Revolutionary Science Saniclave 200, RS-SC-200 Instruction Manual

The Saniclave 200

Instruction Manual

RS-SC-200

Revolutionary Science RS-SC-200

Table of Contents

Introduction 2

Display, Symbols, Control and Parts 3

Installation, Instructions and Intended Use 4

Intended Use 4

Safeguards and Cautions 5

Operating the Saniclave 200 6

Printer 6

Troubleshooting and Error Modes 10

Warranty, Registration and Policy 12

Instruction Manual for the

Saniclave 200

Specifications 13

Contact Information 13

Checklist and Notes of Service Record 14

Care, Storage and Maintenance 15

Sterilization Monitoring Guidelines 16

NOTE: Read this manual before use! This manual contains important information, safeguards

and operating instructions for the operation of the REVOLUTIONARY SCIENCE model RS­SC-200 Saniclave 200 by Alternative Pioneering Research & Development, Inc. (APR&D, Inc.)

© Alternative Pioneering Research and Development, Inc.

1

Introduction

Dear Valued Customer,

Thank you for purchasing the Revolutionary Science RS-SC-200 Saniclave 200. We are
confident that when used correctly, the Saniclave 200 will provide years of reliable service.
The high quality of construction and durable parts deliver a performance equivalent to much
costlier equipment.

You are invited to visit our web site at www.revsci.com. Please know that we welcome any
feedback that might help us enhance and improve future RevSci products.

Sincerely yours,

REVOLUTIONARY SCIENCE

2

3

Installation Instructions

Remove Saniclave 200 from packaging and place it on a dry level surface. Plug it into an
accessible 120 VAC power receptacle. For printer setup, see page 6. The Saniclave 200 is
now ready for use. See operating instructions on page 7.

Upon receiving the Saniclave 200, it is important that you follow these simple steps:

1. Examine carton and contents for possible damage to the product caused during shipping.
If damage is present contact carrier at once. Failure to do so immediately may
release the carrier from any liability of damage.

2. Fill out the checklist (see instruction manual). If the shipment is incomplete, please
contact us at [e-mail] or 651-257-0633.

3. Carefully read this instruction manual before operating the Saniclave 200.

4. Fill out warranty registration card and mail it to

Revolutionary Science

17319 Lake Blvd.

Shafer, MN 55074.

Intended Use

The Revolutionary Science Saniclave 200 is designed to be used in medical and dental clinics,
hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize
wrapped and unwrapped heat and moisture stable solid instruments, mated surfaces, knurled
and hinged devices (excluding lumened devices and dental hand pieces) that are compatible
with saturated steam sterilization at 121 degrees Celsius for 30 minutes.

4

Safeguards & Cautions

WARNING! Do not use this autoclave in an explosive or oxygen rich atmosphere. Failure
to do so may result in serious injury or death.

Limitations of Use

Revolutionary Science is not responsible for misuse of the Saniclave 200

1. NEVER attempt to dismantle or modify the Saniclave 200.

2. NEVER leave operating Saniclave 200 unattended.

3. NEVER block drain (located on the inside of the chamber below heating element).

4. NEVER block steam trap (located on the inside of the chamber, near the top, directly above drain).

5. NEVER operate the Saniclave 200 with a damaged cord or plug or after the appliance malfunctions
or has been damaged in any manner.

6. NEVER use accessory attachments not recommended by Revolutionary Science. Their use may
cause fire, electrical shock or injury.

7. NEVER place the Saniclave 200 or any part of the Saniclave 200 on or near a hot gas or electric
burner or other heating source.

8. NEVER use the Saniclave 200 or any purpose other than the intended use.

9. ALWAYS close the door properly before operating.

10. NEVER attempt to force the door open or release pressure while sterilizer is in operation.

11. ALWAYS turn off the unit by using the 'CLR/OFF' button before unplugging the Saniclave 200 from
the power outlet.

12. ALWAYS use ONLY distilled water and never fill chamber with more or less than the
recommended amount of distilled water.

13. NEVER reuse water left in the exhaust tank. Re-used water may contain endotoxins. Drain
water tank and refill chamber with clean, distilled water before each cycle.

14. NEVER attempt to modify the plug to fit an outlet other than the required 3-slot, grounded outlet.
The enclosed 3 prong plug is equipped with a grounded type 3 conductor wire to further ensure
the safe operation of the Saniclave 200.

15. NEVER immerse the autoclave, cord, or plug in water or operate on wet surfaces.

16. NEVER fill the exhaust tank with water (See page 3 for location of exhaust tank and cap). The
Saniclave 200 must be filled by pouring water directly into the chamber.

17. ALWAYS load the Saniclave 200 with instruments compatible with steam sterilization at 121
degrees Celsius for at least 30 minutes. Always contact the instrument’s manufacturer if you are
unsure that this sterilization technique is suitable for instruments being sterilized.

18. ALWAYS inspect the silicone seal before each use for dirt, grime or cracks.

19. NEVER clean the Saniclave 200 with organic solvents like thinner or benzene. It will damage the
surfaces.

20. ALWAYS test regularly with Geobacillus stearothermophilus. See page 14 for sterilization
monitoring and control for more information.

21. This sterilizer has not been validated for double pouching.

Operating the Saniclave 200

5

Preparation for Sterilization (Default mode)

1. Warm up cycle: Run a warm up cycle each day prior to use. Cycle may be aborted during the
sterilization mode to conserve on time. Remove door. Unplug the cord, replug the cord and
commence with sterilization needs.

2. Preclean instruments according to their manufacturer's recommendations.

3. Follow instrument manufacturer’s instructions for correct cleaning and lubricating procedures.

WARNING! Failure to properly clean instruments before autoclaving, may result in unsterile
equipment. Using unsterile equipment may result in serious injury or death.

4. It is recommended that all instruments be dismantled, if possible.

5. Make sure packs do not touch. Do not stack packs or single piece instruments on top of each
other.

CAUTION: Stacking instruments improperly may result in unsterile equipment!

6. Use a sterilization indicator strip with each set of instruments being autoclaved.

7. The recommended load is 4.5 lbs (not including the rack). Never exceed the maximum load.

Exceeding maximum load may result in unsterile equipment.

8. Run a biological indicator spore test (Geobacillus stearothermophilus) at least weekly to confirm
proper sterilization. For additional information on purchasing biological indicators, see page 12.

Printer installation and operation

The recommended printer model is the Zebra 2844 with a serial cable connection. Printouts should be made in accordance to

your facility’s standard operating procedures. Printers are available for purchase through Revolutionary Science. Printer
paper must accommodate printout width of 4 inches. Follow printer manufacturer’s recommendations for regular repair,
cartridge replacement and service.

The printer must be powered and connected to the Saniclave 200 via a serial cable prior to use. Sufficient paper must be

installed in the printer. At the end of the cycle (whether it is a complete cycle or a failure), the SET button, found on the
control panel may be pressed to obtain the printout. If the Saniclave 200 is reset or powered down, the printout data
cannot be recovered.

Sample printout. A successful printout should look similar to the following:

6

Operating Instructions

1. Place Saniclave 200 on a dry, level surface.

2. Remove chamber door by rotating door counter clockwise.

3. Fill chamber with 500mL of distilled water.

4. Place rack in the bottom of the chamber and place instruments to be sterilized (wrapped or
unwrapped) on top of rack.

5. Inspect the door to assure that the seal is clean and not damaged. Be sure that the inner portion of
the door is also clean and clear, ensuring a secure fit.

6. If the silicone seal has been removed re-install silicone seal in the door by evenly tucking seal
under all lugs. Seal may be cleaned with warm, soapy water (replace seal when it becomes
noticeably cracked or worn).

7. Place the door on the chamber, ensuring that the arrow on the door is aligned with the “open”
arrow on the autoclave.

8. Press the door in snugly and gently turn the door handle clockwise until it can no longer turn. The
door arrow should be aligned with the “close” arrow on the autoclave.

9. Insert the plug of the cord into the wall outlet. NEVER modify the plug to make it fit, as the plug will
only fit in one way. Autoclave must be grounded when in use.

10. Standby Mode: The 4-digit LED indicator will turn on and appear as “0000.”

11. Press 'START/STOP' to begin the default 30 minute sterilization cycle.

12. Preheat Mode: Display will change to 'Ph' for the preheat mode (about 25 minutes).

13. Observe the display. If an error warning is displayed, the cycle will be aborted (see
troubleshooting section on page 10).

14. Sterilization Mode: After the preheat mode, the display will automatically begin to count down
from 30 minutes. For your convenience, the display will show the temperature reading. To view
the pressure or cycle time left, see page 8

15. To abort the cycle at any time, press 'START/STOP' again. Display will then read “Err 1” and
chamber will instantly depressurize. Allow a few minutes for the chamber to depressurize before
opening the door.

16. Drain Mode: At this point, the display will read “dry” and the unit will automatically depressurize.

Due to door locking safety feature of the silicone seal, the opening of the door is not possible until

the chamber is completely depressurized.

You may hear sound of the chamber depressurizing. This is normal.

17. Dry Mode: After the chamber drains, the autoclave will sound an audible alarm that reads “turn
door.” Rotate door counter clockwise until it is in the “open/dry” position. Then press the
ADVANCE button and the alarm will cease. During this mode, the heater warms the chamber for
30 minutes. Moist air vents out of the door gap.

18. Cycle Complete: “CC” will display if the cycle was successful.

19. Print Mode: If the Saniclave 200 is connected to a printer, a cycle report will print when SET
button is pressed, showing the date/time, preset and achieved parameters.

Caution: internal chamber contents may be hot to the touch.

7

Recommended Load Configuration

Load including the trays must not exceed 4.5 lbs.

Cycle Phases

Fill Display reads “Fill” if the 'START' button is pressed and the chamber has

not yet been filled with sufficient water.

Preheat Mode. Display will read 'Ph' for Preheat. This mode will usually last for

about 30 minutes, depending on the load size.

Sterilization Mode Display will show temperature in Celsius:

• Press ADVANCE to view the pressure reading in PSIg.

• Press SET to view the cycle time remaining.

Dry Mode When the sterilization cycle is successfully completed, the display

will read 'dry,' for drain mode. As the water drains, the chamber
completely depressurizes and shortly thereafter (if selected), the
Dry Mode begins. Display will alternate between “dry” and the 30
minute timer. When the display reads “turn door,” the door must
be opened by rotating the door counter clockwise to the “open/dry”
position until the Dry Mode is complete.

CC Mode After a successful completion of the entire cycle, the display will

read 'CC' for Cycle Complete. Remove the door and remove the
instruments. Instruments may be warm to the touch.

Print Date/time, preset and achieved parameters are printed only if the

printer is on and properly connected to the printer port.

8

Setting Your Saniclave 200.

The sterilization cycle parameters are as follows: 30 minutes, 121C, 15psi. The sterilization
cycle parameters cannot be adjusted.

Load Settings

Load type Instructions

Unwrapped Loads

Wrapped Loads

Note: For wrapped loads, the user must use wraps or pouches that are cleared by the
FDA for human use. Unwrapped loads must be used immediately upon sterilization.

Set Time and Date – To set the time and date, press and hold the 'SET' button. The

'ADVANCE' button may be used to advance from the time, date and year. The 'START'
and 'SET' buttons can be used to adjust the settings up and down. Disconnecting the
power between uses may interrupt the clock's timing. Date and time may need to be
reset. If set correctly, the time and date will be printed on the printout.

Print – To print, the printer must be connected to mains and plugged into the Saniclave 200

prior to use. After a cycle is complete, when display reads 'CC,' press the SET button
once. Other than the cycle count, date and time, the Saniclave 200 does not store cycle
data. If you wish to keep records, the printer must be properly connected.

Press and hold the ADVANCE button. The display should change
from “0000” to “oooo.”Press ADVANCE once more. The SET button
can be used to toggle between “dry” and “off.” Select "off." Dry
mode will not commence at the end of the cycle.

The dry mode should not be used for unwrapped loads.

Press and hold the ADVANCE button. The display should change
from “0000” to “oooo.”Press ADVANCE once more. The SET button
can be used to toggle between “dry” and “off.”Select "dry."Dry time
is 30 minutes.Dry mode will commence at the end of the cycle.

The dry mode should be used for wrapped loads.

See page 6 for more printer information.

9

Troubleshooting

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. Contact Revolutionary Science if problem persists.

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 arrows 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 the problem
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.

10

6. Exhaust tank full: The display will read 'Fill' if water is in the exhaust
tank. Drain water from the tank into a sink or bucket
by opening the manual drain valve. Close the valve
and restart the cycle.

Printouts

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.

Additional errors

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 200 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 valve is left

open. Check drain valve and move it into the 'closed'
position. If leaking persists, unplug from mains and
contact Revolutionary Science.

If any of the above occurs, turn off Saniclave 200 and investigate. If problem persists,
contact Revolutionary Science

11

Warranty Registration

Please fill out this page, or a copy of it, and send it to the address below to validate your
warranty. Warranty Registration Card for the REVOLUTIONARY SCIENCE RS-SC-200
Saniclave 200. (Please Print)

Date Purchased ______________________ Serial Number_____________________________

Purchased
From________________________________________________________________________

(Please check one) ________ Company ________ School ________ Individual____

Name of Department or Institution:

____________________________________________________________________________

Address:

____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________

Intended use:

____________________________________________________________________________

Where did you hear of our product?
____________________________________________________________________________

Comments:

____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________

Warranty

Your REVOLUTIONARY SCIENCE RS-SC-200 Saniclave 200 is warranted to be free from
defects of material and workmanship under normal use for a period of two years from date of
purchase. If your RS-SC-200 Saniclave 200 proves to be defective within this warranty period,
APR&D, Inc. will repair or replace your unit at our option. This warranty will be void if
malfunction is caused by accident, misuse, negligence, tampering, abuse, and/or damage in
transit. This warranty excludes any relief for incidental or consequential damages.

12

Specifications

Power requirements: 120 VAC, 500 watts,
grounded outlet

Net weight: 20 lb.

Dimensions: 16 in. tall x 13.5 in. wide x

21 in. deep

Internal chamber dimensions: 9 in. diameter x 10.5 in. long

Pressure: 15-18 psi

Normal operating temperature: 121-124°C

Temperature lower tolerance: 121°C

Temperature upper tolerance: 124°C

Preheat time: Automatic

Sterilization time: 30 minutes

Dry time: 30 minutes

Capacity: 12.5 Liters

Further Questions?

Contact Information

Revolutionary Science

17319 Lake Blvd

Shafer, Minnesota 55074, USA

Customer Service: 1(800) 775-7942

Technical Assistance: [phone]

Fax: [phone]

Web site: www.revsci.com E-mail: [e-mail]

13

Checklist

(See page 3 for visual identification of checklist parts)

Part: Model number:

_ Autoclave 200-A00001

_ Door 100-A00002

_ Silicone seal 200-A00003

_ Rack 100-A00004

_ Manual 310-A00001

_ Detachable power cord

Notes & Service Record

For your own future reference and to expedite answers to your questions, please complete the
following information:

Date Purchased: _________________________________________

Serial Number: __________________________________________

Model Number: __________________________________________

Purchased From: _________________________________________

Your Notes:
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
________________________________________________

Revolutionary Science recommends the weekly use of G. Bacillus Stearothermophilus
biological indicator ampules. Place indicator in center of full load and test weekly.

14

Care, Storage and Maintenance Instructions

Daily Inspect and clean door gasket wild 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.

Weekly Clean rack and coils with warm water and a mild soap or detergent. Inspect rack

and holder 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 and

ink cartridges as needed and according to printer manufacturer's instructions.

For regular Sterilizer Monitoring Guidelines, see page 16

When storing the Saniclave 200:

1. Disconnect Saniclave 200 from mains and printer.

2. Drain all water from the chamber and exhaust water tank. To drain the water
exhaust tank, turn the manual drain valve (located in the rear, right side of the
unit to the open position. When exhaust tank is empty, close the manual drain
valve.

In the rare situation where water remains in the chamber after use (such as after
a power failure). Drain the chamber by tipping the Saniclave 200 unit forward,
emptying the chamber into a shallow vessel or sink.

Caution: Water from the exhaust water tank or chamber may be warm or
hot!

3. When your Saniclave 200 is cool, wipe both the exterior and the interior of the
autoclave with a clean, dry paper towel or terry cloth. If needed, clean plastic
parts with warm water or isopropyl alcohol. To remove calcium buildup, pour a
small amount of calcium, lime and rust removal (such as CLR® ) into chamber
and clean thoroughly with a dry terry cloth.

ALL REPAIRS MUST BE PERFORMED BY A TRAINED PROFESSIONAL. CONTACT
REVOLUTIONARY SCIENCE FOR MORE INFORMATION. (SEE THE CONTACT SECTION
ON PAGE 12)

15

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. A record of each load's actual cycle time, temperature and
pressure can be created by use of the optional printer.

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 200. 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: Improper wrapping , packing and loading
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
200 shall be used to monitor sterility conditions of loads processed in Saniclave 200.

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: Improper
wrapping , packing and loading 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 200 shall be used to monitor sterility of loads
processed in Saniclave 200.

Use an FDA approved biological indicator (BI) weekly to confirm sterility. Follow the BI
manufacturer's instructions. Revolutionary Science recommends the use of BI's manufactured by
SPS Medical.

SPSmedical Supply Corp. 6789 W Henrietta Road Rush, NY 14543 USA
[phone] www.spsmedical.com

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