User`s manual - M Dairy Solution
Contents
1. WARNING The blank calibration procedure is essential for the proper operation of the ReadSensor that is why the operator is forced to repeat it regularly During real measurements which may only happen after a blank calibration the equalized optical density curve relative reflectance curve will look like shown below Test line Control line Test line The evaluation of the Twinsensor or Tetrasensor dipstick is the following There is a control line and two test lines on the dipstick of the Twinsensor and only one test line on the dipstick of the Tetrasensor The reader calculates a ratio number from the integration area of these coloured lines on the reagent surface then compares this ratio with defined calibration curve range limits and outputs a qualitative result The photometrical precision of the device remains below the precision of immunological measurements The accuracy of the system derives from the dipstick Please refer to the User s Manual of the kit product for further information READSENSOR INSTRUCTIONS Version 1 3 December 2007 16 38 2 3 Components and Functions Component Function 1 Printer cover Flips up for insertion of printer paper 2 Display keypad LCD display and three function keys for menu driven operation and interfacing with the user 3 Test dipstick slot Receives the dipstick tray 4 On Off switch Powers the unit on and off 5 Power socket Socket used to connect the analyzer to the mains2. conditions In operating In storage Temperature 15 to 30 C 20 to 70 C Relative humidity 20 to 80 20 to 85 Optimum operating conditions Temperature 20 to 26 C Relative humidity 30 to 60 Interfaces PC HOST RS 232 D Sub socket 9 pin female unidirectional AT PC keyboard 6 pin PS2 socket female READSENSOR INSTRUCTIONS Version 1 3 December 2007 37 38 11 2 Safety Notices Readsensor meets the requirements of the European Directive 98 79 EC on in vitro diagnostic medical devices Furthermore this analyzer was designed and manufactured to comply with international standard IEC 1010 1 Safety requirements for electrical equipment for measurement control and laboratory use part 1 general requirements and left the factory in a safe condition This international standard is equivalent to the standards UL 3101 1 for the USA CSA C22 2 No 1010 1 for Canada and EN 61010 1 for EU The Readsensor fulfils the requirements of the EMC Directive on electromagnetic compatibility This product fulfils the requirements of Directive 98 79 EC on in vitro diagnostic medical devices In order to keep your instrument in a perfect and safe condition it is up to the user to observe all instructions and warnings included in this manual The instrument must only be operated with the prescribed power supply unit Class Il protection Opening covers or removing parts of the instrument except where this can be
3. A RAPID designer v7 02 AmE NE e A ee Averages 9 2 Seeking limits red lines Ratios of the lines Little circle buttons Test type Integration limits light blue lines Line related data Change style of the diagram READSENSOR INSTRUCTIONS Version 1 3 December 2007 10 38 VA ReadSensor CHAPTER Il General User s manual Version 1 2 Pending the upgraded version READSENSOR INSTRUCTIONS Version 1 3 December 2007 11 38 T INTRODUCTION au ante 12 2 SYSTEM DESCRIPTION uns ae 2 1 Twinsensor or Tetrasensor dpstcks 2 2 Measuring principles eene 2 3 Components and Funectons cece cess cee ceecsececeeseeeececseeseseseeesssseeecsesseeesssssesecassseseeeseessssaeaseeeaee SORT VV E 16 3 1 VEL VIC W ee EE Ee Ee Soca Sve ta Ee 16 32 Men Structure Flowchart u u 0 ne880 Rare Eeer lern 16 3 3 Readsensor Menu detailed description u uusesssessesnennenesnennennenennennennnnennennenennennenennenennsnennnnnenannennnnnn 20 3 3 1 The MEAS REENEN 20 333 2 The SET TIN GS Men EE 22 3 3 3 CHECK Menu Eresch EE 25 4 READSENSOR INSTALLATION AND QUICK START uunssnneennnnnnnnnnnnnennnnnnnn 26 4 1 H rdware checklist 4 2 38 eaea aa e antene raaa a aae e Eea a e E aa a a a E S a 26 4 2 Tnstr ment Connection e os ENEE a te a a OE aE T OaE Aaa Ea eea aaa o NEAN EEIE E EEES 26 5 gt CHECK MEASURE nn a a EE 29 6 NORMAL MEA SURE 1 2 2228 een ee 30 6 1 Ee le
4. defined reflectance readings The purpose of the check measure is to verify for ageing effects failure and infection of the optical system Check lines on the check dipstick have exact area values which required during the check measure If the measured value is not in the limits the normal tests probably will not valid Procedure Press the middle function key CHECK to carry out the Check measure 1 Take a blank calibration See section 6 1 2 Remove a Check Dipstick from the Check Dipstick container Be careful not to touch the check line surface and do not allow that those to come into infect with anything 3 Insert the Check Dipstick with the check lines facing upwards to the Reader leading Before calibrating ensure that the Dipstick is clean and the strip is not scratched ATTENTION It is very important that the Check Dipstick locks into the instrument correctly in order to ensure the quality of the calibration 4 As the reader recognised the Check Dipstick it starts to carry out the reading and the evaluation automatically Check line 1 2 and check line 3 on the strip are read 5 Check line areas are printed and displayed on LCD but is not stored in memory Remove the Check Dipstick CAUTION Regular Check measurement is necessary to ensure the quality of the results obtained Unisensor SA cannot warrant the correctness of results if the system is not checked regularly ATTENTION You can make a Check measuremen
5. Back Cancel the reading and return to the previous screen ee gt READSENSOR INSTRUCTIONS Version 1 3 December 2007 26 38 4 Readsensor installation and quick start WARNING Read the Readsensor User s Manual carefully before installation so as to ensure proper operation of the analyser from the outset For a quick installation the following simple steps should be done e verify the hardware checklist checking for damage during transport connect the accessories and your PC to the reader according to your need make the initial basic settings on the reader 4 1 Hardware checklist Upon receipt check that the Readsensor box contains all of the following items e 1 Readsensor e 1 Dipstick tray e 1 AC Adapter e 1 AC connecting cable for the adapter e 1 roll of thermo printer paper e 1 User s Manual CAUTION To ensure your readings are always accurate do not set up Readsensor in close proximity to devices that create high frequency fields as they may interfere and produce false results Such devices include for instance walkie talkies mobile telephones microwave ovens and diathermic equipment ATTENTION In the event of damage to goods during transit contact your local representative ATTENTION If your analyzer has been exposed to marked changes in temperature and or humidity wait for it to acclimatize sufficiently before operating it 4 2 Instrument connection Power on 1 Unpack the Readsensor and place
6. Main menu PLEASE WAIT Check the fixed position of the blank Dipstick That is important for the proper blank calibration If it passed automatically switches to a new screen Back Cancel the calibration and return to the Main menu BLANK IN PROGRESS The blank calibration As the reader recognised the non used strip it starts to carry out a calibration automatically Wait until the next screen appears Back Cancel the calibration and return to the previous screen BLANK TIME The blank time is not valid in check mode Each check measure needs a blank calibration But after the check measure it is not need in normal measure mode for twenty four hours Within this period there is no need to carry out blank calibration again except the Reader switch off on or carry out a check measure PLEASE WAIT Check the fixed position of the check card That is need for the proper reading of Dipstick If it passed automatically switches to a new screen Back Cancel the reading and return to the previous screen CHECK LOT nb Introduce the lot number of the Check dipsticks that are used READING IN PROGRESS The reading and the evaluation of the test strip As the reader recognised the check Dipstick it starts to carry out the reading and the evaluation automatically The evaluation is done based on the pre defined test Dipstick features It takes about 20 seconds after complete insertion Wait while the next screen appears
7. PRECAUTIONS e Read the kit insert Manual carefully before installation so as to ensure proper operation of the analyzer from the outset e Do not use any components of the kits after expiration date e Do not eat drink or smoke in the area where the specimens or kits are N handled e Handle all specimens as if they contain infectious agents Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens READSENSOR INSTRUCTIONS Version 1 3 December 2007 13 38 STORAGE AND STABILITY The kit can be stored refrigerated 2 8 C The test device is stable through the expiration date printed on the label The microwells and dipsticks must remain in their original sealed pouch or bottle until use WARNING Do not freeze Do not use beyond the expiration date 2 2 Measuring principles The Readsensor uses the incident light emitted by an internal light source reflected by the test strip surface as primary information In other words the reader sees exactly the same thing as the human eye does except the fact that the colour of the light source is adjusted to the spectral properties of the test strip in order to improve contrast and sensitivity That is why green light is radiating from the insertion window during the measurement CAUTION As the reader sees the same way as the human eye does it is subject to the same interfering effects No
8. achieved manually without the use of any tools may expose voltage carrying components Connectors can be live too Never try to maintain or repair an open instrument which is carrying voltage If you suspect that the instrument can no longer be operated safely turn it off and take steps to ensure that no one will subsequently attempt to use it Make sure that only trained members of staff operate the Readsensor analyzer Any personal computer to which the analyzer is connected must meet the EN 60950 requirements for data processing equipment ATTENTION The data and information contained in this manual are accurate at the time of going to press Any substantial changes will be incorporated in the next edition In case of conflict between this manual and information given in package inserts the package inserts shall take precedence 11 3 Manufacturer s Warranty Unisensor SA warrants Readsensor against defects in materials and workmanship for a period of one year from the date of purchase The warranty ceases to apply if the instrument has been misused poorly maintained or tampered with Liability under this warranty is limited to the repair of defective parts or at the discretion of Unisensor SA to the issue of a replacement instrument A right to rescind the purchase agreement only exists if the replacement instrument is also found to be defective Claims other than these will not be entertained Damage caused by misuse maltreatment
9. adapter 6 PS 2 socket For connecting a PC keyboard 7 RS 232 interface For connection to a personal or host computer 8 RJ 11 6 connector Connector is used only in manufacturing or servicing 9 Program chip key under the printer cover Contains the software needed to drive the analyzer as well as the standard range limits 3 Software 3 1 Overview The Readsensor software provides a user interface that enables all laboratory specific settings and recurrent functions to be selected via the liquid crystal display and function keys see Sections 3 2 and 3 3 The three function keys assume the particular function displayed on the second line of the liquid crystal display The first line of the display is used for system status and user information The user interface is self explanatory so that only details of the major functions are presented here Pressing the BACK button within any submenu to return to previous menu screen 3 2 Menu Structure Flowchart Have a look to the Readsensor screen menu READSENSOR INSTRUCTIONS Version 1 3 December 2007 17 38 START Check menu Op name Ok Back Waiting anew check Waiting a new blank test BLANK Back Back PLEASE WAIT PLEASE WAIT Stabilization and checking the position Back Stabilization and checking the position BLANK IN PROGRESS READING IN PROGRESS Back Calibrati
10. appear on LCD The Dipstick has to be removed and reinserted the reader does not accept any strip already residing in the optics at the start of any measurement In the other case gt gt PUSH DIPSTICK IN gt gt message displayed on LCD When the strip is accepted the reader will display BLANK IN PROGRESS in the first line After it automatically set the lighting for the correct reading it is the countdown on the LCD The purpose of calibrating the analyzer is to compensate for ageing effects that influence the optical system If the compensation needed is excessive for example because the test strip is badly soiled or an LED is defective and cannot emit the required amount of light an error message is displayed see below Procedure 1 Tear off a normal Dipstick The Dipstick must be totally blank and clear Remove the Dipstick from the bottle Be careful not to touch the surface of strip in the Dipstick and do not allow them to come into contact with anything 2 Press the left side button Start BLANK STRIP appears 3 When gt gt PUSH DIPSTICK OUT gt gt appears place the calibration strip with the test window facing upwards and out with the sample tearing window ATTENTION It is very important that the blank Dipstick locks into the instrument correctly in order to ensure the quality of the calibration 4 Equipment set the correct lighting An acknowledging beep sounds Remove the blank Dipstick I
11. data are displayed on the bottom side of the window position tolerance area amplitude 1 Change the test type The radio buttons at the right bottom side of the Rapid Designer window could be used to choose the required type of test When one of these buttons is clicked the reading will restart 2 Taking white image blank calibration Take a blank image of the unused dipstick first The Normalized values are calculated based on it Insert the unused dipstick into the reader Wait while the full image is displayed and set the proper lighting It can be done by clicking to the ncrease light or Decrease light and displaying the white blank curve can be viewed by choosing white in the View section The current light setting is displayed in the status row of the window bottom e g Lighting 5 The white curve should not reach the top of the diagram because it means that saturation Store the white curve by clicking the Blank calibration button on the bottom of the window The white image can be displayed any time by choosing White in the Picture section Set also the start line where the picture will start It can be done by clicking the Increase start ccd line and Decrease start ccd line next to the display field Store the lighting and start line by clicking the Save lighting and lines button 3 Taking and analyzing images The program refreshes the display and displays the actual image of the reader automatically
12. if the Actual is set in the Picture section It can be stopped and restarted by clicking on the Stop and Start buttons upper side of the window READSENSOR INSTRUCTIONS Version 1 3 December 2007 7 38 Teach the line position to the Reader Before doing any changes please note the setting value of position and tolerance in order ot re set whenever you want Line Position and Tolerance are set into the system but you can teach the line position at any time as follow Insert a used strip to the reader and wait while the full image is displayed 1 Select that line which would be set It could be done by click on the little circle button in the proper line section on the bottom of the window Test line 2 Control line Test line 1 2 Clicking the left mouse button at the desired line position on the image of the strip upper picture 3 The line positions could be set in the other way Write the desired line position in the desired line section Test line 2 Control line Test line 1 and press Enter Set the line tolerances Write the desired line tolerance in the desired line section Test line 2 Control line Test line 1 and press Enter When the position and the tolerance of the lines is set they could be saved by clicking the Save lighting and lines button The curves are displayed on the diagram section of the window The following curves can be calculated and displayed White the stored white blank curve is d
13. image on surface of the CCD 3 The CCD consists of an A D converter and sends a digital electrical signal to CPU Then the microprocessor 4 converts this digital reading to a relative reflectance lighting curve by referring it to a calibration standard blank lighting curve The reader calculates a ratio number from the integration area of the coloured lines on the test Dipstick surface Test dipstick is read photometrically after a lead incubation time The CCD can see the entire surface of the test strip but it is directed onto a 32 pixel wide zone of the relevant reaction area The footprint of the optics the area which is projected onto the sensor array is called the field of view FOV READSENSOR INSTRUCTIONS Version 1 3 December 2007 15 38 The width of the dipstick is about 5mm and it is measured in the cross direction of the strip The limits of the FOV are measured along the strip and are fixed for all Readers The reader recognises the darkness and colour change only within the FOV The illumination of the test strip and the sensitivity of the CCD element are not uniform along the FOV and not constant in long term Due to these facts the reader has to make a white calibration or blanking on a regular base With the blanking procedure it is possible to equalize the non uniformity of the optics as it is shown above After a blank calibration a blank Dipstick is measured to have the same colour at each position
14. inserted Repeat calibration if necessary after switch off on Remove external sources of interference ifthere are any NO PRINTOUT Printer Off has been selected or the printer software is defective or the printer is out of paper Insert paper if needed Choose Printer On to re activate the printer Request a patient report via the Print function If this fails activate the Linefeed function If there is still no response the instrument is defective READSENSOR INSTRUCTIONS Version 1 3 December 2007 35 38 10 Connecting to Other Devices 10 1 RS 232 Serial Interface The RS 232 serial interface through which it can be connected to PC is located at the rear side of the Readsensor If requested Unisensor SA supplies appropriate standard data cable for data transfer between the Readsensor and host PC Connected PC must satisfy the electrical safety requirements laid down in EN 60950 The protocol is unidirectional with the following parameters 9600 Baud 8 databits No parity 1 stopbit Data cable D sub 9 pin male on instrument side female on PC side Connections 1 1 2 RxD 2 3 TxD 3 4 DIR 4 5 GND 5 6 6 7 7 8 8 9 9 Records stored in the memory can be transmitted from the Readsensor to PC That is how old measurements can be archived on host PC On PC side only a serial terminal program is needed for successful data transfer Any kind of serial termina
15. is displayed After the last line the first one is displayed again Quit Return to Main Menu 3 3 2 The SETTINGS menu Setups and settings of the reader reading memory recall transfer and enter the user address can be done under this menu SETTINGS User name or Administrator Enter the user name administrator It can be some information about the measuring place person or other important things about the measure in five rows Output Set the output features of the meter USER ADDRESS LINE X Write the X line of the user address Number of the current line displayed on right side of the LCD s first line Each row can be 20 characters READSENSOR INSTRUCTIONS Version 1 3 December 2007 23 38 Press lt ENTER gt on the keyboard to enter the current line The equipment stores it after the switch off too Return to the Settings menubox OUTPUT Output features of the reader can be set under this sub menu Print Send Printer settings and memory access for printing out and sending to a host PC Display Display date time and language settings Back Return to the previous screen PRINT SEND Printer settings and memory access to printouts and sending to a host PC Printer The online printing reports are printed out immediately after the measurement can be switched on or off Memory Memory access for printing or sending Back Return to the previous screen PRINTER PrON PrOFF The indicator is displa
16. is stopped during its course for a longer period of time 1 2 seconds the reader might start the measurement Such operation could lead to false readings despite of the thorough measurement validity checks that the reader performs during result evaluation When the reader accepts the strip as stabilized it starts the measurement procedure indicated by READING IN PROGRESS in the first line of the display After a few seconds the result is evaluated and is printed on paper and on demand line by line on the LCD screen If the reader does not accept the strip as a valid test strip e g missing control reference line or test redrawn during measurement E06 STRIP INVALID error message will be displayed 5 When gt gt PUSH DIPSTICK IN gt gt appears place the Dipstick with the test window facing upwards and out with the specimen tearing window 6 When Dipstick is measured calculating the result and print and or send it 7 Selecting the Measure menu point to take another measure After the completion of a measurement a new one can be initiated by selecting the Measure menu This will restart the measurement procedure READSENSOR INSTRUCTIONS Version 1 3 December 2007 32 38 6 3 Result Report The result report is printed out together with the sequence number date and time The sample s name may be entered manually on the printout If a sample s ID was entered in advance of the reading see Section 6 2 it will be
17. it on a stable level surface Do not expose the analyzer to direct sunlight or other source of direct light for example a spot lamp 2 Connect the AC adapter to the power socket at the rear of the instrument and to an AC wall socket 3 Switch on the Readsensor using the on off switch at the rear of the instrument 4 When all the elements are properly connected and the reader is plugged into the mains socket version information should appear first for 3 seconds followed by the Main Menu screen on the LCD If you get an E05 NO CODEPIN error READSENSOR INSTRUCTIONS Version 1 3 December 2007 27 38 message on the screen please open the printer cover and check whether the code pin is properly placed in the nut on the left of the printer paper roll The code pin should be sitting firmly in its position if it is loose insert it properly This happens whenever the instrument is switched on If an error occurs consult the User s Manual or contact your local Readsensor representative Basic initial settings before starting any measurement Normally there are three things to do before starting the first measurements Insert a new paper roll if there is no paper in the printer Set the proper language Check the date and time Paper insertion Flip open the printer cover of the instrument instrument must be switched on The paper roll is easily inserted if it is cleanly cut with a scissors Hold the printer paper with the thermose
18. other object should be placed over the test strip before insertion The surface of the strip should be plain no bending of the strip is allowed The surface must be free of scratches and other disturbing objects drawing writing dust etc It is recommended to take care of the correct positioning of the strip otherwise it going to give incorrect results READSENSOR INSTRUCTIONS Version 1 3 December 2007 14 38 Reflectance to detector L_ Light source green LEDs 2 Test dipstick Reagent strip in dipstick format Lens Mirror 4 3 Result Test strip on holder The reflectance image is projected with an optic onto a CCD sensor which resolves the picture into 320x90 pixels along the test strip The optical density curve has a lower value in positions where the strip is dark and it has a higher value where the strip is close to white The reader does all further processing on the resulting optical density curves The user moves the dipstick under the LED reading head and the mirror The analyzer reads the control and the test lines on the dipstick Reading is done electro optically as follows The LED 1 emits light of a defined wavelength on to the surface of the test pad 2 at an optimum angle The light hitting the test zone is reflected more or less intensely depending on the darkness of the lines on dipstick and is picked up by the detector through a mirror and a lens The lens produces an upside down
19. printed out together with the sequence number The reports are printed out in the following form 6 4 Strip Measurement Error If any error message appears during the measure the test strip and or analyzer have probably been incorrectly used Refer to Section 8 for details READSENSOR INSTRUCTIONS Version 1 3 December 2007 33 38 7 Interpretation of Results The Readsensor gives results in a qualitative form which means in 3 ranges One NEGATIVE one LOW POSITIVE and one POSITIVE These are the following For Twinsensor POS when TEST CTRL B C or T C lt 0 9 LOW POS when 0 9 lt TEST CTRL lt 1 1 NEG when TEST CTRL B C or T C gt 1 1 For Tetrasensor POS when T C lt 0 95 LOW POS when 0 95 lt T C lt 1 3 NEG when T C gt 1 3 For the visual interpretation of the measurement results please refer to the User s Manual of the Test Dipstick 8 Cleaning and Maintenance Readsensor is designed for maintenance free operation Protect the instrument from extremes of temperature and high atmospheric humidity see Section 10 and keep it out of bright light direct sunlight spot lamps etc Maintain hygiene by keeping the exterior parts and surfaces of the instrument clean For cleaning apply a commercial cleaning agent or disinfectant preferably 70 alcohol with a moist cloth Take care that no liquid enters the instrument 9 Error and warning messages The Readsensor has an intelligent error detect
20. printer should start forwarding blank lines on this action the paper edge should be adjusted into the paper in slit until the paper forwarding mechanism of the printer takes hold of it When the paper length at the paper out slot has reached about 2 3 cm press the Stop button for a second to finish the linefeed procedure After this close the printer cover so that the paper juts out through the printer cover s slit 6 To set the language of your choice press the key sequence Settings Output Display Language see Sections 3 2 and 3 3 7 Press the key sequence Settings Output Display Date Time to set the proper date and time settings See Menu Structure Section 3 2 8 Readsensor leaves the factory with the default settings for Printer Language and Date time see Menu Structure Section 3 2 H your laboratory works differently individual preferences can be entered via the menus Power off We recommend that the analyzer be switched off at the end of each working day and that the mains adapter be unplugged from the AC wall socket see Section 7 Cleaning A READSENSOR INSTRUCTIONS Version 1 3 December 2007 29 38 5 Check measure Readsensor is calibrated before leaving the factory When installed it must be recalibrate with Check Dipstick before the first samples are read and thereafter every hundredth measure Check Dipstick strip has three check lines on it That is standardized to give constant
21. the non used strip and return to the Meas menubox PLEASE WAIT Check the fixed position of the blank Dipstick That is important for the proper blank calibration If it passed automatically switches to a new screen Back Cancel the calibration and return to the Meas menubox BLANK IN PROGRESS The blank calibration As the reader recognised the non used strip it starts to carry out a calibration automatically Wait until the next screen appears Back Cancel the calibration and return to the previous screen BLANK TIME The blank calibration is valid for twenty four hours Within this period there is no need to carry out blank calibration again except the Reader switch off or carry out a check measure SAMPLE ID Enter the sample ID to be tested Type the sample by using the keyboard It can be 15 characters long depending on the language setting User can use alphanumerical characters Press lt ENTER gt on the keyboard to enter the name The typed code name number will not remain to the next measuring cycle The user has to type it in for every measurement The reader accepts empty identifier field too OK Accepts without any identifier OK will disappear if any key pressed on the keyboard Back Cancel the modification of patient name and return to the Meas menubox OK Accepts without any identifier OK will disappear if any key pressed on the keyboard Back Cancel the modification of birthday and retur
22. 30 6 2 Sample preparation and applicapgon eee cece cee cseeecsececseeececsecsesecsessesessessesecsessesseeesessseaseeseeeags 31 6 3 Result Report nn EE 32 6 4 Strip Measurement Brot 32 7 INTERPRETATION OF RESULTS uuu2ea EENS 32 8 CLEANING AND MAINTENANCE uunssnnnsennnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnn 33 9 ERROR AND WARNING MESSAGES uunsnsnnnnnnnnnnnennnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnn 33 10 CONNECTING TO OTHER DEVICES ccssecccseseeeeeseeeeeenseeeeeeseeeeneeseneeeenss 35 TOT RS 232 Seri l e acne ea nai eed A oa ee ea oes 35 10 2 AT PC Keyboard ee 8 Bee ana RR Ben En 35 11 TECHNICAL INFORMATION AND NOTICES uunnsssssnnnennnnnnnnnnnnnnnnnnnnnnnnnn 36 LE Technical D ta 4 24442 452er deed eet Ae 36 TLDs Safety EE 37 11 3 Mantfacturer s Warranty NENNEN levee cont yae diode co vader ANESEC os NAS 37 READSENSOR INSTRUCTIONS Version 1 3 December 2007 12 38 1 Introduction Readsensor is a reflectance photometer designed to read and evaluate the appropriate Twinsensor or Tetrasensor dipsticks The Twinsensor was designed for the safe and reliable detection of B lactams and tetracyclines compounds in milk with high sensitivity only tetracycline for the Tetrasensor which is a key feature under the requirements of today s high standards in quality control systems The Readsensor reads the dipsticks under standardized conditions saves the results to memory and outp
23. RUCTIONS Version 1 3 December 2007 8 38 IMPORTANT When the moving line in the picture is not visible do not use the saving function Database function If you click the Datatable button on the upper side of the Rapid Designer program an other window will appear This is the data collector window which can open and save dbf files 1 Firstly a dbf file need to be created or opened to start collect the data 2 Click on the Open or create a table button then choose an exist dbf file or write in a new name 3 Now the program ready to collect data the 3 area and amplitude values 4 The data line number which you want to collect could be set on the bottom side of the data table window The default values is 10 This little window works like at the Continuous saving function 5 A new data line will be added to the data table when the picture comes up fully 6 If the all data line which you set is collected the data table could be saved by click on Save and close table button The saved dbf extension file could be opened in MS Excel for the further evaluating Creat data table Save table X Datatable Ir d Save and close table Nr Areat ss Areas Amp1 Amp2 ane 1 data line The little window for set the number of series data line There are still bn READSENSOR INSTRUCTIONS Version 1 3 December 2007 9 38 Moving line Test line 2 Control line Lighting set buttons Test line 1
24. VA ReadSensor User s manual Developped by 77 Elektronika KFT for UNISENSOR SA READSENSOR INSTRUCTIONS Version 1 3 December 2007 2 38 VA ReadSensor CHAPTER I SHORT NOTE Rapid Designer Howto use Short note PRINTING MODE amp PC MODE READSENSOR INSTRUCTIONS Version 1 3 December 2007 3 38 The Readsensor can by used without PC and with PC To move from the use with or without PC you have to change the electronic key photo nb 1 that is located just close to the printer paper under the bleu cap photo nb 2 WHEN YOU CHANGE THE KEY PLEASE SWITCH OFF THE READER There are 2 keys provided with the Readsensor The first named anyCheckValues is for the use of the paper printer and the other key camera allows connexion of the readsensor to your PC Both keys are placed into the small plastic pouch For using the paper printer proceed as follow 1 2 3 connect the small keyboard photo nb 3 connect to power supply photo nb 3 Switch on rear panel photo 3 and after 2 sec the system ask for the name of operator Introduce the name with the keyboard and press ENTER with the keyboard The system request to have a BLANK dipstick Take the tray and deposit a blank dipstick into the furrow of the tray The dipstick must facing out of the reader The sample pad of the dipstick must be visible outside the reader when the dipstick is introduced If the dipstick is in the wrong position turn i
25. alog No Service Records Last modification 25 JULY 2006 v1 2
26. in case of choose a non checked test Waiting anew test PLEASE WAIT Back 4 READING IN PROGRESS l Stabilization and checking the position Back Measure lt lt RESULTS gt gt Restart Printout lt lt Printout lines gt gt Next Line Restart Quit Print Quit READSENSOR INSTRUCTIONS Version 1 3 December 2007 19 38 ReadSensor PrON FF Start Check Settings Settings menu SETTINGS Organisation Output Back OUTPUT PrON FF Print Send Display Back ORGANISATION DISPLAY Name Back Language Date Time Back Address Back Next ADMINISTRATOR Main mens gt Name Back LANGUAGE ENGLISH OK Next Quit LANGUAGE XXXXXXX OK Next Quit LANGUAGE XXXXXXX ADDRESS DD MM YYYY HH MM SS OK Next Quit PRINT SEND PrON FF Printer Memory Back Select report SELECTED LAST Change OK Back TRANSMISSION IN PROGRESS PRINTER PrON FF ON Linefeed Back PRINTER PrON FF iz OFF Linefeed Back PRINT LINEFEED PRINTING Start Stop Printing READSENSOR INSTRUCTIONS Version 1 3 December 2007 20 38 3 3 Readsensor Menu detailed description The user can choose from the sub menus by pressing buttons under the display The current function of the pushbuttons is indicated right above on the display To leave the current sub men
27. ing system to minimize the error of the routine test In case of an error together with an audible signal and the blinking of the LED in red a message appears on the display An error warning message consists of an error code and a short text refers to the source of the error In case of the error messages the reader stops its functional working what can be continued only after the action of the user In case of the warning messages the reader pauses its functional working for the short period of the warning and steps back automatically to the previous screen The possible error and warning messages the possible causes and troubleshooting are detailed in the following E04 WRONG CODEKEY The chip module on the left of the analyzer underneath the printer cover is not valid or damaged Check the codepin and change to a proper one E05 NO CODEKEY The electronic codepin is not correctly inserted Insert the codepin correctly If the error persists withdraws the codepin delicately cleans the contactors and introduces again delicately READSENSOR INSTRUCTIONS Version 1 3 December 2007 34 38 E06 STRIP INVALID The measured strip is not valid No test strip is present or the Dipstick is incorrectly positioned control line did not develop properly or a test strip different from the set one is used The test strip was removed during the measurement Press Next button to carry out a measurement again Change the test strip to a pr
28. ipstick must be PLANNAR and placed suitably in the groove of the black dipstick tray Ensure that the lower edge of the dipstick the edge which was in milk is against the lower edge of the groove the edge close to the part for holding the black tray If dipstick is badly positioned the reading can be disturbed For using with the computer proceed as follow 1 Switch off the reader 2 Open the blew cover and replace the electronic key by the camera electronic key 3 Connect to computer with the serial cable 4 Switch on the reader READSENSOR INSTRUCTIONS Version 1 3 December 2007 6 38 Installation Insert the CD and go to READSENSOR SOFTWARE 702 and start SETUP and follow the instructions to install the Rapid Designer program to your computer Connect the reader through its serial line to the serial port of your computer Start the Rapid Designer program and choose the proper serial port using the Ports section of the window Switch the reader on The Rapid Designer program The program displays the image of the reader together with the curve s which is are calculated based on it The curves are the integration of the pixel values in vertical direction Only those pixels are used and integrated which are between the two horizontal red lines So only that part of the image is used for any further processing curve calculation data saving which are between the lines The test and control line related
29. isplayed Actual the curve of the actual image Normalized Actual White 100 If the Clear in the bottom left corner function is set only the last selected curve is displayed If it is not set all the curves are displayed 4 Save Load data Use the Load and Save data buttons on the upper left corner of the window Save data button will store the picture of the cassette and the actual light and line settings The Load button will display these data picture light and line settings It is practical if you use the Continuous saving button this button is also in the upper left corner in the Rapid Designer program to save the pictures and data 1 Firstly write the number that how many measurement you would like to save to the little window at the right side of Continuous saving button 2 Then click the Continuous saving button which will stay pressed state 3 The program will only ask for the file name once and then save the measurement serially while the set number become zero So the program will take as many series measurement as you set in the little window on right of the Continuous saving button 4 The program will save your data with the previous name but an increasing number will be added to the file name e sample_006 rap 5 When this number becomes zero the continuous saving button will be unpressed state automatically but the series measurement could be stopped by click the Continuous saving button READSENSOR INST
30. l program can be used The manufacturer recommends the use of Hyperterminal which is supplied with every Windows operating system CAUTION Use of data cable not meeting the specification of the manufacturer may damage the Readsensor or may result data loss 10 2 AT PC Keyboard User address Sample or Patient IDs can be entered via an AT PC keyboard Power is supplied by the PS2 interface Interface specification 6 pin PS2 socket female Pinouts 1 data 2 n c 3 GND 4 5V 5 clock 6 n c READSENSOR INSTRUCTIONS Version 1 3 December 2007 36 38 11 Technical Information and Notices 11 1 Technical Data Dimensions Width 195 mm Depth 200 mm Height 75mm Weight 7859 Power supply External mains adapter Model SA125A 0735U S Sino American Input 100 240 V AC 50 60 Hz Output 7 5 V DC 3000 mA Consumption Operating max 3 Watt System description Type reflectance photometer Light source LEDs light emitting diodes Wavelengths 528 nm green Reader head CCD with a 320 90 useful resolution Sample 80 ul capillary blood or serum two drop of regular volume Measuring and displayed range lt 8ng ml 3 5ng ml 5 10ng ml 10 20ng ml gt 20ng ml Measuring cycle approx 60 sec serial measure Max throughput 60 Dipstick hour serial measure Printer thermal printer Display liquid crystal display 2 lines of 24 characters Memory 26 samples Date time integrated clock Operating Storage
31. n to the Meas menubox NEW TEST Insert the strip to test into the reader Ensure the proper positioning of the strip After insertion the reader automatically recognizes the strip and switches to a new screen Back Stops the waiting for the test strip and return to the Meas menubox READSENSOR INSTRUCTIONS Version 1 3 December 2007 22 38 PLEASE WAIT Check the fixed position of the test Dipstick That is need for the proper reading of test If it passed automatically switches to a new screen Back Cancel the reading and return to the Meas menubox READING IN PROGRESS The reading and the evaluation of the test strip As the reader recognized the test strip it starts to carry out the reading and the evaluation automatically The evaluation is done based on the pre defined test strip features It takes about 10 seconds after complete insertion Wait while the next screen appears Back Cancel the reading and return to the previous screen RESULT The qualityative result is displayed Measure Carry out a new measurement again Readout The report printout can be displayed line by line The first line is displayed and then the next display will appear Quit Return to Main Menu printout line Displaying the lines of the report printout in the upper row of the display Measure Carry out a new measurement again Next Line Displays the next line of the printout report At each button press the next line
32. nsitive side facing downward and insert it into the lower printer slit I Press the linefeed function key The paper is automatically fed in Let the printer proceed with the paper insertion until several centimetres are visible on the printer s output slit Press the left function key Stop close the printer cover with one hand and use the other hand to feed the paper in such a way that it protrudes above the printer cover and is not jammed This avoids malfunctions ATTENTION To remove the printed test report tear off the paper by pulling it in front across the edge of the printer cover The paper must protrude above the slit 5 In order to insert a new paper roll first remove the eventual remaining piece of the previous roll If necessary pull the paper out from the upper paper out slit Reverse movement of the paper is not possible forcing the wrong direction can lead to damage Take a new paper roll cut off the adhesive tape if necessary and cut a clean sharp edge for insertion Open the printer cover and put the paper roll into its position Take the edge of the paper and insert it horizontally into the paper in slot The smooth shiny side outer surface of the roll should be facing down otherwise there won t be any normal printout Using the user menu and the pushbuttons enter the menu Setting Output Print Send READSENSOR INSTRUCTIONS Version 1 3 December 2007 28 38 Printer Linefeed Start The
33. on TYPE OF TEST Twin Tetra Twin Tetra Back Is the check meas Valid Twin TetraSensor CHECK LOT nb Ok Back CHECK NOT ACCEPTED Restart Printout Quit Print lt lt Printout lines gt gt Restart Next Line Quit Twin TetraSensor EXP date Ok CHECK CCEPTED Measure Printout Quit L lt lt Printout lines gt gt Measure Next Line Quit Error messages E20 WRONG DATE E25 EXTERNAL LIGHT Next Quit E04 WRONG CODEKEY E21 WRONG TEST CODE E28 BLANK OPTIC FAULT OK New Cal Quit E05 NO CODEKEY E22 CALIBRATION ERROR E30 WRONG FORMAT E06 SAMPLE INVALID E23 PRINTER ERROR Next Quit Quit READSENSOR INSTRUCTIONS Start menu Is the blank calibration valid lt 24h No Version 1 3 BLANK ReadSensor Start December 2007 Check PrON FF Settings Waiting a new blank test PLEASE WAIT Back Stabilization and checking BLANK IN PROGRESS Back the position Calibration Settings menu TYPE OF TEST Twin Tetra Twin Tetra Twin TetraSensor Test code Ok Back Twin TetraSensor KIT LOT Twin TetraSensor EXP date Ok Ok Twin TetraSensor SAMPLE ID NEW TEST Ok 18 38 Go to the check menu
34. oper one E10 WRONG POSITION The strip is not properly placed Check the position of the strip E11 WRONG LOT NUMBER Either the wrong LOT number was entered or the codekey was replaced while the reader was on E20 WRONG DATE An invalid date was entered Check the date and enter the valid one E22 CALIBRATION ERROR The reader was not able to carry out the calibration Repeat the calibration again taking care of all the details E23 PRINTER ERROR Printing failure because of the stucked paper Switch off and clear the stucked paper if there is one Switch the analyzer on again If the error message appears again the instrument is defective E25 EXTERNAL LIGHT An external light is affects the measured area of the Dipstick Do not expose the slut of the optic system to bright and direct light E28 BLANK OPTIC FAULT During the blank calibration the calibration strip is not smooth enough or it has some scratches coloration at the lines position and the optic system get soiled Check the blank Dipstick that there is not any coloration or soil and clean the inside mirror VALUES OBTAINED ARE IMPLAUSIBLE WHEN COMPARED WITH THOSE FROM VISUAL EVALUATION Test Dipstick incorrectly positioned proper incubation intervals not kept Electromagnetic interference from other devices see Section 4 Repeat the measurement with a new Readsensor Test Dipstick Follow the directions carefully and ensure the test Dipstick is correctly
35. previous screen PRINT It can be chosen whether the reports should be printed too Yes Print out the reports No Do not print out the reports Quit Return to Main Menu PRINTING Printing is in progress Quit Cancel printing and return to Main Menu DISPLAY Display date time and language settings Language Language selection Date Time Date and time setting Back Return to the previous screen dd mm yyyy HH MM SS The currently set date and time are displayed All fields can be set from year to seconds Increase the current field Decrease the current field Next Move the blinking cursor to the following field After the last field return to the main menu LANGUAGE For the moment the available language of the display and the report printouts is English OK Select the currently displayed language Next Skip to the next language Quit Return to Main Menu without changing the current language setting READSENSOR INSTRUCTIONS Version 1 3 December 2007 25 38 3 3 3 CHECK menu A check measurement can be carried out under this menu BLANK STRIP A non used white strip is needed for blank calibration Insert a non used Dipstick into the reader in order to carry out a blank calibration Ensure the proper positioning of the strip After insertion the reader automatically recognises the strip and switches to a new screen Back Stops the waiting for the non used strip and return to the
36. t for 180 like in the photo nb 4 IT IS VERY IMPORTANT TO INTRODUCE THE DIPSTICK IN THE RIGHT WAY THAT IS THE SAMPLE PAD ALWAYS OUTSIDE facing out The system make the blank calibration automatically and than ask for the type of test you want to run Switch on the black button from the reader to indicate the type of test and for running a Twinsensor switch on the first black button just under TWIN The reader request to have a CHECK dipstick and you have to introduce the check lot number with the keyboard so please type 051612 and ENTER Enter the EXP date that is 16 12 2006 and ENTER note that the year should be in 4 numbers The reader ask you to pull the BLANK dipstick out and to insert a TWIN CHECK dipstick in Remember the way to insert always the sample pad outside the reader photo nb 4 Now the system print a small ticket indicating that the blank and check have been done correctly The reader is now free for any additional measurements To continue please switch on Measure the first black button again 10 Tell what you want to do for instance switch on START again the first button 11 Tell the type of test again the first black for Twinsensor reading 12 Inter the test code that is BT00640 ENTER with the keyboard 13 Enter the LOT number in 6 numbers like 061303 ENTER 14 Enter the EXP date like for the check EXP date 13 03 2007 ENTER 15 Enter the SAMPLE ID like MILK Nb1 ENTER 16 The reader ask you to pull
37. t at any time even if the one hundred measures have not elapsed since the last calibration for example if a Readsensor Test Dipstick has returned an implausible result Start the Check procedure by pressing the middle function key Check with the analyzer in main menu Follow the calibration procedure described section Check measure Calibration errors In case of an invalid check measure the equipment does not give any error messages READSENSOR INSTRUCTIONS Version 1 3 December 2007 30 38 6 Normal measure 6 1 Blank calibration Readsensor is very easy to use The first step of a measurement series is the blank calibration This blank calibration is necessary for the equalization of the optics for more details refer to the section 2 2 Measuring principles The blank calibration is valid for twenty four hours The blank calibration should be performed with an unused white and clean test The reader checks the correct positioning of the strip and the calibration will not be carried out with a not properly placed strip It is important to perform the calibration carefully because a wrong calibration might spoil all following measurements If there is no valid calibration the first time must carry out one The reader will display BLANK STRIP and asks for a blank Dipstick for blank calibration Insert a blank Dipstick into equipment If the white test was already inserted lt lt PULL DIPSTICK OUT lt lt message
38. t may use for an hour yet to normal measure READSENSOR INSTRUCTIONS Version 1 3 December 2007 31 38 6 2 Sample preparation and application Follow instruction in KIT INSTRUCTIONS Doc TWINSENSOR V1 6 or upgraded This document is provided with each kit CAUTION There are a few aspects that should be kept in mind during measurements e The reaction time has to be kept accurately e The correct test dipstick positioning is essential the dipstick must be planar with both top and bottom part included in the furrow of the rapid designer Some dipstick might be a bit large or small and you should regard this as a major when loading the dipstick on the furrow e There are some disturbing effects that the reader itself cannot detect The reader can not distinguish big scratches from coloration thus strips with such defects should not be measured or the measurement result has to be used cautiously ATTENTION To ensure that Readsensor is carried out correctly read the package insert included with the test strip If the Dipstick was already inserted lt lt PULL DIPSTICK OUT lt lt message appear on LCD The Dipstick has to be removed and reinserted the reader does not accept any strip already residing in the optics at the start of any measurement In the other case gt gt PUSH DIPSTICK IN gt gt message displayed on LCD Insert the Dipstick into the slot of the optics with a single continuous movement If the strip
39. tampering human error and extreme force are excluded from this warranty This warranty is only valid if the date and the stamp and signature of the dealer are entered on the warranty card on the date of purchase The warranty period is not extended by any claim made under this warranty READSENSOR INSTRUCTIONS Version 1 3 December 2007 38 38 Readsensor developed for Unisensor SA By 77 ELEKTRONIKA Kft UNISENSOR S A Z du DOSSAY 1116 Budapest Feh rvari ut 98 3 rue du DOSSAY HUNGARY BELGIUM Tel 36 1 206 1480 Tel 32 42 52 66 02 Fax 36 1 206 1481 Fax 32 42 52 90 55 E mail sales e77 hu E mail info unisensor be IVD for professional use REF RAC 9903 1 CE The following symbols are used throughout this document Symbols Signs Explanation WARNING CAUTION Indicates a potentially hazardous N situation that if not avoided could result in personal injury or damage to the instrument This symbol is also used to highlight situations that can compromise results BIOHAZARD Indicates a potentially dangerous situation involving the presence of biohazardous material All safety precautions must be taken to prevent personal injury or damage to the equipment ATTENTION Indicates special problems or important information Read the accompanying text carefully In Vitro Diagnosticum CE 98 79 EC IVD directive Readsensor equipment Consult instructions for use 3 H N Serial No Manufacturer REF Cat
40. the dipstick out until you see the indication Insert a dipstick and than introduce it in the right position like on the photo nb 4 Than the system display and print the paper READSENSOR INSTRUCTIONS Version 1 3 December 2007 4 38 17 There is the result on the reader screen and if you want to screen all information print on print out second black button again and again to see the list of information that were printed If you wish to continue the reader will keep in memory all information but you are always obliged to type the sample name or to leave it blank To do so switch on START first black button and than on ENTER with the keyboard to accept what is on the screen if you want to change you can change using the keyboard PHOT 1 Electronic key 8 2 ss 26 53 29 ZS PHOTO 2 Location of Electronic key Electronic Key location READSENSOR INSTRUCTIONS Version 1 3 December 2007 5 38 PHOTO 3 Rear panel of the Readsensor Switch on off button Serial port to computer serial port Power supply Keyboard PHOTO 4 Position of dipstick into the tray holder for the Readsensor Sample pad of dipstick always outside facing the operator The arrow indicates the direction to introduce the tray into the reader The arrow indicates also the direction of the milk liquid running onto the dipstick TAKE CARE ON DIPSTICK POSITION IN THE TRAY HOLDER D
41. u and return to the Main Menu press the Quit button To return to the previous screen menu press Back button Meas Starts the measurement Check Run a check measurement Settings The setting of the instrument 3 3 1 The MEAS menu A routine measurement can be carried out under this menu Type of TEST Select the type of test among Twinsensor TWIN or Tetrasensor TETRA Start Measure with the actual Type of Test Back Back to the main menu Test code Introduce the code of the kit in use that should looks like AB12345 Kit lot number Introduce the kit lot number that is indicated on any kit labels and press ENTER with the keyboard The number can be found in the packaging of the Dipstick The number storages in the device after the first typing If the number is invalid an error message will appear If no keyboard is attached the number can be given by the buttons of the devices Expiry date Introduce the expiry date that is written on any kit labels It must be in the following format DD MM YYYY OK Accept the actually selected items BLANK STRIP A non used white strip is needed for blank calibration Insert a non used Dipstick into the reader in order to carry out a blank calibration Ensure the proper positioning of the strip After insertion the reader automatically recognises the strip and switches to a new screen READSENSOR INSTRUCTIONS Version 1 3 December 2007 21 38 Back Stops the waiting for
42. uts them via its own inbuilt printer and or serial RS 232 interface This instrument is designed for In Vitro Diagnostic IVD use for professional use only BIOHAZARD Treat all samples of animal origin as being potentially infectious Always observe good laboratory practice Using Readsensor eliminates factors known to affect visual evaluation of test Dipsticks such as e Objective readings especially in visually doubtful cases Different reaction time for the Dipsticks Automatic documentation for quality assurance purposes Clerical errors 2 System description 2 1 Twinsensor or Tetrasensor dipsticks Twinsensor or Tetrasensor dipsticks for the qualitative detection of total B lactams N and tetracycline or tetracycline in food products The Readsensor works only with these kind of dipsticks For professional use only INTENDED USE The Twinsensor dipsticks are rapid chromatographic immunoassay for qualitative detection of Total B lactams and tetracycline in food products The Readsensor system will only indicates qualitative level of B lactams and tetracycline and should not be used as the sole criteria for concentration evaluation PRINCIPLE The Twinsensor or Tetrasensor dipsticks are qualitative nitrocellulose membrane based immunoassay for the detection of antibiotics in food products The principle is described in each kit insert and can be obtained from the web site www twinsensor com and www tetrasensor com
43. yed according to the current setting on the upper right corner of the display OFF ON Alter the printer setting and return to the Main Menu For switching off the printer when the printout of results is only required at the end of a series of readings activated by the Print Send function or when results are to be sent via the interface to a personal computer or host only Linefeed Feeds paper into the printer or causes paper to advance Back Return to the previous screen LINEFEED Paper forwarding control Start Start the paper forwarding Stop Stop the paper forwarding Quit Return to Main Menu SELECTED LAST XX Select the number of reports to be printed out and sent to the PC Type the number in using the keyboard The memory capacity of the reader is 26 reports so the last 26 or less report will be printed out and sent If the memory is full the automatically overwrite the oldest report The details of sending to PC can be found in the chapter PC CONNECTION Press lt ENTER gt on the keyboard or press READSENSOR INSTRUCTIONS Version 1 3 December 2007 24 38 OK button to enter the number If enter a greater number than the number of data blocks in the memory it change to number of data blocks The displayed number after entering this menu can be accepted and immediately send the dates to PC by pressing lt ENTER gt or OK OK Enter the number of the reports to be printed out and sent Back Return to the
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