To Run a Session Using ELLAB TS Pro Porbes
Contents
1. 6 5 8 Continue until all the loggers positions are defined in the template If the position of the yellow information box requires to be changed double click on it a 4 pointed arrow appears as the curser and allows the yellow SOP 07 VL 016 04 NIBT PAGE 13 of 16 position box to be moved To remove the yellow information box completely right click on it And then click on remove mm 6 5 9 Click OK and Close to close the Unit dialog box The unit will be saved for future use in the unit list and can be added to a session to define the probe positions in a mapping 6 5 10 Start the loggers as described in 6 3 8 Close the Start Logger dialog box Print out the unit configuration and use it to place the started cleaned loggers according to the unit configuration in the area to be mapped 6 5 11 The chamber or area being mapped will have a notice placed on it FORM DD 863 to indicate that a mapping session Is in progress and to request that details of the time and duration of the door opening is documented 6 6 Using Units 6 6 1 The TS Pro logger system can be started using the unit function To start a session using a unit click File New and TrackSense Session or click on the TrackSense quick start icon E 7 6 6 2 The New Session dialog box opens alB x eet Haa Pias Pitches 2 December 2005 7 adctaadeon a Fiaa l Caran Ted Virol DpH hajs m fin fp Proia _2. required Start Time and do the same for the chosen Stop Time and select a Sample Rate 1 Sample rate for 24 hour mapping is 5 minutes maximum Sample rate for a week long mapping is 15minutes maximum Sample rate for the Dometic freezer mapping is 1minute maximum Primary Conirol Sisi Time 5 00 00 eos a Aust Siop Time psigo k Samos Rate 1 0 oo 01 4 0 200 D Aiue Continue as for 6 3 8 6 5 To Create a New Unit 6 5 1 Click TrackSense select Unit TrackSense E fal Start Logger Red Logger Logger List 6 5 2 The Unit dialog box opens Wen a Ee fees cee Click Add New 6 5 3 The Unit can be configured according to Unit Type Unit Name Unit Description Placement Method Position Name Position Description Sensor Sample Rate and Images There are predefined unit types present but it is also possible to type in the field Wire Tepe Astat AubaClswe Urik Type Acom Plant i Roam IO AEE SOP 07 VL 016 04 NIBT PAGE 11 of 16 6 5 4 Enter correct Unit Type Unit Name and Unit Description and select the Placement Method lf By Sensor Number is selected the sensor number field turns active lf By Position is selected the sensor number turns inactive NIBTS usually use Position Name as placement type The Position Name can either be entered manually or selected from the Pre Defined Names database using the small scroll down arrow or the position can be defined
3. Select the loggers to be started by clicking on them individually or checkmark Select all logger devices 6 4 12 Right Click on the logger position and select Logger Settings Or Click the Logger Settings button at bottom right of the Start Logger dialogue box Refresh Logger Settings Eatery Test 6 4 13 Each Sensor type has individual settings Click the down arrow to choose a different sensor The dialog box lists the different sensor types present in the reader station NOTE Multiple sensor types cannot be started simultaneously If there is a need to use different sensor types in a session e g for NIBTS General Stores which has 2 dual RH temperature probes in the unit you need to ensure the dual RH temperature probes are placed in the reader block by themselves and check the unit logger positions are correct for the probes in the block at the time Start the probes as required SOP 07 VL 016 04 NIBT PAGE 10 of 16 Track Sense Fro Temperature PT 1000 2000 oe aoe or Tra ene Pro Tangarat PTI 20m0 Simgk Sensor Tr ere se Pro Temper oth ee PT 003000 Dh oe Senz P Track Sense Mini Tempe erature PT 1000 2000 Sing 5 Track Se ine Pn Relainre Hurree AH HIH A Siop Time erto Semple Aste 1 Tinea dit 6 4 14 Click logger settings to start the probes or to set up a delayed start For a delayed start a start time click the Start Time Adjust check box Enter the
4. as 1 2 3 etc By Sensor Number By Position Continue to add positions until all those required are identified and then add a probe position for beside the REES Comark continuous temperature monitoring probe s and an ambient probe also occasionally a second ambient is required 6 5 5 Click the Images button the images box opens f Taito Postion Desorption Sample 1 000500 EEEEEEEER Eeee ee SERRE 1 i Right click on the input area and select Load Bitmap An Open dialog box opens SOP 07 VL 016 04 NIBT PAGE 12 of 16 Go to the Ellab folder on the I drive to upload a picture or diagram specific for the unit Hz zx Dg m fag UritSamgple1 _5ide bmp lE UinitSamelel Top bmo le UnitSangkes Sia bmp H UnitSample2_Top bmp 6 5 6 Diagrams of a side view and a top down view of the equipment or area being mapped are normally used Select a picture and click Open The image is added to the unit A second image can also be added in the same way EEEE ER ERE EX ES ER ES It may be necessary to right click on the added picture to resize it 6 5 7 Highlight the first Position line left click and draw the cursor to the picture at the place where the logger should be positioned Release the mouse button and the position number is marked using a yellow information box The information box may define the position number or the sensor number Em km e ee EXER EX ERS
5. predefined number of loggers and positions for a specific area equipment The unit numbers can be found on the mapping by month list on the Mapping Information Board in RA amp C department To add a unit highlight the session name right click select add unit a window opens with a list of units highlight the correct one for the area to be mapped and click on Ok The unit is added to the session SOP 07 VL 016 04 NIBT PAGE 6 of 16 7 To start the loggers Click on TrackSense fa in the ValSuite toolbar select Logger Start and the Start Logger dialog box opens Le niria Debris C Logue Damai i Loge ad Hisi That Lees Lii jar Saari Fi 6 3 5 Select the loggers to be started or checkmark Select all logger devices 6 3 6 Right Click on the logger position and select Logger Settings Or Click the Logger Settings button at bottom right of Start Logger dialogue box 6 3 7 In Logger Settings each Sensor type has individual settings Click the down arrow to choose a different sensor type The dialog box lists the different sensor types present in the reader station NOTE Multiple sensor types cannot be started simultaneously If there is a need to use different sensor types in a session e g for NIBTS General Stores which has 2 dual RH temperature probes in the unit you need to ensure the dual RH temperature probes are placed in the reader block by themselves and check the un
6. 6 6 3 Session name box is completed with the name of the area being mapped To the session text box is added the mapping number for this session Profile is not currently used in NIBTS so add N A In the Process box choose the Temperature Mapping option or type Click OK The application window opens Highlight the session name and select Add Unit Add Camm ent SOP 07 VL 016 04 NIBT PAGE 14 of 16 AP 107083 01 NIBT BB21 40 Upright BBank i R 40 Upright Freezer 6 6 4 The Unit dialog box opens 6 6 5 Each NIBTS area mapped has a mapping unit identified by a number A list of units is recorded on the Mappings by Month sheet found on the mapping Information Board and in the Ellab folder on the I drive 6 6 6 Highlight the unit and click OK Note the number of loggers required for the unit again this information is on the Mappings by Month Sheet or highlight the unit right click and select view to view the unit Place the number of loggers required to be started beside the reader station so that the correct number of loggers will be started Place the loggers in the reader station and click TrackSense Start Logger To start the loggers Click on TrackSense in the ValSuite toolbar select Logger Start and the Start Logger dialog box opens Loge Snir Select al bea Jra Ch Logue Detected any Li ad Tisi k Ea baz Lii Go A 6 6 7 Select the loggers to be started or checkmark Select all logger devic
7. SOP 07 VL 016 04 NIBT PAGE 1 of 16 STANDARD OPERATING PROCEDURE Northern Ireland Blood Transfusion Service Operational Copy Document Details Document Number SOP 07 VL 016 04 NIBT No of Appendices NONE Supersedes Number SOP 07 VL 016 03 NIBT Document Title TO RUN A SESSION USING ELLAB TS PRO PROBES Prepared By Eileen Taylor Job Title Validation Officer Department REGULATORY AFFAIRS amp COMPLIANCE DEPARTMENT Document Authorisation Issue amp Implementation Prepared By E Taylor Date Approved By A Macauley Date Regulatory Affairs amp Compliance Manager ISSUE DATE 6 JANUARY 2014 EFFECTIVE DATE 6 FEBRUARY 2014 CROSS REFERENCES This SOP refers to the following documents Doc Title Type Administration and Maintenance of Ellab Thermal Monitoring Equipment Result retrieval and analysis using Ellab Probe Data NA Ellab ValSuite User Manual gt EE ee eee SOP 07 VL 016 04 NIBT PAGE 2 of 16 Key Change from Previous Revision Minor changes only 1 RESPONSIBILITY 1 1 Validation Officer BMS RA amp C Compliance Officer 2 INTRODUCTION 2 1 GENERAL NIBTS purchased a temperature mapping system for use throughout the Service to provide in house thermal mapping and permit full compliance with the current regulations The system purchased by NIBTS consists of a Master module and one Slave module each with four TS Pro logger slots which would allow 8 loggers to be read at one time
8. ckSense Pro reader station 4 1 7 Ellab TrackSense Pro Slave reader station 4 1 8 Colour Printer 4 1 9 Digital Camera 4 1 10 70 Alcohol wipes 4 2 SPECIMEN REQUIREMENTS AND MEANS OF IDENTIFICATION Not Applicable 4 3 REAGENTS STANDARDS OR CALIBRANTS AND INTERNAL CONTROL MATERIALS Not Applicable 5 CALIBRATION 5 1 The Ellab probes are posted to the supplier Ellab for annual calibration or repair 6 PROCEDURE 6 1 Preparing to start a TS Pro Session 6 1 1 It is important to attach any additional expansion modules to the Master Reader station before connecting the USB cable to the Master Reader and then to the PC 6 1 2 Assemble the TrackSense TS Pro X loggers as described in SOP VL 015 adding a suitable sensor 6 1 3 Ellab TS Pro Sensor types available in NIBTS are Single Rigid Temperature Sensor Single Flexible Teflon Temperature Sensor Dual Temperature RH 42 with an internal temperature Sensor 6 1 4 Log onto the ValSuite programme and enter your Username and Password SOP 07 VL 016 04 NIBT PAGE 4 of 16 6 1 5 6 1 6 akule User verification E Username i seter Foe cm CE Carcel Confirm the presence of the Reader icon with a GREEN cable in top right hand corner of the ValSuite screen ValSuite f D a x File SKY TrackSense E ValFlex ETS Tools Windows Help S A A amp R 99 ae This icon confirms that the Reader Station is attached If the icon is not there connect t
9. ed unit a unit attached to a session can be changed using the Edit function or removed using the Remove function prior to the probes being started A Unit template can be created using sensor number if required instead of position 6 4 5 To start a session using a unit click File New and TrackSense Session or click on the TrackSense quick start icon 6 4 6 The New Session dialog box opens staa H ame Process m o E Eran Ted Yia Fas T il cr o 6 4 7 Session name box is completed with the name of the area being mapped To the session text box is added the mapping number for this session Profile is not currently used in NIBTS so add N A In the Process box choose the Temperature Mapping option or type 6 4 8 Complete the session details Click OK The application window opens Highlight the session name right click and select Add Unit F 19 duget 2 Add Camment add unk 6 4 9 The Unit dialog box opens SOP 07 VL 016 04 NIBT PAGE 9 of 16 Highlight the unit to be selected and click OK The unit is added to the session AP 101088 01 NIBT a BB 1 40 Upright BBank i hi 40 Upright Freezer 6 4 10 Place the loggers in the reader station and on the top bar click TrackSense Start Logger The Start Logger dialog box opens i Loge Scr ea Lise Sees teed E Sebris bogs Ser rae Ligaa Deed pia Liege Srkod Sheri F Tato Lewes Lii Gio Suet Fleck Sete 2D deegure 6 4 11
10. ee the loggers started on other PC s Review detail to confirm they were programmed correctly 6 8 To Read the IrackSense Pro Loggers 6 8 1 Once the application is complete place the loggers in the reader station Click TrackSense Read Logger The Read Logger dialog box opens and scans the reader for loggers 00 F EH E ee ji i 6 8 2 Click the Select all logger devices box Click Read to read the selected loggers Once the loggers are read the graph appears in the application window Click Close to close the Read Logger window 6 9 Further Information on Ellab Probes and the Software Further information on Ellab probes and the software used may be obtained from the ValSuite User Manual 6 10 LIMITATIONS OF THE EXAMINATION 6 10 1 The Ellab probes can only be used by those trained in their use 6 10 2 The Ellab probes must only be used within their calibration period 6 10 3 In the event the Ellab probes reader station or ValSuite software did not work an external contractor would have to carry out temperature mapping until the mapping equipment was repaired or replaced RESULTS 7 1 Data Analysis Refer to SOP VL 017 Result Retrieval and Analysis of Ellab Probe Data
11. es 6 6 8 Right Click on the logger position and select Logger Settings Or Click the Logger Settings button at bottom right of Start Logger dialogue box Logger Settings Battery last SOP 07 VL 016 04 NIBT PAGE 15 of 16 6 6 9 In Logger Settings each Sensor type has individual settings Click the down arrow to choose a different sensor type The dialog box lists the different sensor types present in the reader station Tracks ense Pro Medea PT 1000 2000 Single Sensor 3 Sere TID00 2000 Singh Sens Tr acks FEN oie Tempe a PTT ODL 2000 Dual S O Track Sense Mini Temperature Balio SOOO Sir ngle Seno TrackSen aa Pi Relative Hunidity PSRH HIH 3602 Slop Time i Adjust Semple Aste 1 PTE 6 6 10 For Quick Start ensure the start and stop adjust boxes are blank Frima Comiral Start Time fas 0000 1705 2005 FF Adjust dwli hama hene Fr Agus 7 Semole Rae 1 00 0m H Add a start time if a delayed start is required and click Start If there are more than 8 loggers in the unit place the first 8 started in a carrier box Set sample rate 15mins for week long mappings 5 mins for 24 hour mappings 1 min for the Dometic freezers mapping a run Click OK lf more loggers need to be started for the same unit then place them into the reader station click the refresh button you will be asked to confirm that you wish to do this Repeat the logger set
12. gers according to the unit configuration in the area to be mapped Make a note on this print out where the REES Comark continuous temperature monitoring probe s are positioned 6 3 10 Clean loggers with 70 Alcohol wipes place as unit configuration in area to be mapped along with notices as appropriate Also place a completed DD 863 Temperature Mapping in Progress form on the access points to the area being mapped so that door openings activity in the area is logged 6 3 11 Place a form DD 863 Temperature Mapping in Progress form onto the front door of the chamber or area being mapped to indicate that a mapping session is in progress and to request that details of the time and duration of the door opening is documented N B Relative Humidity RH loggers measure RH and temperature at the same time e g If using 1 Ellab RH logger and wish to use position names in the unit configuration 2 positions names will have to be pre assigned to the unit 2 for each RH logger 6 3 12 Check Loggers Go to TrackSense and activate Logger List This will list all active programmed loggers that you have started you will not be able to see the loggers started on other PC s Review detail to confirm they were programmed correctly 6 4 Delayed Start using units 6 4 1 A delayed start is helpful for tests or studies that require a period of time for the loggers to equilibrate prior to collecting data or if a start timeout is after hours or when a user is
13. he Reader Station to the PC Confirm the green power light on the reader station and place the loggers with sensors attached in the reader slots 6 2 Starting the session 6 2 1 6 2 2 The start time and date is automatically noted in the session data Each session must have a unique ID it is impossible to restart a run or start a new session with the same ID There are a number of ways to start an Ellab session depending on the user s needs In NIBTS the Quick Start and Delayed Unit start are the preferred options others may be found in the Ellab User Manual 6 3 Quick Start 6 3 1 6 3 2 6 3 3 The Quick Start option is the most direct and the fastest way to start a session The session can be started either by placing loggers in the reader station and clicking File New TrackSense Session or TrackSense Start Logger or by clicking the TrackSense T icon The New Session dialog box opens ait xd Enter the session information into the fields SOP 07 VL 016 04 NIBT PAGE 5 of 16 6 3 4 Click OK the application window opens Click on the Tracksense icon in the ValSuite toolbar and select Start Logger The loggers can be started this way without a specified unit configuration It is possible to start the loggers immediately or to delay the Start by clicking on Logger Settings N B Normally in NIBTS the unit configuration specific to the area to be mapped is added to the session This unit has a
14. however a session can control more than 100 loggers The loggers are not linked to a specific position on the master or slave modules therefore a logger can be started in position A and read in position B It is possible to run many different sessions at the same time limited only by the loggers and sensors available This SOP explains how to use the Ellab equipment and software to run a temperature mapping session Information on administrative features and maintenance of the Ellab equipment is in SOP VL 015 Administration and Maintenance of Ellab Thermal Monitoring System Data analysis of results obtained is found in SOP VL 017 Result Retrieval amp Analysis of Ellab Probe Data 2 2 CLINICAL RELEVANCE PURPOSE OF EXAMINATION 2 2 1 Temperature Mapping is a requirement of GMP 2 3 PRINCIPLE OF EXAMINATION 2 3 1 Ellab temperature RH probes are used to record temperature RH and are placed in the area to be temperature RH mapped according to a pre defined unit configuration 3 HAZARD AND SAFETY PRECAUTIONS 3 1 The use of Ellab TS Pro Probes poses no significant health and safety risk 4 MATERIALS 4 1 EQUIPMENT AND SPECIAL SUPPLIES SOP 07 VL 016 04 NIBT PAGE 3 of 16 4 1 1 PC Computer system with ValSuite Pro software 4 1 2 Ellab TrackSense Pro X Data Logger 4 1 3 Ellab Single Rigid Temperature Sensors 4 1 4 Ellab Single Flexible Teflon Sensors 4 1 5 Ellab RH 2 with internal temperature sensors 4 1 6 Ellab Multi Tra
15. it logger positions are correct for the probes in the block at the time Refresh Logger Settings Eatery Test Track Sense Pro Tempernture PT 1000 2000 Single Sensor j TrackSense Pro Temparaiee PT 1000 2000 Single Senso TrackSense Pro Temperatuee PT 1000 2000 Dual Sensor Track Sense Mini Temperature PT 1000 2000 Single Sarsa TrackS ange Pro Relathes Humidity SAH HIH 3602 Siop Time Semple Aste 1 0 0x01 6 3 8 For Quick Start ensure the start and stop adjust boxes are blank Promacy Coniol Start Time 15 0000 176 2005 Ajust Stop Time oo 1706205 Aun Sample Aate 1 o ag i lt Add a start time if a delayed start is required and click Start If there are more than 8 loggers in the unit place the first 8 started in a carrier box SOP 07 VL 016 04 NIBT PAGE 7 of 16 Set sample rate 15mins for week long mappings 5 mins for 24 hour mappings 1 min for the Dometic freezers mapping a run Click OK lf more loggers need to be started for the same unit then place them into the reader station click the refresh button you will be asked to confirm that you wish to do this Repeat the logger settings as all loggers started for a unit must have the same logger settings applied After all loggers have been started click Close to close the Start Logger dialog box 6 3 9 Print out the unit configuration and use it to place the started log
16. n t available to manually start the loggers This is the most commonly used start option in NIBTS temperature and RH mapping 6 4 2 There are equilibration times for each temperature range mapped during which the probes must be placed in the mapping positions 80 C freezers equilibration time is 6 hours 40 C freezers equilibration time is 4 hours SOP 07 VL 016 04 NIBT PAGE 8 of 16 20 C freezers equilibration time is 3 hours 2 C to 6 C 8 C or 10 C fridge cold room equilibration time is 3 hrs Room Temperature Incubators labs stores equilibration time is 1 5 hrs There is no equilibration time for the Dometic Freezers mappings NOTE the Dometic freezers mapping cannot use a delayed start so use a quick start with no defined start or stop times 6 4 3 A Unit is a predefined program giving the probe positions descriptions and including a photograph or diagram showing where the probes are to be placed and the sample rate In NIBTS a specific unit is created for each piece of equipment or area mapped and is saved for future use Users performing the same study many times with the same configuration of loggers will want to use the Unit to save time make the start up process much easier and to link the Position and the Ssensor Logger number when the probes are started 6 4 4 The Unit by Position option is used in NIBTS All defined units can be Saved as templates and reloaded from the unit list in the toolbar and the loggers started A load
17. tings as all loggers started for a unit must have the same logger settings applied After all the loggers have been started click Close to close the Start Logger dialog box 6 6 11 Print out the unit configuration and use it to place the started loggers according to the unit configuration in the area to be mapped Make a note on this print out where the REES Comark continuous temperature monitoring probe s are positioned Clean loggers with 70 Alcohol wipes 6 6 12 Place the loggers according to the unit configuration in the area to be mapped along with notices as appropriate Also place a completed DD 863 Temperature Mapping in Progress form on the access points to the area being mapped so that door openings activity in the area is logged 6 6 13 Place a form DD 863 Temperature Mapping in Progress form onto the front door of the chamber or area being mapped to indicate that a mapping session is in progress and to request that details of the time and duration of the door opening is documented N B Relative Humidity RH loggers measure RH and temperature at the same time e g If using 1 Ellab RH logger and wish to use position names in the unit configuration 2 positions names will have to be pre assigned to the unit 2 for each RH logger SOP 07 VL 016 04 NIBT PAGE 16 of 16 6 7 Check Loggers 6 7 1 Goto TrackSense and activate Logger List This will list all active programmed loggers that you have started you will not be able to s
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