Designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture.
Sterilization Process is hydrogen peroxide gas plasma
Principle of operation combined use of hydrogen peroxide vapor and plasma safely and rapidly sterilizes most medical instruments and materials without leaving toxic residues
Recommended Materials: Common materials found in reusable medical devices. All medical devices should be processed in accordance with the medical device manufacturer’s recommendations.
Approximate Total Cycle Time: within 1 hour
Chamber Volume: chamber capacity 120-150 liter
Operator Interface: 5-12 inch touch screen
Display parameters: Temperature. Pressure. Working Time. Equipment status and alarms.
Alarms for at least:
• Power failure.
• Low water.
• Door not closed.
• Pressure and/or Temperature out-limit.
• Sterilization cycle failure.
• End of sterilization cycle.
Printer for cycle verification
Fifty hydrogen peroxide gas plasma cartridges
Risk classification: Class A (GHTF Rule 12);Class II (USA); Class I (EU, Japan, Canada and Australia)
Regulatory approvals: Should be FDA or CE approved product.
International Standard: ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes (Australia, Canada and EU)
ISO 14971:2007 Medical devices — Application of risk management to medical devices