Chemdye CD30 Multivariable Indicators

Results Reference Guide

NOTE: Reference colors exhibited in printed prospects as well as those displayed in our website and soft copies of other documents, do not necessarily represent the real color as shown in the actual indicators.

Product Authorized by ANMAT PM 1614-4. Exclusive use for professionals and Health Institutions.

Explanation of Symbols

• [DRY symbol] Product designed for use with Dry Heat sterilization cycles.
• [CE mark] CE mark.
• [MD mark] Medical Device.
• [LOT symbol] Batch number.
• Authorized representative in the European Community.
• Expiration Date.
• Manufacturer.

Multivariable Indicators (EN)

For Dry Heat sterilization

Type 4 indicators according to ISO 11140-1

Product description

Chemdye® Multivariable Indicators are designed to react to Dry Heat sterilization processes within loads, ensuring an adequate control of the effectiveness of sterilization processes (temperature and time). Dark blue ink was developed to turn to brown when the process reaches the selected variables. Multivariable indicators allow to rapidly detect whether the critical parameters of the sterilization process for which they have been designed to respond have been reached.

Characteristics

• Chemical strips of 105 x 18 mm.
• Indicators 100% free of toxic heavy metals [metal-free symbol]

Indications for use

Use Chemdye® Multivariable Indicators for monitoring Dry Heat sterilization processes.

Endpoint conditions: 160 °C, 40 minutes // 180 °C, 20 minutes.

Precautions

Do not expose Chemdye® Multivariable Indicators to Steam, Ethylene Oxide or any sterilization processes other than Dry Heat.

Instructions for use

• Place a Chemdye® Multivariable Indicator within each package, bag or tray that will be sterilized by Dry Heat.
• In rigid containers place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has been reached the most inaccessible areas.
• After completing the process analyze the results. The indicator must turn to the reference color for considering that the established conditions were met.

Storage and shelf life

• Indicators should be stored in a dry place, away from light and at temperatures between 10-30 °C, 30-80% relative humidity. Do not wet. Do not store close to sterilizing agents.
• Indicators have an expiration date of 5 years from the date of manufacture when stored in recommended conditions. Both the expiration date and batch number of the product are specified on the package label and in each unit of the product. Do not use indicators after their expiration date.
• After use, the indicator will not change within 6 months when stored at previously indicated conditions.

Disposal

Discard chemical indicators after use according to your country's healthcare and safety regulations.

Manufacturer Information

Terragene S.A.

Ruta Nacional Nº 9, Km 280 - CP 2130.

Parque Industrial Micropi-Alvear-Santa Fe-Argentina.

[Terragene logo placeholder]

[MD mark] [CE mark]