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3M 2134MM - Comply Thermalog Steam Chemical Indicator 4"X3/4", 250/PK
2134MM Steam Chemical Integrators250F/121C and 270F/132C gravity and vacuum-assisted steam sterilization processes
3M Comply 2134MM Steam Chemical Integrators are chemical indicators consisting of a paper wick and steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked SAFE or UNSAFE; the extent of migration depends on steam, time, and temperature.
As an internal pack monitor, the 3M Comply (Thermalog) Class 5 Steam Chemical Integrators offer immediate, accurate and easy to read method of monitoring the sterilization process conditions inside each pack. It can be used in all steam sterilizers. The easy-to-read moving front style has been shown to have a higher reading accuracy than color interpretation style indicators.
Class 5 Integrating Indicator as classified by ANSI/AAMI/ISO 11140-1:2005 and EN/ISO 11140-1:2005.Stated Values: See Stated Values listed in the table on the front of the package. The table lists the time in minutes at the corresponding temperature for chemical indicators inthis lot to reach their endpoint when tested in a steam resistometer under highly controlled conditions with saturated steam.This compares with a 1 x 106spore population of Geobacillus stearothermophilus with a D-value of 1.6 minutes at 121C and a z-value of 10.0C.
- After processing in vaporized hydrogen peroxide, the blue bar changes to the color of the color match or pink. If the color change is not complete, inadequate exposure to vaporized hydrogen peroxide is indicated.
- For use in STERRAD 100 System, STERRAD 100S System, STERRAD NX System, and STERRAD 100NX System vaporized hydrogen peroxide sterilizers.
- Consistent blue-to-pink color change for all 3M chemical indicators for vaporized hydrogen peroxide.
- ANSI/AAMI/ISO 11140-1:2005 Class 5 Integrating Indicator for use in determining whether the steam sterilization process conditions were met inside each pack.
- Can be used in all 250-275F steam sterilization cycles.
- Moving front ink technology provides easy to read "Safe or Unsafe" result.
- Response correlates with a Biological Indicator at 3 time/temperature relationships under ideal steam sterilization conditions.
Instructions for Use
- Carefully tear or use scissors at the tear notch at the top of the foil package to make the initial opening. Remove only the number of Comply 2134MM steam chemical integrators needed. Reseal the package.
- Place a Comply 2134MM steam chemical integrator in the center of each pack, peel pouch or unwrapped tray to be steam sterilized. Place a chemical integrator in at least two opposing/diagonal corners of rigid containers or in the area determined by product testing to be the greatest challenge.
- Process the load according to established procedures.
- After processing, the dark color should have entered the SAFE window of the Comply 2134MM steam chemical integrator. If the dark color has not entered the SAFE window, an UNSAFE result is indicated and the items in the pack, peel pouch, unwrapped tray, or rigid container were not exposed to sufficient steam sterilization conditions. These items should be returned for reprocessing.
- If several packs, peel pouches, or trays in a load contain integrators with UNSAFE results, review the biological indicator results. Check all areas of the process for cause offailure.
Product Details
- Manufacturer: 3M Health Care
- Manufacturer's Product ID: 2134MM
- Brand: Comply
- Size: 4" x 3/4"
- Model: 2134MM
- Product Type: Chemical Indicator
- Product Use: Pack Monitoring
- Sterilization Method: Steam
- Trademark: Comply
- Width: 0.7 Inch, 0.75 Inch