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operating room ventilation systems for class 1

operating room ventilation systems for class 1

operating room ventilation systems for class 1

Product catalog summary
Introduction
This document discusses the prevention of bacterial biofilms and capsular contracture in breast implants, focusing on the reduction of surgical site infections through advanced ventilation systems.

Specifications
The document highlights the use of a horizontal focused laminar air flow system, which reduces contamination in the operating room by up to 95%. This system ensures sterility during both the preparation and surgical phases without requiring construction work, making it ideal for existing operating rooms and implant surgeries.

Procedures
The focused laminar air flow system directs air filtered through HEPA filters directly onto surgical instruments and the surgical site, maintaining sterility and reducing bacterial load significantly compared to conventional systems. Instruments can be prepared under this airflow, ensuring sterility even during long operations.

Standards and Compliance
The system complies with ISO class 5 standards for extreme sterile conditions and bears the CE marking, adhering to the Medical Device Directive 93/42 EEC. It includes a barcoded sterile cover for traceability in defensive medicine.

Recommendations
For optimal aseptic conditions, the use of focused laminar air flow systems is recommended, especially in surgeries involving implants where even minimal bacterial presence can lead to biofilm infections or implant rejection.

Data and Analysis
Comparative data shows that conventional ventilation systems result in a bacterial load of 63.5 - 381 CFU/m3, whereas focused laminar air flow systems reduce this to 0.2 - 0.52 CFU/m3, demonstrating their effectiveness in maintaining sterility.
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Catalog excerpts

operating room ventilation systems for class 1-1

Prevention of Bacterial Biofilms and Capsular Contracture in Breast Implants Prevention of surgical site infections A horizontal focused laminar air flow reduces the contamination in the operating room up to 95% and ensures that the instruments and the operating field maintain the sterility not only during surgery but already during the phase of preparation. The system is mobile and can immediately be used without any construction works. It is ideal to improve immediately aseptic conditions in existing operating rooms and especially suitable for implant surgeries. Reduce surgical field and instrument contamination up to 95 % with traceability system for medical defence purpose combating bacterial biofilm infections The focus laminar air flow keeps the instruments and the operating field extreme sterile as there are no obstacles like surgical lights or operating staff in between

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operating room ventilation systems for class 1-2

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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