very easy to position the Operio unit.
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, therefore ensuring a higher level of asepsis compared to traditional systems affecting all the air in the operating theatre.
This operating principle achieves up to 95% more “sterility” for the operating area and instruments than conventional air supply via ceilings . 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 or examination rooms quickly and cost-effectively. Upgrade of ambulatory surgery: implant surgery, plastic surgery, reconstructive and aesthetic surgery, hand surgery, opthalmology 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 actual source of the bacteria is not in the air, but in the people in the operating theatre, who are the origin of the fatal pathogens that arise during implant insertion. Humans can shed hundreds to thousands of bacteria-bearing particles per minute (Bethune, 1975; Whyte et al., 1976; Whyte et al., 1978), which can settle onto surfaces in the operating theatre environment and especially on instruments. It can be assumed that 90% of early perioperative infections of joint prostheses are caused by microbial entry during surgery, whereby the entry of microorganisms into the wound is caused either by direct contact or by aerogenic contamination. (Uckay et al. (2009)
TOUL focused laminar flow is direct and reaches the operating field and/or surgical instruments without any interposed obstacles, therefore ensuring a higher level of sterilization compared to traditional systems affecting all the air in the operating theatre.
Since the flow is horizontal, all obstacles are bypassed: inside it, there are only sterile elements, including the operators hands, thus preventing contamination.
Many people in the general public think of ORs as ultra clean, even sterile, environments. For anyone working in ORs, it is clear that this view is far from the truth. Although modern ORs have strict measures to reduce contamination, the OR environment becomes contaminated with every person entering the operating room. The more people are present in an operating room the higher is the contamination with pathogens that cause infections including SSIs. Especially implant surgery and eye surgery need a very aseptic environment as already a few pathogens can cause infections which are devastating and very expensive to treat.
The decisive criterion for the occurrence of postoperative wound infections is contamination of the operating area and instruments/implants with pathogens during the surgical intervention. The units create an asepsis for the instruments and operating area (and that’s what matters!) that is comparable to an ISO 5 operating theatre, because the Sterile Air Flow directly and immediately protects the instruments and the operating area without obstructions – such as operating theatre lights or the operating theatre team.
the operating room laminar flow is horizontally focused to maximize its efficiency and avoid any obstacles in standard vent air flows, for optimal protection to the operating field, surgical instruments, patients and healthcare professionals;
the sterile hood is traceable for defensive medicine purposes: there’s a label on the hood sterile housing and a barcode read by the device when it switches on and stored in the memory (it can also be filed);
Operio complies with Standard ISO 5 even in case of intense activity, and without any time restraints.
The units utilise 2-stage filtering (F7 and H14 Hepa filters). Operio Focused Laminar Air Flow units are extremely small and easy to handle, and they can also be used in very small spaces. The Operio removable instrument table is available in different lengths of 45 cm (for intravitreal injections), 60 cm (for ophthalmological operations, outpatient operations, and intravitreal injections) and 75 cm (for operations requiring many instruments). The electrical height adjustment feature can be operated by the sterile operating theatre personnel (using a sterile covered display) as well as by the other operating theatre personnel (using a separate display). This eliminates the need to purchase a separate instrument table for storing the instruments. The bacteria level in the entire operating theatre can also be reduced by constantly cleaning the air with Hepa filters.
The units bear the CE label and meet the requirements for medical devices 93/42 EEC/Class I, 2007/47 EEC, as well as those of the directives 2004/108/CE, EN 60601-1-2:2014, EN 60601-1:2006, EN ISO 14971:2012 and EN ISO 13485:2012. The protective effect is achieved in accordance with ISO 5 per ISO 14644-1 -2, and ISO 14698-1 and -2.
no engineering works required for its installation
creation of a sterile area in just a few seconds
light, transportable and easily movable device
nocold air and it is also very quiet – comparable to a projector.
Many studies and hygiene reports
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