Revolutionary Science SANICLAVE FRONT-LOADER Series User manual

Instrucon Manual
SANICLAVE FRONT-LOADER SERIES

TABLE OF CONTENTS
Introducon 2
Display, Symbols, Control and Parts 3
Installaon Instrucons Intended Use 4
Limitaons of Use 4
Safeguards Cauons 5
Operang the Saniclave 6
Printer 6
Troubleshoong and Error Modes 10-12
Warranty, Registraon and Policy 13
Specicaons 14
Contact Informaon 14
Checklist and Notes of Service Record 15
Care, Storage and Maintenance 16
Sterilizaon Monitoring Guidelines 18
Addional Product Images 20
Instrucon Manual for the Revoluonary Science
SANICLAVE FRONT-LOADING SERIES
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NOTE: Read this manual before use! This manual contains important informaon, safeguards and operang
instrucons for the operaon of the REVOLUTIONARY SCIENCE model Saniclave by Alternave Pioneering
Research & Development, Inc. (APR&D, Inc.)
© Alternave Pioneering Research and Development, Inc.

Saniclave Front-Loading Series
INTRODUCTION
Dear Valued Customer,
Thank you for purchasing the Revoluonary Science Saniclave. We are condent
that the Saniclave will provide years of reliable service. The high quality of
construcon 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
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Rev. 11-2021

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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 oponal printer setup, see pg. 6.
The Saniclave is now ready for use. See operang instrucons on pg. 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 caused
during shipping. If damage is present contact the carrier at once. Failure to do
so 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 [e-mail] or [phone] x 2.
3. Carefully read this instrucon manual before operang the Saniclave.
4. 4. Visit the product registraon webpage provided on pg. 12 by scanning
the QR code or entering the URL manually and complete the registraon
online.
INTENDED USE
The Revoluonary Science Saniclave is designed to be used in medical and dental
clinics, hospitals and other facilies 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 compable with saturated steam sterilizaon at
121 degrees C° 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 aer operaon.
Hot water may drip from cover during removal and can cause scalding.
Occasionally parts such as the door seal, control panel decal, and ZPD
should be replaced aer heavy usage: These easily replaceable parts are
available through Revoluonary Science. No tools are required.
Saniclave Front-Loading Series
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LIMITATIONS OF USE
Revoluonary Science is not responsible for misuse of the Saniclave.
1.The load should be considered non-sterile unless the display reads ‘CC’
aer the cycle.
2. NEVER aempt to dismantle or modify the Saniclave.
3. NEVER leave an operang Saniclave unaended.
4. NEVER block the drain (located on the inside of the chamber below
heang element).
5. NEVER block the 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 aer the unit
malfuncons or has been damaged in any manner.
7. NEVER use accessory aachments not recommended by Revoluonary
Science. Their use may cause re, electrical shock or injury.
8. NEVER use the Saniclave or any purpose other than the intended use.
9. ALWAYS close the door properly before operang.
10. NEVER aempt to force the door open or release pressure while sterilizer
is in operaon.
11. ALWAYS use dislled water. The sensor detects ion content in the water
If dislled 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 dislled water is recommended.
12. NEVER reuse water le in the exhaust tank. Re-used water may contain
endotoxins. Drain water tank and rell chamber with clean, dislled water
before each cycle.
13. NEVER aempt to modify the plug to t 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 operaon of
the Saniclave.
14. NEVER immerse the autoclave, cord, or plug in water or operate on wet
surfaces.
15. NEVER ll the exhaust tank with water (See pg. 3 for locaon of
exhaust tank and cap). The Saniclave must be lled by pouring water
directly into the chamber.
16. ALWAYS load the Saniclave with instruments compable with steam
sterilizaon at 121 degrees C° for at least 30 minutes. Always contact
the instrument’s manufacturer if you are unsure that this sterilizaon
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
as it will damage the surfaces.
19. ALWAYS test regularly with Geobacillus stearothermophilus. See pg. 17
for sterilizaon monitoring and control for more informaon.
20. This sterilizer has not been validated for double pouching.
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Saniclave Front-Loading Series

OPERATING THE SANICLAVE
PREPARATION FOR STERILIZATION (DEFAULT MODE)
Important:The load should be considered non-sterile unless the display reads
‘CC’ aer the cycle.
1. Preclean instruments according to their manufacturer’s recommendaons.
WARNING! Failure to properly clean instruments before autoclaving, may
result in unsterile equipment. Using unsterile equipment may result in serious
injury or death.
2. It is recommended that all instruments be dismantled, if possible.
CAUTION: Stacking instruments improperly may result in nonsterile
equipment.
3. Use a sterilizaon indicator strip with each set of instruments
being autoclaved.
4. The recommended load is 4.5 lb (not including the tray). Never exceed the
maximum load. Exceeding maximum load may result in nonsterile equipment.
5. Run a biological indicator spore test (Geobacillus stearothermophilus) at
least weekly to conrm proper sterilizaon. For addional informaon on
purchasing biological indicators, see pg. 17.
PRINTER INSTALLATION AND OPERATION
Saniclave: The recommended printer model is the Zebra 2844 with a serial
cable connecon. Printer paper must accommodate printout width of 4
inches. Follow printer manufacturer’s recommendaons 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 axed on the right side of the autoclave.
The Saniclave 200P printer requires 2” wide thermal paper.
Sucient paper must be installed in the printer. At the end of the cycle
(whether it is a complete cycle or a failure), the SET buon, 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 operang procedures.
A successful printout should look similar to
the following sample printout:
Saniclave Front-Loading Series
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OPERATING INSTRUCTIONS
1. Place the Saniclave on a dry, level surface and rest the drain tube in a sink,
bucket, or other receptacle. Alternavely, the drain tube may be pinched shut and
the water drained every few cycles (see pg. 10).
2. Remove the chamber door by rotang door counterclockwise.
3. Fill the chamber with approximately 500mL of dislled water (unl the heang
element is fully submerged and the metal poron of the temperature sensor is in
contact with the water). ALWAYS use dislled water. The sensor detects ion content
in the water. If dislled water is too pure, the autoclave may not detect the water.
Salt may be added to the water to increase detecon. Class III dislled water is
recommended.
4. Place the tray support in the boom of the chamber, put the tray on the support,
and load the instruments to be sterilized (wrapped or unwrapped) on top of the tray.
5. Inspect the door to assure that the seal is clean and not damaged. Be sure that
the inner poron of the door is also clean and clear, ensuring a secure t.
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 noceably cracked or worn).
7. Place the door on the chamber, aligning the marking on the door with the ‘OPEN’
marking on the autoclave. To close, rotate the door clockwise, ensuring that the
marking on the door is aligned with the ‘CLOSE’ marking on the autoclave. Never
aempt to rotate the door past this CLOSE marking! Improper closing of the door
can cause pressure leaks or damage to the autoclave.
8. Insert the plug of the cord into the wall outlet. NEVER modify the plug to make it
t, as the plug will only t in one way. The autoclave must be grounded when in use.
9. The 4-digit LED indicator will turn on and show ‘0000.’
10. Press ‘START/STOP’ to begin the sterilizaon process for wrapped items. If using
unwrapped items press the ‘ADVANCE’ buon instead.
NOTE: To abort the cycle at any me, 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.
11. The display will briey read ‘C1’ or ‘C2’ for wrapped and unwrapped cycles
respecvely, then change to ‘Ph’ for the preheat mode which takes around 25
minutes to complete.
NOTE: Monitor the display for any errors. If an error warning is displayed, the
cycle will be aborted (see troubleshoong secon on pg. 10).
12. When the preheat mode is nished the display will automacally begin to count
down during the 30-minute sterilizaon cycle. For your convenience, the display will
show the temperature reading. To view the pressure or cycle me le, 12. see pg. 8.
13. Aer the sterilizaon cycle the display will read ‘drn’ and the unit will
automacally depressurize and begin draining. Due to door locking safety feature
of the seal, opening the door is not possible unl the chamber is completely
depressurized. You may hear sound of the chamber depressurizing, which is normal.
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Saniclave Front-Loading Series

17. When the chamber has completed draining the autoclave will make an audible
beep. and the screen will read ‘turn door’ or ‘CC’ aer wrapped or unwrapped
sterilizaon cycles respecvely. If you autoclaved a wrapped load, rotate the door
counterclockwise, remove the door from the chamber, and tuck the boom lip of
the door under the retainer clip so that the door gently rests against the autoclave
providing a small air gap for the drying cycle. Then press the ADVANCE buon to
begin the drying mode. During this mode, the heater warms the chamber for 30
minutes and moist air vents out of the door gap. When drying is completed, the
screen will read ‘CC’. To avoid condensaon let your items cool for an addional
30 minutes before removing. If you autoclaved an unwrapped load, rotate the
door counterclockwise, remove the door from the chamber, and recover your
items. Use cauon as internal chamber contents may be hot to the touch.
18. If the Saniclave is connected to a printer, a cycle report will print when SET
buon is pressed, showing the date/me, preset and achieved parameters.
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/STOP’ buon is pressed and the chamber
has not yet been lled with sucient water.
Preheat Mode.
Display will read ‘Ph’ for Preheat. This mode usually lasts about 30 minutes,
depending on the load size.
Sterilizaon Mode Display will show temperature in Celsius:
•Press ADVANCE to view the pressure reading
•in psi
•Press SET to view the cycle me remaining.
Dry Mode
When the sterilizaon cycle is successfully completed, the display will read ‘drn,’
for drain mode. As the water drains, the chamber completely depressurizes and
shortly thereaer (if selected), the Dry Mode may be iniated. During dry mode,
the display will alternate between ‘dry’ and the 30-minute mer.
CC Mode
Aer a successful compleon of the enre 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/me, preset and achieved parameters are printed.
Saniclave Front-Loading Series
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SETTING YOUR SANICLAVE
The sterilizaon cycle parameters are as follows: 30 minutes, 121 °C, 15 psi. These
parameters cannot be adjusted.
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 sterilizaon.
Seng the Time and Date – To set the me and date, press and hold the ‘SET’
buon. The ‘ADVANCE’ buon may be used to move from the me, date, and year.
The ‘START/STOP’ and ‘SET’ buons adjust the sengs up and down. Disconnecng
the power between uses may interrupt the clock’s ming and it may need to be reset.
If set correctly, the me and date will be printed on the printout.
Print – Aer a cycle is complete, when the display reads ‘CC,’ press the SET buon
once. The Saniclave does not record cycle data other than the printouts.
See pg. 6 for more printer informaon.
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Saniclave Front-Loading Series

TROUBLESHOOTING
Please visit the Revoluonary Science troubleshoong webpage by scanning the
QR code or entering it in manually to view instruconal videos covering potenal
Saniclave issues and their soluons.
hps://www.revsci.com/pages/troubleshoong.
Saniclave Front-Loading Series
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TROUBLESHOOTING CONTINUED...
Error Condions and Display Readings
Note: If a failure occurs, the load must be considered non-sterile. The sterilizer and load
should then be invesgated. Contact Revoluonary 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 anyme during preheat, sterilize, or dry phases.
If the 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
iniated, the cycle will fail when the autoclave cannot pressurize. The display will
read ‘Err 2.’ Press SET to acknowledge the error then take o the door. Remove
the door seal and inspect the door seal for cracks; replace with a new seal if
necessary. Reinstall the seal into door and properly close the door by lining up the
marking on the door with the marking on the autoclave body and twist the door
clockwise to close. Restart the cycle.
3. Over Temperature Alarm: If the internal temperature exceeds a maximum of
124 °C the display will read ‘Err 3.’ Allow the unit to fully drain the chamber into
the exhaust tank or sink. Press SET to acknowledge the error. Open the door
when the chamber has cooled and remove the load from chamber. Rell the
chamber with dislled water and reinsert the load, then close the door and restart
the cycle. If an over temperature condion occurs again, contact Revoluonary
Science to invesgate the problem further and disconnue use unl problem is
resolved.
4. Under Temperature Alarm: If the temperature or pressure of the chamber
falls below 121 °C during the sterilizaon cycle, the digital display will read ‘Err 4.’
Press SET to acknowledge the error. Aer the chamber has cooled open the door,
remove the load from the chamber, rell the chamber with dislled water, reinsert
the load, close the door, and restart the cycle. If an under-temperature condion
occurs again please contact Revoluonary Science to invesgate further and
disconnue use unl the problem is resolved.
5. Low Water: The display will read ‘Err 5’ if there is an insucient amount of
water in the chamber. Press SET to acknowledge the error, ll the chamber up to
the temperature sensing probe, and restart the cycle.
6. Exhaust tank full: Aer a few cycles, the Saniclave display will ash ‘drn tank
full.’ If the end of the drain tube is already resng in a sink or bucket and water
is drained aer each cycle then press any buon to clear the warning. However,
if the drain tube has been blocked by pinching, plugging, etc. because a sink or
bucket was not readily available for drainage during sterilizaon then the exhaust
tank has accumulated water during cycles. At this point, the exhaust tank must
be emped by unblocking the drain tube and allowing water to drain from the
exhaust tank into a sink or other receptacle. If the exhaust tank is not drained
water may overow during the draining phase.
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Saniclave Front-Loading Series

TROUBLESHOOTING CONTINUED
7. Door is dicult to open or close:
There may be a few reasons why the door is dicult to open or close.
1) Ensure that the door seal is tucked under all lugs in the door (see pg. 19).
2) The seal oset 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 ve minutes aer
the display reads ‘CC,’ ‘turn door’ or an error mode to aempt to
open the door.
4) If the door feels loose, but it is sll 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 dicult to rotate, the door seal may need lubricaon. To do
this, remove and dry the seal completely. Lightly dust the seal with
talcum powder (or talc-based baby powder) and spread evenly around the
enre seal approximately once every 50 to 100 cycles or as needed. Cauon:
Never use oil or petroleum jelly for lubricaon.
8. Display reads ‘8888’
This means that your real me clock has reset. The me and date sengs will reset
if the Saniclave is le unplugged longer than three days. See pg. 9 for seng the
date and me. Unplug and replug the power cord. The display should now read
‘0000’ and you can commence with sterilizaon. The real me 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 descripon of the failure. The printout will not display
any sterilizaon me if the failure occurred during the sterilizaon mode.
Addional errors
Power Outage: If a power outage occurs the display will revert to standby mode and
read ‘0000.’ It will not display ‘CC’ unl the Saniclave is restarted and a successful
cycle has occurred. This will happen even if the outage took place aer a successful
compleon of a cycle and the unit was le unaended. If this happens rell with
water and restart the sterilizaon cycle.
Water Leakage: Water may leak from the unit if the drain tube is not placed in a
sink or water receptacle. To troubleshoot rst check the drain tube. If leaking comes
from another source, unplug the machine and contact Revoluonary Science.
If any of the above occurs, turn o the Saniclave and invesgate. If the problem
persists, contact Revoluonary Science.
Saniclave Front-Loading Series
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Saniclave Front-Loading Series
WARRANTY REGISTRATION
Please visit the registraon webpage by scanning the QR code or entering it in
manually to register your Revoluonary Science Saniclave.
hps://www.revsci.com/pages/product-registraon-and-feedback
WARRANTY
Your Revoluonary Science Saniclave is warraned 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 defecve within this warranty period,
APR&D, Inc. will repair or replace your unit at our opon. This warranty will be void
if malfuncon is caused by accident, misuse, negligence, tampering, abuse, and/or
damage in transit. This warranty excludes any relief for incidental or consequenal
damages.

Saniclave Front-Loading Series
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SPECIFICATIONS
Power requirements: 120 VAC, 700 was, 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 operang temperature: 121-124°C
Temperature lower tolerance: 121°C
Temperature upper tolerance: 124°C
Preheat me: Automac
Sterilizaon me: 30 minutes
Dry me: 30 minutes
Capacity: 10 Liters
PRODUCT SAFETY AND COMPLIANCE STANDARDS:
FDA Lisng: RS-SC-200 is a 510k cleared product for medical use. K112811
FDA Registered: Revoluonary 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: Revoluonary Science is an ISO Registered Company
IQ/OQ/PQ:
Revoluonary Science provides a range of compliance statements and IQ/OQ/
PQ documents that will enable customers to successfully validate their products
in accordance with regulaons and standards. Contact Revoluonary Science for
IQ/OQ/PQ documentaon.
CONTACT US
REVOLUTIONARY SCIENCE
17319 Lake Blvd. Shafer, MN 55074 USA
Toll Free: [phone]
Fax: [phone]
E-mail: [e-mail]
Web site: www.revsci.com

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Saniclave Front-Loading Series
CHECKLIST
(See pg. 3 for visual idencaon of checklist parts)
Part: Model number:
__ Autoclave
__Door seal 200-A00003
__Tray 100-A00104
__Tray support 100-A00105
__Manual 310-A00001
__Power cord 400-P00004
Notes & Service Record
For your own future reference and to expedite answers to your quesons, please
complete the following informaon:
Date Purchased: ______________________________________________________________
Serial Number: ________________________________________________________________
Model Number: _______________________________________________________________
Purchased From: ______________________________________________________________
Your Notes:
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
Revoluonary 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 recommendaons for class 5 integrator use.

Saniclave Front-Loading Series
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CARE, STORAGE AND MAINTENANCE INSTRUCTIONS
Daily Inspect and clean door seal with mild soap or detergent. Rinse with
dislled 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,
dislled water and wipe with a clean,
lint-free cloth.
As
Needed
Replace door seal if torn or cracked. If a printer is installed, replace
paper as needed and according to printer manufacturer’s instrucons.
For regular Sterilizer Monitoring Guidelines, see pg. 17
When storing the Saniclave :
1. Unplug the Saniclave.
2. Drain all water from the chamber and exhaust water tank.
In the rare situaon where water remains in the chamber aer use (such as
aer a power failure). Drain the chamber by pping the Saniclave unit forward,
emptying the chamber into a vessel or sink.
Cauon: 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 plasc 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
Revoluonary Science for more informaon. (See the contact secon on pg. 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
1CC
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 sterilizaon cycle.
This table may be copied.
17
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Saniclave Front-Loading Series

Saniclave Front-Loading Series
18
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STERILIZATION MONITORING GUIDELINES
Note
Revoluonary Science provides the following informaon only for reference. The user
must contact state and local government for proper regulaons regarding sterilizer
use and sterilizaon monitoring. Addionally, the Centers for Disease Control and
Prevenon (CDC), American Dental Associaon (ADA) and the Organizaon for
Safety and Asepsis Procedures (OSAP) may be contacted for further informaon
regarding infecon control.
Physical Monitors
Sterilizer malfuncons 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 condions exceed the proper limits.
Note
Only FDA cleared chemical indicators and biological indicators designed for steam
sterilizaon are to be used. Addionally, such indicators must be compable with the
cycle parameters of the Saniclave. When monitoring the cycle with such indicators,
load the chamber according to your facility’s standard operang procedures.
Chemical Indicators
The purpose of chemical indicators (CI) is to determine whether the sterilizaon
cycle parameters are sucient to accomplish an eecve sterilizaon. CIs 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 conguraon and
sterilizer shall be invesgated, 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 addion, the failure may be a result of sterilizer malfuncon.
Check load conguraon and verify that it is in accordance with the manufacturer’s
instrucons. Also, check the CI’s instrucons 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 me and temperature) of the Saniclave shall be used to
monitor sterility condions of loads processed in Saniclave.