Normeditec

Portable Laminar Airflow: Revolutionizing Operating Room Ventilation for Sterility and Safety

Infection control is critical in operating room environments, especially during procedures involving implants, where the consequences of contamination can be severe and costly. The Operio Mobile Laminar Air Flow system offers a state-of-the-art solution for operating room ventilation by providing focused and direct sterile horizontal airflow. Unlike traditional ceiling-based ventilation systems, Operio eliminates turbulence and bacterial contamination by delivering sterile air directly to the surgical area and instruments, ensuring the highest level of asepsis.

This advanced system achieves up to 95% greater sterility for operating fields compared to conventional systems, reducing the risk of surgical site infections (SSIs) caused by bacteria shed by individuals in the operating theatre. Studies show that humans release hundreds to thousands of bacteria-bearing particles per minute, which can settle on instruments and surfaces, contributing to 90% of early perioperative infections in joint prostheses.

Operio’s Features and Benefits:

• Horizontal Laminar Flow: Prevents obstruction by operating lights or staff, ensuring an ultraclean environment.
• Cost-Effective and Mobile: Easily upgrades existing operating rooms, minor procedure areas, and examination rooms without major renovations.
• Broad Applications: Ideal for implant surgeries, plastic and reconstructive surgery, ophthalmology, hand surgery, and other procedures requiring aseptic conditions.
• ISO 5 Conditions: Provides sterile airflow for highly aseptic environments, previously only achievable in costly operating theatres.

The mobility and affordability of Operio make it an invaluable tool for healthcare facilities, enabling ambulatory surgeries and minor procedures to be performed under hospital-grade sterile conditions.

Advantages Over Conventional Air Flow Systems

1. Direct Protection:
   • Operio delivers sterile air directly to instruments and the surgical area without obstructions from lights or staff.
   • Reduces contamination risks, with CFU levels dropping to as low as 0.4 CFU/m³ compared to 63.5 CFU/m³ in conventional setups.
2. Patient and Staff Comfort:
   • Unlike ceiling-based systems, Operio’s laminar flow avoids uncomfortable cold air.
   • Maintains ambient temperature, ensuring a pleasant environment.
3. Rapid Deployment:
   • Upgrades conventional ISO 7 rooms to ISO 5 conditions in minutes.
   • No extensive renovations or additional equipment required.
4. Cost-Effectiveness:
   • Reduces infection-related costs.
   • Amortization achievable within days due to increased surgical throughput.

Applications

1. Ophthalmology: Ideal for cataract and glaucoma surgeries, ensuring critical aseptic conditions.
2. Orthopedics: Enhances sterility for knee and hip implants.
3. Cardiology: Optimizes conditions for TAVI and pacemaker implantations.
4. Plastic Surgery: Protects implants from contamination during procedures.
5. Outpatient Surgeries: Enables aseptic environments in non-traditional settings.

Key Features

1. High-Efficiency Filtration:
   • Utilizes a 3-step filtration system, including the HEPA H14 filter.
   • Removes 99.995% of bacteria and microorganisms, exceeding ISO 5 standards.
2. Mobility and Flexibility:
   • Compact (32 cm wide), making it ideal for small operating rooms.
   • Plug-and-play functionality with a standard power socket.
3. Energy Efficient and Quiet:
   • Consumes only 290W, comparable to a TV.
   • Operates silently, ensuring comfort for both staff and patients.
4. Enhanced Sterility:
   • Achieves over 300 air exchanges per hour in the surgical field.
   • Maintains aseptic conditions even in challenging scenarios like ophthalmology or cardiac procedures.

• Key Advantages of Operio Laminar Air Flow

  1. Direct and Unobstructed Sterile Protection
     The Operio system provides focused horizontal laminar airflow that protects the operating field and instruments without obstructions caused by operating theatre lights or staff. This precision ensures optimal sterile conditions during surgical procedures, safeguarding patients, healthcare professionals, and equipment.
  2. Optimized Efficiency with Horizontal Laminar Flow
     Unlike traditional ventilation systems, Operio’s horizontally focused sterile air flow avoids obstacles found in standard vertical air flows. This design eliminates turbulence, delivering highly effective protection to the surgical field and maintaining a clean environment.
  3. Traceable Sterile Laminar Air Flow (LAF) Screen for Defensive Medicine”The sterile LAF screen features a built-in barcode system for comprehensive traceability. Each time the device is activated, the barcode is scanned and stored, ensuring full compliance with defensive medicine standards. This system provides clear and reliable proof of usage, supporting quality assurance, legal documentation, and patient safety protocols.
  4. The sterile LAF screen features a built-in barcode system for comprehensive traceability. Each time the device is activated, the barcode is scanned and stored, ensuring full compliance with defensive medicine standards. This system provides clear and reliable proof of usage, supporting quality assurance, legal documentation, and patient safety protocols.
  5. ISO 5 Compliance Without Limitations
     Even in high-activity operating rooms, Operio maintains ISO 5 sterility levels, ensuring continuous aseptic conditions without time restraints.
  6. Plug-and-Play Mobility
     • No structural modifications required: Operio units are ready for immediate use.
     • Space-saving design: At just 32 cm wide, Operio is ideal for small operating theatres and procedure rooms.
     • Integrated instrument table: Enhances convenience and functionality during surgeries.

  Why Choose Operio for Your Operating Theatre?

  By achieving ultra-clean air conditions efficiently and affordably, Operio enables healthcare facilities to reduce postoperative infections and improve surgical outcomes. Its compact, traceable, and mobile design makes it a versatile and indispensable tool for any medical setting.

Certified Safety and Compliance: Meeting the Highest Standards in Medical Technology

The Operio Mobile Laminar Air Flow system is certified to meet the most stringent requirements for medical devices, ensuring safety, reliability, and performance in surgical environments. These certifications guarantee compliance with international, European, and U.S. medical standards, making Operio a trusted choice for healthcare providers worldwide.

Key Certifications and Standards:

• CE Mark Certification: Demonstrates compliance with the highest European health, safety, and environmental protection standards.
• FDA Certification: Approved by the U.S. Food and Drug Administration (FDA), ensuring adherence to strict regulatory requirements for medical devices in the United States.
• EU Regulation 2017/745: Fully aligned with the European Union’s regulation for medical devices, ensuring top-tier performance and patient safety.
• Directive 2007/47/EEC: Guarantees adherence to essential requirements for medical equipment.
• Standards Compliance: Operio meets additional critical standards, including:
  • EN 60601-1-2:2014: Electromagnetic compatibility requirements for medical electrical equipment.
  • EN ISO 13485:2012: Internationally recognized standard for quality management systems in the medical device industry.

By adhering to these rigorous certifications, including FDA approval, Operio ensures that healthcare professionals can rely on its performance for aseptic operating room environments across the globe.

Contact Normeditec for Advanced Surgical Solutions

We’re dedicated to helping you enhance your surgical environment with the Operio Mobile Laminar Air Flow Unit. Reach out to us for expert advice, detailed product information, or personalized assistance tailored to your needs.

Contact Information

• Email: info@normeditec.com
• Phone:
  • Germany: +49 7139 2090859
  • Italy: +39 348 730 24 45
• WhatsApp Support:
  • Germany: +49 176 62 13 16 34
  • Italy: +39 348 730 24 45
• Languages Spoken: English, German, French, Italian
• Website: www.normeditec.com

Global Reach and Expert Support

We deliver worldwide and are available via video call for real-time support and guidance. Let us help you implement cutting-edge aseptic solutions to revolutionize your practice.

Contact us today to take your surgical solutions to the next level!