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StaRRsed Flex User Manual

1. 145 Pipette number 5 XXXXX 150 Sedimentation time minutes 5 XXXXX 155 Temperature 5 XXXXX 160 Dilution rate 5 XXXXX 165 Column height mm 5 XXXXX 170 Error code 5 XXXXX See section ESR error codes 175 Limit error message results 30 text See section Limit error message on page 131 205 Reserved spaces 50 text 255 Checksum 1 CS See section Checksum calculation 256 End of text 1 256 Text left aligned followed by spaces number digits 0 9 with leading spaces Non specified positions are filled with spaces Sample codes Aspect codes Sample type Transmitted code Aspect Transmitted code Patient sample 0 Clear 0 QC normal 1 Hazy lt 10 1 QC abnormal 2 Hazy lt 25 2 Hazy gt 25 3 Page 246 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Note Transmission of QC codes 1 and 2 is part of the internal QC procedure ESR error codes No cells plasma found 1 ERROR no result transmitted ESR Probably gt 140 mm ERROR no result transmitted Too many borders found Limit error 7 ERROR see Limit error messages on page 131 Note See analyzer manual for more information about limit error settings When a limit error occurs the fields for ESR 30 min ESR 60 min temperature corrected ESR and ESR 120 min are filled with spaces and thus results are not send to LIMS T
2. a aM 168 15 5 Compact 8 16 o pax ibo it ba 169 p EEG rm 171 15 6 1 Diluter system not sufficiently primed 171 15 6 2 DINGS BITOIS ico AK a p RI E EE iE 172 15 6 3 Air bubbles entering the Diluent system 172 15 7 odis cece scarce edad tima abd Mu 175 15 7 1 Vacuum stabilisation problems ssesesseeeeeennnn 175 15 72 Vacuum ETT UTE 176 15 8 Needle m 177 StaRRsed Flex User Manual Page 9 Version 1 02 MRN 151 EN Contents 15 8 1 15 8 2 15 9 1 15 9 2 15 9 3 15 9 4 15 9 5 15 9 6 15 10 15 11 15 12 15 13 15 14 15 15 15 16 15 17 15 17 1 15 18 15 18 1 15 18 2 15 18 3 15 19 15 20 15 21 15 22 19 INDEX Page 10 Needle not in top position Sample probe fails to go down 15 9 Air bubbles Foam in column Pipette looks like zebra crossing One air bubble about 5 mm under meniscus One air bubble rising in pipette Small air bubbles rising in pipette Random air bubbles in pipette Leaking pipettes Rinse nozzle wash station alignment Hazy reports Contaminated instrument Fill time out
3. 31 5 4 1 Stickers of the reagents containers 31 6 COMPACT FLEX PROGRAM e 33 6 1 Software VOFSIOUL uteretur asbtecc atat ema deutet onc en drip Pan U eR XI MAR PESUE UR ER bles UI 34 p 2 Sample SCIBBTFI eere paint Kec esM ta nU UFU iU RR MAE 34 6 2 1 S72 18 12 Eee ee eee 35 6 2 2 Measure StANON 35 6 2 3 WSIS eceran OO o 36 6 2 4 eer ee eee ee eee 36 6 2 5 E 36 6 2 6 Sample mode MT 36 6 2 7 biceps 36 6 2 8 Sample information 2 36 6 2 9 36 6 2 10 Sample screen with keyboard 37 6 211 Pipette INONNMAlOM px EPI 38 6 3 History CA MM EM Eas 40 6 3 1 Display o o D 41 6 3 2 Display Sample 42 6 3 2 1 Display patient diuo 43 6 3 3 rell ele Mere Em
4. 137 9 4 2 Turn off Sequence E mo 137 10 QUALITY arose 139 10 1 H 139 10 2 Monitoring measurement quality with StaRRsed Control 139 10251 ioci e d 139 10 2 2 Expected value RUM IRR SISURURE 140 10 2 3 Temperature COITOClIOnL ii eontra eura ER Rab ui 140 10 2 4 Usage options 140 10 2 5 Quality control procedure 141 prs EC 2 0 ERR 142 10 2 QC Error messages ahem as 142 10 2 6 2 QC Result analysis erba bob rs Ri Fa pu Lp ekenin aiaei 143 11 WASTE DISPOSAL 145 11 1 Waste line connection to central waste system 145 11 2 Replacing the waste container retra trant tu pu pE rax bA SU EUR E MES 145 12 COMPACT SYSTEM Mex 147 12 1 System messates sc tb ER epi UN pL UN EUN MEM e DUM DNA MEE 147 12 2 094 c r c 148 12 3 System tiMe Out lt XXXX gt RE 148 T2 4 Error MGSSage Ss icais sess cctsicrsentstetacelsiareienrmiaclenien e R EEA EE AAR 148 Page 8 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronic
5. Position error Separator Haageriis Reagents alarm Fill NO ZZ Gs Fill nozzle does not engage with pipette Fill nozzle not at fill position Fill nozzle not at home position Piercing error uoce t eerte Not reading the barcode Quality control trouble shooting 16 APPENDIX FOR STARRSED FLEX 16 1 connections for StaRRsed Flex Windows 7 17 WORK INSTRUCTION STARRSED FLEX 18 GLOSSARY OF TERMS mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics 1 Introduction INTRODUCTION The StaRRsed Blood Sedimentation Rate Instrument hereafter called StaRRsed Flex is an in vitro diagnostic medical device that automatically carries out the erythrocyte sedimentation rate analysis according to the Westergren method conforming to CLSI approved standard H02 A5 using closed sample tubes filled with citrate or EDTA blood The StaRRsed Flex is an advanced ESR system that offers many unique features and benefits over the traditional ESR procedures Automating this method has the following advantages The Westergren pipettes are always filled to the correct level Using closed sample tubes reduces the possibility of contamination for the user and environment Standard glass Westergren pipettes are used in whi
6. 4 Manually added code XX gt wo N gt 1 12 2 a EN E EA ES EM 39 Pipette number 3 Sedimentation time Temperature in degree Default 46 C EDTA message MMMMMMMMMM asou Dec STX ASCII 02 ETX ASCII 0 EOT ASCII 24 33 37 41 45 48 71 LF ASCII CR ASCII 68 1 byte Text left aligned followed by spaces ASCII 20 Xx number made of xx digits 0 9 ASCIII 30 39 with leading zeros Leading zeros and non specified positions are filled with spaces ASCII 20 Page 230 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Appendix for StaRRsed Flex Appendix Sedmatic 100 string format Normal result string pp JPPPPPPPPPP JWWWNWT JE JEJE JE JEJE 26 data characters Total length 28 characters Or Result string with Aspect pp JPPPPPPPPPP JWWWW J Jf JL TE JL TEL JAAAAAAAAAAA cr If Or Result string with Error pp JPPPPPPPPPPT JEJE JE JCC ICICI IL IL I I JEEEEEEEEEEE cr If 37 data characters Total length 39 characters p poen o E S R in mm 60 min WWWW StaRRsed Flex User Manual Page 231 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Text left aligned followed by spaces ASCII 20 xx number made up of xx digits 0 9 ASCIII 30 39 with leading zeros Leading zeros and non specified positions are filled with
7. i 90 120 130 140 150 160 170 180 190 200 80 Aspect ESR60min ESR60min code me T Cor mm 133397702 61 53 ESR time Dfution Temperature i LL Qn _ CO _ meter 170 01 12 2008 13 14 41 Ins 3 bs Error code El In the window Select date to show results double click on the file name to select the results of the selected date Press Refresh to refresh the list of available files In the window Sample ID type the sample ID information and press Search Press Options for the following search options e Show today s results e Show today s results from a selected time frame of the day e Show results of a number of past days Default value is set for 7 days e Show results of a specific day e Show results of the range between the first selected date to the next selected date StaRRsed Flex User Manual Page 43 Version 1 02 MRN 151 EN Compact FLEX program mechatronics From the selected Sample ID detailed information is shown on this screen Sample ID ASPECT code ESR 30 min ESR 60 min ESR 60 min T CORR Date time ESR time min Dilution 96 TEMPERATURE C Pipet number Error code Page 44 Sample Identification number Shows the aspect code e g Hazy 10 The 30 minute method is used This is the measured 30 minutes value When the 60 minute method is used this is the measured 60 minutes value When the 30 minutes method is used this
8. 55 02 0ec0810 4703 6 123 macio tA 5 3405802 29 DecO81529 3 14 2 lt EOTA 5 5 29305002 29 08 11 15 58 is 22 08 Dec 08 03 Dec 35 8 08 Dec 08 11 31 Hn 2990002 1 ASPECT EDTA 23 wzeo jet 0 89 4 a Compact FLEX program By selecting one of the three Hazy aspect codes all the samples with this aspect code are displayed in the table also in case of an error In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 59 RR mechatronics Compact FLEX program 6 3 8 History analyse error i Analyse results a NR Odeo 143211 43 23 Nocelsiplasmafound 02 0ec 08 12 22 58 Neceksipamafoud 8 Dec 08 cels plasma Found 29 Dec 08 11 04 27 HU E SSS ee Sj oni i Com imm Dcum gt ERROR By selecting one of the error codes all the samples with this error code are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order Page 60 StaRRsed F
9. 13 1 4 Explanation of available documentation eeese 14 2 INSTRUMENT DESCRIPTION iirrata oto doin toa Ex ben uae rn 15 2 1 Technical specifications M Ub U PURUS M ANUS 16 2 2 ACCESSOry NN mU RT 19 3 GENERAL SAFETY INSTRUCTIONS ocaaen anon e ou annua tn nn neu tuna aa uaxo nen Rnu 19 3 1 21 4 INSTALLATION w n w kA aAa 23 5 STANDARD OPERATING PROCEDURES 5 0 25 5 1 Basics of BIO Safety 25 5 2 S O P for working with bio hazardous 26 5 2 1 Facts and definitions 26 5 2 2 Medical requirements 26 5 2 3 General laboratory practices 26 5 2 4 Specific laboratory practices and 27 5 3 Declaration StaRRsed Compact 28 5 4 Labels and stickers on
10. Instrument Compact Revision 001 February 2005 Replace the pinch valve tube ESRIO10246 1 2 3 Alor EL _ i Open the left cover Pull the tube out the pinch valve Disconnect the silicon tube from the bottom connector and the top connector Remove the tube Connect the silicon tube to the bottom connector and the top connector Push the tube in the pinch valve Close the left cover StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 307 mechatronics Work instruction Number 181 7 Page 1 of 1 Purpose Replace diluter syringe Teflon tip Safety None Bio Hazard area Instrument Compact with new diluter Revision Draft October 2001 version Disassembly diluter syringe Unscrew the syringe from the attachment 1 2 3 ae E Ex 1 2 Take the syringe from the diluter assembly Pull the plunger out of the syringe Cut the Teflon tip of the plunger with a sharp knife Be careful not to damage the metal plunger Replace the O ring and then the tip Replace the old tip for the new tip assembly From repair set QWLV030902 Moisten the tip with water to ease the tip back into the glass syringe barrel Install the syringe back on to the attachment Prime diluent MAINTENANCE PRIME DILUENT Repeat this step until there are no air bubbles in the total diluent system Check your dilution settings
11. Statistics graph Batch QCSE44AA0S OC9E42AA25 23 7 7 mt 0210172012 07012012 10 01 2012 13 01 2012 16 01 2012 19 01 2012 22 01 2012 2501 2012 2810112012 31 61 2012 Date Calculated mean mm Standard deviation mm Coefficient of variation Number of OC results Display Statistics graph All QC results from the chosen StaRRsed Control batch are shown in a Levey Jennings chart Shown in the graph e QC results red values of measurements per date e Calculated mean yellow mean value of all QC results of the specific batch e Expected ESR green Assay mean value of chosen StaRRsed Control Shown as value e Calculated mean mean value of all QC results of the specific batch e Standard deviation the average deviation of all QC results compared with the expected ESR e Coefficient of variation ratio of the standard deviation to the expected ESR expressed in a percentage e Number of QC results Page 54 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program This graph gives a first indication of the measuring stability of the StaRRsed Flex Further analysis and identification of systematic errors have to be performed in the user s Quality Control System CLOSE Return to History Screen 6 3 4 7 Display sample history QC Ree This screen shows all patient results that have been measured after the selected QC result and up to the
12. EI New tube replacement 1 Open left cover 2 Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex ONO OPO StaRRsed Flex User Manual Page 287 Version 1 02 MRN 151 EN Ta mechatronics Work instruction Number 166 Page 1 of 2 Purpose Peristaltic waste pump cassette replacement Safety Bio Hazard area Instrument Compact Revision Draft October 2008 Clean Waste Cassette The waste system must be cleaned before replacing the waste pump cassette 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Liftthe stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Remove bacterial HEPA filter 5 Fill waste separator with 100ml disinfectant or 100 ml water with 296 bleach 6 Replace bacterial HEPA filter 7 Liftleft cover 8 Lift stainless steel vacuum tube u
13. Visually check the bottom of the pipette V shape Hook pipette assembly on to the pipette belts EEU COU e Make sure that pipettes are correctly fitted on to height u Incorrect fitted pipettes may cause mechanical damage to the instrument Check for leakage with Fill amp Clean Replace the top cover 1 Put the cover carefully over the instrument Page 294 StaRRsed Flex User Manual Version 1 02 MRN 151 EN 2 Fasten the two rear screws of the top cover If present if needed StaRRsed Flex User Manual Page 295 Version 1 02 MRN 151 EN R mechatronics Work instruction Number 178 Page 1 of 1 Purpose Hazy problems Safety Bio Hazard area Instrument StaRRsed Flex Revision 002 December 2013 Prepare disinfectant Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution Cleaning the diluent system Step 1 Poh gt 5 Remove the suction tube from the diluent bottle Place the suction tube in chlorine solution Use the PRIME DILUENT function This fills the dispenser system with the disinfectant After the prime sequence stops press PRIME DILUENT 5 times to fill the dispenser system with the disinfectant Leave the disinfectant in the system for 15 minutes Step 2 Take the diluent suction tube out of the disinfectant Wipe the tube clean and dry with a tissue Place t
14. 15 6 3 Air bubbles entering the Diluent system 1 Check the diluter syringe tip 2 Check on the T piece Y piece joints and connectors for leaks and replace if necessary 3 Check the connectors on the EDTA flow sensor for leaks and replace if necessary Page 172 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting Select MAINTENANCE gt PRIME gt PRIME DILUENT vacuum pump is on and system must be filled with Diluent When the citrate is priming liquid should be seen flowing through the tube connection to the fill nozzle cap Occasionally when the diluter system is primed for the first time air locks occur in the tubing and the diluter will not self prime If this occurs disconnect the luer fitting at the syringe and connect a syringe filled with Diluent to the tubing and fill system manually 1 Check pick up tube at the Diluent container it may be kinked 2 One of the Diluent lines has become blocked or kinked Fill nozzle cap Fill nozzle ar Fill vacuum valve uL T Sample tube ESRI070406 ESRIO70508 Diluter syringe Water Disinfectant valve valve i ESRI070112 z T m Dilution tubing Omuert Deionized Orsitectamt water StaRRsed Flex User Manual Page 173 Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 7 Vacuum The Compact uses vacuum for both aspirating and the wash rinse system If trouble occurs it i
15. e 1 Se oe Eg Eur p p j Lamm ae ee SSS ee SSS Ss ee _ SEL EE rea Sn eati Ee ESS E id EES ig m ESS lp ey 0 um maji pe m4 i l a a D mei uu n L L Lo Gl E This table shows information of the samples in the carousel during the selected ESR process time After measuring the pipette the pipette data is transferred to the sample history files In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 41 am RR mechatronics Compact FLEX program 6 3 2 Display Sample history C Sample li History lir Reagents Maintenance Settings m Service he 02 01 2013 09 03 09 02 01 2013 10 16 07 02 01 2013 09 03 41 02 01 2013 09 04 33 I bubbles on top ESR HAZY 10 EDTA EDTA EDTA EDTA EDTA EDTA 10210142013 09 10 53 02 01 2013 10 22 57 124 160 EDTA 02 61 2013 09 11 41 4 z EDTA 02 01 2013 09 12 29 EDTA 02 01 2013 09 13 17 EDTA 02 01 2013 09 14 05 11 22 60 EDTA 1021017
16. 6 5 5 Maintenance info When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE This screen is divided in 6 maintenance level sections For maintenance levels 1 to 4 the status is monitored and flagged if it is overdue Press the button Info to open the work instruction for a specific maintenance level When this maintenance is done press the button Done to log the completed work in the maintenance log file StaRRsed Flex User Manual Page 81 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 5 5 1 Maintenance info overview When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE This screen is divided in 6 maintenance level sections For maintenance levels 1 to 4 the status is monitored and flagged if it is overdue Press the button Info to open the work instruction for a specific maintenance level When this maintenance is done press the button Done to log the completed work in the maintenance log file 6 5 6 Close e Start End nf day wash procedure or close program ot Make the selection End of day wash procedure or Close program End of day wash procedure will start to wash all pipettes needle fill nozzle and rinse nozzle wash station The function can be set up for automatic execution in the following screen Close program will only close down the program Page 82 StaRRsed Flex User Manual Version 1 02 MRN 151 E
17. C Display graph uer Temperature C ESR sedimentation time min 35 sample probe depth mm Settings Service C Fast filing GD srs keybord c Gout peters rf Q Check for dupicate 10 s 97 Pipette wash time sec Js Pipette dry time sec This screen has five sub screens 1 General settings on page 84 2 Carousel control on page 88 3 Diluter settings on page 98 4 Limit error settings on page 100 5 QC Settings on page 102 Page 84 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program Selections are made by an ON OFF switch in the screen and by numerical inputs If virtual keyboard is switched ON a virtual keyboard pops up for input the data When Virtual keyboard is switched OFF the arrow keys must be used for input of data When ready with press SAVE SETTINGS before you continue LANGUAGE The selection box for the language is marked with a symbol depicting a globe Select the language for the software and the Instructions For Use by clicking on the appropriate language name Note To switch to the selected language the first time close and restart the software StaRRsed Flex User Manual Page 85 Version 1 02 MRN 151 EN Compact FLEX program mechatronics The following selections can be switched ON or OFF 1 30 MIN METHOD e 30MIN METHOD ON ESR s are measured after 30 minutes e 30MIN METHOD OFF
18. Reagents alarm is also set when the expire date of the reagent is exceeded or opened more than three months The message Not allowed now See REAGENTS appears Processing of new samples is stopped A log is available for all reagents and can be accessed by clicking on DISPLAY REAGENT HISTORY on page 67 StaRRsed Flex User Manual Page 66 Version 1 02 MRN 151 EN Rm mechetronics Compact FLEX program 6 4 1 Explain bottle screen The alarm status of the reagent containers and separator are shown in this screen An empty container is marked by a flashing red to yellow mark When the status screen is active the reagent audio alarm is switched off Reagent information is shown in the little text boxes To input new reagent information when reagent container is replaced click on the appropriate text box Note When the expire date is exceeded the text box will flash red The software checks the reagent level status before starting a new aspiration If a level alarm is ON it will not process the new sample If an alarm comes ON during an aspiration it will finish to aspirate that sample 10 samples max Washing dirty pipettes always continues as to avoid that the samples are left in the pipettes Reagents alarm is also set when the expire date of the reagent is exceeded or opened more than three months The message Not allowed now See REAGENTS appears Processing of new samples is stopped A log is available for all reagents a
19. Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 6 2 Diluter errors Dilution error If the display shows dilution errors it indicates that the current sample has not been diluted correctly e g 21 Diluent added to the sample After the sample measurement the dilution rate will be printed as EDTA 079 Dilution errors can be caused by Solution Irregular filling speed due to poor vacuum Check the vacuum settings Blocked sample probe Remove the blockage Blocked T piece Y piece Unblock the the T Piece Y Piece by using a syringe with hot water Sample tube pinch valve error Check if the sample tube pinch valve is working Sample tube not correct in the sample tube Check the sample tube is still fitted correctly in the pinch valve pinch valve Insufficient sample volume Check before sampling if the sample tube has sufficient blood volume Wrong diluter settings Check change diluter settings in software See Diluter settings on page 98 for all possible settings Dilution errors can be solved by the user when all the mentioned solutions does not help to solve the problem technical assistance is needed Display shows Diluter failure May be caused by Mechanical obstruction Diluter power cable loose A defective diluter motor Top or bottom position sensor failure Broken flexible print cable or connector Motor tacho failure oe Ms For Diluter failure technical assistance is needed
20. e ls in conformity with the requirements of the following EC directives 98 79 EC 2006 42 EC IVD devices conformity assessment according Annex III of this directive Machinery conformity assessment according Annex VIII of this directive The product is classified as General IVD The following harmonized standards have been applied EN 12100 1 EN 12100 2 EN 61010 2 101 Safety of machinery Part 1 Basic terminology methodology Safety of machinery Part 2 Technical principles Safety requirements for electrical equipment for measuring control and lab use Particular requirements for in vitro diagnostic IVD medical equipment EN 591 Instructions for use for in vitro diagnostic instruments for professional use EN 980 Symbols for use in the labelling of medical devices EN ISO 14971 Medical devices Application of risk management to medical devices EN ISO 13485 Medica devices Quality management systems Requirements for regulatory purposes The CE mark was applied for the first time on this instrument model in 2013 Zwaag The Netherlands January 17 2 os A f Nowee Director Sales amp Marketing 2014 Mechatronics Manufacturing BV Conditions By the ORGALIME GENERAL CONDITIONS 52000 of August 2012 Any other conditions are herewith explicitly rejected by us StaRRsed Flex User Manual Page 29 Version 1 02 MRN 151 EN mechatronics Standard Operating Procedur
21. 15 11 Rinse nozzle wash station alignment If there is a mechanical obstruction the rinse nozzle may not align correctly with the pipette Check that the two pieces of plastic tubing connected to the rinse nozzle have enough slack to allow for movement of the nozzle Technical support is needed if the rinse nozzle does not line up with the pipette StaRRsed Flex User Manual Page 183 Version 1 02 MRN 151 EN Ro mechatronics Trouble shooting 15 12 Hazy reports Hazy reports are usually caused by build up of proteins on the inner wall of the pipettes Another cause is growth of micro organisms in the diluter system It is extremely important that the system is kept sterile First run an extra Fill amp Clean sequence then check after a day s run if haziness is decreased When there are still many reports it is recommended to fill the diluter system with a 5 chlorine solution See WI 178 Hazy problem on page 296 i A picture example of haziness Page 184 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm 7 mechatronics Trouble shooting 15 13 Contaminated instrument The StaRRsed Flex has bacterial and micro organism s growth Clean the instrument monthly with a strong cleaning agent See work instructions WI 215 Fill and Clean with adapte on page 299 r and WI 195 Cleaning the diluent system on page 303 for details 15 14 Fill time out error Normally the fill sequence takes about 3 s
22. Pinch valve not working or blocked e Replace pinch valve tube technical assistance is needed D 15 2 6 Saline pump failure 1 Liquid flowing back to the saline container e Replace the saline pump tube 2 Needle is not washed sufficiently e Replace the saline pump tube see WI 163 saline tube replacement on page 287 15 2 7 Pipettes not dry after washing and drying If pipettes are not dried after the wash cycle the following items need to be checked 1 Does the vacuum pump work e Check the vacuum pressure by using the option CHECK FLOW SENSOR 2 Rinse vacuum control valve not working technical assistance is needed 3 Waste separator leaking remove separator and reassemble 4 Rinse nozzle not aligning e Re alignment for the rinse nozzle technical assistance is needed 15 3 Liquid level sensor not sensing 1 Liquid in the container is not detected This occurs sometimes with the DE IONIZED WATER bottle and is caused by a very low conductivity 2 Add one or two drops of SALINE to the DE IONIZED WATER to increase the conductivity StaRRsed Flex User Manual Page 167 Version 1 02 MRN 151 EN Rm mechatronics Trouble shooting 15 4 Flushing liquids After each sample aspiration the entire system is washed automatically If there is no liquid flow e Check that the peristaltic pumps are running If the pump tubes are worn or leaking replace the tubes e Check that the pump tubes are in
23. StaRRsed Control should not be used past the expiration date Mechatronics as supplier of the StaRRsed Control shall not be liable for any claimed damages arising from other than intended usage StaRRsed Flex User Manual Page 139 Version 1 02 MRN 151 EN mechatronics Quality control 10 2 2 Expected value range StaRRsed Control is assayed for the StaRRsed ESR analyzers The assayed mean values and expected ranges are derived from multiple analyses at different sites and on multiple instruments The values provided on the package insert and encoded in the tubes barcode are specific for this lot of product The lab should establish its own acceptable ranges Whenever the Controls fail to perform consistently within the acceptable ranges patient results should be considered invalid Contact your StaRRsed instrument provider for assistance If results vary outside the specified assay ranges discard the tube and utilize a new tube If difficulties persist contact your supplier for further assistance and or instructions 10 2 3 Temperature correction The assayed values are based on an 60 minutes ESR with dilution and temperature correction Therefore the measured ESR value should be compared with the expected value using temperature correction The calculation of a 30 minute measurement to a 60 minute ESR result with temperature correction influences the QC result See chapter QC Results on page 142 for more information 1
24. The fill nozzle did not reach the fill position in a certain time limit Possible reason e Fill nozzle motor is faulty e Fill nozzle motor driver is faulty e Fill nozzle is blocked e Fatal error call distributor 15 18 3 Fill nozzle not at home position E13 is the error code and in the status line the text Fill nozzle did not reached the Home position within a certain time limit The fill nozzle did not reach the home top sensor with a certain time limit e Fill nozzle motor faulty e Fill nozzle motor driver is faulty e Fill nozzle is blocked Fatal error call distributor StaRRsed Flex User Manual Page 191 Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 19 Piercing error There are two error codes related to a piercing error E7 and E20 E7 Outer needle motor position error Timeout piercing The Outer needle did not go down within a certain time limit This can be caused by e Tube motor position error e Blockage of the Outer needle e Faulty Outer needle motor e Faulty Tube motor driver on the needle board E20 Outer needle motor position error piercing error The Outer needle could not go down all the way This can be caused by e Piercing position sensor was triggered e Piercing position sensor was not triggered check the piercing position sensor For error numbers and details see the Appendix Error list FLEX Compact on page 217 15 20 Communications The error numb
25. When the result is out of range an error message is shown in the status line of the Sample screen and the QC icon is blinking on the Sample screen When the sample mode is started again by the operator the following messages appears Last QC result was out of range Continuing could produce incorrect results Do you still want to continue Press Accept to continue sampling without performing a new QC press Cancel to return and take appropriate action Messages when the general setting Temperature Correction is switched ON e E116 QC is out of acceptable range The Sample mode is switched OFF automatically Remaining filled pipettes are processed in the normal manner Messages when the general setting Temperature Correction is switched OFF The software always calculates a temperature corrected result because only temperature corrected results can be compared with the Assay mean value e E116 QC is out of acceptable range The uncorrected and the corrected result are out of range e E117 Uncorrected QC result is out of acceptable range but corrected result is within range The uncorrected result is out of range but the corrected result is within range e E118 Uncorrected QC result is within acceptable range but corrected result is out of range The uncorrected result is within range but the corrected result is out of range See Quality control trouble shooting on page 194 and QC Results screen on page 46 for
26. mechatronics Appendix for StaRRsed Flex OPUS string format stx PPPPPPPPPP www WWW AAAAAAAAmm ppp TTT CC EEEEEEEEEEEEEEEEEEEEEE lf eot stx 80 data characters cr f eot Checksum OFF 60 min stx 80 data characters er etx cs eot Checksum ON 60 min f Data consists if 30 min output is switched to OFF Postion Deseripton CS Patient identification text PPPPPPPPPP E S R in mm 60 minute WWW 2 E S R in mm 60 min corrected Manually added code ss Sedimentation time Temperature in degree Default EN C XX CS 1 byte checksum 256 modulo 256 ASCII string sum OR 128 ASCII string sum the ASCII sum of all preceding characters incl stx cr If and ext modulo 256 ASCII string sum the remainder of the ASCII string sum when divided by 256 OR 128 setting the MSB bit to 1 s Prete number U 256 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex OPUS string format stx PPPPPPPPPP hhh www WWW AAAAAAAAAmm ppp CC EEEEEEEEEEEEEEEEEEEEEE 1 eot stx 80 data characters cr f eot Checksum OFF 30 min stx 80 data characters er etx cs eot Checksum ON 30 min f Data consists if 30 min output
27. 2 Wipe the tube clean and dry with a tissue 3 Empty the diluent bottle and refill it with hot de ionized water 80 4 Place diluent suction tube in the diluent bottle with hot water 5 Use the PRIME function 6 After the prime sequence stops press PRIME again to fill the dispenser system with the hot water Step 3 1 Empty the diluent bottle 2 Clean the diluent bottle with new hot de ionized water 806 3 Refill the diluent bottle with new diluent solution 4 Perform another PRIME 5 After the prime sequence stops press PRIME again to fill the dispenser system with the new diluent solution StaRRsed Flex User Manual Page 303 Version 1 02 MRN 151 EN mechatronics Work instruction Number 196 Page 1 of 1 Purpose Cleaning liquid separator Version 2 Safety Bio Hazard area Instrument Compact Revision 002 March 2013 Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline
28. 7 Limit error Error One of the following limits are out of the setting range e ESR Time e Column height e Dilution e Bubbles on top e Hazy aspect e Temperature Page 270 mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Sysmex SE9000 protocol SE9000 Sample data record format 234 bytes This is a modified data record from SE9000 without instrument ID Sample data record format 234 bytes Parameter tot Comment NN 23 Day 23 Sample distinction code Rack no 1234 Rack number 1234 ID information 4 Barcode from barcode label Analysis information NEG POS ERR information POSITIVE diff POSITIVE morph POSITIVE count ERROR func ERROR result EW Order information Reserve Reserve Reserve Reserve Reserve IP message information 0 BC 6 123000 Esr value 123 mm StaRRsed Flex User Manual Page 271 Version 1 02 MRN 151 EN Day Tube position no 2 Sample ID number N N i ha ha o o ooo po o ooo ooo ooo mechatronics Appendix for StaRRsed Flex 01200 Temperature degr Celsius i e 12 01200 Sedimentation time in minutes i e 12 min MCHC 12300 30 minute ESR value 123 n a Not applicable SE 9000 Sample data flag record format 131 bytes Parameter E2 fanne emmen OOO Comment Text d
29. 9 6 12 n 1 0 o x 2 i i QC9A3SNSOS StaRRsed Flex User Manual Version 1 02 MRN 151 EN i __ 24 09 2012 07 36 31 03 02 2012 505 9 J6 ree ae bell Boal Ral pa Sead fad IL p 12 RIS SeS 1 2 pz E is 2 Is a size 7 da s N e z 6 z2 7st a2 IS E22 m 5 IS zs s 122 11 pz 25 1 Emu SS pee ae eri imm 5 117 Uncorrected QC result is c 5 5 5 5 ss 117 Uncorrected resuk is c Page 47 mechatronics Compact FLEX program Display Results table Results are shown in table as default QC sample ID Read from the barcode The original StaRRsed Control barcode batch number Linked lab ID The Lab ID is given if it is linked to the StaRRsed Control sample ID Sampling date The date and time when the QC sample was aspirated Expiry date If the StaRRsed Control expiry date is exceeded it is not possible to continue with this QC sample The sample is not measured but the failed attempt is logged in the table Expected ESR This is the temperature corrected mean value incorporated in the StaRRsed barcode and the accepted range of deviation The applicable values for the acceptable range depend on the user setting ESR 60 Uncorrected result from QC sample ESR 60 T CORR Temperat
30. Before the confirmation of the function the warning PIPETTE DATA WILL BE LOST is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram Page 90 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 6 2 2 Flow test flow Before the confirmation of the function the warning lt PIPETTE DATA WILL BE LOST gt is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram StaRRsed Flex User Manual Page 91 Version 1 02 MRN 151 EN R mechatronics Compact FLEX program 6 6 2 3 Flow test absolute arme x Before the confirmation of the function the warning lt PIPETTE DATA WILL BE LOST gt is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram Page 92 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 6 2 4 Flow
31. Insert the liquid separator sliding it over the support shelf 10 Push the liquid separator towards the rear with the sensor connectors in the holes 11 Release the stainless steel vacuum tube 12 Replace the waste container 13 Close left cover StaRRsed Flex User Manual Page 349 Version 1 02 MRN 151 EN Exchange Waste Cassette and blotting washer 1 Disconnect the two tubes from the waste pump cassette 2 Press levers at three o clock and nine o clock positions and pull at the same time 3 Clean peristaltic pump motor shaft using a tissue soaked in alcohol 4 Remove the old blotting washer ESRI090026 around the motor shaft 5 Place the new blotting washer ESRIO90026 6 Insert new waste pump cassette ESRIO90921 until it clicks into place 7 Remove the protection caps on from the tubes 8 Connect the two tubes to new waste pump cassette 7 Exchange Pinch valve tube Replace the pinch valve tube ESRIO10246 1 Open the left cover 2 Pull the tube out the pinch valve 3 Disconnect the silicon tube from the bottom connector and the top connector 4 Remove the tube 5 Connect the silicon tube to the bottom connector and the top connector 6 Push the tube in the pinch valve 7 Close the left cover 8 Final preparation Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 596 solution This disinfectant is for
32. Last updated 01 09 2014 Extra explanation Reason Solution StaRRsed Flex User Manual Page 217 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex E2 Communication error Board s x Command x TWSR E E3 Measure motor timeout E4 Sample probe not in top position home E5 Duplicated ID E6 Program was not properly shut down Check settings before continuing E7 Outer needle motor position error Timeout piercing Page 218 Communication lost after 3 retries between Computer and StaRRsed Flex Measure head motor did not move or motor is blocked Sample probe not back at Home position after sampling a tube Sample rejected Sample already in carousel There is a possibility that changed settings which were not saved to disk are lost Outer needle did not go down within a certain time limit mechatronics Power cable not connected on the communication PCB mounted on the back panel An 12 cable not connected Serial cable not connected No power on one of the PCB s Short circuit or fault on one of the PCB s Measure head is not at the Home position Check the Home sensor Motor is faulty Motor driver on drive board is faulty Check sample probe home sensor Sample probe motor is faulty Sample probe motor driver on needle board is faulty Sample probe is blocked Wait until sample is measured Check general set
33. MECHATRONICS result record Data 253 characters mechatronics Position Data field of Bytes Format Comment 1 Start of text 1 STX 2 Text distinction code 8 ESRRE Left aligned followed by spaces 10 Instrument ID 20 text If applicable 30 Sample ID 40 text 70 Reserved spaces 15 text 85 Aspiration date 10 ddmmyyyy Text format E g 01012010 January 1 2010 Page 240 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex 95 Aspiration time 5 hhmm Text format E g 0001 0 01 24 hour clock 100 E S R 30 minutes mm h 5 XXXXX 105 E S R in mm 60 minute mm h 5 XXXXX 110 E S R 60 minutes temperature corrected mm h 5 XXXXX 115 E S R 120 minutes mm h 5 XXXXX If applicable 120 Reserved spaces 10 text 130 Sample code 5 XXXXX See section Sample codes 135 Aspect code 5 XXXXX See section Aspect codes 140 Manually added code 5 XXXXX 145 Pipette number 5 XXXXX 150 Sedimentation time minutes 5 XXXXX 158 Temperature 5 XXXXX 160 Dilution rate 5 XXXXX 165 Column height mm 5 XXXXX 170 Error code 5 XXXXX See section ESR error codes 175 Limit error message results 30 text See section Limit error message on page 131 205 Reserved spaces 50 text 255 Checksum 1 CS See section Checksum calculation 256 End of text 1 ETX Total 256 Text lef
34. Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator StaRRsed Flex User Manual Page 311 Version 1 02 MRN 151 EN Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover 3 Exchange Rinse and Saline tube assembly New rinse pump tube assembly New saline pump tube assembly ESRIO90902 ESRI090903 t EI ia New tube replacement 1 Open left cover Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of
35. Select display dilution on SETTINGS gt GENERAL SETTINGS gt DISPLAY DILUTION gt ON Run 10 samples through the instrument and make a note of the dilution rate Calculate the mean value of the 10 samples Make adjustment if necessary in SETTINGS gt DILUTER SETTINGS gt DILUTION ADJUSTMENT StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 308 RR mechatronics Work instruction Number 218 Page 1 of 9 Purpose Maintenance level 2 Safety Bio Hazard area Instrument StaRRsed Flex Revision 002 March 2014 Perform maintenance when the StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU OVERVIEW StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on FlexLab36 Overview FSE 10 54 16 gt Samples Tests Exceptions InpuvOutput StaRRsed Centrifuge 1 Cenfiguration Centrifuge 2 Centrifuge 13 C Architect i2000sr 1 Architect 2000 2 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module IM will go to Offline eFlexLab36 SteRRsed Status preme Me Eror Select an Option Node 10 Status 3 moon for Empty Carrlers Room for Routine Sample Room for STAT Samples o Expected 491 Incomplete 26 Complets 60 StaRRsed Flex User Manual Page 309 Ve
36. gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fillstop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor lt 200 600 gt 700 StaRRsed Flex User Manual Page 323 Version 1 02 MRN 151 EN 4 Final preparation 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required 2 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped 3 Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with di
37. hazardous materials or from small physical objects Personal outer clothing should not be stored in the blood laboratory Lab coats worn in the blood laboratory should not be worn outside of the blood laboratory and should not be stored with personal outer clothing to avoid transfer of contaminants Gloves are considered contaminated after ones wearing Avoid contamination of work surfaces with gloves Dispose of gloves into a biohazard container The use of eye protection is advised while processing samples Remove and properly dispose of gloves and wash hands before leaving the laboratory StaRRsed Flex User Manual Page 27 Version 1 02 MRN 151 EN mechatronics Standard Operating Procedures S O P 5 3 E C Declaration StaRRsed Compact Flex Page 28 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Ro mechatronics Mechatronics Manufacturing B V Standard Operating Procedures S O P R mechatronics De Corantijn 13 225 1688 AN ZWAAG 1620 AE HOORN The Nethertands The Nethertands Telephone 31 0 229 201126 Fax 31 0 228 241534 E mail ni E C DECLARATION OF CONFORMITY VAT number NL 3048 22 979 801 C o C number 36048153 at Barker ABN AMRO Account number 5335 19 985 Swift address ABNANL2A BAN NLOS ASNA 0533 5199 55 Herewith we declare that the rocyte Sedimentation Rate lyser StaRRsed Flex Product ID FLEX109000 GMDN code 35488 Analyser hematology sedimentation rate
38. mechatronics Index Monitoring measurement quality with QC Normal results table 47 StaRRsed Control 139 QC normal results screen extended 49 MRN 355 QC Result analysis 57 143 MSDS 355 QC Results 140 142 N QC Results screens 41 46 142 QC Settings 56 57 84 102 142 143 Needle Control 111 QUALITY CONTROL 139 Needle not in top position 177 Quality control procedure 141 Needle system 177 Quality control trouble shooting142 194 224 New reagent input 68 Quick start up 135 New reagent input cont 68 R Not reading the barcode 193 Random air bubbles in pipette 182 Reagents 189 One air bubble about 5 mm under meniscus Reagents alarm 189 180 Reagents preparation 117 One air bubble rising in pipette 181 Reagents replacement 158 OPERATION 135 Reagents screen 33 35 66 159 Replace bacterial filters 155 Replacing the waste container 145 PC connections for StaRRsed Flex 215 Report 30 Minute mode 129 PC connections for StaRRsed Flex Windows Report 60 Minute mode 127 7 216 REPORTING 125 PC Operation and User Interface 12 Reporting range 131 Peristaltic pumps 165 Result path 109 Piercing error 192 Result Printout 125 Pipette information 38 Rinse nozzle wash station alignment 183 Pipette looks like zebra crossing 180 Rinse pump failure 166 Pipette 36 Rinse solution not primed through the system Pipettes not dry after washing and drying167 165 Position error 186 Rinse solution QRR 010934 119 Power failure 161 Rinse solution spilling
39. of the utmost importance To maintain the maximum reliability of the instrument the maintenance procedures must be strictly followed All procedures are based on a number of samples Maintenance levels WI Work instruction Daily WI Daily maintenance Weekly WI Weekly maintenance Level 4 Maintenance WI Level 4 maintenance Every 7500 samples Level 3 maintenance Wl 194 Level maintenance Every 22500 on page 156 samples Level 2 maintenance Wl 198 Level 2 maintenance Every 45000 on page 157 samples Level 1 maintenance WI Level 1 maintenance notification on on page 157 page 355 Every 90000 samples Note Numbers are based on 5 days week with 350 samples per day Perform maintenance when the StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU Overview StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on eFlexLab36 TN Overview FSE 105416 gt r 4 d 4 Oz Us d Samples Tests Exceptions Inputi Output StaRRsed Centrifuge 1 Configuration Centrifuge 2 Centrifuge 3 C Architect 120003771 Architect 2000 2 StaRRsed Flex User Manual Page 149 Version 1 02 MRN 151 EN Rm mechatronics Maintenance 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module IM will go to Of
40. 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex e If the StaRRsed Flex does not receive the conformation string within 10 seconds it will send the request string again After 3 attempts it won t do an ESR on this sample and goes to the next sample e fthe StaRRsed Flex receives a it will send the request string again After 3 attempts it will stop communication and generate an error e If the StaRRsed Flex does not get any response timeout 10 sec it will send the request string again After 3 attempts it will stop communication and generate an error Request string example Sample ID 123456789 Request string ESRSR 123456789 R 31 bytes Sample result e Checksum ON OFF user defined e 30 minute output ON OFF user defined The sample result will be output according to the standard Compact StaRRsed ESR string See String format for StaRRsed If the host computer receives the result string it should reply by sending an ACK or a NACK e If the StaRRsed Flex receives an ACK it will start sending the next result e f the StaRRsed Flex receives a NACK it will send the result string again After 3 attempts it will start sending the next result e If the StaRRsed Flex does not get any response from the host timeout 10 sec it will send the result string again After 3 attempts it will stop communication and generate an error StaRRsed Flex User Manual Page 255 Version 1 02 MRN 151 EN
41. 1 02 MRN 151 EN mechatronics Compact FLEX program 6 6 3 2 Dilution error detection 0 till 25 Dilution error detection 0 till 25 Dilution Error deviation report If a dilution error occurs during the aspiration sequence an audible alarm sounds and the deviation value will be shown on the screen When the measure unit has evaluated the sample the deviation value will be printed after the text EDTA Sending or not sending results with dilution errors to the output is optional see Limit error settings on page 100 Example Dilution error detection is set at 10 When the dilution error is outside the 10 range in the last column of the report EDTA 079 or EDTA 121 is printed which indicating this sample is 21 under or over diluted 6 6 3 3 Auto dilution adjust Auto dilution adjust The Automatic Dilution adjust is by default setting ON Feature to automatically make a correction to the dilution rate if set to ON This mode checks the dilution rate if the dilution rate tends to get too low or too high it automatically makes a correction to the manual dilution adjust setting In this way long term instability or long term changes will be corrected The system looks to the mean average of the 32 last dilutions to estimate the corrections on the syringe speed calculations If Auto dilution adjust is set to OFF the system works with the number which is set in Dilution adjustment 60 till 140 If Auto dilution adjust
42. 120 unidirectional ONOaARWN gt StaRRsed Flex User Manual Page 107 Version 1 02 MRN 151 EN RR mechatronics Compact FLEX program 17 InteRRliner For more details see Section 9 Protocols on page 125 and the Appendix 6 7 3 Compact settings C Sample History Reagents lt Maintenance Settings Service BB Compact connected to comport ASRLI INSTR Proterport WaseiioninsTR Result Path TI QUE iss to deve USB IO Device Number Search in example history On off DEL LLLOLAULLALLLLLLAAAAAAAAAAABXL ED Page 108 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program Select which port the StaRRsed Flex is connected to No need to change the default setting ASRL1 INSTR Select which PRINTER PORT is connected to the printer No need to change the default setting ASRL10 INSTR e f SEARCH IN EXAMPLE HISTORY is OFF this file cannot be selected in the history window e f SEARCH IN EXAMPLE HISTORY is ON this can be selected the history window Setting for the OUTER NEEDLE DEPTH No need to change the default 70 0 mm setting 6 7 3 1 Printer port Select which PRINTER PORT is connected to the printer No need to change the default setting ASRL10 INSTR 6 7 3 2 Compact connected to Select which port the StaRRsed Flex is connected to No need to change the default setting ASRL1 INSTR 6 7
43. 3 1 Printer DOU E PREIS 109 6 7 3 2 Compact connected 10 eate edere vade fedibus iens adiens 109 SACRE EM Result pathi T 109 6 7 3 4 Search in example 109 6 7 3 5 USB IO DOVIDE medietas ee sep piste iren iE 109 6 7 4 Manual e 110 6 7 4 1 All pumps DRIED cuoi ee ree 111 6 7 4 2 Needle Precio aa tuc igneo 111 ONE 4 5 112 WP CO n ee ee ee ee eee 112 6 7 4 5 Actuator ea csc oe ocak CUIR MES 112 6 7 5 Display error history Service 113 6 7 6 Display maintenance history Service 114 6 7 7 A EE EE NEREA E E ENEE RA EEE HO 115 7 GETHING SARE aaia es 117 7 1 Limit filter settings eer ee eee eee 117 ior 117 7 3 Reagents preparation ES 117 7 3 1 Rinse solution QRR 119 T32 Saline QRR 010933 120 7 3 3 Diluent QRR 010931 c abana 120 7 3 4 De ionised water Km T 120 StaRRsed Flex User Manual Page 7 Version 1 02 MRN 151 EN mechatronics Contents 7
44. 5 1 Qceeas 5 0 QCA 9 5 8 NR a 118 Uncorrected QC is StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 51 mechatronics Compact FLEX program The results from StaRRsed Control level A are shown Display Results table QC sample ID Read from the barcode The original StaRRsed Control barcode batch number Linked lab ID The Lab ID is given if it is linked to the StaRRsed Control sample ID Sampling date The date and time when the QC sample was aspirated Expiry date If the StaRRsed Control expiry date is exceeded it is not possible to continue with this QC sample The sample is not measured but the failed attempt is logged in the table Expected ESR This is the temperature corrected mean value incorporated in the StaRRsed barcode and the accepted range of deviation The applicable values for the acceptable range depend on the user setting ESR 60 Uncorrected result from QC sample ESR 60 T CORR Temperature corrected result from QC sample T Temperature at which the sample was measured Error Warning Only special QC errors are mentioned here general ESR warnings errors are mentioned in the next column After these columns additional data is shown pipette number dilution rate ESR30 ESR time and Aspect Scroll to the right Results are always shown with and without Temperature correction independe
45. 6 5 2 1 Check Sensors in service mode 76 6 5 2 2 Fil SOM SENSOM iecore poc bo Cea Ro ees bu via x eim cu UU ER E RE 77 6 5 2 8 lemperature eor a Eo ev Era 77 6 5 2 4 _ Diluter RT erara 77 6 5 2 5 Diluent flOoW SOIISOL iier nr netten e senior ea x ke iR 77 6 5 2 6 Separator co T 77 ps7 BOW SEHSUR aito iun cuc DUE M Mun 77 p 52 8 Measure SOlnSOl 78 6 5 3 cervam 79 6 5 4 Display maintenance 80 6 5 5 Maintenance AMO me 81 6 5 5 1 Maintenance info 82 Page 6 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Contents 6 5 6 ce M 82 6 5 7 End of day wash schedule SettingS cccccesssscceceeeeeeeeeneteneeeeeeeeeeeeeees 83 6 5 8 End of day wash Ro E EUER Kia EUsIR SUR Du ERMEUS RR E 83 66 General UID oom OUT 84 6 6 1 Language selection eene nennen nnns 88 6 6 2 Carousel control REO o 88 6 6 2 1 Flow test potentiometer mean 90 6 562 29 Flow test OW ie o tt
46. Celsius 12 degr ID information Instrument ID number EE EE Analysis information Reserved RET RET CD o 2 o c 3 5 Oo 5 2 W O IRF LFR MFR HFR Reserved 01200 Sedimentation time in minutes 12 min 10100 Dilution rate 101 12300 30 minute ESR value 123 n a not applicable StaRRsed Flex User Manual Page 259 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Page 260 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex R3500 Sample data flag record format 131 bytes Parameter OMEN Comment Tex asioina i o EE 1 avs ooooiuoe Sample datneioncoge U bw be apas O Tube postion no e __05 Tube poston nrack 5 i NN sample IDrumber Patene Fam na R3500 Inquiry data record format 21 bytes Parameter TERN Comment Test asioina sample Dro Paten a R 3500 order information record format 156 bytes Parameter MM Comment Text distinction code distinction code Text distinction code a 9 Information status sample does not exist sample exists Sample ID no Must be the same as inquiry record 7 StaRRsed Flex User Manual Page 261 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Inquiry m
47. Control schedule Quality Control scheduling is the responsibility of the user The StaRRsed software does not provide Quality Control scheduling functionality 10 2 5 Quality control procedure StaRRsed Control is provided in ready to use sample tubes and is used in the same manner as patient samples StaRRsed Control is to be used for the Westergren method with dilution only as prescribed by the ICSH review of the measurement of the ESR 2011 and the CLSI Procedures for the ESR Test Approved standard H02 A5 2011 Citrate mode When the StaRRsed analyzer is used in the Citrate mode the StaRRsed Control material must be diluted manually by transferring the necessary amount of material into a pre citrated ESR blood collection tube Immediately after re suspending transfer the necessary amount of material into a pre citrated tube according instructions of the tube manufacturer Close the tube with the mixture and invert at least 12 times then place the sample into the analyzer 1 When using LAB ID Link the Lab ID with StaRRsed Control Sample ID see chapter Linked QC ID s on page 56 Attach the lab ID label on the tube on top of the original StaRRsed Control label 2 Invert the StaRRsed Control tube until packed cells have been completely re suspended Continue mixing for 30 seconds at least 12 complete inversions Avoid foaming DO NOT VORTEX NOTE To ensure consistent and reproducible results the Control material must be th
48. DILUENT function Wipe outer surface and stainless steel plate below the pipettes with disinfectant Exchange air filter Pull both tube connectors out of the blue filter Place new blue filter Reconnect the tube connectors on the filter 9 Replace diluter syringe tip Replace diluter tip 1 2 3 N O RE Take the syringe from the diluter assembly Pull the plunger out of the syringe Cut the Teflon tip of the plunger with a sharp knife Be careful not to damage the metal plunger Replace the O ring and then the tip Replace the old tip for the new tip assembly From repair set QWLV030902 Moisten the tip with water to ease the tip back into the glass syringe barrel Install the syringe back on to the attachment Clean dilution system 1 2 Perform PRIME DILUENT Repeat above step until there are no air bubbles in the whole diluent system anymore StaRRsed Flex User Manual Page 317 Version 1 02 MRN 151 EN Check dilution settings Go to tab SETTINGS GENERAL SETTINGS and select DISPLAY DILUTION OFF Run 10 samples through the instrument and make a note of the dilution rate Calculate the mean of the 10 samples Make dilution adjustment if necessary in SETTINGS DILUTER SETTINGS Go to tab SETTINGS GENERAL SETTINGS and select DISPLAY DILUTION ON prod tes Finishing maintenance 1 Check diluter drip tray empty if necessary 2 Recover any outstanding errors on the Flexlab GIU 3 Putthe StaRRs
49. ESR s are measured after 60 minutes 2 DISPLAY DILUTION e DISPLAY DILUTION ON The dilution rates of all samples are shown in the status line on the screen directly after aspiration e DISPLAY DILUTION OFF Dilution rates are only shown if they are outside the selected accepted range 3 EDTA MODE e EDTAMODE ON Samples are presented in EDTA sample tubes The samples are diluted in the StaRRsed Flex e EDTAMODE OFF Samples are presented in pre diluted CITRATE sample tubes Dilution on the StaRRsed Flex is switched OFF 4 DISPLAY GRAPH e DISPLAY GRAPH ON A graphical presentation from the measured sample data is shown on the Main screen e DISPLAY GRAPH OFF Default setting no graph is shown 5 SAMPLE PROBE PROTECTION e SAMPLE PROBE PROTECTION OFF The sample probe motor will push the sample probe inner needle down to the set depth e SAMPLE PROBE PROTECTION ON The sample probe motor will stop when a certain current limit is exceeded and returns to the home position e Reset the SAMPLE PROBE PROTECTION switch from ON to OFF and ON again 6 TEMP CORRECTION e TEMP CORRECTION ON A temperature corrected value for the ESR is shown besides the actual measured value e TEMP CORRECTION OFF Only the actual measured ESR value is shown 7 FAST FILLING e FAST FILLING OFF Default setting The carousel is filled with optimum pipette usage but completion of a sample rack takes a little longer The rotation sequence of the carousel is evenly div
50. Fill amp Clean adapter ON 16 Select button OK 17 The needle goes down and the fill and clean process is started it will take around 90 minutes 18 When all the pipettes are filled the needle goes back to the home position 19 Enable Sample Mode On 20 Select on Flexlab GIU Overview StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform the Fill amp Clean on 21 Select DiAcNosrics and hit the blue tick 22 Select TUBE LOCKER and hit the blue tick 23 Select TuBE UNLOCK and hit the blue tick The Tube Locker moves upwards and unlocks the adapter 24 Lift the hood with the elevator switch on the StaRRsed Flex 25 Remove the adapter unit 26 Lower the hood with the switch 27 Recover any outstanding errors on the Flexlab GIU 28 Put the StaRRsed Flex back online StaRRsed Flex User Manual Page 301 Version 1 02 MRN 151 EN mechatronics Work instruction Number 188 Page 1 of 1 Purpose Replace diluter tip Safety None Bio Hazard area Instrument Compact Revision 001 August 2014 Replace diluter tip 1 2 3 SU pg Take the syringe from the diluter assembly Pull the plunger out of the syringe Cut the Teflon tip of the plunger with a sharp knife Be careful not to damage the metal plunger Replace the O ring and then the tip Replace the old tip for the new tip assembly From repair set QWLV03
51. MSDS is short for Material Safety Data Sheet In this type of MSDS all kind of important data can be found on reagents T 18 1 1 1 10 Temperature correction The sedimentation of blood cells is a temperature dependent process To achieve comparable results temperature correction should always be used The ESR results are then corrected to the value they would have been at the standard temperature of 18 3 Page 357 Glossary of Terms U 18 1 1 1 11 Unidirectional Unidirectional communication means that there is only one way communication from the StaRRsed Flex to the HOST Only sample results and result related messages are send W 18 1 1 1 12 WI WI is short for Work Instruction and is used with an index number for a range of work instructions Page 358 R mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics 19 INDEX A Accessory kit 19 Actuator 112 Advanced 115 Air bubbles 130 136 179 205 207 262 263 268 272 276 280 Air bubbles entering the Diluent system1 72 All pumps OFF 111 Analyser 133 Appendix 30 minutes reporting 206 Appendix 60 minutes reporting 203 Appendix Article reference list Compact Flex 19 198 Appendix Cable connection diagram StaRRsed Flex FLEX089000 200 Appendix Compact system messages208 Appendix Default settings StaRRsed Flex 212 Appendix Error list 148 192 217 Appendix Maintenance schedule 225 Appendix Pr
52. OK activates the settings 9 4 2 Turn off sequence e Close the StaRRsed Flex software e Switch the PC and monitor OFF e Switch optional printer OFF e Switch the Compact OFF StaRRsed Flex User Manual Page 137 Version 1 02 MRN 151 EN Rm mechatronics Quality control 10 QUALITY CONTROL 10 1 Control pipettes The correct function of the hardware and software of the StaRRsed Flex measurement unit should be checked at regular intervals with the aid of Mechatronics Control Pipettes Order nr QTST049000 More information can be found in the Control Pipette User Manual MRN 019 10 2 Monitoring measurement quality with StaRRsed Control StaRRsed Control is an in vitro diagnostic quality control material to monitor the accuracy and precision of Erythrocyte Sedimentation Rate ESR instruments and procedures This instruction is only applicable for StaRRsed Control used on Mechatronics ESR StaRRsed instruments StaRRsed Control is available in Abnormal range Level A Normal range Level N The software can produce statistical data for further analysis for e Defining control limits accept or reject patient results e Error detecting systematic or random errors e Evaluation of QC results 10 2 1 Limitations StaRRsed Control is to be used for Erythrocyte Sedimentation Rate testing only and shall not be used to control any other hematology procedure StaRRsed Control shall not be used as a standard
53. Remove the O ring QWLV050004 Install new O ring QWLV050004 Page 344 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Assemble fill nozzle holder Assemble fill nozzle 1 Connect the silicon tube to the fill Push the plasti inst th ush the plastic top part down against the nozzle spring pressure 2 Putthe fill nozzle into the holder 1 Turn the plastic top part until you hear Push the fill nozzle upwards and turn of feel a click the holder to the left 2 Turn the plastic top part clokwise for 1 5 turns 2 Clean Liquid Separator and exchange filters Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator StaRRsed Flex User Manual Page 345 Version 1 02 MRN 151 EN Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 If applicable replace the bacterial HEPA filter For Mai
54. T 65 6 4 Reagents 66 6 4 1 Explain bottle screen Ue 67 6 4 2 Display reagent ener a pr Eee re tesa n n s 67 6 4 3 lE nA 68 6 4 3 1 New reagent input CONT sssssieidioeee ire BEttat un ERE nuit 68 p 5 Maintenance SCIEN ta SURE pax RAN Ia SU SOLUM EUR RUE 69 6 5 1 Prime CA p er 70 6 5 1 1 Prime Rinse SollftlDfis uio rane rta Sr te pq entia 70 6 5 1 2 Prime ee etri ederet POE 70 6 5 1 3 eee 71 6 5 1 4 Prime de ionized Walter oneri ether pes ua 71 6 5 1 5 Prime DISIMG Gla RE 71 6 5 1 6 Prime all units 71 6 5 1 7 Wash each pipette ria tior ERU ERE 71 6 5 1 8 Wash only sample pipettes 71 6 5 1 9 Wash all S 71 6 5 1 702 Pill and CISA c 72 6 5 1 11 Fill and Clean with cleaning 72 6 5 1 12 End of day wash 72 6 5 2 Check ub bsc uius Haare Sus 73
55. Temp correction Fast filling Virtual keyboard Print after measurement Temperature ESR sedimentation time Sample probe depth Pipette wash time Pipette dry time Page 212 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex SETTINGS gt LIMIT ERROR SETTINGS General settings Software Factory Setting Client Settings Default Setting Send results when time N exceeded Send results with dilution errors Send results with column height errors Send results with bubbles on top warning Send results with hazy aspect Send results with temperature exceeded SETTINGS gt QC SETTINGS No No No No No SERVICE gt FLEXLAB CONNECTION SETTINGS Software Default Setting Factory Setting Client Settings Baud rate settings 19200 19200 SERVICE gt SERIAL OUTPUT SETTINGS Set serial output comport eines Fates _ m _ bam ey EE StaRRsed Flex User Manual Page 213 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Set protocol settings Select protocol 30 Minute Output SERVICE gt SERIAL OUTPUT SETTINGS StaRRsed Flex settings Software Default Setting Factory Setting Client Settings StaRRsed Flex T connected to comport l o ASRL1 INSTR l o ASRL1 INSTR Printer port l o ASRL10 INSTR 1 ASRL1 INSTR Search in example 1 0 Outer Needle se
56. Tube position no Tube position in rack 5 ID information Barcode from barcode label Sample ID number e Patient number Compact HAZY code messages The code appears in the sample data record at variable RBC This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear Sample is Hazy 10 1 2 Sample is Hazy 25 3 Sample is Hazy 25 Results with hazy aspect can be suppressed in the menu Limit error settings Compact ERROR code messages This code appears in the sample data record at variable HGB The following 7 codes are defined 0 No errors 1 Nocells plasma found Error No contents could be detected in the pipette 2 ESR Probably 140 mm Error Extremely high ESR value StaRRsed Flex User Manual Version 1 02 MRN 151 EN Appendix for StaRRsed Flex Page 269 Appendix for StaRRsed Flex Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179
57. U Lo Barcode from barcode label ID information 4 Sample ID number Patient number 5 lt ine N N N 1 information POSITIVE diff StaRRsed Flex User Manual Version 1 02 MRN 151 EN Sequence no Appendix for StaRRsed Flex Page 275 Appendix for StaRRsed Flex 1 1 1 1 1 ooo o ooo o ooo S na 00000 Hazy code 12 n a Not applicable 0 HE pg a NEN EN E EN 123000 Page 276 mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex SE9000 Sample data flag record format 131 bytes 0 a Text distinction code 1 Text distinction code II Sample distinction code 1 O Tuve postion no Je 05 Tube postoninrack 5 oma Peene i Compact HAZY code messages The code appears in the sample data record at variable RBC This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear StaRRsed Flex User Manual Page 277 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex 1 Sample is Hazy lt 10 2 Sample is Hazy lt 25 3 Sample is Hazy gt 25 Results with hazy aspect can be suppressed in the menu Limit error settings Compact ERROR code messages This code appears in the sample data record at
58. USE CUSTOM ASSAY RANGE e ON The lab can establish their own acceptable ranges both ranges can be set from a minimum of 2 mm to a maximum of 15 mm e OFF USE DEFAULT ASSAY RANGE is used Page 102 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program Note It is advised to use the default assay ranges Use caution when setting the custom ranges A too narrow range may cause unjustified rejection of QC sample results subsequent rejection of patient results and undue burden on maintenance SEND QC REQUEST TO LIMS e ON A sample request for the QC sample is send to LIMS The QC sample will only be processed if the LIMS responds with YES Use this setting if the ESR result of the QC sample will be send to LIMS as well and LIMS requires that all samples are requested first If the QC sample is linked with a Lab ID the sample will be requested at LIMS with the Lab ID If the QC sample is used with the original StaRRsed Control sample ID the sample will be requested at LIMS with the StaRRsed Control sample ID e OFF Default setting All QC samples will be processed without requesting at LIMS SEND QC RESULT TO LIMS e ON QC results are send to the LIMS as a standard ESR result If the QC sample is linked with a Lab ID the result will be send to LIMS with the Lab ID If the QC sample is used with the original StaRRsed Control sample ID the result will be send to LIMS with the StaRRsed Co
59. User Manual Version 1 02 MRN 151 EN e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor lt 200 600 gt 700 6 Exchange Waste cassette assembly Be careful as there may be blood in the cassette First make up some disinfectant and put this in the liquid separator Press PRIME DISINFECTANT to pump disinfectant through the pump cassette Clean Waste Cassette The waste system must be cleaned before replacing the waste pump cassette 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note i The separator has two sensor connectors at the rear 4 Remove bacterial HEPA filter 5 Fill waste separator with 100ml disinfectant or 100 ml water with 2 bleach 6 Replace bacterial HEPA filter 7 Lift left cover 8 Lift stainless steel vacuum tube up 9
60. before executing this function 6 5 2 3 Temperature sensor e Check temperature sensor Value must be equal to the actual room temperature near the pipette belt The value can be set in tab SETTINGS 6 5 2 4 Diluter start e Check Diluter start sensor This sensor is only used in EDTA mode If the diluter does not start during the aspiration the status of this sensor must be checked The value should be Diluter start sensor400 700 6 5 2 5 Diluent flow sensor e Check Diluent flow sensor This sensor is only used in EDTA mode When activated the LED Down is green and the LED Up is red When the button Test is clicked the LED Up must become green After finishing the test both LED s must be green 6 5 2 6 Separator sensor e Check Separator sensor The value must be in range of lt 200 600 gt 700 6 5 2 7 Flow sensor e Check Flow sensor The vacuum unit switches on and the values must be in this range For StaRRsed Flex Flow 0925 0980 1020 Abs 0300 360 0390 Note If for example the yellow orifice is blocked the flow will be Offset 0045 0050 0055 StaRRsed Flex User Manual Page 77 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 5 2 8 Measure sensor e Check Measure sensor In Service mode When the sensor is not engaged with the pipette the Value must be within the following limits MS 40 50 60 Press the button MEASURE The pipette currently at the measure position will be measured The re
61. bottle full Empty waste bottle and clear e Check level sensor error E23 Fill sensor out of The Fill sensor has reached a e Check and or clean the Fill range Check clean this critical level sensor aie puro Continuing could result in filling errors E24 Diluter Start sensor out The Diluter Start sensor has Check and or clean the of range Check clean this reached a critical level Diluter Start sensor Sensor Continuing could result in filling errors E25 Measure sensor out of The Measure sensor has Check and or clean the range Check clean this reached a critical level Measure sensor senson Continuing could result in wrong ESR results E26 Diluent Flow sensor out The EDTA Flow sensor has Check and or clean the of range Check clean this reached a critical level EDTA Flow sensor sensor Continuing could result in filling errors Page 220 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex E27 Temperature sensor The measured room Check the temperature out of range Check Settings temperature has reached a sensor setting critical level Check and or clean the Continuing could result in Temperature sensor wrong ESR results StaRRsed Flex User Manual Page 221 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex E29 Result path not found Switched to default D Check Result Path setting E30 No A
62. box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor lt 200 600 gt 700 6 Exchange Waste cassette assembly Be careful as there may be blood in the cassette First make up some disinfectant and put this in the liquid separator Press PRIME DISINFECTANT to pump disinfectant through the pump cassette Clean Waste Cassette The waste system must be cleaned before replacing the waste pump cassette 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note i The separator has two sensor connectors at the rear 4 Remove bacterial HEPA filter 5 Fill waste separator with 100ml disinfectant or 100 ml water with 2 bleach 6 Replace bacterial HEPA filter 7 Lift left cover 8 Lift stainless steel vacuum tube up 9 Insert the liquid separator sliding it over the support shelf 10 Push the liquid separator towards the r
63. builds up in the Westergren pipettes and needs to be deproteinized using a strong cleaning agent Detailed instructions of this procedure can be found in the Work Instruction WI 193 level 4 maintenance 13 3 1 Rinse pump tube replacement New rinse pump tube assembly ESRIO90902 Riny SOLU ALINE 5 ER fene Y silo neire New tube replacement 1 Open left cover 2 Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder 3 Remove the old tube from the peristaltic pump rotor 4 Disconnect the tubing at both ends of the tube connectors 5 Connect new tubing to both ends of the connectors StaRRsed Flex User Manual Page 153 Version 1 02 MRN 151 EN Re mechatronics Maintenance D Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor 8 Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex N If the tube is not fitted correctly or is worn the following symptoms can occur e Liquid flowing back into the container e First glass tube on the pipette belt is not washed sufficiently Note The wider bore tube is for the rinse pump 13 32 Saline pump tube replacement New saline pump tube assembly ESRI090903 RIN SOLU ALINE exse mone tele 4 zy New tube replacement 1 Op
64. is the calculated 60 minutes value Temperature correction is used This is the 60 minutes value corrected to 18 Date and time of the measurement of the result Actual duration of the ESR The calculated dilution rate after aspiration of the sample Room temperature at the time of the measureme nt of the sample Pipette in which the sample was measured Shows any ESR error codes e g Too many borders found StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics 6 3 3 ESR Statistics screens ESR Statistics 60 50 40 30 20 10 0 71 02 5 11 08 Sep 11 Date 1 1 04 5 11 06 5 11 1 10 5 11 Compact FLEX program e Daily mean mm C Dilution 9 5 Q Bubbles on top 95 O ESR errors C Number of samples Dilution error 10 diluter setting Period From 8 12 Oct 11 f J monthts back 12 Sep 11 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 45 mechatronics Compact FLEX program A statistical graph is produced over a selected period Make a selection of the following graphs e Daily mean mm Use this to check variations in the daily mean ESR e Hazy Increasing hazy aspects are an indication for contamination of the instrument see Aspect Hazy on page 132 e Dilution Increasing dilution errors indicate the need for maintenance of the diluter system e Bubbles on to
65. more details Page 142 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Quality control 10 2 6 2 QC Result analysis Authorized staff should identify and differentiate acceptable unacceptable random errors and trends and or shifts in systematic errors from the statistical data Depending on the users Quality Control Procedures analytical results could be accepted or rejected Changes in QC results can be gradual or abrupt Gradual changes can be caused by contamination and incidental environmental variations Abrupt changes can be caused by change of QC material batch or possible hardware errors If results are continuously out of range due to significant difference between calculated mean and control value but the statistics show precise results with small deviations it should be considered to expand the acceptable assay range with QC Settings on page 102 If results are incidentally out of range it is advised to perform a daily maintenance and or fill and clean step and then perform another QC sample step before releasing patient results If results are not send to the LIMS QC Results can be exported to MS Excel CSV files for further analysis in lab s own Quality Control data system StaRRsed Flex User Manual Page 143 Version 1 02 MRN 151 EN Rm mechatronics Waste disposal 11 WASTE DISPOSAL The waste container is located within the cabinet in a separate compartment to prevent contaminatio
66. off Note If vacuum pump is OFF rinse solution will spill over the Auto rack unit 6 7 4 1 All pumps OFF ALL PUMPS OFF All active pumps will be switched OFF The waste pump is switched ON for one minute 6 7 4 2 Needle Control StaRRsed Flex User Manual Page 111 Version 1 02 MRN 151 EN RR mechatronics Compact FLEX program 6 7 4 3 Valve control CIA Sample Reagents Maintenance Ju 6 7 4 4 Valves 1 VALVE OUTER NEEDLE Energizing the outer needle solenoid valve 2 SAMPLE CONTROL SOLENOID Sample control solenoid fill sequence energized The function of this solenoid is to build up a vacuum in the Westergren pipette before the aspiration starts 3 V VALVE WASH SECTION Pipette wash vacuum control valve controls the main vacuum line between the wash station and separator 4 VALVE FILL SECTION Vacuum control fill nozzle sample probe controls the main vacuum line between the fill nozzle cap and separator 6 7 4 5 Actuator Actuator control 1 RINSEACTUATOR Rinse solenoid active rinse valve block down 2 FILL ACTUATOR Fill solenoid active fill valve block down Page 112 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 7 5 Display error history Service A list of the error detection during operation This list contain error numbers what can be useful for the field engineer to check the problems with the instrument in
67. on the screw thread of the glass jar 3 Assemble the separator StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 304 Replacing 1 8 9 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes Release the stainless steel vacuum tube Replace the waste container 10 Close left cover StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 305 m mechatronics Work instruction Number 201 Page 1 of 1 Purpose Disassembly and assembly of the fill nozzle Safety Bio Hazard area Instrument Compact Revision Draft February 2005 Instructions for disassembling and assembling the fill nozzle Note For the O ring replacing only take the top part away from the fill nozzle StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 306 RR mechatronics Work instruction Number 205 Page 1 of 1 Purpose Replace the pinch valve tube ESRIO10246 Safety Bio Hazard area
68. operation To access other menus select the required tab on the display and press the mouse button To access the other sub menus in the selected tab select the required button and press the mouse button The following screens are selectable via the associated tabs SAMPLE screen on page 34 HISTORY screen on page 40 REAGENTS Screen on page 66 MAINTENANCE Screen on page 69 SETTINGS screen on page 84 SERVICE screen on page 104 o um mmm The above picture is an example of the SAMPLE screen of the Compact in the normal operation mode If the Service mode button with light is shown in the Status line the Compact is running in the service mode The User Manual button is also in the status line Click this button to open the StaRRsed Flex User manual When the Compact is running in the Service mode all kinds of settings can be changed and the instrument will run with the changed settings For instance when ESR time is set to 12 minutes the Carousel will move according this time setting to be in time at the measure position When the Compact is running in the NORMAL MODE the instrument uses the standard saved settings For instance the ESR time is set back to 60 minutes or 30 minutes according the used method 6 2 1 Carousel Carousel This is a graphical representation of the Compact carousel When an ESR is required the carousel is moving to the Measure position On the display the belt is also moving accordingly Th
69. page 179 7 Limit error Error One of the following limits are out of the setting range ESR Time Column height Dilution Bubbles on top Hazy aspect Temperature StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 263 mechatronics Appendix for StaRRsed Flex Appendix Protocol Sysmex R 3500 EPU R 3500 sample data record format 202 bytes This is a modified data record coming from a R 3500 o 9 9 0 Q o a h i r N o zs o Parameter Text distinction code Text distinction code ll 2 sn 05092014 Format ddmmyyyy 084626 Format hhmmss 001234 Rack number 1234 05 Tube position in rack 5 Sample distinction code Measurement data Measurement time Rack no ha ha o o ooo Inquiry mode N Sample ID number Reserved IP Messages ESR 60 MINUTES HAZY CODE ERROR CODE SEDIMENTATION TIME DILUTION RATE ESR 30 MINUTES Reserved Aspiration date Aspiration time Reserved Text distinction 1 D Text distinction 1 1 Sample distinction code 1 Measurement data 8 05092014 Measurement ime 6 084626 Rackno 6 001234 Tube position no 2 0 Inquiry mode Jif 1 Sample ID number 20 Reserved Joj _ IP Messages 6 ESR 60 MINUTES 6 000123 HAZYCODE 5 0000 ERROR CODE 5 TEMPERATURE 5
70. page 106 Manual control on page 110 OOS OQ Ny gt Advanced e LOAD SETTINGS is used for reloading the stored software settings Display error history on page 79 Display error history and Display maintenance history e SAVE SETTINGS AS is used for storing software settings to a file There are no restrictions for the file name e SAVESETTINGS is used for storing software settings after settings are changed or altered Page 104 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics 6 7 1 FlexLab settings C Sample HI History Alli d Reagents Maintenance gt Settings FlexLab connection LAS settings Compact FLEX program m Service B Lm Baud rate J 19200 0 Commurication busy FlexLab general settings In this screen e Baud rate settings for the FlexLab connections can be changed e A local fill test can be performed StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 105 RR mechatronics Compact FLEX program 6 7 2 LIMS settings C Sample jj feo Reagents Maintenance Settings Service BB i t i Visible in case of _ Select a communication port to communicate with the Compact 6 7 2 1 Set LIMS communication settings Communication with LIMS can be a serial or an ethernet connection USE SERIAL OUTPUT Serial output comport ASRL2 INSTR By default Baud rate Sele
71. program 6 4 Reagents screen s Sample Settings m Service il History Reagents Maintenance Separator Rinse solution Saline Diluent De ionized Disinfectant Lot number 123456789 Expire date 11 2011 Placed 06 Oct 11 Lot number 123456769 Expire date 11 2011 Placed 06 Oct 11 number 123456789 Expire date 11 2011 Placed 06 Oct 11 water number flot number 123456789 123456789 Expire date Expire date 11 2011 11 2011 Placed Placed 06 Oct 11 06 Oct 11 When there is a sensor alarm alarm indicator is shown the tab REAGENTS The alarm status of the reagent containers and separator are shown in this screen An empty container is marked by a flashing red to yellow mark When the status screen is active the reagent audio alarm is switched off Reagent information is shown in the little text boxes To input new reagent information when reagent container is replaced click on the appropriate text box Note When the expire date is exceeded the text box will flash red The software checks the reagent level status before starting a new aspiration If a level alarm is ON it will not process the new sample If an alarm comes ON during an aspiration it will finish to aspirate that sample 10 samples max Washing dirty pipettes always continues as to avoid that the samples are left in the pipettes
72. readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 Hazy detection 50 0 Meniscus detection gt 25 hazy 10 25 25 lt 10 mm 10 dea lt 3mm _3 celis 100 90 NI E T cear hazy lt 10 mm 60 z 40 4 out off measure arca 20 10 LA i ae plasma UT 50 100 150 200 250 pipet column bottom sedimentation 110mm height Graphic showing typical absorption values of a sample StaRRsed Flex User Manual Page 13 Version 1 02 MRN 151 EN mechatronics Introduction 1 4 Explanation of available documentation Manuals for the StaRRsed Flex are available on three levels for the operator the supervisor and the service engineer The following manuals are available 1 Instructions for Use IFU Intended for the operator Contains instructions for normal operation safety preventive maintenance and trouble shooting procedures to solve the most common problems Available in several languages 2 User Manual UM Intended for the lab supervisor Contains information from the IFU and additional information concerning settings service higher maintenance levels and trouble shooting procedures to solve more compli
73. rinse unit e Checks position of the rinse unit if incorrect the unit will be re positioned by the system 3 Test measure unit e Checks position of the measure unit if incorrect the unit will be re positioned by the system 4 Test Needle unit e Checks position of the needle unit if incorrect the unit will be re positioned by the system 5 Test Diluter unit e Check the position of the syringe if incorrect the unit will be re positioned by the system 6 Test drive e Checks position of the drive unit if incorrect the unit will be re positioned by the system During normal operation the following System time out errors may occur These are usually fatal errors Call distributor or your local supplier of the Compact 1 Drive unit e Compact was not able to position the pipette belt within a certain time limit e Check for mechanical obstructions 2 Measure unit e Compact was not able to position the measure unit within a certain time limit e Check for mechanical obstructions 3 Rinse unit e Compact was not able to position the rinse unit within a certain time limit e Check for mechanical obstructions 4 Fill nozzle unit e Compact was not able to position the fill nozzle unit within a certain time limit e Check for mechanical obstructions 5 Needle adapter StaRRsed Flex User Manual Page 209 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex e Compact was not able to position the
74. sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor lt 200 600 gt 700 Page 326 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 216 Page 1 of 7 Purpose Maintenance level 4 Safety Bio Hazard area Instrument StaRRsed Flex Revision 002 March 2014 Perform maintenance when the StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU Overview StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on erFlexLab36 ATA Overview FSE 10 54 16 gt gt Samples Tests Exceptions Input Output StaRRsed Centrifuge 1 Configuration Cantrifuge 2 Centrifuge 3 C Architect 120003771 Architect 2000 2 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module
75. separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator Page 322 SiaRRsed Flex User Manual Version 1 02 MRN 151 EN Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover 3 Check sensors Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE
76. system 6 3 5 History analyse Analyse results Dilution error Aspect Error phones O Et No cellsfplssma fond 5 wt height fo Opwonsuo fus CC Marys S ER ESR Probably gt 140mm O Wa Measure error o Q Hazy gt 25 5 Too many borders Found W3 Bubbles on top ESR 11 0 08 11 39 48 2 many borders Found _ 11 0815 0 10 33 T2 I zi Too many borders found 11 0ec08 12 32 06 Too many borders found 50247102 110 08 16 10 47 Too many borders Found 11600002 11 0ec08 10 18 45 3 if many borders found 11315702 11 Dec 08 14 48 58 11314402 11 Dec08 14 49 46 11315102 110ec 8 14 47 22 i2 many borders found 750408602 11 Dec 08 14 42 34 11315002 11 08 14 46 36 50367602 01 Dec08 16 20 41 12 many borders found 11314702 11 0ec08 14 36 35 ii 50407202 08 14 41 46 5 50403902 10 08 13 32 47 6 2 11 Too many borders found 11003802 11 Dec 08 09 09 25 11007002 11313602 11 4 814 50 34 1 11315502 11 Dec 09 14 48 10 37654402 11 0ec08 15 02 94 3 11001502 11 06 08 09 05 33 11310902 TY tec 14 63 StaRRsed Flex User Manual Page 57 Version 1 02 MRN 151 EN mechatronics Compact FLEX program DILUTION ERROR The dilution error detection
77. the hot de ionized water in the adapter 3 Place the cap on the adapter and mix well StaRRsed Flex User Manual Page 347 Version 1 02 MRN 151 EN Start Fill and clean procedure 1 Select MAINTENANCE PRIME CLEAN 2 Select Fill amp Clean to start the process Pipette data will be lost Use Fill amp Clean adapter ON 3 Select button OK 4 The needle goes down and the fill and clean process is started it will take around 90 minutes 5 When all the pipettes are filled the needle goes back to the home position Note Each pipette on the pipette belt will be filled with cleaning agent after one hour the first pipette is washed and dried Fill and clean takes about 1 1 2 hours to complete See also WI 178 Hazy problems on page 296 and WI 195 Cleaning the diluent system on page 303 Cleaning with chlorine 5 Sensor check Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check Page 348 StaRRsed Flex
78. the past The key CLEAR will delete all errors from the list StaRRsed Flex User Manual Page 113 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 7 6 Display maintenance history Service _ Sample ij History Reagents l Maintenance Settings Service i 05 05 2008 08 45 11 Measure sensor checked This list contains a log of all the maintenance what is done which can be useful for the field engineer to check the problems with the instrument in the past The key CLEAR will delete all errors from the list Page 114 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 7 7 Advanced This screen is used for input direct commands into the software to control all kinds hardware and software settings This is only used by Mechatronics engineers and is not available for third parties StaRRsed Flex User Manual Page 115 Version 1 02 MRN 151 EN mechatronics Getting started 7 GETTING STARTED Check the general settings and select the required options 30 minutes Default is OFF Display dilution Default is OFF EDTA mode Default is ON Display graph Default is OFF Sample probe protection Default is ON Temperature correction Default is ON Fast filling Default is ON Virtual keyboard Default is ON 9 Print after measurement Default is OFF 10 Check for duplicate ID s 11 Check the limit filt
79. the reagents containers 31 System messages 147 System time out lt gt 148 Technical specifications 16 Temperature correction 140 355 Temperature sensor 77 Test messages 148 TROUBLE SHOOTING 163 Turn off 137 Turn off sequence 137 U Unidirectional 356 Usage options 140 USB IO Device 109 V Vacuum 175 Vacuum error 176 Vacuum stabilisation problems 175 Valve control 112 Valves 112 Version information 36 W Wash all pipettes 71 Wash each pipette 71 Wash only sample pipettes 71 Wash station 36 Waste disposal 123 Page 362 mechatronics WASTE DISPOSAL 145 Waste line connection to central waste system 145 Weekly 152 WI 356 WORK INSTRUCTION STARRSED FLEX 283 StaRRsed Flex User Manual Version 1 02 MRN 151 EN
80. when it reaches the rinse station This indicator is also on when a sample could not be aspirated properly Pipette leak Reserved for future use StaRRsed Flex User Manual Page 39 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 3 History screen 02 01 2013 09 03 09 02101 2013 10 16 07 eooo 6 22 6 020203090433 2 60 1028012013 10 16 26 3 18 60 ii ANE 04 In History the following options can be selected e DISPLAY PIPETTE DATA on page 41 Use button PRINT to send the selected data to the printer DISPLAY SAMPLE HISTORY on page 42 e DISPLAY FULL PATIENT RESULT In Display sample history are the following options available PRINT Send the selected result to the printer PRINT RESULT HEADER Only if option Settings General settings PRINT AFTER MEASUREMENT is switched ON it is possible to print a result header SEND ALL TO HOST Send all results again to the HOST SEND PATIENT RESULT TO HOST Send only the selected patient result to the HOST Page 40 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechetronics Compact FLEX program e ANALYSE RESULTS on page 57 e ESR STATISTICS on page 45 e QC RESULTS on page 46 e LINKED QC ID s on page 56 6 3 1 Display pipette data B EEE aa ae ee i ge em ii
81. 0 2 4 Usage options StaRRsed Control can be used in two ways 1 With original StaRRsed barcode label The StaRRsed software maintains internal QC history and sends an error message when test results are out of range 2 With user barcode label The user can use his own ID labels hereafter called Lab ID Existing QC procedures and LIMS interface settings can be maintained without any changes The Lab ID is linked within the StaRRsed software to the original StaRRsed Control barcode An external barcode reader can be used to read the 10 character QC barcode labels on the tube or the package insert to create the link The barcode symbology is Code 39 When StaRRsed Control label or a linked user barcode label is used e The StaRRsed software recognises the StaRRsed Control sample by the structure of the barcode which contains the following information Level A or N the expected mean value and range and the expiry date e The history of QC results is maintained internally Error messages are generated when the QC results are outside the acceptable range e QC samples can be optionally requested by the LIMS and QC results can be send to the LIMS Page 140 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Quality control StaRRsed Control can be used on StaRRsed analysers in EDTA or in Citrate mode Quality Control sampling can be performed at any time during the normal ESR procedure depending on users Quality
82. 02 MRN 151 EN Compact FLEX program mechatronics 6 5 4 Display maintenance history 7 Sample iil History fr Reagents Maintenance Settings m Service BB 12 Oct 11 13 56 19 Fill amp Clean finished 12 Oct 11 13 56 16 amp Clean executed 12 Oct 11 13 55 18 Fill amp Clean finished 12 Oct 11 13 55 18 Fill amp Clean executed 12 Oct 11 13 55 13 Fill amp Clean cancelled 12 Oct 11 13 53 37 Fill amp Clean executed 12 Oct 11 11 03 47 stop sensor checked 12 Oct 11 11 03 45 Measure sensor 12 Oct 11 11 03 42 Flow sensor checked 11 Oct 11 09 03 30 Fyll amp Rensa avbrutet 11 Oct 11 09 01 10 amp Rensa genomf rt 11 Oct 11 08 58 55 Fyll amp Rensa 11 Oct 11 08 53 54 amp Rensa genomf rt 10 Oct 11 09 43 53 Measure sensor checked 03 Oct 11 08 18 57 Temperatursensorn kontrollerad 03 Oct 11 08 18 41 Temperatursensom kontroller ad 03 Oct 11 08 18 41 Sp dningsfl dessensorn kontrollerad 03 Oct 11 08 18 40 Separatorsensorn kontrollerad 03 Oct 11 08 16 38 Mitningssensorn kontrolleradi When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All performed maintenance functions are logged automatically This log can be saved e g to a memory stick by clicking button Save As Page 80 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm 7 mechatronics Compact FLEX program
83. 0902 Moisten the tip with water to ease the tip back into the glass syringe barrel Install the syringe back on to the attachment Clean dilution system 1 2 Perform PRIME DILUENT Repeat above step until there are no air bubbles in the whole diluent system anymore Check dilution settings E ee Go to tab SETTINGS GENERAL SETTINGS and select DISPLAY DILUTION OFF Run 10 samples through the instrument and make a note of the dilution rate Calculate the mean of the 10 samples Make dilution adjustment if necessary in SETTINGS gt DILUTER SETTINGS Go to tab SETTINGS gt GENERAL SETTINGS and select DISPLAY DILUTION ON StaRRsed Flex User Manual Page 302 Version 1 02 MRN 151 EN mechatronics Work instruction Number 195 Page 1 of 1 Purpose Cleaning diluent system Safety Bio Hazard area Instrument StaRRsed Flex Revision 003 August 2014 Step 1 1 Remove the suction tube from the diluent bottle and empty the diluent bottle 2 Fill the diluent bottle with 50 ml bleach sodium hypochlorite and 950 ml de ionized water 5 solution 3 Place the suction tube in chlorine solution 4 Use the PRIME function to fill the dispenser system with the disinfectant 5 After the prime sequence stops press PRIME to fill the dispenser system with the disinfectant 6 Leave the disinfectant in the system for 15 minutes Step 2 1 Take the diluent suction tube out of the disinfectant
84. 133 Version 1 02 MRN 151 EN mechatronics Operation 9 OPERATION 9 1 Quick start up This section describes a quick start up procedure and a general description of what to do before starting a large batch of samples to run through the system 9 1 1 Check list Run this checklist before each large batch of samples Waste container should be empty Check the liquid levels All covers closed StaRRsed in status Online in Flexlab system Pons Note BE SURE THAT THE COMPACT IS SET TO THE CORRECT MODE i e EDTA or CITRATE 9 1 2 Power up sequence Switch ON procedure e Switch ON the Compact e Switch ON the PC and monitor e Wait until Windows is ready for use e Start the Compact software 9 1 3 Liquid levels The StaRRsed Flex has liquid level sensors When the level sensor alarm appears replace reagent as soon as possible StaRRsed Flex User Manual Page 135 Version 1 02 MRN 151 EN Rm mechatronics Operation 9 2 Checks during operation e Perform regularly visual checks for air bubbles in the sample pipettes see Air bubbles on page 179 e Check regularly the ESR statistics in the software for any increase in ESR errors haziness dilution errors or bubbles on top warnings see ESR Statistics screens on page 45 In case of a considerable number of pipettes with air bubbles e Perform the necessary maintenance or contact the service representative 9 3 Priming the fluid sys
85. 151 EN Trouble shooting R mechatronics 15 9 2 Pipette looks like zebra crossing If this always occurs in the same pipette check the bottom of the pipette for the following 1 Glass may be chipped e Replace pipette 2 Dirt e g dried blood e Clean the pipette e Check disinfectant flow at the rinse nozzle 3 Perpendicularity and straightness of the bottom face e Replace pipette If this happens randomly or with each pipette check the following 1 Fill nozzle O ring or flat washer 2 Fill nozzle alignment to pipette e Check the nozzle arm is tight on the rear vertical shaft Usually engineer s assistance is required A pipette which looks like zebra crossing gives ESR Error 3 15 9 3 One air bubble about 5 mm under meniscus Page 180 The filling aspiration speed is not critical but should be within certain limits 1 If just one air bubble is found about 5mm below the meniscus the filling speed may be too high 2 The blood column should not exceed the filling height sensor by more than 10mm One air bubble can result in ESR Error 3 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 9 4 One air bubble rising in pipette r1 r 1 Usually this is caused by a wet or dirty fill nozzle e The blood column should not reach right to the base of the pipette There must be a clear air gap of 4 5mm at the bottom of each pipette 2 Insufficient sam
86. 2 EDTAIIO 1 30117602 09 Dec 08 16 01 45 83 10 42761302 09 Dec 06 17 38 09 2 iT EDTAL10 08300402 08 Dec 08 13 46 45 3 I EDTAMO Too many borders found 05300802 05 06 10 35 05 27 2 ELSE COLE d iata 33509402 05 0 08 12 49 32 29 EDTAIIO 03310602 03 Dec 08 11 46 17 Ii 01605302 020608 082142 22 T EDTATIO 39400002 02 Dec 08 13 02 20 EDTALIO 01315802 01 Dec 08 12 07 46 29 i I T EDTAL10 01602502 01 Dec08 14 23 14 3 2 1 EDTAL10 1 4425130 22 Der 13 16 29 3 1 2 Fhr tit DILUTION ERROR The dilution error detection is a user setting and can be changed in SETTINGS dilution error detection to 0 25 In this example the dilution error detection is set to 10 and limit errors set to YES By selecting Dilution gt 110 all the samples with a dilution rate gt 110 are displayed in the table By selecting Dilution lt 90 all the samples with a dilution rate lt 90 are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order Page 58 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechetronics 6 3 7 History aspect Analyse results DES 3 Too iy sri 02Dec08 16 16 20 23 uve jr B 030ec0812 53 9 z3 mazei
87. 2013 09 14 53 17 EDTA 02 01 2013 09 15 41 s 23 160 02 01 2013 09 06 16 02 01 2013 09 06 53 60 60 160 60 60 60 160 60 6 60 o 60 60 60 In the window Select date to show results double click on the file to select the results of the selected date Press Refresh to refresh the list of available files In the window Sample ID type the sample ID information and press Search Press Options for the following search options e Show today s results e Show today s results from a selected time frame of the day e Show results of a number of past days Default value is set for 7 days e Show results of a specific day e Show results of the range between the first selected date to the next selected date Select in the table a Sample ID and click the button DISPLAY FULL PATIENT RESULT for more detailed information of the selected sample In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order Page 42 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 3 2 1 Display patient results i Sample fe Reagents oe Maintenance Settings Service a BH Display pipette data Display sample history Refresh Ont iu imis LL Heel FARE
88. 3 3 Result path Select location for storage of ESR results at RESULT PATH The underlying folder structure year month day is created by the software 6 7 3 4 Search in example history e f SEARCH IN EXAMPLE HISTORY is OFF this file cannot be selected in the history window e f SEARCH IN EXAMPLE HISTORY is ON this can be selected the history window 6 7 3 5 USB IO Device USB IO DEVICE Switch ON if a Status indicator is part of the StaRRsed Flex If switched ON a device can be selected at USB IO Device number StaRRsed Flex User Manual Page 109 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 7 4 Manual control To control assemblies separately by using the ON OFF switch VACUUM PUMP ON the main vacuum pump is switched on OFF the main vacuum pump is switched off WASTE PUMP ON the waste pump is switched on OFF the waste pump is switched off The waste pump is used for emptying the liquid separator Do not leave this function ON as it may cause waste pump damage Page 110 StaRHRHsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program SALINE PUMP ON the saline peristaltic pump is switched on OFF the saline peristaltic pump is switched off Note If vacuum pump is OFF rinse solution will spill over the Auto rack unit RINSE PUMP ON the pipette wash peristaltic pump is switched on OFF the pipette wash peristaltic pump is switched
89. 3 5 Disinfectant QRR 010947 sess 120 7 3 6 eI peces 121 7 3 7 Waste disposal M aeea Ea A EERE ENE EA NEES 123 8 REPORTING casas esas eee eee eee ele eee eee 125 MEE ri T mm 125 8 2 R su lt RERE 125 8 2 1 Report 60 Minute 127 8 2 2 Report 30 Minute mode eremi kan 129 8 2 3 ESR EMOL r Mr LEE 129 8 2 3 1 ESR Error and Warning code 129 8 2 4 Limit error SETINGS nce 131 8 2 5 Reporting range RE ET o S 131 8 2 6 cci rM 132 8 2 6 1 Analyser HAZY code 133 MEE s qot rr 135 9 1 135 9 1 1 gud c 135 9 1 2 Power Up Sequence Tn 135 9 1 3 E E EEE 135 9 2 Checks during 136 9 3 Priming 8 136 gA TU Onne e a a a a a 137 9 4 1 End of day wash procedure
90. 45 StaRRsed Flex User Manual Page 5 Version 1 02 MRN 151 EN mechatronics Contents 6 3 4 QC Results screens e 46 6 3 4 1 QC Normal results Iablo 1 rta bride tea rrt terrier ben bei beside 47 6 3 4 2 QC normal results screen 49 6 3 4 3 OC normal results iieri ct eui eta Rd rtt Lem a 50 6 3 4 4 QC abnormal results table 51 6 3 4 5 QC abnormal results screen extended 53 6 3 4 6 QC abnormal results 54 6 3 4 7 Display sample history QC 55 6 0 4 6 Linked OC ID S ER 56 6 349 OC Hesult analysis operta UU M DUM DU IM NIME UE 57 6 3 5 History E a i m 5 6 3 6 History analyse results high dilution 58 6 3 7 lactea d oot RC ee oa See eae 59 6 3 8 History analyse Ec DEO MERE 60 6 3 9 History analyse warning ausus iii n RUNI RUM RUP Ubi EN SE 61 6 3 10 History sample analyse 62 6 3 11 History sample analyse option 63 OMNES CNN CU RET mS 64 6313 Setend dalem
91. 51 EN 100 240V Slow blow 220V Slow blow 110V Standby Maximum 50 60Hz 2 5 Amp 5 0 Amp 60 VA 500 VA Page 17 Instrument description Heat output Standby Full operation mechatronics 70 Watt 360 Watt StaRRsed Flex environment Sound level Environment temperature Relative humidity StaRRsed Flex dimensions Width Dimensions cabinet Height Depth Weight empty Dimensions Compact unit Height Depth Weight Total dimensions Floor space Minimum Working space Total height cabinet and Compact Data storage unit Weight empty Weight full max 30 Gb Hard disk on external PC Storage medium Less than 65 dBA 18 28 10 90 865 700 605 90 kg 740 mm 770 mm 400 mm 45 kg 865x605 mm 1800x1800 mm 1470 mm 135 kg 235 kg approx 5 Mb per 1000 samples results and raw data Storage capacity indication Page 18 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics General safety instructions 2 2 Accessory kit The StaRRsed Flex comes with an accessories kit For a complete list of the the contents of accessories kit see Appendix Article reference list on page 198 3 GENERAL SAFETY INSTRUCTIONS The instrument described in this manual is designed to be used by properly trained personnel only For the correct and safe use of this instrument it is essential that both operating and servicing pe
92. AGEMENT 161 De ionised water 120 De ionized water 168 Diluent flow check 100 Diluent flow sensor 77 Diluent QRR 010931 120 Diluter 171 Diluter errors 172 Diluter settings 84 98 100 172 Diluter start 77 Diluter system not sufficiently primed 171 Dilution adjustment 60 till 140 98 Dilution error detection 0 till 25 99 Dilution principle 13 Disinfectant 168 Disinfectant QRR 010947 120 Display error history 69 79 104 Display error history Service 113 Display maintenance history 69 80 Page 359 Index Display maintenance history Service 114 Display patient results 43 Display pipette data 40 41 Display reagent history 66 67 Display Sample history 40 42 55 Display sample history QC 55 Document history overview 3 E E C Declaration StaRRsed Compact Flex28 EDTA mode 355 End of day wash options 83 End of day wash procedure 72 137 End of day wash schedule settings 83 Error Messages 148 ESR 355 ESR Error 46 129 195 ESR Error and Warning code messages129 142 ESR Statistics screens 41 45 136 Expected value range 140 Explain bottle screen 67 Explanation of available documentation 14 F Facts and definitions 26 Fill and Clean 72 Fill and clean procedure 155 Fill and Clean with cleaning adapter 72 Fill nozzle 191 Fill nozzle does not engage with pipette191 Fill nozzle not at fill position 191 Fill nozzle not at home position 191 Fill station 36 Fill stop sensor 77 Fill time out error 185 Fill nozzle
93. C results compared with the expected ESR Coefficient of variation ratio of the standard deviation to the expected ESR expressed ina percentage e Number of QC results Page 50 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program This graph gives a first indication of the measuring stability of the StaRRsed Flex Further analysis and identification of systematic errors have to be performed in the user s Quality Control System CLOSE Return to History Screen 6 3 4 4 QC abnormal results table m l 05 01 2012 07 23 5 27 01 2012 08 23 5 2012 08 23 25 01 2012 08 16 59 2012 08 16 5 2012 08 16 59 2012 08 16 5 2012 08 16 5 it 2 LUS i i 12 37 10 ama 3064 19 0 03 02 2012 03 02 2012 12 37 10 10 10 E 3 i 1 1 1 6 01 2012 07 45 5 2012 07 23 02 01 2012 09 34 1 25 __________ 0201 2012073459 Elm Y u Ea 22 E N 3 12 3701 10 2 37 10 2 2 V 2 2 2 m 37 10 37 CH 10 37 10 m 31919 H E _ r fems QCIASSAAZS 5 8 Qaa 1 densus Qcoaseaus 5 5 0 0 QC9ASAROS 0 Qcasaus 5 8 QCRASSAAZS 9 5 3 25 8 Qcesss 5 0 0 Qcasww s j csse QcasaMs
94. CK NACK received from host after sending inquiry E31 NACK received from host after sending inquiry E32 LIMS Connection timeout Host not found Selected result path is not valid Software is using the default setting No response from Host within a certain time limit after sending an inquiry 3 times Did not receive ACK from Host after sending inquiry 3 times The Compact could not establish a connection with the HOST server via TCP IP mechatronics Check result path setting Check if network or USB devices are used Check communication cable between Host and StaRRsed Flex computer Check serial port settings baud rate etc Check protocol settings Check Host computer See E30 Check TCP IP settings Check network cable Check HOST settings No response from Host within See E30 E34 No response from host after sending Sample data record E35 No response from host after sending Sample flag record E36 No ACK NACK received after sending Sample result string E37 NACK received from host after sending Sample result string E40 Position settings error Settings loaded from Eeprom Check settings before sampling E41 Timeout settings error Settings loaded from Eeprom Check settings before sampling Page 222 a certain time limit after 3 attempts No response from Host within a certain time limit after 3 attempts No response from Host wit
95. Capital Y at position 28 of the string Sample refuse string definition replied by the host computer to skip the ESR test sm sp fels R s R isp i 2 3 s 6 7 9 10 11 12 1 14 15 16 17 spies N Capital N at position 28 of the string If either the host computer as well the StaRRsed Flex receives a string it should reply by sending an Acknowledge char 06 if the string is found Okay If either the host computer as well the StaRRsed Flex receives a string it should reply by sending a Non Acknowledge char 15 if the string is found faulty Checksum ON OFF always ON After sending the request string the StaRRsed Flex expects a ACK NACK see Opus protocol request string from the Host computer e If the StaRRsed Flex receives an ACK it will wait for the conformation string and respond with a ACK NACK according to the protocol definition e When the conformation string is received it will Respond with an ACK if the conformation string is OK and goes to the next sample e When the string is not OK it is responding with the Host computer must send the conformation string again After 3 attempts the Host computer must stop sending the conformation string and the StaRRsed Flex won t do an ESR on this sample and goes to the next sample The Host computer needs to be ready for the request string of the next sample Page 254 StaRRsed Flex User Manual Version 1
96. Check power is ON 3 Reagents level empty message e All reagent containers have level detectors the display shows an error that indicates which reagent container s is are empty e The expiry date of the reagent is exceeded or the container is opened longer than three months Prepare new reagent as described in section Reagents preparation 4 Waste bottle full message or No waste bottle message e The waste container also has a level detector If a waste error is shown on the display the StaRRsed Flex will stop filling and cleaning pipettes until a new or empty container has been installed e Empty the waste container and press Clear error 5 Fatal separator error e The Separator container has a level detector If the Fatal Separator error message is indicated on the display the Compact will stop the rinse cycle until the separator is empty e The cause of this problem can be foam or the waste pump is not working The Compact will continue to measure and send the ESR results on time to the printer but the rinse and fill sequences are stopped until the error is solved Page 208 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex uring the start up sequence all the positioning sensors are tested if incorrect the instrument will generate Test messages 1 Test fill nozzle unit e Checks position of the fill nozzle unit if incorrect the unit will be re positioned by the system 2 Test
97. Compact is switched to the 30 min method the output string has the same format The Compact automatic applies the conversion table to the 60 min method e f temperature correction is switched on the ESR value will be the temperature corrected ESR value e fthe result has an error the ESR value will be 4 space characters ASCII 20 Page 236 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix String format Vesmatic CR SP XX SP SP AAAAAAAAAAAAA SP NNN SP cr 24 data characters Total length 25 characters 2 Data consists if 30 min method is switched to OFF 3 Pipette number 1 84 XX Patient identification text AAAAAAAAAAAAA The ESR value 60 minute method NNN If error is detected E and an error number see table for number translation sp EN xx StaRRsed Flex User Manual Page 237 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex If error is detected 1 E and an error number see table for number translation sp JEN Text left aligned followed by spaces ASCII 20 number made up of xx digits 0 9 ASCII 30 39 Leading zeros and non specified positions are filled with spaces ASCII 20 The following error codes are No cells plasma found ESR Probably gt 140 mm Too many borders found Note If the Compact is switch to the 30 min method the output string has the s
98. D RESULTS WITH BUBBLES ON TOP WARNING e setto YES always transmit results to the output e set to NO transmit no results to the output when there is generated a warning for bubbles on top e SEND RESULTS WITH HAZY ASPECT e setto YES always transmit results to the output e set to NO three options are possible Hazy gt 10 Hazy 25 and Hazy gt 25 transmit results to the output as specified SEND RESULTS WITH TEMPERATURE EXCEEDED e setto YES always transmit results to the output e set to NO the settings can be set changed between a minimum of 15 and maximum of 34 When an option is set to YES and this limit error occurs results will be printed send to the LIMS StaRRsed Flex User Manual Page 101 Version 1 02 MRN 151 EN RR mechatronics Compact FLEX program 6 6 5 QC Settings C_i Sample History fr Reagents Maintenance Settings m Service MB Qi Use default assay range Default NORMAL range Default ABNORMAL range C Use custom assay range Custom NORMAL range Custom ABNORMAL range B send QC request to LIMS BD send QC resut to ums DD automaticaly remove irked QC ID after resuk In QC settings the following options can be selected USE DEFAULT ASSAY RANGE e ON Default setting The default assay range which is predetermined for the current batch of StaRRsed Control is used These ranges cannot be changed in this option e OFF USE CUSTOM ASSAY RANGE is used
99. ECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check Page 314 StaRRsed Flex User Manual Version 1 02 MRN 151 EN e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor lt 200 600 gt 700 6 Exchange Waste cassette assembly Be careful as there may be blood in the cassette First make up some disinfectant and put this in the liquid separator Press PRIME DISINFECTANT to pump disinfectant through the pump cassette Clean Waste Cassette The waste system must be cleaned before replacing the waste pump cassette 1 Open
100. GS password 3964 CAROUSEL CONTROL the Rinse position e Select SET RINSE POSITION e CHANGE RINSE POSITION e Enter the right value of the pipette number at the rinse station e Close pop up menu 2 Select SET RINSE POSITION e CHANGE RINSE POSITION e Press LEARN CAROUSEL POSITION e Close pop up menu Change rinse position E18 Carousel position error Check Rinse position Page 186 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting Check if the position error is solved Select GO TO RINSE POSITION enter a higher value than the actual rinse position and the carousel should move without position error If position error is solved 1 Select the Service mode Icon to leave service mode 2 If samples or liquid is present in any pipette go to tab MAINTENANCE PRIME CLEAN WASH ALL PIPETTES which removes the liquid from the pipettes All sample information will be lost If there is still a position error If the position is still not correct or if position errors occur frequently and the solutions above does not solve the problem the following procedure must be carried out 1 Select the Service mode Icon to leave service mode 2 a If liquid or samples are present in isolated pipettes use a combination of GO TO RINSE POSITION at the service tab and MAINTENANCE PRIME RINSE SOLUTION to remove the blood samples All sample information will be lost or b Go to tab SETTINGS and selec
101. IM will go to Offline FlexLab36 StaRRsed Status Status Ondine No Error Select an Option Node 10 vv Room for Empty Carriers Room for Routine Samples Room for STAT Samples StaRRsed Flex User Manual Page 327 Version 1 02 MRN 151 EN 1 Clean Fill nozzle and exchange O ring Fill Nozzle Disassemble the fill nozzle Disassemble fill nozzle holder 1 Turn the holder to the right 1 Turn the holder to the right 2 The fill nozzle can now be removed 2 The holder can now be removed 3 Disconnect the silicon tube from the fill nozzle The use of a toothbrush and detergent is recommended 1 Carefully scrub the fill nozzle inner part 2 Useatissue to dry the fill nozzle Replace O ring Remove the O ring QWLV050004 Install new O ring QWLV050004 Page 328 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Assemble fill nozzle holder Assemble fill nozzle 1 Connect the silicon tube to the fill Push the plasti inst th ush the plastic top part down against the nozzle spring pressure 2 Putthe fill nozzle into the holder 1 Turn the plastic top part until you hear Push the fill nozzle upwards and turn of feel a click the holder to the left 2 Turn the plastic top part clokwise for 1 5 turns 2 Clean Liquid Separator and exchange filters Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel v
102. INTENANCE HIST on page 80 MAINTENANCE INFO on page 81 StaRRsed Flex User Manual Page 69 Version 1 02 MRN 151 EN Rm 7 mechatronics Compact FLEX program 6 5 1 Prime Clean jil History E Reagents Maintenance Settings Service EJ When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All maintenance functions for the fluid system are grouped under button PRIME CLEAN on page 70 After each reagent change the fluid system must be primed to fill the relevant tubes with reagent and remove air This is also part of the daily start up Use the applicable button to perform the automatic priming cycle for this reagent 6 5 1 1 Prime Rinse solution PRIME RINSE SOLUTION After each measurement the pipettes are washed and dried automatically 6 5 1 2 Prime Saline e PRIME SALINE After each aspiration the outer needle sample probe and fill nozzle are washed with saline Page 70 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 5 1 3 Prime Diluent PRIME DILUENT The Diluter prime cycle is 5 strokes of the syringe 6 5 1 4 Prime de ionized water PRIME DE IONIZED WATER After each aspiration the fill nozzle is flushed with de ionized water 6 5 1 5 Prime Disinfectant e PRIME DISINFECTANT During a pipette rinse cycle a small amount of disinfectant is flushed around the bottom of t
103. Maintenance Schedule StaRRsed Flex Example Sample volume 350 per day 5 working Daily Weekly Level 4 Level 3 Level 2 Level 1 Parts Total days amount year Perform End of day wash Clean outside aspiration needle Check needle condition Check tubing diluent syringe Clean outside instrument Clean Fill nozzle Clean Liquid separator Check sensors Replace Fill nozzle O ring Replace bacterial air filter HEPA StaRRsed Flex User Manual Page 225 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex Replace Rinse tube assembly Replace Saline tube assembly Run Fill and clean Replace Waste cassette assembly Replace Blotting washer waste pump Replace Pinch valve tube Replace Blue disc filter Replace diluter syringe tip Replace Waste pump motor Replace Fill block washer Replace Sample probe assembly Check Pipette valves bodies and replace if necessary 84 pieces Replace all tubing Tubing set Replace outer needle assembly Page 226 mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix String format for StaRRsed ESR string format for StaRRsed 60 minutes format stx PPPPPPPPPP www WWW AAAAAAAAmm ppp TTT CC EEEEEEEEEEEEEEEEEEEEEE MMMMMMMMMM cr 1f eot stx 80 data characters cr lf eot Checksum OFF 60 min stx 80 data characters cr lf etx cs eot Check
104. N mechatronics Compact FLEX program 6 5 7 End of day wash schedule settings End of day wash procedure All pipettes will be washed once needle fill nozzle and rinse nozzle wash station are primed Shutdown settings Please select when to schedule the End of day wash procedure weekdays Ji hour minute o clock Current time 6 2 2014 11 39 57 Select the time of the day in hours and minutes for automatic start of this function 6 5 8 End of day wash options End of day wash procedure All pipettes will be washed once needle fill nozzle and rinse nozzle wash station are primed 4 Shutdown settings Please select when to schedule the End of day wash procedure Mo Shutdown 7 Immediately Single Weekdays Current time 6 2 2014 11 40 48 StaRRsed Flex User Manual Page 83 Version 1 02 MRN 151 EN Compact FLEX program The following settings can be selected for the function No End of day wash The function is not active Rm _ mechatronics Immediately The function runs immediately after pressing the button OK Only once The function runs only once at the selected time Weekdays The function runs only on working days monday till friday at the selected time Daily The function runs on a daily base at the selected time 6 6 General settings a es Sample jil History E Reagents 2 0 Maintenance at GZ 30me method D gt QU
105. O ring replacement 155 FlexLab settings 104 105 Flow sensor 77 Flow test absolute 92 Flow test Fill sensor air 94 Flow test Fill sensor glass 95 Flow test flow 91 Flow test leakage 93 Flow test potentiometer mean 90 Flow test start 96 Flushing liquids 168 Foam in column 46 179 Folder Structure on PC 161 Page 360 mechatronics G General laboratory practices 26 GENERAL SAFETY INSTRUCTIONS 19 General settings 33 35 84 GETTING STARTED 117 H Hazy 355 Hazy reports 184 History analyse 41 57 History analyse error 60 History analyse results high dilution 58 History analyse warning 61 History aspect 59 History sample analyse option 62 History sample analyse option day 63 History screen 33 35 40 141 Host 355 INSTALLATION 23 INSTRUMENT DESCRIPTION 15 INTRODUCTION 11 IVD 355 L Labels and stickers on containers 31 Language selection 88 Leaking pipettes 182 Level 1 maintenance 149 157 Level 2 maintenance 149 157 Level 3 maintenance 149 156 Level 4 maintenance 153 Limit error settings84 99 100 131 241 243 246 247 Limit filter settings 117 Limitations 139 LIMS settings 104 106 Linked QC ID s 41 46 56 141 Liquid level sensor not sensing 167 Liquid levels 117 135 M MAINTENANCE 149 Maintenance info 69 81 Maintenance info overview 82 Maintenance screen 33 35 69 Manual control 104 110 Measure sensor 78 Measure station 35 Medical requirements 26 StaRRsed Flex User Manual Version 1 02 MRN 151 EN
106. RIO10246 1 Open the left cover 2 Pull the tube out the pinch valve 3 Disconnect the silicon tube from the bottom connector and the top connector 4 Remove the tube 5 Connect the silicon tube to the bottom connector and the top connector 6 Push the tube in the pinch valve 7 Close the left cover 8 Final preparation Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 596 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required Page 316 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Air filter replacement ESRI QWLV0400003 1 2 3 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with disinfectant Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 70 and perform the PRIME
107. RROR code messages This code appears in the sample data record at variable HGB The following 7 codes are defined No errors 1 Nocells plasma found Error No contents could be detected in the pipette StaRRsed Flex User Manual Page 273 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex mechatronics ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 7 Limit error Error One of the following limits are out of the setting range ESR Time Column height Dilution Bubbles on top Hazy aspect Temperature Page 274 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix Protocol Sysmex SE 9000 unidirectional SE9000 Sample data record format 234 bytes This is a modified data record from SE9000 without instrument ID Sample data record format 234 bytes Parameter tel Text distinction code 1 ee Text distinction code II 1 PO Sample distinction code
108. Rsed Flex 1713395 100620 passers Age SDN Duvet weJBeip suonoauuoo eqn cone unesa __ Meuse bomen Ag S3Iu0JJEU29 N a juenpg juejoojuisig eujes asuy pesn jou inding pe yas Buiqni ui jou adhi 1 I t 100401453 gt gt Jld anger p biune tte g e aonana ie ds e 5060101459 8050201453 200020VH3A 2110201053 uonsmuuna oun i j 020101459 00Z01483 gt M 4 dund OAA UMNA gr 060201NS3 mM 2070201553 000 i 500020v33A geri I xe di v00Z0A MO f sozozolys3 who 8060201553 972010145 e anea GO unnoeA uia dund uma josues ayu axhues 2 3 000 0V33A E c E a T moe la en azm WOR qa S f apo 106020V83A es 61604019453 2080201953 8080201553 8160401559 ne Mo g see sonm 0202002220202 00604015453 901001453 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 202 mechatronics Appendix for StaRRsed Flex Appendix 60 minutes reporting Colums gt 9 Patient number Not corrected 30 minute ESR result only in use if 30 minute mode is active N
109. Rsed Flex User Manual Version 1 02 MRN 151 EN Start Fill and clean procedure 1 Select MAINTENANCE PRIME CLEAN 2 Select Fill amp Clean to start the process Pipette data will be lost Use Fill amp Clean adapter ON 3 Select button OK 4 The needle goes down and the fill and clean process is started it will take around 90 minutes 5 When all the pipettes are filled the needle goes back to the home position Note Each pipette on the pipette belt will be filled with cleaning agent after one hour the first pipette is washed and dried Fill and clean takes about 1 1 2 hours to complete See also WI 178 Hazy problems on page 296 and WI 195 Cleaning the diluent system on page 303 Cleaning with chlorine 5 Sensor check Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check StaRRsed Flex User Manual Page 339 Version 1 02 MRN 151 EN e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR
110. SEDIMENTATION TIME 5 00030 DILUTIONRATE 5 ESR 30 MINUTES 5 Reseved 10 Aspiration date 8 Aspirationtime 6 Reserved 80 oo n a not applicable This code appears in the sample data record at column 5 The following 4 codes are defined Page 264 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics 0 Sample is clear 1 Sample is Hazy lt 10 2 Sample is Hazy lt 25 3 Sample is Hazy gt 25 Appendix for StaRRsed Flex Results with hazy aspect can be suppressed in the menu Limit error settings Compact ERROR code messages The following 7 codes are defined 0 No errors 1 No cells plasma found Error No contents could be detected in the pipette ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 7 Limit error Error One of the following limits are out of the setting range e ESR Time e Column height e Dilution e Bubbles on
111. STARRSED FLEX USER MANUAL Version 1 02 MRN 151 EN Master Registration Number MRN 151 EN mechatronics Manufacturer Mechatronics Manufacturing B V Phone 31 0 229 29 11 29 Fax 31 0 229 24 15 34 E mail support mechatronics nl Internet http www mechatronics nl P O Box 225 Postal address 1620 AE Hoorn The Netherlands De Corantijn 13 Office address 1689 AN Zwaag The Netherlands Copyright Mechatronics BV All rights reserved Subject to changes without prior notice Issued by the After Sales Department of Mechatronics mechatronics Document history overview Document history overview MRN 151 EN 1 02 October Introduction e General safety instructions H a Safety e Explanation of a Error list documentation Protocol 3500 Appendix added Error list revised and E21 E29 E32 added January All First official release H 2014 Schavemak er All Start of manual H Schavemak er Published date 22 October 2014 StaRRsed Flex User Manual Page 3 Version 1 02 MRN 151 EN mechatronics Document history overview Page 4 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Contents CONTENTS 1s MIN TOU ceca cece wc eck ence cea ce Sc tc tance amet nc cece 11 1 1 PC Operation and User Interface 12 1 2 Dilution principle 13 1 3 Sedimentation measurement principle
112. Service mode is switched OFF 3 SAMPLE PROBE DEPTH in millimeters 4 PIPETTE WASH TIME SEC in seconds Default value 7 This setting is reset to default when Service mode is switched OFF 5 PIPETTE DRY TIME SEC in seconds Default value 5 This setting is reset to default when Service mode is switched OFF LANGUAGE The selection box for the language is marked with a symbol depicting a globe Select the language for the software and the Instructions For Use by clicking on the appropriate language name Note To switch to the selected language the first time close and restart the software StaRRsed Flex User Manual Page 87 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 6 1 Language selection LANGUAGE The selection box for the language is marked with a symbol depicting a globe Select the language for the software and the Instructions For Use by clicking on the appropriate language name Note To switch to the selected language the first time close and restart the software 6 6 2 Carousel control Page 88 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program CAROUSEL POSITION This display presents the position of the carousel for the Measure station position Rinse station position and the Fill station position FORWARD AND BACKWARD MOVEMENT OF THE CAROUSEL With this function the carousel can be moved one position backwards and forwards Warni
113. WLV040001 only applicable if internal waste container is used Teflon tip of syringe on the Diluter assembly NOG PON gt The following items need to be checked and replaced if needed annually 1 Outer needle and sample probe 2 Pipette valves bodies and replace if necessary 84 pieces QTST040001 Check 1 Adjustment of fill nozzle and rinse nozzle All these parts are included in the PM kit Periodical Maintenance Kit See Appendix Maintenance schedule StaRRsed Flex User Manual Page 157 Version 1 02 MRN 151 EN m mechatronics Maintenance 13 7 Reagents replacement The StaRRsed Flex is equipped with the genuine Mechatronics bulk reagent containers with level sensors Each container has a specific position see Reagent location label Disinfectant To replace the bulk reagent containers Open cabinet and slide drawer forwards Remove level sensors and spacers from the empty container Remove empty container Place new container Remove the container screw caps and pull the necks of the bottle packs out of the cardboard box 6 Install the level sensors and spacers according the following pictures Make sure to place the appropriate level sensors in the containers by matching the color codes on the tube and on the container Qr d orm Page 158 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics The sensors and the reagents have the following numbers
114. a 161 14 1 Power failure Mc 161 14 2 RS232 serial OU DUL eer emet pb pterea nn eee ue Ru ER 161 14 3 Specifications for ihe 5232 Polls edicere aii eaten 161 14 4 Folder Structure on ieieinin ccestetasscaseiacccsiseciaeneviassdeistesetneeeess 161 15 TROUBLE SHOOTING innt enar Ear Sono Egan En AER 163 AME C CHUA enin 163 15 2 PSS tell pUMpS ciue pue dein rtu ipei EE I 165 15 2 1 Rinse solution not primed through the 165 15 2 2 Rinse solution spilling over the 165 15 2 3 Rinse pump failure 166 15 2 4 Sample probe is not washed after 166 15 2 5 Saline dripping in the sample tube 166 15 2 6 Saline ioxic i prr c m 167 15 2 7 Pipettes not dry after washing and 167 15 3 Liquid level sensor not SOMSING pEMURIMEREMEAPKEREMURIM RE E UApM RU DS EA DES 167 15 4 Flushing liquids Meets 168 168 1542 Disinfectant
115. acuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator StaRRsed Flex User Manual Page 329 Version 1 02 MRN 151 EN Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover 3 Exchange Rinse and Saline tube assembly New rinse pump tube assembly New saline pump tube assembly ESRIO90902 ESRI090903 t EI ia New tube replacement 1 Open left cover Pull pump tube slightly downwards and at th
116. aintenance on page 150 or at least the End of day wash procedure This will help to keep the instrument clean and almost free of bacterial growth for a period of days WARNING Always be aware of the dangers of infection especially during maintenance Take the appropriate precautions Note The StaRRsed Flex may remain switched ON continuously However the customer should consider environmental issues such as energy consumption when the instrument is not to be used for some time It is also recommended to completely restart the instrument and if applicable Windows once in a while to clear the memory and ensure a stable operating system 9 4 1 End of day wash procedure Select the tab MAINTENANCE and press the button End of day wash A pop up screen is shown Selecting Close program will stop the program immediately without running the End of day wash o eS wash procedure is selected a selection screen for this function is shown The following options are available for this function 1 Select from the list the desired option e No End of day wash The function is not active e Immediately The function runs immediately after pressing OK e Only once The function runs only once at the selected time e Weekdays The function runs only on the working days Mo Fr at the selected time e Daily The function runs on a daily base at the selected time 2 Select the time of the day in hours and minutes for the selected option Pressing
117. ame format The Compact automatics apply the conversion table to the 60 minute method If temperature correction is switched on the ESR value will be the temperature corrected ESR value Page 238 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix Protocol MECHATRONICS 01 bidirectional MECHATRONICS 901 request workorder record Appendix for StaRRsed Flex STX Data 125 characters Position Data field of Bytes Format Comment 1 Start of text 1 STX 2 Text distinction code 8 ESRSR Left aligned followed by spaces 10 Instrument ID 20 text If applicable 30 Sample ID 40 text 70 Reserved spaces 55 text 125 Request workorder 1 text Request Y ESR yes ESR no 126 Space 1 text 127 Checksum 1 CS See section Checksum calculation 128 End of text 1 ETX Total 128 Text left aligned followed by spaces number digits 0 9 with leading spaces Non specified positions are filled with spaces StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 239 Appendix for StaRRsed Flex Request record from analyzer to LIMS Request capital R on position 125 STX Data space CS ETX Workorder record from LIMS to analyzer ESR Yes capital Y on position 125 STX Data Y space CS ETX ESR No capital on position 125 STX Data space CS ETX
118. and color codes Connector Reagent number Color code RINSE SOLUTION Number 34 Green SALINE Number 35 Yellow DILUENT Number 36 Grey DE IONIZED WATER Number 37 Blue DISINFECTANT Number 38 White Maintenance NOTE Wrongly placed pickup tubes may cause incorrect results or instrument malfunction 7 Slide drawer back and close cabinet 8 Enter new reagent information see Reagents screen on page 66 After each reagents change the fluid system must be primed 1 Select MAINTENANCE gt PRIME CLEAN page 70 2 Perform the applicable prime step to fill the relevant tubes with reagent and remove air StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 159 Rm mechatronics Data safety management 14 DATA SAFETY MANAGEMENT The StaRRsed Flex has its own external PC This means that all collected data is stored on the hard disk of the external computer This means that all raw data and results are kept irrespective of a power failure or if the instrument is un intentionally turned off After the start up procedure the software checks whether there are any ESR s still outstanding If so these will be carried out first After a power failure the sedimentation time 60 or 30 min may be exceeded However the start time is saved and therefore the actual sedimentation time can be checked Important system settings are kept in an internal Flash Eprom inside the instrument In ca
119. anual Version 1 02 MRN 151 EN R mechatronics Getting started 7 3 6 Cleaning solution The cleaning agent needs to be prepared for a cleaning procedure which is used in level 4 maintenance 1 Fill a container with hot 80 C de ionised water 2 Add cleaning agent QRR 010905 to the container 3 Stir well Do not shake StaRRsed Flex User Manual Page 121 Version 1 02 MRN 151 EN R mechatronics Getting started 7 3 7 Waste disposal The waste container is located within the cabinet in a separate compartment to prevent contamination of the reagent containers The waste container has a level sensor and as soon as the level sensor generates a waste error the container must be emptied and replaced with a cleaned one Disclaimer Check your local environment rules about discharging the waste StaRRsed Flex User Manual Page 123 Version 1 02 MRN 151 EN mechatronics Reporting 8 REPORTING The StaRRsed Flex is able to handle different types of protocols The selection is made in SERVICE SERIAL OUTPUT SETTING 8 1 Protocols A protocol is a set of rules governing the communication and the transfer of data between machines as in a computer system It is also a formal set of rules and procedures to be followed during a request for information before data is transferred between machines and computer systems The following protocols can be selected for data transfer to the Laboratory data processo
120. azy lt 10 mm dynamicaly determined 39 9 out off measure arca Bato column sodimentation 110mm height Graphic showing typical absorption values of a sample Page 132 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Reporting The sedimentation value is the distance in millimeters between the cells plasma level 87 5 absorption and the meniscus If there is no haze the absorption drops quickly to a value below the 75 level If the distance between the 87 5 and the 75 level is less then 3mm the report will state CLEAR If the distance between 87 5 and 75 level is more than 3mm then the report will state HAZY Depending on the length of the hazy area three classes of haziness are reported Length of Reported area class Hazy area area Hazy area gt 25mm 25mm Hazy gt 25mm Hazy gt 25mm mm Hazy reports are shown when the change from the hazy level to the cell plasma separation level occurs not within a given distance The following code messages are reported in column 5 8 2 6 1 Analyser HAZY code messages This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear 1 Sample is Hazy lt 10 2 Sample is Hazy lt 25 3 Sample is Hazy gt 25 Results with hazy aspect can be suppressed in the menu Limit error settings StaRRsed Flex User Manual Page
121. cated problems Only available in English 3 Service Manual SM Intended for trained service engineers Describes maintenance servicing and repair of the instrument in detail Contains detailed descriptions of parts assembly drawings modifications extended trouble shooting flow diagrams etc Only available in English 4 Installation Manual IM Intended for trained service engineers Contains instructions and procedures for installation and start up Only available in English Manuals are available in PDF and HTML format and can be downloaded from http www rrmechatronics com Page 14 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Instrument description 2 INSTRUMENT DESCRIPTION The Inpeco FlexLine provides the StaRRsed Flex with samples All samples are mixed on the FlexLine before the tubes are put in aspiration position Each sample is identified by a barcode reader The Inpeco Laboratory Automating System LAS checks if an ESR is requested and if so blood is aspirated by the StaRRsed Flex Aspiration takes place via Mechatronics proprietary double needle mechanism If no ESR is requested the sample tubes are moved further The citrate dilution takes place in a 4 1 ratio and is achieved with 3 accuracy Eighty four Westergren pipettes are housed in the carousel Each is of precision bore glass After each cycle the pipette is cleaned automatically with low foam detergent followed by a drying cycl
122. ch the measurement can be corrected to a constant temperature 18 C Celsius Even small ab normalities can be detected over a longer period of time irrespective of where and when the blood sample was taken Every sedimentation measurement is directly linked to an identified sample so that a manual work sheet is unnecessary Patient ID s are provided by the Laboratory Information Systems The StaRRsed Flex is designed for integration in the Inpeco FlexLine In the EDTA mode the accuracy of dilution of EDTA blood with citrate is considerably better than manual dilution achieved either by tipping off or using evacuated blood collection tubes pre filled with citrate solution The data can be send to your Lab Information System The used sedimentation pipettes are automatically washed and dried Minimum sample volume is 1 4 ml Windows based System Software is running on an external computer StaRRsed Flex User Manual Page 11 Version 1 02 MRN 151 EN Rm mechatronics Introduction 1 1 PC Operation and User Interface The entire operation of the StaRRsed Flex is driven by a personal computer with Windows operating system The user interface is intuitive and can be activated via the keyboard or the optional touch screen All the data from each sample including the raw measuring data and a pictorial representation of the pipette is stored and may be retrieved later if needed The Main screen shows which pipettes are in use Th
123. cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required Page 350 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Air filter replacement ESRI QWLV0400003 1 2 3 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with disinfectant Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 70 and perform the PRIME DILUENT function Wipe outer surface and stainless steel plate below the pipettes with disinfectant Exchange air filter Pull both tube connectors out of the blue filter Place new blue filter Reconnect the tube connectors on the filter 9 Replace diluter syringe tip Replace diluter tip 1 2 3 N O RE Take the syringe from the diluter assembly Pull the plunger out of the syringe Cut the Teflon tip of the plunger with a sharp knife Be careful not to damage the meta
124. ct lab benches and any equipment Spills Small spills of biohazard material should be treated by first covering them with an absorbent paper to avoid the formation of aerosols Disinfect the spill by slowly pouring on a disinfecting solution working from the outside to the centre of the spill in a circular motion Leave the spill long enough for disinfection to take place check decontaminating instructions on the disinfectant container for time and then carefully wipe up wearing gloves Pick up any glass using forceps Once all the material has been removed disinfect the area thoroughly Inform the Technician in Charge of the spill Food No food or beverages will be brought into or consumed inside a blood laboratory at any time Accident reporting All accidents and injuries must be reported within 24 hours to the technician in Charge to the Departmental Joint Health and Safety Committee and to the Department of Environmental Health and Safety using an Incident Report from the main office or the Technician in Charge Laboratory access Access to the haematology laboratory is limited to persons who are directly involved with the testing equipment Children are not permitted in the laboratory Personal protective equipment Laboratory and maintenance personnel are expected to use a laboratory coat while working in the blood laboratory We advice the use of non canvas closed toe shoes wherever there is a potential for foot injury from
125. ctable 1200 4800 and 9600 Data bits Selectable 7 or 8 data bits Party bit Selectable none space mark even and odd Stop bits Selectable 1 1 5 or 2 stop bits Flow control Selectable for e None e XON XOFF e RTS CTS e DTR DSR oo e ct 106 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program e XON XOFF amp RTS CTS e XON XOFF amp DTR DSR When the selection button is pressed the virtual keyboard pops up Type the correct numbers into the numerical fields for instance in the baud rate field 9600 UsE TCP IP Select IP Adress and TCP Port 6 7 2 2 Set protocol settings The following protocols can be selected for out putting data No Serial output MECHATRONICS 01 Bidirectional MECHATRONICS 02 Unidirectional SE 9000 SE 9000 Unidirectional R3500 R3500 unidirectional Compact unidirectional When selected the following keys will pop up e Checksum On Off e 30 Minute method On Off e Ack Nack On Off 9 Compact Bidirectional When selected the following keys will pop up e Checksum On Off e 30 Minute method On Off 10 StaRRsed v14 When selected the following keys will pop up e Checksum On Off e 30 Minute method On Off e Ack Nack On Off 11 Vesmatic 12 Sedimatic 15 13 Sedimatic 100 14 OPUS When selected the following keys will pop up e Checksum On Off e 30 Minute method On Off 15 Advia 120 16 Advia
126. d goes to the next sample The Host computer needs to be ready for the request string of the next sample e If the StaRRsed Flex does not receive the conformation string within 10 seconds it will send the request string again After 3 attempts it won t do an ESR on this sample and goes to the next sample e If the StaRRsed Flex receives a it will send the request string again After 3 attempts it will stop communication and generate an error e If the StaRRsed Flex does not get any response timeout 10 sec it will send the request string again After 3 attempts it will stop communication and generate an error Request string example Sample ID 123456789 Request string ESRSR 123456789 R 31 bytes Sample result e Checksum ON OFF user defined e 30 minute output ON OFF user defined The sample result will be output according to the standard Compact StaRRsed ESR string See String format for StaRRsed If the host computer receives the result string it should reply by sending an ACK or a NACK e If the StaRRsed Flex receives ACK it will start sending the next result e f the StaRRsed Flex receives a NACK it will send the result string again After 3 attempts it will start sending the next result e If the StaRRsed Flex does not get any response from the host timeout 10 sec it will send the result string again After 3 attempts it will stop communication and generate an error StaRRsed Flex Use
127. d bottom clamp For cleaning use a cotton bud dipped in deionised water or aerosol air blower make sure the cotton bud is just damp Do not use any organic solvents Pipette removal Ti B 3 Push and pull vertically the pipette from the holding position of the belts Take pipette off the carousel Store the pipette on a safe place Switch Compact ON 2 3 4 Carefully clean the inner part of the measuring sensor by using a cotton bud Check the values of the Measure sensor MS 40 50 60 by using the CHECK MEASURE SENSOR function If not in range repeat cleaning the inner part of the measuring sensor When in range switch OFF the Compact StaRRsed Flex User Manual Page 291 Version 1 02 MRN 151 EN Pipette installation 1 Hook pipette assembly on to the pipette belts 2 Make sure that pipettes are correctly fitted on to the pipette belts 3 Visually check if all pipette valves are at the same height 4 Visually check the bottom of the pipette V shape ring 5 Incorrect fitted pipettes may cause mechanical damage to the instrument 6 Check for leakage with Fill amp Clean Replace the top cover 1 Put the cover carefully over the instrument 2 Fasten the two rear screws of the top cover If present if needed Switch ON the StaRRsed Flex Page 292 X T H au m mn Lug X Li StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics W
128. day wash procedure when Fill amp Clean is used End of day wash is not required StaRRsed Flex User Manual Page 341 Version 1 02 MRN 151 EN Air filter replacement ESRI QWLV0400003 1 2 3 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with disinfectant Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 70 and perform the PRIME DILUENT function Wipe outer surface and stainless steel plate below the pipettes with disinfectant Exchange air filter Pull both tube connectors out of the blue filter Place new blue filter Reconnect the tube connectors on the filter Finishing Maintenance 1 2 3 4 Check diluter drip tray empty if necessary Recover any outstanding errors on the Flexlab GIU Put the StaRRsed Flex back online Page 342 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 218 Page 1 of 9 Purpose Maintenance level 2 Safety Bio Ha
129. dix for StaRRsed Flex e L err means limit error e hhhis the 30 minutes ESR e www is the 60 minute ESR e ttt is the temperature corrected 60 minute ESR e ccc is the column height ddd is the 120 minute ESR if applicable Example of a limit error message without 30 minute ESR and 120 minute ESR L_err 123 89 200 Page 244 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Protocol MECHATRONICS 02 unidirectional 2 254 255 Data 253 characters Position Data field of Bytes Format Comment 1 Start of text 1 STX 2 Text distinction code 8 ESRRE Left aligned followed by spaces 10 Instrument ID 20 text If applicable 30 Sample ID 40 text 70 Reserved spaces 15 text 85 Aspiration date 10 ddmmyyyy Text format E g 01012010 January 1 2010 95 Aspiration time 5 hhmm Text format E g 0001 0 01 24 hour clock 100 E S R 30 minutes mm h 5 XXXXX 105 E S R in mm 60 minute mm h 5 XXXXX 110 E S R 60 minutes temperature corrected mm h 5 XXXXX 115 E S R 120 minutes mm h 5 XXXXX If applicable 120 Reserved spaces 10 text 130 Sample code 5 XXXXX See section Sample codes 135 Aspect code 5 XXXXX See section Aspect codes 140 Manually added code 5 XXXXX StaRRsed Flex User Manal TTT Page 245 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex mechatronics
130. dle complete with sample probe together out the needle assembly 4 Mark each tube for easier reconnecting to the correct nipple 5 Disconnect the tubes from the outer needle Needle exchange Install new sample probe ESRIO50909 together with a new outer needle VERA059009 Slide the new sample probe into the new outer needle Make sure the Sample probe has a new O ring QWLV050003 Install new sample probe ESRIO50909 together with the new outer needle Put the sample probe in the outer needle Replace the needles onto the needle assembly m du Re D ct StaRRsed Flex User Manual Page 353 Version 1 02 MRN 151 EN 7 Tighten the sample probe Do not over tighten the sample probe in the Y piece or it will crack or strip the threading inside the block 8 Replace the correct tubes on the outer needle 9 Fasten the outer needle bolt Do not over tighten the screw 10 Lower cover from the needle unit Page 354 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Work instruction Number 199 Page 1 of 1 Purpose Maintenance level 1 Safety Bio Hazard area Instrument Compact Revision 001 January 2013 We recommend that this procedure is carried out by dealers service engineers The following items need to be replaced annually All tubing ESRIO79200 and additional tube set Waste pump motor ESRI090920 Waste pum
131. e The fill line is back flushed using saline solution The temperature is corrected to the standard value of 18 and ESR s may be read after one hour or 30 minutes A foretell one hour result is presented in the 30 minute mode The StaRRsed Flex can be interfaced bidirectionally with Laboratory Information Management Systems LIMS through a variety of interface protocols Results of the test are expressed in millimeters This data together with the patient ID number is sent to the Laboratory Information System along with the sedimentation time used 60 or 30 minutes the temperature and the dilution ratio StaRRsed Flex User Manual Page 15 Version 1 02 MRN 151 EN mechatronics Instrument description The StaRRsed Flex analyzer consists of the following units StaRRsed Compact analyzer e ESR measuring instrument with a belt holding 84 precision s bore glass Westergren pipettes e Automated aspiration of the sample tube e Automated dilution of EDTA blood sample with citrate e Automated measurement of ESR after 30 or 60 minutes e Automated cleaning and drying of pipettes FlexLine Units e Diluter needle module with pneumatic operated cover Cabinet e Cabinet for reagent containers spare reagent storage and waste container e Status indicator PC with touch screen LCD monitor e Windows based platform e Dedicated instrument software e Optional network connections e USB port This model uses large bulk co
132. e StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU OVERVIEW StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on FlexLab36 Overview FSE 10 54 16 gt Samples Tests Exceptions InpuvOutput StaRRsed Centrifuge 1 Cenfiguration Centrifuge 2 Centrifuge 13 C Architect i2000sr 1 Architect 2000 2 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module IM will go to Offline eFlexLab36 SteRRsed Status preme Me Eror Select an Option Node 10 Status 3 moon for Empty Carrlers Room for Routine Sample Room for STAT Samples o Expected 491 Incomplete 26 Complets 60 StaRRsed Flex User Manual Page 334 Version 1 02 MRN 151 EN 1 Clean Fill nozzle and exchange O ring Fill Nozzle Disassemble the fill nozzle Disassemble fill nozzle holder 1 Turn the holder to the right 1 Turn the holder to the right 2 The fill nozzle can now be removed 2 The holder can now be removed 3 Disconnect the silicon tube from the fill nozzle The use of a toothbrush and detergent is recommended 1 Carefully scrub the fill nozzle inner part 2 Useatissue to dry the fill nozzle Replace O ring Remove the O ring QWLV050004 Install new O ring QWLV050004 StaRRsed Flex User Manual Page 335 Ver
133. e decimal numbers next to the pipettes are the numbers on the pipette belt When a pipette is filled successfully a red dot marks the filled pipette In case of a failure the pipette is marked with a flashing red dot All the sample information can be found in tab HISTORY 6 2 2 Measure station Measure station This is the position of the measure station where the ESR of the sample is measured StaRRsed Flex User Manual Page 35 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 2 3 Wash station Wash station Also named Rinse station This is the position where the sample is washed out of the pipette The pipette is clean and dry after this process 6 2 4 Fill station Fill station This is the position where the pipette is filled with a blood sample 6 2 5 Pipette Pipette This is a graphical representation of the pipette It is generated from the results of the ESR measurement It can be used to locate possible air bubbles 6 2 6 Sample mode button Sample mode button This is the button to start or stop the run mode of the instrument 6 2 7 Version information Version information Shows the version information of the software 6 2 8 Sample information Sample information After measurement the results of the sample are shown in this window This window is refreshed after every new result of a sample 6 2 9 Status Status Information about the current status of the instrumen
134. e for bacterial growth The solution should be discarded if it becomes turbid or infected 15 17 1 Reagents alarm The software checks the level status of the reagents before starting a new aspiration If a level alarm is ON it will not process a new sample If an alarm comes ON during sampling it will finish the aspiration Washing dirty pipettes always continues as to avoid that the samples are left in the pipettes The Status Indicator gives a red signal Reagents alarm is also set when the expire date of the reagent is exceeded or opened more than three months The message Not allowed now See REAGENTS appears Processing of new samples is stopped StaRRsed Flex User Manual Page 189 Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 18 Fill nozzle Normally the fill sequence takes about 3 seconds However if the fill sequence exceeds 10 seconds a fill time out error will be generated The Compact aborts the fill sequence and this error message will be shown on the display and reported to the printer Check for mechanical obstructions and remove them If the error returns call for service 15 18 1 Fill nozzle does not engage with pipette 1 Motor time out generated fill nozzle stops half way up 2 Check for mechanical obstruction 3 Motor failure Fatal error call distributor 15 18 2 Fill nozzle not at fill position E8 is the error code and in the status line the text Fill nozzle not in the fill position
135. e is at the wash station 4 Wash station or tubing from wash station may be blocked e Activate the PRIME DISINFECTANT function The disinfectant must flow through the system 15 2 3 Rinse pump failure 1 Liquid flows back into the rinse container e Replace the rinse pump tube 2 At the start of the rinse sequence the first pipette is not washed e Replace the rinse pump tube WI 162 rinse tube replacement on page 286 15 2 4 Sample probe is not washed after aspiration 1 Check saline level in saline container e If the level is insufficient usually a message will be on the display and the alarm sounds 2 Check pick up tube in saline container e It may have become detached from the tube connector e Loosen the cap of the saline container in order to inspect 3 Check the saline peristaltic pump tube condition e may be worn or leak See Level 4 maintenance e An incorrectly fitted saline peristaltic pump tube may cause the same problem e One of the tubes carrying saline maybe blocked or bended 15 2 5 Saline dripping in the sample tube adapter If Saline drips from the needle assembly check the following 1 Does the vacuum pump work Page 166 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting e Check the vacuum pressure by using the option CHECK FLOW SENSOR Sample probe may be blocked Fill nozzle may be blocked Waste line may be blocked Outer needle may be blocked
136. e on the pipette or fill nozzle Check if outer needle is clogged up with rubber Sample probe maybe bend Sample probe motor is faulty Sample probe motor driver on needle board is faulty Sample probe is blocked Check diluent flow sensor Check tubes diluter system Fill nozzle motor is faulty Fill nozzle motor driver on nozzle board is faulty Fill nozzle is blocked Check home top sensor Outer needle motor is faulty Outer needle motor driver on needle board is faulty Outer needle is blocked Page 219 mechatronics Appendix for StaRRsed Flex E18 Carousel position error Value of potentiometer does Check if the rinse position Check Rinse position not match the value stored in is right memory of the current rinse position Set correct rinse position and do a Learn carousel positions Check mechanical connection potentiometers E19 Drive motor timeout Drive motor did not move or Check the home sensor motor is blocked Motor is faulty Motor driver on drive board is faulty E20 Outer needle motor Outer needle could not go Check piercing position position error piercing error down all the way Piercing sensor position sensor was triggered E21 No USB IO device USB IO Device enabled but Check power to USB IO detected Check USB IO not detected Device Device settings Check USB cable USB IO Device driver not installed Check USB IO Device settings E22 Waste
137. e prp e ULM UU B PUR MR NIMM 91 6 6 2 3 Flow test absolute iiis o rat intu rtu let 92 6 6 2 4 Flow Test IGakdga uiei ein Cuisecit etii SE 93 6 6 2 5 Flow test Fill sensor air essesseesseeeesennnmnrennn 94 6 6 2 6 Flow test Fill sensor glass Ibo tert ber Ebo te iler EUH ptr boi 95 6 6 2 7 EID 96 6 6 2 8 Set new rinse 97 6 6 3 ee ee f EIE 98 6 6 3 1 Dilution adjustment 60 till 1409 98 6 6 3 2 Dilution error detection 0 till 259 99 6 6 3 3 Auto TE 99 6 6 3 4 Diluent flow check eR 100 6 6 4 Limit error A E S 100 6 6 5 QC SS 102 6 7 SECES OON eerie ad cnc ad ra urs ix EK MT REM I E EM NT 104 6 7 1 Py Sel Notes cette eo eee 105 6 7 2 LIMS 106 6 7 2 1 Set LIMS communication settings 106 6 7 2 2 Set protocol settings eem 107 6 7 3 Compact settings M T E 108 6 7
138. e same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex m 330 SiaRRsed Flex User Manual Version 1 02 MRN 151 EN 4 Fill and clean Cleaning agent preparation StaRRsed Flex Fill and clean 1 Fill the adapter FLEX110901 with hot de ionized water 150 ml 2 Add 15 ml cleaning agent QRR 010905 to the hot de ionized water in the adapter 3 Place the cap on the adapter and mix well StaRRsed Flex User Manual Page 331 Version 1 02 MRN 151 EN Start Fill and clean procedure 1 Select MAINTENANCE PRIME CLEAN 2 Select Fill amp Clean to start the process Pipette data will be lost Use Fill amp Clean adapter ON 3 Select button OK 4 The needle goes down and the fill and clean process is started it will take around 90 minutes 5 When all the pipettes are filled the needle goes back to the home position Note Each pipette on the pipette belt will be filled with cleaning agent after one hour the first pipette is washed and dried Fill and clean takes about 1 1 2
139. e section in the middle of the layout gives the sample number and status for each pipette including time to go before the result is due A pictorial representation of the pipette at the measuring position and a graph of the optical density over the length of the entire pipette is shown on the side This data is retained in memory for subsequent retrieval if required The status indicator next to the StaRRsed Flex shows a green run sample orange service or red error signal for indication on distance C Sample Maintenance Settings m Service li ti History a Reagents NUES d Compact FlexLab Error code No celis plasma found Page 12 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Introduction 1 2 Dilution principle The principle of adding Diluent to a flow of whole blood is unique The StaRRsed Flex has the capability of monitoring the air displacement during the aspiration cycle This is called on line dilution The CPU receives data from the airflow sensor and calculates the syringe speed Diluter accuracy is 3 1 3 Sedimentation measurement principle The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these
140. ear with the sensor connectors in the holes 11 Release the stainless steel vacuum tube 12 Replace the waste container 13 Close left cover Page 340 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Exchange Waste Cassette and blotting washer 1 Disconnect the two tubes from the waste pump cassette 2 Press levers at three o clock and nine o clock positions and pull at the same time 3 Clean peristaltic pump motor shaft using a tissue soaked in alcohol 4 Remove the old blotting washer ESRI090026 around the motor shaft 5 Place the new blotting washer ESRIO90026 6 Insert new waste pump cassette ESRIO90921 until it clicks into place 7 Remove the protection caps on from the tubes 8 Connect the two tubes to new waste pump cassette 7 Exchange Pinch valve tube Replace the pinch valve tube ESRIO10246 1 Open the left cover 2 Pull the tube out the pinch valve 3 Disconnect the silicon tube from the bottom connector and the top connector 4 Remove the tube 5 Connect the silicon tube to the bottom connector and the top connector 6 Push the tube in the pinch valve 7 Close the left cover 8 Final preparation Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 596 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of
141. eck barcode QC sample is not accepted and StaRRsed Control ID is not e Check barcode not performed known in LIMS QC result is not visible in QC A specific QC result cannot be Check Lab ID link History found in the list of results Deviating results Extra information Systematic QC errors with shift in control values QC results are out of range Systematic QC errors with a trend in control values QC results out of the range or nearly out of the range Note on QC Errors The measured control values change abruptly up or downwards Do not compare 30 minute method with 60 minute method result The calculation method can give some deviation in the general QC results statistics The measured control values change gradually upwards or downwards Check clean instrument and perform a new QC sample If these errors persist perform maintenance step Compare only results from one batch If Lab ID is used check the linked StaRRsed Control ID Itis possible that a new batch is in use without changing to the new assayed mean value Irregular or insufficient maintenance can cause unnecessary QC errors and ESR errors warnings Error messages are only shown and stored in QC results and not send to LIMS QC result is given with the same general errors and warnings as a normal patient ESR result Page 196 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Appendix f
142. econds However if the fill sequence exceeds 5 seconds a fill time out error will be generated The Compact aborts the fill sequence and this error message will be shown on the display and reported to the HOST Fill time out error may be caused by Blood clots or rubber debris from the tube cap in the sample e Check the condition of the outer needle Filling procedure stopped by operator Insufficient sample volume e Should be at least 1 4 ml 4 Faulty filling nozzle or filling nozzle washer O ring e Check filling nozzle and washer O ring Incorrectly adjusted sample probe depth e Check needle depth SETTINGS GENERAL SETTINGS SAMPLE PROBE DEPTH default 5 mm 6 Noor poor vacuum e Check vacuum MAINTENANCE CHECK SENSORS CHECK FLOW SENSOR o To e StaRRsed Flex User Manual Page 185 Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 15 Position error E18 is the error code for Carousel position error StaRRsed Flex was not able to position the carousel There was a difference found in the pipette memory position table and the actual measured position of the position sensor A position error can occur if the StaRRsed Flex is switched OFF while the carousel is moving to the next position When the Rinse nozzle sticks up this can also cause a position jump Warning It is highly recommended to wash all samples after a position error Position error solutions 1 Check in tab SETTIN
143. ed Flex User Manual Page 73 Version 1 02 MRN 151 EN mechatronics Compact FLEX program When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All functions to check the status of the sensors are grouped under button CHECK SENSORS on page 73 e Check Fill stop sensor Click the Check button The green light is shown if the sensor value is in range e Check temperature sensor Value must be equal to the actual room temperature near the pipette belt The value can be set in tab SETTINGS e Check Diluter start sensor This sensor is only used in EDTA mode If the diluter does not start during the aspiration the status of this sensor must be checked Click the Check button The green light is shown if the sensor value is in range e Check Diluent flow sensor This sensor is only used in EDTA mode When activated the LED Down is green and the LED Up is red When the button Test is clicked the LED Up must become green After finishing the test both LED s must be green e Check Separator sensor Click the Check button The green light is shown if the sensor value is in range e Check Flow sensor Click the Check button The green light is shown if the sensor value is in range e Check Measure sensor Click the Check button The green light is shown if the sensor value is in range Press the button MEASURE The pipette currently at the measure position will be measured The results are displayed in grap
144. ed Flex back online Page 318 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 221 Page 1 of 2 Purpose Daily maintenance Safety Bio Hazard area Instrument StaRRsed Flex Revision 001 September 2013 Perform maintenance when the StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU Overview StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on eFlexLab36 ATA Overview FSE 10 54 16 gt T T Samples Tests Exceptions Input Output StaRRsed Centrifuge 1 Configuration Cantrifuge 2 Centrifuge 3 C Architect i2000sr 1 Architect 2000 2 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module IM will go to Offline Select an Option Status 9 Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required 2 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks StaRRsed Flex User Manual Page 319 Version 1 02 MRN 151 EN oo
145. en left cover Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex m o N O amp Page 154 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm 7 mechatronics Maintenance If the tube is not fitted correctly or is worn the following symptoms can occur e Liquid flowing back into the container e Sample needle is not washed sufficiently Note The narrower bore tube is for the saline pump 13 3 3 Replace bacterial filters Detailed instructions of this procedure can be found in WI 196 Cleaning liquid separator on page 304 As part of the Cleaning liquid separator procedure the bacterial Hepa filter QWLV040002 is replaced with a new one Exchange bacterial filter QWLV040001 on the waste bottle assembly 13 3 4 Fill nozzle O ring replacement As the fill nozzle O ring QWLV050004 ages it looses its flexibility and air bubbles may occur in the Westergren pipettes the washer needs to be replaced Symptoms for a bad fill nozzle O ring After the aspiration the Westergre
146. enfiguration Centrifuge 2 Centrifuge 13 C Architect i2000sr 1 Architect 2000 2 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module IM will go to Offline eFlexLab36 SteRRsed Status preme Me Eror Select an Option Node 10 Status 3 moon for Empty Carrlers Room for Routine Sample Room for STAT Samples o Expected 491 Incomplete 26 Complets 60 StaRRsed Flex User Manual Page 321 Version 1 02 MRN 151 EN Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Clean Fill nozzle Disassemble the fill nozzle Assemble fill nozzle Turn the holder to the right 1 Connect the silicon tube to The fill nozzle can now be the fill nozzle removed 2 Putthe fill nozzle into the Disconnect the silicon tube holder from the fill nozzle 3 Push the fill nozzle upwards and turn the holder to the The use of a toothbrush and left detergent is recommended 1 2 Carefully scrub the fill nozzle inner part Use a tissue to dry the fill nozzle 2 Clean Liquid separator Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid
147. er before you continue using the instrument Example e A collision with a moving object or a person e Something falling on the instrument Liquids spilling into the instrument StaRRsed Flex User Manual Page 21 Version 1 02 MRN 151 EN R mechatronics Installation 4 INSTALLATION The instrument must be unpacked installed and checked by a trained engineer prior to first operation Detailed installation instructions are given in the StaRRsed Flex Installation manual StaRRsed Flex User Manual Page 23 Version 1 02 MRN 151 EN mechatronics Standard Operating Procedures S O P 5 STANDARD OPERATING PROCEDURES S O P In this section the following issues can be found Basics of Bio safety S O P for working with bio hazardous materials Safety warning StaRRsed Incident Report E C Declaration Labels and stickers on containers 5 1 Basics of Bio safety Basic rules on bio safety in a laboratory Wash hands after handling biological materials removing gloves or before leaving work area Don t eat drink etc in the work area Never mouth pipette Take extreme precautions when sharps must be used Dispose sharps carefully and properly Conduct procedures likely to create splashes sprays or aerosols within a biological safety cabinet that is certified annually Decontaminate work surfaces at least daily Decontaminate waste materials before disposal Wear a BUTTONED lab coat to protect street c
148. er needle Put the sample probe in the outer needle Replace the needles onto the needle assembly Tighten the sample probe Do not over tighten the sample probe in the Y piece or it will crack or strip the threading inside the block NO gi o mr StaRRsed Flex User Manual Page 151 Version 1 02 MRN 151 EN mechatronics Maintenance 8 Replace the correct tubes on the outer needle 9 Fasten the outer needle bolt Do not over tighten the screw 10 Lower cover from the needle unit 13 2 Weekly The purpose of the weekly maintenance is to carry out the daily maintenance and additionally check the optical sensor of the measure head and the vacuum pressure Detailed instructions of this procedure can be found in the Work Instruction Weekly maintenance on page 321 13 2 1 Check the sensors in service mode Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR b
149. er settings as recommended set by default Pt eae oe The tab Settings is protected by the password Select the tab Settings type the password 3964 and press the ENTER key 7 1 Limit filter settings Check the LIMIT FILTER SETTINGS If it is certain that the LIMS has been programmed to handle all these exceptions correctly these options may be set to YES In all other situations the options should be set to NO to avoid that results associated with exceeded limits are transmitted to LIMS and or printed 7 2 Liquid levels The StaRRsed Flex has liquid level sensors When the level sensor alarm appears replace reagent as soon as possible 7 3 Reagents preparation Use the genuine Mechatronics bulk reagent containers with level sensors Each container has a specific position see Reagent location label Disinfectant_ 7 1 Reagents preparation e Use only the reagent containers which are supplied with the StaRRsed Flex StaRRsed Flex User Manual Page 117 Version 1 02 MRN 151 EN R mechatronics Getting started e To open the bulk reagent packages remove the perforated flap from the cardboard box pull the opening out of the box and fit the taps 2 Remove the container screw caps and pull the necks of the bottle packs out of the cardboard box 3 Install the level sensors and spacers according the following pictures Make sure to place the appropriate level sensors in the containers by matc
150. eristaltic waste pump cassette ESRI 090921 including the Blotting washer ESRIO90920 Be careful as there may be blood in the cassette First make up some disinfectant and put this in the liquid separator Press PRIME DISINFECTANT to pump disinfectant through the pump cassette Symptoms for a bad or faulty waste pump cassette e Waste separator error Page 156 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Maintenance e Taking too long before the separator empties Detailed instructions of this procedure can be found in the Work Instruction Level 3 maintenance 13 5 Level 2 maintenance Level 2 maintenance is level 3 maintenance and add the following extra s Replace the Teflon tip on the syringe of the diluter assembly From repair set QWLV030902 See Work Instruction WI 181 Dis and re assembly diluter syringe on page 308 Detailed instructions of this procedure can be found in the Work Instruction number WI 198 Level 2 maintenance 13 6 Level 1 maintenance Annual maintenance Level 1 maintenance is Level 2 Maintenance and the following extras We recommend that this procedure is carried out by dealers service engineers The following items need to be replaced annually All tubing ESRIO79200 and additional tube set Waste pump motor ESRI090920 Waste pump cassette ESRIO90921 Blue Vacuum filter disc Part no QWLV040003 Fill block washer Part no ESRI030906 Waste container filter disc Q
151. ers E30 till E37 are related to ACK NACK handshake communications between the StaRRsed Flex and the Host Computer e Check the communication cable between the StaRRsed Flex and Host computer e Check the serial port settings Baudrate etc e Check protocol settings e Check Host Computer settings The error numbers E110 till E112 are related to communication with the FlexLab system e Check communication cable between StaRRsed Flex and the FlexLab system e Check serial port settings In case of message Compact FlexLab not found there is no communication between PC and the Compact ESR unit Page 192 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Trouble shooting 15 21 Not reading the barcode In some cases the barcode is not accepted because the format of the code is not correct Check the settings of the external barcode reader or check the label on the sample tube StaRRsed Flex User Manual Page 193 Version 1 02 MRN 151 EN Trouble shooting 15 22 Quality control trouble shooting mechatronics Error messages Extra information as E115 QC expired not sampled E116 QC is out of acceptable range E117 Uncorrected QC result is out of acceptable range but corrected result is within range E118 Uncorrected QC result is within acceptable range but corrected result is out of range Page 194 The used StaRRsed Control is out of date no ESR result is given Result is out
152. es S O P Page 30 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Ro mechatronics 5 4 Labels and stickers on containers 5 4 1 Stickers of the reagents containers SIAR SED QRRO10931 DILUENT 1234567890 201301 r fis reen Dv Cors Tee Tempe orem fw Speo etl STAR SED QRRO10947 DISINFECTANT 5L 2013 01 inm ITA med r ua n Un Comme 11 AM teg ivo Cc sateen partes te osn penton StaRRsed Flex User Manual Version 1 02 MRN 151 EN QRR010934 RINSE SOLUTION 20L Rome onion So emat Sautan de de vado 1234567890 201301 nmn I 2 T 25110 Demiwater Aqua dest 5 DE IONIZED WATER 5L Eau desionis e Acqua deionizzata Agua desionizada gua desionizada Standard Operating Procedures S O P B BA Mechatiocca ver menm De Coram 12 1089 AN The E 1 3002929119 mechatronics 2 ss SSS QRRO010933 1234567890 LOLE ni 2015 01 31 mechatronics Compact FLEX program 6 COMPACT FLEX PROGRAM The StaRRsed Flex is controlled via an external computer on which runs the StaRRsed Flex software The software functions are grouped on
153. ex Appendix String format for StaRRsed V14 ESR string format for StaRRsed 60 minutes format stx PPPPPPPPPP www WWW AAAAAAAAmm ppp TTT CC EEEEEEEEEEEEEEEEEEEEEE MMMMMMMMMM cr 1f eot stx 80 data characters cr lf eot Checksum OFF 60 min 80 data characters etx cs eot Checksum ON 60 min Postion Deb E S R 60 min corrected for temp EN ERE st se Mme mm sw ss Poeren ERI INN EN EM CS 1 byte checksum 256 modulo 256 ASCII string sum ASCII string sum the ASCII sum of all preceding characters incl stx cr If and ext modulo 256 ASCII string sum the remainder of the ASCII string sum when divided by 256 StaRRsed Flex User Manual Page 229 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex ESR string format for StaRRsed 30 minutes format stx PPPPPPPPPP hhh www WWW AAAAAAAAAmm ppp CC EEEEEEEEEEEEEEEEEEEEEE MMMMMMMMMM cr 1f eot stx 80 data characters cr lf eot Checksum OFF 30 min stx 80 data characters cr lf etx cs eot Checksum ON 30 min Data consists if 30 min output is switched to ON 10 Patient identification text PPPPPPPPPP E S R in mm Half hour method xw m CS E S R in mm calculated to 60 X WWW minutes E S R in mm 60 min corrected for x temp
154. ex User Manual Page 147 Version 1 02 MRN 151 EN mechatronics Compact system messages 12 2 Test messages During the start up sequence all the positing sensors are tested if incorrect the instrument will generate a Test message Switch printer on Test fill nozzle unit Test rinse unit Test measure unit Test needle unit Test drive unit ot ee AS 12 3 System time out lt gt If during normal operation the following system time out errors occur call distributor or local supplier of this instrument These errors are usually fatal and need engineer s assistance Drive unit Measure unit Rinse unit Fill nozzle unit Needle adapter Sample probe D gt 12 4 Error Messages The following error messages may occur during normal operation Vacuum error Vacuum stabilisation error Fill time out error Diluter error Position error Up sensor or down sensor error Rinse head up error Measure head not home error Separator full error uoc gt The explanation of all these messages be found in Appendix Error list FLEX Compact on page 217 Page 148 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Maintenance 13 MAINTENANCE The StaRRsed Flex is an analyzer that operates with considerable amounts of whole blood virtually undiluted and stores it in a pipette for one hour For this reason instrument maintenance is
155. flap 15 2 1 Rinse solution not primed through the system Heel 1 Check the rinse tube condition It may be worn or leaking or incorrectly fitted Check the pick up tube in the rinse container it may have become detached from the tube connector in the cap See WI 162 rinse tube replacement on page 286 2 Check rinse solution level in rinse solution container e If the level is insufficient a message is displayed and the alarm sounds 3 One ofthe tubes carrying the rinse solution may be blocked or kinked 15 22 Rinse solution spilling over the instrument If rinse solution spills over the top of the pipettes the following items must be checked 1 Is the vacuum pump working StaRRsed Flex User Manual Page 165 Version 1 02 MRN 151 EN mechatronics Trouble shooting Check the vacuum pressure Check the airflow go to MAINTENANCE tab CHECK SENSORS and select CHECK FLOW SENSOR Note In Sample mode the indicators are shown green the vacuum is ok In Service mode the indicators are showing numbers 1 When rinsing the rinse actuator must be energised e rinse actuator be found under the top cover at the top of pipette being rinsed 2 Wash station must engage with pipette e The Wash station is the white Rinse nozzle that engages the bottom of the pipettes 3 Check the piercing pin in the wash station it must be straight e The piercing pin is to pierce the bottom meniscus when a filled pipett
156. fline Select an Option Status Room for Empty Carriers M Room for Routine Sample Room for STAT Samples 13 1 Daily The purpose of the daily maintenance is to keep the instrument clean and contamination as low as possible Clean all parts that are exposed to blood wipe the outer surface and the stainless steel plate below the pipette belt See WI Daily maintenance on page 319 Page 150 SiaRRsed Flex User Manual Version 1 02 MRN 151 EN Ro mechatronics Maintenance 13 1 1 Check or replace sample probe or outer needle A faulty or broken needle can cause a fill time out error or a dilution error Inspect sample needle condition each day clean if necessary If necessary replace the sample probe or outer needle Turn button on panel to move the top cover from the needle unit 1 Unfasten the screw which prevent the outer needle to drop out of the assembly Undo the sample probe 3 Pull the outer needle complete with sample probe together out the needle assembly 4 Mark each tube for easier reconnecting to the correct nipple 5 Disconnect the tubes from the outer needle m Needle exchange Install new sample probe ESRIO50909 together with a new outer needle VERA059009 Slide the new sample probe into the new outer needle Make sure the Sample probe has a new O ring QWLV050003 Install new sample probe ESRIO50909 together with the new out
157. following QC result The results are presented in the layout of the DISPLAY SAMPLE HISTORY on page 42 screen Depending on the frequency of QC samples related patient results may span over multiple days and are listed per date All general ESR data and errors of QC samples are shown here StaRRsed Flex User Manual Page 55 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 3 4 8 Linked QC ID s 54 QC Statistics and Results Use this screen to link the StaRRsed Control sample ID with a Lab ID or to check which links are active 1 StaRRsed Control sample ID Enter the lot number or scan the barcode from the original StaRRsed Control tube label If the original label is already covered by the Lab ID label find the lot number and barcode on the package insert 2 Lab ID Enter the patient number or scan the barcode from the label that the lab is using to identify the sample 3 Click button Link ID s to add the linked ID s to the list The Date linked will be added automatically 4 Attach the Lab ID label on the StaRRsed Control sample tube so that the original barcode is completely covered to ensure that only the Lab ID barcode can be scanned by the StaRRsed Flex If the StaRRsed Control sample ID is not correct or the expiry date is exceeded a message will be shown and the ID s are not added to the list To remove a link that will no longer be used select the link in the table and cl
158. for StaRRsed Flex Appendix 30 minutes reporting Columns Patient number Not corrected 30 minute ESR result only in use if 30 minute mode is active Not corrected 60 minute ESR result 60 minute ESR result in millimeters corrected for 18 only in use if temperature correction is active Aspect clear hazy Manually entered code number Sedimentation pipette number number on the pipette belt Actual sedimentation time in minutes 9 Temperature in degrees Centigrade 10 Error message if the Analyser detects an error 11 EDTA mode gt 93 7 REPORT EXAMPLE Not to scale StaRRsed Date 20 05 14 Time 15 28 1 2 3 4 5 6 7 8 9 10 11 915001 42 84 75 CLEAR 17 30 23 EDTA This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear Sample is Hazy 10 1 2 Sample is Hazy 25 9 Sample is Hazy 25 Results with hazy aspect can be suppressed in the menu Limit error settings ESR ERROR and WARNING code messages This code appears in the sample data record at column 10 The following codes are defined Page 206 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex 0 No errors 1 No cells plasma found Error No contents could be detected in the pipette 2 ESR Probably gt 140 mm Error Extremely
159. he pipette and into the waste system 6 5 1 6 Prime all units When the StaRRsed Flex has been idle for more than eight hours some reagents may have dropped from the tubes due to gravity Prime all tubing before sampling with e PRIME ALL UNITS All priming functions are sequentially performed one time 6 5 1 7 Wash each pipette e Wash each pipette When the pipette belt turns one position the pipette at the rinse position will be rinsed and dried regardless if it was filled or not 6 5 1 8 Wash only sample pipettes e Wash only sample pipettes All pipettes which are currently holding samples are washed and dried ones A warning is shown on the display lt Pipette data will be lost gt NOTE Before executing this function check carefully if there are samples in the pipette belt that need to be measured Any remaining samples will be washed away and will NOT be measured 6 5 1 9 Wash all pipettes e Wash all pipettes All pipettes on the pipette belt are washed and dried ones A warning is shown on the display lt Pipette data will be lost gt NOTE Before executing this function check carefully if there are samples in the pipette belt that need to be measured Any remaining samples will be washed away and will NOT be measured StaRRsed Flex User Manual Page 71 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 5 1 10 Fill and Clean e Fill amp Clean This button starts the Fill amp C
160. he diluent suction tube in hot de ionized water 80 Use the PRIME DILUENT function After the prime sequence stops press PRIME DILUENT 5 times to fill the dispenser system with the hot water Step 3 Clean the diluent bottle s with the disinfectant Rinse the diluent bottle with hot de ionized water 80 Rinse the diluent bottle with diluent solution Refill the diluent bottle with new diluent solution Use the PRIME DILUENT function After the prime sequence stops press the PRIME DILUENT key 5 times to fill the dispenser system with the new diluent solution Step 4 1 2 3 Prepare a Fill and Clean arrangement Run the fill and clean sequence When all the pipettes are filled the needle goes back to the home position Remove the Fill and clean arrangement StaRRsed Flex User Manual Page 296 Version 1 02 MRN 151 EN RQ mechatronics Work instruction Number 179 Page 1 of 1 Purpose Replace blue air filter Safety Bio Hazard area Instrument Compact Revision Draft October 2001 Remove of the top cover 1 Switch StaRRsed Flex OFF 2 Remove the two rear screws of the top cover 3 Lift the top cover carefully from the instrument Air filter replacement ESRI QWLV0400003 1 Pull both tube connectors out of the blue filter 2 Place new blue filter 3 Reconnect the tube connectors on the filter Replace the top cover 1 Put the cover carefully ove
161. hical form Measure head start position correct Tra rra a qr rar nr ar Er rrr per rr ERE rr rrr prar prater 20 40 60 8 100 120 140 160 180 200 Measure head start position wrong ee cen ec ener ee ee nn 0 20 40 60 80 100 120 140 160 180 200 NOTE Clean sensors first before executing this function Page 74 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program NOTE When a test pipette is installed at the measuring position the result of the test pipette is displayed in the field ESR mm Note When the sensor is out of range and the light is red the sensor values on page 76 can be checked by turning on the service mode StaRRsed Flex User Manual Page 75 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 5 2 1 Check sensors in service mode Check Dister start sensor Sans ins Check Flow sensor i ator sensor a t Separator sensor E Wr When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All functions to check the status of the sensors are grouped under button CHECK SENSORS on page 73 Page 76 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 5 2 2 Fill stop sensor e Check Fill stop sensor Values must be within the following limits FS 90 140 165 NOTE Clean sensors first
162. high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 7 Limit error Error One of the following limits are out of the setting range e ESR Time e Column height e Dilution e Bubbles on top e Hazy aspect e Temperature StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 207 Appendix for StaRRsed Flex mechatronics Appendix Compact system messages The Compact generates four types of messages System messages Test messages System time out messages Error messages During normal operation the following System messages may occur Jm Waiting tube If a filled pipette is at the measuring position before the elapsed time has finished and the operator is ready to fill the next pipette the Waiting tube message will be displayed To continue the sample loading sequence the operator must wait until the pipette at the measuring position has been measured 2 Printer failure Check paper feed and quantity e Check printer cable connection e Printer must be on line e
163. hin a certain time limit after 3 attempts Did not receive ACK from Host after sending Sample result string 3 times not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check positions and save settings Timing settings in Eeprom does not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check timeouts and save settings See E30 See E30 See E30 Position settings in Eeprom do e Configuration file maybe corrupted Configuration file maybe corrupted StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics E56 Checksum error motor settings table E57 Checksum error current table E58 Checksum error time table E59 Checksum error position table E104 Needle unit not in up position E110 No response from FlexLab system E111 NACK received from FlexLab system after sending Status message StaRRsed Flex User Manual Version 1 02 MRN 151 EN Checksum error on motor settings stored in Eeprom Settings are loaded from file Check Motor settings and save settings Checksum error on current settings stored in Eeprom Settings are loaded from file Check Current settings and save settings Checksum error on timing settings stored in Eeprom Settings are loaded from file Check Timeout settings and save settings Checksum error on position settings stored in Eeprom Settings are loaded from file Check Po
164. hing the color codes on the tube and on the container StaRRsed Flex User Manual Page 118 Version 1 02 MRN 151 EN RR mechatronics Getting started The sensors and the reagents have the following numbers and color codes Connector Reagent number Color code RINSE SOLUTION Number 34 Green SALINE Number 35 Yellow DILUENT Number 36 Grey DE IONIZED WATER Number 37 Blue DISINFECTANT Number 38 White NOTE Wrongly placed pickup tubes may cause incorrect results or instrument malfunction Guide the level sensors through the clips on the level sensor box and tigthen the clips 7 3 1 Rinse solution QRR 010934 Rinse solution is used for rinsing the Westergren pipettes approximately 8 ml is used for each sample The Rinse container is a 20 liter container QRR 010934 Pre flush reagent bottle with de ionized water Fill rinse container with rinse solution from the 20 liter container StaRRsed Flex User Manual Page 119 Version 1 02 MRN 151 EN mechatronics Getting started 7 3 2 Saline QRR 010933 Saline is used for cleaning the needle and fill nozzle assembly approximately 1 ml of saline is used for each sample The saline container is a 5 liter container QRR 010933 Pre flush the saline bottle using saline from the saline container Fill saline bottle from the 5 liter container 7 3 3 Diluent QRR 010931 Sodium citrate is used for diluting the EDTA sample e Approxima
165. hlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Go to tab MAINTENANCE and perform the End of day wash procedure when Fill amp Clean is used End of day wash is not required 2 Check system for leakage e Inspect the peristaltic pump tubes and connections for leaks e Check that liquid does not run back into the supply bottles after the pumps have stopped 3 Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 70 and perform the PRIME DILUENT function Wipe outer surface and stainless steel plate below the pipettes with disinfectant Check diluter drip tray empty if necessary Recover any outstanding errors on the Flexlab GIU 0 Put the StaRRsed Flex back online oon StaRRsed Flex User Manual Page 333 Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 217 Page 1 of 9 Purpose Maintenance level 3 Safety Bio Hazard area Instrument StaRRsed Flex Revision 002 March 2014 Perform maintenance when th
166. hours to complete See also WI 178 Hazy problems on page 296 and WI 195 Cleaning the diluent system on page 303 Cleaning with chlorine 5 Sensor check Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fill stop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure sensor check Page 332 StaRRsed Flex User Manual Version 1 02 MRN 151 EN e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK MEASURE SENSOR box Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor lt 200 600 gt 700 6 Final preparation Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypoc
167. ick on REMOVE LINK Depending on the optional setting AUTOMATICALLY REMOVE LINKED QC ID AFTER RESULT SETTINGS QC SETTINGS ON PAGE 102 the links can be removed automatically when a usable ESR result has been reported for this particular Lab ID Page 56 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 3 4 9 QC Result analysis Authorized staff should identify and differentiate acceptable unacceptable random errors and trends and or shifts in systematic errors from the statistical data Depending on the users Quality Control Procedures analytical results could be accepted or rejected Changes in QC results can be gradual or abrupt Gradual changes can be caused by contamination and incidental environmental variations Abrupt changes can be caused by change of QC material batch or possible hardware errors If results are continuously out of range due to significant difference between calculated mean and control value but the statistics show precise results with small deviations it should be considered to expand the acceptable assay range with QC Settings on page 102 If results are incidentally out of range it is advised to perform a daily maintenance and or fill and clean step and then perform another QC sample step before releasing patient results If results are not send to the LIMS QC Results can be exported to MS Excel CSV files for further analysis in lab s own Quality Control data
168. ided In 60 minute method the carousel moves one position every 40 seconds approx In 30 minute method the carousel moves one position every 20 seconds approx Page 86 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program e FAST FILLING ON The carousel is filled with optimum sample speed The sample tubes in the rack are faster available for the user but the carousel shows more unused pipettes 8 VIRTUAL KEYBOARD e VIRTUAL KEYBOARD ON If keyboard input is required a virtual keyboard automatically pops up on the screen e VIRTUAL KEYBOARD OFF No pop up screen of virtual keyboard 9 PRINT AFTER MEASUREMENT e This will print the measured result on a single line directly to a dot matrix printer If this option is switched ON it is also possible to print a new header at the top of the results When other printers then dot matrix are used every result is printed on one new page 10 CHECK FOR DUPLICATE ID S e CHECK FOR DUPLICATE ID s ON It is not possible to run the same sample ID as long as this ID is in the pipette carousel data buffer e CHECK FOR DUPLICATE ID s OFF It is possible to run the same sample ID even when it is still stored in the carousel data buffer The following numerical inputs can be made 1 TEMPERATURE IN CELSIUS for the correct room temperature 2 ESRSEDIMENTATION TIME IN MINUTES for the correct time 30 or 60 minutes This time is reset to default when
169. ies Y Capital Y at position 28 of the string Sample refuse string definition replied by the host computer to skip the ESR test sm sp fels R s R isp i 2 3 s 6 7 9 10 11 12 1 14 15 16 17 spies N Capital N at position 28 of the string If either the host computer as well the StaRRsed Flex receives a string it should reply by sending an Acknowledge char 06 if the string is found Okay If either the host computer as well the StaRRsed Flex receives a string it should reply by sending a Non Acknowledge char 15 if the string is found faulty Sample request Checksum always ON After sending the request string the StaRRsed Flex expects a ACK NACK seeCompact bi directional protocol definition from the Host computer e If the StaRRsed Flex receives an ACK it will wait for the conformation string and respond with a ACK NACK according to the protocol definition e When the conformation string is received it will Respond with an ACK if the conformation string is OK and goes to the next sample 250 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex e When the string is not OK it is responding with an NACK and the Host computer must send the conformation string again After 3 attempts the Host computer must stop sending the conformation string and the StaRRsed Flex won t do an ESR on this sample an
170. ings Screen messages Extra information es QC icon is blinking at Sample The last QC sample was not Press on QC icon screen within acceptable range or has e Press Accept to no result continue sampling without performing a new QC continuing could produce incorrect results Press Cancel to return Try new QC sample tube normal samples will be finished QC result out of range e Perform a new QC sample normal samples will be finished e If this error persists check clean instrument QC sample expired e Use a new batch of Starrsed Control It is not possible to link this Lab The Linked QC ID s table may Consider changing ID Lab ID is already linked only contain one link to a AUTOMATICALLY REMOVE LINKED QC particular Lab ID ID AFTER RESULT option to YES Last QC result was out of Result of last QC sample was The last QC result should be range Continuing could not within acceptable range evaluated by authorized staff produce incorrect results Do to decide whether the you still want to continue StaRRsed Flex may run patient samples depending on the the nature of errors Press Yes to continue sampling without performing a new QC press No to return and take appropriate action StaRRsed Flex User Manual Page 195 Version 1 02 MRN 151 EN Trouble shooting mechatronics General errors Extra information TEE Barcode is not accepted Barcode cannot be read Data is incorrect Ch
171. is a user setting and can be changed in SETTINGS dilution error detection to 0 25 In this example the dilution error detection is set to 10 and limit errors set to YES By selecting Dilution gt 110 all the samples with a dilution rate gt 110 are displayed in the table By selecting Dilution lt 90 all the samples with a dilution rate lt 90 are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order 6 3 6 History analyse results high dilution Analyse results Dilution error Aspect Error Op mones lt io O Et No cellsfplasma found 5 O Wi colum height fo dation gt 110 fris Hazy s 9 O EZ ESR Probably 140mm 14 C War Measure error QE Too many borders Found C W3 Bubbles on top ESR 104 EZ mk error 3s 38588502 11 Dec 08 15 19 22 S2 EDTAL10 41721102 1t0ec0813 112 19 8 23 il EDTAMO 30575502 10 Dec 08 12 47 08 EDTAMO 42762702 10Dec0813 2458 54 EDTAMO 11 Bubbles on top ESR 43187202 10 Dec 08 13 08 02 2 1 jEDTAMO 09310002 09 Dec 08 12 10 37 EDTALIO 11 Bubbles on top ESR 09312402 09 Dec 08 14 22 29 2 i EDTAMO H Bubbies on top ESR 36309802 109 0 08 16 28 42 2 EDTAMO 36950302 09 Dec 08 12 08 52 T EDTALIO 37216902 09 Dec 08 16 11 30
172. is set to ON the software automatically set the Dilution adjustment 60 till 140 Instructions to set up the Auto dilution adjust Set the Auto dilution adjust OFF Set in SETTINGS GENERAL SETTINGS Display dilution ON Run a few representative fresh blood samples of the day and note the dilution rates which are displayed at the status line Add the found dilution rate and take the average By entering the percentage deviation a correction value can be made Example If the average dilution rate is 92 enter 108 in order to correct to a 100 dilution rate If no input is given a warning lt Out of range gt is displayed Note Use only recent samples lt 12 hours otherwise the software settings will not be representative e Set the average dilution rate in Dilution adjust 60 140 e Runmore samples to inspect the dilution rate again e If the dilution rates are in expectation continue to the following steps e Set Auto dilution adjust ON e Runa few more samples to inspect the dilution rate again StaRRsed Flex User Manual Page 99 Version 1 02 MRN 151 EN R mechatronics Compact FLEX program 6 6 3 4 Diluent flow check e Diluent flow check The Diluent flow check is default switched ON When the flow sensor is still giving errors after trouble shooting and there are no detectable faults in the liquid flow use the switch OFF function This check is now not active call for service Return to Diluter settings
173. is switched to ON Patient identification text PPPPPPPPPP E S R in mm calculated to 60 18 www minutes a E S R in mm 60 min corrected for 32 Aspect AAAAAAAAA Manually added code 22 32 4 39 43 46 temp Sedimentation time mn oe in degree Default 69 Error messages 80 EDTA message MMMMMMMMMM StaRRsed Flex User Manual Page 257 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex ti fason e pec asp soz o et et ate Pes tome Text left aligned followed by spaces ASCII 20 number made up of xx digits 0 9 ASCIII 30 39 with leading zeros Leading zeros and non specified positions are filled with spaces ASCII 20 Page 258 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Sysmex R 3500 Protocol R 3500 sample data record format 202 bytes This is a modified data record coming from a R 3500 os C NEN m Mmns makh 05 Tube position in rack 5 o 9 9 0 Q o a h i r N o zs o Parameter Text distinction code Text distinction code ll Sample distinction code Day Month Year Rack no Sequence no Tube positon nrack 5 4 Barcode rom barcode iabe na 00200 Error code 2 01200 Temperature in degr
174. istinction code distinction code Text distinction code a Sample v W a Sequencer ooo Sanpie Dramor jm Oa SE9000 Inquiry data record format 21 bytes Parameter COEM Comment Text distinction code distinction code Text distinction code Inquiry mode 4 E ases Real time inquiry Sample ID no Patient number same as sample data Tube position no Tube position in rack 3 SE9000 order information record format 171 bytes Page 272 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Parameter RN Comment Text distinction code Lope o eS sample does not exist 1 sample exists Daeodeei Sampie Dro Mustbe te same as inguin record _ a LLL 2 mwm S S o Patentnane ip as _ ow wem sampiecommens 40 we r Cg 0 ESR no T ESRyes awe Compact HAZY code messages The code appears in the sample data record at variable RBC This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear Sample is Hazy 10 1 2 Sample is Hazy 25 3 Sample is Hazy 25 Results with hazy aspect can be suppressed in the menu Limit error settings Compact E
175. k the main fuse The main fuse can be found at the main input socket from the Compact Page 169 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 6 Diluter 15 6 1 Diluter system not sufficiently primed Before aspirating the citrate system must be free of air bubbles Select MAINTENANCE gt PRIME gt PRIME DILUENT vacuum pump is on and system must be filled with Diluent When the citrate is priming liquid should be seen flowing through the tube connection to the fill nozzle cap Occasionally when the diluter system is primed for the first time air locks occur in the tubing and the diluter will not self prime If this occurs disconnect the luer fitting at the syringe and connect a syringe filled with Diluent to the tubing and fill system manually 1 Check pick up tube at the Diluent container it may be kinked 2 One of the Diluent lines has become blocked or kinked 3 Check all tubes are still connected 4 Check if the 2 tubes ESRIO70508 are still connected with the tubes ESRIO70406 5 Check if the 2 tubes positioned correctly in the pinch valve Fill nozzle cap HL Filnozzie Fill vacuum valve Sample tube ESRIO70406 NO Bubbles in these lines Touer needle ESRIO70508 Diluter valve QWLV020004 Diluter 49 syringe Water Disinfectant ST ESRIO70112 MAILH i ii Dilution tubing StaRRsed Flex User Manual Page 171
176. l Analysis information NEG POS ERR information POSITIVE diff POSITIVE morph POSITIVE count ERROR func ERROR result EW Order information Reserve Reserve Reserve Reserve Reserve IP message information 0 BC 6 123000 Esr value 123 mm Day Tube position no 2 Sample ID number N N i ha ha o o ooo po o ooo ooo ooo 280 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex MCV Sedimentation time in minutes i e 12 min MCHC 12300 30 minute ESR value 123 n a Not applicable No Sample data flag record format This protocol contains no sample flag record Tdlims Inquiry data record format 21 bytes Paramore TAN Comment Dno s Paten number same a samale Tdlims order information record format 171 bytes Parameter A Comment Text distinction code EJP S a sample does not exist 1 sample Dro ___ Mstbe the same as inguin record _ Patentname a StaRRsed Flex User Manual Page 281 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex Sex Patient birthday Doctor name Ward Sample comments Wbc Reserved mechatronics ca wmm O __ 1 Esrflag 0 ESR no 1 ESR yes _ Compac
177. l plunger Replace the O ring and then the tip Replace the old tip for the new tip assembly From repair set QWLV030902 Moisten the tip with water to ease the tip back into the glass syringe barrel Install the syringe back on to the attachment Clean dilution system 1 2 Perform PRIME DILUENT Repeat above step until there are no air bubbles in the whole diluent system anymore StaRRsed Flex User Manual Page 351 Version 1 02 MRN 151 EN Check dilution settings Go to tab SETTINGS GENERAL SETTINGS and select DISPLAY DILUTION OFF Run 10 samples through the instrument and make a note of the dilution rate Calculate the mean of the 10 samples Make dilution adjustment if necessary in SETTINGS DILUTER SETTINGS Go to tab SETTINGS GENERAL SETTINGS and select DISPLAY DILUTION ON prod tes Finishing maintenance 1 Check diluter drip tray empty if necessary 2 Recover any outstanding errors on the Flexlab GIU 3 Putthe StaRRsed Flex back online Page 352 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Work instruction Number 219 Page 1 of 1 Purpose Sample probe or outer needle replacement Safety Bio Hazard area Instrument StaRRsed Flex Revision 001 May 2013 Turn button on panel to move the top cover from the needle unit 1 Unfasten the screw which prevent the outer needle to drop out of the assembly 2 Undo the sample probe 3 Pull the outer nee
178. lean procedure During prolonged use of the instrument proteins are building up in the Westergren pipettes which need to be removed using a strong cleaning agent This function fills all pipettes with a cleaning agent and removes the cleaning agent after a specified time 6 5 1 11 Fill and Clean with cleaning adapter Fill amp Clean Automatic fill and clean function each individual pipette on pipette belt will be filled with cleaning solution During prolonged use of the instrument proteins are building up in the Westergren pipettes which need to be removed using a strong cleaning agent This cycle takes about 90 minutes The Fill amp Clean function is part of the monthly maintenance procedure A warning is shown on the display lt Pipette data will be lost gt Fi clean Pipette data will be lost qi Use Fill amp Clean adapter ON By toggling the switch ON the Fill and clean adapter is used Detailed instructions of this procedure can be found in the Work Instruction WI 215 Fill and Clean with adapter 6 5 1 12 End of day wash procedure e End of day wash All pipettes will be washed once and needle fill nozzle and rinse nozzle wash station are primed Page 72 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 5 2 Check sensors QE oce ier eth temperate enel EE 0 C Ee 885 Ou On E oe StaRRs
179. lex User Manual Version 1 02 MRN 151 EN Rm mechetronics 6 3 9 History analyse warning Analyse results o WARNING A Peete Temp Aspet Error Compact FLEX program By selecting one of the warning codes all the samples with this warning code are displayed in the table In the header of the table the names of the columns are shown Double click the header of any column to sort the table by this column in ascending order StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 61 Compact FLEX program 6 3 10 History sample analyse option pr Make a selection for 1 Aspecific number of past days 2 Aspecific date 3 Arange of days from start date to end date Page 62 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 3 11 History sample analyse option day Za Search options selection for all of today s results or only today s results between start time and end time StaRRsed Flex User Manual Page 63 Version 1 02 MRN 151 EN Compact FLEX program 6 3 12 Set start date Search options Input the Start date and time Page 64 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 3 13 Set end date Search options Input the End date and time StaRRsed Flex User Manual Page 65 Version 1 02 MRN 151 EN mechatronics Compact FLEX
180. lex User Manual Page 95 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 6 2 7 Flow test start 12 4 2010 10 37 51 Before the confirmation of the function the warning lt PIPETTE DATA WILL BE LOST gt is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram Page 96 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 6 2 8 Set new rinse position Change rinse position Click on CHANGE RINSE POSITION and enter via the keyboard the accurate rinse position and press the LEARN CAROUSEL POSITION key for learning a new position table Note This option is used when there is a position error StaRRsed Flex User Manual Page 97 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 6 3 Diluter settings 6 6 3 1 Dilution adjustment 60 till 140 Dilution adjustment 60 till 140 For adjusting the dilution rate run a number of sample tubes filled with fresh blood Write down the dilution rate which is shown in the numerical window By entering the percentage deviation a correction value can be made Example The average dilution rate is 92 enter 108 in order to correct to a 100 dilution rate Page 98 StaRRsed Flex User Manual Version
181. lothes Wear gloves when hands may contact potentially infectious materials contaminated surfaces or equipment Wear eye face protection if splashes or sprays are anticipated during work outside a biological safety cabinet Transport materials outside of the laboratory using secondary containment and a cart Avoid public areas during transport Transfer materials to and from the MCG according to federal and international regulations Be familiar with written instructions for laboratory procedures and proper responses to emergencies Report spills exposures illnesses and injuries immediately StaRRsed Flex User Manual Page 25 Version 1 02 MRN 151 EN mechatronics Standard Operating Procedures S O P 5 2 S O P for working with bio hazardous materials Purpose To inform and educate all engineers that work with biohazards Effective Date July 27 2004 5 2 1 Facts and definitions Biological hazards are present in all human and animal tissues and body fluids The normal research activities carried out in a blood laboratory expose workers to human blood urine sweat semen saliva and muscle tissue For the purpose of assessing risk we assume that all volunteers to our clinical studies are not normal healthy individuals and take appropriate precautions We remain aware at all times that increased knowledge of disease transmission and occupational hazards may result in situations currently considered safe t
182. m lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 7 Limit error Error One of the following limits are out of the setting range e ESR Time e Column height e Dilution e Bubbles on top e Hazy aspect e Temperature Page 130 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Reporting 8 2 4 Limit error settings When an option at Limit error settings is set to YES and this limit error occurs results will be printed send to the LIMS When an option is set to NO and this limit error occurs the fields for 30 min ESR 60 min ESR and the temperature corrected ESR are filled with spaces and thus results are not printed send to the LIMS The error message in the error field column 10 indicates that at least one of the limits ESR time dilution rate column height bubbles on top hazy aspects and temperature has been exceeded Together with the sedimentation time and dilution rate which are still printed at the usual position the operator analyst can see what caused the error and may or may not use the ESR values which are preserved in the error message Description of the error message L_err hhh www ittt ccc e L_err means it is a limit error e hhh is the 30 minutes ESR e www is the 60 minu
183. n c NI e Check that liquid does not run back into the supply bottles after the pumps have stopped Clean and inspect the sample needle e Inspect sample needle condition If necessary replace the sample probe or outer needle See Work Instruction Sample probe or outer needle replacement e Clean the outer needle with disinfectant Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 70 and perform the PRIME DILUENT function Wipe outer surface and stainless steel plate below the pipettes with disinfectant Check diluter drip tray empty if necessary Recover any outstanding errors on the Flexlab GIU 10 Put the StaRRsed Flex back online 11 Page 320 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 222 Page 1 of 4 Purpose Weekly maintenance Safety Bio Hazard area Instrument StaRRsed Flex Revision 002 March 2014 Perform maintenance when the StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU OVERVIEW StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on eFlexLab36 ATA Overview FSE 10 54 16 gt Samples Tests Exceptions InpuvOutput StaRRsed Centrifuge 1 C
184. n of the reagent containers The waste container has a level sensor and as soon as the level sensor generates a waste error the container must be emptied and replaced with a cleaned one Disclaimer Check your local environment rules about discharging the waste 11 1 Waste line connection to central waste system If the waste line is to be connected to a centralised waste collection system the following requirements must be met 1 Waste tube must not exceed 5 meters or 18 feet in length 2 Drain height must not be higher than the original waste container inside the instrument Note The original waste container cannot be removed due to waste container alarm 11 2 Replacing the waste container 1 2 3 4 5 6 7 Note If you are re cycling waste containers make sure that they are bleached and rinsed thoroughly A Unscrew the cap Lift the slider the cap moves up Lift the waste container out of the compartment Close container with the provided cap Place new and empty waste container Place and tighten the screw cap of the new waste container Press ESC to clear the error StaRRsed Flex User Manual Page 145 Version 1 02 MRN 151 EN mechatronics Compact system messages 12 COMPACT SYSTEM MESSAGES The Compact generates four main types of error messages e System messages e Test messages e System time out messages e Error messages 12 1 System messages During normal operation
185. n pipette has a zebra pattern air blood air blood nicely divided in the column Vacuum stabilisation errors may occur 13 3 5 Fill and clean procedure Cleaning agent preparation StaRRsed Flex Fill and clean 1 Fill the adapter FLEX110901 with hot de ionized water 150 ml 2 Add 15 ml cleaning agent QRR 010905 to the hot de ionized water in the adapter 3 Place the cap on the adapter and mix well StaRRsed Flex User Manual Page 155 Version 1 02 MRN 151 EN mechatronics Maintenance Start Fill and clean procedure 1 Select MAINTENANCE PRIME CLEAN 2 Select Fill amp Clean to start the process Fill and clean Pipette data will be lost Use Fill amp Clean adapter ON 3 Select button OK 4 The needle goes down and the fill and clean process is started it will take around 90 minutes 5 When all the pipettes are filled the needle goes back to the home position Note Each pipette on the pipette belt will be filled with cleaning agent after one hour the first pipette is washed and dried Fill and clean takes about 1 1 2 hours to complete See also WI 178 Hazy problems on page 296 and WI 195 Cleaning the diluent system on page 303 Cleaning with chlorine 13 4 Level 3 maintenance Level 3 maintenance is level 4 maintenance adding the following extra s 1 Replace the pinch valve tube ESRIO10246 2 Replace the blue disk filter QWLV040003 3 Replace the P
186. ncorrected QC result is d t Bubbles on top ESR ji ji Il 4 8 Um EU SrSrSESESISESESTSESTSESTSESI aia sizigia TH Bubbles on top ESR After scrolling the general data from the QC results are shown StaRRsed Flex User Manual Page 49 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 3 4 3 QC normal results graph m OC Statistics and Results QC NORMAL Statistics amp Results QC ABNORMAL Statistics amp Results Linked QC ID s QC results mm Display Calculated mean mm Mast table Expected ESR mm statistics graph Batch QC9E43NS05 Srey N505 350 D D D D 1 02 01 2012 07 01 2012 10 01 2012 13 01 2012 16 01 2012 19 01 2012 22 01 2012 25 01 2012 28 01 2012 31 01 2012 bah Calculated mean mm i Standard deviation mm Coefficient of variation Number of OC results Display Statistics graph All QC results from the chosen StaRRsed Control batch are shown in a Levey Jennings chart Shown in the graph e QC results red values of measurements per date e Calculated mean yellow mean value of all QC results of the specific batch e Expected ESR green Assay mean value of chosen StaRRsed Control Shown as value e Calculated mean mean value of all QC results of the specific batch Standard deviation the average deviation of all Q
187. nd can be accessed by clicking on DISPLAY REAGENT HISTORY on page 67 6 4 2 Display reagent history Display Reagent log Lot number i 4 E SED 123456789 09 2011 06 Oct 2011 RINSE SOLUTION 123456789 11 2011 30 Aug 2011 2900 mil Spoelviceistof 4d Sp ll sung Solution de rin age Soluzione di lavaggio Soluci n de lavado Solu o rinse m E hal mechatro Rinse solution Select reagent E Rinse solution Th E d Saline Diluent O De ionized water Disinfectant Export to Excel CSV rame StaRRsed Flex User Manual Page 67 Version 1 02 MRN 151 EN mechatronics Compact FLEX program This screen shows the history of the used reagents Select the reagent type on the right side For external use of the information all the logged reagent data can by exported to EXCEL CSV format by clicking Export to Excel CSV 6 4 3 New reagent input 4 New Reagent Information Select action RINSE SOLUTION 2500 e Enter new reagent information Spoelvioesstof Sp ll sung Delete current reagent information Solution de ringage Soluzione di lavaggio Soluci n de lavado Solu o rinse Rinse solution To continue click Next Input screen for new reagents Make a selection to add new default se
188. needle adapter within a certain time limit e Check for mechanical obstructions 6 Sample probe e Compact was not able to position the sample probe within a certain time limit e Check for mechanical obstructions The following Error messages may occur during normal operation 1 Vacuum error e Check if vacuum is available e Check in screen MAINTENANCE CHECK SENSORS the value of flow sensor e Fatal error call distributor 2 Vacuum stabilisation error Compact was not able to get a stable reading during the vacuum test before aspiration the sample e Check for leakage on the pipette or fill nozzle e Fatal error call distributor 3 Fill time error The fill sensor was not triggered in time e Not enough liquid was sucked up in the pipette e Insufficient sample e No vacuum or a blocked needle or fill block 4 Diluter error Diluter not started e be seen in the sample mode display as EDTA 001 e Check in screen MAINTENANCE CHECK SENSORS the value of the diluter sensor e Check in screen MAINTENANCE CHECK SENSORS if vacuum is available e Check in screen MAINTENANCE CHECK SENSORS the value of flow sensor e Fatal error call distributor 5 Position error e E18 is the error code for Carousel position error StaRRsed Flex was not able to position the carousel There was a difference found in the pipette memory position table and the actual measured position of the position sensor 6 Upor Do
189. ng Only for trained personnel When this function is used the built in safety functions are not active be careful GO TO RINSE POSITION Enter a pipette number the carousel will then turn to the stop position which is always the Rinse station SET RINSE POSITION The Compact has a self encoding pipette position system If an intermittent position error is displayed the position must be entered manually PIPETTE FLOW TEST Warning Pipettes must be empty before starting this function Before the confirmation of the function the warning Pipette data will be lost is displayed This is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are sent to the printer DELETE PIPETTE DATA This function will erase all pipette data Make sure that there are no samples on the pipette belt LANGUAGE The selection box for the language is marked with a symbol depicting a globe Select the language for the software and the Instructions For Use by clicking on the appropriate language name Note To switch to the selected language the first time close and restart the software StaRRsed Flex User Manual Page 89 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 6 2 1 Flow test potentiometer mean 12 4 2010 10 37 51 t EEEE Izigele seal 1 zs
190. nnector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover 3 Exchange Rinse and Saline tube assembly New rinse pump tube assembly New saline pump tube assembly ESRIO90902 ESRI090903 t EI ia New tube replacement 1 Open left cover Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex m StaRRsed Flex User Manual Page 337 Version 1 02 MRN 151 EN 4 Fill and clean Cleaning agent preparation StaRRsed Flex Fill and clean 1 Fill the adapter FLEX110901 with hot de ionized water 150 ml 2 Add 15 ml cleaning agent QRR 010905 to the hot de ionized water in the adapter 3 Place the cap on the adapter and mix well Page 338 SiaR
191. nt of the setting TEMP CORRECTION ON or OFF The following options can be selected Page 52 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Compact FLEX program RELATED PATIENT RESULTS This screen is simular to the Display sample history screen The background colour of the patient history table is switched to light yellow to distinguish these QC related patient results from the standard patient history table Depending on the frequency of QC samples related patient results may span over multiple days and are listed per date EXPORT TO EXCEL CSV Results can be exported to a CSV file and imported in an MS Excel file for further analyses BATCH All used batches of StaRRsed Control are shown results are shown for chosen batch ID CLOSE Return to History Screen 6 3 4 5 QC abnormal results screen extended m QC Statistics and Results alalelalal E as i 4 meg EL18 Uncorrected QC result is v n e After scrolling the general data from the QC results are shown StaRRsed Flex User Manual Page 53 Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 3 4 6 QC abnormal results graph 4 OC Statistics and Results QC ABNORMAL Statistics amp Results Linked QC ID s QC results mm Display Calculated mean Results table Expected ESR mm
192. ntainers for reagent supply and is delivered with level sensors and special reagents cover assemblies 2 1 Technical specifications Technical specifications for the StaRRsed Flex StaRRsed Flex instrument models Model name Catalogue number Model StaRRsed Flex FLEX109000 Page 16 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics ESR method Instrument description ESR method Westergren method Temperature compensation method R W Manley J clin Path 1957 10 354 30 minute method R Rogers Medical Laboratory World 1994 Allowed blood specimen types e For EDTA mode Whole blood with lt 1 EDTA anticoagulant e For Citrate mode Whole blood 4 vols with sodium citrate anticoagulant diluent 1 vol Automatic dilution 4 vols blood 1 vol sodium citrate diluent 3 2 NaCl accuracy 3 Reported result mm after 1 hour Reagents Reagents used Reagent barcode label information Blood volume QRR 010931 Diluent QRR 010947 Disinfectant QRR 010933 Saline QRR 010934 Rinse solution De ionized water Code39 Aspirated blood volume per sample 1 4 ml in EDTA mode 1 6 ml in Citrate mode Tube types Sample tube types Most commonly used brands types Closed tubes with concentric cap only StaRRsed Compact Mains voltage Fuse 20 x 5 mm Power consumption StaRRsed Flex User Manual Version 1 02 MRN 1
193. ntenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube connector on the top section Lift left cover Lift stainless steel vacuum tube up Insert the liquid separator sliding it over the support shelf Push the liquid separator towards the rear with the sensor connectors in the holes 8 Release the stainless steel vacuum tube 9 Replace the waste container 10 Close left cover 3 Exchange Rinse and Saline tube assembly New rinse pump tube assembly New saline pump tube assembly ESRIO90902 ESRI090903 t EI ia New tube replacement 1 Open left cover Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex m 346 StaRRsed Flex User Manual Version 1 02 MRN 151 EN 4 Fill and clean Cleaning agent preparation StaRRsed Flex Fill and clean 1 Fill the adapter FLEX110901 with hot de ionized water 150 ml 2 Add 15 ml cleaning agent QRR 010905 to
194. ntrol sample ID Note When the MECHATRONICS 01 or MECHATRONICS 02 protocols are used the Sample code or Sample type flag is set accordingly to mark the QC samples e OFF Default setting Results will not be send to LIMS data is only available on the StaRRsed Flex AUTOMATICALLY REMOVE LINKED QC ID AFTER RESULT e ON Default setting The link between StaRRsed Control Sample ID and Lab ID will be deleted after a useable result has been reported for this particular lab ID For each QC sample a new link must be created This link will stay active if there is no result or a general ESR error is generated This setting is useful when the lab issues a new and unique Lab ID for every QC sample e OFF The link will be available until its deleted manually This could be useful when using a general Lab ID for QC monitoring Only in case of a new batch of StaRRsed Control a new link has to be created When ready press SAVE SETTINGS before you continue StaRRsed Flex User Manual Page 103 Version 1 02 MRN 151 EN Compact FLEX program 6 7 Service screen Sample i j History E Reagents Maintenance Settings FlexLab connection LAS settings Re mechatronics Service Communication busy This menu has all the functions related to the following items FlexLab settings on page 105 Serial output settings on page 106 on page 106 Compact settings on
195. o be reclassified as having risk Universal Precautions describes a set of procedures for dealing with subjects based on the assumption that they are positive for blood borne pathogens Other precautions are necessary to prevent exposure to potential respiratory diseases 5 2 2 Medical requirements Routine personal medical assessments are advised at regular intervals yearly for all personal exposed to potential biohazard Immunisation for Hepatitis B is recommended for everyone who is taking blood samples or dealing with human blood or bodily fluids 5 2 3 General laboratory practices The laboratory is a shared facility it must be booked in advance with the Technician in Charge All users must follow all Departmental Safety Guidelines and Bio safety Policy Each user is responsible to leave a clean disinfected and tidy work place All biohazard waste must be properly disposed Page 26 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Standard Operating Procedures S O P 5 2 4 Specific laboratory practices and requirements Biohazard waste Dispose blood tubes into a biohazard sharps container Dispose sharps into a biohazard sharps container All other bio hazardous waste is to be deposited into a biohazard bag All bio hazardous waste is deposited into the Medical Waste Management MWM bin for pick up Decontamination procedures Routine At the end of each experiment or each day disinfe
196. ode Patient ID no Patient name Sex Patient birthday Doctor name Ward Patient comments Reserved RET O Esfilag 0 ESRno1 ESR yes Reserved Compact HAZY code messages The code appears in the sample data record at variable RBC This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear 1 Sample is Hazy 10 2 Sample is Hazy 25 3 Sample is Hazy 25 Results with hazy aspect can be suppressed in the menu Limit error settings Compact ERROR code messages This code appears in the sample data record at variable HGB The following 7 codes are defined No errors 1 No cells plasma found Error No contents could be detected in the pipette 2 ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height nnn Warning Column height must be between 180 and 210mm nnn the actual column height 5 Measure error Warning The down count is not equal to the up Page 262 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on
197. of range the applicable values for the acceptable range depend on the user setting E116 is shown in the status line of the Sample screen and the QC icon is blinking on the Sample screen ESR Result is given ESR Result is given Temperature correction not activated ESR Result is given Temperature correction not activated Check expire date Use a new batch of StaRRsed Control Try new QC sample tube normal samples will be finished Check acceptable range in QC settings If results are continuously out of range but the statistics show identical stable results it should be considered to expand the acceptable assay range with QC Settings If this error persists check clean instrument Consider QC Sample as correct The mean value is assayed with temperature correction Check temperature correction setting Consider QC Sample as not correct Try new QC sample tube normal samples will be finished Check acceptable range in QC settings If this error persists check clean instrument Check temperature correction setting StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting QC result with ESR error no ESR Result is given Check general ESR data see ESR Error on page 129 Check sample tube volume Try new QC sample tube QC result with ESR warning ESR Result is given Check general ESR data general ESR Warnings on page 129 Check limit sett
198. ogether with the other data fields e g the sedimentation time the operator can see what caused the error and may or may not use the ESR values which are preserved in the limit error message Description of the limit error message L_err hhh www ttt ccc ddd StaRRsed Flex User Manual Page 247 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex e L err means limit error e hhhis the 30 minutes ESR e www is the 60 minute ESR e ttt is the temperature corrected 60 minute ESR e ccc is the column height ddd is the 120 minute ESR if applicable Example of a limit error message without 30 minute ESR and 120 minute ESR L_err 123 89 200 CS Checksum XOR sum off all the data with the exception of CS STX and ETX E g CS byte2 XOR byte3 XOR byte 4 XOR etc Note Cannot be equal to that of the ETX byte 03h The CS byte verifies the accuracy of each transmitted message Before transmission the value of the CS byte is calculated by the exclusive or ing of all data bytes in the message with the exception of CS STX and ETX Since the CS byte precedes the ETX byte within the data stream the calculated value for CS cannot be equal to that of the ETX byte 03h Therefore if the calculated CS value is 03h the transmitted CS byte is set to the substitute value 83h in order to avoid erroneous action by the receiving device Page 248 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mecha
199. on page 98 screen 6 6 4 Limit error settings Sample jj History Reawents Maintenance Settings m Service p i Limit error settings C Send results when time exceeded C Send results with dilution errors Send results with column height errors LD Send results with bubbles on top warning Cc Send results with hazy aspect X Hazy 10 O Hazy 25 Hey 525 C Send results when temperature exceeded T C gt gs C When option is set to YES and this imk error occurs results will be printed send to the LIMS When an option set to NO ond this limit error occurs results are not printed send to the LIMS The screen Limit error settings has the following options e SEND RESULTS WHEN TIME EXCEEDED e setto YES always transmit results to the output e set to NO transmit no results to the output when the ESR time is outside the selected range e SEND RESULTS WITH DILUTION ERRORS e setto YES always transmit results to the output e set to NO transmit no results to the output when the dilution rate is outside the selected range set with Diluter settings Page 100 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program e SEND RESULTS WITH COLUMN HEIGHT ERRORS e setto YES always transmit results to the output e setto NO transmit no results to the output when the column height is outside the selected range e SEN
200. or StaRRsed Flex 16 APPENDIX FOR STARRSED FLEX Appendix section StaRRsed Flex User Manual Page 197 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Article reference list Compact Flex The StaRRsed Flex is delivered with a complete accessories kit ESRI 110993 This reference list is for article order numbers only QWFG010131 Glass jar Separator 198 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics QWLV040001 Disc filter 25mm Waste cont White QEPT100001 Parallel Printer cable ESRI110001 Ruler StaRRsed Compact ESRI110004 Tube silicon 1 5 3 2 Fill amp clean QEDV130022 Fuse 5 A 110V Slow 5x20 mm QEDV130019 Fuse 2 5 A 230V Slow 5x20 mm QWLV030901 Teflon tip repair set Syringe StaRRsed Flex User Manual Version 1 02 MRN 151 EN Appendix for StaRRsed Flex Page 199 R mechatronics Appendix for StaRRsed Flex Appendix Cable connection diagram StaRRsed Flex FLEX089000 Page 200 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Appendix for StaRRsed Flex 13 yun UOHNISUUOD jqep JUSOIUCQEWISUT 5 AS 201 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Appendix for StaRRsed Flex Appendix Tube connection StaR
201. ored on D QC NORMAL batchXxXX and DAQCVABNORMADL batch YY Y StaRRsed Flex User Manual Page 161 Version 1 02 MRN 151 EN R mechatronics Trouble shooting 15 TROUBLE SHOOTING Occasionally small faults may cause major problems This chapter may help to solve the most common faults and explain why a specific problem occurs A lot of the problems or errors are due to a lack of maintenance Remember that this instrument operates with a considerable amount of whole blood virtually undiluted stores it in a pipette for one hour and then cleans pipettes for re use Therefore it is important to keep to the maintenance schedules It is recommended that trained service personnel checks and applies service to the instrument at least once a year Errors which are not explained in this section can usually not be solved by the operator Refer to the Service manual for more information available only in English The error numbers are displayed in the PC software 15 1 Status indicator The StaRRsed Flex has a Status Indicator Green Instrument in Sample mode Orange Instrument in Service mode Orange Green Instrument in Service mode Sample mode activated Instrument in error An error message is given in Status line on screen StaRRsed Flex User Manual Page 163 Version 1 02 MRN 151 EN Rm mechatronics Trouble shooting 15 2 Peristaltic pumps The Peristaltic pumps are located under the Waste bottle housing assembly
202. ork instruction Number 175 Page 1 of 3 Purpose Pipette handling valve tube Safety Bio Hazard area Instrument Compact Revision Version 1 October 2007 Remove of the top cover 1 Switch StaRRsed Flex OFF 2 Remove the two rear screws of the top cover 3 Lift the top cover carefully from the instrument StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 293 Pipette removal 1 2 3 Push and pull vertically the pipette from the holding position of the belts Take pipette off the carousel Store the pipette on a safe place Re assemble pipette 1 Re assemble valve body ESRI 030522 and silicon valve tube ESRI 030516 Insert the re assembly in top pipette clamp Wet the top of the pipette with water black C clip indicates pipette top Compress the valve body into the pipette clamp and insert the pipette into pipette clamp The black C clip must be as close to the pipette clamp as possible The flat surface of the C clip must be next to the pipette clamp Remove the valve body and check the silicon tube position it must mun be exactly centred Fit the bottom tube clamp and V seal ring Check the position of the valve If incorrect disassemble pipette valve and tube re assemble again H f Pipette installation 5 6 the pipette belts i XX Visually check if all pipette valves are at the same wy VAN i 1 n
203. oroughly mixed and handled in the same manner each time 3 Place StaRRsed Control tube immediately after mixing into the analyzer 4 Start the Sample mode The StaRRsed Control sample is processed in the same manner as a patient sample Depending on the settings in QC settings a request and or result is send to the LIMS 5 Restore tube after each use at 18230 For detailed information see the StaRRsed Control Package Insert The contents of one tube of 5ml is sufficient for three Control samples Do not mix residual material with material from other tubes Do not re use empty tubes The software interface is described in the chapter History screen on page 40 StaRRsed Control should be disposed of as medical waste StaRRsed Flex User Manual Page 141 Version 1 02 MRN 151 EN mechatronics Quality control 10 2 6 QC Results The measured QC results are compared with the Assay mean value and the acceptable range The applicable values for the acceptable range depend on the user setting See chapter QC Settings on page 102 for more information If applicable the QC result is reported to LIMS using the chosen settings regarding temperature correction display of dilution rate and limit error settings 10 2 6 1 QC Error messages The general ESR errors and warnings are also applied on the QC results see ESR Error and Warning code messages on page 129 When the result is within range no message is shown
204. ot corrected 60 minute ESR result 60 minute ESR result in millimeters corrected for 18 only in use if temperature correction is active Aspect clear hazy Manually entered code number Sedimentation pipette number number on the pipette belt Actual sedimentation time in minutes Temperature in degrees Centigrade 10 Error message if the Analyser detects an error 11 EDTA mode StaRRsed Flex User Manual Page 203 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex REPORT EXAMPLE Not to scale StaRRsed Date 20 05 14 Time 15 28 1 9 NNNM M 905001 84 75 CLEAR 17 60 23 EDTA 905002 14 13 Hazy lt 10mm 18 60 23 EDTA 905003 22 21 Hazy lt 25mm 19 60 23 EDTA 905004 67 61 Hazy gt 25mm 20 60 23 EDTA 905005 CLEAR 21 60 23 EDTA 905006 5 5 CLEAR 22 60 23 EDTA 079 905007 24 60 23 many borders found 905008 25 60 23 L err 84 75 200 EDTA 905002 905003 905004 Sample results with hazy aspect 905005 Sample result with a manual aspect where the manual aspect is shown as a number 3 in column 6 of this data record sample 905006 In this sample the dilution rate has a dilution failure of 2196 and that is printed as EDTA 079 905007 Sample results with a text error This sample gives Too many borders found Result of a pipette possibly filled with air bubbles 905008 Sample result with a text error This sample is given limit error L_err 84 75 200 This code a
205. otocol Compact bidirectional 125 249 Appendix Protocol MECHATRONICS 01 bidirectional 125 239 Appendix Protocol MECHATRONICS 02 unidirectional 125 245 Appendix Protocol Opus bidirectional1 25 253 Appendix Protocol Sysmex SE 9000 unidirectional 125 273 Appendix Sedmatic 100 string format125 231 Appendix Sedmatic 15 string format 125 235 Appendix String format for StaRRsed125 227 Appendix String format for StaRRsed V14 125 229 Appendix String format Vesmatic125 237 Appendix Sysmex R 3500 Protocol125 259 Appendix Sysmex R 3500 unidirectional protocol 125 265 Appendix Sysmex SE9000 protocol125 269 Appendix TDLIMS protocol 278 Appendix Tube connection StaRRsed Flex 202 APPENDIX FOR STARRSED FLEX 197 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Index Aspect Hazy 46 132 Auto dilution adjust 99 B Basics of Bio safety 25 Bidirectional 355 C Carousel control 84 88 Carousel 35 Check list 135 Check or replace sample probe or outer needle 151 Check sensors 69 73 74 76 Check sensors in service mode 75 76 Check the sensors in service mode 152 Checks during operation 136 Citrate mode 355 Cleaning liquid separator 153 Cleaning solution 121 Close 82 Communications 192 Compact connected to 109 COMPACT FLEX PROGRAM 33 Compact settings 108 Compact stalls 169 COMPACT SYSTEM MESSAGES 147 Contaminated instrument 185 Control pipettes 139 D Daily 137 150 DATA SAFETY MAN
206. over the instrument165 Power up sequence 135 Rinse pump tube replacement 153 Prime Clean69 70 136 159 315 318 322 RS232 serial output 161 331 340 349 S Prime all units 71 Prime de ionized water 71 S O P for working with bio hazardous Prime Diluent 71 materials 26 Prime Disinfectant 71 Safety warning 21 Prime Rinse solution 70 Saline dripping in the sample tube adapter Prime Saline 70 166 Priming the fluid system 136 Saline pump failure 167 Printer port 109 Saline QRR 010933 120 Protocols 108 125 Saline pump tube replacement 154 Q Sample information 36 Sample mode button 36 QC abnormal results graph 54 Sample probe fails to go down 177 QC abnormal results table 51 Sample probe is not washed after aspiration QC abnormal results screen extended 53 166 QC Error messages 142 Sample screen 33 34 35 QC normal results graph 50 Sample screen with keyboard 37 StaRRsed Flex User Manual Page 361 Version 1 02 MRN 151 EN Search in example history 109 Sedimentation measurement principle 13 Separator error 188 Separator sensor 77 Service screen 33 35 104 Set end date 65 Set LIMS communication settings 104 106 Set new rinse position 97 Set protocol settings 107 Set start date 64 Small air bubbles rising in pipette 181 Software version 34 Specific laboratory practices and requirements 27 Specifications for the RS232 port 161 STANDARD OPERATING PROCEDURES S O P 25 Status indicator 163 Status 36 Stickers of
207. ox Measure sensor MS 40 50 60 Temperature sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK TEMPERATURE SENSOR box Temperature sensor TS Room temperature Diluent flow sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK DILUENT FLOW SENSOR box Press test When test is finished signal Down and signal Up must be green Separator check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK SEPARATOR SENSOR box Separator sensor 200 600 gt 700 Page 152 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Maintenance 13 22 Cleaning liquid separator The separator is designed to separate liquid from the air and can handle a lot of blood rinse and other used reagents from the instrument After a period of time the separator is getting dirty and therefore it needs to be cleaned weekly Detailed instructions of this procedure can be found in the Work Instruction WI 196 Cleaning liquid separator on page 304 Symptoms of a dirty separator 1 Separator errors 2 Foam in the separator 3 Waste pump cannot sufficiently remove the waste from of the separator 13 3 Level 4 maintenance The purpose of level 4 maintenance is to carry out the daily weekly maintenance and replace the pump tubing bacterial filters and the Fill nozzle O ring After replacing those items the instrument needs a Fill and Clean sequence to clean the pipettes Over a monthly period protein
208. p Increasing samples with bubbles indicate the need for maintenance of the aspiration system see Foam in column on page 179 e ESR errors Increasing ESR errors may indicate the need for maintenance see ESR Error on page 129 e Number of samples This can be used to document variations in work load 6 3 4 QC Results screens In this section results and statistics from QC samples are shown in the section Linked QC ID s on page 56 links can be created between QC sample ID s and Lab ID s The results from StaRRsed Control level N and level A are separated on their own tabs Both tabs have the same layout and options Results can be displayed in table format or in graphical format When the StaRRsed Control sample ID is used results are only listed here When Lab ID barcode is used QC results are also listed in Patient results Note This part of the software can only be used in combination with StaRRsed Control as quality control material Page 46 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics 6 3 4 1 QC Normal results table QC Statistics and Results Compact FLEX program SOLZOIZOTSIS 030012 509 9 E117 Uncorrected QC resut s c as a ELI7 Uncorrected QC result is c QCSASNNSUS 27 01 2012 07 36 03 02 20 QC9ASeNSOS 2401201207 35 3 03 02 2012 SS SS ETIUU en SGS 05 25 01 2012 07 96 3 0302 2012 54
209. p 9 Insert the liquid separator sliding it over the support shelf 10 Push the liquid separator towards the rear with the sensor connectors in the holes 11 Release the stainless steel vacuum tube 12 Replace the waste container 13 Close left cover Prime Saline 1 Select PRIME SALINE Repeat the prime saline until the liquid separator is empty StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 288 Exchange Waste Cassette and blotting washer 1 2 Disconnect the two tubes from the waste pump cassette Press levers at three o clock and nine o clock positions and pull at the same time Clean peristaltic pump motor shaft using a tissue soaked in alcohol Remove the old blotting washer ESRI090026 around the motor shaft Place the new blotting washer ESRI090026 Insert new waste pump cassette ESRI090921 until it clicks into place Remove the protection caps on from the tubes Connect the two tubes to new waste pump cassette StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 289 mechatronics Work instruction Number 168 Page 1 of 1 Purpose Pipette handling valve Safety Bio Hazard area Instrument Compact Revision Version 1 October 2008 Remove of the top cover 1 Switch StaRRsed Flex OFF 2 Remove the two rear screws of the top cover 3 Lift the top cover carefully from the instrument Pipette valve check or replacement 1 Hold
210. p cassette ESRIO90921 Blue Vacuum filter disc Part no QWLV040003 Fill block washer Part no ESRI030906 Waste container filter disc QWLV040001 only applicable if internal waste container is used Teflon tip of syringe on the Diluter assembly Bo wd The following items need to be checked and replaced if needed annually 1 Outer needle and sample probe 2 Pipette valves bodies and replace if necessary 84 pieces QTST040001 Check 1 Adjustment of fill nozzle and rinse nozzle StaRRsed Flex User Manual Page 355 Version 1 02 MRN 151 EN mechatronics 18 GLOSSARY OF TERMS B 18 1 1 1 1 Bidirectional communication means that there is two way communication from the StaRRsed Flex to the HOST sample requests and results and from the HOST to the StaRRsed Flex confirmation or denial of sample requests C 18 1 1 1 2 Citrate mode is used for pre diluted samples collected in tubes with sodium citrate anticoagulant diluent The samples are not diluted on the StaRRsed Flex during aspiration The concentration of sodium citrate within the diluent solution in the tube should be 3 2 This is not to be confused with the required dilution rate of blood and diluent For example in a citrate tube with a total draw volume of 1 6 ml 5 volumes the amount of pre filled diluent must be 0 32 ml 1 volume If this information is not provided by the tube manufacturer it should be checked by the cus
211. ple volume e Need more blood in the sample tube One air bubble rising can result in ESR Error code 3 15 9 5 Small air bubbles rising in pipette Usually this is caused by a dirty or damaged fill nozzle e Observe the maintenance schedules e Clean the fill nozzle e Check the fill nozzle for damage If necessary replace the fill nozzle Sample tube is leaking on the fill nozzle side e Replace the silicon sample tube Small air bubbles result in ESR Error 3 StaRRsed Flex User Manual Page 181 Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 9 6 Random air bubbles in pipette r3 1 Check Diluent flow by priming the diluter system 2 Insufficient sample volume E mm Random air bubbles result in ESR Error 3 15 10 Leaking pipettes If blood or cleaning solutions leak from a pipette perform the following procedures and check the performance of the system after each step to see if the problem has been solved If the completion of the following steps does not result in a correction of the problem contact technical support 1 Check for specks of dirt or hairs in the pipette valves 2 Ascratched valve tube 3 Ascratched valve body 4 Valve on top of the pipette is dirty or damaged 5 Check pipette bottom glass may be chipped 6 Check the pipette valve for contamination or wear Page 182 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Rm mechatronics Trouble shooting
212. ppears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear Sample is Hazy 10 1 2 Sample is Hazy 25 3 Sample is Hazy 25 Results with hazy aspect can be suppressed in the menu Limit error settings ESR ERROR and WARNING code messages Page 204 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Appendix for StaRRsed Flex This code appears in the sample data record at column 10 The following codes are defined 0 errors 1 No cells plasma found Error No contents could be detected in the pipette ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 7 Limit error Error One of the following limits are out of the setting range e ESR Time e Column height e Dilution e Bubbles on top e Hazy aspect e Temperature StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 205 mechatronics Appendix
213. r e WI 179 Replace blue air filter on page 297 6 Defective flow sensor board e Needs replacement fatal error 7 Outer needle valve is not functioning correctly and vacuum is leaking away check outer needle valve e StaRRsed Flex User Manual Page 175 Version 1 02 MRN 151 EN P mechatronics Trouble shooting 15 7 2 Vacuum error The Compact monitors the vacuum pressure If the vacuum pressure drops below a pre set level a Vacuum error message will be indicated on the Main screen Vacuum error may caused by 1 Blocked filter Replace the blue filter e WI 179 Replace blue air filter on page 297 2 Liquid separator wrongly assembled or blocked e WI 196 Cleaning liquid separator page 304 3 Main vacuum pump defective e Fatal error technical assistance is needed 4 Bad vacuum Adjustment needed on the vacuum e Fatal error technical assistance is needed 5 Blockage in the 3 way vacuum manifold e Fatal error technical assistance is needed Page 176 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 8 Needle system As soon as the barcode is accepted the sample will be processed 15 8 1 Needle not in top position E4 E4 is the error code and the text in the status line Sample probe not in top position home Piercing needle returns not at the home position after sampling a tube e Check the home sensor e Sample probe motor is fault
214. r computer No Serial output MECHATRONICS 01 bidirectional on page 239 MECHATRONICS 02 unidirectional on page 245 Sysmex SE 9000 on page 271 Sysmex SE 9000 unidirectional on page 275 Sysmex R 3500 on page 259 Sysmex 3500 unidirectional on 267 Sysmex H 3500 EPU on page 9 Compact bidirectional on page 249 10 Compact unidirectional String format for StaRRsed on page 227 11 StaRRsed V14 on page 229 12 Vesmatic on page 237 13 Sedimatic 15 on page 235 14 Sedimatic 100 on page 231 15 Opus bidirectional on page 253 16 Advia 120 bidirectional 17 Advia 120 unidirectional N m wm amp m The protocol be set in tab SERVICE Serial output settings After selecting a protocol save the new settings by pressing the Save setting key 8 2 Result Printout The results of the ESR measurements are send to the printer The layout of the report depends on the selection of the 60 or 30 minute method StaRRsed Flex User Manual Page 125 Version 1 02 MRN 151 EN mechatronics Reporting 8 2 1 Report 60 Minute mode Colums Patient number Not corrected 30 minute ESR result only in use if 30 minute mode is active Not corrected 60 minute ESR result 60 minute ESR result in millimeters corrected for 18 only in use if temperature correction is active Aspect clear hazy Manually entered code number Sedimentation pipette number number on
215. r Manual Page 251 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Page 252 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Protocol Opus bidirectional Bidirectional protocol definition of the sample request string from the StaRRsed Flex to the Host computer Positions in the string 1 2 rr 12 13 14 15 16 17 18 19 20 21 22 23 24 26 26 2720 29 30 31 ESR Sample request string definition from StaRRsed Flex to host computer sm sejE sjR sjR se 1 2 3 4 5 617 8 9 jt0 t1 12 13 14 15 t6 17 18 SP R SP es Definition of the string STX and ETX are at fixed position first 1 and last 31th position respectively SP Space character 20 E Capital letter E S Capital letter S R Capital letter R 1 18 Position of the sample identification left adjusted and filled up with spaces at the end of the string cs Checksum one char 00 FF sum off all the data OR 128 R At position 28 means that this is the Request string STX Char 02 ETX Char 03 StaRRsed Flex User Manual Page 253 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Sample conformation string definition replied by the host computer to perform an ESR test sm sp fels Ris R isp i 2 3 s e 7 a 9 10 11 12 1 14 15 16 17 18 5 Y spies Y
216. r the instrument 2 Fasten the two rear screws of the top cover If present if needed StaRRsed Flex User Manual Page 297 Version 1 02 MRN 151 EN R mechatronics Work instruction Number 180 Page 1 of 1 Purpose Prepare disinfectants bleach Safety Bio Hazard area For cleaning bio hazard area s Instrument StaRRsed Flex Revision Draft October 2001 Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 298 RR mechatronics Work instruction Number 215 Page 1 of 2 Purpose Fill and Clean with adapter Safety Bio Hazard area Instrument StaRRsed Flex Revision 001 September 2013 gt Fill the adapter FLEX110901 with hot de ionized water 150 ml Add 15 ml cleaning agent QRR 010905 to the hot de ionized water in the adapter Place the cap on the adapter and mix well Select on Flexlab GIU OVERVIEW StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform the Fill amp Clean on eFlexLab36 ATA Overview Samples Tests Exceptions InputOutput Configuration Centrifuge 2 Centrifuge 3 FSE hd gt StaRRsed Centrifuge 1 Architect 2000 1 A
217. ration the Westergren pipette must be free of air bubbles In the following examples different patterns of air bubbles which can appear in the pipettes are shown Air bubbles can affect the sedimentation and are mostly reported as errors and no ESR result is reported Usually bubbles are caused by a leakage at the bottom of the pipette If air bubbles are visible in the pipette check the following 15 9 1 Foam in column nese E 98 haved A layer of air bubbles that is concentrated on top of the blood column does not affect the sedimentation process itself The sedimentation develops normally below the bubbles However too many bubbles bring about a shortening of the effective blood column which is a deviation from the Westergren method A layer of bubbles up to 5 mm No message Normal ESR result is reported A layer of bubbles from 5 to 25 mm ESR warning 6 Bubbles on top Results should be reviewed before release A layer of bubbles larger than 25 mm ESR Error 3 Too many borders found No ESR result is given 1 Check that tube connections are not leaking 2 Check the fill nozzle condition e Inspect for any cracks or deep scratches in the base that holds the fill nozzle washer or O ring Check for air in diluter system Check that the sample probe O ring is not leaking 5 Check transparent T piece or Y piece block for cracks gt StaRRsed Flex User Manual Page 179 Version 1 02 MRN
218. rchitect 2000 2 5 Select STATUS from the dropdown box and hit the blue tick 6 Select GOING OFFLINE The StaRRsed Interface Module IM will complete testing of all of the tubes within the secondary lane and then the StaRRsed IM will go to Offline Select an Option Q StaRRsed Flex User Manual Version 1 02 MRN 151 EN 36 tatus Node ID Room for Empty carriers Room for Routine Samp Room for STAT Samples Page 299 7 Lift the hood with the elevator switch on the StaRRsed Flex 8 Put the adaptor on the track at pipette position under the needle and aligned with the edges of the tube locker 9 Lower the hood with the switch 10 Select on Flexlab GIU Overview StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform the Fill amp Clean on Select an Option Diagnostics 09 Init why Error code 11 Select DIAGNosTics and hit the blue tick 12 Select TUBE LOCKER and hit the blue tick The Tube locker moves down and locks the adapter Select an Option Tube Lock o 13 Ensure that the StaRRsed Flex is in Service mode and Sample mode off is selected the status is also indicated with orange LED light 14 Select MAINTENANCE PRIME CLEAN Page 300 StaRRsed Flex User Manual Version 1 02 MRN 151 EN 15 Select amp Clean to start the process Fill and clean dg Pipette data will be lost Qu Lise
219. rsion 1 02 MRN 151 EN 1 Clean Fill nozzle and exchange O ring Fill Nozzle Disassemble the fill nozzle Disassemble fill nozzle holder 1 Turn the holder to the right 1 Turn the holder to the right 2 The fill nozzle can now be removed 2 The holder can now be removed 3 Disconnect the silicon tube from the fill nozzle The use of a toothbrush and detergent is recommended 1 Carefully scrub the fill nozzle inner part 2 Useatissue to dry the fill nozzle Replace O ring Remove the O ring QWLV050004 Install new O ring QWLV050004 Page 310 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Assemble fill nozzle holder Assemble fill nozzle 1 Connect the silicon tube to the fill Push the plasti inst th ush the plastic top part down against the nozzle spring pressure 2 Putthe fill nozzle into the holder 1 Turn the plastic top part until you hear Push the fill nozzle upwards and turn of feel a click the holder to the left 2 Turn the plastic top part clokwise for 1 5 turns 2 Clean Liquid Separator and exchange filters Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5
220. rsonnel follow generally accepted safety procedures in addition to the safety precautions specified in this manual Execute your work according to this manual Read the instructions before operating the instrument Observe all cautionary markings in the manual and on the instrument Keep this manual for future reference Follow the bio safety procedures when working with blood contaminated parts Be cautious to prevent stinging during cleaning or replacing the needle assembly Repair can only be executed by trained and qualified personnel Wear protective clothing When the instrument is running it is not allowed to e Open and remove safety covers e Touch moving parts It is not allowed to give access to the instrument to a non authorised person at any time Whenever it is likely that safety protection has been impaired the instrument must be made inoperative and be secured against any unintended operation The matter should then be referred to qualified technicians Safety protection is likely to be impaired if for example the instrument fails to perform the intended measurements or shows visible damage or unusual smells smoke liquids are flowing out StaRRsed Flex User Manual Page 19 Version 1 02 MRN 151 EN mechatronics General safety instructions 3 1 Safety warning When there was an incident with the StaRRsed Flex which caused damage to the instrument please notify your superior and your local equipment deal
221. s Contents 13 hectic eet ee eee 149 taie Daly ce 150 13 1 1 Check or replace sample probe or outer 151 13 2 0 152 13 2 1 Check the sensors in service 152 13 2 2 Cleaning liquid sepatator pini 153 19 3 Level A maintenance uus ne apre pui EN UP IUD ERU EC 153 13 3 1 Rinse pump tube replacement 153 13 3 2 Saline pump tube 154 19 3 3 Replace bacterial filters eii o itis pr tuyo tic pueri i tedio sapi 155 13 3 4 Fill nozzle O ring 155 13 3 5 clean procedure ierunt rri erano SR REPa 155 13 4 Level 3 maintenance sssssssssssssssesseeeeeeneennnnnn nennen nennen tnter nnns 156 13 5 Level 2 maintenance eee ert p erret rr rk x idi ee Die idein 157 13 6 Level 1 maintenance sensies eare MUI SUN 157 13 7 Reagents replacement sessssesssssessseeeenenee ennemis 158 14 DATA SAFETY MANAGEMENT acean nn icu turp naa uon aua EE xax Ea nA san
222. s most likely because of poor or no vacuum Check the airflow go to MAINTENANCE tab CHECK SENSORS and select CHECK FLOW SENSOR Note In Sample mode the indicators are shown green the vacuum is ok In Service mode the indicators are showing numbers The following values are shown on the screen Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If for example the yellow orifice is blocked the flow will be 0050 offset value Low value for the airflow may be caused by a dirty or blocked blue disc filter or orifices especially the yellow one Start the pipette wash sequence via MAINTENANCE tab PRIME CLEAN WASH ALL PIPETTES and observe the drying process pipettes must be free of water spots 15 7 1 Vacuum stabilisation problems The Compact checks the vacuum built up in a pipette just before Sampling A vacuum stabilisation error will occur if it takes too long to evacuate a pipette or vacuum level is not stable Vacuum stabilisation error may caused by 1 Leak in sample tube connecting T piece Y piece and fill nozzle e Replace the silicone sample tube 2 Fill block washer defective or not in place e Needs replacement fatal error Leaking washer in the fill nozzle replace fill nozzle washer e WI 203 Replace the fill nozzle O ring 4 Sample tube pinch valve next to fill nozzle not operating e Needs replacement fatal error 5 Wet or dirty blue air filter on flow sensor board replace blue air filte
223. se of corrupted files the program will automatically load and use the backup files 14 1 Power failure If a power failure occurs it is recommended that the StaRRsed Flex is switched OFF by the power switch When the power returns the instrument can be switched ON After the standard start up process the StaRRsed Flex will continue to process the remaining samples 14 2 RS232 serial output The StaRRsed Flex PC is equipped with a serial port which can be connected to any laboratory host computer system or PC The data sent by the Auto Compact PC can also be sent to a host computer or PC for further processing 14 3 Specifications for the RS232 port The Serial RS232 settings need to be set in SERVICE SERIAL OUTPUT SETTINGS Baud rate can be set from 1200 to 19200 baud default setting is 2400 baud Transmission protocol is default setting 8 bit data 1 stop bit and no parity To change the baud rate go to SERIAL OUTPUT SETTINGS For more detail information on the Serial connection see the Appendix RS 232 hardware connections Compact 14 4 Folder Structure on PC Patient result files including measured raw data are stored on the D drive as default setting It is possible to change this location The underlying folder structure is created by the software and each result can be found in subfolders Year Month Day for example D 2014 01 03 01 2014 Each result is stored with the sample ID as document name QC results are st
224. sinfectant 4 Check tubing from the syringe for trapped air bubbles Check Diluent syringe for trapped air bubbles If trapped air bubbles are found go to tab MAINTENANCE click button PRIME CLEAN ON PAGE 70 and perform the PRIME DILUENT function Wipe outer surface and stainless steel plate below the pipettes with disinfectant Check diluter drip tray empty if necessary Recover any outstanding errors on the Flexlab GIU 10 Put the StaRRsed Flex back online 11 oon 324 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Work instruction Number 204 Page 1 of 2 Purpose Check sensor values Safety Bio Hazard area Instrument Compact Revision 001 January 2014 Check sensor values in Service mode Boom 4 Check Separator sensor StaRRsed Flex User Manual Page 325 Version 1 02 MRN 151 EN Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FLOW SENSOR box Flow 0925 0980 1020 Abs 0300 360 0390 Offset 0045 0050 0055 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor Fill Stop sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select CHECK FILL STOP SENSOR box Fillstop sensor FS 90 140 165 Diluter Start sensor check e Go to tab MAINTENANCE gt CHECK SENSOR Select DILUTER START SENSOR box Diluter start sensor 400 700 Measure
225. sion 1 02 MRN 151 EN Assemble fill nozzle holder Assemble fill nozzle 1 Connect the silicon tube to the fill Push the plasti inst th ush the plastic top part down against the nozzle spring pressure 2 Putthe fill nozzle into the holder 1 Turn the plastic top part until you hear Push the fill nozzle upwards and turn of feel a click the holder to the left 2 Turn the plastic top part clokwise for 1 5 turns 2 Clean Liquid Separator and exchange filters Removing 1 Open the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note The separator has two sensor connectors at the rear 4 Disconnect the silicon tube from the tube connection on the top section 5 Remove bacterial HEPA filter 6 Remove and disassemble the liquid separator Cleaning 1 Clean all parts with hot water and a brush 2 Use some acid free vaseline on the screw thread of the glass jar 3 Assemble the separator Page 336 SiaRRsed Flex User Manual Version 1 02 MRN 151 EN Replacing 1 Replace the top section A little silicon grease on the rim of separator will make the assembling and adjustment easier 2 If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange bacterial HEPA filter QWLV040002 3 Re connect the silicon tube to the tube co
226. sition settings and save settings Could not start the position motor because the outer needle or sample probe is not its home position top FlexLab system did not response to a message from StaRRsed Flex FlexLab system rejected Status message from StaRRsed Flex Appendix for StaRRsed Flex Possible hardware failure in Eeprom Possible hardware failure in Eeprom Possible hardware failure in Eeprom Possible hardware failure in Eeprom Check outer needle home sensor Check sample probe home sensor Faulty Outer needle motor Faulty Sample probe motor Check if needles are blocked Faulty motor drivers on the needle board Check communication cable between StaRRsed Flex and the FlexLab system Check serial port settings Check communication cable between StaRRsed Flex and the FlexLab system Check serial port settings Page 223 Appendix for StaRRsed Flex E112 NACK received from FlexLab system after sending SampleStatus message E116 118 Page 224 FlexLab system rejected SampleStatus message from StaRRsed Flex Quality Control Errors R mechatronics Check communication cable between StaRRsed Flex and the FlexLab system Check serial port settings See section Quality control trouble shooting on page 194 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Maintenance schedule
227. six tabbed screens The software is controlled by mouse pointer or directly via the touch screen A virtual keyboard is automatically displayed on screen when numerical or alphanumerical input is required Normal operational screens are the SAMPLE and the HISTORY screen The REAGENTS screen is used to check the reagent levels and log reagent replacement To activate priming sequences and cleaning operations the screen MAINTENANCE is used The SETTINGS and SERVICE screens are protected by a password to prevent accidental change of settings The SERVICE menu is used for service and control purposes SAMPLE Screen on page 34 of HISTORY screen on page 40 REAGENTS Screen on page 66 MAINTENANCE Screen page 69 SETTINGS screen on page 84 General settings password protected 3964 SERVICE screen on page 104 password protected 3964 StaRRsed Flex User Manual Page 33 Version 1 02 MRN 151 EN Rm mechetronics Compact FLEX program 6 1 Software version The latest software and manuals for the StaRRsed Flex can be downloaded from our website www rrmechatronics com The following program description is valid for software up to version 5 01 Software version V5 00 and higher runs only on a Windows 7 PC 6 2 Sample screen Page 34 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program The main menu is displayed during
228. spaces ASCII 20 Aspect messages Hazy 10 Hazy 10 Hazy 25 Hazy 25 Hazy 25 Hazy 25 Error messages 1 No cells plasma found 1 2 ESR Probably gt 140 mm Error 2 3 Too many borders found Error 3 232 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Note If the Compact is switched to the 30 min method the output string has the same format The Compact automatic apply the conversion table to the 60 min method If temperature correction is switched on the ESR value will be the temperature corrected ESR value StaRRsed Flex User Manual Page 233 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Sedmatic 15 string format Data 28 characters stx RO4PPPPPPPPO1ppO1WWWNWTI JETETETEJE Data consists Patient identification text Pipette number E S R in mm 60 min Checksum Checksum EXOR sum off all 28 data characters If checksum is equal to the ETX character the checksum is converted to DEL N TX TX CK ACK EL Page 235 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Text left aligned followed by spaces ASCII 20 number made of xx digits 0 9 ASCIII 30 39 with leading zeros Note e Timeout for response ACK NACK from HOST is 20 seconds e If the
229. stalled correctly e Check the tubes between the containers and pumps valves e Unscrew the cap from the container Check the pick up tubes and level sensors in the container and make sure that there is enough liquid in the container e Check the tubes for blockages or kinks 15 4 1 De ionized water Select from MAINTENANCE gt PRIME CLEAN gt PRIME DE IONIZED WATER the vacuum pump should operate and liquid flows through the thin tube connected to the side of the fill nozzle cap After each sample aspiration the fill nozzle aspiration tube is washed automatically with de ionized water If there is no liquid flow and no reagent alarm 1 Unscrew the cap of the deionized water container to check 2 One of the de ionized water lines may be blocked or kinked 15 4 2 Disinfectant To disinfect the Compact waste Select from MAINTENANCE gt PRIME CLEAN gt PRIME DISINFECTANT the vacuum pump should operate and liquid must be seen flowing through the thin tube connected to the side of the wash station After each wash cycle approximately 0 5 ml of disinfectant will be flushed through the wash station If no disinfectant flows 1 Unscrew the cap of the disinfectant container to check 2 One of the disinfectant lines may be blocked or kinked Page 168 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Trouble shooting 15 5 Compact stalls When the Compact is not working again chec
230. sults are displayed in graphical form Raw data is also stored on the D drive D MeasureTest txt Measure head start position correct ee 0 20 40 60 80 100 120 140 160 180 200 Measure head start position wrong Oe 0 20 40 60 50 100 120 140 160 180 200 NOTE Clean sensors first before executing this function NOTE When a test pipette is installed at the measuring position the result of the test pipette is displayed in the field ESR mm Page 78 StaRRsed Flex User Manual Version 1 02 MRN 151 EN Re mechatronics TO Compact FLEX program 6 5 3 Display error history 4 Sample jil History fr Reagents Maintenance EE Settings 05 Oct 11 10 32 14 Measure sensor checked 05 Oct 11 10 32 13 flow sensor checked 05 Oct 11 10 32 12 Dikter start sensor checked 05 Oct 11 10 32 12 Fill stop sensor checked 05 Oct 11 09 13 26 Separator sensor checked 05 Oct 11 09 13 25 Diluent flow sensor checked When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE All errors that occurred during operation are logged automatically This list can be used by field engineers to check check the status of the instrument and locate possible problems This log can be saved e g to a memory stick by clicking button Save As StaRRsed Flex User Manual Page 79 Version 1
231. sum ON 60 min Pho Descrpion Pome s CC Temperature in degree Default CS 1 byte checksum 256 modulo 256 ASCII string sum ASCII string sum the ASCII sum of all preceding characters incl stx cr If and ext modulo 256 ASCII string sum the remainder of the ASCII string sum when divided by 256 ESR string format for StaRRsed 30 minutes format stx PPPPPPPPPP hhh www WWW AAAAAAAAAmm ppp CC EEEEEEEEEEEEEEEEEEEEEE MMMMMMMMMM cr 1f eot stx 80 data characters cr lf eot Checksum OFF 30 min stx 80 data characters cr lf etx cs eot Checksum ON 30 min Data consists if 30 min output is switched to ON Polon Dein Format _ Patient identification text PPPPPPPPPP StaRRsed Flex User Manual Page 227 Version 1 02 MRN 151 EN R mechatronics Appendix for StaRRsed Flex E S R in mm calculated to 60 xxx WWW minutes EN temp Manually added code 32 T Temperature in degree Default C EDTA message MMMMMMMMMM Creme Text left aligned followed by spaces ASCII 20 Xx number made up of xx digits 0 9 ASCIII 30 39 with leading zeros Leading zeros and non specified positions are filled with spaces ASCII 20 Page 228 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Fl
232. t HAZY code messages The code appears in the sample data record at variable RBC This code appears in the sample data record at column 5 The following 4 codes are defined 0 Sample is clear 1 Sample is Hazy 10 2 Sample is Hazy 25 3 Sample is Hazy gt 25 Results with hazy aspect can be suppressed in the menu Limit error settings Compact ERROR code messages This code appears in the sample data record at variable HGB The following 7 codes are defined 0 No errors 1 No cells plasma found Error No contents could be detected in the pipette 2 ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210mm lt nnn gt the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 Page 282 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Appendix for StaRRsed Flex 7 Limit error Error One of the following limits are out of the setting range ESR Time Column height Dilution Bubbles on top Hazy aspect Tempera
233. t DELETE PIPETTE DATA The carousel stops moving Use the sequence mentioned above to remove the blood samples 3 Check mechanical connection potentiometers If the position error is not solved after all the mentioned actions the positioning device needs replacement This is a fatal error call distributor StaRRsed Flex User Manual Page 187 Version 1 02 MRN 151 EN Rm mechatronics Trouble shooting 15 16 Separator error If it takes too long for the waste pump to empty the liquid separator the system generates a separator error Extensive foam build up in the liquid Check the separator assembly and connections for separator possible air leaks Waste tube between liquid separator and Replace the tube waste pump is blocked Waste tube between waste pump and Replace the tube waste container blocked Waste pump failure Exchange the waste pump cassette If the error returns call for service Electrical bridge between the waste level Clean liquid separator see WI 196 Cleaning liquid electrodes separator on page 304 Page 188 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 17 Reagents Check the expire dates of the reagents regularly Do not use the reagents if expired Note If expired reagent has been used accidentally the results obtained with these reagents may only be used when the expire date was not exceeded more than 30 days DILUENT is sensitiv
234. t aligned followed by spaces StaRRsedFlexUserManual TTT Page 241 Version 1 02 MRN 151 EN Appendix for StaRRsed Flex XX number digits 0 9 with leading spaces Non specified positions are filled with spaces Sample codes Aspect codes Sample type Transmitted code Aspect Transmitted code Patient sample 0 Clear 0 QC normal 1 Hazy lt 10 1 QC abnormal 2 Hazy lt 25 2 Hazy gt 25 3 Page 242 mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Note Transmission of QC codes 1 and 2 is part of the internal QC procedure ESR error codes No cells plasma found 1 ERROR no result transmitted ESR Probably gt 140 mm ERROR no result transmitted Too many borders found Limit error 7 ERROR see Limit error messages on page 131 Note See analyzer manual for more information about limit error settings When a limit error occurs the fields for ESR 30 min ESR 60 min temperature corrected ESR and ESR 120 min are filled with spaces and thus results are not send to LIMS Together with the other data fields e g the sedimentation time the operator can see what caused the error and may or may not use the ESR values which are preserved in the limit error message Description of the limit error message L_err hhh www ttt ccc ddd StaRRsed Flex User Manual Page 243 Version 1 02 MRN 151 EN mechatronics Appen
235. t is shown here such as the selected mode EDTA or Citrate selected method 60 or 30 minute and symbols that draw attention to certain maintenance conditions or QC sample status if applicable Error Page 36 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Compact FLEX program 6 2 10 Sample screen with keyboard To view the status of a specific pipette click directly on the pipette itself or click the open space in the center of the belt representation A virtual number pad is shown Type the number of the requested pipette and press the OK button The following screen is shown StaRRsed Flex User Manual Page 37 Version 1 02 MRN 151 EN Compact FLEX program 6 2 11 Pipette information StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 38 mechatronics Compact FLEX program The following information is shown e Sample ID The sample identification barcode of the sample tube e Dilution The dilution rate of this sample as calculated during the aspiration process e Time filled The date and time when the sample was aspirated e TIME TOGO The number of minutes to wait until the sample will be measured The indicators at the right side show the current status of the selected pipette Pipette filled OK A sample has been aspirated into the pipette without problems Pipette dirty The sample has been measured and the pipette is marked to be washed
236. te ESR e ttt is the temperature corrected 60 minute result e ccc is the column height Example of a limit error message e L err 42 84 75 200 means 42 mm in the 30 minute method and temperature correction 75 with a correct column height e L_err 84 75 200 means 84 mm the 60 minute method and temperature correction 75 with a correct column height 8 2 5 Reporting range The reporting range in the columns 2 3 and 4 are in millimeters The start of the measure range is at the top of the meniscus down to 140 mm If the detection of cells plasma is over 140 mm then the report will be 2140 StaRRsed Flex User Manual Page 131 Version 1 02 MRN 151 EN mechatronics Reporting 8 2 6 Aspect Hazy The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 96 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 Hazy detection 50 0 Meniscus detection gt 25mm hazy 10 25 mm 25 hazy 10mm _10 dea lt 3mm 3 celis p 100 70 Clear h
237. te ESR result 60 minute ESR result in millimeters corrected for 18 only in use if temperature correction is active Aspect clear hazy Manually entered code number Sedimentation pipette number number on the pipette belt Actual sedimentation time in minutes 9 Temperature in degrees Centigrade 10 Error message if the Analyser detects an error 11 EDTA mode gt 99 cw mop REPORT EXAMPLE Not to scale StaRRsed Date 20 05 14 Time 15 28 1 2 3 4 5 6 7 8 9 10 11 915001 42 84 75 CLEAR 17 30 23 EDTA 8 2 3 ESR Error Error messages can be found on the printout in column 10 If errors are found during the measurement the Compact will give an audible alarm The Error message is displayed on the main screen 8 2 3 1 ESR Error and Warning code messages ESR ERROR and WARNING code messages This code appears in the sample data record at column 10 The following codes are defined StaRRsed Flex User Manual Page 129 Version 1 02 MRN 151 EN Reporting mechatronics O No errors 1 No cells plasma found Error No contents could be detected in the pipette 2 ESR Probably gt 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height lt nnn gt Warning Column height must be between 180 and 210m
238. tely 0 5 ml Diluent is used for each sample e Approximately 2 5 ml is used for one Prime cycle The diluent container is a 5 liter container QRR 010931 The solution should be discarded if it becomes turbid If the Diluent does become turbid clean the Diluent container thoroughly with a 596 Na hypochlorite solution After cleaning rinse the container thoroughly with de ionized water Before refilling flush the Diluent bottle with a little Diluent from the bulk container NOTE The latest version of the Material Safety Data Sheet MSDS of the used reagents can be found on our web site www mechatronics nl http www mechatronics nl 7 3 4 De ionised water De ionised water is used for rinsing the fill nozzle approximately 0 5 ml The outside of the metal fill nozzle tube is washed automatically after each aspiration Note Add one or two drops of saline to the de ionised water to avoid bottle empty alarms 7 3 5 Disinfectant QRR 010947 The disinfectant is used to disinfect the waste system approximately 0 5 ml disinfectant is used after each pipette rinse The disinfectant bottle is a 5 liter container QRR 010947 Note Since January 2013 Disinfectant QRR 010932 is no longer be used and is replaced by QRR 010947 See Information bulletin IB 2013001 Pre flush the disinfectant bottle using disinfectant from the disinfectant container Fill disinfectant bottle from the 5 litre container Page 120 StaRRsed Flex User M
239. tem Select MAINTENANCE gt PRIME CLEAN on page 70 and perform all prime sequences manually Check fluid flow through the applicable tubing repeat a step if fluid flow is not correct 1 PRIME RINSE SOLUTION activates the Rinse pump RINSE SOLUTION must flow through the pipette 2 PRIME SALINE activates the SALINE pump Liquid must flush through the needle assembly 3 PRIME DILUENT activates the diluter prime cycle Diluter system must be filled with diluent and free of air bubbles e Diluter prime cycle is executed once In order to fully prime the system it will be necessary to perform this step several times One cycle is 5 strokes of the Diluter 4 PRIME DE IONIZED WATER activates the fill nozzle water valve DE IONIZED WATER must flow through the tube connected to the fill nozzle cap 5 PRIME DISINFECTANT activates the disinfectant valve Disinfectant must flow through the small tube connected to the pipette wash station When the StaRRsed Flex has been idle for more than eight hours some reagents may have dropped from the tubes due to gravity Prime all tubing before sampling with PRIME ALL UNITS All priming functions are sequentially performed one time Page 136 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Operation 9 4 Turn off It is recommended to turn the StaRRsed Flex off at the end of the day Before the instrument is turned off it is good practice to carry out the Daily m
240. test leakage Before the confirmation of the function the warning lt PIPETTE DATA WILL BE LOST gt is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram StaRRsed Flex User Manual Page 93 Version 1 02 MRN 151 EN Rm mechatronics Compact FLEX program 6 6 2 5 Flow test Fill sensor air 12 4 2010 10 37 51 sesS 292322222 Before the confirmation of the function the warning PIPETTE DATA WILL BE LOST gt is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram Page 94 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics Compact FLEX program 6 6 2 6 Flow test Fill sensor glass SRR Rae gag gigigigs Before the confirmation of the function the warning lt PIPETTE DATA WILL BE LOST gt is displayed This test is a useful function for checking the pipette position adjustment vacuum adjustment and filling height sensor positioning adjustment Each individual pipette is tested and results are displayed in their own line of the diagram StaRRsed F
241. the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex m 312 SiaRRsed Flex User Manual Version 1 02 MRN 151 EN 4 Fill and clean Cleaning agent preparation StaRRsed Flex Fill and clean 1 Fill the adapter FLEX110901 with hot de ionized water 150 ml 2 Add 15 ml cleaning agent QRR 010905 to the hot de ionized water in the adapter 3 Place the cap on the adapter and mix well StaRRsed Flex User Manual Page 313 Version 1 02 MRN 151 EN Start Fill and clean procedure 1 Select MAINTENANCE PRIME CLEAN 2 Select Fill amp Clean to start the process Pipette data will be lost Use Fill amp Clean adapter ON 3 Select button OK 4 The needle goes down and the fill and clean process is started it will take around 90 minutes 5 When all the pipettes are filled the needle goes back to the home position Note Each pipette on the pipette belt will be filled with cleaning agent after one hour the first pipette is washed and dried Fill and clean takes about 1 1 2 hours to complete See also WI 178 Hazy problems on page 296 and WI 195 Cleaning the diluent system on page 303 Cleaning with chlorine 5 Sensor check Vacuum pressure check e Go to tab MAINTENANCE gt CHECK SENSOR Select CH
242. the following System messages may occur 1 Waiting tube e lf a filled pipette is at the measuring position before the elapsed time has finished and the operator is ready to fill the next pipette the Waiting tube message will be displayed e continue the sample loading sequence the operator must wait until the pipette at the measuring position has been measured 2 Reagents level empty message e All reagent containers have level detectors the display shows an error that indicates which reagent container s is are empty e The expiry date of the reagent is exceeded or the container is opened longer than three months 3 Prepare new reagent as described in section Reagents preparation Waste bottle full message or No waste bottle message e The waste container also has a level detector If a waste error is shown on the display the StaRRsed Flex will stop filling and cleaning pipettes until a new or empty container has been installed e Empty the waste container and press Clear error 4 Fatal separator error e The Separator container has a level detector If the Fatal Separator error message is indicated on the display the Compact will stop the rinse cycle until the separator is empty e The cause of this problem can be foam or the waste pump is not working The Compact will continue to measure and send the ESR results on time to the printer but the rinse and fill sequences are stopped until the error is solved StaRRsed Fl
243. the left cover and remove the waste container The liquid separator is now visible 2 Lift the stainless steel vacuum tube with use of the lever 3 Pull the liquid separator towards the front of the Compact Note i The separator has two sensor connectors at the rear 4 Remove bacterial HEPA filter 5 Fill waste separator with 100ml disinfectant or 100 ml water with 2 bleach 6 Replace bacterial HEPA filter 7 Lift left cover 8 Lift stainless steel vacuum tube up 9 Insert the liquid separator sliding it over the support shelf 10 Push the liquid separator towards the rear with the sensor connectors in the holes 11 Release the stainless steel vacuum tube 12 Replace the waste container 13 Close left cover StaRRsed Flex User Manual Page 315 Version 1 02 MRN 151 EN Exchange Waste Cassette and blotting washer 1 Disconnect the two tubes from the waste pump cassette 2 Press levers at three o clock and nine o clock positions and pull at the same time 3 Clean peristaltic pump motor shaft using a tissue soaked in alcohol 4 Remove the old blotting washer ESRI090026 around the motor shaft 5 Place the new blotting washer ESRIO90026 6 Insert new waste pump cassette ESRIO90921 until it clicks into place 7 Remove the protection caps on from the tubes 8 Connect the two tubes to new waste pump cassette 7 Exchange Pinch valve tube Replace the pinch valve tube ES
244. the pipette belt Actual sedimentation time in minutes 9 Temperature in degrees Centigrade 10 Error message if the Analyser detects an error 11 EDTA mode gt 99 cw mop StaRRsed Flex User Manual Page 127 Version 1 02 MRN 151 EN P mechatronics Reporting REPORT EXAMPLE Not to scale StaRRsed Date 20 05 14 Time 15 28 905001 84 75 CLEAR 17 60 23 EDTA 905002 14 13 Hazy lt 10mm 18 60 23 EDTA 905003 22 21 Hazy lt 25mm 19 60 23 EDTA 905004 67 61 Hazy gt 25mm 20 60 23 EDTA 905005 CLEAR 3 21 60 23 EDTA 905006 5 5 CLEAR 22 60 23 EDTA 079 905007 24 60 23 Too many borders found 905008 25 60 23 L err 84 75 200 EDTA 905002 905003 905004 Sample results with hazy aspect 905005 Sample result with a manual aspect where the manual aspect is shown as a number 3 in column 6 of this data record sample 905006 In this sample the dilution rate has a dilution failure of 2196 and that is printed as EDTA 079 905007 Sample results with a text error This sample gives Too many borders found Result of a pipette possibly filled with air bubbles 905008 Sample result with a text error This sample is given limit error L_err 84 75 200 Page 128 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Reporting 8 2 2 Report 30 Minute mode Columns Patient number Not corrected 30 minute ESR result only in use if 30 minute mode is active Not corrected 60 minu
245. the top pipette clamp and remove the valve body QTST040002 2 Clean or replace the valve body 3 Check the silicon tube position inside the pipette clamp it must be in the centre of the hole and equidistant from the sides 4 Re install pipette valve body Pipette installation 1 Hook pipette assembly on to the pipette belts mur mur wm LUE 2 Make sure that pipettes are correctly fitted on to height 4 Visually check the bottom of the pipette V shape ring 5 Incorrect fitted pipettes may cause mechanical damage to the instrument 6 Check for leakage with Fill amp Clean Replace the top cover 1 Putthe cover carefully over the instrument 2 Fasten the two rear screws of the top cover If present if needed StaRRsed Flex User Manual Version 1 02 MRN 151 EN the pipette belts i A XX 3 Visually check if all pipette valves are at the same rm i 1m lU Page 290 mechatronics Work instruction Number 172 Page 1 of 2 Purpose Cleaning Measure sensor Safety Bio Hazard area Instrument Compact Revision 002 February 2014 Remove of the top cover 1 2 Remove the two rear screws of the top cover 3 Lift the top cover carefully from the instrument Switch StaRRsed Flex OFF If the measure sensor is out of range the sensor must be cleaned In order to clean the measure sensor remove the pipette at the measuring position complete with top an
246. tings Check for duplicate ID s Program stopped and computer needed to be reset Computer reset after power failure Outer needle motor is faulty Outer needle motor driver on needle board is faulty Outer needle is blocked StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics E8 Fillnozzle not in fill position E9 Air flow failure E10 Sample probe was jammed Check both needles before sampling E11 Sample probe not on position going down Timeout error E12 Dilution error wrong or no diluent flow Check the diluter E13 Fillnozzle not in home position E14 Outer needle motor position error home StaRRsed Flex User Manual Version 1 02 MRN 151 EN Fill nozzle did not reach the fill position within a certain time limit Compact was not able to get a stable reading during the vacuum test before aspiration the sample Sample probe was probably jammed when going down and exceeded the maximum current level Sample probe went back to its home position after the error Sample probe did not go down within a certain time limit Diluter malfunction Fill nozzle did not reach the Home position within a certain time limit Outer needle did not reach the home top sensor within a certain time limit Appendix for StaRRsed Flex Fill nozzle motor is faulty Fill nozzle motor driver on nozzle board is faulty Fill nozzle is blocked Check for leakag
247. tomer E 18 1 1 1 3 EDTA mode EDTA mode is used for undiluted samples collected in tubes with EDTA anticoagulant The samples are automatically diluted on the StaRRsed Flex during aspiration The usual amount of EDTA in sample tubes is 1 8 mg per 1 ml blood 1 ml of blood weighs ca 1060 mg and the concentration of EDTA is therefore 0 1796 and well within the requirements for the EDTA mode on this instrument Bidirectional Citrate mode StaRRsed Flex User Manual Version 1 02 MRN 151 EN Glossary of Terms 18 1 1 1 4 ESR ESR is short for Erythrocyte Sedimentation Rate It is the amount of sedimentation setting of erythrocytes red blood cells in a blood column during a specified time H 18 1 1 1 5 Hazy A sedimentation is reported to be hazy when the boundary between blood plasma and erythrocytes can not be defined clearly 18 1 1 1 6 Host In this manual the term HOST is used to indicate the computer system and associated software LIMS that provides the sample management for the laboratory 18 1 1 1 7 IVD IVD is short for In Vitro Diagnostic This kind of diagnostic is performed on biological samples in a test tube or more generally in a controlled environment outside a living organism n vitro means in glass in Latin M 18 1 1 1 8 MRN is short for Master Registration Number It is used as an identification number for any manual for Mechatronics products 18 1 1 1 9 MSDS
248. top e Hazy aspect e Temperature StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 265 mechatronics Appendix Sysmex R 3500 unidirectional protocol R 3500 sample data record format 202 bytes This is a modified data record coming from a R 3500 Sample data record format 202 bytes S O WMom3emad 05 Tube pesttoninrack 5 4 Barcode from barcode label mae Parameter Text distinction code NEED Text distinction code II Sample distinction code D Month Year 5 lt Rack no Tube position no Sequence no ID information Sample ID number Instrument ID number Text distinction code 1 D Text distinction 1 Sample distinction code 1 u Day __ _ Month 2 Year 2 4 124 Tube position no 2 0 Sequence no 5 0000 ID intormation 1 4 Sample ID number 13 Instrument ID number 9 Analysis information 1 0 Analysis information StaRRsed Flex User Manual Version 1 02 MRN 151 EN Appendix for StaRRsed Flex Page 267 Appendix for StaRRsed Flex n a not applicable R 3500 Sample data flag record format 131 bytes Parameter TAN Comment Textdistinetion code t YY Text distinction codel BY Sample distinction code 1 UP GYert 2q0 O Page 268 mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics
249. tronics Appendix for StaRRsed Flex Appendix Protocol Compact bidirectional Bidirectional protocol definition of the sample request string from the StaRRsed Flex to the Host computer Positions in the string 1 2 4 5 6 7 10 1 12 13 14 15 16 17 18 19 20 21 22 23 24 26 26 27 20 29 30 31 ESR Sample request string definition from StaRRsed Flex to host computer sx sp e sjrjs r sej1j2 3 4 5 6 7 8 9 10 11 12 1 14 15 16 t7 T8 SP SP es Definition of the string STX and ETX are at fixed position first 1 and last 31th position respectively SP Space character 20 E Capital letter E S Capital letter S R Capital letter R 1 18 Position of the sample identification left adjusted and filled up with spaces at the end of the string Checksum one char 00 that is the EXOR sum of all the data Data The position from position 2 up to and including position 29 Take position 2 and position 3 and EXOR those 2 Take the result and EXOR this with position 3 ect till the position 29 R At position 28 means that this is the Request string STX Char 02 ETX Char 03 StaRRsed Flex User Manual Page 249 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Sample conformation string definition replied by the host computer to perform an ESR test sm sp fels Ris R isp i 2 3 s e 7 a 9 10 11 12 1 14 15 16 17 18 5 Y sp
250. tting or delete the current information and continue with Next Note Only the Rinse solution input screen is shown in this manual The input screens are the same for all reagents 6 4 3 1 New reagent input cont New Reagent Information New reagent information IN Ruso SED Lot number RINSE SOLUTION Lot number 2500 E Spoelvioeistof Sp ll sung Solution de ringage Expire date Soluzione di lavaggio Soluci n de lavado Month Year Solu o rinse a 1 2000 Placed R mechatronics 3 ES Rinse solution solution To save new information click OK Page 68 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Compact FLEX program Data can be entered with the keyboard or with a barcode reader 1 2 3 4 5 First enter read the Article number Enter read Lot number Enter read the Expiry date if barcode reader is used cursor has to be in one of the two boxes If necessary adjust the date when the reagent was placed Check if the preview box shows the correct information then press OK 6 5 Maintenance screen C Sample tl History E Reagents Maintenance E E Settings m Service ED When there is a sensor alarm an alarm indicator is shown in the tab MAINTENANCE This screen has 5 sub screens emos pe cs PRIME ON PAGE 70 CLEAN CHECK SENSORS on page 73 DISPLAY ERROR HISTORY on page 79 DISPLAY MA
251. ttings 71 0 Page 214 StaRRsed Flex User Manual Version 1 02 MRN 151 EN RR mechatronics ee Appendix for StaRRsed Flex PC connections for StaRRsed Flex At the back side of the computer the following connections must be made e VGA monitor cable comes from the monitor e USB cables comes from the touch screen and the USB connection on the keyboard e serial cable1 comes from the StaRRsed Flex e Power cable comes from the power supply e Internal power cable comes from the power switch on the keyboard e When the printer is used connect the printer cable onto the 25 pink connector e The serial cable2 is a spare connection for HOST StaRRsed Flex User Manual Page 215 Version 1 02 MRN 151 EN m echatronics Appendix for StaRRsed Flex 16 1 PC connections for StaRRsed Flex Windows 7 1 VGA monitor cable comes from the monitor When a printer with a serial cable is used connect the printer cable onto the 25 pin printer port connector Com 2 not used Power switch on keyboard assembly Power cable 12V to power adapter HDMI not used Compact serial cable comes from the Interface RS232 to IIC USB connection to USB interface box in cabinet 9 USB connection for touch screen 10 USB connection to the keyboard assembly 11 Ethernet connection m o 400 RO Page 216 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Error list
252. ture StaRRsed Flex User Manual Version 1 02 MRN 151 EN Page 283 R mechatronics Work instruction StaRRsed Flex 17 WORK INSTRUCTION STARRSED FLEX Work instruction section StaRRsed Flex User Manual Page 285 Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 162 Page 1 of 1 Purpose Change Rinse pump tube Safety None Bio Hazard area Instrument Compact Revision 001 October 2012 New rinse pump tube assembly ESRIO90902 Rin SOLU ALINE New tube replacement 1 Open left cover 2 Pull pump tube slightly downwards and at the same time towards the front of the unit to release the tube out of the pump plate holder Remove the old tube from the peristaltic pump rotor Disconnect the tubing at both ends of the tube connectors Connect new tubing to both ends of the connectors Place one end of the tube in the pump plate holder Pull the new tube over the peristaltic pump rotor Pull pump tube slightly downwards and at the same time towards the back of the StaRRsed Flex ONO OPO StaRRsed Flex User Manual Page 286 Version 1 02 MRN 151 EN RR mechatronics Work instruction Number 163 Page 1 of 1 Purpose Change Saline pump tube Safety None Bio Hazard area Instrument Compact Revision 001 October 2012 New saline pump tube assembly ESRI090903 Riny SOLU ALINE EE d
253. ure corrected result from QC sample T Temperature at which the sample was measured Error Warning Only special QC errors are mentioned here general ESR warnings errors are mentioned in the next column After these columns additional data is shown pipette number dilution rate ESR30 ESR time and Aspect Scroll to the right Results are always shown with and without Temperature correction independent of the setting TEMP CORRECTION ON or OFF The following options can be selected Page 48 StaRRsed Flex User Manual Version 1 02 MRN 151 EN R mechatronics Compact FLEX program RELATED PATIENT RESULTS This screen is simular to the Display sample history screen The background colour of the patient history table is switched to light yellow to distinguish these QC related patient results from the standard patient history table Depending on the frequency of QC samples related patient results may span over multiple days and are listed per date EXPORT TO EXCEL CSV Results can be exported to a CSV file and imported in an MS Excel file for further analyses BATCH All used batches of StaRRsed Control are shown results are shown for chosen batch ID CLOSE Return to History Screen 6 3 4 2 QC normal results screen extended 54 OC Statistics and Results E117 Uncorrected QC result is T Bubbles on top ESR E117 Uncorrected QC resut is H Bubbles on top ESR irt E117 U
254. variable HGB The following 7 codes are defined 0 No errors 1 Nocells plasma found Error No contents could be detected in the pipette ESR Probably 140 mm Error Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles on page 179 4 Column height nnn Warning Column height must be between 180 and 210mm nnn the actual column height 5 Measure error Warning The down count is not equal to the up count from the measure head 6 Bubbles on top Warning Air bubbles on top of the ESR See Section Trouble shooting Air bubbles on page 179 Page 278 mechatronics StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics 7 error Error One of the following limits are out of the setting range ESR Time Column height Dilution Bubbles on top Hazy aspect Temperature StaRRsed Flex User Manual Version 1 02 MRN 151 EN Appendix for StaRRsed Flex Page 279 mechatronics Appendix for StaRRsed Flex Appendix TDLIMS protocol Tdlims sample data record format 234 bytes This is a modified data record coming from a SE9000 with instrument ID Sample data record format 234 bytes Parameter tot Comment NN 23 Day 23 Sample distinction code Rack no 1234 Rack number 1234 ID information 4 Barcode from barcode labe
255. wn sensor error Compact was not able to detect the position of the fill nozzle on the sensors e Up sensor failure the fill nozzle is not at the fill position Page 210 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex e Down sensor failure the fill nozzle is not at the home position e Check for mechanical obstruction around the fill nozzle e Fatal error call distributor 7 Rinse head up error The Rinse head down sensor was not triggered during the movement time of the carousel e Check the gap between the top of the rinse nozzle and the bottom of the pipette Should be 1 5 to 2 mm e Check if the sensor is correct or re adjust the sensor e Fatal error call distributor 8 Measure head not home error Measure head is not at the home position e Check the home sensor e Measure motor is faulty 9 Separator full error It takes too long for the waste pump to empty the liquid separator e Check separator assembly on air leaks e Replace waste tubes e Exchange waste pump cassette e Clean liquid separator StaRRsed Flex User Manual Page 211 Version 1 02 MRN 151 EN mechatronics Appendix for StaRRsed Flex Appendix Default settings StaRRsed Flex SETTINGS gt GENERAL SETTINGS Software Factory Setting Default Setting 30 min Method Off Off General settings Display dilution Off Off EDTA mode Display graph Sample probe protection
256. y e Sample probe motor driver on needle board is faulty e Sample probe is blocked e Fatal error call distributor E14 E14 is the error code and the text in the status line Outer needle motor position error home Outer needle did not reach the home sensor within a certain time limit e Check home top sensor e Outer needle tube motor is faulty e Outer needle motor driver on needle board is faulty e Motor is blocked e Outer needle is blocked e Fatal error call distributor 15 8 2 Sample probe fails to go down Under normal circumstances the sample probe goes down If sample probe fails to go down check the following e Sample probe depth wrong Check the correct sample depth SETTINGS GENERAL SETTINGS SAMPLE PROBE DEPTH e fthe sample probe has being set too deep it will touch the bottom of the sample tube The sample probe then pushes the sample tube slightly downwards and the aspiration cycle will be aborted StaRRsed Flex User Manual Page 177 Version 1 02 MRN 151 EN R mechetronics Trouble shooting e broken outer needle may cause a similar fault e Check for mechanical obstructions e Electronic failure e Fatal error call distributor e Mechanical failure e Fatal error call distributor See the Error list for other sample probe errors Page 178 StaRRsed Flex User Manual Version 1 02 MRN 151 EN mechatronics Trouble shooting 15 9 Air bubbles After a normal aspi
257. zard area Instrument StaRRsed Flex Revision 002 March 2014 Perform maintenance when the StaRRsed Flex is set in service mode in program indicated by the orange signal 1 Select on Flexlab GIU OVERVIEW StaRRsed If you have multiple StaRRsed ESR Flex select the correct instrument that you wish to perform maintenance on FlexLab36 Overview FSE 10 54 16 gt Samples Tests Exceptions InpuvOutput StaRRsed Centrifuge 1 Cenfiguration Centrifuge 2 Centrifuge 13 C Architect i2000sr 1 Architect 2000 2 2 Select STATUS from the dropdown box and hit the blue tick 3 Select GOING OFFLINE The StaRRsed Interface Module IM will go to Offline eFlexLab36 SteRRsed Status preme Me Eror Select an Option Node 10 Status 3 moon for Empty Carrlers Room for Routine Sample Room for STAT Samples o Expected 491 Incomplete 26 Complets 60 StaRRsed Flex User Manual Page 343 Version 1 02 MRN 151 EN 1 Clean Fill nozzle and exchange O ring Fill Nozzle Disassemble the fill nozzle Disassemble fill nozzle holder 1 Turn the holder to the right 1 Turn the holder to the right 2 The fill nozzle can now be removed 2 The holder can now be removed 3 Disconnect the silicon tube from the fill nozzle The use of a toothbrush and detergent is recommended 1 Carefully scrub the fill nozzle inner part 2 Useatissue to dry the fill nozzle Replace O ring

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