Spore Test Strip for S40® Instructions

Italian

Intended Use

The Verify® Spore Test Strip for S40® is intended to provide users with a means to assess spore kill by S40 sterilant use dilution in the SYSTEM 1E Liquid Chemical Sterilant Processing

System. A “no growth” result from the Verify Spore Test Strip for S40 after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary

to kill at least 1 x 105 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the SYSTEM 1E Liquid Chemical Sterilization Cycle.

Twenty (20) spore strips contained within individual glassine envelopes are provided along with twenty (20) media vials containing a modified tryptic soy broth with phenol red pH indicator,

The Verify Spore Test Strip for S40 is validated for a 24-hour incubation period for Geobacillus stearothermophilus, and it contains sufficient growth medium for incubation up to seven

days, if desired.

INSTRUCTIONS FOR USE: (Refer to diagrams)

1. Load the SYSTEM 1E Processor as directed in its Operator Manual.

2. Aseptically open one glassine envelope by peeling two sides apart at the arrow. Peel apart far enough to expose the end of the spore strip (2).

Caution: The Packaging Of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

3. Using the provided transfer clip, grasp the spore strip and remove it from the glassine envelope (3).

4. Place transfer clip and spore strip in processing tray channel (4a), accessory rack or in processing container (4b).

Note: The Verify Chemical Indicator for SYSTEM 1E Processor should be used with each spore strip tested. Refer to the Verify Chemical Indicator for SYSTEM 1E Processor instructions.

5. Run the SYSTEM 1E Liquid Chemical Sterilization Cycle per the Operator Manual.

from vial (8a,8b).

9. Aseptically remove the transfer clip with the processed spore strip from the SYSTEM 1E Processor, taking care not to touch spore strip or allow it to touch a non-sterile surface (9).

10. Insert spore strip into previously opened vial (10a). Screw vial into cap (10b). Make sure spore strip is fully immersed.

11. Mark this vial “Test” and place in incubator (11). Incubate at 55-60°C (131-140°F) for at least 24 hours. Sufficient media is provided for incubation up to 7 days.

11.1. If the Test culture demonstrates turbidity or a color change from red to yellow, the intended conditions for kill of all spores on the strip were not achieved. Follow depart-

mental procedures for reporting liquid chemical sterilization process failures. Discontinue operation of SYSTEM 1E Processor immediately and do not process devices

until failure has been investigated and resolved (see Step 13).

11.2. If the Test culture remains red and clear, this demonstrates that the S40 sterilant use dilution present in the processor was adequate to kill at least 5 logs of Geobacillus

stearothermophilus spores on the strip.

12. Verify S40 Spore Test Strip Controls

ing failures.

13. Investigation of failed Verify Spore Test Strip for S40

13.1. If Test culture exhibits growth (color change and/or turbidity) have microbiology lab identify organism type using Gram stain. The test organism is a Gram positive to Gram

variable spore forming rod. Growth of other types of organisms suggests likely environmental contamination.

13.2. If growth is not a Gram positive to Gram variable rod, assume that contamination has occurred. Thoroughly review challenge and culturing techniques to identify possible

causes prior to any subsequent testing.

13.3. If growth is identified as a Gram positive to Gram variable rod, operation of SYSTEM 1E Processor is suspect. Thoroughly review challenge and culturing techniques to

identify or rule out other possible causes. In particular, ensure that the transfer clip supplied by STERIS was used properly during testing, and that gloves were put on

after starting the challenge cycle to minimize potential for transfer of spores from handling the unprocessed Test strip or a Control strip. Repeat test.

13.4. If repeated test also shows growth of a Gram positive to Gram variable rod, assume that any items processed since the last negative (passing) test are not liquid chemi-

1. The Verify Spore Test Strip for S40 and growth medium are for single use only. Do not reuse either component.

2. Verify Spore Test Strip for S40 should not be used by anyone with color blindness specific to the colors used in the test. Ensure that users are able to correctly distinguish between the

color changes indicative of growth.

3. All personnel involved must be trained in the proper use of the Verify Spore Test Strip for S40 and a system for reporting failures must be established.

4. If there are any problems interpreting the results from this product, contact STERIS Corporation.

5. Do not use if damage or leakage has occurred to any of the media vials.

6. Verify Spore Test Strip for S40 holds a minimum of 1.5 x 105 spores upon manufacture. A limited number of spores are subject to removal during the liquid chemical sterilization cycle.

Each strip will retain a population of at least 1 x 105 spores at the end of the cycle. Therefore a “no growth” result after 24 hours of incubation indicates that the liquid chemical steriliza-

tion process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the test strip; it does not confirm the expected full performance of the SYSTEM 1E Liquid

Chemical Sterilization Cycle.

Before discarding, treat as appropriate for standard microbial waste, non-pathogenic species, e.g., steam autoclave at 121°C (250°F) for not less than 30 minutes, incinerate, or use other

suitable means.

Media showing no growth and expired culture media vials can be discarded as standard waste.

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SYSTEM 1E

Spore Test Strip for S40® Instructions