Introduction
CBM, established in 1943 by Cav. Busatti, specializes in medical sterilization equipment. Operating from a 30,000 m2 facility in Italy, CBM offers over 4000 products and is certified under UNI EN ISO 9001 and UNI EN ISO 13485, ensuring high-quality standards.
InnovationThe Permaside Filters system improves sealing, steam penetration, and air filtration in
sterilization containers. Innovations include vertical PTFE filter cartridges and the use of stainless steel and aluminum, enhancing durability without adding weight. The design complies with ISO 11607-1 standards.
Container System FeaturesCBM's container system is designed for modern sterilization needs, featuring:
- Rounded upper rims for stability and gasket protection.
- Silicone gaskets for easy replacement.
- Anti-crushing devices to prevent damage from stacking.
- Riveted components for secure sealing.
- Aseptic opening and stable stacking systems.
- Disposable seals for tamper evidence.
- Ergonomic handles for safe transport.
- Traceability through aluminum plates and paper labels with chemical indicators.
- Design facilitating easy cleaning.
Standards and ComplianceCBM complies with European regulations and standards, including:
- European Regulation (UE) 2017/745 and Directives 2007/47/CE and 93/42/CE for medical devices.
- EN ISO 9001 and EN ISO 13485 for quality management systems.
- EN ISO 17665-1 for sterilization processes.
- EN ISO 11607-1 and EN ISO 11607-2 for packaging requirements.
- EN 868-8 and EN ISO 11140-1 for sterilization containers and chemical indicators.
- EN 285 for steam sterilizers.
Materials
CBM uses reliable materials that meet current regulatory requirements for container production, including a Magnesium-Aluminium alloy and AISI304 stainless steel. Aluminum containers undergo anodizing processes to enhance surface properties and resistance to corrosive agents.
Specifications
CBM manufactures containers using reliable materials that meet current standards. The containers are made from a Magnesium-Aluminium alloy and AISI304 stainless steel. The aluminium containers undergo anodizing processes, either soft or hard, to enhance surface properties and resistance to corrosive agents. Stainless steel containers are naturally resistant to corrosion and do not require additional surface treatments.
Procedures
The anodizing process provides a protective surface coating on aluminium, making it resistant to water steam and allowing for color differentiation of container lids. Hard anodizing improves mechanical surface properties, giving a brownish color to the containers.
Norms and Recommendations
Stainless steel containers, made from AISI304, offer superior mechanical properties compared to aluminium, allowing for thinner walls without compromising strength. The weight difference between filled aluminium and steel containers is minimal, and both materials provide similar heat transmission resistance.
Sterile Barrier Systems
CBM offers a range of sterile barrier systems, including containers with replaceable and permanent filters, protected filters, and valve systems. The Permaside Filters system features a permanent microbial barrier positioned vertically, reducing dust and condensation accumulation and ensuring sterility during transport and storage.
Key Features of Permaside Filters
The system requires minimal maintenance, with PTFE filters certified for over 2000 cycles and a shelf life of 5 years. Containers are equipped with unique serial numbers for traceability. The vertical filter position prevents steam penetration issues and enhances steam saturation quality. The design allows for a higher load volume compared to standard containers.
Technical Features
The vertical filter position avoids steam penetration problems from incorrect stacking. The reduced inlet surface improves steam saturation quality. The permanent cartridge size is optimized according to container height, ensuring uniform steam penetration and facilitating sterilization.
Overview of the Filtering System
The CBM patent for the lateral filtering system enhances the steam penetration and air filtration capabilities of rigid containers used for steam sterilization. This system is efficient and cost-effective for sterilization centers.
Key Innovations- Vertical Filter Position: Prevents steam penetration issues due to faulty stacking and maintains a consistent distance from the steam inlet to the load center.
- Filter Dimensions: Optimized according to container height, reducing consumable management costs.
- Protection from Contaminants: Dust, dirt, and condensed water do not accumulate on the filters, ensuring sterility during transport and storage.
Container Specifications
Containers are available in various materials such as stainless steel and aluminum with hard or soft anodizing. They come in different sizes and configurations, including options for non-removable lids and oversized handles.
Protected Valve Containers
This mechanical filtering system requires no maintenance and operates through a series of valve positions during and after sterilization to ensure sterility.
Mini Containers
Designed for small-scale operations, these containers are robust and flexible, conforming to European standards. They are ideal for organizing small surgical sets and reducing disposable material usage.
Available Options- Non-removable hinged lids.
- Oversized handles with ergonomic coverings.
- Colored handles and lids for easy identification.
Overview
CBM offers a comprehensive range of accessories and consumables for both its own containers and those of other brands. The document details various products, including seals, plates, adhesive supports, filters, and baskets, highlighting their specifications and uses.
Seals and Plates
CBM provides universal plastic seals, some with chemical indicators, and aluminum and stainless steel plates, available in neutral or engraved forms. These are designed for secure locking and identification purposes.
Adhesive Supports and Document Holders
The document lists various adhesive supports for documents and plates, emphasizing high-performance adhesives resistant to washing and sterilization cycles, ensuring permanent fixation on metallic surfaces.
Filters
CBM offers a variety of filters, including disposable paper filters with chemical indicators, cotton filters for up to 70 cycles, synthetic filters for up to 200 cycles, and long-lasting PTFE filters for up to 2000 cycles. These filters are designed for CBM containers and other brands, with options for different sizes and configurations.
Basket System
CBM's basket system is highlighted as a versatile solution for handling and washing surgical instruments. The baskets, made from stainless steel AISI304, feature a unique design with perforated sheets and rounded corners, enhancing water drainage and preventing instrument displacement. The baskets are available in standard and customizable sizes, with retractable handles for easy handling.
Environmental and Cost Benefits
The use of PTFE filters is noted for its environmental benefits, reducing paper consumption and sterilization costs, while offering extreme chemical resistance and longevity.
Specifications
The document details various stainless steel and aluminum plates, fixing systems, and labels. It includes dimensions and specifications for engraved and neutral plates, as well as fixing systems using rings, cables, and clips. The plates are designed for use in wire baskets and trays.
Procedures
The document outlines the use of trays in standard baskets to create additional levels for instruments, optimizing space and separating fragile items. The Easy Fit System is highlighted for its versatility in positioning and protecting surgical instruments, allowing for quick configuration changes and compatibility with sterilization processes.
Standards and Recommendations
The Easy Fit System is recommended for its ability to withstand sterilization and disinfection processes. The use of silicone and stainless steel materials is emphasized for durability and safety. The document also suggests using Flexymat silicone mats for better steam circulation and water drainage during sterilization.
Key Data from Tables and Diagrams
The document includes detailed tables listing various supports, their dimensions, and configurations. Each support is supplied with screws for easy installation. The tables provide information on the number of slots, diameters, and lengths for different support types, such as Small Star, Big Star, Comb, and others.
Critical Information
The document emphasizes the importance of using the correct fixing systems and supports to ensure the safe handling and sterilization of surgical instruments. It also highlights the flexibility of the Easy Fit System in adapting to different instrument sizes and configurations.
Specifications
1. The document describes various types of baskets and dispensers used in surgical settings, specifically for microsurgery, neurosurgery, laser surgery, and robotic surgery instruments.
2. Baskets are equipped with hinged flat lids, handles, and inner trays. They include silicone mats and supports to secure instruments during sterilization processes.
3. The materials used include stainless steel AISI304, known for its durability and resistance to high temperatures and corrosion.
Procedures
1. The baskets are designed for the safe handling, washing, and sterilization of surgical instruments.
2. The Easy Fit System ensures instruments are securely held in place, preventing damage during handling.
3. The design includes features like perforations for steam flow and liquid drainage, and smooth surfaces to prevent damage to packaging.
Standards and Recommendations
1. The baskets are suitable for steam and low-temperature sterilization processes.
2. They are designed to avoid any mixing of instruments and to protect delicate components like optical fibers and Kirschner wires.
3. The use of non-toxic silicone supports is emphasized for safety and hygiene.
Key Features and Benefits
1. The baskets' design includes rounded edges and smooth surfaces to ensure safe handling and prevent damage to instruments and packaging.
2. The use of electro-polished stainless steel prevents discoloration and water stains.
3. The baskets are equipped with various support systems to accommodate different types of surgical instruments, including those used in robotic surgery.
Limitations
1. Specific dimensions and configurations are provided for each type of basket, indicating their suitability for different instruments.
2. The document specifies the number of instruments each basket can hold, ensuring proper usage and capacity management.
Conclusion
The document provides a comprehensive overview of surgical baskets and dispensers, highlighting their design, materials, and functionality. The emphasis is on ensuring the safety and integrity of surgical instruments during sterilization and handling processes.
Specifications
1. The document describes various medical instrument frames and containers made primarily from stainless steel AISI304, ensuring durability and resistance to sterilization processes.
2. The frames and containers are equipped with Easyfit silicone supports for secure placement of instruments.
3. DEKO containers are available in stainless steel or anodized aluminum, designed for the first decontamination of surgical instruments.
Procedures
1. Laparoscopic frames facilitate the creation of single-patient surgery kits and ensure proper steam circulation during sterilization.
2. Arthroscopic instrument frames can be fixed inside perforated sheet baskets using screws, allowing functional arrangement of instruments.
3. Small set baskets are designed for sterilizing, cleaning, and transporting small instruments, with a focus on safety and effective steam penetration.
Norms and Recommendations
1. The DEKO system prevents cross-contamination during transport of contaminated materials.
2. Baskets and containers are electropolished to prevent color changes and water spots during sterilization.
3. Transport trolleys are made from stainless steel AISI304, ensuring long service life and resistance to corrosion.
Key Features and Benefits
1. Easyfit silicone supports and Softlips silicone lips ensure instruments remain in place during processes.
2. DEKO containers feature a high level of tightness, preventing overflow of disinfectant liquids.
3. Transport trolleys are equipped with antistatic wheels and perimetric bumpers for safe and efficient transport.
Limitations
1. Dimensions specified in the tables are indicative and may vary.
2. The document does not provide detailed assembly instructions for the frames and containers.
Good Practices
1. Ensure proper handling of containers and trolleys to maintain their integrity and functionality.
2. Regularly check the tightness of DEKO containers to prevent leaks and contamination.