The STERLINK mini is a low-temperature plasma sterilizer designed to effectively sterilize medical devices by using hydrogen peroxide vapor. This system offers an efficient, safe, fast, economical, easy-to-use, reliable, and flexible sterilization method, making it suitable for processing both metal and nonmetal medical devices in healthcare facilities. It is particularly useful for heat- and moisture-sensitive medical instruments.
Function Description
The STERLINK mini operates by diffusing hydrogen peroxide vapor into a chamber where medical devices are placed. The process involves a series of steps: preheating, loading, sterilization cycles, and completion. The sterilization cycle is designed to inactivate microorganisms through the action of hydrogen peroxide. The system supports two consecutive identical sterilization phases, with the critical process parameters being controlled to ensure effective sterilization. The sterilization process is validated by using a half-cycle overkill method to demonstrate a 10⁻⁶ SAL (Sterility Assurance Level).
The sterilization cycle involves two main phases:
- Diffusion: Hydrogen peroxide is increased in the chamber to supply hydrogen peroxide to the surfaces of the devices and into the lumens of the load.
- Plasma purification/Vacuuming: The pressure within the chamber is decreased to eliminate the residual sterilant. Plasma is applied to the plasma source to break the residual hydrogen peroxide into reactive species that recombine to form water vapor and oxygen.
The STERLINK mini is designed to be operated in chamber modes, which include Smart Ready (SR™), Sterilization, and Smart Complete (SC™) processes. The sterilizer is designed to operate only with the STERLOAD™ mini sterilant cassettes. Each cassette has an individual barcode that is scanned by the sterilizer to start the sterilization cycle automatically.
Important Technical Specifications
- Product Name: Low temperature plasma sterilizer
- Model: STERLINK mini
- Manufacturer: Plasmapp Co., Ltd.
- Dimensions (Main unit): 275 mm (W) x 440 mm (D) x 330 mm (H)
- Dimensions (Pump Module): 275 mm (W) x 440 mm (D) x 330 mm (H)
- Chamber Volume: 7 liters
- Safety Device: Opening prevention by door sensor and vacuum
- Electrical: Insert rated fuse for overcurrent prevention
- Cycle Temperature: < 60 °C
- Pressure Range: 0 – 760 torr
- Base Pressure: < 3.0 torr
- Diffusion Pressure: 20 – 100 torr
- Process Verification: Chemical indicator (CI) Class 1 (Compliance: ISO 11140-1)
- Vacuum: Base pressure < 3.0 torr, Vacuum leakage < 0.1 torr/sec
- Cycle Time (SR™/SC™ Process):
- Sterilization Process: 8 min
- CHAMBER mode: 10 min
- Overall Cycle: 18 min
- Sterilant: Hydrogen peroxide (H₂O₂: 58 – 59.5%)
- Purification: Plasma discharge treatment (Low frequency)
- Display Size: 153.1 (W) x 85.6 (H)
- Resolution: 800 x 480 pixel
- Port: IEC-320 C14, RJ-45, USB type A, USB type B, cable connector
- Electrical Characteristic: Rated power 100-125 VAC, 10 A; Rated frequency 50/60 Hz
- Humidity: Below 90%
- Atmosphere Pressure: 70 – 106 kPa
- Temperature: -10 – 55°C
Usage Features
- User-Friendly Interface: The sterilizer features an intuitive display that shows the current status of the sterilization cycle, preheating progress, and other relevant information. Users can easily navigate through the menus and monitor the process.
- Sterilant Cassettes: The system uses STERLOAD™ mini sterilant cassettes, which contain hydrogen peroxide. Each cassette is designed for a single use and should be disposed of according to regulations. The barcode on the cassette is scanned to initiate the sterilization cycle.
- Loading: Proper preparation of pouches and instruments is crucial. Biological indicators (BI) are used to load-related problems. The system supports loading Tyvek® rolls for chamber mode operation and various types of pouches.
- Sterilization Cycle Management: The sterilizer displays the progress and completion of the sterilization cycle. Users can confirm the cycle completion and print a summary report. In case of issues, the system provides options to cancel the cycle and displays error messages.
- Access Levels: The STERLINK mini offers different access levels:
- Operator-level access: Allows users to perform daily operations, start and cancel cycles, print cycle history reports, and view cycle history files.
- Administrative-level access: Includes all authorities of operator-level access, plus additional privileges such as running diagnostic tests, performing calibration, emergency action functions, and system setup.
- Service-level access: For use by Plasmapp customer service representatives, including software updates and modification of process parameters.
- Additional Utilities Menu: This menu allows administrators to configure time settings, sterilization system settings, and diagnostic tests. It includes options for password management, language configuration, system configuration, and history logs.
- Reports and Data: The system automatically creates a cycle report upon completion of the sterilization cycle, summarizing the cycle date, time, process mode, and result. These reports can be printed and stored. The sterilizer also stores historical data, with the capacity to store data for the last 80 cycles.
- Medical Device Compatibility: The STERLINK mini is compatible with a wide range of medical devices, including those made of aluminum, stainless steel, titanium, polypropylene, polytetrafluoroethylene (PTFE), and silicone. It is suitable for instruments with diffusion-restricted spaces and medical devices with single stainless-steel lumens.
Maintenance Features
- Cleaning: Regular cleaning of the exterior/interior of the sterilizer is essential. This involves using a soft cloth and a mild, nonabrasive detergent solution. The chamber should be cleaned with a soft cloth or damp soft cloth with no running water.
- Replacing Printer Paper: The label printer roll should be replaced when empty. This involves opening the front cover, pressing both sides of the middle cover, removing the label-printer roll, pulling out the roll, and inserting a new label-printer roll.
- Routine Sterilizer Maintenance: The usage level of each registered sterilizer is indicated in the user registered ITS™ system. Plasmapp customer support representatives can provide guidance on maintenance.
- Long-Term Shutdown and Disposal: If the system is to be reinstalled or moved, it should be turned off and the power cord pulled from the power outlet. The system should be reactivated after long-term storage by contacting the manufacturer. Disposal of the system should be done in accordance with local regulations.
- Troubleshooting: The system provides alarm messages with intuitive figures to help users identify and resolve problems. In case of persistent issues, users should contact Plasmapp customer support. The manual includes a self-diagnosis function with an error list to help identify specific malfunctions.
- Warranty: The manufacturer provides a warranty for a period of one year from the delivery date, covering defects in materials and workmanship. The warranty does not apply to repairs or replacements required due to accident, misuse, neglect, failure to maintain, or damage due to natural disasters or fire.
The STERLINK mini manual emphasizes several safety warnings and cautions:
- Hydrogen Peroxide: Concentrated hydrogen peroxide is corrosive and can cause severe irritation to the skin, eyes, nose, throat, and gastrointestinal tract. Users should always wear latex, PVC (vinyl), or nitrile gloves when handling items from the sterilizer.
- Disposal of Hydrogen Peroxide: Hydrogen peroxide is a hazardous medical waste and should be disposed of in accordance with applicable local regulations (U.S. Waste Disposal Regulations: U.S. EPA 40 CFR 262).
- Electrical Shock Hazard: The device must be connected to a power supply with protective ground.
- Hot Surfaces: The interior of the sterilizer chamber may be hot. Do not touch the inside of the chamber or door without protective gloves.
- Hand Crush Hazard: Keep hands away from the device during operation.
- Respiratory Irritation: Inhalation of hydrogen peroxide vapor can cause severe irritation. If inhaled, move to a location with fresh air.
- Non-Sterile Device: Cycle cancellation may result in a non-sterile device.
- Damage to Medical Instruments: Do not sterilize items or materials that are not permitted for use in this sterilizer.
- Chamber Hot: The temperature in the chamber may be very high. Wear protective gloves and be careful of burns.
- Heavy Product: The product is heavy and should be carried and moved by two or more people.
The STERLINK mini is a sophisticated low-temperature plasma sterilizer designed for efficient and safe sterilization of medical devices, offering a comprehensive solution for healthcare facilities.
To Next Page
Need help?
General
