Usage

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Control of plasma or vaporized H2O2 sterilization processes. 

 

Applicable Regulation

Designed under Quality Management Systems standards ISO 13485:2016/NS-EN ISO 13485:2016.

ISO 11140-1:2014.

FDA 510(k) K191021

 

Characteristics

Type 1 Chemical Indicator (according to ISO 11140-1). Varnished strips printed with indicator ink.

Size: 105 x 18 mm (approximate).

Initial color: Red.

Final color: Yellow.

100 % Toxic Heavy Metals free

To interpret results visually, use the reference guide found in the Indications for Use.

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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).

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Environmental conditions during manufacture

T= 15-30 °C, RH= 30-80 %.

Storage conditions

T= 10-30 °C, RH= 30-80 %, keep out of direct light.

 

Transport

Storage conditions should be strictly followed.

Transport in closed and reinforced boxes in order to avoid damage. The transport of this product does not represent a risk for health.

 

Shelf life

5 years.

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Packing

250 strips per aluminum foil bag.

Packing information: product description, instructions for use, storage conditions and manufacturer information.

 

Labelling

On product ́s packing: product code and description, process for intended use, classification according to regulation, color change, product presentation, batch number, manufacture and expiration date, barcode and datamatrix code.

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Other important information

Read product’s instructions for use thoroughly before use.

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Precautions

Do not store the product near sterilizing agents.

Do not expose this product to Steam, Dry Heat or any sterilization processes other than H2O2.

Do not reuse the sterilizer until the indicator has changed into the color indicated in the product.