Wireless Data Logger EBI 10 for Validation

Product catalog summary

Overview: The document provides a detailed description of the EBI 10 wireless data logger system used for process validation in medical settings, specifically for steam-sterilizers and washer-disinfectors, in compliance with ISO 17665 and ISO 15883 standards.

System Components: The EBI series data loggers are designed to measure and record temperature, pressure, and time. The system includes high-accuracy data loggers and the Winlog.validation software for programming, evaluation, calibration, and report generation.

Key Features:

Compliance with international standards such as EN 285, ISO 17665, and ISO 15883.
User-friendly and tamper-proof software that automatically evaluates cleaning, disinfection, and sterilization processes.
Automatic determination of relevant parameters like AO-value and FO-value.
FDA 21 CFR Part 11 compliance.

Technical Specifications:

Temperature measurement range: -50 °C to +150 °C.
Pressure measurement range: 1 mbar to 4,000 mbar.
Memory capacity: 100,000 measurements.
Sampling rate: 250 ms to 24 h.
Protection class: IP 68 (NEMA 6).

Validation Sets: The document outlines various validation sets for different applications:

SL 2000: For washer-disinfectors, includes temperature and pressure data loggers, interface, software, and testers.
SL 3000: For small steam-sterilizers, includes temperature/pressure logger, interface, software, and protection box.
SL 3100: For steam-sterilizers, includes multiple temperature data loggers, pressure logger, interface, software, and testers.

Standards and Recommendations: The document emphasizes the importance of adhering to standards like ISO EN 17665, EN 285, and ISO 15883 to ensure validated processes that prevent hazards from processed medical products. It recommends specific sensor configurations for effective process validation.

Contact Information: ebro® Electronic GmbH provides contact details for further inquiries and support.

Catalog excerpts

Wireless Data Logger EBI 10 for Validation-1

Wireless Data Loggei EBI 10 for Validation PRQCESS VALIDATIoN AccQRDING TQ Iso 17665 / Iso 15883 mdical | cssd a xylem brand

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Wireless Data Logger EBI 10 for Validation-2

Only 3 Easy Steps ...ebro® Validation Systems Setup 1 Evaluate Report 3 2 Measurement systems: The ebro Winlog validation system is a combination of high accuracy dataloggers and powerful reporting and evaluation software. The system consists of: EBI sries Data Loggers: Datalogger to measure and record process conditions (temperature, pressure, time). TGV validation, FDA 21 CFR Part 11 conform, IQ / OQ documentation, allows evaluation according to international standards (EN 285, ISO 17665, ISO 15883) Winlog.validation Easy-to-use software for programming, evaluation, calibration and report generation....

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Wireless Data Logger EBI 10 for Validation-3

Technical Data Type Cable Logger EBI 10-T and EBI 10-TP Sensors 2, 3 or 4 (probes are factory replaceable) Temperature measurement range -50 °C ... +150 °C (-58 °F ... +302 °F) Pressure measurement range 1 mbar ... 4,000 mbar (0.015 psi ... 58 psi) Temperature resolution 0.025° C (0.045 °F) Pressure resolution 1 mbar (0.015 psi) Temperature accuracy 0.1° C (0.045 °F) Pressure accuracy 10 mbar (0.15 psi) Memory 100,000 measurements (Total) Sampling rate 250 ms ... 24 h Measurement mode endless, start / stop time, start immediately, start immediately until end of memory Battery 3.6 V (exchangeable)...

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Wireless Data Logger EBI 10 for Validation-4

Accessories EBI 10 Cable Logger Probe AL 171 PT1000 PTFE coated Probe length = 3 cm Probe diameter = 1.2 mm Cable length = 1,200 mm ocess validation in washer-disinfectors nd steam steam-sterilizers Temprature and pressure loggers complying with the requirements of the standard EN ISO 15883-1 must be used during the process validation in washer-disinfectors. The sensors are placed between the instruments and in proximity to the washer-disinfector's own measurement points. In addition, measurement points must be selected on the load carriers and on the chamber walls of the washer-disinfectors....

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Wireless Data Logger EBI 10 for Validation-5

Process validation in steam-sterilizers Laws and Standards Various laws and standards call for appropriate validated processes in order to avoid hazards for patients and hospital staff emanating from processed medical products. These regulations are based on the standards ISO EN 17665, EN 285 (steam-sterilizers), or pr DIN 58929 / DIN EN 13060 (small steam-sterilizers) as well as ISO 15883 (washer-disinfectors). The aim of the technical validation process is to provide a documented verification that each particular steam-sterilizer supplies the sterilization results required. Thermoelectric measurements...

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Wireless Data Logger EBI 10 for Validation-6

a xylem brand ebro® Electronic GmbH PeringerstraBe 10 D-85055 Ingolstadt Tel. +49 (0) 841 - 9 54 78-0 Fax +49 (0) 841 - 9 54 78-80 Internet: www.ebro.com e-Mail: [email protected] All names are registered tradenames or trademarks of ebro® Electronic GmbH -Specifications are subject to change without notice-

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