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TrackSense LyoPro User Manual

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TrackSense
LyoPro
User Manual
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TrackSense
LyoPro
Version 3.3
Page 1 of 53
User Manual
User Manual TrackSense LyoPro – MAN 7

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Summary of Contents for TrackSense LyoPro

  • Page 1 ® TrackSense LyoPro User Manual ® TrackSense LyoPro Version 3.3 Page 1 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 2: Table Of Contents

    Online Activation - The PC is Connected to the Internet ......18 4.1.1. Manual Activation – The PC is Not Connected to the Internet .... 18 4.1.2. Releasing the License ..................19 How to Start Logging Data with TrackSense LyoPro ..........19 ® TrackSense LyoPro Loggers ..................23 ®...
  • Page 3 BufferClip ......................... 38 9.5.1. Standard Versions & Reference Numbers – BufferClips ....... 39 10. Examples on how to Configure LyoPro Using LyoStopper or Various LoggerClips ..........................39 11. Firmware Update ......................41 11.1. Reader Station and LyoPro Loggers ..............41 11.1.1.

  • Page 4: Safety Information

    If the equipment is wet or has been in a wet environment, take necessary measures to remove moisture prior to applying power. The equipment is intended for indoor use only. ® TrackSense LyoPro Version 3.3 Page 4 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 5: Electrical Hazards

    Do not allow them to be dropped, struck, stressed or overheated. TrackSense Clock (Internal) When using TrackSense LyoPro loggers, ValSuite will start an internal clock in the logger. Beware that the max time deviation at 23 °C will be +/- 5 seconds over 24 hours.

  • Page 6: Directives

    ISO/IEC 17050. It does not affect the warranty obligations of the supplier. We reserve the right to exceed the standards as part of our product development program. ® TrackSense LyoPro Version 3.3 Page 6 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 7: Important Notice Regarding Ellab Lyopro Equipment

    1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device. ® TrackSense LyoPro Version 3.3 Page 7 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 8: Arib

    2. L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. 1.4.4.1. FCC and ISED Applicable to TrackSense LyoPro Access Point FCC: To comply with FCC RF exposure requirements this device with its antennas must be installed and operated with a min separation distance of 20 cm to any human body.

  • Page 9: New Order Contents

    Do not immerse the reader station in water under any circumstances • Although the TrackSense LyoPro 10-slot reader station is quite robust, it should be handled with care. Dropping or exposing it to heavy mechanical shock may loosen or damage the electronic connections •...

  • Page 10: Lyopro Reader Station

    Connected to PC via USB or LAN (ethernet) • Only 1 LyoPro reader station can be used at a time 3.2. Communication Setup – Hardware Settings All TrackSense LyoPro 10-slot Reader Stations can be connected to PC via USB or LAN (ethernet). 3.2.1. USB connection •...

  • Page 11: Lan Connection

    Connect the 5V DC power supply and ethernet cable to the reader station Connect the reader station to the PC using the USB cable Read and note the reader station IP address located under the station Open the ValSuite user menu, LyoPro  Hardware Settings ® TrackSense LyoPro Version 3.3...

  • Page 12: Live Data Option - Access Point

    The reader station should now function remotely 3.3. LIVE Data Option – Access Point The TrackSense LyoPro system concept facilitates radio frequency data transmission between data logger and reader station – as well as LIVE data transmissions to a PC, running the ValSuite software package, via the built-in transmitter to the external Access Point.

  • Page 13: Access Point: Sensitivity To Esd

    Leaving the antenna attached to the Access Point, even during transportation, helps avoiding damage to the connector and is therefore highly recommended ® TrackSense LyoPro Version 3.3 Page 13 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 14: Communication Setup - Live Hardware Settings

    Insert name and choose connection mode: USB Once the access Point has been defined and set up, drag and drop the box into the Template box: ® TrackSense LyoPro Version 3.3 Page 14 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...
  • Page 15 Access Point is blinking green, i.e. indicating that communication between the data logger and Access Point has been established Insert name and choose connection mode: Ethernet (Static or DHCP) ® TrackSense LyoPro Version 3.3 Page 15 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...
  • Page 16 Once the access Point has been defined and set up, drag and drop the box into the Template box: The completed template can now be selected and used when starting a session ® TrackSense LyoPro Version 3.3 Page 16 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 17: Valsuite ® Software Installation Requirements

    ValSuite Pro is our reputable validation and calibration software ideal for lyophilization. It is fully FDA CFR21 Part 11 compliant and combines all equipment systems including LyoPro into a single platform. • ValSuite Pro offers features like customized reports with clear pass/fail criteria, test templates, data analysis, monitoring, live data and much more •...

  • Page 18: Online Activation - The Pc Is Connected To The Internet

    Select the Manual activation option if the PC is not connected to the internet Send an e-mail to Ellab with the computer ID ® TrackSense LyoPro Version 3.3 Page 18 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 19: Releasing The License

    Click License Click Clear License. This will remove the license from this PC. The license will then be released and ready to be used again on another 5. How to Start Logging Data with TrackSense LyoPro Starting TrackSense LyoPro Loggers: ®...
  • Page 20 Ensure that the battery has enough capacity to cover the expected session length. If the battery is new, activate it separately in the delivered activator for 60 minutes before placing it in the LyoPro data logger with the pole facing...
  • Page 21 Select LyoPro  Start Logger. A New Session window will then appear. Enter a name for the session (mandatory), session text (optional) and click OK. A window will appear displaying a graphic representation of the reader station slots Choose Select All and Scan. The software will automatically scan for loggers which, when found, turn dark blue and show individual ID numbers.
  • Page 22 10. After the settings are setup, select Start. When all selected slots turn green the data loggers are programmed and will start logging data. Select Close 11. Go to LyoPro  Logger List. This will showcase all active/programmed data loggers. Review the details to confirm that they were programmed correctly ®...

  • Page 23: Tracksense ® Lyopro Loggers

    Reading TrackSense LyoPro Data Loggers and Creating Reports: 12. Place the data loggers into the Reader Station. Go to LyoPro  Read Logger, then Select All and Scan 13. Select Read. The software will read all data loggers and display the data in the graph.

  • Page 24: Proper Use

    All data loggers have a unique serial number. The serial number allows compliance with GMP & GDP regulations. The serial number for the TrackSense LyoPro data logger is located on the side of the black housing. The data logger serial number can be found here ®...

  • Page 25: Disassembling / Assembling Data Loggers

    BLUE terminal. Do not tighten the screws too hard in order to avoid possible damage of the thermocouple. ® TrackSense LyoPro Version 3.3 Page 25 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 26: Procedure For Cleaning Tracksense Lyopro Data Loggers

    6.1.6. Procedure for Changing the Data Logger O-Ring The TrackSense LyoPro data logger contains one o-ring, which is located at the battery compartment lid. The o-ring should be replaced with every battery change. Apply a light coat of grease to the o-ring. Be careful and keep the grease away from any battery contacts.

  • Page 27: Battery

    This battery is by performance identical to the standard red and blue batteries, but as label is different (shorter) only this battery will work in the LyoPro logger. At the same time, the different color helps identify the correct battery.

  • Page 28: Proper Use Of Tracksense Lyopro Batteries

    Proper Use of TrackSense LyoPro Batteries • The TrackSense LyoPro data loggers have a standby battery usage that will empty the battery in 28pprox..12 months, even if the data logger is not used. It is therefore recommended to remove the battery from the data logger when it is not used for several weeks •...

  • Page 29: Activating And Testing Tracksense Lyopro Battery

    7.1.2. Activating and Testing TrackSense LyoPro Battery • TrackSense LyoPro data loggers do not use enough power to activate the battery by itself. Therefore, the activator unit must be used • New batteries must be activated initially for exactly 1 hour. See the image below.

  • Page 30: Calibration

    8.1. Ellab Factory Calibration It is recommended that TrackSense LyoPro data loggers are returned to Ellab at least once a year for factory calibration. Ellab performs the factory calibration, which adjusts and notes a new calibration date in the data logger. A certificate is generated, and the as found / as left data are included by default.

  • Page 31: Ellab Temperature Standard (Ets)

    In order to maintain the accuracy of the ETS, it is recommended that they are recalibrated by Ellab at least once every 12 months ® TrackSense LyoPro Version 3.3 Page 31 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...
  • Page 32 If using the USB connection, install the Ellab USB driver first Disconnect all the equipment The driver can be found on the ValSuite USB Key ® TrackSense LyoPro Version 3.3 Page 32 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 33: Installation For Windows 7, 8 And Windows 10

    115 to 230 VAC 20000425 PTC 425A +33 to +425 °C / 50-60Hz 115 to 230VAC / 20000156 RTC 156A -30 to 155 °C 50-60HZ ® TrackSense LyoPro Version 3.3 Page 33 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 34: Valsuite ® Calibration Options

    ValSuite software. 9. Accessories Ellab manufactures a wide range of accessories allowing the LyoPro data logger to be adapted to every standard vial from 2R to 100R. Meaning nominal volumes between 4 and 123 ml, as well as a height between 35 and 100 mm according to norm ISO 8362-1:2019.

  • Page 35: Stopperclip

    LoggerNest, StopperClip, LyoStopper and/or LoggerClip. 9.1. StopperClip The StopperClip provides an effortless connection between the LyoPro data logger and the vial – ensuring that they are safely steered together. The clip comes with an integrated stopper system, while simultaneously fixing the position of the sensor at the predefined measuring point.

  • Page 36: Loggernest

    This is mainly important when used with automatic loading systems. The LoggerNest has a built-in holder to keep the LyoPro data logger in place, even during rough handling/movements.

  • Page 37: Standard Versions & Reference Numbers - Stopperclips

    31208003 StopperClip 100R 9.4. LoggerClip The LoggerClip is the connection between the LyoPro and the vial that steers them together. It works like a dual clip placed between the vial neck and the LyoPro logger. This LoggerClip is made of PEEK and designed to keep the vial and data logger together, while keeping it flexible enough to allow the twists and turns of typical conveyer belts.

  • Page 38: Standard Versions & Reference Numbers - Loggerclips

    This clip consists of PEEK and initial tests have shown that, especially with low volume vials, there could be small deviations on the sample vial. Making the use of a buffer vial placed in between the LyoPro data logger and sample vial worth considering.

  • Page 39: Standard Versions & Reference Numbers - Bufferclips

    BufferClip for 50R vials 31203004 BufferClip for 100R vials 10. Examples on how to Configure LyoPro Using LyoStopper or Various LoggerClips This is required for a complete 2R system setup using buffer vial: 31201000: LyoPro data logger with thermocouple sensor...
  • Page 40 This is required for a complete 4R system setup using buffer vial: 31201000 – LyoPro data logger with thermocouple sensor 31203041 – 4R LoggerNest 31203042 – 4R Logger Clip Buffer Vial 4R w. rubber stopper 31203044 – 4R Buffer Clip Vial 4R w/o rubber stopper 31203023 –...

  • Page 41: Firmware Update

    Firmware Update 11.1. Reader Station and LyoPro Loggers Purpose: Firmware updater for reader station and logger. Install the TS LyoPro firmware updater located on the provided USB key. Procedure for installing the firmware upgrading tools for LyoPro Reader Station and Loggers: Double click the TSLyoProFirmwareUpdateSetup_xxxxyyzz.msi...
  • Page 42 Select Next. Select a folder in the Change Directory if necessary and click select Next. ® TrackSense LyoPro Version 3.3 Page 42 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 43: Procedure For Updating The Lyopro Logger And Reader Station Firmware

    Select Next Select Close to finish installation. 11.1.1. Procedure for Updating the LyoPro Logger and Reader Station Firmware WARNING: Before updating, users must check the current battery power, since updating loggers will use a lot of battery power. If the battery power is depleted in this process, the logger will need to be shipped to Denmark in order to be re-flashed, as it cannot be restarted manually.
  • Page 44 Open the firmware updater, which is placed under Programme (x86) by default, and select Ellab  TS LyoPro Firmware Update Select the Loggers button and push Scan. Push Select/Deselect to toggle all checkmarks – only positions check marked will be considered.
  • Page 45 The firmware updater program will proceed through 4 stages (write file, verify file, flash and reboot) which will be shown as in window below. ® TrackSense LyoPro Version 3.3 Page 45 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 46: Procedure For Updating The Lyopro Reader Station Firmware

    Once done, the logger will appear with the new firmware as shown below. 11.1.2. Procedure for Updating the LyoPro Reader Station firmware Open the firmware updater, which is placed under Programme (x86) by default and select Ellab  TS LyoPro Firmware Update Select the Reader Station button. Push Update. ® TrackSense LyoPro Version 3.3...
  • Page 47 Reader Station (writing, verifying and flash bootloader and firmware). Progress will be shown as in window below. ® TrackSense LyoPro Version 3.3 Page 47 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 48: Ellab Service Contract

    Ellab offers annual service agreements. Contact your local Ellab sales representative for pricing and details. ® 12.1. TrackSense LyoPro Equipment Warranty Ellab offers an industry leading 2-year warranty on the LyoPro logger. The thermocouple sensor is not covered, neither is physical damage. ® TrackSense LyoPro Version 3.3...

  • Page 49: Extended Warranty

    12.2. Extended Warranty Ellab also offers an extended warranty on all new TrackSense LyoPro data loggers. The extension is from 2 to 5 years. The extended warranty needs to be purchased together with the data loggers. Contact your local Ellab sales representative for pricing.

  • Page 50: Technical Specifications

    35 x 177 x 148 mm Interface Connection: USB or Ethernet (LAN) Cabinet Material: Anodized Aluminum Communication: RF (Radio Frequency) 2.4 GHz Logger Capacity: 1-10 pcs. ® TrackSense LyoPro Version 3.3 Page 50 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

  • Page 51: Faq

    Therefore, any data logger that turns green should not be refreshed. I replaced the battery in my LyoPro data logger, but I still get a low/critically low battery warning when I try to start it? The error messages are collected on the data loggers last read.
  • Page 52 Can I use my computer for other jobs while running a TrackSense LyoPro session? Yes , you can completely close your computer down if necessary. Upon reopening the ValSuite software, the software will automatically allocate the data loggers to the session that they were started in.

  • Page 53: Changelog

    Added New Template option and description Updated section title 3.3.3.1 + 3.3.3.2 Added additional steps to the guide 1.4.4.1 New section 2021-11-30 ® TrackSense LyoPro Version 3.3 Page 53 of 53 User Manual User Manual TrackSense LyoPro – MAN 7...

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