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Characteristics

-The system consists of a reactive solution and a high absorption swab, which allows the collection of samples from different types of surfaces with the same efficiency.

-Pen diameter: 12.4 mm; Pen length: 161 mm; Swab length: 111.9 mm.

-Limit of quantification: 1.0 µg of BSA.

-Sensitivity: 0.3 μg of BSA.

-Qualitative analysis: Incubate using the Bionova® IC10/20 incubator (temperature: 60± 2 º°C; 7 minutes) and interpret visually by using the reference guide available inside the product€™s box.

-Quantitative analysis: Using the Bionova® IC10/20FR, Bionova® IC10/20FRLCD or Bionova® MiniPro auto-reader incubators. Read the instructions for use of the device previously.

Incubation time: using the Bionova® IC10/20FR or the Bionova® IC10/20FRLCD auto-reader incubators: 7 minutes; using the Bionova® MiniPro auto-reader incubators: 4 minutes. Incubation range: 60± 2 °C.

Do not open until use. Do not reuse. Do not touch the swab or the inside of the device with your hands. Wear gloves, surgical mask and other hygiene measures.

Do not freeze. High concentrations of alkaline detergents may cause false negative results in some cases. Hydrogen peroxide-based disinfectants may cause a false positive color change reaction.

Although Chemdye® PRO1 MICRO has high sensitivity, it is not a microbiological monitoring device, and the surfaces should not be considered sterile according to the results obtained.

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Control of Steam sterilization processes between 118 °C and 138 °C.

FDA cleared

Please review the instructions for use for applicable cycles in your country

Characteristics

Type 5 Integrating Indicator (according to ISO 11140-1).

Size: 52 mm x 21 mm.

Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature.

The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 10^6 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C.

Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual).

Instructions for Use

1. Carefully open the package and remove only the number of indicators needed.

Reseal the package tightly.

2. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent.

3. Perform de sterilization cycle.

4. After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used.

Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance.

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Bowie-Dick Test Pack is designed for testing air removal efficiency of dynamic-air-removal steam sterilizers operating at 132 °C for 4 minutes and at 134 °C for 3.5 minutes. Please review the instructions for use for applicable cycles in your country

FDA cleared

Characteristics

Type 2 Chemical Indicator

Equivalent in performance to the ANSI/AAMI ST79 Bowie-Dick Towel

Pack.

Detects residual air in the sterilizer chamber due to air leaks, air removal failures or steam quality.

Holds an early warning sheet designed for early detection of air removal failures before they appear on the test sheet.

Initial Color: yellow

Final Color: dark brown/black (should change homogeneously in the

whole sheet)

Size: 16 mm x 125 mm x 113 mm

Assembly: 1 impermeable barrier - 1 Foam - permeable barriers - 1 Glassine paper - 1 Test Sheet - permeable barriers - 1 Glassine paper - 1 Warning Sheet - permeable barriers - 1 impermeable barrier. Wrapped with crepe paper.

Instructions for use

1. Run a warm-up cycle to properly heat the sterilizer.

2. Place the Bowie-Dick Test Pack horizontally with the label facing up in an empty vacuum assisted sterilizer chamber, in the bottom/front of the sterilizer rack and over the drain. The Test Pack should read "THIS SIDE UP" when placed correctly.

3. Run the sterilizer cycle for 3.5 min. - 134 ºC / 4 min. - 132 °C.

4. Remove the test pack from sterilizer and allow it to cool down. Check color change of type 1 indicator on the label.

5. Unwrapped the pack and remove the test and warning sheets. Check them for color change and record the results.

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