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Q1: 

What is the PyroButton?
 
A: 

PyroButtons are rugged, self-sufficient systems that measure temperature (temperature/humidity combination data-logger will be available in the 3rd quarter of 2004) and record the result in a protected memory section. The recording is done at a user-defined rate, both as a direct storage of temperature values as well as in the form of a histogram. Every PyroButton is factory-lasered with a guaranteed unique 64-bit registration number that allows for absolute traceability. The durable stainless-steel package is highly resistant to environmental hazards such as dirt, moisture, and shock. PyroButton is ideal for data logging missions in the -40 °C to 125 °C temperature range.

Q2: 

Can you tell me a few applicaton of PyroButton data-logger?
 
A: 

You can use the PyroButton anywhere you want to monitor temperatures from -40 °C to 125 °C. Extremely durable and only 16mm in diameter, the PyroButtons are widely used on the field of pharmaceutical, biotechnology, medical device, food, healthcare, confectionery industries and the military.

Areas of PyroButton application:

  • Storage (warehouses, cold-rooms, refrigerators, freezers...)

  • Transportation (refrigerator vans, ships, airplanes, trucks..)

  • Distribution (cold rooms, display-type food freezers, refrigerators, freezers ...)

  • Agro-industry (green houses, incubators, plant-improvement, animal-breeding, fish-cultivation, processing...)

  • Environmental protection (waters, caves...)

  • Laboratories (thermostats, incubators, cold-rooms, cell-cultures, culture-mediums...)

  • Pharmaceutical (autoclaves, incubators, freezers, water-baths, warehouses, clean-rooms, transportation, stability chambers, processing facilities...)



  • Q3: 

    What is the expected life-time of PyroButton?
     
    A: 

    Either 10 years or 1 million temperature measurements (at 50C or less), whichever comes first. The expected life time is influenced by temperature range, sampling rate, temperature resolution and the utilization. Each program include life expectancy model and actual evaluation model.

    Q4: 

    Can I recharge or replace the PyroButton lithium battery?
     
    A: 

    Yes, under existing valid warranty conditions the battery can be replaced. Note: the battery life time is very long (10 years or 1 million temperature measurements (at 50C or less), whichever comes first).

    Q5: 

    What does 'water-resistant' mean for PyroButton?
     
    A: 

    The PyroButton-G has been certified to IP68 at 1m of water for 1 hour. We have seen it survive more rugged requirements, but since no standard test exist for greater depths and times longer than IP68 we have to leave it to the customer to have the PyroButton tested to see if it meets their needs. The PyroButton-L and PyroButton-T have a new "can" design that allows them to be used in water up to 1m deep for up to 30 days. Therefore, we would recommend these versions for all submerged applications. If you are using the PyroButtons in very wet environments, you may want to place them in a plastic bag or coat them with latex to keep them dry while logging temperatures.

    Q6: 

    What maintenance is neccessary?
     
    A: 

    There is no special requirements.

    Q7: 

    Is it possible to sterilize the PyroButton in autoclave?
     
    A: 

    Yes, but in this case you have to turn off the data-logger.

    Q8: 

    Can I turn off the PyroButton if I want to disuse it for longer period?
     
    A: 

    Yes. It is possible to turn off the clock oscillator of the PyroButton. To do this, please refer to the software user manual

    Q9: 

    Where do I go if I have a question concerning the PyroButton?
     
    A: 

    For general questions try the PyroButton Forum. If the Forum doesn't answer your question ask our Engineers and they will respond to your query as soon as possible.

    Q10: 

    Can I read the data-logger on the measurement site (fixed)?
     
    A: 

    Yes! The PyroButton adapter can be applied on to the data-logger ( in this case you need an adapter and a computer nearby or a laptop). You can either stop, reprogram or just read tha data from the logger without stopping it.

    Q11: 

    How many PyroButton do I need to control and validate desired object (e.g. refrigerator, cold room, storehouse)
     
    A: 

    There is no universal recipe. In the first step advisable to map the object and find the Critical Control Points (CCPs). After the result evaluation you can decide how many PyroButton do you need and where to place them. If you are uncertain, please consider Opulus validation service.

    Q12: 

    What is the minimal configuration necessary to run the PyroButton software?
     
    A: 

    Minimal configuration of PyroButton wireless temperature data-logger system:

  • 1 pc. PyroButton wireless temperature data-logger

  • 1 pc. PyroButton adapter

  • 1 pc. PyroButton software

  • 1 pc. Computer


  • Please, visit the PyroButton Catalog.

    Q13: 

    Can I extend the life-time of the PyroButton data-logger?
     
    A: 

    Yes. To extend the life time of the PyroButton, please consider the followings:
  • Do not use faster sampling rate than it absolutely necessary (do not collect more data what you need)

  • Choose the smallest temperature resolution as possible

  • Use the data-logger only if necessary

  • Store the disused data-loggers between -40C and + 25C (Use or store the data-logger above 50C will significantly reduce the life-time)

  • When not in use for a mission, the PyroButton should be turned off and device should be stored at a temperature not exceeding 25C.


  • Q14: 

    What is the response time of PyroButton?
     
    A: 

    The response time (10-90%) of the PyroButton is max. 40 s/°C.
    Calculation: measure the time it takes the temperature to grow from 10-90% of its final value.




    Q15: 

    Can I set threshold value?
     
    A: 

    In the PyroButton software you can set temperature limits (upper and lower) and critical temperature limits (upper and lower) of the measurement. If the critical temperature limit is exeeded during the measurement, a (low or high) temperature alarm event is induced. This alarm could be sent via internet or SMS (to any mobil phone).

    Q16: 

    Is it possible to enhance tha data-logger accuracy?
     
    A: 

    With calibration you can enhance the accuracy. In the regulated industry the data-loggers need to be calibrated (or recalibrated) from time to time, according to the effective regulations. Our company calibrates the data-loggers to NIST Standard, according to your request. For conditions and prices please visit the PyroButton Catalog.

    Q17: 

    How much learning is required to use PyroButton-Basic program?
     
    A: 

    The installation and learning can be performed within 1 hour. The PyroButton software has a simple and easy-to-use graphical User Interface that will make you "feel at home" in less than 30 minutes.

    Q18: 

    Is the PyroButton temperature monitoring system meets the authority requirements?
     
    A: 

    Yes. PyroButton software is document-oriented system, which means that PyroButton measurement records are saved as electronic document files. Their use in FDA regulated applications requires 21 CFR Part 11 compliance. PyroButton software is in full compliance with 21 CFR Part 21.

    Q19: 

    Can I manipulate the raw data subsequently?
     
    A: 

    No. You can not modify the raw data in any way. This is because of 21 CFR Part 11 compliance.

    Q20: 

    Is audit trail available?
     
    A: 

    PyroButton software has time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. In the audit trail window you can review all events concerning the PyroButtons and users of your PyroButton program.

    Q21: 

    What kind of data are included in the measure-document?
     
    A: 

    The Measure-Document has five sections:

  • Measurement Configuration shows you the specification data of the PyroButton and the parameters set during the Measurement Configuration.

  • Temperature Table displays all measurements performed by the PyroButton, giving the time zone, the moment of the measurement, the measured temperature and a comment showing whether the temperature limits or the temperature ranges have been exceeded.

  • Temperature Alarms displays in a table all temperature alarm events that took place during the measurement.

  • Temperature Graph shows the graph of the temperature data in time.

  • Histogram shows the number of measurements within temperature intervals.


  • Q22: 

    Can I export the data?
     
    A: 

    The measurement data can be saved in XML format, or exported into Excel worksheets.

    Q23: 

    Can I use temperature scale other than Celsius?
     
    A: 

    Yes! In the program you can set three different temperature scales (Celsius, Fahrenheit and Kelvin).

    Q24: 

    Can I schedule the start of the measurement?
     
    A: 

    The time of the first measurement can be defined in several ways:

  • Absolute - enter a specific date & time (in yyyy-mm-dd hh:mm:ss format)
  • Relative - start date will be the date counted from the configuration of the temperature-measuring device.
  • Immediate - measurement starts immediately after configuring the device.

    For the PyroButton-L and PyroButton-T, it is possible to define the time of the first measurement upon the first temperature alarm event after the above given date and time.

  • Q25: 

    Can I stop the measurement before the specified time?
     
    A: 

    Yes! You can stop the measurement any time and then reprogram the data-logger.

    Q26: 

    Can I estimate the attrition of the PyroButton data-logger?
     
    A: 

    Yes! The PyroButton software has a device life-time estimation function. Here you can give in some PyroButton-usage data and the program computes the Current Attrition and a Life-time prediction for a PyroButton attached to your computer.

    Q27: 

    What is the difference between the softwares represented in the Catalog?
     
    A: 

    The PyroButton software has two major application fields: a, pharmaceutical applications and b, non-pharmaceutical applications. The software designed for pharmaceutical use has a higher price. This price includes the 21 CFR Part 11 certificate plus the IQ-OQ-PQ protocol. These documents are essential for the regulated industry.

    Q28: 

    What does 'softwere license' mean?
     
    A: 

    1 license legitimate to install the software on a single workstation.

    Q29: 

    Can I immerse the data-logger to liquid? If yes, then to what liquid?
     
    A: 

    The PyroButton data-logger due to the stanless steel housing and the special sealing is suitable for temperature measurements in various liquids. You can use them in water, weak acids, bases, salt solutions, blood, milk, soup etc.

    Q30: 

    How can I use the PyroButton calibration certificate?
     
    A: 

    You can use the PyroButton Calibration Certificate like other temperature calibration certificates. The data-logger can be used as a calibrated device in the calibration range represented in the Calibration Certificate! Within this range the real temperature can be calculated as the sum of the mesured temperature and the correction factor.
    The exact correction factor can be determined with linear interpolation!

    The PyroButton-Standard software makes automatic temperature correction!

    Q31: 

    Is it neccessary to calibrate the temperature data-logger?
     
    A: 

    The calibration is not compulsory, but strongly recommended. The data-loggers need to be calibrated (or recalibrated) from time to time, according to the effective regulations (FDA and related organizations, or company regulations). Opulus calibrates the data-loggers to NIST Standard, according to your request.
    The benefits are:
  • Higher temperature accuracy

  • Extended warranty period (calibrated data-loggers have 2 years warranty)

  • Calibration Certificate (regulatory considerations)





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