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Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes

Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes

Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes

Product catalog summary
Product Overview
Trazanto is an automatic system designed for quality control and traceability of cleaning, disinfection, and sterilization processes. It is part of the Infection Control Division and includes various accessories.

Usage
The system is used for the readout and detection of several indicators, including:
  • Chemdye® Trazanto splat CDWA3 and CDWA4 for monitoring washing machines.
  • Chemdye® Trazanto Lumenia CDWE for evaluating reprocessing washing machines.
  • Integron® Trazanto IT26 series for monitoring steam sterilization processes.
  • Chemdye® Trazanto CD42, CD29, CD40, and CD50 for monitoring different sterilization processes.
  • Chemdye® Trazanto BD125X series for detecting air removal and steam penetration in sterilizers.
  • Bionova® Trazanto PCDBI-2-RC for monitoring steam sterilization processes.

Applicable Regulations
The product is designed under ISO 13485:2016 standards, IEC 60950-1:2005/A1:2009/A2:2013, and RoHS Directive 2011/65/EU.

Characteristics
The Trazanto system consists of two main modules:
  • Trazanto Optical Reader: Dimensions are 270 x 270 x 40 mm, with a voltage range of 100 – 240 V AC, frequency of 50-60 Hz, and power of 18 W. It connects via USB to a personal computer.
  • Analysis Module: Developed for Microsoft® Windows 7 and later, it integrates with the optical reader for automatic readout and detection of indicators. It features intelligent algorithms and is compatible with Bionova® Traceability Software.

Environmental and Storage Conditions
Manufacturing conditions are 15-35 °C and 35-85% RH. Storage conditions are 10-30 °C and 30-80% RH, in a dark place. Transport should follow storage conditions, using closed and reinforced boxes.

Shelf Life and Packaging
The product has a shelf life of 2 years and is packed one unit per box, with labeling including product code, description, storage conditions, and manufacturer information.

Target Markets
The system is suitable for healthcare, food, pharmaceutical, and medical device industries.

Additional Information
Trazanto is fully compatible with Bionova® Traceability Software, which enhances its capabilities by storing and tracing readings. Reports can be generated in PDF format.

Precautions
Do not pour or immerse in liquids. Use only indoors and disconnect the power cord before cleaning. Avoid abrasive cleaners and ensure proper power connection. Use only the included power adapter and AC cable.
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Catalog excerpts

Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes-1

Infection Control Division | Accessories TrazantoAutomatic system for quality control and traceability of cleaning, disinfection and sterilization processes Usage For readout and detection of: • Chemdye® Trazanto splat CDWA3 cleaning indicator for monitoring automatic and ultrasonic washing machines effectiveness. • Chemdye® Trazanto splat CDWA4 cleaning indicator for monitoring automatic and ultrasonic washing machines effectiveness. • Chemdye® Trazanto Lumenia CDWE cleaning indicator to be used with Chemdye® Lumenia devices to evaluate automatic reprocessing washing machines. • Integron® Trazanto IT26-1YS Unique point Chemical Integrator for monitoring Steam sterilization processes. • Integron® Trazanto IT26-C Moving Front Chemical Integrator for monitoring Steam sterilization processes. • Integron® Trazanto IT26SBL Unique Point Chemical Integrator for monitoring Steam sterilization processes. • Integron® Trazanto IT26SAD Unique Point Chemical Integrator with self-adhesive support for monitoring Steam sterilization processes. • Chemdye® Trazanto CD42 Process Indicator for monitoring Hydrogen Peroxide sterilization processes. • Chemdye® Trazanto CD29 Multivariable Chemical Indicator for monitoring Steam sterilization processes. • Chemdye® Trazanto CD40 Multivariable Chemical Indicator for monitoring Hydrogen Peroxide sterilization processes. • Chemdye® Trazanto CD50 Multivariable Chemical Indicator for monitoring Formaldehyde sterilization processes • Chemdye® Trazanto BD125X/1 Bowie-Dick test pack to detect inadequate air removal and steam penetration in vacuum-assisted Steam sterilizers. • Chemdye® Trazanto BD125X/2 Bowie-Dick test pack to detect inadequate air removal and steam penetration in vacuum-assisted Steam sterilizers. • Bionova® Trazanto PCDBI-2-RC Chemical Integrator Record Card (within the process challenge device) for monitoring Steam sterilization processes. Applicable regulation Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. Ruta Nac. N° 9, Km 280, CP 2130, Parque Industrial Micropi, Alvear, Santa Fe, Argentina Tel +54 341 5587007 - [email protected] - www.

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Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes-2

Infection Control Division | Accessories Characteristics Trazanto is a system comprised by two main modules: a hardware module composed by the Trazanto Optical Reader, and a software-implemented Analysis Module. Trazanto Optical Reader • USB connection between the Trazanto reader and a general-purpose personal computer. Analysis Module • Developed for Microsoft® Windows 7 and later. • Complete and robust integration with Trazanto optical reader. • Automatic readout and detection of compatible indicators for cleaning, disinfection, and sterilization commercialized by Terragene® • Intelligent algorithms...

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Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes-3

Product Description Rev. 2 | Date: 02-2022 Infection Control Division | Accessories Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes Labeling On the product and on product’s box: product code and description, storage conditions, batch number, serial number, barcode and manufacturer information. Possible target markets Healthcare, Food, Pharmaceutical and medical devices industries. Other important information Trazanto is fully compatible with Bionova® Traceability Software. The Traceability Software enhances Trazanto’s capabilities...

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Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes-4

Division Control de Infecciones | Accesorios r n Uso previsto Para lectura y deteccion de: • Indicador de lavado Chemdye® Trazanto splat CDWA3 para control de la efectividad de maquinas lavadoras automaticas y lavadoras ultrasonicas. • Indicador de lavado Chemdye® Trazanto splat CDWA4 para control de la efectividad de maquinas lavadoras automaticas y lavadoras ultrasonicas. • Indicador de lavado Chemdye® Trazanto Lumenia CDWE utilizado en dispositivos Chemdye® Lumenia para controlar la efectividad de lavadoras reprocesadoras automaticas. • Integrador Quimico de un punto Integron® Trazanto IT26-1YS...

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Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes-5

Descripción de producto Rev. 2 | Fecha: 02-2022 División Control de Infecciones | Accesorios Trazanto Sistema automático para control de calidad y trazabilidad de procesos de lavado, desinfección y esterilización Características El sistema Trazanto está compuesto por dos módulos principales: un módulo de hardware compuesto por el Lector Óptico Trazanto, y por un Módulo de Análisis implementado en software. Lector óptico Trazanto • Dimensiones: 270 x 270 x 40 mm • Rango de voltaje: 100 – 240 V AC • Frecuencia: 50-60 Hz • Potencia: 18 W • Conexión USB entre el lector Trazanto y una computadora...

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Trazanto Automatic system for quality control and traceability of cleaning, disinfection and sterilization processes-6

Descripción de producto Rev. 2 | Fecha: 02-2022 División Control de Infecciones | Accesorios Trazanto Sistema automático para control de calidad y trazabilidad de procesos de lavado, desinfección y esterilización Etiquetado En el producto y en el envase: código y descripción del producto, condiciones de almacenamiento, lote, número de serie, código de barras y datos del fabricante. Posibles mercados de destino Área de la salud, industria Alimenticia, Farmacéutica y de Productos Médicos. Otra información relevante El sistema Trazanto es totalmente compatible con el Software de Trazabilidad Bionova®....

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