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510(k) Data Aggregation
(343 days)
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is intended to be used in medical, dental, surgical, healthcare, and laboratory applications (e.g hospitals, nursing homes, surgical centers, healthcare clinics, or dental offices) to sterilize heat and moisture-stable reusable loads that are solid, hollow, porous, or delicate, in either wrapped or unwrapped arrangements.
Validated sterilization cycles of LifeUltra include:
Class B cycles
- 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments, hand pieces, textiles, and porous loads (max 7 kg).
- 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate or wrapped/unwrapped loads (max 7 kg).
Class S cycles
- 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments and hand pieces (max 7 kg).
- 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate loads (max 7 kg).
The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).
This autoclave uses steam as a sterilizing agent.
The autoclave is equipped with a vacuum system, which supports:
- Removal of residual air from packs and porous load and most kinds of tubes (rubber, Plastic etc.) by vacuum at the first stage of the cycle.
- Steam penetration into the load; resulting in effective sterilization.
- Temperature uniformity.
- Post sterilization drying phase
The device has a built-in thermal printer with the following feature:
- The Thermal printer can print the cycle data immediately after cycle completion.
- The print data includes Realtime values of Temperature (°C/°F) and pressure (Bar/kPa) including the overall cycle time.
- The print data also includes overall conditioning time, pressurizing time, sterilization time, and the drying time with the maximum and minimum temperature attained during the sterilization along with the Pass/Fail results.
LifeUltra™ is controlled by a micro-controller with installed software that has pre-set programs to run standard B, S sterilization cycles and test cycles. Saturated steam for sterilization is generated from distilled water, produced in an onboard water distiller, so users can directly tap into municipal facility water. For this feature, the device is programmed to run an automatic water distilling cycle and a manual tank descaling cycle. The integrated software manages the air-water-steam system through precision sensors, probes, and switches that both monitor and control the device's vital parameters in real-time, assuring safe and successful results. The operation of the device is through a back-lit display and control interface.
The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.
The chamber door has the following features protecting personnel from hazards:
- One door micro-switch indicates that the door is closed. Without this indication steam is not introduced into the chamber. An electrical door locking pin that blocks door opening during cycle operation. The micro-switch prevents opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
- Additionally, a mechanical lock that blocks door opening at positive pressure.
In addition, the following safety devices are installed in the autoclave to optimize its safe operation:
- A safety thermostat to prevent over-heating of the chamber heating elements.
- A safety thermostat to prevent over-heating of the steam generator.
- A pressure safety valve to prevent over-pressurizing of the chamber.
There is a municipal water inflow input port for up to 500 ppm. There are 2 output ports for demineralized water tank and wastewater tank overflow/drain outlet. The chamber is made of corrosion-resistant 316L stainless steel, and the door is made up of Aluminum Hard Anodized with Teflon coating. The outer covers are made of Carbon Steel with coating.
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