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TrackSense

®

 LyoPro 

                  Version 3.3 

Page 3 of 53 

 

User Manual 

                                               

         User Manual TrackSense LyoPro – MAN 7 

 

7.1.1.

       

Proper Use of TrackSense

®

 LyoPro Batteries ........................................... 28

 

7.1.2.

       

Activating and Testing TrackSense

®

 LyoPro Battery .............................. 29

 

8.

 

Calibration ........................................................................................................................ 30

 

8.1.

 

Ellab Factory Calibration ...................................................................................... 30

 

8.1.1.

       

Calibration Types – TrackSense

®

 LyoPro .................................................. 30

 

8.2.

 

In-House Calibration Solutions ........................................................................... 30

 

8.2.1.

       

Ellab Temperature Standard (ETS) .............................................................. 31

 

8.2.2.

       

Installation for Windows 7, 8 and Windows 10 ...................................... 33

 

8.2.3.

       

Ellab Dry Blocks .............................................................................................. 33

 

8.3.

 

ValSuite

®

 Calibration Options ............................................................................. 34

 

8.3.1.

       

Manual Calibration ......................................................................................... 34

 

9.

 

Accessories ...................................................................................................................... 34

 

9.1.

 

StopperClip .............................................................................................................. 35

 

9.2.

 

LyoStopper ............................................................................................................... 35

 

9.2.1.

       

Standard Versions & Reference Numbers ................................................ 35

 

9.3.

 

LoggerNest ............................................................................................................... 36

 

9.3.1.

       

Standard Versions & Reference Numbers ................................................ 36

 

9.3.2.

       

Standard Versions & Reference Numbers – StopperClips .................... 37

 

9.4.

 

LoggerClip ................................................................................................................ 37

 

9.4.1.

       

Standard Versions & Reference Numbers – LoggerClips ...................... 38

 

9.5.

 

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.

       

Procedure for Updating the LyoPro Logger and Reader Station 

Firmware………….. .............................................................................................................. 43

 

11.1.2.

       

Procedure for Updating the LyoPro Reader Station firmware .......... 46

 

12.

 

Ellab Service Contract ................................................................................................... 48

 

12.1.

 

TrackSense

®

 LyoPro Equipment Warranty ....................................................... 48

 

12.2.

 

Extended Warranty ................................................................................................ 49

 

13.

 

Technical Specifications ............................................................................................... 50

 

14.

 

FAQ ..................................................................................................................................... 51

 

15.

 

Changelog ........................................................................................................................ 53

 

 

 

 

 

Содержание LyoPro

Страница 1: ...TrackSense LyoPro Version 3 3 Page 1 of 53 User Manual User Manual TrackSense LyoPro MAN 7 TrackSense LyoPro User Manual ...

Страница 2: ...ta Option Access Point 12 3 3 1 Specifications 12 3 3 2 Access Point Sensitivity to ESD 13 3 3 3 Communication Setup LIVE Hardware Settings 14 3 4 ValSuite Software Installation Requirements 17 4 Activating ValSuite 17 4 1 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 5 How to Start Logging...

Страница 3: ...35 9 2 1 Standard Versions Reference Numbers 35 9 3 LoggerNest 36 9 3 1 Standard Versions Reference Numbers 36 9 3 2 Standard Versions Reference Numbers StopperClips 37 9 4 LoggerClip 37 9 4 1 Standard Versions Reference Numbers LoggerClips 38 9 5 BufferClip 38 9 5 1 Standard Versions Reference Numbers BufferClips 39 10 Examples on how to Configure LyoPro Using LyoStopper or Various LoggerClips 39...

Страница 4: ...ing and stability studies The customer needs to verify the temperature range of the equipment being used before placing it into an application 1 2 General DO NOT use the equipment for any application other than its intended use e g thermal validation monitoring and stability studies Any other use of the equipment may cause unknown hazards to the user DO NOT use the equipment in environments other ...

Страница 5: ...ns Always operate TrackSenseLyoPro Reader Stations at room temperature between 5 C and 50 C 41 F and 122 F DO NOT operate this equipment in an excessively wet oily dusty or dirty environment The equipment is a precision instrument Although it has been designed for optimum durability and trouble free operation it must be handled with care The equipment including any probes or loggers are sensitive ...

Страница 6: ...b products which must be recycled or handled separately are marked with the WEEE label in accordance with Directive 2012 19 EU Waste from Electrical and Electronic Equipment In addition Ellab A S accept scrapped equipment from customers and sort it for waste disposal Used equipment returned to Ellab A S for service may also be scrapped in accordance with the Directive However it is not legal to sh...

Страница 7: ...alled and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference b...

Страница 8: ... with its antennas must be installed and operated with a min separation distance of 20 cm to any human body This radio transmitter IC 8758A LYOAP1 has been approved by Innovation Science and Economic Development Canada to operate with the antenna types listed below with the maximum permissible gain indicated Antenna types not included in this list that have a gain greater than the maximum gain ind...

Страница 9: ...r Stations The Ellab reader station is intended to be used at room temperature The station should not be exposed to temperatures below 5 C or above 50 C 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 elec...

Страница 10: ...tion 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 Connect the USB cable to the reader station and PC USB 3 0 is required Connect the 5V DC power supply to the reader station option When connecting the 10 slot reader station the generic driver is automatically detecte...

Страница 11: ... MAN 7 3 2 2 LAN connection 1 Connect the 5V DC power supply and ethernet cable to the reader station 2 Connect the reader station to the PC using the USB cable 3 Read and note the reader station IP address located under the station 4 Open the ValSuite user menu LyoPro Hardware Settings ...

Страница 12: ... 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 3 3 1 Specifications Temperature Range 5 to 50 C Anodized aluminum housing LED indicators Supports up to 100 loggers requires ValSuite 6 0 16 0 or later Up to 1 12 Access Points per session Using multiple Access Points requires the use of a sepa...

Страница 13: ...ing the risk of component damage caused by static electricity 1 Before handling any antenna Access Point immediately drain any electrostatic charge on your body by touching a grounded object Alternatively obtain and wear a commercially available wrist strap device which should be removed for potential shock reasons prior to applying power to the unit 2 The antenna should only be removed connected ...

Страница 14: ...atio between sample rate and transmission rate is automatically set to be less than 1 20 Select channel numbers for antenna A and B or use suggested default values 3 3 3 1 USB 1 Connect the USB cable to the Access Point and PC 2 Verify that the USB is providing power to the Access Point power light should be green 3 Once a LIVE data session has been started verify that the Wireless LED light on th...

Страница 15: ...PC 1 Connect the Ethernet cable to the Access Point and LAN network 2 Connect the 5VDC power supply and USB cable to the Access Point Reference the software manual in order to properly setup the IP address in the ValSuite software 3 Once a LIVE session has started verify that the Wireless LED light on the Access Point is blinking green i e indicating that communication between the data logger and ...

Страница 16: ...ge 16 of 53 User Manual User Manual TrackSense LyoPro MAN 7 5 Once the access Point has been defined and set up drag and drop the box into the Template box 6 The completed template can now be selected and used when starting a session ...

Страница 17: ...g systems Note Windows server 2003 Windows XP Windows VISTA Windows 2000 Windows NT 4 00 and Windows ME are not supported Note Do not update the ValSuite software during active sessions The logger list will be updated and replaced with a new empty list 4 Activating ValSuite ValSuite Pro is our reputable validation and calibration software ideal for lyophilization It is fully FDA CFR21 Part 11 comp...

Страница 18: ...he License Key is invalid try to copy and paste the key again or retype the code The License Key has expired The License Key is a trail and will expire 4 Select Activate If the activation went well the License window will close automatically The evaluation of the License key can have the following remarks Icon Description The License Key is valid and can be activated The License Key has already be...

Страница 19: ...se Key is valid and ready to be activated The License Key has already been activated on another PC 5 The License window will close automatically if the key is valid and the ValSuite software will open 4 1 2 Releasing the License Users who wish to release the license so that it may be used on another PC must follow the procedure below 1 Select Help About ValSuite 2 Click License 3 Click Clear Licen...

Страница 20: ...gger with the pole facing downwards 2 If not already mounted connect the thermocouple sensor to the data logger using the supplied screwdriver It is important that the RED wire goes in the RED screw terminal And that the BLUE wire goes in the BLUE terminal Do not tighten too hard in order to avoid possible damage to the thermocouple 3 Place the data logger s in the reader station slot s 4 Select L...

Страница 21: ...raphic representation of the reader station slots 6 Choose Select All and Scan The software will automatically scan for loggers which when found turn dark blue and show individual ID numbers Alternatively mark the data loggers that you want to include in your study 7 If an immediate start unprogrammed is required press Start 8 The slots will turn green and begin showing the first live data The dat...

Страница 22: ... Define Sample Rate and optionally Programmed Start Stop conditions and activate Primary Control Choose Select All Apply Close 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 the...

Страница 23: ...laced on the graph A Select Data Viewer compare data sets B Select Interval Data Viewer numerically display data C Select Add Label place special information directly in the graph D Select Copy Graph copy graph to the clipboard E Select Set Axis Min Max scale a graph either automatically or fixed F Select Properties define data series For more information on the many other ValSuite software featur...

Страница 24: ...tery contacts verify that the data logger is not leaking Lightly clean the area using a cotton swab and alcohol then change the o ring Any data logger with recurring problems should be returned to Ellab for service When data loggers have not been used for an extended period of time they must be tested every three months by running a short test at room temperature When data loggers are not used for...

Страница 25: ... according to the indication on the housing pole downwards Exchange the o ring and put the lid back before tightening the spanner by hand The battery should be placed in separate activator for 60 minutes before inserted Thermocouple Sensor If not already mounted connect the thermocouple sensor to the data logger using the included screwdriver It is important that the RED wire goes into the RED scr...

Страница 26: ...n of 10 Autoclaved sterilized at 121 C for a max of 30 mins 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 Logger O Ring Ordering co...

Страница 27: ...sed for lyophilization applications 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 Users will have to manually keep track of the number of hours each battery has been used and the date it was inserted into data l...

Страница 28: ...nded to remove the battery from the data logger when it is not used for several weeks If the battery is removed from the data logger for a longer period of time more than one week it is necessary to reactivate the battery again Only use Ellab batteries The use of other batteries will void any warranty on the equipment Other batteries have not been tested in extreme temperatures environments and th...

Страница 29: ...ly for exactly 1 hour See the image below The same procedure applies if the battery has not been installed used in a data logger for more than 1 week A new battery has a voltage of approximately 3 6V Over time the voltage will drop a little and towards the end of its lifespan it will increase to around 3 7V before it rapidly drops to zero When testing the battery with a voltmeter it is important t...

Страница 30: ...ault automatically warn users 12 months after the last calibration date which should be considered a recommendation for temperature sensors built on Ellab s experience The factory calibration date can only be changed by Ellab this means that the factory calibration cannot be affected by any of the possible user calibration procedures performed in the ValSuite software Please note that the calibrat...

Страница 31: ... will loosen or damage the electronic connections The platinum resistor is extremely sensitive drift can therefore occur if not handled properly Only use cables USB provided by Ellab The ETS system must be properly grounded Never use the ETS outside the measuring range Any ETS with recurring problems should be returned to Ellab for service In order to maintain the accuracy of the ETS it is recomme...

Страница 32: ...ent ways It can be used as a standalone unit with a display in connection with the ETS Suite software or it can be setup in connection with the ValSuite software Setup Stand Alone Unit w Display 1 Connect the ETS using a USB cable to the ETS display 2 Connect the display to the power supply Setup ETS using ETS Suite Note USB drivers must be installed first for firmware versions older than 2 0 1 Co...

Страница 33: ...ation for Windows 7 8 and Windows 10 Note This section is only relevant for users with ETS firmware versions older than 2 0 8 2 3 Ellab Dry Blocks Ordering code Model Power Measuring Range 20000155 PTC 155A 115 to 230 VAC 50 60Hz 25 to 155 C 20000425 PTC 425A 115 to 230 VAC 50 60Hz 33 to 425 C 20000156 RTC 156A 115 to 230VAC 50 60HZ 30 to 155 C ...

Страница 34: ...g the power 5 Using the software manual verify that ValSuite is detecting the dry block 8 3 ValSuite Calibration Options ValSuite software includes three different methods for calibrating data loggers Manual Calibration Semi Automatic only for temperature and Full Automatic only for temperature 8 3 1 Manual Calibration First enter the reference value temperature then select the time of the referen...

Страница 35: ...sing fully automatic robotic systems The PEEK StopperClip is also designed to offer room for an additional buffer vial that can be placed between the data logger and vial and can be manufactured according to any vial dimension 9 2 LyoStopper The LyoStopper is made of Silicone rubber and a PEEK tube that covers the two internal neck diameters namely ø7 mm for 2R and 4R vials ø12 6 mm for 6R 100R vi...

Страница 36: ...re shaped as the vial in question and will follow the data logger throughout the conveyer band operation while at the same time bringing the data logger to the exact same height as the vial 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 9 3 1 Standard Versions Refere...

Страница 37: ...topperClip 10R StopperClip 15R StopperClip 20R StopperClip 25R StopperClip 30R StopperClip 50R 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 f...

Страница 38: ... 10R vials ConnectionClip for 15R vials ConnectionClip for 20R vials Connection Clip for 25R vials ConnectionClip for 30R vials Connection Clip for 50R vials Connection Clip for 100R vials 9 5 BufferClip As placing the LyoPro data logger between vials may have an impact on the temperature measured in the sample vial a special BufferClip is available This clip consists of PEEK and initial tests hav...

Страница 39: ...p for 8R vials BufferClip for 10R vials BufferClip for 15R vials BufferClip for 20R vials BufferClip for 25R vials BufferClip for 30R vials BufferClip for 50R vials 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 1 31201000 LyoPro data logger with thermocouple sensor 2 3120302...

Страница 40: ...gerNest 3 31203042 4R Logger Clip 4 Buffer Vial 4R w rubber stopper 5 31203044 4R Buffer Clip 6 Vial 4R w o rubber stopper 7 31203023 4R LyoStopper This is required for a complete 6R system setup using buffer vial 1 31201000 LyoPro data logger with thermocouple sensor 2 31203061 6R LoggerNest 3 31203062 6R LoggerClip 4 Buffer Vial 6R w rubber stopper 5 31203064 6R BufferClip 6 Vial 6R w o rubber s...

Страница 41: ...ip 4 Buffer Vial 100R w rubber stopper 5 31203004 100R BufferClip 6 Vial 100R w o rubber stopper 7 31203003 100R LyoStopper 11 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 ...

Страница 42: ...TrackSense LyoPro Version 3 3 Page 42 of 53 User Manual User Manual TrackSense LyoPro MAN 7 2 Select Next 3 Select a folder in the Change Directory if necessary and click select Next ...

Страница 43: ... 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 ...

Страница 44: ...yoPro MAN 7 1 Open the firmware updater which is placed under Programme x86 by default and select Ellab TS LyoPro Firmware Update 2 Select the Loggers button and push Scan 3 Push Select Deselect to toggle all checkmarks only positions check marked will be considered 4 Select Update ...

Страница 45: ...rsion will be shown if Update to latest firmware is check marked or a complete list of available versions 6 Highlight the requested FW version and push Select Firmware 7 The firmware updater program will proceed through 4 stages write file verify file flash and reboot which will be shown as in window below ...

Страница 46: ...e done the logger will appear with the new firmware as shown below 11 1 2 Procedure for Updating the LyoPro Reader Station firmware 1 Open the firmware updater which is placed under Programme x86 by default and select Ellab TS LyoPro Firmware Update 2 Select the Reader Station button 3 Push Update ...

Страница 47: ...will show available firmware versions to choose from 5 Highlight and push Select FW 6 The firmware update program will go through multiple cycles updating the interface and main board inside the Reader Station writing verifying and flash bootloader and firmware Progress will be shown as in window below ...

Страница 48: ...e new firmware as shown below 12 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 ...

Страница 49: ...oPro MAN 7 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 ...

Страница 50: ...each compartment Height 32 mm Weight 27 Grams Memory Capacity 100 000 Samples Minimum Sample Rate 1 Second Maximum Sample Rate 24 Hours Time Accuracy 5 Seconds Per 24 Hours Battery Type TSL 150 Expected Battery Lifetime at a 60 C 30 sec sample rate 2 400 hours Reader Station Specification Ambient Temperature Range 5 50 C Environmental 0 90 RH non condensing Operating Voltage External adapter 100 2...

Страница 51: ...ion If the loggers are too hot or too cold to be held by hand they are not to be placed in the reader station When I read my logger it gave me no data What can cause this Option 1 Broken Sensor If the reader station slot turned green and the data appears in graph the logger read ok Check the data and see if there is 1 sample around 62 C or 62 C If this is the case the sensor must be exchanged to a...

Страница 52: ...ro MAN 7 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 ...

Страница 53: ... name of section to include StopperClip 2021 01 21 TWF 3 0 2 1 3 3 3 3 1 3 3 2 3 3 3 3 3 3 1 3 3 3 2 3 4 7 1 8 2 1 1 9 3 2 Added Access Point option New sections on live data and access point Former section 3 3 Updated the estimated lifetime in battery example Updated ETS models and added new ETS devices Corrected ordering code 31208043 2021 07 01 TWF 3 1 1 4 4 13 Added mention of FCC ID XUS LYOAP...

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