REVSCI RS-SC-200 Saniclave Front-Loader Series Sterilizer Instruction Manual

REVSCI RS-SC-200 Saniclave Front-Loader Series Sterilizer

INTRODUCTION

Dear Valued Customer,
Thank you for purchasing the Revolutionary Science Saniclave. We are confident that the Saniclave 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 website 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

Saniclave Front-Loading Series

INSTALLATION INSTRUCTIONS

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

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

1. Examine carton and contents for possible damage to the product cause during shipping. If damage is present contact carrier at once. Failure to do immediately may release the carrier from any liability of damage.
2. Fill out the checklist (see pg 14). If the shipment is incomplete, please contact us at support@revsci.com or 651-257-0633.
3. Carefully read this instruction manual before operating the Saniclave.
4. Fill out warranty registration card and mail it to

Revolutionary Science
17319 Lake Blvd. Shafer, MN 55074.

INTENDED USE
The Revolutionary Science Saniclave 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.

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.
CAUTION: Chamber contains hot water and steam during and after operation. Hot water may drip from cover during removal and can cause scalding.
Occasionally parts should be replaced with heavy usage: The door seal, Control panel decal and ZPD. These easily replaceable parts are available through Revolutionary Science. No tools are required.

LIMITATIONS OF USE

Revolutionary Science is not responsible for misuse of the Saniclave.

1. The load should be considered non-sterile unless the display reads ‘CC’ after the cycle.
2.  NEVER attempt to dismantle or modify the Saniclave.
3.  NEVER leave operating Saniclave unattended.
4.  NEVER block drain (located on the inside of the chamber below heating element).
5. NEVER block steam trap (located on the inside of the chamber, near the top, directly above drain).
6. NEVER operate the Saniclave with a damaged cord or plug or after the unit malfunctions or has been damaged in any manner.
7.  NEVER use accessory attachments not recommended by Revolutionary Science. Their use may cause fire, electrical shock or injury.
8. NEVER use the Saniclave 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 use distilled water. The sensor detects ion content in the water If distilled water is too pure, the autoclave may not detect the presence its presence. Salt may be added to the water to increase detectability. Class III distilled water is recommended.
12.  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.
13.  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.
14.  NEVER immerse the autoclave, cord, or plug in water or operate on wet surfaces.
15.  NEVER fill the exhaust tank with water (See page 3 for location of exhaust tank and cap). The Saniclave must be filled by pouring water directly into the chamber.
16.  ALWAYS load the Saniclave 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.
17. ALWAYS inspect the silicone seal before each use for dirt, grime or cracks.
18. NEVER clean the Saniclave with organic solvents like thinner or benzene It will damage the surfaces.
19.  ALWAYS test regularly with Geobacillus stearothermophilus. See page 14 for sterilization monitoring and control for more information.
20. This sterilizer has not been validated for double pouching.

OPERATING THE SANICLAVE

PREPARATION FOR STERILIZATION (DEFAULT MODE)
Important:The load should be considered non-sterile unless the display reads ‘CC’ after the cycle.

1. Preclean instruments according to their manufacturer’s recommendations.

2. Follow the 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.

3. It is recommended that all instruments be dismantled, if possible. CAUTION: Stacking instruments improperly may result in nonsterile equipment.

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

5. The recommended load is 4.5 lbs (not including the tray). Never exceed the maximum load. Exceeding maximum load may result in nonsterile equipment.

6. 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

• Saniclave: The recommended printer model is the Zebra 2844 with a serial cable connection. 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 via a serial cable prior to use.
• Saniclave 200P: The printer is affixed on the right side of the autoclave. The Saniclave 200P printer requires 2” wide thermal paper.
• 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 is reset or powered down, the printout data cannot be recovered.
• Printouts should be made in accordance to your facility’s standard operating procedures. A successful printout should look similar to the following sample printout:

Saniclave Front-Loading Series

OPERATING INSTRUCTIONS

1. Place Saniclave on a dry, level surface.

2. Remove chamber door by rotating door counter clockwise.

3. Fill chamber with approximately 500mL of distilled water (until the heating element is fully submerged and the metal portion of the temperature sensor is in contact with the water). ALWAYS use distilled water. The sensor detects ion content in the water. If distilled water is too pure, the autoclave may not detect the presence of water. Salt may be added to the water to increase detectability. Class III distilled water is recommended.

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

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

7. Closing the door: Place the door on the chamber, aligning the marking on the door with the “OPEN” marking on the autoclave. To close, rotate the door clock wise, ensuring that the marking on the door is aligned with the “CLOSE” marking on the autoclave. Never attempt to rotate the door past this CLOSE marking!Improper closing of the door can cause pressure leaks or damage to the autoclave.

8. Press the door in snugly and gently turn the door handle clockwise. The door marking should be aligned with the marking 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 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 position. Tuck the door under the retainer clips below the door opening. 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 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.

A RECOMMENDED LOAD CONFIGURATION
Load must not exceed 4.5 lbs. Stand packs upright if possible.

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 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.

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

to ‘C1’ and the preheat mode will immediately follow. Af- ter the sterilization mode is complete, the display will read ‘turn door.’ At this time, remove the door and insert the bottom edge under the retainer clips. Press ADVANCE to begin the dry mode. When the dry mode ends, the unit will read ‘CC’

This setting employs the dry mode .

Unwrapped Loads| Press the UNWRAPPED button. The display should change from 0000 to ‘C2’ and the preheat mode should commence. When the sterilization cycle ends, the unit will read ‘CC’

This setting does not employ the dry mode.

Load Settings

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 – After a cycle is complete, when display reads ‘CC,’ press the SET button once. Other than the printouts, the Saniclave does not record cycle data.
See page 6 for more printer information.

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 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.

8. Ensure that the door seal is tucked under all lugs in the door. (see page 19)

9.  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.

10. 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.

11. 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.

12. 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.

13. 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 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.

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

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 Saniclave
• (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 Saniclave 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 Saniclave 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.

SPECIFICATIONS

• Power requirements:  120 VAC, 700 watts, grounded outlet
• Net weight:  20 lb.
• Dimensions:  V
• Internal chamber dimensions: Pressure: deep 9 in. diameter x 10.5 in. long
• Normal operating temperature: Preheat time: 15-18 psi
• Temperature lower tolerance:121-124°C
• Temperature upper tolerance: 121°C
• Sterilization time:Automatic
• Dry time:30 minutes
• Capacity:30 minutes.

PRODUCT SAFETY AND COMPLIANCE STANDARDS:

• FDA Listing: RS-SC-200 is a 510k cleared product for medical use. K112811

• FDA Registered: Revolutionary Science is an FDA Registered Company

• CE / IEC Safety:

• RS-SC-200 tested to and found to be compliant with IEC 61010A and associated safety standards.

• ISO 9001: Revolutionary Science is an ISO Registered Company

• IQ/OQ/PQ:

• Revolutionary Science provides a range of compliance statements and IQ/OQ/PQ documents that will enable customers to successfully validate their products in

• accordance with regulations and standards. Contact Revolutionary Science for IQ/OQ/PQ documentation.

• CONTACT US

• REVOLUTIONARY SCIENCE
  17319 Lake Blvd. Shafer, MN 55074 USA

• Toll Free: 800-775-7942

• Fax: 775-218-7015

• E-mail: support@revsci.com

• Web site: www.revsci.com

CHECKLIST

(See page 3 for visual identification of checklist parts) Part: Model number:

•  Autoclave
• Door seal 200-A00003
• Tray 100-A00104
• Tray supportM 100-A00105
• Manual 310-A00001
• Power cord 400 -P00004

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.
The use of FDA-cleared class 5 integrators should be used with each load. Follow the manufacturer’s recommendations for class 5 integrator use.

CARE, STORAGE AND 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.

For regular Sterilizer Monitoring Guidelines, see page 17

When storing the Saniclave :

1. Disconnect Saniclave from mains.

2. Drain all water from the chamber and exhaust water tank.|
   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 unit forward, emptying the chamber into a vessel or sink.
   Caution: Water from the chamber may be warm or hot!

3. When your Saniclave 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 CLR® or Alfa Clean® 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 13)

SANICLAVE CYCLE DOCUMENTATION TABLE

Serial #| Time cycle started| Date| Set cycle parameters (default): 121C for 30 minutes| Results according to class 5 Integrator| Cycle #| Display reading at cycle end| Signature
---|---|---|---|---|---|---|---
102281A| 10:45:00

AM

|  | 121C for 30 minutes| Parameters were met| 1| CC|
 |  |  | 121C for 30 minutes|  |  |  |
 |  |  | 121C for 30 minutes|  |  |  |
 |  |  | 121C for 30 minutes|  |  |  |
 |  |  | 121C for 30 minutes|  |  |  |
 |  |  | 121C for 30 minutes|  |  |  |

It is recommended to keep records of each sterilization cycle. This table may be copied.

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).

Door Seal
Proper placement of the door seal. The door seal should be tucked under the lugs.

References

• Revolutionary Science
• Revolutionary Science

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