RR Mechatronics STARRSED RS User Manual Download Page 123

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Quality control

10.1 - Control pipettes

The correct function of the hardware and software of the Starrsed RS 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:

•

Defining control limits (accept or reject patient results)

•

Error detecting (systematic or random errors)

•

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.

Starrsed Control should not be used past the expiry date.

Mechatronics as supplier of the Starrsed Control shall not be liable for any claimed damages arising from

other than intended usage.

10.2.2 - Expected value range

Starrsed Control is assayed for Starrsed ESR analyzers. The software always calculates a temperature

corrected result because only temperature corrected results can be compared with the Assay mean value.

The assayed mean values, expected ranges and reference values are derived from validation measurements

on multiple instruments at different sites. All these values are mentioned on the product insert (the assayed

mean value encoded in the tubes barcode) and are lot-specific. 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. The values from the

Quality control

MRN-071-2-EN version 7.02 Starrsed RS

123

Summary of Contents for STARRSED RS

Page 1: ...User Manual Starrsed RS MRN 071 2 EN version 7 02 ...

Page 2: ......

Page 3: ...Sedimentation measurement principle 22 2 Instrument description 23 2 1 Technical specifications 25 2 2 Technical specifications contd 26 2 3 Used reagents 28 2 3 1 Starrsed Rinse solution 28 2 3 2 Starrsed Saline 28 2 3 3 Starrsed Diluent 28 2 3 4 Deionized water 28 2 3 5 Starrsed Disinfectant 29 2 3 6 Starrsed Cleaning Agent 29 2 4 Accessory kit 29 2 5 Starrsed line of ESR instruments 29 3 Genera...

Page 4: ... 43 6 3 History screen 45 6 3 1 Display pipette data 46 6 3 2 Display Sample history 47 6 3 2 1 Display patient results 48 6 3 3 ESR Statistics screens 49 6 3 4 Display rack history 50 6 3 4 1 Display rack status 51 6 3 5 QC Results screens 52 6 3 5 1 QC Normal results table 52 6 3 5 2 QC abnormal results table 53 6 3 5 3 QC abnormal results graph 55 6 3 5 4 QC abnormal results screen extended 56 ...

Page 5: ...ice mode 72 6 5 3 Display error history 74 6 5 4 Display maintenance history 75 6 5 5 Maintenance info 76 6 5 6 Close 76 6 5 7 End of day wash options 77 6 5 8 End of day wash schedule settings 78 6 6 General settings 78 6 6 1 Display settings 81 6 6 2 Carousel control 82 6 6 2 1 Pipette flow tests 83 6 6 2 2 Flow test start 86 6 6 2 3 Set new rinse position 87 6 6 3 Diluter settings 87 6 6 4 Limi...

Page 6: ...7 4 4 Valves and Actuators 106 6 7 5 Display error history Service 107 6 7 6 Display maintenance history Service 108 7 Getting started 109 7 1 Liquid levels 109 7 2 Limit filter settings 109 7 3 Reagents preparation 110 7 3 1 Starrsed Rinse solution QRR 010934 111 7 3 2 Starrsed Saline QRR 010933 111 7 3 3 Starrsed Diluent 111 7 3 4 De ionised water 111 7 3 5 Starrsed Disinfectant QRR 010947 111 7...

Page 7: ... Result Printout 117 9 2 1 Report 60 Minute mode 118 9 2 2 Report 30 Minute mode 119 9 3 ESR Error 119 9 3 1 ESR Error and Warning code messages 119 9 4 Limit error settings 120 9 5 Reporting range 121 9 5 1 Reporting range minumum value 121 9 6 Aspect Hazy 121 10 Quality control 123 10 1 Control pipettes 123 10 2 Monitoring measurement quality with Starrsed Control 123 10 2 1 Limitations 123 10 2...

Page 8: ...13 2 Weekly 131 13 2 1 Check the sensors in service mode 132 13 2 2 Cleaning waste separator 132 13 3 Level 4 maintenance 133 13 3 1 Pump tube replacement 133 13 3 2 Replace bacterial filters 134 13 3 3 Fill nozzle O ring replacement 134 13 3 4 Fill and clean procedure 134 13 4 Level 3 maintenance 136 13 5 Level 2 maintenance 136 13 6 Level 1 maintenance 137 13 7 Two years maintenance 137 13 8 Rea...

Page 9: ...tarrsed RS stalls 146 15 4 Diluter 147 15 4 1 Diluter system not sufficiently primed 147 15 4 2 Diluter errors 147 15 4 3 Air bubbles entering the Diluent system 148 15 5 Vacuum 150 15 5 1 Vacuum stabilisation problems 150 15 5 2 Vacuum error 150 15 6 Flushing liquids 151 15 6 1 De ionized water 151 15 6 2 Disinfectant 152 15 7 Needle system 152 15 7 1 Needle not in top position 152 15 7 2 Sample ...

Page 10: ...165 15 20 3 Check the mixer 166 15 21 LIMS Communication errors 166 15 22 Barcode reader test 166 15 23 Tube sensor detection test 167 15 24 Tube not in 1 position 167 15 25 Temperature error 167 15 26 Communication error E2 168 15 27 Quality control troubleshooting 168 16 Appendix for Starrsed RS 172 16 1 Article reference list Starrsed RS 173 16 2 Cable connection diagram 175 16 3 Tube connectio...

Page 11: ...17 Work instruction Starrsed RS 208 18 Glossary of Terms 254 Index 256 Contents MRN 071 2 EN version 7 02 Starrsed RS 11 ...

Page 12: ...net www rrmechatronics com Postal address P O Box 225 1620 AE Hoorn The Netherlands Office address De Corantijn 13 1689 AN Zwaag The Netherlands Copyright RR Mechatronics Manufacturing B V All rights reserved Subject to changes without prior notice Issued by the Support Department of RR Mechatronics Copyright 12 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 13: ...tenance instructions and maintenance information H Schavemaker 6 69 December 2015 Maintenance Appendix Addition of technical specifications Instrument naming WI 194 198 modified R 3500 EPU Protocol changed H Schavemaker 6 68 October 2014 Introduction Safety Technical specifications History screen Service screen Data management Appendix General safety instructions Explanation of documentation Fill ...

Page 14: ...endix Settings Add new the new MECHATRONICS 01 and 02 string Language selection Make a new Settings screen for limit error Replaced History and Amendment record for Document history H E van Dijk 6 50 July 2009 Reporting section Add new analyzer error number to the list 7 is limit error H E van Dijk 6 40 June 2009 Update screens to apply for the software update version 2 22 Update screens to apply ...

Page 15: ...n 5 6 1 3 to 4 Insert section 5 6 1 2 Conveyer motor test Insert in the 5 4 the fill and clean procedure All the screen shots are updated Add new work instructions 202 and 203 Correction made in WI 191 192 193 194 Add in settings carrousel the pipette flow diagram pop up screens H E van Dijk 3 00 September 2005 All sensor values are the same in the following sections Appendix Maintenance Section C...

Page 16: ...Document history overview 16 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 17: ...Date Maintenance Fill and clean without adapter with hot 80 C water may 2020 NOTE Drawing revisions for assembly purposes only are not mentioned Editorial changes and typing errors are identified with TR xxx In This Chapter List of Temporary revisions ...

Page 18: ...mity with the Westergren standard For professional use in medical laboratories only To be used for all patient populations not restricted by age or any other anatomical or physiological particulars 1 2 Indication for use of device For screening and follow up of patients with suspected inflammatory conditions Introduction 18 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 19: ...e identified sample so that a manual work sheet is unnecessary In the EDTA mode the dilution of EDTA blood with citrate is considerably more accurate 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 LIS LIMS The used sedimentation pipettes are automatically washed and d...

Page 20: ...ury due to rotating parts Warning sign to prevent personal injury due to sharp objects Warning sign to prevent personal injury due to hot surfaces Warning sign to prevent personal injury due to electrical shocks General warning General note Introduction 20 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 21: ...oubleshooting procedures to solve more complicated 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 troubleshooting flow diagrams etc Only available in English 4 Installation Manual IM Intended for train...

Page 22: ...n the natural variation in Hct between individual humans and will not have significant influence on the accuracy of the ESR measurement 1 9 Sedimentation measurement principle The automatic reading of the Westergren sedimentation pipettes is performed by moving an optical sensor along the pipettes While the sensor is moving it is taking a reading every 0 25 mm The sensor is reading the absorption ...

Page 23: ...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 cycle The fill line is back flushed using saline solution The temperature is corrected to the standard value of 18 C and ESR s may be read after one ho...

Page 24: ...ore sampling Needle unit Diluter module PC with touch screen LCD monitor Windows based platform Dedicated instrument software Optional network connections USB port Option External barcode reader which can be connected to the USB port of the ESR analyser unit This barcode reader can be used for reagent handling and for ID input in sample history search Starrsed RS with long level sensors This model...

Page 25: ...54 30 minute method R Rogers Medical Laboratory World 1994 Allowed blood specimen types For EDTA mode Whole blood with 1 EDTA anticoagulant Automatic dilution 4 vols blood 1 vol Starrsed Diluent Reported result mm after 1 hour Throughput 100 ESR requirement on total number of samples 30 minute method 135 hour 60 minute method 75 hour Reagents Reagents used QRR 010931 Starrsed Diluent QRR 010947 St...

Page 26: ...approx 5 Mb per 1000 samples results and raw data LIS connectivity Communication Ethernet and serial bi directional according various protocols 2 2 Technical specifications contd Environment Sound level Less than 65 dBA Environment temperature 18 28 C Relative humidity 10 90 Total power specifications Mains voltage 100 230V 50 60 Hz Fuse 20 x 5 mm Slow blow 230V 2 5 Amp 115 V 5 Amp Power consumpti...

Page 27: ...mensions Table space incl PC 1500x660 mm Height 770 mm Weight empty ESR unit rack 70 kg Table size Min Width excl space for PC 1100 mm Width incl space for PC 1500 mm Depth 660 mm Instrument description MRN 071 2 EN version 7 02 Starrsed RS 27 ...

Page 28: ...developed exclusively for the automatic dilution of blood samples in Starrsed ESR analyzers Approximately 0 5 ml Diluent is used for each sample Approximately 2 5 ml is used for one Prime cycle This reagent is supplied in a 5 liter container QRR 010931 The solution should be discarded if it becomes turbid If onboard containers are used If the diluent does become turbid clean the diluent bottle tho...

Page 29: ...y kit The Starrsed RS comes with an accessories kit For a complete list of the the contents of accessories kit see Appendix Article references 2 5 Starrsed line of ESR instruments The Starrsed line of ESR automated instruments is unique by the fact that it has automated the Westergren Method and fully complies with the published reference method including working with diluted EDTA blood The Starrs...

Page 30: ... When the instrument is running it is not allowed to Open and remove safety covers 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 technicia...

Page 31: ...d checked by a trained engineer prior to first operation Detailed installation instructions are given in the Starrsed RS Installation manual Connect the instrument only to a properly earthed power connection Installation MRN 071 2 EN version 7 02 Starrsed RS 31 ...

Page 32: ...s at least daily Decontaminate waste materials before disposal Wear a BUTTONED lab coat to protect your clothes Wear gloves when hands may come in contact with 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...

Page 33: ...tices 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 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...

Page 34: ...nce personnel are expected to use a laboratory coat while working in the blood laboratory We advise the use of non canvas closed toe shoes wherever there is a potential for foot injury from 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 ...

Page 35: ...5 3 E C Declaration Starrsed RS Standard Operating Procedures S O P MRN 071 2 EN version 7 02 Starrsed RS 35 ...

Page 36: ...5 4 Stickers for the onboard reagents bottles Standard Operating Procedures S O P 36 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 37: ...5 5 Stickers of the reagents cubitainers Standard Operating Procedures S O P MRN 071 2 EN version 7 02 Starrsed RS 37 ...

Page 38: ...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 Note In the next sections move the mouse over the tab and click ...

Page 39: ... downloaded from the RR Mechatronics website www rrmechatronics com Login part The following program description is valid for software from version 6 00 and up 6 2 Sample screen The main menu is displayed during operation To access other menus select the required tab on the display The following screens are selectable via the associated tabs Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 3...

Page 40: ...ng 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 The User Manual button is at the bottom of the menu Click this button to open the Starrsed RS User manual 6 2 1 Sample screen sections explanation 1 Carousel This is a graphical representation of the carousel Pipettes are filled on positi...

Page 41: ...or this sample ESR is required and waiting to be done Sample was aspirated successfully Sample was aspirated but with fill errors After processing the rack the information of the rack is transferred to the Display rack history screen 3 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 4 Sa...

Page 42: ...nput of a barcode from a sample tube 8 Status Information about the current status of the instrument 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 6 2 2 Sample screen with keyboard To view the status of a specific pipette click directly on the pipette itself...

Page 43: ...6 2 3 Pipette information The following information is shown Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 43 ...

Page 44: ...tte is marked to be washed when it reaches the rinse station This indicator is also on when a sample could not be aspirated properly Pipette disabled In case of a failing missing or broken pipette individual pipettes can be disabled only when sample mode is deactivated Click on the blue circle of the pipette click on the check box Pipette disabled and confirm disabling Disabled pipettes are indica...

Page 45: ...elected 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 Display rack history Display rack details Analyse results ESR Statistics QC Results with Starrsed Co...

Page 46: ... 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 program 46 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 47: ...m a selected time frame of the day Show results of a number of past days Default value is set for 7 days Show results of a specific day 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 co...

Page 48: ...number of past days Default value is set for 7 days Show results of a specific day Show results of the range between the first selected date to the next selected date From the selected Sample ID detailed information is shown on this screen Sample ID Sample Identification number Aspect code Shows the aspect code e g Hazy 10 ESR 30 min The 30 minute method is used This is the measured 30 minutes val...

Page 49: ...code Shows any ESR error or warning code e g Too many borders found A complete overview of measurement data is shown with activating the option Display raw data 6 3 3 ESR Statistics screens A statistical graph is produced over a selected period Make a selection of the following graphs Daily mean mm Use this to check variations in the daily mean ESR Hazy Increasing hazy aspects are an indication fo...

Page 50: ...e see ESR Error Number of samples This can be used to document variations in work load 6 3 4 Display rack history The combinations of the pictograms have the following meaning Barcode could not be read read failure Barcode was read correctly waiting for response from LIMS Barcode was read correctly but ESR is not required for this sample Starrsed program 50 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 51: ...d restart to build up a new rack history file 6 3 4 1 Display rack status More detailed information of the samples in the selected rack is shown in the status table The last 10 racks are stored and can be selected The Clear rack history button will clear the contents of the rack history file and restart to build up a new rack history file Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 51 ...

Page 52: ...esults 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 6 3 5 1 QC Normal results table The results from Starrsed Control level N are...

Page 53: ...ration 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 Unco...

Page 54: ...he LIMS available if Send QC result to LIMS is activated at QC Settings 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 ove...

Page 55: ...ated mean mean value of all QC results of the specific batch Standard deviation the average deviation of all QC results compared with the expected ESR Coefficient of variation ratio of the standard deviation to the expected ESR expressed in a percentage Number of QC results This graph gives a first indication of the measuring stability of the Starrsed RS Further analysis and identification of syst...

Page 56: ...6 3 5 4 QC abnormal results screen extended After scrolling the general data from the QC results are shown 6 3 5 5 Display sample history QC Starrsed program 56 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 57: ...ckage 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 IDs 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 ...

Page 58: ...ulated 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 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 sent to the LIMS QC Resul...

Page 59: ...6 3 7 Set start end date Enter the Start End date and time Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 59 ...

Page 60: ... and limit errors set to YES By selecting Dilution 110 all the samples with a dilution rate 110 are displayed in the table By selecting Dilution 90 all the samples with a dilution rate 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 Starrsed program 60 MRN 071 2 EN ...

Page 61: ...ples 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 program MRN 071 2 EN version 7 02 Starrsed RS 61 ...

Page 62: ...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 6 3 11 History analyse warning Starrsed program 62 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 63: ...ory to fill in all reagent information If not filled in correctly the instrument will give an alarm and does not aspirate samples The article number always has to be added this to prevent replacing a reagent with the wrong reagent Note When the expire date is exceeded the text box will flash red The software checks the reagent status before starting a new rack If a level alarm is ON it will not pr...

Page 64: ...ame for all reagents Input screen for new reagents Make a selection to add new default setting or delete the current information and continue with Next 6 4 1 1 New reagent input cont Data can be entered with the keyboard or with a barcode reader Starrsed program 64 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 65: ... reagent was placed 5 Check if the preview box shows the correct information then press OK 6 4 2 Display reagent history 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 Starrsed program MRN 071 2 EN version 7 02 Starrsed RS...

Page 66: ... sensor alarm an alarm indicator is shown in the tab This screen has 5 sub screens 1 Prime Clean 2 Check sensors 3 Display Error history 4 Display Maintenance hist 5 Maintenance Info Starrsed program 66 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 67: ...e Pipettes After each measurement the pipettes are washed and dried automatically Prime Needle nozzle After each aspiration the outer needle sample probe and fill nozzle are washed Prime Diluter The Diluter prime cycle is 5 strokes of the syringe Prime Nozzle with water After each aspiration the fill nozzle is flushed with de ionized water Prime Waste system During a pipette rinse cycle a small am...

Page 68: ... and will NOT be measured All pipettes which are currently holding samples are washed and dried once A warning is shown on the display Pipette data will be lost Fill Clean This button starts the Fill Clean 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 ...

Page 69: ... is used By toggling the switch OFF the Fill and clean without adapter is used See chapter Maintenance Fill and clean procedure for more information 6 5 1 2 Fill and Clean without cleaning adapter Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 69 ...

Page 70: ...the needle location 5 Push the silicon tube over the sample probe 6 Press Continue 7 The Fill and Clean process is started 6 5 1 3 End of day wash procedure End of day wash All pipettes will be washed once and needle fill nozzle and rinse nozzle wash station are primed 6 5 2 Check sensors Starrsed program 70 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 71: ...uent flow sensor This sensor is only used in EDTA mode When activated the indicator Stand by is activated and the indicator Flow is not When the button Test is clicked the indicator Flow must be shown as activated After finishing the test both indicators must be shown as activated Check Separator sensor Click the Check button the OK sign is shown if the sensor value is in range Check Flow sensor C...

Page 72: ...position the result of the test pipette is displayed in the field ESR mm When the sensor is out of range and a red X is shown the sensor values can be checked by turning on the service mode 6 5 2 1 Check sensors in service mode Starrsed program 72 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 73: ...dicator Stand by is activated and the indicator Flow is not When the button Test is clicked the indicator Flow must be shown as activated After finishing the test both indicators must be shown as activated Check Separator sensor The value must be in range of 200 600 700 Check Flow sensor The vacuum unit switches on and the values must be in this range Flow 0980 60 Abs 0320 10 Note If for example t...

Page 74: ...ory 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 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 program 74 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 75: ...l measurements 67890 number of total aspirations including failed measurements 6 5 4 Display maintenance history 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 Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 75 ...

Page 76: ...tenance level When this maintenance is done press the button Done to log the completed work in the maintenance log file 6 5 6 Close 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 Starrsed program 76 MRN ...

Page 77: ...The function is not active 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 defined working days default monday till friday at the selected time Other days can be set with Custom Daily The function runs on a daily base at the selected time Custom To define customised working days sun...

Page 78: ...t the time of the day in hours and minutes for automatic start of this function 6 6 General settings This screen has six sub screens 1 General settings 2 Display settings 3 Carousel control Starrsed program 78 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 79: ...samples are diluted in the Starrsed RS EDTA mode OFF Samples are presented in pre diluted CITRATE sample tubes Dilution on the Starrsed RS is switched OFF 3 Temp Correction Temp Correction ON A temperature corrected value for the ESR is shown besides the actual measured value Temp Correction OFF Only the actual measured ESR value is shown 4 Fast filling Fast filling OFF Default setting The carouse...

Page 80: ...n to the set depth Sample probe protection ON The sample probe motor will stop when a certain current limit is exceeded and returns to the home position Reset the Sample probe protection switch from ON to OFF and ON again The following numerical inputs can be made 1 Temperature in Celsius To set the correct room temperature 2 ESR sedimentation time in minutes To set the correct sedimentation time ...

Page 81: ... dilution OFF Dilution rates are only shown if they are outside the selected accepted range Results main screen To show ESR30 ESR60 and or ESR TC result on the sample screen during sampling Possible settings depends on general settings ESR30 ON OFF and Temperature correction ON OFF Sample history table column s To show ESR30 ESR60 and or ESR TC as a column in the Sample history screen Possible set...

Page 82: ...the carousel will then turn to the stop position which is always the Rinse station Set Rinse position The ESR analyser unit 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 wil...

Page 83: ...ing this function 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 adjustment Each individual pipette is tested and results are displayed in their own line of the diagram Potentiometer mean test Starrsed program MRN 071 2 EN version 7 02 Starrse...

Page 84: ...Flow Absolute flow test Leakage test Starrsed program 84 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 85: ...Fillsensor air flow test Fillsensor glass flow test Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 85 ...

Page 86: ... 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 adjustment Each individual pipette is tested and results are displayed in their own line of the diagram Starrsed program 86 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 87: ...ey for learning a new position table Note This option is used when there is a position error 6 6 3 Diluter settings 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 Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 87 ...

Page 88: ...ons 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 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 sa...

Page 89: ...tion with great caution and check the functioning very carefully See Settings Limit error settings 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 The screen Limit error settings has the following options Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 89 ...

Page 90: ... always transmit results with bubbles on top warning to the output set to NO transmit no results to the output when there is generated a warning for bubbles on top Send results with hazy aspect set to YES always transmit results with hazy aspect to the output as specified in the settings set to NO three options are possible Hazy 10 Hazy 25 and Hazy 25 transmit results to the output as specified Se...

Page 91: ...mum of 15 mm OFF Use default assay range 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 ON A sample request for the QC sample is send to LIMS The QC sample will only be processed if the...

Page 92: ... Control 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 OFF Default setting Results will not be send to LIMS data is only available on the Starrsed RS Automatically remove linked QC ID after result ON Default setting The link between Starrsed Control Sample ID and Lab ID will be deleted aft...

Page 93: ...e stored software settings Save settings as is used for storing software settings to a file There are no restrictions for the file name Save settings is used for storing software settings after settings are changed or altered 6 7 1 Rack unit setting This screen gives access to 1 Mixer motor settings 2 Conveyer motor settings 3 Position motor 4 Timing settings Starrsed program MRN 071 2 EN version ...

Page 94: ...d the number of the second mix is set default for 1 mix Check both mixing settings with the Test button Observe the numbers in the numerical field Mixing motor settings 1 Mixing direction Default setting is left 2 Mixing speed default setting 90 3 Hold level default setting 30 4 Homing speed default 20 After setting use Save settings to save the new settings If Save settings is not pressed the old...

Page 95: ...ack moves a rack in the Input pool to the catch pins CATCH rack moves a rack to the gripper when the gripper is in the IN position RELEASE rack moves a rack from the gripper release position into the END pool Switch conveyer motor OFF or ON for testing Starrsed program MRN 071 2 EN version 7 02 Starrsed RS 95 ...

Page 96: ...rument The following rack types can be selected Sysmex Low profile with multi tube holders Low profile with clips Low profile with clips and barcode id plates Coulter Coulter short Abbot long black Bayer advia Abbot Short white ABX open ABX closed Roche can be used with software version 5 02 and up See for rack example information Appendix Rack adapters Starrsed program 96 MRN 071 2 EN version 7 0...

Page 97: ...barcode label is not read correctly see section Troubleshooting Switch Check tube detection sensor Use this switch to check the correct adjustment of the optical sensor that checks for the presence of sample tubes in the rack See Troubleshooting Tube sensor does not detect tubes for further instructions Switch Always read barcode Use this switch to read the barcode at every position in the rack Th...

Page 98: ... the clamp 2 Go to MIX position This is the rotation position where the rack clamp is engaged to secure the rack for mixing the sample tubes 3 Go to 1 TUBE position This is the first hole position in the grabber cover plate at the needle position 4 Go to RELEASE position This is the position for releasing the rack The grabber will be opened and the rack is transported to the Rack out position Go t...

Page 99: ...on Troubleshooting 6 7 1 3 5 Test tube sensor Switch Check tube detection sensor Use this switch to check the correct adjustment of the optical sensor that checks for the presence of sample tubes in the rack See Troubleshooting Tube sensor does not detect tubes for further instructions Switch Always read barcode Use this switch to read the barcode at every position in the rack This tube is correct...

Page 100: ...rvice purpose only The time is factory set and there is no need to alter the time settings The timing settings T8 and T11 are used for the mixer setting 6 7 2 LIMS settings Starrsed program 100 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 101: ...SR 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 Address and TCP Port as supplied locally 6 7 2 1 Set protocol settings The following protocols can be selected for out putting data 1 No Serial output 2 MECHATRONICS 01 Bidirectional 3 MECHATRONICS 02 Unidirectional 4 ...

Page 102: ... Checksum On Off 30 Minute method On Off Ack Nack On Off 12 Vesmatic 13 Sedimatic 15 14 Sedimatic 100 15 OPUS When selected the following keys will pop up Checksum On Off 30 Minute method On Off 16 Advia 120 17 Advia 120 unidirectional 18 InteRRliner For more details see the Protocol Handbook 6 7 3 ESR unit settings Starrsed program 102 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 103: ...the Starrsed RS is connected to No need to change the default setting COM1 Select barcode reader is used in the Starrsed RS for selecting which barcode reader is used There is no need for re selecting this setting is already done by the factory 6 7 3 1 Outer needle depth Setting for the Outer needle depth Do not change the default 51 0 mm setting the setting is accomplished at the factory Select l...

Page 104: ... the ON OFF switch 6 7 4 1 Pumps 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 Do not leave this function ON as it may cause waste pump damage OFF the waste pump is switched off The waste pump is used for emptying the waste separator Saline pump ON the saline peristaltic pump is switched on OFF the saline per...

Page 105: ... home position 2 Outer needle down The Outer needle is sent to the down position 3 Sample probe up The Sample probe is sent to the up home position 4 Sample probe down The Sample probe is sent to the down position 5 Fill nozzle up The Fill nozzle is sent to the pipette position 6 Fill nozzle down The Fill nozzle is sent to the fill nozzle home position 7 Rinse nozzle up The Rinse nozzle is sent up...

Page 106: ...ence energized The function of this solenoid is to build up a vacuum in the Westergren pipette before the aspiration cycle starts 3 V Valve wash section Pipette wash vacuum control valve controls the main vacuum line between the wash station and separator 4 V Valve fill section Vacuum control fill nozzle sample probe controls the main vacuum line between the fill nozzle cap and separator Actuators...

Page 107: ...ap and separator Actuators 1 Rinse actuator Rinse solenoid active rinse valve block down 2 Fill actuator Fill solenoid active fill valve block down 6 7 5 Display error history Service Load settings is used for reloading the stored software settings Save settings as is used for storing software settings to a file There are no restrictions for the file name Save settings is used for storing software...

Page 108: ...tions for the file name Save settings is used for storing software settings after settings are changed or altered This list is a log of all the maintenance what is done which can be useful for the field engineer to check and analise the problems with the instrument The key Clear will delete all errors from the list not advised option Starrsed program 108 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 109: ...ER button 7 1 Liquid levels Liquid containers and levels must be checked frequently If the small onboard bottles are used wash and keep the bottles clean to avoid bacterial growth The Starrsed RS has liquid level sensors When the level sensor alarm appears replace reagent as soon as possible 7 2 Limit filter settings Check the Limit filter settings If it is certain that the LIMS has been programme...

Page 110: ...ies on the level sensor block Use the cable clips for guiding the electric cables 3 Remove the cubitainer screw caps and pull the necks of the bottle packs out of the cardboard box 4 Install the level sensors and spacers 5 Add new reagent information in the software WARNING Wrongly placed pickup tubes causes incorrect results or instrument malfunction Make sure to place the appropriate level senso...

Page 111: ...l is used for one Prime cycle The diluent container is a 5 liter container QRR 010931 7 3 4 De ionised water Add one or two drops of Starrsed Saline to the deionized water to avoid Reagent alarm 7 3 5 Starrsed Disinfectant QRR 010947 Pre flush the disinfectant bottle using disinfectant from the disinfectant container Fill disinfectant bottle from the 5 litre container 7 3 6 Starrsed Cleaning Agent...

Page 112: ...ssing a large batch of samples 1 Waste container should be empty 2 Check the reagents levels in containers 8 1 2 Power up sequence Switch ON procedure Switch ON the ESR analyser unit Switch ON the PC and monitor Wait until Windows is ready for use Start the Starrsed software 8 1 3 Priming the fluid system Select Maintenance Prime Clean and perform all prime sequences manually Check fluid flow thro...

Page 113: ...ore sampling by using the function Prime all units All priming functions are sequentially performed one time 8 1 4 Fill procedure Fill the sample rack with the sample tubes Observe that the barcodes are visible through the opening in the rack Place the rack in a rack adapter Set the Rack adapter in the rack loader with the barcodes facing the rack grabber Select the tab Sample and press the button...

Page 114: ...ironmental 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 8 3 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...

Page 115: ...8 3 2 Turn off sequence Close the Starrsed RS software Switch the Starrsed RS OFF Switch optional printer OFF Switch the ESR analyser unit OFF Operation MRN 071 2 EN version 7 02 Starrsed RS 115 ...

Page 116: ...3 MECHATRONICS 02 unidirectional 4 Sysmex SE 9000 5 Sysmex SE 9000 unidirectional 6 Sysmex R 3500 7 Sysmex R 3500 unidirectional 8 Sysmex R 3500 EPU 9 Compact bidirectional 10 Compact unidirectional String format for StaRRsed 11 StaRRsed III V14 12 Vesmatic 13 Sedimatic 15 14 Sedimatic 100 15 Opus bidirectional 16 Advia 120 bidirectional 17 Advia 120 unidirectional The protocol can be set in tab S...

Page 117: ...oubleshooting Air bubbles 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 9 2 Result Printout The results of the ESR measurements can be send to the printer The layout of the report depends on the selection of the 60 or 30 minute method Columns 1 Sample ID Patient number 2 Hh Not corrected 30 minute...

Page 118: ...R 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 21 and that is printed as EDTA 079 905007 Sample results ...

Page 119: ... No ESR result is given Warning Result should be reviewed before release The following codes are defined 0 No errors 1 No cells plasma found Error No contents could be detected in the pipette 2 ESR Probably 140 mm Error Extremely high ESR value 3 Too many borders found Error More than three borders found possibly air bubbles See Section Troubleshooting Air bubbles 4 Column height nnn Warning Colum...

Page 120: ...ted 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 Description of the error message L_err hhh www ttt ccc L_err means it is a limit error hhh is the 30 minutes ESR www is the 60 minute ESR ttt is the temperature corrected 60 minute result ccc...

Page 121: ...ding every 0 25 mm The sensor is reading the absorption of infrared 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 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 Hazy detecti...

Page 122: ... 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 Depending on the length of the hazy area three classes of haziness are reported Length of area Reported class Hazy area 25 mm Hazy 25 mm Hazy area 10 mm 25 mm Hazy 25 mm Hazy area 3 mm 10 mm Hazy 10 mm Hazy area 3 mm CLEAR 3 mm Reporting 122 MRN 071 2 EN...

Page 123: ...or 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 Starrsed Control should not be used past the expiry date Mechatronics as supplier of the Starrsed Control shall not be liable for any claimed damages arising from other than intended usage 10 2 2 Expected value range Starrsed Control is ass...

Page 124: ...der 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 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...

Page 125: ...n the same manner each time 4 Place Starrsed Control tube immediately after mixing into the analyzer 5 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 sent to the LIMS 6 Restore tube after each use at 18 30 C For detailed information see the Starrsed Control Package Insert The ...

Page 126: ...t 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 troubleshooting and QC Results screen for more details 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 statist...

Page 127: ... 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 Disclaimer Check the specifications of the central waste system for rules about discharging the waste 11 1 Replacing the waste container 1 Lift the left cover and pull the waste container forwards 2 Unscrew the cap 3 Place the new waste c...

Page 128: ...er than three months Prepare new reagent as described in section Reagents preparation 3 Waste bottle full message or No waste bottle message The waste container also has a level detector If a waste error is shown on the display the Starrsed RS will stop filling and cleaning pipettes until a new or empty container has been installed Empty and or replace waste container and press Clear error 4 Fatal...

Page 129: ... Drive unit 2 Measure unit 3 Rinse unit 4 Fill nozzle unit 5 Needle adapter 6 Sample probe 12 4 Error Messages The following error messages may occur during normal operation 1 Vacuum error 2 Vacuum stabilization error 3 Fill time out error 4 Diluter error 5 Position error 6 Up sensor or down sensor error 7 Rinse head up error 8 Measure head not home error 9 Separator full error The explanation of ...

Page 130: ...ction Daily WI 187 Daily maintenance Weekly WI 191 Weekly maintenance Level 4 maintenance WI 193 level 4 maintenance Every 7500 samples Level 3 maintenance WI 194 Level 3 maintenance Every 23000 samples Level 2 maintenance WI 198 Level 2 maintenance Every 46000 samples Level 1 maintenance WI 199 Level 1 maintenance Every 91000 samples Note Numbers are based on 5 days week with 350 samples per day ...

Page 131: ...nless steel plate below the pipette belt See WI Daily maintenance 13 2 Weekly The purpose of the weekly maintenance is to carry out the daily maintenance and additionally check the sensors inspect the sample needle and the vacuum pressure Detailed instructions of this procedure can be found in the Work Instruction Weekly maintenance General maintenance MRN 071 2 EN version 7 02 Starrsed RS 131 ...

Page 132: ...ntenance Check sensor Select Check Temperature sensor box Temperature sensor TS Room temperature Diluent flow sensor check Go to tab Maintenance Check sensor Select Check Diluent flow sensor box Press test When test is finished signal Standby and Flow must shown as activated Separator check Go to tab Maintenance Check sensor Select Check Separator sensor box Separator sensor 200 600 700 13 2 2 Cle...

Page 133: ...ssembly ESRI090903 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 6 Place one end of the tube in the pump ...

Page 134: ...s a zebra pattern air blood air blood nicely divided in the column Vacuum stabilisation errors may occur 13 3 4 Fill and clean procedure Note Each pipette on the pipette belt will be filled with Starrsed Cleaning Agent after one hour the first pipette is washed and dried Fill and clean with adapter Cleaning agent preparation Starrsed RS Fill and clean This cycle takes about 90 minutes 1 Fill the c...

Page 135: ...edle goes down and the fill and clean process is started 4 When all the pipettes are filled the needle goes back to the home position and the adapter is moved to the release position and will be transported into the End pool Fill and clean without adapter General maintenance MRN 071 2 EN version 7 02 Starrsed RS 135 ...

Page 136: ... the Blotting washer ESRI090026 Be careful as there may be blood in the cassette First prepare some disinfectant and put this in the waste separator Press Prime Disinfectant to pump disinfectant through the pump cassette Symptoms for a bad or faulty waste pump cassette Waste separator error Taking too long before the separator empties Detailed instructions of this procedure can be found in the Wor...

Page 137: ... applicable for Diluter syringe QWLV030009 Diluter syringe QWLV030021 has to be replaced after 2 years The following items need to be replaced annually 1 Outer needle and sample probe if needed 2 Pipette valve bodies 84 pieces QTST040001 Check 1 Adjustment of fill nozzle and rinse nozzle 2 Check measurement unit with Control pipettes All these parts except for the Control pipettes are included in ...

Page 138: ... replace the bulk reagent containers 1 Remove level sensors and spacers from the empty container 2 Remove empty container 3 Place new container 4 Remove the cubitainer screw caps and pull the necks of the bottle packs out of the cardboard box 5 Install the level sensors and spacers 6 Add new reagent information in the software WARNING Wrongly placed pickup tubes causes incorrect results or instrum...

Page 139: ...form the applicable prime step to fill the relevant tubes with reagent and remove air 13 9 Check or replace sample probe or outer needle A faulty or broken needle can cause a fill time out error or a dilution error If necessary replace the sample probe or outer needle Remove the top cover from the Rack unit General maintenance MRN 071 2 EN version 7 02 Starrsed RS 139 ...

Page 140: ...mple probe in the outer needle Replace the needles onto the needle assembly 1 Tighten the sample probe 2 Replace the correct tubes on the outer needle 3 Fasten the outer needle bolt Do not over tighten the screw 4 Replace the cover on the Rack unit 13 10 Cleaning Touch screen display Any standard glass cleaner can be used to clean the touchscreen but avoid products containing ammonia or high conce...

Page 141: ...e Starrsed RS will continue to process the remaining samples 14 2 PC output The Starrsed RS PC is equipped with an ethernet connection Software 5 0 and higher and a serial port which can be connected to any laboratory host computer system or PC The data sent by the software can also be sent to a host computer or PC for further processing 14 3 Specifications for the RS232 port The Serial RS232 sett...

Page 142: ...luted 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 availa...

Page 143: ... in the cap See Peristaltic pump tube replacement 2 Check rinse solution level If the level is insufficient a message is displayed and the alarm sounds 3 One of the tubes carrying the rinse solution may be blocked or kinked 15 1 2 Rinse solution spilling over the instrument If rinse solution spills over the top of the pipettes the following items must be checked 1 Vacuum pump Check the vacuum pres...

Page 144: ...t the rinse position 5 Flow from the rinse nozzle The nozzle or tubing may be blocked Check with Prime Disinfectant if sufficient disinfectant flows through the system 15 1 3 Rinse and Saline pump failure Rinse pump 1 Liquid flows back into the rinse bottle or cubitainer Replace the rinse pump tube 2 At the start of the rinse sequence the first pipette is not washed Replace the rinse pump tube see...

Page 145: ...ic pump tube may cause the same problem One of the tubes carrying saline may be blocked or bent 15 1 6 Saline dripping from the needle assembly If Saline drips from the needle assembly check the following 1 Does the vacuum pump work Check the vacuum pressure by using the option Check flow sensor in menu Check sensors 2 Sample probe may be blocked 3 Fill nozzle may be blocked 4 Waste line from the ...

Page 146: ...or the rinse nozzle needed only allowed for a trained technician 15 2 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 15 3 Starrsed RS stalls When the Starrsed RS is not working check the main...

Page 147: ...lled with Diluent to the tubing and fill system manually 1 Check pick up tube at the Diluent bottle or cubitainer it may be kinked 2 One of the Diluent lines has become blocked or kinked 3 Check if all tubes are still connected 4 Check if the 2 tubes ESRI070508 are still connected with the tubes ESRI070406 5 Check if the 2 tubes positioned correctly in the pinch valve 15 4 2 Diluter errors If the ...

Page 148: ...cal obstruction 2 Diluter power cable loose 3 A defective diluter motor 4 Top or bottom position sensor failure 5 Broken flexible print cable or connector 6 Motor tacho failure For Diluter failure only allowed for a trained technician 15 4 3 Air bubbles entering the Diluent system 1 Check the diluter syringe tip 2 Check on the Y piece joints and connectors for leaks and replace if necessary 3 Chec...

Page 149: ...1 Check pick up tube at the Diluent bottle or cubitainer it may be kinked 2 One of the Diluent lines has become blocked or kinked Troubleshooting MRN 071 2 EN version 7 02 Starrsed RS 149 ...

Page 150: ...nit checks the vacuum built up in a pipette just before Sampling A vacuum stabilization error will occur if it takes too long to evacuate a pipette or if vacuum level is not stable Vacuum stabilization error may caused by 1 Leakage in sample tube connecting mixing piece and fill nozzle Replace the silicone sample tube 2 Fill block washer defective or not in place Needs replacement 3 Leaking O ring...

Page 151: ...id flow Check that the peristaltic pumps are running If the pump tubes are worn or leaking replace the tubes Check that the pump tubes are installed correctly Check the tubes between the containers and pumps valves Unscrew the cap from the bottle or cubitainer Check the pick up tubes in the bottle or cubitainer Check the tubes for blockages or kinks 15 6 1 De ionized water Select from Maintenance ...

Page 152: ...locked or kinked 15 7 Needle system As soon as the barcode is accepted or the ID number keyed in manually the sample will be processed 15 7 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 Check the home sensor Sample probe motor is faulty Sample probe mo...

Page 153: ...ar fault Check for mechanical obstructions Electronic failure Fatal error call distributor Mechanical failure Fatal error call distributor See the Error list for other sample probe errors 15 8 Air bubbles After a normal aspiration 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...

Page 154: ... 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 Inspect for any cracks or deep scratches in the base that holds the fill nozzle washer or O ring 3 Check f...

Page 155: ...ipette Check the nozzle arm is tight on the rear vertical shaft Usually engineer s assistance is required It also could be that there was not enough blood in the sample tube left for complete filling A pipette which looks like zebra crossing gives ESR Error 3 15 8 3 One air bubble about 5 mm under meniscus The filling aspiration speed is not critical but should be within certain limits 1 If just o...

Page 156: ...d in the sample tube One air bubble rising can result in ESR Error code 3 15 8 5 Small air bubbles rising in pipette Usually this is caused by a dirty or damaged fill nozzle Observe the maintenance schedules Clean the fill nozzle Check the fill nozzle for damage If necessary replace the fill nozzle Sample tube is leaking on the fill nozzle side Replace the silicon sample tube Small air bubbles res...

Page 157: ...f 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 A scratched valve tube 3 A scratched valve body 4 Valve on top of the pipette is dirty or damaged 5 Check pipette bottom glass may be chipped 6 Check the pipet...

Page 158: ...mely important that the system is kept sterile Erroneous haziness looks more like haemolytic plasma than normal hazy plasma If there is an abnormal number of hazy aspects check the dispenser system carefully and clean it if there is any doubt Symptoms for a contaminated instrument 1 If more than 3 5 out of 20 measurements are reported HAZY 2 Poor meniscus may be reported 3 Incorrect results In cas...

Page 159: ...with a strong cleaning agent and clean in case of recurrent hazy results the diluent system See instructions Fill and Clean and Cleaning the diluent system for details 15 13 Fill time out error 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 ESR analyser unit aborts the fill sequence and this error message...

Page 160: ...ce Check sensors Check flow sensor 15 14 Carousel position error E18 is the error code for Carousel position error Starrsed RS 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 RS is switched OFF while the carousel is moving to the next position o...

Page 161: ...procedure must be carried out 1 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 select Delete pipette data The carousel stops moving Use the sequence mentioned above to remove the b...

Page 162: ...ettes always continues as to avoid that the samples are left in the pipettes Do not use the reagents if expired If expired reagent has been used accidentally the results obtained with these reagents may only be used when the expiry date was not exceeded more than 30 days Diluent is sensitive for bacterial growth The solution should be discarded if it becomes turbid or infected When using the small...

Page 163: ...the fill position The fill nozzle did not reach the fill position in a certain time limit Possible reason Fill nozzle motor is faulty Fill nozzle motor driver is faulty Fill nozzle is blocked Fatal error call distributor 15 17 3 Fill nozzle not at home position E13 is the error code and in the status line the text Fill nozzle did not reach the Home position within a certain time limit The fill noz...

Page 164: ...and set in Tube number 1 The Gripper motor will move the rack to the first position of the rack Check if the needle is above the first hole If the needle is not above the first hole turn the wheel on the motor until the needle is above the hole Check that the needle is going though the hole by using the Outer needle function DOWN Get the needle out of the hole press the function UP By turning the ...

Page 165: ...ext begins with Position motor error is on the IN position Could not send the rack to the IN pool to the first stop position is not on the OUT position Could not release the rack from the gripper is not on the IN position Could not send rack to the gripper Causes and solutions Check the position motor For more error numbers and details see the Error list Starrsed RS 15 20 2 Mixer module E60 and E9...

Page 166: ...er and will start mixing as soon the first barcode label is read Check the movement during the mixing and check the mixer has enough clearance to turn Check the following settings in Service Rack unit Mixer conveyer motor Number of turns long mix default 8 This is the first mix of a new rack Number of turn s short mix default 1 This is the second third etc mix of the same rack 15 21 LIMS Communica...

Page 167: ... Press TUBE position TUBE 2 the sensor indicator must not light up No tube is shown next to the grey block 8 Repeat this for all applicable tube positions If tube detection errors are persisting call for service 15 24 Tube not in 1 position Test the first hole settings select Service Rack unit Position motor Insert a sample rack with a sample tube in the grabber 1 Press IN position and put the rac...

Page 168: ...6 Command 28 TWSR 0 E 3 The indication of the board gives the first location to check but because all PCB s are internally connected the error can be originated on another location in the instrument The other codes command XX TSWR XX and E XX are indicators for status actions from software and I2C connections Each board has its own range of commands and can not be explained in one way Most common ...

Page 169: ...ature correction Check temperature correction setting E118 Uncorrected QC result is within acceptable range but corrected result is out of range ESR Result is given Temperature correction not activated 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 correct...

Page 170: ...ked QC IDs table may only contain one link to a particular Lab ID Consider changing Automatically remove linked QC ID after result option to YES Last QC result was out of range Continuing could produce incorrect results Do you still want to continue Result of last QC sample was not within acceptable range The last QC result should be evaluated by authorized staff to decide whether the Starrsed RS ...

Page 171: ... give some deviation in the general QC results statistics 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 It is possible that a new batch is in use without changing to the new assayed mean value Systematic QC errors with a trend in control values QC results...

Page 172: ...16 Appendix for Starrsed RS Appendix section Appendix for Starrsed RS 172 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 173: ...SRI090902 Rinse Tube assembly ESRI090903 SESRI090903 Saline Tube assembly ESRI090921 SESRI090921 Wastepump cassette assembly ESRI110001 SESRI110001 Ruler Starrsed ESR unit ESRI110004 SESRI110004 Tube silicon 1 5x3 2 Fill clean ESRI110105 SESRI110105 Label Waste 2500ml QEDK100001 SQEDK100001 Euro power cable straight QEDV130019 SQEDV130019 Fuse 2 5 A 230V Slow QEDV130022 SQEDV130022 Fuse 5 A 110V S...

Page 174: ...ill and clean rack QWFG010500 SQWFG010500 Plug for Fill and clean adapter ESRI110920 SESRI110920 Spacer for cubitainer When using Plastic container for Deionized water storage ESRI110106 SESRI110106 Deionized water sticker 5L QWFG010903 SQWFG010903 Bottle 5L for Deionized water QWLV020244 SQWLV020244 Adapter for Deionized water bottle QWLV010245 SQWLV010245 Cap for Deionized water bottle ESRI11094...

Page 175: ...16 2 Cable connection diagram Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 175 ...

Page 176: ...16 3 Tube connection Starrsed RS Appendix for Starrsed RS 176 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 177: ...Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 177 ...

Page 178: ...f Virtual keyboard On On Print after measurement Off Off Check for duplicate IDs Off Off Temperature 18 C 18 C ESR sedimentation time 60 Min 60 Min Sample probe depth 5 mm 5 mm Pipette wash time 7 sec 7 sec Pipette dry time 9 sec 9 sec Mixing interval 90 sec 90 sec Diluter settings Settings Diluter settings Dilution adjust Automatic Automatic Dilution error detect 10 10 Auto dilution adjust On On ...

Page 179: ...d results with temperature exceeded No No Settings QC Settings Use default assay range On On other options Off Off Mixer motor settings Service Rack unit settings Software Default Setting Factory Setting Client Settings Mixing direction Right Right Mixing speed 90 90 Hold level 30 30 Homing speed 20 20 Conveyer motor Conveyer belt speed 100 100 Position motor Rack selection depending on customer S...

Page 180: ...ompact unidirectional Checksum On On 30 Minute Output Off Off Ack Nack Off Off Service serial output settings Starrsed RS settings note ASRL with Windows XP COM with Windows 7 10 Software Default Setting Factory Setting Client Settings Starrsed RS connected to comport I o COM1 I o COM1 Printer port I o LPT1 I o LPT1 Select barcode reader Opticon Opticon Search in example history Off Off Outer Need...

Page 181: ...d results with bubbles on top warning No Yes Send results with hazy aspects Hazy 10 Yes Yes Hazy 25 No Hazy 25 No Send results when temperature exceeded No 18 25 Yes Note When an option is set to YES and this limit error occurs results will be printed send to the LIMS Note When an option is set to NO and this limit error occurs results are not printed send to the LIMS Appendix for Starrsed RS MRN ...

Page 182: ...o accept check digits however this needs to be programmed by the distributor Coda bar Code 39 Code128 UPC EAN and ITF 2 or 5 barcode types can be read with these barcode reader types To set up the barcode readers to client specifications use the set up tools for the barcode readers Detailed information can be found in Keyence Configuration manual MRN 011 or in Opticon Configuration manual MRN 015 ...

Page 183: ... monitor cable comes from the monitor USB cable comes from the touch screen The serial cable comes from the Starrsed RS Power cable comes from the power supply When the printer is used connect the printer cable onto the 25 pin connector The host serial cable is connected to the connecter with the arrow Windows 7 Version Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 183 ...

Page 184: ...ed 4 Power switch on keyboard assembly 5 Power cable 12V to power adapter 6 HDMI used for wide screen monitor cable comes from the monitor 7 Com1 Compact serial cable comes from the Interface RS232 to IIC 8 USB connection not used 9 USB connection for touch screen 10 USB connection not used 11 Ethernet connection Windows 10 Version The computer has the following connections Appendix for Starrsed R...

Page 185: ...Ethernet connection for LIMS 5 Ethernet connection 6 USB Ports for Touch screen monitor and Interface RS232 to IIC 7 VGA not used 8 COM 3 Serial connection not used 9 COM2 Serial connection for LIMS 10 COM 1 Serial connection RS232 to IIC 11 HDMI monitor cable comes from the monitor 12 Power cable Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 185 ...

Page 186: ... Home sensor Motor is faulty Motor driver on drive board is faulty E4 Sample probe not in top position home Sample probe not back at Home position after sampling a tube Check sample probe home sensor Sample probe motor is faulty Sample probe motor driver on needle board is faulty Sample probe is blocked E5 Duplicated ID Sample rejected Sample already in carousel Wait until sample is measured Check...

Page 187: ...s home position after the error Check if outer needle is clogged up with rubber Sample probe maybe bend E11 Sample probe not on position going down Timeout error Sample probe did not go down within a certain time limit Sample probe motor is faulty Sample probe motor driver on needle board is faulty Sample probe is blocked E12 Dilution error wrong or no diluent flow Check the diluter Diluter malfun...

Page 188: ...Check piercing position sensor E21 No USB IO device detected Check USB IO Device settings USB IO Device enabled but not detected Check power to USB IO Device Check USB cable USB IO Device driver not installed Check USB IO Device settings E22 Waste bottle full Empty waste bottle and clear error Check level sensor E23 Fill sensor out of range Check clean this sensor The Fill sensor has reached a cri...

Page 189: ...twork or USB devices are used E30 No ACK NACK received from host after sending inquiry No response from Host within a certain time limit after sending an inquiry 3 times Check communication cable between Host and Starrsed RS computer Check serial port settings baud rate etc Check protocol settings Check Host computer E31 NACK received from host after sending inquiry Did not receive ACK from Host a...

Page 190: ...d E43 Motor settings error Settings loaded from Eeprom Check settings before sampling Motor settings in Eeprom do not match settings saved to file Settings in Eeprom OK and loaded from Eeprom Check motor settings and save settings Configuration file maybe corrupted E44 Settings in Eeprom does not match with settings saved to file Check settings before sampling Settings stored in Eeprom are OK and ...

Page 191: ...Eeprom Settings are loaded from file Check Motor settings and save settings Possible hardware failure in Eeprom E57 Checksum error current table Checksum error on current settings stored in Eeprom Settings are loaded from file Check Current settings and save settings Possible hardware failure in Eeprom E58 Checksum error time table Checksum error on timing settings stored in Eeprom Settings are lo...

Page 192: ...E64 Position motor error Not on position IN Gripper did not reach the IN catch position Starting point MIX position See E61 E65 Position motor error Not on position MIX Gripper did not reach the MIX position Starting point FILL position See E61 E66 Gripper error Rack not in gripper Follow the instructions on the screen Check height of the tubes in the rack Check gripper sensor Check rack adapter E...

Page 193: ...tion motor E75 Position motor error Not on position IN Could not send start the conveyer belt motor the rack into the gripper because the position gripper motor is not on the IN position Check the position motor E76 Can t start mixing long Rack not on mix position Could not start the mixer motor because the position gripper motor is not on the MIX position Check the position motor E77 Can t start ...

Page 194: ...sition MIX Gripper did not reach the MIX position Starting point OUT position See E61 E89 Position motor error Can t initialize motor due to a possible hardware error Please exit and then restart Starrsed RS If this error occurs repeatedly please note the error code before seeking assistance After an rack error the position motor tried to initialise its home position but could not succeed due to a...

Page 195: ...sition MIX Gripper did not reached the MIX position Starting point FILL position See E61 E100 Position motor error Not on position MIX Gripper did not reached the MIX position Starting point IN position See E61 E101 Position motor error Not on position FILL Gripper did not reached the FILL position Starting point last sampled tube See E61 E102 Position motor error Not on position MIX Gripper did n...

Page 196: ...ean outside aspiration needle X X X X X X Check tubing diluent syringe X X X X X X Clean outside instrument X X X X X X Clean Fill nozzle X X X X X Clean waste separator X X X X X Check sensors X X X X X Replace Fill nozzle O ring X X X X QWLV050004 12 Replace bacterial air filter HEPA X X X X QWLV040002 12 Replace Disc filter white Only if internal waste container is used X X X X QWLV040001 12 Re...

Page 197: ...washer X ESRI030906 1 Replace Sample probe assembly X ESRI050909 1 Replace Pipette valves bodies 84 pieces X QTST040001 84 Only applicable for Diluter syringe QWLV030009 Diluter syringe QWLV030021 has to be replaced after 2 years Replace Outer needle assembly X VERA059009 1 Replace all tubing with Tubing set X VERA079200 1 Check Rack transport unit X Note Periodical Maintenance Kit VERA110985 cont...

Page 198: ...ESRI070924 Fill tube assembly to regulator ESRI070924 Fill tube assembly from regulator QWLV030021 Diluter Syringe QWLV080002 Quad Ring Appendix for Starrsed RS 198 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 199: ...th clips when racks are used in which sample tubes are not fixed Some rack adapters holds two racks simultaneously and should always be loaded with two racks Sysmex Use VERA149002 when the Starrsed RS is used with racks from a Sysmex XN line Modification set to convert VERA149001 to VERA149002 Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 199 ...

Page 200: ...For manual patient id handling Beckman Coulter Appendix for Starrsed RS 200 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 201: ...Abbott Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 201 ...

Page 202: ...Bayer Horiba Yumizen H Horiba ABX Appendix for Starrsed RS 202 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 203: ...Roche Order number overview VERA149001 Sysmex Low profile with multi tube holders Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 203 ...

Page 204: ...bot Short white CD3500 3700 VERA149008 ABX open Pentra 80 VERA149009 ABX closed Pentra 120 VERA149010 Coulter HmX VERA149011 Horiba Yumizen H VERA149021 Beckman Coulter DXH 800 VERA149022 Roche Rack adapters for other rack types can be developed on request Please contact support rrmechatronics com for details Appendix for Starrsed RS 204 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 205: ...munication setting for the barcode reader and is set on default 9600 baud The right row JP2 is for the communication port settings and is set on default 4800 baud To change the port setting replace the jumper to the required setting you want Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 205 ...

Page 206: ...2 SD TXD Output Transmit Data a k a TxD Tx Sending data to DTE 3 RD RXD Input Receive Data a k a RxD Rx Arriving data from DCE 4 DTR Output Data Terminal Ready Raised by DTE when powered on In auto answer mode raised only when RI arrives from DCE 5 GND SG ground 6 DSR Input Data Set Ready Raised by DCE to indicate ready 7 RS RTS Output Request To Send Raised by DTE when it wishes to send Expects C...

Page 207: ...following connections must be made Female side Pin no Male side Pin no 2 2 3 3 5 5 If you have no result you can try changing the following pin wires Female side Pin no Male side Pin no 2 3 3 2 5 5 Appendix for Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 207 ...

Page 208: ...17 Work instruction Starrsed RS Work instruction section Work instruction Starrsed RS 208 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 209: ... 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 6 Place one end of the tube in the pump plate holder 7 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 RS Note The w...

Page 210: ...h the waste 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 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 Remove the old blotting washer ESRI09002...

Page 211: ...lamp 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 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...

Page 212: ... 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 1 Push and pull vertically the pipette from the holding position of the belts 2 Take pipette off the carousel 3 Store the pipette on a safe place Switch Starrsed RS ON 1 Carefully clean the inner part of the measuring sensor by using a cotton bud 2 Check...

Page 213: ...ally 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 Clean Replace the top cover 1 Put the cover carefully over the ESR unit 2 Fasten the two rear screws of the top cover If present if needed Switch ON the Starrsed RS Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 213 ...

Page 214: ...he top cover 1 Switch Instrument OFF 2 Remove the two rear screws of the top cover 3 Lift the top cover carefully from the ESR unit Pipette removal 1 Push and pull vertically the pipette from the holding position of the belts 2 Take pipette off the carousel 3 Store the pipette on a safe place Work instruction Starrsed RS 214 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 215: ...ed 8 Fit the bottom tube clamp and V seal ring 9 Check the position of the valve If incorrect disassemble pipette valve and tube and re assemble again 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 sh...

Page 216: ...repair set QWLV030901 5 Moisten the tip with water for easy re assembly of the tip back into the glass syringe barrel 6 Install the syringe back on to the attachment 7 Replace the new plunger in the diluter assembly Clean dilution system 1 Perform Prime diluent Repeat above step until there are no air bubbles in the whole diluent system anymore Check your dilution settings 1 Select display dilutio...

Page 217: ...ll parts with hot water and a brush B Use some acid free vaseline on the screw thread of the glass jar the top rim of the glass jar the O ring for the HEPA filter and the black PVC pipe on the back Replacing C If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange filter QWLV040002 Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 217 ...

Page 218: ...d assembling the fill nozzle replace O ring QWLV050004 or fill nozzle pipe ESRI030263 1 2 3 Clean fill nozzle The use of a toothbrush and detergent is recommended Carefully scrub the fill nozzle inner part Use a tissue to dry the fill nozzle Take the top part away from the fill nozzle for O ring replacement Work instruction Starrsed RS 218 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 219: ...Place Fill nozzle Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 219 ...

Page 220: ...of 1 Purpose Replace the pinch valve tube ESRI010246 Safety Bio Hazard area Instrument Starrsed RS Revision 002 February 2019 Replace the pinch valve tube ESRI010246 Work instruction Starrsed RS 220 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 221: ... plate below the pipettes with disinfectant 12 Disconnect waste connection 13 Disconnect power 14 Cover machine with dust protection Before starting normal operation ESR unit 1 In case of physical removal of instrument check levelling 2 Check tubes and replace tubes if needed 3 Connect saline and rinse pump tubes 4 Re install tubes in pinch valves 5 Replace fill nozzle o ring 6 Check needle condit...

Page 222: ...ved from all tubing 7 Remove tubing from reagent pumps 8 Release tubing from pinch valves Diluter valve Sample valve and Vacuum valve 9 Check if the separator is clean 10 Clean outside of the sample needle 11 Clean outside of instrument Wipe outer surface and stainless steel plate below the pipettes with disinfectant 12 Disconnect waste connection 13 Disconnect power Preparation for temporary stor...

Page 223: ... disinfectant 6 Leave the disinfectant in the system for 15 minutes Step 2 1 Take the diluent suction tube out of the disinfectant 2 Wipe the tube clean and dry with a tissue 3 Empty the bottle and refill it with hot de ionized water 80 C 4 Place diluent suction tube in the bottle with hot water 5 Use the Prime function 6 After the prime sequence stops press Prime again to fill the dispenser syste...

Page 224: ... Inspect the peristaltic pump tubes and connections for leaks Check that liquid does not run back after the pumps have stopped 3 Clean the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles 5 Check Diluent syringe for trapped air bubbles 6 If trapped air bubbles are found go to tab Maintenance click button Prime Clean and perform the Prime Diluent Diluter functi...

Page 225: ...nstrument Starrsed RS Revision 003 2019 Clean Fill nozzle 1 2 3 4 Clean fill nozzle The use of a toothbrush and detergent is recommended Carefully scrub the fill nozzle inner part Use a tissue to dry the fill nozzle 5 6 7 Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 225 ...

Page 226: ...e on the screw thread of the glass jar the top rim of the glass jar the O ring for the HEPA filter and the black PVC pipe on the back Replacing C If applicable replace the bacterial HEPA filter For Maintenance Level 4 Exchange filter QWLV040002 Work instruction Starrsed RS 226 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 227: ... 50 10 Temperature sensor check Go to tab Maintenance Check sensor Select Check Temperature sensor box Temperature sensor TS Room temperature Diluent flow sensor check Go to tab Maintenance Check sensor Select Check Diluent flow sensor box Press test When test is finished signal Down and signal Up must be green Separator check Go to tab Maintenance Check sensor Select Check Separator sensor box Se...

Page 228: ...an the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles 5 Check Diluent syringe for trapped air bubbles 6 If trapped air bubbles are found go to tab Maintenance click button Prime Clean and perform the Prime Diluent Diluter function 7 Wipe outer surface and stainless steel plate below the pipettes with disinfectant Work instruction Starrsed RS 228 MRN 071 2 EN...

Page 229: ...d RS Revision 004 2019 Clean Fill nozzle and exchange O ring Fill Nozzle 1 2 3 4 5 6 Clean fill nozzle The use of a toothbrush and detergent is recommended Carefully scrub the fill nozzle inner part Use a tissue to dry the fill nozzle 7 8 9 Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 229 ...

Page 230: ... Clean all parts with hot water and a brush B Use some acid free vaseline on the screw thread of the glass jar the top rim of the glass jar the O ring for the HEPA filter and the black PVC pipe on the back Work instruction Starrsed RS 230 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 231: ...ll 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 6 Place one end of the tube in the pump plate holder 7 Pull the new tube over the peristaltic pump rot...

Page 232: ...apter and mix well 4 Put the adapter in the Input pool 5 Select Maintenance Prime Clean button Fill and clean Start Fill and clean procedure 1 Select button OK 2 The adapter will be transported to the needle position 3 The needle goes down and the fill and clean process is started 4 When all the pipettes are filled the needle goes back to the home position and the adapter is moved to the release p...

Page 233: ...r MS 50 10 Temperature sensor check Go to tab Maintenance Check sensor Select Check Temperature sensor box Temperature sensor TS Room temperature Diluent flow sensor check Go to tab Maintenance Check sensor Select Check Diluent flow sensor box Press test When test is finished signal Down and signal Up must be green Separator check Go to tab Maintenance Check sensor Select Check Separator sensor bo...

Page 234: ...an the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles 5 Check Diluent syringe for trapped air bubbles 6 If trapped air bubbles are found go to tab Maintenance click button Prime Clean and perform the Prime Diluent Diluter function 7 Wipe outer surface and stainless steel plate below the pipettes with disinfectant Work instruction Starrsed RS 234 MRN 071 2 EN...

Page 235: ...d RS Revision 003 2019 Clean Fill nozzle and exchange O ring Fill Nozzle 1 2 3 4 5 6 Clean fill nozzle The use of a toothbrush and detergent is recommended Carefully scrub the fill nozzle inner part Use a tissue to dry the fill nozzle 7 8 9 Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 235 ...

Page 236: ...0902 New saline pump tube assembly ESRI090903 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 Work instruction Starrsed RS 236 MRN 071 2 EN version 7 02 Starrs...

Page 237: ...the adapter 180 ml 2 Add cleaning agent QRR 010905 till the second marker in the adapter 18 ml 3 Place the two caps on the adapter and mix well 4 Put the adapter in the Input pool 5 Select Maintenance Prime Clean button Fill and clean Start Fill and clean procedure 1 Select button OK 2 The adapter will be transported to the needle position 3 The needle goes down and the fill and clean process is s...

Page 238: ...easure sensor MS 50 10 Temperature sensor check Go to tab Maintenance Check sensor Select Check Temperature sensor box Temperature sensor TS Room temperature Diluent flow sensor check Go to tab Maintenance Check sensor Select Check Diluent flow sensor box Press test When test is finished signal Down and signal Up must be green Separator check Go to tab Maintenance Check sensor Select Check Separat...

Page 239: ...eparator 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 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 Remove the old blotting washer ESRI090026 around the ...

Page 240: ...ck that liquid does not run back after the pumps have stopped 3 Clean the outer needle with disinfectant 4 Check tubing from the syringe for trapped air bubbles 5 Check Diluent syringe for trapped air bubbles 6 If trapped air bubbles are found go to tab Maintenance click button Prime Clean and perform the Prime Diluent Diluter function 7 Wipe outer surface and stainless steel plate below the pipet...

Page 241: ...ier hoort ook 21490 in Check your on board diluent container Recommendation is to clean the bottle when you replace the 5 liter container Diluent Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 241 ...

Page 242: ...RS Revision 004 Jan 2019 Clean Fill nozzle and exchange O ring Fill Nozzle 1 2 3 4 5 6 Clean fill nozzle The use of a toothbrush and detergent is recommended Carefully scrub the fill nozzle inner part Use a tissue to dry the fill nozzle 7 8 9 Work instruction Starrsed RS 242 MRN 071 2 EN version 7 02 Starrsed RS ...

Page 243: ...0902 New saline pump tube assembly ESRI090903 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 Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed R...

Page 244: ...Starrsed RS 4 Fill and clean Start Fill and clean procedure 1 Select button OK 2 The adapter will be transported to the needle position 3 The needle goes down and the fill and clean process is started 4 When all the pipettes are filled the needle goes back to the home position and the adapter is moved to the release position and will be transported into the End pool Work instruction Starrsed RS 24...

Page 245: ...easure sensor MS 50 10 Temperature sensor check Go to tab Maintenance Check sensor Select Check Temperature sensor box Temperature sensor TS Room temperature Diluent flow sensor check Go to tab Maintenance Check sensor Select Check Diluent flow sensor box Press test When test is finished signal Down and signal Up must be green Separator check Go to tab Maintenance Check sensor Select Check Separat...

Page 246: ...eparator 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 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 Remove the old blotting washer ESRI090026 around the ...

Page 247: ...er 3 Replace the O ring and the tip 4 Replace the old tip for the new tip assembly From repair set QWLV030901 5 Moisten the tip with water for easy re assembly of the tip back into the glass syringe barrel 6 Install the syringe back on to the attachment 7 Replace the new plunger in the diluter assembly Clean dilution system 1 Perform Prime diluent Repeat above step until there are no air bubbles i...

Page 248: ...ontainers after the pumps have stopped 2 Check tubing from the syringe for trapped air bubbles 3 Check Diluent syringe for trapped air bubbles 4 If trapped air bubbles are found go to tab Maintenance click button Prime Clean and perform the Prime Diluent Diluter function 5 Wipe outer surface and stainless steel plate below the pipettes with disinfectant 11 Exchange air filter Air filter replacemen...

Page 249: ...rt no QWLV040003 5 Fill block washer Part no ESRI030906 6 Waste container filter disc QWLV040001 only applicable if internal waste container is used 7 Teflon tip of syringe on the Diluter assembly Only applicable for Diluter syringe QWLV030009 Diluter syringe QWLV030021 has to be replaced after 2 years The following items need to be replaced annually 1 Outer needle and sample probe if needed 2 Pip...

Page 250: ...e second marker in the adapter 18 ml 3 Place the two caps on the adapter and mix well 4 Put the adapter in the Input pool 5 Select Maintenance Prime Clean button Fill and clean Start Fill and clean procedure 1 Select button OK 2 The adapter will be transported to the needle position 3 The needle goes down and the fill and clean process is started 4 When all the pipettes are filled the needle goes ...

Page 251: ...Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 251 ...

Page 252: ...bber 6 Press TUBE position 1 mixer is now moving to the 1 position 7 Adjust the sensor with a screw driver until the sensor LED changes from orange to green and also a Tube detected is shown next to the green block on the software screen 8 Press Mix position The sensor indicator on the software screen must not light up No tube is shown next to the grey block The sensor LED is still orange B Activa...

Page 253: ...If the barcode could not be detected the tube position is logged as empty In that case the barcode reader itself must be adjusted Work instruction Starrsed RS MRN 071 2 EN version 7 02 Starrsed RS 253 ...

Page 254: ...for Erythrocyte Sedimentation Rate It is the amount of sedimentation setting of erythrocytes red blood cells in a blood column during a specified time Hazy A sedimentation is reported to be hazy when the boundary between blood plasma and erythrocytes can not be defined clearly HOST In this manual the term HOST is used to indicate the computer system and associated software LIMS that provides the s...

Page 255: ...WI is short for Work Instruction and is used with an index number for a range of work instructions MRN 071 2 EN version 7 02 Starrsed RS 255 ...

Page 256: ...ter 151 Diluter 147 Diluter errors 147 Diluter settings 87 Diluter system not sufficiently primed 147 Dilution principle 22 Disinfectant 152 Display error history 74 Display error history Service 107 Display maintenance history 75 Display maintenance history Service 108 Display patient results 48 Display pipette data 46 Display rack history 50 Display rack status 51 Display reagent history 65 Disp...

Page 257: ...vice 18 Installation 31 Instrument description 23 Instrument overview 19 Intended use of device 18 Introduction 18 L Leaking pipettes 157 Level 1 maintenance 137 Level 2 maintenance 136 Level 3 maintenance 136 Level 4 maintenance 133 Limit error settings 89 Limit error settings 120 Limit filter settings 109 Limitations 123 LIMS Communication errors 166 LIMS settings 100 Linked QC IDs 57 Liquid lev...

Page 258: ...sult Printout 117 Rinse and Saline pump failure 144 Rinse nozzle wash station alignment errors 158 Rinse solution not primed through the system 143 Rinse solution spilling over the instrument 143 RS 232 board baud rate settings 205 S S O P for working with bio hazardous materials 32 Safety warning 30 Saline dripping from the needle assembly 145 Sample probe fails to go down 153 Sample probe is not...

Page 259: ... Test position motor 98 Test tube sensor 99 Timing settings 100 Troubleshooting 142 Tube connection Starrsed RS 176 Tube not in 1 position 167 Tube sensor detection test 167 Turn off 114 Turn off sequence 115 Two years maintenance 137 U Usage options 124 Used reagents 28 V Vacuum 150 Vacuum error 150 Vacuum stabilisation problems 150 Valve control 106 Valves and Actuators 106 W Waste disposal 127 ...

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