Saniclave-Autoclave 250 – FDA Cleared
The Saniclave 250 is designed and manufactured by Revolutionary Science, a leader in high tech laboratory equipment and sterilization. This American made sterilizer is one of the newest FDA listed autoclaves (K180272) on the market and is specifically designed and tested to sterilize standard medical instruments and hormone pelleting trocars. The thermally protective polymer exterior eliminates burn risk. The product includes all standard accessories and literature, internal tray, door seal, etc.
Assembled in USA
FDA cleared K180272
Power Requirements: 110-130 VAC, 50-60Hz, 700 W, grounded cord
Safety approvals: FDA cleared (K112811), IEC compliant, CE marked and ANSI/AAMI – ST55 Standard Approved, ST79 approved sterilization cycle.
Net weight: 20 lb.
Maximum Instrument Size: 12”
Chamber Capacity: 10.5L*
Chamber Dimensions: 9″ wide x 10.5″ deep
Simple push-button operation
Simple one-button automatic operation
ST79 approved sterilizing cycle
Stainless steel chamber and rugged ABS enclosure
Dry mode allows you to sterilize and dry wrapped instruments!
Front loading door
Temperature, time and pressure on digital display
Printer access port (for optional printer or computer connection)
Under and over temperature alarms
Insufficient water alarm
Silicone rubber gasket
The Saniclaves are table-top steam sterilizers, also known as autoclaves. Revolutionary Science has been manufacturing and providing the Saniclave autoclave product line since 2005.
The United States Food and Drug Administration (FDA) cleared the first Saniclave model [(10 liter Saniclave 200 and Saniclave 200P (with an embedded printer)] in 2012 for medical use, followed by the smaller 8 liter, top loading Saniclave 102 and later, the Saniclave 250 which is validated for lumened devices, such as trocars.
Steam sterilizers and autoclaves work by boiling water inside a stainless steel pressurized chamber. The heating element and sensors are controlled and read by a microprocessor to maintain precise levels of pressure, temperature and time. As the steam saturates, hot water droplets condense on the surfaces of autoclaveable instruments (referred to as the load) in pressure of 15 psi and temperature of 121C (250F) for a period of 30 minutes. Steam sterilization is judged by the FDA to be the most effective form of killing dangerous pathogens and microorganisms in both medical and laboratory settings. Although Revolutionary Science also manufactures laboratory autoclaves, all of Revolutionary Science’s medical autoclaves are assembled in the USA and registered with the FDA as Class II medical devices cleared for human use.
Common uses for the simple, small, user friendly Revolutionary Science Saniclave sterilizers are sterilizing media and asceptic techniques in the microbiology field, medical and surgical instruments, bio-identical hormone therapy (BHRT) trocars, dental instruments, orthodontic instruments, veterinary supplies, tattoo and body-art, nail salon nippers, clippers and other devices, medical waste and general clinical applications. The Saniclave is extremely popular and press releases about the Saniclave were featured on NPR, The Boston Globe and other well known news outlets.
General lab use
Inspect and clean door gasket with mild soap or detergent. Rinse with distilled water, wipe with damp lint-free cloth. Inspect for cracks. Reinstall in door. Clean Chamber with mild soap or detergent. Inspect chamber for
calcium or other deposits. Wipe with damp, lint-free cloth. If needed, repeat cleaning procedure. Do not use harsh chemicals in autoclave. Unplug unit at the end of each day.
Clean tray with warm water and a mild soap or detergent. Inspect for residues or deposits. Repeat cleaning if necessary. Rinse in warm, distilled water and wipe with a clean, lint-free cloth.
Replace door gasket if torn or cracked. If a printer is installed, replace paper as needed and according to printer manufacturer’s instructions.
STERILIZATION MONITORING GUIDELINES
Revolutionary Science provides the following information only for reference. The user must contact state and local government for proper regulations regarding sterilizer use and sterilization monitoring. In addition, the Centers for Disease Control and Prevention (CDC), American Dental Association (ADA) and the Organization for Safety and Asepsis Procedures (OSAP) may be contacted for further information regarding infection control.
Sterilizer malfunctions may be detected by pressure and temperature measurement devices. The sterilizer’s programming aborts the cycle and displays a message on the display screen if physical conditions exceed the proper limits.
Only FDA cleared chemical indicators and biological indicators designed for steam sterilization are to be used. Additionally, such indicators must be compatible with the cycle parameters of the Saniclave . When monitoring the cycle with such indicators, load the chamber according to your facility’s standard operating procedures.
The purpose of chemical indicators (CI) is to determine whether the sterilization cycle parameters are sufficient to accomplish an effective sterilization. CI’s are not intended to be used to validate the sterility of the load. However, if the CI shows failure, the load must be considered non-sterile and the load configuration and sterilizer shall be investigated, due to the fact that proper cycle parameters may have not been correctly achieved. Note: Wrapping, packing and loading improperly may result in failures. In addition, the failure may be a result of sterilizer malfunction. Check load configuration and verify that it is in accordance with the manufacturer’s instructions. Also, check the CI’s instructions for proper use, storage and disposal. Only CI’s that are cleared by the FDA and labeled for use with the same cycle parameters (of exposure time and temperature) of the Saniclave shall be used to monitor sterility conditions of loads processed in Saniclave.
Microbial devices such as biological indicators (BI) are designed to accompany a load to be sterilized. When a BI shows failure, the load must not be considered sterile. Note: Wrapping, packing and loading improperly may result in failures. In addition, the failure may be a result of sterilizer malfunction. Check load configuration and
verify that it is in accordance with the manufacturer’s instructions. Also, check the BI’s instructions for proper use, storage and disposal. Only BI’s that are cleared by the FDA and labeled for use with the same physical parameters (of exposure time and temperature) of the Saniclave shall be used to monitor sterility of loads processed in Saniclave.
Class 5 Integrators
A Class 5 integrator are a type of chemical indicator. It does not contain microbial organisms. A Class 5 Integrator monitors the time, temperature and pressure. These single use devices are calibrated to confirm that parameters have been met. Only use FDA cleared integrators that are validated for 121C for 30 minutes. Follow manufacturer’s recommendations.” Use an FDA approved biological indicator (BI) weekly to confirm sterility and STEAMPlus Class 5 integrators with each load. Follow the BI manufacturer’s instructions. Revolutionary Science recommends the use of biological indicators and class 5 integrators (not supplied by Revolutionary Science).
Error Conditions and Display Readings
Note: If a failure occurs, the load must be considered non-sterile. The sterilizer and load should then be investigated.
1. Manual Cycle Abort: If ‘START’ is pressed, display will read ‘Err 1’ for cycle abort. User may abort the cycle anytime, during, preheat, sterilize or dry modes. If cycle is aborted, the contents of the load shall be considered non-sterile. Press SET to acknowledge the error.
2. Preheat too long (Door Ajar): If door is not closed properly and the cycle is initiated, the cycle will fail when the autoclave cannot pressurize. Display will read ‘Err 2.’ Press SET to acknowledge the error. Take off the door. Remove door gasket. Inspect the door gasket for cracks. Replace with a new gasket if necessary. Reinstall gasket into door. Properly close door by lining up markings on door and on body and twisting the door closed. Restart the cycle.
3. Over Temperature Alarm: If temperature exceeds the maximum of 124°C the display will read ‘Err 3.’ Allow unit to drain the reservoir fully into the exhaust tank or sink. Press SET to acknowledge the error. Open door when chamber has cooled. Remove load from chamber. Refill reservoir. Reinsert load. Close the door. Restart cycle. If an over temperature condition occurs again, contact Revolutionary Science to investigate the problem further. Discontinue use until problem is resolved.
4. Under Temperature Alarm: If the temperature or pressure of the chamber falls below sterilization temperature of 121°C during the sterilization cycle, the digital display will read ‘Err 4.’ Press SET to acknowledge the error. Open door when chamber has cooled. Remove load from chamber. Refill reservoir. Reinsert
load. Close the door. Restart cycle. If an under temperature condition occurs again, contact Revolutionary Science to investigate further. Discontinue use until problem is resolved.
5. Low Water: The display will read ‘Err 5’ if there is an insufficient amount of water in the chamber. Press SET to acknowledge the error. Fill reservoir up to the temperature sensing probe. Restart cycle.
6. Exhaust tank full: After every five cycles, the Saniclave display will flash ‘drn tank full.’ At this point, the exhaust tank must be emptied if the end of the drain tube is not already resting in a sink or bucket. Revolutionary Science recommends that the drain tube be left in the sink or other reservoir for regular drainage. The drain tank warning can be bypassed by pressing any button. If exhaust tank is not drained after every sixth cycle, water may overflow.
7. Door is difficult to open or close:
There may be a few reasons why the door is difficult to open or close.
1) Ensure that the door seal is tucked under all lugs in the door. (see page 19 in manual)
2) The gasket offset spring (bent steel piece on the door) must rest against the outside diameter of the seal and should not overlap the seal.
3) The chamber may have not yet depressurized. Wait up to five minutes after the display reads ‘CC,’ ‘turn door’ or an error mode to attempt to open the door.
4) If the door feels loose, but it is still hanging up, the edge of the door may be caught on the edge of the chamber. Try wiggling the door loose.
5) If the door is difficult to rotate, the door seal may need lubrication. To do this, remove and dry the seal completely. Lightly dust the seal with talcum powder and spread evenly around the entire seal (or talc based baby powder) approximately once every 50 to 100 cycles or as needed. Caution: Never use oil or petroleum jelly for lubrication.
8. Display reads ‘8888’
This means that your real time clock has reset. The time and date settings will reset if the Saniclave is left unplugged longer than three days. See page 9 in manual for setting the date and time. Unplug and replug the power cord. The display should now read ‘0000’ and you can commence with sterilization. The real time clock does not need to be set properly in order to operate the Saniclave.
If the printer is connected and SET is pressed following the displayed error, a printout will provide a brief description of the failure. The printout will not display any sterilization time if the failure occurred during the sterilization mode.
Note: A printout will not be provided for the following.
Power Outage. If a power outage occurs the display will revert to standby mode and read ‘0000.’ It will not display “CC” until the Saniclave is restarted and a successful cycle is passed. This would happen even if the outage took place after a successful completion of a cycle and the unit was left unattended. If this occurs refill with water and restart sterilization cycle.
Water Leakage. Water may leak from the unit if the drain tube is not placed in a sink or water receptacle. Check drain tube. If leaking comes from another source, unplug from mains and contact Revolutionary Science.