3M 1292 Benutzerhandbuch

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Validation of Reduced Incubation Times (Readout Reliability Data)
The 3‑hour and 48‑hour incubation times have been correlated with a 7‑day incubation period. Sterilized indicators were examined daily for detection of a visual pH color change. The 
3‑hour fluorescence change reading and the 48‑hour visual pH color change reading were compared to the 7‑day visual pH color change readings to determine the readout reliability of 
the indicator. Readout reliability of the Attest™ 1292 rapid readout biological indicator was determined using the sensitivity calculation described below:
Sensitivity =      (Number of Growth Positives after 168 hours) – (Number of False Negatives)      X 100
Number of Growth Positives after 168 Hours
Attest™ 1292 Rapid Readout Biological Indicators 
121°C (250°F) Gravity Displacement and 132°C (270°F) Vacuum Assisted 
Steam Sterilization Processes 
Validation of Reduced Incubation Time ‑ Readout Reliability Summary
Sterilization 
Process
Incubation 
Temperature
Tested
# Growth 
Positives at 
168 hours
Growth
Fluorescence
# False 
Negatives at 
48 hours
Sensitivity 
at 48 hours
# False 
Negatives at 
3 hours
Sensitivity 
at 3 hours
121°C (250°F) 
Gravity 
Displacement
60°C (140°F) 1620
800
5
99.4
0
100
132°C (270°F) 
Vacuum 
Assisted
60°C (140°F) 1270
654
2
99.7
0
100
These data demonstrate that ≥ 97% of the 7‑day (i.e. 168 hours) growth visual positives were detected by fluorescence within 3 hours of incubation and by the visual pH color within 
48 hours of incubation. The 3M™ Attest™ 1292 Rapid Readout Biological Indicator therefore meets readout reliability of ≥ 97% for the 3 hour fluorescence results and the 48 hour 
visual color change results.
Explanation of Symbols
Caution, see instructions for use
Do not reuse
Use by date
Batch code
Manufacturer
Catalog number
For France and other countries that 
recognize the CE mark for this device.
Made in U.S.A. by
 3M Health Care
2510 Conway Ave. 
St. Paul, MN 55144 
1‑800‑228‑3957 
www.3M.com
3M and Attest are trademarks of 3M. 
Used under license in Canada. 
© 2013, 3M. All rights reserved. 
3M Deutschland GmbH 
Health Care Business 
Carl‑Schurz‑Str. 1 
41453 Neuss 
Germany