Terragene CD16 Multi Variable Chemical Indicator User 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.
Uso exclusivo para profesionales e Instituciones Sanitarias.
Producto Autorizado por ANMAT PM 1614-4
Explanation of Symbols
Intended Use Table
Terragene® and Chemdye® are registered trademarks of Terragene S.A.
Multivariable Process Indicators
For Ethylene Oxide sterilization processes
Indications for Use
United States
Terragene® Chemdye® CD16 is a Chemical Process Indicator intended for monitoring the efficacy of Ethylene Oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met. See Intended Use Table for reference.
Outside the United States
Chemdye® CD16 Chemical Indicator has been designed for monitoring Ethylene Oxide (EO) sterilization processes.
Device Description
Chemdye® CD16 Multivariable Process Indicators (Type 4 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of punched paper double strips printed with indicator ink. These indicators have been designed to monitor Ethylene Oxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Innovative highly sensitive purple/brown ink was developed to turn to green when the indicator is exposed to Ethylene Oxide considering the critical process variables which provides additional quality assurance.
Endpoint condition: 30 °C, 30 minutes, 600 mg/l EO, RH 60 %; 54 °C, 20 minutes, 600 mg/l EO, RH 60 %.
Indicators 100 % free of toxic heavy metals.
Precautions
Do not expose Chemdye® CD16 Multivariable Process Indicators to Steam, Dry heat or any sterilization processes other than Ethylene Oxide. Do not reuse.
Instructions for Use
- Place a Chemdy® CD16 Multivariable Process Indicator within each package, bag or tray that will be sterilized by Ethylene Oxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas.
- Perform the sterilization cycle.
- After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Ethylene Oxide, the ink must turn to the green reference color when the sterilization parameters are reached. For reference color, please refer to Result Reference Guide.
NOTE: If any serious incident occurs in relation to the device, it should be reported to Terragene S.A. and the competent authority of the State in which the user is established.
Monitoring frequency
Follow facility Policies and Procedures which should specify a chemical indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As a good practice and to provide optimal patient safety, Terragene® recommends that every sterilization load be monitored with an appropriate chemical indicator.
Storage
Indicators should be stored in a dry place, protected from light at temperatures between 10-30 °C, 30-80 % relative humidity. Do not wet. Do not store near sterilizing agents.
Shelf Life
Chemical Indicators have an expiration date of 5 years from the date of manufacture when stored at recommended storage 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.
Endpoint Stability Reaction: chemical indicator endpoint shall remain unchanged for a period of not less than 6 months when stored at previously indicated conditions.
Disposal
Discard chemical indicators after use along with paper waste, according to your country´s healthcare and safety regulations.
Terragene S.A.
Ruta Nacional Nº 9, Km 280 – CP 2130.
Parque Industrial Micropi-Alvear-Santa Fe-Argentina
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