User manual - readwell STRIP - 3.4A.DOC
Contents
1. Effective Date Nov 2011 USER MANUAL readwell STRIP Rear View e Power socket and Mains switch e RS232 output connector e Identification and QC passed label e Contrast Pot ON OFF RS232 _ switch Contrast Pot e SMPS 5 2 Micro strip Carriage The instrument is provided with a carriage to convey the micro strip towards the internal optical reader The micro strip can have 8 or 12 wells The program allows selection between these two possibilities Strip Carrier e t Supports both 8 well Strip and 12 well Strip e t also supports less than 8 wells Micro strip positioning The instrument has been programmed assuming that the micro strip 8 or 12 wells will be used in the order as indicated for each case COCOCOCO 23 45 6 7 1 8 Priority 1 Blank if requested 2 Calibrators or Controls 3 Samples Locate the micro strip into the carriage making sure that the micro strip is properly inserted in the above indicated order Using Strip holder LOCK Place strip holder lock firmly to hold the strip in its position Version No 3 4A Page No 11 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 5 3 Instrument working principle On starting the test the strip will be conveyed into the instrument Strip is moved in step by step by a well controlled mechanism and each well is positioned precisely below the optical path Optical density of each well is measured as explained below Based on selecte2. Has the equipment been exposed to any of the following delete as applicable a Blood body fluids pathological specimens YES NO If YES please specify b Other Biohazard YES NO if YES Please specify Effective Date Nov 2011 USER MANUAL readwell STRIP 15 SPARE PARTS 15 1 Ordering Spare Parts Parts subject to deterioration or defectives which need to be replaced have to be ordered by giving following details Ordering the spare parts the following data are to be mentioned o Customer s purchase order No o Name and version of the instrument o Instrument code number o Part code number o Description of the part o Requested quantity o Name and company address for delivering the ordered goods While replacing the parts the use of ORIGINAL SPARE PARTS guarantees the efficiency and a lasting instrument life Version No 3 4A Page No 45 of 45 Effective Date Nov 2011
3. of LPCS LPOSC gt N ll QC by LPOS CNTR Y N YES NO QC by Cut CNTR Y N C O factor Cut Off range Y N YES NO Positive gt Negative lt Grey Zone Y N NO Enter percentage Page No 30 of 45 Version No 3 4A Effective Date Nov 2011 Yes readwell STRIP How to operate Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter number of Low Positive control to be run max 3 amp press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER to skip press enter Enter minimum Value using Number Keys amp Decimal Keys amp Press ENTER Quality Control by Low Positive Control This is the minimum ratio of PC LPC Enter Value using Number Keys amp Decimal Keys amp Press ENTER This is the maximum ratio of NC LPC Enter Value using Number Keys amp Decimal Keys amp Press ENTER Quality Control by Cut off Control This is the minimum ratio of PC CC Enter Value using Number Keys amp Decimal Keys amp Press ENTER This is the maximum ratio of NC CC Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter Factor as given in the kit Enter Cut off range as given in the kit Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter Grey Zone Value in terms of USER MANUAL readwell STRIP Enter Value using Number Keys am
4. 2 1 Enter Clinic Name Please refer point No 6 10 8 2 2 Recalling Saved Test Press MENU Key Choose Test Enter Test Number to be recalled Store Graph Y N The Instrument will use previously stored value New Calibrators will have to be run New values will be stored to the program Version No 3 4A Page No 20 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 8 2 3 Listing Saved Test Press MENU Key Press 129 amp Press Enter Choose Test The Instrument will print a list of saved Tests 8 3 LAMP Key This Key is used to switch the Lamp ON OFF 8 4 PAUSE Key This key is used to enable or disable the PAUSE function When Pause is enabled the STRIP will move only when you press ENTER after each well reading When Pause is disabled the STRIP moves automatically and wells are read in sequence This function is available in all modes 8 5 CLEAR Key Press once to go to the previous position and press twice exit 8 6 ENTER Key To either entering to data or proceed any test 8 7 INTRP Key The sample may be labeled as positive or negative according to the user entered criteria by pressing INTRP key this function can be accessed The positive and negative cut off limits can be selected for all the modes except ABSORBANCE and CUT OFF modes and should be selected just before loading the STRIP Either of the cut off limit values can be bypassed by pressing ENTER key
5. DUP Samples Y N NO YES Load Strip amp Press ENTER Control amp Interpretation Place the Strio in strio Holder Ref 5 2 Ref 8 8 amp 8 7 Enter the number of wells to be run amp press No of Wells ENTER Version No 3 4A Page No 27 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP The instrument again displays LOAD STRIP AND PRESS ENTER place the STRIP on the STRIP track carefully press ENTER key The instrument loads the STRIP on to the optical system reads all the wells in sequence and transports them The readings are displayed as well number BLANK CALIBRATOR SAMPLE identification and absorbance Mean absorbance is printed in case the calibrator and sample are run in duplicates 10 3 A Cut Off Mode In this mode a cut off point is determined for interpretation of specimens as per formula given in the reagent manual the negative controls are read followed by the positive controls Cut off control low positive control Blanking on the first well is optional The instrument calculates the mean of the negative controls and the mean of the positive control Cut off controls Low positive is also calculated OPERATION CALCULATION CO Cut off absorbance MNC Mean of the negative controls MPC Mean of the positive controls MCC Mean of cut off control MLPC Mean of low positive controls X Y W Z are user entered coefficients as given in the interpretation criteria of the test tha
6. In all modes the operation begins by asking the filter to be selected The followings 4 filters have been provided Filter Identification Key Filter Wavelength No Operation After selecting programming mode instruments prompts for filter selection Choose Filter Enter required filter ID number and press Enter Choose Secondary Filter Select Filter by entering Key as explained above If Not Required Press NO amp and press ENTER Press ENTER Offset Tabs Y N Offset abs Enter Required Absorbance amp Press Enter Load Strip amp Press ENTER Blank can also be selected by pressing blank key just before the instrument starts reading the first strip The Instrument will read every well at both wavelengths and calculate the absorbance Version No 3 4A Page No 24 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 9 2 Blanking The blank material must always be in the El well and is always read singly except in cut off mode The absorbance of this well is automatically subtracted from subsequent absorbance measurements before printing and calculating In the SINGLE CALIBRATOR MODE and the ABSORBANCE MODE the first well is automatically treated as a Blank Blanking is not mandatory for the other calculation modes However if selected the first well is always treated as a blank by the instrument Blanking can be selected by pressing the BLANK key before loading the STRIP 9 3
7. N Enter Cal No Accept Curve Y N Version No 3 4A Effective Date Nov 2011 Press YES to plot Graph Enter Calibrator No to be deleted amp press ENTER Maximum No of 5 Calibrators can be deleted Press YES to accept the curve amp Save Page No 37 of 45 USER MANUAL 10 4 2 Point to Point Mode OPERATION Display NO CALS in DUP Y N NO DUP Samples Y N NO Load Strip amp Press ENTER Control amp Interpretation No of Wells Version No 3 4A Effective Date Nov 2011 readwell STRIP How to operate Press No Key to select Point to Point Mode Refer Selecting FILTER Press YES key for Blank Selection Enter Total number by using number keys min 2 max 7 Enter Concentration of Calibrators by using number keys Press YES for duplication of Calibrators Press YES for duplication of Samples Place the Strip in Strip Holder Ref 5 4 Ref 8 8 and 8 7 Enter the number of wells to be run amp press ENTER Page No 38 of 45 USER MANUAL readwell STRIP Plot Graph Y N Press YES to plot Graph Delete Calibrator No Y N YES Enter Calibrator No to be deleted amp press ENTER Maximum No of 5 Calibrators can be leted Accept Curve Y N delete Press YES to accept the curve amp Save Calibrator No 10 4 3 Plotting Graph After all wells have been read the instrument plots the graph OPERATION Display How to operate PLOT GRAPH
8. To enter Lot No and Expiry Date To enter expiry date and lot No test has to be saved first Press MENU key Display How to operate Choose test Edit EXP DATE Y N Choose test Enter 212 AND PRESS ENTER Press YES key ENTER the saved test No in which you require to save the Lot No and expiry date And press ENTER Key The instrument displays DATE DD MM YY Enter date month and year in the same format Press ENTER key The instrument displays Enter Lot No Y N A string of variables will be displayed move with arrow keys 4 and 6 Select by ENTER Key and press ENTER Key twice continuously to finish Now when Recalled Expiry date and Lot No Will be printed as well as displayed Version No 3 4A Page No 25 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 10 PROGRAMMING MODE 10 1 Absorbance In this mode the instrument reads and prints the monochromatic and bichromatic differential absorbance at the user selected wavelengths Blanking is optional OPERATION Use ABS key to enter the mode Display How to operate ABSORBANCE SE Select Filter Ref 9 1 Load Strip amp Press Enter Place the Strip in strip Holder Ref 5 2 No of Wells Enter the number of wells to be run amp press EN The instrument loads the STRIP on the optical system reads all the wells in sequence and transports them out again After the STRIP has been read load the second STRIP and
9. Y N Press YES Key to Plot Graph on the Printer The user can continue reading the next STRIP by loading the STRIP and pressing ENTER key Version No 3 4A Page No 39 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 10 5 Percentage Absorbance Mode The Percent Absorbance Mode requires one calibrator read singly or duplicate In this mode a single calibrator is considered to have an absorbance of 100 The absorbance s of unknown samples are read and compared to the calibrator absorbance and reported as absorbance of calibrator DATA INTERPRETATION and CONTROL OPTION can be used in this mode Blank is compulsory on the first well OPERATION Press ABS Key Display How to operate ABSORBANCE Select Filter CALS in DUP Y N Refer Selecting FILTER Press YES for duplication of Calibrators YES DUP Samples Y N Press YES for duplication of Samples Load Strip amp Press ENTER Control amp Interpretation No of Wells Place the Strip in strip Holder Ref 5 2 Enter the number of wells to be run amp press ENTER Press YES Key to Plot Graph PLOT GRAPH Y N ACCEPT CURVE Y N Press YES Key to accept curve amp Save The instrument now reads the samples and displays prints results as per the graph Version No 3 4A Page No 40 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 11 MAINTENANCE No regular maintenance required for this instr
10. operation till all the Strips are read Version No 3 4A Page No 35 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 10 4 Multi Standard Mode In this mode the instrument accepts a maximum of 7 calibrators and calculates concentration based on the best fit curve Graph is printed with Absorbance on Y axis and concentration on X axis OPERATION Press REGRE key Display How to operate REGRESSION Y N REGRESSION Select FILTER Ref 10 4 2 Displays REGRESSION Point to Point Refer Selecting Filter 9 1 Press YES for Linear NO for other LINEAR Y N YES NO LOG ABS Y N NO SE e LOGIT LOG Y N YES YES Version No 3 4A Page No 36 of 45 Effective Date Nov 2011 USER MANUAL 10 4 1 Linear Mode OPERATION Display Blank Y N No of CALS CALS in DUP Y N DUP Samples Y N YES Load Strip amp Press ENTER Control amp Interpretation No of Wells NO readwell STRIP How to operate Press YES key for Blank Selection Enter Total number by using number keys min 2 max 7 Enter Concentration of Calibrators by using number keys Press YES for duplication of Calibrators Press YES for duplication of Samples Place the Strip in Strip Holder Ref 5 4 Ref 8 8 and 8 7 Enter the number of wells to be run amp press ENTER Instrument Display Plot Graph Y N Delete Calibrator No Y
11. when prompted The criteria used could be either a single upper cut off or both upper and lower cut offs When a single upper cut off is used any concentration which is equal to or greater than the cut off will be labeled as positive All other samples will be labeled as negative If both upper and lower cutoff are used then the concentrations which are greater than or equal to the upper cut off are labelled as positive but only concentration less than the lower cutoff will be labelled as negative The remaining valued label as equivocal Version No 3 4A Page No 21 of 45 Effective Date Nov 2011 USER MANUAL OPERATION Press INTRP key Display POSITIVE gt NEGATIVE lt 8 8 CTRL Key Oo Oo 0 readwell STRIP How to operate Enter a concentration value above which all the samples would be considered as positive for that test Press Enter Key Enter a concentration value above which all the samples would be considered as positive for that test Press Enter Key Press Enter Key each time if no concentration is given It is possible to include the Quality control for Assay The upper and lower limits range of the controls After the Instrument is ready for reading the strip containing the control With the help of CTRL key values for control can be fed The control option can be used for all modes except the Absorbance mode and Cut off mode OPERATION Press CTRL key Display CONTROLS
12. C KEY Idle Mode FUNC Key Strip type Yes Yes 12 wells Printer Y N Programming Mode FUNC Key YES Ref 8 1 1 Saving Test Ref 8 1 3 Modify Date amp Time Option Set printer Y N NO Delete Test Y N NO Set Time Y N Ref 8 1 2 Delete Test NO YES Exit Y N Yes Version No 3 4A Page No 18 of 45 Effective Date Nov 2011 USER MANUAL 8 1 1 Saving Test readwell STRIP To save the programmed test under any programming Mode Display Save Test Y N Yes Name Tests Y N Save Test without name ABDNSDNFNHHJ 8 1 2 Deleting test Display Delete Test Y N Yes Delete Test Deleting Test No Y N Yes Test Deleted Version No 3 4A Page No 19 of 45 Effective Date Nov 2011 How to operate Press YES Key Press YES Key to Enter Name Test Number will be printed on the paper Select Arrow Keys to select Alphabets Press Enter after selection and proceed Press Enter twice after completing selection How to operate Press FUNC Key Press YES Key Enter the Test Number of the Test to be Deleted and Press ENTER USER MANUAL readwell STRIP 8 1 3 Setting Date and Time Please refer point No 6 9 8 2 Menu Key This key is used to recall the test number to be performed Display How to operate Press the MENU key CHOOSE TEST Enter the test number and press ENTER key 8
13. E CUT OFF MODE Blank Low Blank value less than the specified range Negative Control Low a control less than the specified Positive Control High Ce Control greater than Specified Cut Off Control High co Control greater than Specified Low Positive Control High Low Positive Control greater than Specified range Ratio of PC LPC or PC CC is greater eeh than Entered Value RAT NC Low Ratio of PC LPC or PC CC is lower than Entered Value Version No 3 4A Page No 42 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 13 DECONTAMINATION 13 1 Decontamination Procedure If the instrument is to be shipped after being exposed to potentially hazardous material it should be decontaminated The following procedure outlines the method of decontaminating the instrument before packaging and shipment 13 2 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument during shipping handling and servicing 13 3 General Considerations e Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious Organisms however small abrasions and cuts may not be always visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated Gloved hands should be considered contaminated at all times and
14. HI 1 LO 0 Version No 3 4A Page No Effective Date Nov 2011 How to operate Select either one of the options by pressing corresponding number key and enter the high or low control values 22 of 45 USER MANUAL On Pressing Key 1 for High Control Display ROW A H Strip No 1 12 On Pressing Key 0 for LO Control Display Strip No 1 12 Version No 3 4A Page No 23 of 45 Effective Date Nov 2011 readwell STRIP How to operate Press Enter Key Enter Row number in if you are running in consecutive strips which high control has been dispensed Key No 1 A 2 B 3 C 4 D 5 E Enter well number in which high control has been dispensed in the range of high control Enter the lower value of the range The range of high control here enter the higher value of the range Press Enter Key How to operate Press Enter Key Enter Row number in if you are running the control in the consecutive strips which Low control has been dispensed Key No 1 A 2 B 3 C 4 D 5 E Enter well number in which high control has been dispensed Enter the higher limit of the high control Enter the lower limit of the low control Press Enter Key USER MANUAL readwell STRIP 9 GENERAL FUNCTIONS 9 1 Selecting Primary and Secondary Filters The instrument asks the operator to select the primary and secondary filters Select the filter using identification number given below
15. Positive control to be run max 3 amp press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER to skip press enter Enter Value using Number Keys amp Decimal Keys amp Press ENTER Quality Control by Low Positive Control This is the maximum ratio of PC LPC Enter Value using Number Keys amp Decimal Keys amp Press ENTER This is the minimum ratio of NC LPC Enter Value using Number Keys amp Decimal Keys amp Press ENTER Quality Control by Cut off Control This is the ratio of PC CC Enter Value using Number Keys amp Decimal Keys amp Press ENTER This is the ratio of NC CC Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter Factor as given in the kit Enter Cut off range as given in the kit Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter Grey Zone Value in terms of USER MANUAL readwell STRIP Enter Value using Number Keys amp Decimal Keys amp Press ENTER 1MPC MNC gt Y N MPC MNC Il gt Enter Value using Number Keys amp Decimal Keys amp Press ENTER Load Strip amp Press ENTER Place the Strip in strip Holder Ref 5 2 Enter the number of wells to be run amp press No of WELLS ENTER The instrument loads the STRIP on to the optical system reads all the wells in sequence and transports them out again Press ENTER key to continue the
16. USER MANUAL readwell STRIP readwell STRIP ELISA Strip Analyser USER MANUAL Version 2 AA J g R ZOO ROBONIK INDIA PVT LTD A 374 TTC MIDC Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 3 4A Page No 1 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP TABLE OF CONTENTS 1 GENERAL INFORMATION eet eege Eed 4 1 1 WARRANTY Tele 4 1 2 TECHNICAL SERVICE EH 4 NES DISPOSAL INSTRUC TON EE 4 EE eer Oe A 2 GENERAL SAFETY WARNINGS ecsesscesessesseeseenseensnenseeseeseeeseeeseeseeenseeneesneeseaeneensnens 5 2 1 DANGER WARNINGS SYMBOLS 1 cscsccsssscsssessceusscessescessesscessscesseecesseuscesscesseesenseseeenses 5 2 2 USE OF THE INSTRUMENT EE 6 g INTRODU C TO E 7 Be I Re Cl e ME 7 32 SPECIAL an TEE 7 3 3 SPECIFICATIONS E 8 A PACKING TRANSPORT amp STORAGE c ccscssssssssesssenseeneesseeseeeseenseeneeseesseeseesneennens 9 4 1 GENERAL GEREENT 9 BEE PRC TEE 9 4 3 INSTRUMENT TRANSPORTATION c ccscsccsssccessssssssesscessccesscessssessossaccesseasessansoevaccesscasoasans 9 4 4 STORAGE OF THE INSTRUMENT 0 cssccscsssccesscscesscesceusccesseesesssecceusoeesseeeessessceusceesseesesens 9 5 INSTRUMENT DESCRIPTION ccsscssssssesssssnsssnesseeesecsnesnnnsnossnesseeseeeaeenesnessnesseeeses 10 Py Ls P EA SPEC BIN ee VIEW cecssncec ects tees caus ote t
17. a obtained from samples and indicates interpreted results on the display screen or prints them on the thermal printer It is compact light weight portable and it is designed to measure the samples either monochromatically or bichromatically amp interpret results accordingly The strip carriage is designed in such a way that the strip automatically moves and positions itself accurately in the optical measurement path Readings are taken continuously and the average value is calculated and results are presented according to the option selected It is intended for in vitro diagnostic use 3 2 Special Features e Accommodates both 8 wells and 12 well strip configurations e Accommodates both FLAT and ROUND BOTTOM wells e In built Voltage Stabilizer ensures a wide voltage range thus not needing an external voltage stabilizer e A 20 column in built Thermal printer for fast and silent printo uts e Unique PAUSE options to note down the readings manually when printer is not available e Optional lamp saving mode e Selection of both primary and secondary filters e Blanking option e Date and time can be entered e Storing deleting and recalling of tests e Multiple calibrator modes e Selection of duplicates for both calibrators and samples e Selection of Positive Equivocal or Negative cut off e Several pre programmed calculation modes provide data processing of enzyme immunoassays The following menu driven modes are prov
18. as described in this manual If it is not use the protection provided by the instrument may be impaired gt Alterations to the instrument are strictly prohibited The user is liable and solely responsible for any improper modification to the instrument and for the consequences derived as a result gt Should the instrument need extraordinary maintenance contact ROBONIK service or an authorized service center Specialized technicians who will be able to repair the instrument using original spare parts will carry out the maintenance gt This IVD equipment complies with the emission and immunity requirements as per IEC61326 series gt Warning This equipment has been designed and tested to CISPER11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference gt An advisory that the electromagnetic environment should be evaluated prior to operation of the device gt Warning Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded international RF sources as these may interfere with the proper operation Version No 3 4A Page No 6 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 3 INTRODUCTION 3 1 Description The readwell STRIP is a Micro Well Strip analyser It is fully automatic with microprocessor control It uses a built in ELISA algorithm to process and analyze dat
19. d programming mode sophisticated algorithms are used for analyzing the measured value amp presenting the same on the printer display amp RS232 serial port for computer Interface White light produced by the lamp is focused into a beam by the lens amp passes through the sample Part of the light is absorbed by the sample amp the remaining light is transmitted It is filtered by interference filter amp focused onto the photodiode The photodiode converts the received light in to an electrical signal which is in turn transformed into digital form from which the microprocessor calculates the absorbance taking in account of the blank amp bio chromatic selection The following diagram represents the main functional elements of the instrument Micro Processor Analog Frequency Converter Interferenc Filters Display RS232 Interface Photodiod Amplifier Version No 3 4A Page No 12 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 6 INSTALLATION AND VERIFICATION CRITERIA 6 1 Unpacking instructions Check accessories as per packing list Kindly store all packing materials so as to use it to repack and ship for maintenance or servicing 6 2 Placing the instrument e The instrument has to be placed on a level bench Room temperature should be between 10 and 35 C with a relative humidity below 85 e Protect it from direct sunshine 6 3 Power supply requirements Once th
20. e always available for extraordinary maintenance repair under a yearly maintenance contract or on specific demand 1 3 Disposal instruction In case of removal or disposal of instrument following instructions need to be followed Do not dispose in municipal waste follow local regulations for instrument disposal Plastic parts Electronic PCBs and components can be recycled so return back the instrument to manufacturer 1 4 Contacts Manufacturer ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area MAHAPE NAVI MUMBAI 400710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 3 4A Page No 4 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 2 GENERAL SAFETY WARNINGS 2 1 Danger warnings symbols The following symbols are used to inform the user of the safety rules This symbol indicates generic danger It means that serious damage can occur to the operator if described precautions are not observed This symbol indicates HIGH ELECTRIC VOLTAGE It 8 dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the Supply This symbol indicates that the instrument involves the handling of samples which can be infected urine or human serum In this condition infection or contamination might occur Pay attention to the general safety wa
21. e instrument has been placed plug it into a power source by the locally available approved plug in cable Power cord should be CE CSA and UL marked 115 230 Volts 10 50 60 Hz 6 4 Protective Grounding Warning Please make sure that electrical power source is properly grounded 6 5 Thermal printer The Strip analyser comes with built in 20 columns Thermal Printer User has to take proper care to handle this delicate instrument TIPS FOR CAREFUL USAGE OF PRINTER 1 Do not pull the paper when loaded 2 Lift the paper lever carefully and load the paper 3 Keep the instrument clean and dust free Strip Analyser gives line feed automatically wherever it is necessary for clear reading like a While powering on b In between character lines when display shows load strip and press enter by pressing MENU key line feed can be given However user also can give additional line feed to move the paper forward by a character line Version No 3 4A Page No 13 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP How to insert the paper Insert the thermal paper roll by placing the sensitive side facing down The sensitive paper side is recognizable by its smoother face Before inserting the paper After inserting the paper 6 6 Start up Instructions e Switch on the instrument The instrument will display the model name e The instrument initializes all the parameters internally and carries out a p
22. ffective Date Nov 2011 readwell STRIP How to operate Ref 9 1 Press NO if Positive lt Cut off i e Reverse Cutoff Press YES if Positive lt Cut off Press YES if Blank is required Enter No of Banks to be run Max 5 blanks to be placed successively from the 1 well Enter Value of Blank and Press Enter number of Negative control to be run max 3 amp press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER to skip press enter Enter number Negative Control using Number keys amp Press ENTER Enter Number of Positive Controls to be run max 3 amp press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER to skip press enter Enter Number positive control using number keys amp Press ENTER Enter number of Cut Off control to be run max 3 amp press ENTER Enter number of Value amp Press Enter to skip press enter USER MANUAL Display Cut lt No of LPC LposC lt N ll QC by LPOS CNTR Y N YES Rat PC lt NO Rat NC gt QC by Cut CNTR Y N Rat PC lt Rat NC gt C O factor Wi Cut Off range Y N YES NO vi Positive lt Negative lt Grey Zone Y N rk Version No 3 4A Effective Date Nov 2011 Yes Enter the gray zone value Page No 34 of 45 readwell STRIP How to operate Enter Value using Number Keys amp Decimal Keys amp Press ENTER Enter number of Low
23. ging is needed whenever it is to be transported or shipped by courier or other means To pack the instrument follow the instructions as below described e Decontaminate the instrument as explained in chapter No 13 Decontamination of this manual e Place the instrument into the original packaging box Instrument has to be properly protected by plastic protective material Put copy of safety clearance certificate copy of Safety Clearance certificate is attached at the end of this manual e Mark the package with address instrument identification and warning labels 4 3 Instrument transportation The transportation of the instrument in unpacked condition must be limited within the room where it is used to avoid damage 4 4 Storage of the instrument Before storing the instrument for a long period pack it carefully as described above and store indoors Relative humidity has to be less than 85 and temperature between 0 c and 502c Version No 3 4A Page No 9 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 5 INSTRUMENT DESCRIPTION This section describes different components of Readwell Strip from different views 5 1 Perspective View o ge P e F gt Components of different views of the below pictured instrument Front view e Display e Alphanumerical key pad e Micro strip carriage e Printer The Keyboard has 16 Keys in 4X4 format Version No 3 4A Page No 10 of 45
24. iaaii 20 8 2 9 Listing Saved E 21 83 LAMP KE EE 21 8 4 PAUSE KEY E 21 Be CLEA a ENE E E EE E A E EE 21 8 6 ENTER EE 21 e ATRA HAE EE 21 8 8 OTRE KEV arree a A E Ee E aE EE ea beer E AEEA E ET 22 9 GENERAL FUNCTIONS scsi sicsecccvsscscusiccseateianivcussascscasitwehansteczesastectecasstecr assesses eanetardecieaeaes 24 9 1 SELECTING PRIMARY AND SECONDARY FILTERS J 24 9 2 BLANKING E 25 9 3 TO ENTER LOT NO AND EXPIRY ECKE egener Eeer 25 10 PROGRAMMING MODE wisisinssttsscsesissscvoccsecsnscecctenncienscanscsunsavctveseanseccsencntsanceecsevonsdsinsenten 26 WO PBSORBANCE ci asscteh caigetsss ist T AT 26 10 34 CUT OFF MODE eegen 28 10 3 B REVERSE CUT OFF MODE ies saiedscereaesconeranmncesstoandcercenitonmdatecrmnren tenn ne nenene eneee 32 10 4 MULTI STANDARD WIODE See 36 E AICO MO Ci EE EE 37 10 4 2 Point to ee 38 10 43 Plotting Ee 39 10 5 PERCENTAGE ABSORBANCE ENEE eege ere 40 12 TROUBLE SHOOTIN Le EE 42 13 DECONTAMINATION iiisssiszcsincscdesnassanensactsexssncsciestansedenanssasanauscessvannsieareuestvsmesssncananieeesuekads 43 13 1 DECONTAMINATION PROCEDURE AE EE EE 43 13 2 PURPOSE OF DECONTAMINATION eer 43 13 3 GENERAL CONSIDERATIONS cicvostsetatanesveresnsisenvstdncvsnbeiorhins Heevueryiveenweniecnsthuleiiestigeuted 43 TBA EE eege 43 14 SAFETY CLEARANCE CERTIFICATE ss sccsnscssnsincevavetvesesatsaccowscsvasvexsesnntesctesvensbuevebsteevete 44 15 SPARE PARTS E 45 15 1 ORDERING SPARE PARIS S teen eege eg 45 Ver
25. ided for simple and error free operations ABSORBANCE MODE SINGLE CALIBRATOR MODE CUT OFF MODE MULTI STANDARD MODE ABSORBANCE MODE SOON NAS e Besides providing quick accurate reproducible results the Instrument offers easy operation versatility and economy Each mode is described in detail later Version No 3 4A Page No 7 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 3 3 Specifications 0 000 to 3 000 Absorbance Units A Photometric Accuracy 2 or 0 007 whichever is higher from 0 to 1 5 A 3 0 from 1 5 A to 3 0 A lt 0 007 A hr Optical Measurement Photodiode Filters Type Interference filter Wave Length 405 450 492 and 630 nm Half Bandwidth 10 nm 2 nm Filter Selection Automatic by stepper motor 125 Open Channels Ooo y oe oo y foes Single Standard EE Power Wattage 50 Watts Voltage 115 230 Volts 10 50 60 Hz Operating Conditions Temperature From 18 to 35 C Relative Humidity Upto 85 Storage Condition Temperature From 10 to 60 C Relative humidity Up to 85 Operating Position On Horizontal flat rigid and vibration free surface ABS Fire Retardant Size cm 32 x 35 x 11 5 x b x h 5 Ka Approx Version No 3 4A Page No 8 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 4 PACKING TRANSPORT amp STORAGE 4 1 General warnings Instrument has to be decontaminated before packing for transportation 4 2 Packing Packa
26. must be kept away from eyes mouth and nose at all times e Mucous membranes are considered prime entry routes for nfectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols e Eating and drinking while decontaminating instruments is not advisable 13 4 Procedure e A solution of 0 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using household bleach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it e Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instrument and wipe down the top surface of the instrument base as well as the inside of the top shroud e Reassemble the unit and discard the used gloves and towels Version No 3 4A Page No 43 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 14 SAFETY CLEARANCE CERTIFICATE Please complete all information requests on this form prior to returning the instrument to the manufacturer or your local distributor for servicing repairs or return Thank you for your co operation Customer Contact Address Position Dept Tel Country Fax Post Code Model No ___ CCCs Serial No Accessories Returned Date of Purchase if known Complaint
27. ower on self test It then displays model name and the time indicating that initialization is complete If a printer is enabled model name the time and the date will be printed If the correct date and time are not displayed switch off the instrument and switch on again e Once initialization is over a lamp located within the instrument will glow This lamp requires 45 seconds for stabilization The instrument is now in IDLE mode and ready for use Version No 3 4A Page No 14 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 6 7 Printer setting operations In case lever is disabled with printer in on condition or if printer has run out of thermal paper following message will displayed SET PRINTER PR ENTER SKIP PRINTER PR YES User may operate the instrument by disable the printer To Set Printer Press FUNC key Strip type Y N Press NO key Delete test Y N Press NO key Set time Y N Press NO key Set printer Y N Press NO key to switch off the printer press YES key to switch On the printer 6 8 Keyboard check Check key board by pressing MENU key first and all other keys later one should get a beep and either alpha numerical or numerical should appear on display 6 9 Setting Date and Time Setting of date and time can be done with the help of FUNC key Press FUNC key Strip type Y N Press NO key Delete test Y N Press NO key Set time Y N Press YES key The ins
28. p Decimal Keys amp Press ENTER I MPC MNC gt Y N I MPC MNC gt Enter Value using Number Keys amp Decimal Keys amp Press ENTER Load Strip amp Press ENTER Place the Strip in strip Holder Ref 5 2 Enter the number of wells to be run amp press No of WELLS ENTER The instrument loads the STRIP on to the optical system reads all the wells in sequence and transports them out again Press ENTER key to continue the operation till all the Strips are read Version No 3 4A Page No 31 of 45 Effective Date Nov 2011 USER MANUA L readwell STRIP 10 3 B Reverse Cut Off Mode CALCULAT ION C O X MNC Y MPC W MCC Z MLPC Cut off Factor C O MNC MPC MCC MLPC X Y W Z Version No 3 4A Effective Date Nov 2011 Cut off absorbance Mean of the negative controls Mean of the positive controls Mean of Cut off control Mean of low positive controls User entered coefficients as given in the interpretation criteria of the test that can have any positive or negative numerical value including 0 and1 X and Y can be entered to two decimal places while FAC can be entered to three decimal places Page No 32 of 45 USER MANUAL OPERATION Press CUT key Display Select Filter Pos if gt C O Y N Pos if lt C O Y N YES Blank Y N NO NO No of Blanks Blank gt Number of NCs Version No 3 4A Page No 33 of 45 E
29. press ENTER Continue the operation till all the Strips are read Version No 3 4A Page No 26 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP A 10 2 Single Standard Mode A In this mode the instrument accepts the calibrator singly or in duplicate and then calculates the concentration based on the single point standard curve passing through the point 0 0 A blank is mandatory in the first well A factor is generated in this mode and then multiplied by subsequent absorbance to determine the concentration A single calibrator standard of a known concentration is used to calibrate the instrument so hat the concentration of unknown samples can be calculated according to Beer s Law The absorbance is read at user selected wavelengths The instrument will automatically blank on the first well and subtract its absorbance from each subsequent well The second well is treated as the calibrator standard well The third well is also treated as calibrator standard well if the calibrator standard is in duplicate CALCULATION Calculated by the instrument Factor Concentration of the calibrator Absorbance of the calibrator Sample Concentration Factor x Sample absorbance The first well should always contain the BLANK OPERATION Press STND key How to operate Display Select Filter Ref 9 1 Select Filter Enter Concentration value of the Calibrator Press YES to select or NO to reject it CALS in Dup Y N
30. rnings when in presence of such biological substances Use Protective clothes gloves and glasses This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if the given warnings are not followed This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal OYS SESS General Symbols Symbol for Manufacturer Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE LI Version No 3 4A Page No 5 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 2 2 Use of the Instrument The instrument has to be used for the designed purposes under specified conditions following proper procedures and safety rules by qualified personnel THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL ONLY gt A qualified user has to make sure that the environmental condition is suitable the installation is correct the use and maintenance are proper according to the general safety rules as well as to the particular precautions described in the manual However the user is not entitled to repair the instrument gt A qualified technician is entitled to maintain and fix the instrument according to the instructions given using the original spare parts gt Maintain room temperature and humidity as specified in the manual gt The instrument has to be used
31. sion No 3 4A Page No 3 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 1 GENERAL INFORMATION 1 1 Warranty Information Each Instrument is completely tested and guaranteed for twelve months from delivery The warranty applies to all the mechanical and electrical parts It is valid only for proper installation use and maintenance in compliance with the instructions given in this manual ROBONIK will at its discretion repair or replace parts which may be found defective in the warranty period The warranty does not include any responsibility for direct or indirect personal and or material damages caused by improper use or maintenance of the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any incidental expenses like travel and man hour service charges will be charged extra 1 2 Technical Service ROBONIK is always accessible to the customers for any kind of information about installation use maintenance etc While asking for service please refer to this manual and report the printed serial number on the identification label Only qualified technicians are entitled to fix the instrument the user as described in this manual should carry out ordinary maintenance ROBONIKk s technical service or an authorized service center with specialized technicians with suitable instrumentation and original spare parts ar
32. t can have any positive or negative numerical value including 0 and 1 X and Y can be entered up to two decimal places while Cut off Factor can be entered up to three decimal places Version No 3 4A Page No 28 of 45 Effective Date Nov 2011 USER MANUAL OPERATION Press CUT key Display Select Filter Pos if gt C O Y N Blank Y N NO No of Blanks Number of NCs off mode Version No 3 4A Effective Date Nov 2011 NO Ref reverse cut Point No 10 4 Page No 29 of 45 readwell STRIP How to operate Ref 9 1 Press YES if Positive gt Cut off Press YES if Blank is required Enter No of Blanks to be run Max 5 blanks to be placed successively from the 1 well Enter maximum Value of Blank and Press ENTER Enter number of Negative control to be run max 3 amp press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER to skip press enter Enter the maximum value of Negative Control using Number keys amp Press ENTER Enter Number of Positive Controls to be run max 3 amp press ENTER Enter Value using Number Keys amp Decimal Keys amp Press ENTER to skip press enter Enter the minimum value of positive control using number keys amp Press ENTER Enter number of Cut Off control to be run max 3 amp press ENTER Enter number of Value amp Press Enter To skip press Enter USER MANUAL Display Cut C gt No
33. trument displays DATE DD MM YY Enter date month and year in the same format Press ENTER key The instrument displays TIME HH MM SS Enter hour minutes and seconds in 24 hr format Press ENTER key The instrument goes back to idle position Version No 3 4A Page No 15 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 6 10 To Enter Clinic Name Press MENU Key Choose Test Enter 132 press ENTER Key Clinic Name Y N Press YES key ABCDEFGHIJKLMN Select the characters using arrow keys key No 4 and 6 confirm by pressing ENTER on blinking character Conclude by pressing ENTER key twice at the last character a maximum number of 15 characters can be entered 6 11 Check lamp amplitude Press MENU key Press 128 and press ENTER key The instrument will print lamp amplitude in the following format 405 Amplitude 450 Amplitude 492 Amplitude 630 Amplitude The amplitude should be in the range of 3 00 to 11 00 After printing amplitude press FUNC key once the instrument shall display SAVE TEST Y N press CLEAR key twice to go back to idle position 6 12 Strip loading procedure Refer 5 2 Micro strip Carriage 6 13 Readings check Checking of readings has to be done through controls and should be with range specified in data sheet of controls care should be taken while preparing and pipetting controls and reagents reagent and control expiry dates need to be checked Version No 3 4A Page No 16 of 45 Effecti
34. tt rac a E amie ateaatenans 10 52 MICRO STRIP CARRIAGE Ee dee dE 11 5 3 INSTRUMENT WORKING PRINCIPLE cssccccssscecssececssececsseceessececsseceesseeeeaeceesaesecseeeeeaeees 12 6 INSTAL EA TION AND ebessen 13 6 1 UNPACKING Tele dE 13 6 2 PLACING THE INS FRUMENTE gue ege Ee dank Nee EE ENEE 13 6 3 POWER SUPPLY REQUIREMENTS sccsssscssssssccssscesssscsseessceesseesestesstessceesseesesesseunseceusess 13 6 4 PROTECTIVE GROUNDING ege eege edel eege 13 6 5 THERMAL ENEE edel eegne Eege 13 EE START UP INSTRUCTIONS neg a aa E e anaa gia a aa aain 14 6 7 PRINTER SETTING OPERA TIONS tere eene Reese duecevastevaieaentnvucuret 15 6 8 REY BOARD CHECK wie an aee r ee a a aa EE 15 6 9 SETTING DATE AND TIME eeeeeeEe EE eEdeEeEeEEAEE 15 6 10 TO ENTER EE ei TEE 16 6 11 CHECK LAMP AMPLITUDE 2 siasct tapxidicletecetadncsSasbestinduslagsndhcntacent Ae leg derhin 16 6 12 STRIP LOADING DECHE DEE eege deed 16 6 13 READNGS CHECK ee ee 16 T PRECAUTION S e e e er aa daaa a aae aaa aaar a de a aira eaaa 17 Version No 3 4A Page No 2 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 8 GENERAL KEY OPERATION swssciciceciccscatetsudecuosasescnessucnavstcsscecetoutestentseveactnasdssteasecanteuieaiies 18 Oe TUN Gr TE EE EE 18 E E Saving EE 19 8 1 2 DEON E 19 8 1 3 Setting Date RRE 20 8 2 MENU KEVA wa vocal see vate tag vat nea onde cs A ea Sear E E S 20 8 2 1 Enter ee 20 8 2 2 Recalling Saved St rrano entana a
35. ument To ensure maximum trouble fee operation the instrument should be kept dry and clean The ambient temperature should be maintained within 18 C to 37 C Extreme humidity or temperature is harmful to filters Temperature change at the rate of more than 5 C per minute is harmful Cleaning may be done using a dry cloth Do not open the instrument without proper training from technical personnel Keep the instrument covered when not in use Version No 3 4A Page No 41 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 12 TROUBLE SHOOTING ERROR MESSAGE If Number of saved tests exceeds 125 Lamp Amplitude is poor Readings are not Consistent Place the STRIP properly and re run the samples Controls Full If the Assay value is not valid this error Invalid Assay appears ReCheck the value and rerun the test Switch on the Printer Keep the printer online by pressing the online key Reset the instrument by pressing the CLEAR key twice or Switch OFF and Switch ON the instrument Insert the STRIP properly and return Reset the instrument by pressing the CLEAR key twice or Switch OFF and Switch ON the instrument Insert the ST o and return To set printer STRIP Movement Jam Sensor Movement Jam RIP properl ERROR MESSAGES IN CUT OFF MODE Blank High Blank value greater than the specified range Negative Control High Negative control greater than the specified range ERROR MESSAGES IN REVERS
36. ve Date Nov 2011 USER MANUAL readwell STRIP 7 PRECAUTIONS e Ensure that the main power switch is in OFF position before connecting the power cord Confirm proper grounding for trouble free operation e Never operate the instrument with ground wire removed e After placing the strip place the strip holder lock firmly Do not attempt to open the instrument or make repair without proper technical training e Do not allow unauthorized persons to operate or repair the instrument Use a clean strip and follow the instructions for blanking and standardizing e Do not read any wells containing bubbles e The volumes of sample calibrators and blanks should be identical for correct readings since the absorbance is proportional to the path length e Pipetting should be proper e Monitoring of the printed or displayed values during operation may help detect an error in making e Check the linearity and calibration of the instrument regularly against some standard reference e Check the micro wells before use They should be scratch free e Recheck the readings of high OD above 2A e Dilute the sample and take another reading to confirm e Place strip holder locks firmly in the strip holder to ensure the strips are in its place to prevent error while reading optical densities of the samples Version No 3 4A Page No 17 of 45 Effective Date Nov 2011 USER MANUAL readwell STRIP 8 GENERAL KEY OPERATION 8 1 FUN
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