Microsed System - star lab company
Contents
1. System USER S MANUAL Manual code MAN 074 Revision date Augus io This user manual follows the directions prescribed by UNI EN 591 2001 Instructions for use for in vitro diagnostic instruments for professional use INSTRUMENT NAME MICROSED SYSTEM ESR Automated Analyzer 10 measuring channels INSTRUMENT MANUFACTURER VITAL DIAGNOSTICS s r l Via Balzella 41 G 4 47122 FORLI ITALY phone 39 0543 72 12 20 fax 4 39 0543 79 60 01 INSTRUMENT DISTRIBUTOR MICROSED USER S MANUAL Vital Diagnostics CONTENTS Page 1 5 C 6 2 IMPROPER USE 6 3 SYSTEM DESCRIPTION 3 1 ANALYZER hsec send e sake iro lea CI 3 2 POWER SUPPEYS s 238 2040 SR EE SU S EN De AES 3 3 DIS PEAY H 3 4 FEADINGIPEATE 3 5 BAR CODE READER OPTIONAL tasas 7 3 6 PRINTER OPTIONAL ie e 7 3 1 anesan no S AA e 7 3 2 TUBES HANDLING REQUIREMENTS eis cette dee eene ederet ee 7 3 3 TUBES STORAGE REQUIREMENTS 7 4 POTENTIAL DANGERS2. 8 Collagenosis intravenously 9 Biliary or portal cirrhosis Normality of ESR most cases 1 Acute and chronic contagious diseases 1 First stage acute appendicitis 2 Acute localised infections in the first 24 hours 3 Reactivation of a chronic infection 2 Precocious integral ectopic pregnancy 4 Rheumatic illness 3 Malarial paroxysm 5 Rheumatoid arthritis 4 Cirrhosis of the liver 6 Myocardial infarction 5 Arthrosis 7 Malignant tumour with necrosis 6 Mononucleosis 8 Hyperthyroidism 7 Acute allergies 9 Hypothyroidism 8 Viruses without complications 9 Peptic ulcer 10 Typhoid fever 11 Undulant fever Pag 16 21 Vital Diagnostics MICROSED USER S MANUAL 13 Acute hepatitis 12 Rheumatic carditis with 14 Ectopic pregnancy cardiac decompensation unbroken after the third month 13 Whooping cough Variation of the ESR due to External agents once blood is in the tube a dilution ratio b bubbles strongly haemolytic samples d sudden agitation temperature time after sample collection 9 direct sunlight h foam lipemic samples A 4 Bybliography 1 THYGESEN J E 1942 The mechanism of blood sedimentation Acta Medica Scandinavia Suppl 134 2 WINTROBE M M and Landsberg J W 1935 A standardised technique for the blood sedimentation test American Journal of Medical Sciences 189 102 3 HARDWICKE J and SQUIRE J R 1965 The basis of the erythrocyte sedimentation rat
3. SAFETY MEASURES AND 0 8 4 1 USER PRECAUTIONS iret eorr debere e rer iles 8 4 2 EPEGTBIGADEQUIPMENT c ettet ee tru dee 4 8 4 3 MEGHANICAL EQUIPMENT te 8 4 4 SAMPBES 2 2 oes t uM UR E E RUE D EN AEE eR Lt 8 4 5 NOTES ON SAFETY MEASURES insere etn 8 4 6 RESIDUAL RISKS t e Leer t A d d aci De Jah acide Mer 9 4 7 DISPOSAL ANDI RECYCLING sec Ate ich ns b eddie sled eee ss 9 5 INSTALLATION 10 5 1 POSITIONING OF THE ANALYZER Qu ccccccccescccsccssccssccssccssscssecsssesssssssecssscssscssscsscesscesssesscesssessessssessecssscsuseaes 10 5 2 INSTRUMENTS TART UP 2 eee E ES tM tit a Sa 10 6 OPERATING PROCEDURE 3 ecissscsccsscseteoscsccovscsnosessvsssececccsdescovedeveceoebeveotessdecbaetedcoussonscoasschsacesiseaeseuesoossesae 11 6 1 SAMPLE S GOLIEGTION eri rie EPOR RO RED NUR RR teu CREAN RE E REN ETUR UR OSTEN NTC TREE 11 6 2 TUBES LABELING 11 6 3 MIXING Detto ca tete te eh tra eed etie ea E ed 11 6 4 SAMPLE INSERTION corr ciam leve e cre D cod ec Dese A X oa ae IAS 11 6 5 SAMPLE IDENTIEIGATION oen e EU E t
4. ONNECTOR DESCRIPTION AND DATA FORMAT NOTE Data format is 9600 bps 8 data bit 1 stop bit no parity hardware protocol RTS CTS for printer no protocol for barcode scanner Instrument 9 pin female connector PIN DIRECTION NAME DESCRIPTION T Do not connect 2 INPUT RXD Barcode data input 3 OUTPU TXD Printer Host data output 4 OUTPU DTR Data Terminal Ready 5 GND Ground 6 sam Do not connect 7 OUTPU 12 Power supply for external custom printer 8 INPUT CTS Clear to send 9 oS Do not connect DIRECT HOST CONNECTION CABLE EXAMPLE Note The connectors of the cable are 9 pin Male instrument Female to host WN Ow ON W HOST PRINTER AND BARCODE CONNECTION CABLE EXAMPLE Note The connectors of the cable are 9 pin The printer must be connected and ready to print 2 Male barcode reader 5 d Male instrument 3 t o 3 Female printer 8 8 5 5 7 7 3 Male host 5 19 21 Vital Diagnostics MICROSED USER S MANUAL E TECHNICAL SPECIFICATIONS Area of application Instrument size Weight Instrument input power External power supply unit input power Operating Conditions Reading channels Reading time selectable Analytical capacity Loa
5. OSED USER S MANUAL Vital Diagnostics AA Bybliography 55 t oe ta eR ta eta f eiu 17 B PERFORMANCE CRITERIA AND LIMITATIONS 17 Bi Performance e eret stet etti Pere oet eene eeu ete ted rises 17 B 2Limitatlong e see ee et e Re ettet RRA 17 C DIP SWITCH CONFIGURAT ION eene sinks tese tas baee anas ess ases n ense sesta aet 18 D RS232 CONNECTOR DESCRIPTION AND I O DATA FORMAT 19 E TECHNICAL SPECIFICATIONS seta e setae base 20 EG DEGLEARATIQN et e ce 21 Pag 5 21 Vital Diagnostics MICROSED USER S MANUAL 1 INTENDED USE The MICROSED SYSTEM ESR analyzer is an automatic instrument for the analysis of the erythrocyte sedimentation rate It constantly and simultaneously scans 10 test tubes which are custom made for ESR analysis 2 IMPROPER USE Following uses are considered improper 1 Use of the device to obtain results different from ESR 2 Use tubes different from those specified in this manual 3 Every attempt to open tubes analyzed by the device 4 Use the device to analyze samples different form those specified The above mentioned uses and every attempt to use the MICROSED SYSTEM ESR analyzer with a purpose different from the intended use must be considered imp
6. agnostics 4 6 Residual Risks Despite of the measures taken in the designing of the machine to guarantee a safe use of it there might happen reasonably predictable occurrences whose risk was possible to reduce but not to eliminate completely RESIDUAL RISKS PROTECTION MEASURES Biological contamination The operator must wear always gloves and protection glasses as prescribed by laboratory regulations Do not ever open tubes Tubes breaking Insert and remove tubes from holes maintaining a vertical position without applying lateral forces 4 7 Disposal and Recycling Herewith we declare that this instrument is subject to the European Directive 2002 96 EC RAEE Directive Therefore the instrument must be disposed separately not as urban waste and delivered to the specific collection center in according to the Directive 2002 96 EC The user can ask to the dealer the collection of the instrument if a new instrument is ordered to replace the old one On the instrument there is a label with the symbol shown in this page The symbol means that the instrument can not be disposed as urban waste Pag 9 21 Vital Diagnostics MICROSED USER S MANUAL 5 INSTALLATION 5 1 Positioning of the analyzer The MICROSED SYSTEM must not be placed near centrifuges oscillating agitators or other vibrating instruments which might cause movement of the bench Please keep in mind that the ESR is very
7. and 2 h Westergren 3 enable temperature compensation at 18 switched ON as default 4 printer output enable note turn off this switch if no printer is connected 5 enable sedimentation graphic printout 6 enable 15 of working time with results mm h Westergren only 7 internal fan enable switched ON as default 8 enable DC power supply for external DPT100 thermal printer NOTE the function is active if the dip switch is on ON position DIP SWITCH CONFIGURATION EXAMPLES DIP SWITCH on on on on on on on on DIP SWITCH on on on on on on on on off off off off off off off off 12345678 DIP SWITCH on on on on on on on on DIP SWITCH on on on on on on on on dip switch on 3 4 7 8 configuration working time 30 results mm 1h Westergren temperature compensation ON printer enable ventilation ON power supply printer ON dip switch on 3 4 6 7 8 configuration working time 15 results mm 1h Westergren temperature compensation ON printer enable ventilation ON power supply printer ON dip switch on 2 3 4 7 8 configuration working time 30 60 results mm 1h and 2 h temperature compensation ON printer enable ventilation ON power supply printer ON dip switch on 1 2 3 4 7 8 configuration working time 30 60 results mm1 2h 1h 2h temperature compensation ON printer enable ventilation ON power supply printer ON Pag 18 21 Vital Diagnostics MICROSED USER S MANUAL D RS232 C
8. annels can cause considerable damage to the instrument 8 1 Cleaning Instructions Dust can be removed using an ordinary vacuum cleaner It is advisable to clean once a month the instrument externally with a disinfectant solution to reduce the microbial contamination Concerning test tubes they must remain well closed and the cap should absolutely not be removed The label must be correctly positioned and well stuck to the test tube surface Label fragments could fall into the test tube and obstruct a correct reading function during analysis 14 21 Vital Diagnostics MICROSED USER S MANUAL 8 2 Trouble Shooting guide Before calling for a service technician please check the handling procedures and operating instructions of sample collection mixing ALARM OR TROUBLE LEV REM T ERR MEC ERROR or ERROR call service Data result is not printed Data result seems not correct One or more samples are shown on the display without tubes introduced Barcode reading not work No info on display PRINTER NOT READY Message Analysis end delay on display Analysis end delay on printer CAUSE 8 sample level high or low b the label was not placed in its proper position Sample has been removed Temperature error sensor malfunction Motor or mechanical malfunction Printer power b Printer cable Instrument printer configuration sample clot sample has foam sample measured af
9. ding pattern Blood draw level acceptance from normal Measuring method Reading resolution Results resolution Temperature correction Results selectable Interface Blood sedimentation rate analysis Height 140 mm Width 180 mm Depth 100 mm about 0 9 kg 12 Vdc 1 5 A external power supply unit 100 240 Vac 50 60 Hz temperature 15 32 room temperature humidity 45 85 not condensed 10 15 30 or 60 minutes max 40 tests h random from 50 to 60 mm from the bottom of the tube correspondent to the 2 rings painted on the tube IR beam 0 2 mm 1 mm automatic compensation referred to 18 Manley in Westergren mm 30 mm 1h mm 2h Single RS 232 port for printer output and barcode scanner input Pag 20 21 Vital Diagnostics MICROSED USER S MANUAL F EC DECLARATION DICHIARAZIONE DI CONFORMIT CE EC DECLARATION OF CONFORMITY conforme all Allegato 11 della Direttiva 98 79 CE Dispositivi Medico Diagnostici In Vitro conforme all Allegato II della Direttiva 2006 42 CE Direttiva Macchine according to Annex III of the Directive 98 79 CE In Vitro Diagnostic Medical Devices according to Annex of the Directive 2006 42 CE Tabonicane Vital Diagnostics S r l manufacturer Via Balzella 41 G 4 indirizzo 47122 FORLI address ITALIA telefono 039 0543 721220 0039 0543 796001 phone fax Identificazione dei prodotti Analizzatore Automatico della VES Pro
10. duct identification ESR Automated Analyzer Nome commerciale MICROSED System Brand name Numero i di catalogo PRD MSS Part number s classificazione dei prodotti dispositivi diversi da quelli elencati nell Allegato della Direttiva 98 79 CE product identification devices other than those mentioned in Annex II of the Directive 98 79 EC General Directives 98 79 EC n 2002 95 n 2003 108 EMC Standards n EN 61326 6 2006 Safety Standards n EN 61010 1 2001 n EN 61010 2 101 2002 norme applicabili applicable standards Machine Directives n 98 37 EC 98 79 EC n 2006 42 EC 5 Si dichiara sotto la propria responsabilit che i dispositivi sopraelencati rispettano le disposizioni applicabili delle normative di cui sopra Tutta la documentazione tecnica richiesta dalle suddette normative conservata a cura del Fabbricante Hereby we declare under our sole responsibility that the above mentioned devices meet the applicable provisions of the directives written above All the supporting documents are retained under the premises of the Manufacturer anno di immissione in commercio year of introduction on the market luogo e data place and date 1997 Forli 19 02 2010 firma 7 d signature Pag 21 21
11. e Clinical Science 11 333 4 International Committee for Standardisation in Haematology 1977 Recommendation for measurement of erythrocyte sedimentation rate of human blood American Journal of Clinical Pathology 68 505 5 LASCARI A D 1972 The erythrocyte sedimentation rate Paediatric Clinics of North America 19 1113 6 MANLEY R W 1957 The effect of room temperature on erythrocyte sedimentation rate and its corrections Journal of Clinical Pathology 10 354 B PERFORMANCE CRITERIA AND LIMITATIONS B 1 Performance Criteria A Mechanical Optical precision of detection 0 2 mm B Reproducibility of analysis C V 5 96 for samples with a ESR 40 mm h C Automatic temperature conversion Accepted range to 18 Manley table Range 15 32 C D Level range for correct analysis from 50 to 60 mm from the bottom of the tube correspondent to the 2 rings painted on the tube F Measuring range 1 140mm h G Results pre indication after about 10 minutes B 2 Limitations A Strongly lipemic or haemolytic samples may alter reading capability B Sed rate values gt 140 mm h will be indicated with this mark only C Temperatures outside the given range will be accepted as 15 min and 32 max Pag 17 21 Vital Diagnostics MICROSED USER S MANUAL C DIP SWITCH CONFIGURATION 1 enable results mm 30 minutes Westergren 2 Working time selection 30 ON 30 60 Results 1 h 1 h
12. ed Vacuum Tube expressly made to be used with the MICROSED SYSTEM They contain sodium citrate at 3 8 and have a fixed vacuum to draw blood item PRD PRV GE011 B PRD PRV GEO 1 1 V for high altitude 3 2 Tubes Handling requirements The vacuum test tube needs to be inserted properly into its holder to obtain the automatic draw of blood required for the analysis Tubes are removed from the holder only after the draw has been terminated completely i e the required amount of blood for the analysis has been properly evacuated If an incorrect blood collection occurs MICROSED SYSTEM will refuse to analyze the sample indicating lev level error because the Sedimentation Rate would be incorrect due to an erroneous ratio with the anticoagulant present in the tube All vacuum test tubes need to be mixed gently immediately after blood collection to ensure a proper mixing of the sodium citrate with the freshly drawn blood Therefore tubes are gently turned completely upside down five times ensuring that the air bubble floats correctly from one end of the tube to the other ESR tests should be carried out no later than 3 4 hours after blood collection if samples are kept at room temperature Refer to Tubes instructions to perform this operation correctly 3 3 Tubes storage requirements Store the test tubes at room temperature always below 30 C Never place the bench top tube container near a heating device or a window where direct sunlight c
13. enete AN M Eo uL 12 6 6 REMAINING TIME 1 tette te cie ice iet ebbe teer E ATETA e eie oe tls 12 6 7 RESUETS PRE INDICATION ET eie e bte ere cebat 12 6 8 SAMPLE REMOVAL itr testet et eer DU etu ee I 13 6 9 INTERNAL QUAEITYSGONTRO FR E RR IB E A Nes alt 13 6 10 INSTRUMENT GALIBBRATION a E EE EE UE FE Te eri terere reet 13 6 11 TEMPERATURE GORREGMION S Es rete vette ce e Oye ete a heres tank 13 7 ERROR AND WARNINGS 14 7 1 WARNINGS INFORMATIONS tre eb ee e ei nore vidi 14 7 2 SYSTEM ERROR WARNINGS rtt cnet tse etre 14 7 3 SERVICE ELEC 14 8 LP adzg elm P 14 8 1 GIUEANING INSTRUCTIONS ri Re re TD RE EE 14 8 2 TROUBLE SHOOTING GUIDE eene 15 APPENDIX eia tse 16 A THEORETICAL INFORMATION wu cece 16 Westergren Method isss e RR RI ORIS RR E 16 A 2 Normal ESR values according to 16 AS Variation tier nre idest reddes ah eie eade did 16 Pag 4 21 MICR
14. ing that it is not dangerous for the operator but it would damage if brought into contact with the parts in movement 4 4 Samples All the biological fluids must be considered potentially infectious by operators Even if for the execution of the analysis the blood is not handled because the operator must not remove the tube stopper the operator has to adopt the national and international standards of precautions to avoid the biological danger The same rules must be adopted by the technical qualified assistance operator when intervenes on this instrument 4 5 Notes on safety measures The operator must pay a special attention to the sample collection Must use the correct vacuum test tubes described for this equipment in this manual since these tubes have been studied to aspirate the right level of blood Every attempt to put the blood into test tubes different to the one described brings serious dangers of infection due to the risk of sample coming out and this moreover will damage the optical part inside the instrument and provoke the loss of the guarantee Refer to the tubes manual to have more detailed On the instrument to assure a correct use of the instrument may be placed the following symbols IVD Attention read use instruction For in vitro diagnostic use only 4 ELECTROSTATIC DISCHARGE SENSITIVE DEVICE ESDS t The device could be damaged by electrostatic potentials Pag 8 21 MICROSED USER S MANUAL Vital Di
15. n Method This is the standard method in accordance with the Clinical and Laboratory Standard Institute CLSI It consists of a support that keeps the Westergren tubes containing incoagulable blood perfectly vertical and hermetically sealed Westergren tubes have a diameter of 2 5 mm and are graduated up to 200 mm As soon as the sample is taken the venous blood is mixed with a sodium citrate solution at 3 896 0 13 M in the ratio of respectively four to one 1 6 ml 0 4 ml of sodium citrate The blood thus prepared and well mixed is drawn into a Westergren tube up to the zero mark The tube is inserted in the appropriate support and the erythrocyte level is read after 60 min A 2 Normal ESR values according to Westergren Mean ESR Age Yrs Male Upper Limit of Normal 18 30 3 1 31 40 3 4 41 50 4 6 51 60 5 6 60 70 5 6 Over 70 5 6 Variation of ESR Net increase of ESR 100 mm or more per hour 1 Multiple myeloma and Waldenstrom macroglobulinemia 10 Ulcerous colitis 11 Serious nephrosis Moderate increase of ESR 10 Lead or arsenic poisoning 11 Nephrosis 12 Internal haemorrhage 15 Broken ectopic pregnancy 16 Menstruation 2 Malignant lymphoma 17 Normal pregnancy after the 3 Leukaemia third month 4 Serious anaemia 18 Oral contraceptives taken 5 Carcinomas 19 Tuberculosis 6 Sarcomas 20 Postcommissurotomy syndrome 7 Serious bacterial infections 21 Dextran administered
16. nal temp This message informs the user on the temperature correction status and on the temperature measured by the instrument Once the Self test is finished the following message will appear Self Test Ok Pag 10 21 Vital Diagnostics MICROSED USER S MANUAL Now the instrument is ready for the analysis The result type and temperature are shown always in the display In the bottom line of the display there are results values The following screen is an example results 1h temp z7 5 C 5 6 7 7 B8 9 10 11 1 13 6 OPERATING PROCEDURE 6 1 Sample s collection Samples must be collected following the vacuum technique using only the right tube previously defined During sample collection wait until the test tube vacuum has completed the drawing of the blood in order to be sure of having drawn the right volume See the tube s instructions for a correct use 6 2 Tubes Labeling A B D Identify the sample by writing on the original test tube label or by applying a bar code label Follow the scheme to carry out this action correctly In the figure the test tube A has the correct blood level and the original label on which to write the patient code or any other relevant data if the bar code label is absent The E part marked shows the transparent zone that must be absolutely free and clear to allow the infrared rays to recognize the end of the blood column The next test
17. ns of values due to different room temperatures 3 2 Power Supply The analyzer is provided with an external power supply with low voltage output The power supply comes along with the analyzer 3 3 Display An LCD display with back lighting allows constant monitoring of the analyses and visualization of the results Sample or system error messages may also be displayed 3 4 Reading Plate One row of 10 test tube positioning channels numbered from 1 to 10 Pag 6 21 MICROSED USER S MANUAL Vital Diagnostics 3 5 Bar Code Reader optional An external barcode reader can be connected to the instrument with a special cable The cable can be requested with the code EEE30 099 Cable MSS10C04 printer barcode The barcode reader must be an RS232 port standard model with its own power supply unit The barcode scanner configuration must be set with the following serial port setting 9600 bps 8 data bits no parity 1 stop bit no handshake control signals 3 6 Printer optional Can be connected to the instrument it prints out ESR results and sedimentation graph according to the loading sequence whenever an analysis is completed It is external so it can be easily replaced Printer Technical Data Type DPT 100 Power supply Direct powered from Microsed input serial RS 232 printing type thermal columns 24 conformity 3 1 Test Tubes The unique test tubes that can be used with this instrument are Monos
18. ould create an unwanted heating effect Pag 7 21 Vital Diagnostics MICROSED USER S MANUAL 4 POTENTIAL DANGERS SAFETY MEASURES AND DISPOSAL 4 1 User Precautions Before beginning work with the analyzer the operator to protect himself from any danger must know the rules for handling potentially infectious materials and for the Electro mechanical systems 4 2 Electrical Equipment As in all electrical equipment the power supply is a potential source of danger For this reason avoid handling parts directly hooked up to the supply without disconnecting them Never carry out maintenance on the equipment when it is under electrical tension Until the equipment remains closed as supplied the operator is protected against electric shock The parts to pay attention to are the power supply and the printer The MICROSED SYSTEM analyzer being powered by low voltage doesn t present the same dangers of the equipment s powered by an electrical line MICROSED SYSTEM analyzer has inside a voltage elevator circuit so it can provoke strong electrical shocks but it is not dangerous for the personnel dedicated to the service assistance In any case we suggest disconnecting the power supply when the operator intervenes on the instrument s internal parts 4 3 Mechanical equipment Even for the mechanical part of the analyzer we suggest you not to open the machine before having disconnected it from the power supply It presents only one handl
19. roper 3 SYSTEM DESCRIPTION 3 1 Analyzer unit The MICROSED SYSTEM ESR analyzer is an automatic instrument exclusively employed for analysis of the erythrocyte sedimentation rate Its total absence of commands its precision and its ability to obtain the result already corrected to a temperature of 18 according to Manley in only 15 or 30 minutes make the Microsed System ESR the most innovative and versatile system for this kind of analysis It constantly and simultaneously scans 10 test tubes which are custom made for ESR with this system MICROSED SYSTEM follows the sedimentation of each sample independently memorizing levels for the whole period of analysis This allows the instrument to be used for random loading of the samples and for a continuous loading up to a capacity of 10 test tubes at a time When the first sample is analyzed it can be replaced by another one so it is possible to achieve up to 40 tests h MICROSED SYSTEM has been conceived to simplify ESR analysis as much as possible avoiding sample manipulation and operators infection risk To perform the analysis the operator must simply place the sample test tube directly into the instrument The result appears on the display in only 15 or 30 minutes When the compensation of the result is active the MICROSED SYSTEM surveys the room temperature and converts the result to the reference temperature of 18 Manley This is necessary in order to avoid considerable variatio
20. sensitive to vibrations that could cause a false increase of results The bench must be flat and level Direct light on the instrument and sudden changes of temperature should be avoided 5 2 Instrument Startup Check the instrument configuration for your needs see appendix for switches information Connect power supply outlet to the instrument Insert the power supply plug in a socket with an earth connection If the instrument has an optional printer and or a bar code scanner they should be connected to the MICROSED SYSTEM with the appropriate cable and plugged in Connect and switch on first the printer then the MICROSED SYSTEM using the switch situated at the rear side of the instrument Each time it is switched on MICROSED SYSTEM carries out an electronic initialization and an instrument self test The following messages will appear Self Test Start During the self test the instrument checks electronics parts and which kind of configuration is set The following messages will appear print curve printer This message inform the user about the printer status and if the sedimentation is active or not check the printer If the printer is not connected to the device this message will appear 30 60 working time results 30 ih 2h mm This message informs the user on the reading time and on how results will be displayed and or printed out 18 temp of reference 27 5 C inter
21. sion Rate instructions for more detailed information 6 10 Instrument Calibration Each instrument is pre calibrated by the manufacturer and it does not require a user re calibration The calibration of each instrument is traceable from the serial number of the instrument 6 11 Temperature Correction The obtained results are correlated to the method of reference related to the room temperature MICROSED SYSTEM constantly measuring the analysis temperature further reconverts the values obtained to the reference one of 18 degrees using the Manley table thus ensuring better reproducibility instead of analyses performed at different temperatures Manley table 18 15 18 20 25 30 C 5 4 5 5 6 8 10 9 10 10 12 16 20 18 20 21 25 31 30 27 30 31 37 45 40 36 40 42 49 58 50 46 50 52 60 71 60 55 60 62 71 82 70 63 70 72 82 93 80 72 80 82 93 104 90 81 90 93 103 114 100 90 100 103 114 125 MICROSED SYSTEM converts the results to 18 degrees as per the table if analysis room temperature is between 15 and 32 degrees C For lower or higher room temperatures the instrument s conversion limits are 15 degrees for lower temperatures and 30 degrees for higher Pag 13 21 Vital Diagnostics MICROSED USER S MANUAL 7 ERROR AND WARNINGS 7 1 Warnings Information These Messages may appear on the display LEV Indicates that the sample level is not into the range permitted by the instrument REM Indicates that the te
22. st tube has been removed from the position in which it had been placed The test tubes are checked in their positions every second Do not touch the test tubes during the whole period of analysis because for the reason described the result will be lost 7 2 System Error Warnings MEC ERROR system stopped or ERROR call service These warnings will be given if the instrument should find problems with the mechanical movement of the reading plate After this indication the instrument will definitely stop its operation and the technical service must be called 7 3 Service In case of malfunctioning of the instrument service can be made only by authorized personnel Only technicians with a certificate which states that they have followed a service training in Vital Diagnostics or made by a Vital Diagnostics authorized person can operate service on the instruments If a technician is not available defective instruments can be sent to Vital Diagnostics after calling the technical service Please contact your instrument distributor 8 MAINTENANCE Due to component parts simplicity MICROSED SYSTEM does not require special maintenance The most sensitive part is the infrared sensors inside the instrument Pay attention to the cleanliness of reading plate when not used it must be covered with the dust cover supplied along with the reader Do not clean the reading plate with liquids The entry of liquids or solid material into ch
23. ter 4 hours from sample collection d sample short mixing temperature conversion is OFF paper pieces or dust on sensors a b internal cable problem a adapter cable problem b scanner power problem c wrong ID procedure Instrument switch problem b Instrument power problem c Internal problem Printer is not connected b Printer out of paper C Printer cable problem a b a Printer is not connected but enabled b Printer out of paper C Printer cable problem d Random samples inserted the reading plate is moving Random samples inserted the reading plate is moving REMEDY 8 repeat sample collection b replace label and repeat analysis repeat analysis data analysis is not converted to 18 C Call service assistance Call service assistance 8 Check power supply b Check cable c Check instrument configuration d Replace printer 8 repeat sample collection b remix gently C check instrument configuration Call service assistance Check adapter cable b Check power of the scanner C read the user manual Check instrument switch Check power supply unit C Call service assistance load a new roll of paper Check the printer cable Check the printer cable d NO PROBLEM results are always correct NO PROBLEM results are always correct Pag 15 21 Vital Diagnostics MICROSED USER S MANUAL APPENDIX A THEORETICAL INFORMATION A 1 Westergre
24. time remaining symbols 6 7 Results Pre indication Approximately 10 minutes after tubes insertion the following symbols will appear on the display giving a pre indication of the results of Sedimentation at 10 minutes Symbol 16 lt 40 gt 40 This is only a pre indication and it can t be used as final result Please note pre indication is shown only on 30 and 60 minutes reading mode Pag 12 21 Vital Diagnostics MICROSED USER S MANUAL 6 8 Sample removal As soon as sample has been analyzed the result will be automatically printed out if a printer is connected Results will stay on the display until the tube removal Remove tubes carefully maintaining tubes in vertical position in order to avoid tubes breaking If the tube is removed before the end of the analysis the instrument prints removed error 6 9 Internal Quality control Good Laboratory Practices suggest to test every day at least one control 1 normal and 1 abnormal to check if the instrument is working correctly Vital Diagnostics developed a special control for ESR values Precision Rate PRD ESRQC This control simulates the behavior of normal and abnormal human blood and can be used to test the instrument s performances Controls must be tested exactly as normal patient s samples and results should be recorded on Quality Control Charts Each laboratory can establish its own acceptability ranges Refer to Preci
25. tube B shows the correct position for the label Test tubes C and D illustrate how erroneous applications of the labels obstruct the reading of the analysis If the MICROSED SYSTEM Analyzer is installed in the surgery the sample can be immediately analyzed by placing samples in a free position Anyway the sample should be analyzed within three hours paying attention to external agents shown below that might alter ESR in the pre analysis phase 6 3 Sample mixing If it is not possible to analyze samples immediately after the collection samples must be mixed delicately by overturning for at least five minutes Use a rotating laboratory agitator or a dedicated mixing device The recommended rpm value for the mixer is 15 20 RPM 6 4 Sample insertion After mixing the sample must be promptly transferred to the analyzer It is also advisable to follow numerical sequence when loading channels Every time a sample is inserted into a free channel an acoustic signal inform the user that the instrument recognized the tube After loading the tenth wait for the results and then remove analyzed samples from their channels before inserting new tubes The sample positions on the plate are numbered from 1 to 10 but numbering is intended progressivel
26. y in groups of 10 so when the tube in channel one is analyzed and removed this position automatically becomes number 11 and so on Pag 11 21 Vital Diagnostics MICROSED USER S MANUAL 6 5 Sample Identification If samples are identified by a barcode label they can be identified using an external barcode scanner The maximum ID length readable by the instrument is 12 digits Do not overrun this limit To perform this procedure correctly follow these steps 1 read the barcode label 2 insertthe tube in the first free channel within 15 seconds form reading The instrument will detect automatically the position of the new inserted tube and the ID will be automatically associated to that position The display will show for some seconds New sample Pos 1 Pat ID 012345678912 If a printer is connected once the instrument finishes an analysis the following information will be printed out Smpl Chan PatIDi no ID present 1 1 were 30 1h 2h 3 5 11 mm Smpl Chan PatIDi ID 123456789012 1 1 123456789012 30 1h 2h 3 5 11 mm If the bar code is not available to identify samples write sample s ID on the label of each sample and prepare a report where to write the sample ID and the correspondent channel of the instrument where the sample has been inserted 6 6 Remaining time During sample analyses on the display appears for each sample the following symbol as indication of the remaining analysis time
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