Administration and Maintenance of ELLAB Thermal Monitoring
Contents
1. Provide a written quotation and service report containing the details of equipment for calibration maintenance or repair from Ellab with the requisition for stores e Equipment for return to Ellab is to be packed suitably and shipped by a courier which is selected according to the amount of insurance required This is arranged through NIBTS Reception or when necessary by the validation officer e Inform Ellab UK when shipped e Update the NIBTS Ellab Equipment log amp Q PULSE e On return to NIBTS the equipment must be verified as working and the printouts placed in the equipment log Calibration certificates must be signed off and placed in the equipment log e Update equipment log and Q PULSE as appropriate giving the equipment status SOP 07 VL 015 03 NIBT PAGE 7 of 16 6 3 3 Periodically check calibration on the single rigid sensors Place all probes into a controlled temperature dry incubator for 1 hour after equilibration Verify REES and Ellab both in air are 1 C from each other sign off the print out and file at the front of the equipment log Note the calibration check on the calibration sheet for single rigid sensors If the results do not meet the acceptance criteria repeat the comparison using a slush bath If the results are not acceptable return out of specification sensors to Ellab for calibration The RH and flex sensors are not calibration checked as these are only used once per year 6 4 TrackSense Pro Batt2. administrators and as Master The Master can set edit the administration profiles of all others administrators and users and can deactivate activate administrators and users An administrator can set edit the administration profile for a user and deactivate activate users only 2 INTRODUCTION 2 1 GENERAL 2 1 1 Current regulations and the MHRA require that along with continuous temperature monitoring all areas storing GMP critical items will be temperature mapped empty and full or operational when new or after significant change or repair and thereafter operationally at least annually NIBTS purchased Ellab equipment and software to use for temperature and RH mapping for use throughout the Service to permit full compliance with the current regulations Data can be collected analysed displayed and reported by the Ellab ValSuite Pro system The system 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 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 SOP 07 VL 015 03 NIBT PAGE 3 of 16 This SOP explains how to assemble and maintain the Ellab equipment how to send it for repair or mainte
3. no longer visible 6 8 3 Add a very thin coating of the supplied lubricant to the O rings Screw on the top cover finger tight Never use tools to do this and do not over tighten as this might damage the threads 6 9 Maintenance of Loggers and Sensors e Do not use the probes outside the measuring range listed in the technical specification e The loggers are to be stored with the batteries removed if not used regularly e The loggers and sensors are to be kept clean and stored in boxes in a cool dry area e The loggers and sensors are sensitive electronic equipment and must be treated with care e Frequently lubricate the O rings with silicone and when necessary change the O rings NOTE If a defective sensor is connected to a logger the logger will start the first time it is used without an error message An error message will appear when the logger is next read It is recommended to test new sensors on receipt to avoid this problem 6 10 Using the Ellab equipment 6 10 1 To use the Ellab equipment to run a session refer to SOP VL 016 NIBT To Run a Session using Ellab TS Pro Probes 6 11 Corrective Action A list of possible error messages and actions are listed below TS Pro Error Codes from the ValSuite 2 8 Edition User Manual page 375 380 SOP 07 VL 015 03 NIBT PAGE 11 of 16 Invalid data in logger send the logger for Bao Start logger memory wa YES NO ifthe error persists please ihe mad for fa
4. status is acceptable SOP 07 VL 015 03 NIBT PAGE 9 of 16 Bathory Satus Tha battar is empty Battery SALLE The bakery skakis is unknown The batery best could not be done When finished continue with starting loggers or click Close Please change battery if the status is low or critical 6 5 The TrackSense Pro logger system 6 5 1 The TrackSense Pro logger system consists of four parts Intelligent sensor ntelligent unit Communications unit with CPU and PT1000 A D non volatle memory including the battery Electronics board 6 5 2 First disassemble the logger by unscrewing the top cover and removing the logger unit and sensor if present from the logger housing using the tool provided Check the battery is the correct number assigned to that logger and is inserted in the correct orientation i e facing the base See 6 4 1 6 6 How to position the tool to unscrew the logger 6 7 H SOP 07 VL 015 03 NIBT PAGE 10 of 16 6 8 Assembling the logger 6 8 4 Add the battery to its housing unit ensuring correct battery orientation 6 8 2 Fitthe sensor by carefully connecting the male and female connectors at the base of the sensor and the top of the logger Take care not to damage the connector pins Ensure the serial number on the logger unit and the logger housing are the same Slip this unit into the logger housing by gently pressing the sensor down until the O rings at the sensor base are
5. the logger and sensor for factory inspection Battery voltage has become low and the battery should be replaced SOP 07 VL 015 03 NIBT PAGE 14 of 16 Info Error message Action ValSuite Output Button Battery voltage has become extremely low and the battery MUST be replaced now Low battery critical warning Logger session partly OK logger stopped invalid only data collected before low battery condition will be transferred to data file Logger session invalid no data will be transferred to data file If the error persists please send the logge for factory inspection Hardware error in logger clock Logger session invalid no data will be transferred to data file Remove battery Incomplete measuring cycle reinsert after 10 seconds If the error persists please send the lo gger and sensor Logger session partly invalid only data Hardware error in sensor collected up to the OK violation will be transferred to data file sensor serial number Logger session partly mismatch Sensor has been invalid only data replaced since logger start or collected up to sensor logger could be violation will be defective transferred to data file SOP 07 VL 015 03 NIBT PAGE 15 of 16 Info Fr Th Actio ValSuite Button sensor exposed to the pr seccing n maximum temperature limit invalid em data applied for this sensor collected up to violation have occured legger
6. will be transferred to data file Sensor exposed to the 4 Logger session partly maximum temperature limit invalid only data applied for this logger collected up to violation Physical damage could E las deal have occurred logger be transferred to data stopped sensor exposed to the mr enee maximum temperature limit nd ae applied for this product collect w eo Physical damage could peu Eel in chil have occurred logge SS stopp agl Contact Ellab to buy a Algorithm ld 5 is NOT newer version of supported no match ValSuite to support all found not defined logger types or firmware Re read loggers again if logger whit out the RF module An Error occurred when reading the logger s Please Coved logger s with RF re read logger module not read logger again the data is OK The files are already in the database you shout at You need to disable Unable to open connection windows firewall see to database Name ELLAB control panels secunty Session already exists session name SOP 07 VL 015 03 NIBT PAGE 16 of 16 J weas When start online mode Error messaqe No SKY logger is Mo Data Series found started x Control water bath 1s stable control stiming is on Reinstall NET used ValSuite installation CD see chapter 9 6 2 Reset Access Status 6 12 LIMITATIONS OF THE EXAMINATIO Not Applicable 7 RESULTS Not Applicable
7. 1 The ValSuite Pro software is designed for three levels of user Master Responsible for the security of the program has access to all ValSuite Pro functions The Master creates the first user and administrators and can deactivate administrators and users The Master can set edit the administration profiles of all others administrators and users The Master can set the password to be changed at next login for administrators and users Administrator Creates users has access to all run functions in ValSuite Pro software An administrator can set edit the administration profile for a user An administrator can set the password to be changed at next login for users User User has access to running ValSuite Pro function User can change their own password The Master or Administrator defines all access 6 2 Adding Users to the Ellab system 6 2 1 The Administrator must add users to the system to enable them to access the ValSuite Pro software and run sessions 6 2 2 To add a user go to Tools Administrator Access Manager as shown on the screen dump below SOP 07 VL 015 03 NIBT PAGE 5 of 16 C NE da ildmmcuicn ce Mode Logger Database Access Manager Calibration Profile Session Change Password Audit Trail Pre defined Names Properties Communication Settings Database General Settings Temperature Extrapolation Firmware Manager Password Settings View Event Log Change Master Password Select Language Note the Mas
8. SOP 07 VL 015 03 NIBT PAGE 1 of 16 STANDARD OPERATING Northern Ireland Blood Transfusion Service PROCEDURE Operational Copy Document Details Document Number SOP 07 VL 015 03 NIBT No of Appendices NONE Supersedes Number 07 VL 015 02 NIBT Document Title ADMINISTRATION AND MAINTENANCE OF ELLAB THERMAL MONITORING EQUIPMENT Prepared By Eileen Taylor Job Title Validation Officer Department R A amp C VALIDATION Document Authorisation Issue amp Implementation Prepared By E Taylor Date Approved By A Macauley Date R A amp C Manager ISSUE DATE 24 APRIL 2012 EFFECTIVE DATE 30 APRIL 2012 CROSS REFERENCES This SOP refers to the following documents Doc Title i SOP 07 VL 015 03 NIBT PAGE 2 of 16 Key Change from Previous Revision General minnor changes Responsibility section updated Access for administrators updated Error codes updated 1 RESPONSIBILITY 1 1 Validation Officer or deputy is responsible for ensuring Ellab equipment is maintained in validated state and calibrated and updated on Q Pulse and in Equipment Log 1 2 Validation Officer and Compliance Officer are responsible for packaging and shipping Ellab equipment for calibration maintenance and repair 1 3 Validation Officer and Compliance Officer responsible for carrying out battery and other in house maintenance calibration checks 1 4 The Validation Officer or deputy has access to the ValSuite system as
9. ctory Invalid data in logger mory Invalid data in sensor If the error dus c Start logger send dai logger for factory YES INOJ P ifthe error persists please logger memory opecton ogger tor factory Hardware emor in sensor memory Battery dE become low and the battery should a be replaced If the batte DE EET bir replaced this wamiung will disappear after the next logger start Battery voltage has become extremely low and the battery MUST be replaced T Hes now If the battery has been aaia replaced this warning will op disappear after the next eP e l lf the error persists please Hardware error in logger Start logger dock n des ogger for factory YES NO SOP 07 VL 015 03 NIBT PAGE 12 of 16 MERE Output Button Remove battery reinsert after 10 seconds If the error Start logger Incomplete measuring cycle persists please send YES NO the logger an sensor f If the error N Siri Inaner Hardware error in sensor please send was ogger YES INO for factory inspex i The application or DLL CAWINDOW S System VOLE 2 DLL is not valid Windows mage Please check this against your installation diskette Install USB drivers in to the PC Only VISTA error Access to path C ProgramData ELLAB Device TrackSensePro In User Account Unelick Use User Account Control UAC to help p IS protect your computer se
10. ery Management Note Only Ellab high performance batteries may be used 6 4 1 The batteries for the loggers are identified by a number Each battery will be assigned to a specific logger and must only be used in that logger This logger battery list is available in the electronic Ellab folder on the I drive and is updated when new batteries are assigned to loggers The batteries are only removed from the loggers if they are to remain unused for 4 weeks or longer 6 4 2 The high performance lithium battery for TrackSense Pro loggers is designed for use within a temperature range of 80 C and 150 C When new or if unused for 4 weeks or more the battery must be placed in an activator unit for 1hour but no longer which prevents draining the battery prior to use with the TrackSense Pro loggers The diagram on the activation unit itself shows the required orientation of the battery within the unit Activator Unit and battery 6 4 3 It is possible to test the battery before running a session Right click on one of the logger positions marked blue and select Battery Test SOP 07 VL 015 03 NIBT PAGE 8 of 16 Dope Selected Q Logger Siarad op cin D Logger Detected The test takes one minute and a bar indicates the time consumption The test result may look like below Waiting symbol The battery condition amp excellent Ths current bethery is Fully cperaticnal Checkmark indicates battery
11. nance as well as a troubleshooting guide on what action to take with an error message Use of the Ellab system to run a temperature mapping session is explained in SOP VL 016 To Run a Session using Ellab Probes Help with data analysis of results obtained is found in SOP VL 017 Ellab Probe Result Retrieval and Analysis NIBTS use the password option at login An administrator can set the password to be changed at next login for users The Master can set the password to be changed at next login for administrators and users 2 2 CLINICAL RELEVANCE PURPOSE OF EXAMINATION Not Applicable 23 PRINCIPLE OF EXAMINATION Not Applicable 3 HAZARD AND SAFETY PRECAUTIONS 3 1 The maintenance and administration of Ellab Thermal Monitoring Equipment poses no significant health and safety risks 4 MATERIALS 41 EQUIPMENT AND SPECIAL SUPPLIES 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 TrackSense Pro reader station 4 1 7 Ellab TrackSense Pro Slave reader station 42 SPECIMEN REQUIREMENTS AND MEANS OF IDENTIFICATION Not Applicable 4 3 REAGENTS STANDARDS OR CALIBRANTS AND INTERNAL CONTROL MATERIALS Not Applicable SOP 07 VL 015 03 NIBT PAGE 4 of 16 5 CALIBRATION Not Applicable 6 PROCEDURE 6 1 Administrator Functions 6 1
12. nsor exposed to maximum temperature limit applied for this i sensor Physical damage could disappear afterthe YES NO This waming will Start logger have occurred next logger start sensor exposed to maximum w temperature Imit applied fortis disappear ater the Siart ogge ls next logger start YES NO D exposed to maximum terr re limit applied for this I a a a Physical damage could ir uud ra Ec x ae next logger start Logger session invalid no data will be transferred to data file If the error persists p send ion Invalid data in logger memory SOP 07 VL 015 03 NIBT khbii qo TE Logger session invalid no data will be Invalid data in logger memory Invalid data in sensor memory memory Hardware error in logger memory Hardware error in sensor PAGE 13 of 16 ValSuite Output Button transferred to data file If the error persists please send the logger ory inspection Logger session invalid no data will be transferred to data file If the error persists please send the logger and sensor for factory inspection Logger session invalid no data will be transferred to data file If the error persists please ias the logger session ian no data will be transferred to data file lf the error persists p send wien ogger Logger session invalid no data will be transferred to data file If the error persists please send
13. ter login must be used to add and edit Administrators Administrators can add and edit users not administrators An individual administrator can edit their own general info There is no profile option for administrators they all have the same access 6 2 3 Ihe Access manager window opens 6 2 4 Click on Add and the window below opens to be completed with the general details of the user Remember to checkmark Change password on next logon SOP 07 VL 015 03 NIBT PAGE 6 of 16 6 2 5 Click on the profile button to open the profile window and select what access the user is to have When complete click OK the window closes 6 3 Calibration Maintenance Repair 6 31 NIBTS Ellab sensors are returned to Ellab headquarters in Denmark for recalibration maintenance or repair The Ellab equipment log and Q PULSE must be updated if the status of the equipment is altered 6 3 2 In the event that Ellab equipment requires calibration maintenance or repair e Contact Ellab UK giving details as required and obtain a returns number for shipping equipment to Ellab Denmark for work to be carried out Obtain a written quotation for work to be carried out except for repairs as costs are not known in advance e Complete a Non Stock requisition to be approved by the Quality Manager or a nominated deputy This order is then passed to NIBTS otores for further processing
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