Autoclave 102 - FDA Cleared - Steam Saniclave

• 8 liter stainless steel chamber

• Sterilizes solid instruments, great for microbiology, cooking media or agarose, garbage, general lab use and veterinary.

• Standard 121ºC, 30 minutes.

• Lightweight, portable, burn-free exterior.

• Approved for human medical use.

Saniclave-Autoclave 102 – FDA Cleared

The FDA approved, American Made Saniclave 102 is fashioned with a simple push button operation. The thermally protective polymer skin eliminates burn risk. Low water and under and over temperature alarms assure safety and effectiveness during operation. A corrosion resistant, stainless steel chamber makes this steam sterilizer durable and easy to clean. The Saniclave 102 delivers exceptional performance at a low price. The product includes all standard accessories and literature, internal basket, seal, etc. This medical grade sterilizer is perfect for General Medical, Dental, Chiropody, Veterinary, Laboratory, Tattooing, Body Piercing, Health, Nail and Cosmetic applications.
Assembled in USA

IEC/CE marked for electrical safety

FDA cleared K12297

SPECIFICATIONS

Pressure: 15 psi
Internal Temperature: 121°C
Sterilization Cycle: 30 minutes
Capacity: 8L
Net Weight: 5.4kg (12lbs)
Power Requirements: 110-130 VAC, 50-60 Hz, 1250 W
Display: Digital time and/or temperature
Durability: Rugged stainless steel chamber and cover
Safety: Over temperature alarm
Load type: Solid, non-lumened, unwrapped medical instruments

Dimensions
External: 13” tall x 12.5” wide x 15” deep
Internal: 9” diameter x 8” tall

FEATURES

One button operation
Durable construction
Safe burn free exterior
Display: Digital time and/or temperature
Safety: Over temperature alarm
Rugged stainless steel chamber and cover
Load type: Solid, non-lumened, unwrapped medical instruments

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.

Area of Focus

Microbiology

Veterinary

General lab use

Academia

Applications

Bacteria slides

Liquid media

Used Petri plates

BHRT Trocars

Scalpels

Dental (excluding dental handpieces)

Liquid media

MAINTENANCE INSTRUCTIONS

Daily
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.
Weekly
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.
As Needed
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

Note
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.

Physical Monitors
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.
Note
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.

Chemical Indicators
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.

Biological Indicators
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).

TROUBLESHOOTING

Note: If an error occurs a warning will show on the display and alarm will sound. The load must be considered non-sterile. The sterilizer and load should then be investigated. Contact Revolutionary Science if problem persists.

Display does not turn on.
If the power cord is unplugged, display will go blank to signal a power disruption or an aborted cycle. User may abort the cycle anytime, during, preheat or sterilize. By unplugging the power cord. If power cord is plugged back in, the display will read ‘-00’ for ‘standby mode.’ The contents of the load shall be considered non-sterile.

If the power cord is plugged in and the display is blank, the cover may not be properly closed and the tab may not be engaging the safety switch in the back of the autoclave. Close the cover again with the tab properly inserted into the slot in the back. See page 8 in manual.

Error: Preheat too long (Leaky seal): Display reads “Lo”
If the chamber gets warm and the door seal is in need of replacement, the display will read ‘Lo’ Press ‘START’ 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 arrows on door and on body and twisting the door closed. Restart the cycle.

Error: Preheat too long (Leaky ZPD): Display reads “Lo”
The ZPD valve is one of the most important parts of the Saniclave. When the steam builds, the ZPD rises and seals so the chamber can build pressure for sterilization. If the chamber gets warm and the ZPD valve (small, blue and aluminum valve inside the chamber cover) is damaged or not fully engaging, steam will continue to leak out the vent tube in the back during sterilization or the cycle will abort and the display will read ‘Lo.’ Press ‘START’ to acknowledge the error. Take off the cover. Inspect the ZPD grommet (small blue grommet in the center of the cover) for cracks. Replace with a new ZPD if necessary. If installed correctly, the ZPD should hang and move up when pushed up and drop down loosely under it’s own weight . Inspect the white rubber steam vent directly above the ZPD to confirm that it is not interfering with the ZPD rising. The two screw handles can be removed for further inspection of the ZPD and steam vent.

Error: Over Temperature Alarm: isplay reads “Oht”
If temperature exceeds the maximum of 124°C the display will read ‘Oht.’ Press ‘START’ 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.

Error: Low Water: Display reads “Lo”
The door must close properly or there will be no power. Verify the door tab is engaged with the corresponding slot in the back of the unit. This will activate safety switch. The tab on the door, must be inside that slot to actuate the safety switch.

Power Outage. Display reads  “–00” partway during cycle initiated.
If a power outage occurs the display will revert to standby mode and read ‘-00.’ 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.