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Professional Data Loggers

Professional Data Loggers

Product catalog summary

Overview: This document provides comprehensive information on professional data loggers used for validation, routine control, and process monitoring in sectors such as medicine, food, and pharmaceuticals. It details the specifications, applications, and benefits of various data logger series offered by Xylem Analytics Germany Sales GmbH & Co. KG, ebro.

Main Sections:

Specifications: The document describes data loggers like the EBI 12, EBI 11, and EBI 310 series, highlighting their capabilities in measuring temperature, pressure, humidity, and conductivity. These loggers are designed for high accuracy and are suitable for thermal validation processes.
Applications: Data loggers are used in applications such as steam sterilization, pasteurization, cold chain monitoring, and process validation in medical, pharmaceutical, and food industries. They ensure compliance with standards like ISO 17665 and EN 285.
Procedures: Procedures for process validation, routine control, and continuous process monitoring are outlined, emphasizing their importance in maintaining equipment performance and ensuring consistent process results.
Training and Seminars: Xylem offers training programs, webinars, and workshops to enhance understanding of process validation and control, providing comprehensive knowledge of data logger hardware and software.
Recommendations: Early booking for seminars is recommended to avail discounts, and regular routine control and monitoring are emphasized to ensure process reliability and compliance.

Key Data and Insights:

Data loggers feature wireless capabilities for real-time monitoring and are available in various configurations to suit different space requirements.
They are crucial for applications such as room monitoring, transport and storage monitoring, and clean room and freezer monitoring.
The document discusses the use of data loggers in hazardous areas, adhering to the ATEX Directive 2014/34/EU and IECEx scheme for equipment protection levels.

Conclusion: Xylem's data loggers are integral tools for ensuring the accuracy and reliability of process monitoring and validation across multiple industries. Their comprehensive training programs further support users in effectively utilizing these technologies.

Device Safety Specifications: Devices categorized under 1G or EPL Ga must ensure a very high degree of safety, even during infrequent disturbances or in the presence of two faults, to prevent ignition. These devices are suitable for use in Zone 0 environments.

Reprocessing of Medical Devices: Medical devices intended for low-germ or sterile applications must be reprocessed using validated procedures as per the manufacturer's instructions to ensure reproducibility and safety for patients, users, and third parties.

Data Logger Systems: ebro® specializes in measurement systems for thermal processes in medical, pharmaceutical, and food industries. The EBI 12 and EBI 11 series data loggers are user-friendly and supported by TÜV certified software for process evaluation. The EBI 16 system is available for Bowie&Dick-test results.

Conformance and Standards: The systems comply with various standards including DIN EN ISO 17665, DIN EN 285, DIN EN ISO 15883, and others related to sterilization and software quality. They also adhere to FDA regulations for electronic records and signatures.

Temperature Data Loggers: The EBI 12 series offers various models with different specifications for temperature measurement, including operating temperature ranges, accuracy, and data memory. These loggers are suitable for applications in medicine, pharmaceuticals, and food industries.

Technical Specifications: The document provides detailed technical specifications for various models of temperature data loggers, including measurement ranges, accuracy, sampling rates, and application samples. The loggers are designed for specific uses such as pasteurization control and sterilization monitoring.

Applications: These data loggers are primarily used in environments requiring precise monitoring of temperature and pressure, such as sterilizers, washer disinfectors, and other controlled environments.

Technical Specifications:

Temperature Measurement Range: 0 °C to +150 °C (+32 °F to +302 °F)
Pressure Measurement Range: 1 mbar to 10,000 mbar
Accuracy: Temperature ±0.1 °C, Pressure ±15 mbar (up to 4,000 mbar), ±20 mbar (4,000 to 10,000 mbar)
Resolution: Temperature 0.01 °C, Pressure 1 mbar
Data Memory: 7,500 measurement values per channel
Battery: Lithium, 2x BR1225A, 3V, user replaceable
Protection Class: IP68

Product Descriptions:

EBI 12-TH100-EX: Temperature/Humidity logger with external sensors, suitable for EtO sterilization.
EBI 16: Electronic Bowie&Dick-Test for steam sterilizers, certified by EN ISO 11140-4.
EBI 11 Series: Mini Temperature Data Loggers with small size for use in confined spaces, such as pasteurization control.

Accessories:

Battery Replacement Set AL 120: Includes batteries, O-rings, and opening tool for EBI 12.
Silicone Protection Boxes: Protects data loggers against heat and mechanical damage, extending their lifespan.
Logger-Check AL 285: For thermal measuring system control in steam sterilizers.

Applications:

Used in sterilization processes, particularly in steam sterilizers and EtO sterilization.
Suitable for routine control and validation of sterilization parameters.

Standards and Certifications:

Conforms to DIN EN 285, ISO 17665, and ISO 11140-4 standards.
Factory calibration certificates provided for temperature and pressure measurements.

Overview: This document provides detailed specifications and descriptions of various data logger systems and accessories offered by Xylem Analytics Germany Sales GmbH & Co. KG, ebro. It includes technical data, calibration certificates, and application areas for different models of data loggers, as well as information on accessories and complete data logger sets for process control and monitoring.

Specifications:

EBI 11-TP110 and EBI 11-TP210: These are mini temperature/pressure data loggers with M5 thread connections. The EBI 11-TP110 has a temperature range of 0 °C to +150 °C and a pressure range of 1 mbar to 10,000 mbar. The EBI 11-TP210 has a temperature range of 0 °C to +140 °C and a pressure range of 1 mbar to 8,000 mbar. Both models have a data memory capacity of 2 x 7,500 measurement values and come with a factory calibration certificate.

Accessories:

Various interface and software sets are available for the EBI 11 and EBI 12 data loggers, including the SI 3300, SI 1300, SI 1100, and SI 2100 sets, which feature USB connections and colored LED signaling for programming and readout.
Battery changing sets (AL 113 and AL 113L) and adapter sets (AL 114 and AL 115) are also available for specific models.

Data Logger Sets:

Complete data logger sets are offered for process control, routine control, mapping, and acceptable quality limit (AQL) applications. These sets include data loggers, evaluation software, and extensive equipment, conforming to FDA 21 CFR Part 11 and TÜV certified standards.
Applications include monitoring and control in steam sterilizers, washer disinfectors, pasteurization, and other thermal processes in the food, pharma, and medical sectors.

Advantages:

These systems offer fully automatic and tamper-proof evaluation, high precision temperature sensors, and a wide range of wireless data loggers for various applications. They are designed for high accuracy and flexibility, with a two-year warranty.

Applications:

Data loggers are used for process and routine control in steam sterilizers, washer disinfectors, pasteurization, and cooking processes, ensuring compliance with food hygiene regulations and quality standards.

Overview: This document provides detailed information on various data logger sets designed for temperature monitoring and validation in pasteurization, sterilization, and other processes. The equipment is manufactured by Xylem Analytics Germany Sales GmbH & Co. KG, ebro.

Data Logger Sets for Pasteurization and Sterilization:

EBI 12-T433 Set: Includes a temperature data logger with varying needle lengths, a can adapter, interface, software, and a carrying case. Suitable for monitoring temperature in tins.
EBI 11-T230 Mini Set: Designed for bottles, includes a mini temperature data logger, bottle adapter, interface, software, and carrying case.

Data Logger Sets for Operation and Process Qualification:

SL 2002 Validation Set: For washer disinfectors, includes multiple temperature and pressure data loggers, a 4-port interface, software, and a carrying case. Complies with ISO 15883.
SL 3001 and SL 3101 Validation Sets: For small and large steam sterilizers, respectively, including temperature/pressure data loggers, interfaces, software, and carrying cases. Complies with ISO 17665.

Accessories:

AL 3305 DAC Adapter Set: For thermal process validation in DAC UNIVERSAL, includes a logger mount and test body.
AL 126 Test Adapter: For validation in washer disinfectors and endoscope washers, includes a test adapter and various connectors.
Carrying Cases and Inlays: Modular and protective storage solutions for data loggers and accessories.

pH and Conductivity Meters:

PHT 830 pH Meter: Features temperature compensation, logging function, and software connectivity. Suitable for a range of pH measurements.
CT 830 Conductivity Meter: Offers auto range, temperature compensation, and logging function. Suitable for conductivity and TDS measurements.

Technical Specifications: Detailed technical data for pH and conductivity meters, including measurement ranges, accuracy, memory capacity, and environmental conditions.

Overview: This document provides technical specifications and descriptions for various measurement and data logging devices produced by Xylem Analytics Germany Sales GmbH & Co. KG, ebro. The devices include conductivity and pH testers, as well as wireless and multi-channel data loggers for temperature and humidity monitoring.

1. TDS 3 Basic Conductivity Tester:

Features dual display, battery charge indicator, replaceable battery, and automatic deactivation.
Measurement range: 0 to 1,999 µS, 0 to 19.99 mS, 0 to 1,999 ppm, 0 to 19.99 ppt.
Accuracy: 1 µS; Resolution: 1 µS.
Operating temperature: 0 °C to +50 °C; Storage temperature: -25 °C to +60 °C.
Protection class: IP67; Dimensions: 170 x 32 x 15 mm; Weight: 70 g.

2. PHX 800 Basic pH Tester:

Includes acoustic signal, battery charge indicator, and automatic deactivation after 15 minutes.
pH measurement range: 0 to 14 pH; Accuracy: 0.1 pH; Resolution: ±0.2 pH.
Operating temperature: 0 °C to +50 °C; Storage temperature: -25 °C to +60 °C.
Protection class: IP65; Dimensions: 170 x 32 x 15 mm; Weight: 70 g.

3. EBI 25 Wireless Data Logger System:

Monitors temperature, humidity, and other measurements with Modbus over IP integration.
Features continuous monitoring, automatic documentation, and worldwide data access.
Resolution: 0.1 °C for temperature; Memory: 288 values per channel.
Battery: 3.6 V lithium, user-replaceable; Battery life: Up to 2 years.

4. EBI 40 Multi-Channel Temperature Data Logger:

Records temperatures with up to 6 or 12 thermocouple sensors.
Measurement range: -200 °C to +1,200 °C; Accuracy: ±0.5 °C at +25 °C.
Features a TFT display and adjustable sampling rate from 0.1 sec to 24 hours.
Protection class: IP40; Dimensions: 140 x 118 x 35 mm.

5. EBI 310 PDF Data Logger:

Multi-use data loggers for temperature and humidity measurement with USB connection.
Automatic PDF report generation and easy programming via online configurator.

Applications: These devices are used for monitoring food in cooling or freezing areas, drugs and vaccines in drug stores, clinical trials in labs, and warehouses. They are also suitable for process monitoring and validation in incubators, refrigerators, climate cabinets, storage rooms, transport studies, and freeze-dryers.

Technical Specifications:
The TA Logger 1100-0121 is designed with a protection class of IP20 and dimensions of 150 x 180 x 45 mm. It operates within a temperature range of -25 °C to +50 °C and features a USB connection (Type B, 100 mA, USB 1.1) and LAN connection (Ethernet 10/100). The material used is ABS.

EBI IF 400 Interface:
This interface facilitates communication between the EBI 25 data logger and software such as Winlog.wave or Winlog.web. It includes an antenna, power supply, and USB cable.

AG 152 Wall Mount:
The AG 152 provides secure attachment for EBI 25 data loggers, including mounting materials like tape, screws, and cable ties.

AL 116 External Antenna:
Designed to be installed in wet areas to extend range, it comes with mounting materials.

EBI 310 PDF Data Loggers:
These loggers are used for cold chain monitoring, automatically generating PDF reports when connected to a PC. They are suitable for mapping warehouses to identify critical temperature spots.

Programming and Usage:
Loggers can be programmed via an online configurator or software like Winlog.basic or Winlog.pro. They connect to PCs via USB, automatically generating PDF reports. They conform to FDA 21 CFR Part 11, DIN EN 12830, and ATP standards.

Benefits:
Key benefits include direct USB connection, automatic PDF report generation, alarm status indication via LED, and compliance with GMP and VO (EG) 37/2005. Firmware updates are available via software.

Digital Interface:
The loggers function as data collectors with optional internal sensors and allow easy exchange of external probes.

EBI 310 Variants:
Different models (EBI 310, EBI 310 TE, EBI 310 TX, EBI 310 TH) cater to various applications like temperature and humidity monitoring, with features like high memory capacity and flexible alarms.

Technical Data:
General specifications include a memory capacity of 120,000 measurements, a sample rate of 1 s to 24 h, and a protection class of IP65. The battery is a lithium button cell with a life of up to 2 years.

Software:
Various software options are available for data evaluation, including Winlog.pro, Winlog.med, Winlog.validation, and Winlog.web, supporting multiple languages and operating systems.

Overview:
This document provides detailed information on the software and calibration services offered by Xylem Analytics Germany Sales GmbH & Co. KG, specifically focusing on the qualification and evaluation of measurement systems.

Software Solutions:

Winlog.pro: A professional software for programming and reading ebro® data loggers, offering easy installation, extensive report generation, and compliance with FDA 21 CFR Part 11. It supports real-time monitoring and includes a formula editor and calibration tool.
Winlog.web: A web-based client/server solution for EBI 25 data loggers, providing real-time data transmission and flexible alarm management. It supports evaluation on PCs and smartphones and complies with FDA 21 CFR Part 11.
Winlog.med and Winlog.validation: TÜV certified software for pharmaceutical and medical applications, offering automatic report generation and user-defined calculations. It supports validation and qualification processes with FDA 21 CFR Part 11 compliance.

Qualification Process:

Design Qualification (DQ): Determines the application for which a device is purchased, ensuring all relevant departments are considered.
Installation Qualification (IQ): Ensures all necessary parts for installation are present and meet requirements, guaranteeing a safe installation.
Operation Qualification (OQ): Tests all system functions to ensure the measurement system operates as intended.
Process Qualification (PQ): Sets, examines, and documents all parameters for specific measurement tasks.

Calibration Services:

Factory Calibration: Ensures functionality and tolerances according to DIN EN ISO / IEC 17025, with certificates issued by trained personnel.
ISO 9000 Calibration: Provides economical and precise calibration, including device adjustment if necessary, with detailed documentation in an ISO certificate.

System Requirements:
For optimal software performance, specific hardware and software requirements are outlined, including processor speed, memory, and operating system compatibility.

Certification:
The document includes a TÜV SÜD Management Service GmbH certificate, confirming compliance with ISO 9001:2015 for quality management systems across various Xylem Analytics Germany sites.

Accredited Calibration: The document outlines the importance of accredited calibration according to DAkkS guidelines, which is essential for high safety measurement procedures in various fields such as medicine and pharmaceuticals. Calibration is performed by accredited laboratories following DIN EN ISO/IEC 17025 standards, ensuring internationally recognized and comparable results. The document recommends annual recalibration for thermometers and pressure meters, and biannual recalibration for humidity meters. Calibration services cover a wide range of temperatures, humidity, and pressure levels.

Calibration Conditions: Detailed conditions for different types of calibrations are provided, including temperature, humidity, and pressure calibrations. Specific measurement ranges and conditions are outlined for various calibration objects, ensuring precise and reliable calibration processes.

Product Compliance: The document declares compliance with Directive 37/2005 EC for specific data logger products, adhering to harmonized standards EN 12830 and EN 13486 for performance and calibration verification.

Conditions of Delivery and Payment: The document specifies general conditions for delivery and payment, including minimum order values, validity of quotations, and terms for custom-made products. It also outlines procedures for inspections, tests, and delivery timelines, emphasizing the importance of adhering to agreed terms and conditions.

Delivery and Acceptance: If the Purchaser fails to accept delivery, they must still pay the due purchase price. The Supplier will store the product at the Purchaser's risk and expense, and may insure it if requested. If the Purchaser does not accept delivery within a reasonable period, the Supplier can terminate the contract and seek compensation.

Alterations and Cancellation: Contract alterations require Supplier approval and may restart delivery timelines. Additional costs from alterations are charged to the Purchaser. If the Purchaser cancels without cause, they must reimburse the Supplier for incurred costs.

Prices and Payment: Prices are based on the Supplier's price list at delivery time. Payments are due within 30 days for domestic sales and in advance for exports. Late payments incur interest, and the Supplier may suspend contract performance. Prices exclude transportation costs and taxes, which are the Purchaser's responsibility.

Warranty and Liability: Warranty claims require timely notification of defects. The Supplier may repair or replace defective products. Liability is limited to foreseeable damages, and no warranty covers damages from improper use by the Purchaser.

Product Liability: The Supplier is not liable for damages caused by the product after delivery. The Purchaser must indemnify the Supplier against third-party claims.

Confidentiality: Confidential information must not be disclosed without written consent, except under specific conditions.

Force Majeure: Performance may be suspended due to uncontrollable events. Contracts can be terminated if such events persist for over six months.

Assignment: The Purchaser cannot assign the contract without Supplier consent. The Supplier may assign rights to affiliates.

Invalidity: Invalid provisions do not affect the rest of the contract, and should be replaced with valid ones reflecting the original intent.

Export Regulations: The Purchaser must comply with export laws and obtain necessary permissions. The Supplier can withhold goods if laws are violated.

Place of Performance: The Supplier's business location is the place of performance.

Disputes and Applicable Law: Disputes are subject to final resolution under applicable law.

Overview: The document provides information about the services offered by ebro®, a brand under Xylem Inc., focusing on customer-oriented solutions in the field of water technology. It highlights the company's commitment to service beyond standard offerings, emphasizing repairs, calibration, and customer support.

Services Offered:

Repairs & Calibration: ebro® offers repair and calibration services for handheld instruments and thermometers. Customers can contact them via phone, fax, or email for assistance.
Service and Calibrations: The company provides calibration services for temperature, pressure, and relative humidity in their accredited DAkkS laboratory.
IQ/OQ Documentation: Customers receive IQ/OQ documentation according to GAMP guidelines.
Maintenance and Field Service: ebro® offers maintenance, field service, and calibration at customer locations, with contact details provided for specific representatives.

Company Information:

Xylem Inc.: A global water technology company focused on creating advanced solutions for water challenges. Their products and services include moving, treating, analyzing, monitoring, and returning water to the environment across various sectors.
Global Presence: Xylem operates in over 150 countries, known for its strong product brands and sustainable solutions.

Contact Information: Xylem Analytics Germany Sales GmbH & Co. KG, ebro, located in Ingolstadt, Germany, provides contact details for further inquiries.

Catalog excerpts

Professional Data Loggers FOR VALIDATION, ROUTINE CONTROL AND PROCESS MONITORING MEDICINE FOOD PHARMACEUTICAL LABORATORY

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You can find more catalogues on our website: Professionelle Datenlogger (Part No. 1347-0111) Professionelle Messtechnik (Part No. 1347-0109) Professional Measurement Technology (Part No. 1347-0110) If you would like to receive further catalogue copies please send your request via e-mail to [email protected]

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Combining theory and hands on work is the basis for the successful concept for our trainings, webinars, and workshops. Our speakers are experts in their specialized fields. The aim of all seminars is that all participants will receive a sound knowledge of the hardware and software. • Routine controls in the RUMED in the hospital • Validation of reprocessing processes in the hospital • Validation of preparation processes in the Sector, e.g. DAC (Sirona), Careclave (Melag) • Temperature monitoring in the hospital (radio monitoring system EBI 25) • Cold chain monitoring & mapping • Qualification...

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EBI 12-TP222 Temperature / Pressure Data Logger 20 EBI 12-TP226 Temperature / Pressure Data Logger 20 EBI 12-TP231 Temperature / Pressure Data Logger 21 EBI 12-TP23X Temperature / Pressure Data Logger 22 EBI 12-TP322 Temperature / Pressure Data Logger 22 EBI 12-TP422 Temperature / Pressure Data Logger 23 EBI 12-TP45X Temperature / Pressure Data Logger 23 EBI 12-TP460 Temperature / Pressure Data Logger 24 EBI 12TC230 Temperature / (Conductivity Data Logger 25 EBI 12-TH100-EXTemperature /Humidity Data Logger 26 EBI 11-T230 to T233 Mini Temperature Data Logger 34 EBI 11-T235 to T237 Mini Temperature...

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| Data Logger from the EBI 12 series Data Logger from the EBI 12 series EBI 12-T222 The logger reacts very quickly on temperature changes caused by the small and fast probe. It is therefore ideally suited for temperature measurement during process validation. EBI 12-T237 The data logger can be used in several measurement applications in the food and pharmaceutical industries. For example in stability chambers, retort sterilization and in pasteurization tunnels. Technical details on page 15 Technical details on page 12 EBI 12-TP237 This data logger is used for simple pressure checks in pipelines...

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ebro® offers data loggers for many different applications: Operation and Process qualification Routine control / Mapping • Highly accurate temperature, pressure, humidity and conductivity data loggers for thermal validation processes • Wide range of probe types and configurations • Wireless data loggers for real time monitoring • Data loggers for low space • Highly accurate temperature, pressure, humidity and conductivity data loggers for thermal process control • Electronic Bowie&Dick-Test according to ISO 17665 and EN 285 / EN 13060 • Data loggers for low space • Data loggers for regular process...

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Room Monitoring and Process controlDescription: • Highly accurate temperature, pressure and humidity data loggers • Standard temperature and humidity data loggers with automatic PDF report generation • Wireless system to monitor temperature and humidity • Multichannel Thermo Couple temperature data loggers • Room monitoring • Transport and storage monitoring • Clean room and freezer monitoring

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Applications • Autoclaves / Sterilizers / Pasteurization Processes • Continuous Fryers • Hydrostatic Retorts • Refrigerators / Freezers / Cooling Rooms • Cooker / Cooler (Reel and Spiral) • Steam Sterilization • Washer disinfectors / bedpan washers • Depyrogenation / heat tunnel • Refrigerators / Freezers / Cooling Rooms • Stability Chambers • Washer disinfectors • Depyrogenation / heat tunnel • Refrigerators / Freezers / Cooling Rooms • Climatic Test Chambers / Sta

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Logger systems Process monitoring, Routine Control and Validation easy and safe Process Validation Is a reproducible proof that a process permanently generates the required results. Validation is a clear demonstration that processes, equipment, materials, work steps or systems actually lead to the expected results. Routine Control Routine control is a regular test to determine the performance of the equipment. It is the verification that the limits are in accordance to the validation. The frequency depends on the device and the process. Continuous Process Monitoring The continuous process check...

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Logger systems TÜV certified evaluation software Winlog.med and Winlog.validation With the Winlog.med / Winlog.validation we offer a TÜV certified, FDA 21 CRF Part 11 compliant software. The system is characterized by high data security. The automatic evaluation of the process is possible as well as the manual evaluation. The software offers the possibility to create user defined evaluations. So it is possible to create individual process parameters and test criteria. Conformance Our systems are compliant with the relevant standards and guidelines. DIN EN ISO 17665 Sterilization of health care...

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Logger systems Temperature data loggers of EBI 12 series General technical specifications for EBI 12 T series perating temperature: logger -90 °C ... +150 °C (-130 °F ... +302 °F)* Operating temperature: radio operation -30 °C ... +150 °C (-22 °F ... +302 °F) Measurement mode Storage temperature Maximum operating pressure Minimum operating pressure Battery Housing material Protection class • Endless measurement • Start / stop measurement • Measure upon start temperature • Start immediately until end of memory -20 °C ... +70 °C (-4 °F ... +158 °F) Temperature logger 10 bar (abs), 4 bar (abs) with...

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Logger systems EBI 12-T100 Temperature Data Logger with internal temperature sensor (*)OS! Application samples • For process monitoring during convenience food production • For routine control in bedpan washers • To measure in raw material storage Technical Data Measurement range EBI 12-T100: -90 °C ... +150 °C (-130 °F ... +302 °F) Data memory 100,320 measurement values Factory calibration certificate -20 °C, 0 °C, +60 °C and +134 °C Radio mode EBI 12-T100: Not possible 1 internal temperature sensor Particularly robust Type Description EBI 12-T100 Internal temperature sensor EBI 12-T100- Internal...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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