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5. Inspect the BI to ensure that the growth medium is purple, the ampoule remained intact during the sterilization cycle, and the spore disc is lying horizontally in the bottom of the growth reservoir.
Note: If the growth medium ampoule burst during the sterilization cycle, the BI is no longer valid.
6. Touch an available well indicator number on the reader’s touch screen.
7. Touch “Test” when asked what type of BI will be added.
8. Scan the barcode on the cap label using the barcode scanner on the front of the Reader.
9. Enter the operator’s name in the space provided or select the operator’s name from the list.
10. Inspect the CI, on the top of the cap, for color change from red/pink to yellow to confirm that the BI has been exposed to hydrogen peroxide (refer to Interpretation of Results for more detailed
instructions).
11. Activate the BI before placing it in the reader. To activate, completely press cap down until the glass ampoule breaks, and visually inspect to ensure the glass ampoule has broken. Shake rapidly
to ensure liquid flows into the growth reservoir (See Figure 2). Failure to do so may result in incorrect reading.
12. Place the processed BI in the selected Reader well. Test results will be available within 30 minutes.
Frequency of Use
To maintain the highest patient safety, Advanced Sterilization Products (ASP) recommends monitoring each sterilization cycle with a STERRAD VELOCITY™ BI. Follow your hospital or healthcare
facility’s policies and procedures, national standards, and professional association recommendations for monitoring frequency of sterilization equipment. A new positive control BI should be performed
at least once every 24 hours using a BI from the same lot as the test BI. The test BI results are considered invalid if there are no positive control BI results.
Interpretation of Results
Chemical Indicator Interpretation
Read the chemical indicator (CI) result by comparing the CI color against the CI of an unprocessed BI. The CI shifts from red/pink (unprocessed) to yellow (processed) after exposure to the hydrogen
peroxide sterilization process. A processed CI may be yellow or yellow with some red/orange/brown dots.
Test BI Interpretation
A negative result on a test BI signifies that a sterilization condition was achieved (sufficient to kill at least one million of the most resistant identified bacterial spores in the BI). Test BI results are only
valid with positive control results.
A positive result on a test BI signifies that a sterilization condition was not achieved.
If a positive result is observed:
1. Follow the current hospital or healthcare facility’s policies and procedures regarding quarantine, or retrieval, and reprocessing of potentially non-sterile instruments and notification of the
physician(s).
2. Repeat the test with a second BI.
If the second BI is negative, run a third BI to confirm sterilizer performance. If either the second or third BI is positive:
i. Follow the current hospital or healthcare facility’s policies and procedures regarding quarantine, or retrieval, and reprocessing of potentially non-sterile instruments and notification of the
physician(s).
ii. Report the positive BI to ASP including the product lot number.
iii. Have the sterilizer checked by ASP and do not use the sterilizer unit until it has been checked.
Positive Control BI Interpretation
A positive result on a positive control BI indicates that both the Reader and the BI are functioning properly.
A negative result on a positive control BI could have several causes. Refer to the Troubleshooting section of the STERRAD VELOCITY™ Reader User’s Guide for detailed instructions.
If a negative result is observed:
1. Repeat the test with a second BI from the same lot number as the BI which had a negative result.
2. If the second BI is negative:
i. Consult the STERRAD VELOCITY™ Reader User’s Guide Troubleshooting section.
ii. Contact Advanced Sterilization Products (ASP).
Optional Visual Interpretation
The STERRAD VELOCITY™ Reader generates results based on fluorescence only and DOES NOT read the visual color results. Visual interpretation is optional and should only be used for frequent
monitoring when the Reader is not available.
Check the CI, on the top of the cap, for color change from red/pink to yellow to confirm that the BI has been exposed to hydrogen peroxide (refer to Chemical Indicator Interpretation for more detailed
instructions). Incubate the test BI and a positive control at 55-60°C (131-140°F) for 5 to 7 days. After incubation, inspect the growth medium in the processed BI for color change. Compare the
processed BI with the positive control and record results.
Note: For easier color comparison, observe the BIs against a white background.
The absence of a color change of the growth medium in the processed BI (i.e. the growth medium remains purple as compared to an unprocessed uncrushed BI) indicates that a sterilization condition
was achieved.
Color change from purple to yellow of the growth medium in the processed BI (as compared to the positive control BI) indicates that a sterilization condition was not achieved.
Storage
• Do not use a STERRAD VELOCITY™ BI beyond the expiration date printed on the package.
• Store BIs in a sealed foil pouch between 5ºC - 30ºC (41ºF - 86ºF) at or below 65%RH.
• Write the discard date on the shelf pack when it is first opened.
• Once opened, the STERRAD VELOCITY™ BIs should be stored between 5ºC - 25ºC (41ºF - 77ºF) at or below 50%RH.
• Discard remaining STERRAD VELOCITY™ BIs 3 months after first opening the foil pouch.
• DO NOT store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde, STERRAD
®
Cassettes, or any other
oxidizers.
Disposal
Any positive BI, including a positive control BI or any biological indicator from a cancelled cycle, should be autoclaved for at least 30 minutes at 121ºC (250ºF) or per your hospital or healthcare facility’s
policies and procedures.
STERRAD
VELOCITY
™
Biological Indicator
REF
43210
WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
State: Released; Released Date: 3/6/2019 12:02:15 AM Eastern Standard Time
