SMART user manual E
Contents
1. 89 Touch Norm Values and Confirm the selection of Touch to go to the confirm your selection with CRP with numerical entry screen of the Ta Limits menu Use and to navigate within the screen smart user manual engl ED 41201 revD1 27 04 2010 page 13 of 29 G Bonecker GETTING STARTED 4 Configuration menu Language Interface Date Time vw 4 Touch Units and confirm the selection with vd 5 Test selection menu Test x CRP A Confirm the selection CRP with vd 6 Units selection menu Unit x mg dl mgfl Touch the selected unit and confirm it with This description is only an example as the configuration of the Eurolyser laboratory photometer models varies depending on how they are equipped Language Interface Date Time d X lt a O O 5 oa s fad ma O 3 3 D Touch Input and confirm the selection by pressing 10 Default sample type menu Default x Last used Blood Serum d X lt Select which type of sample should be marked by default Last used means the sample type last used will be selected How to switch OFF the analyzer Fe j X Samp letype oo aS a ct 3 D 5 HCT g x Select which values to change from the Input menu 11 Default HCT menu HCT male 46 HCT female 46 HCT child 40 E HCT Control TE x Using or N choose which HCT value to change By pressing you can chan2. activates after 10 minutes of idle time dimming the touch screen Touch the screen to re activate it Indicator lights The illuminated green diode LED shows that the machine is connected to the power source The machine may be left plugged in indefinitely How the Eurolyser smart laboratory photometer works The Eurolyser smart laboratory photometer is an open measuring system That means it is able to use diverse reagents from multiple manufacturers When tests are to be performed the smart laboratory photometer is loaded with ERS cartridges which are filled with reagents from the respective reagent manufacturers The instrument can process end point tests as well as kinetic tests and thanks to the latest LED technology it is completely maintenance free The models of smart are differentiated by the wavelengths of their built in light sources For example the name smart 546 stands for a photometer with a 546nm light source Up to two light sources can be integrated into a photometer The instrument is equipped with an RFID card reader module RFID cards are necessary for performing any testing procedures They are included in the testing kits from the respective test manufacturers and contain all the specific steps for the various tests the lot data as well as the calibration data The instrument performs the tests automatically according to that data Numerous types of tests can be selected and performed automatically T
3. blocking the Reposition the test cartridge or testing panel because the cartridge tighten the cap on the cuvette has not been inserted completely or the cuvette has not been capped firmly enough Door blocked Wrong cap The wrong ERS cap is being used Use the correct ERS cartridge and Missing cap or the ERS cap is missing or the cap Missing cartridge cartridge is missing Latch blocked The test cartridge blocks the latch Use the correct ERS cartridge and because the wrong ERS cap is being used Measurement overflow The photometric measurement Repeat the test using a new value is outside the measuring cartridge range e g if a cold cartridge has been used Blank value error The photometric measurement Repeat the test after restarting value is outside the measuring the machine range without the cartridge Temperature error The temperature is outside the Repeat the test after restarting range the machine Wrong sample type The wrong sample type has Select the correct sample type possibly been selected Linearity error The reaction to a kinetic test is Repeat the test using a new not linear e g if a cold cartridge sample and a new cartridge has been used smart user manual engl ED 41201 revD1 27 04 2010 page 25 of 29 G Bonecker ERROR INFORMATION AND TROUBLESHOOTING Service information If the problem persists after the corrective actions are taken contact your local smart laborat
4. detail and Time detail menus detail menu Use W or Disable data will never be to navigate on the screen transmitted to the host Automatic the results will be transmitted to the host after every measurement On request data will only be transmitted upon request smart user manual engl ED 41201 revD1 27 04 2010 page 12 of 29 G Bonecker GETTING STARTED 10 Day date menu 1 Date format menu 2 Time detail menu Day 4 34 el Date Format Hour 8 23 i6 O O N E eou a Er 7 s gt DD HH YYYY VYY HH pDp Second 8 55 42 lias z e x l Tine Format 24 HH D0 T nae Touch the desired digits and Select your preferred date Touch to go to the Time confirm the selected date with format input or Time format menus DD Day To navigate within the screen MM Month use w and fs YYYY Year 13 Time input menu 14 Time format menu al 23 Time Format onra x1 24 12 Touch the digits to enter the Select either the 2 hour time time and confirm your format 12 AM PM or the selection with 24 hour time format 0 23 Jil To exit a menu or to cancel an input use Xx Setting the normal values and the units using a CRP test as demonstration Configuration menu 2 Test selection menu 3 Limits menu Test Lower lin male 0 00 A irae e ae Loner lim female 68 66 ae ne Upper limn female 1 16 Loner lim child 8 68 pater Be E Upper lim child 6
5. regulations Choosing quality control QC materials The authorized manufacturers of the smart test cartridges also supply control materials These control kits contain control materials which allow you to assess the measuring accuracy of the instrument Ensure the measuring methods are compatible with the Eurolyser smart laboratory photometer before using QC kits from other suppliers The measuring methods are listed on the test cartridge s package insert Handling the QC control materials Consult the package insert that comes with each control kit for detailed instructions on the Jil storage and handling of the control materials Follow the instructions in the Testing procedures Analyzing a patient s sample sections pp 15 18 on how to properly perform a control test The measured values must be within the range of target values specified on the control vial label or in the control package insert If the control results fall within the specified range the testing of patient samples may begin If one or more controls tested outside the specified control range Verify that the control materials have been stored according to the directions and that the expiration date has not passed Verify that the handling and testing procedures were performed according to the directions on the package insert Repeat the control test using a new control from the same lot If one or more control results are still outside the speci
6. smart laboratory photometer check the contents against the list below and examine the components for signs of shipping damage The smart package contains the Eurolyser smart laboratory photometer Mains adapter 12V DC 3A 40W Power cable User s manual If any part of the package is missing or damaged please report this to your supplier immediately We recommend that you keep the original packaging in case the instrument ever needs to be transported smart user manual engl ED 41201 revD1 27 04 2010 page 5 of 29 G Bonecker INTRODUCTION Description of the Eurolyser smart laboratory photometer Figure shows the main exterior parts of the SMART laboratory photometer front view Touch Display 2 RFID Card Adapter 3 Testing Panel Figure Do not open the panel manually The main user interface to operate the instrument and read the results The RFID card is inserted here To insert and remove the tests The green light emitting diode LED is illuminated when the instrument is connected to the bower source Figure 2 describes the main exterior parts of the smart laboratory photometer rear view RS232 socket 2 RS232 socket 3 USB socket 4 Power socket Socket for an optional printer PC connection PC connection Connects to the power supply Figure 2 smart user manual engl ED 41201 revD1 27 04 2010 page 6 of 29 G Bonecker INTRODUCTION How t
7. 0 page 3 of 29 G Bonecker TABLE OF CONTENTS Technical specifications Eurolyser smart laboratory photometer Power supply Options thermo printer barcode scanner Declaration of Conformity Manufacturer s Information smart user manual engl ED 41201 revD1 27 04 2010 page 4 of 29 G Bonecker 27 27 27 28 29 INTRODUCTION Intended use of the EUROLYSER smart laboratory photometer The Eurolyser smart laboratory photometer is for in vitro diagnostic clinical chemistry use only The smart laboratory photometer is very compact and is designed as a point of care measuring instrument for the ERS Eurolyser Reagent System It is easy to use and provides quick reliable and accurate results About this user s manual This user s manual will guide you through the installation operation and maintenance of your Eurolyser smart laboratory photometer The user s manual also explains how the photometer works describes the quality assurance system and assists you in troubleshooting any errors or problems We recommend that you familiarize yourself with these instructions before operating the Eurolyser smart laboratory photometer Some of the information in this user s manual is marked with following symbols wv Operator s action Warnings and precautions see accompanying documents J Refer to the user s manual and follow the instructions Inspecting the package contents When unpacking the
8. Settings menu 3 Calibration options menu smartisas Door close Calibration Calibration Insert Card 62 65 7667 Settings 8 Touch C to go to Touch Calibration to go Select Test kit O EOLO i the Settings menu to the Calibration options the Calibration options menu ee 4 Calibration options menu 5 Calibration card menu 6 Calibration data menu Calibration Calibration Calibration Test CEF Insert Calibrator Card Expiration Date 36 63 7689 Lot Hr r ga CRF 2 868 ngfdl The instrument asks you The instrument reads the To perform an ae i ak Ale tic calibrati to insert the calibration calibration data from the p automatic calloration p 7 RFID card supplied with card Confirm it with W touch Auto the calibration kit smart user manual engl ED 41201 revD1 27 04 2010 page 20 of 29 G Bonecker CALIBRATION 7 Insert test card menu 8 Confirmation menu 9 Start analysis menu Calibration Calibration Insert Cartridge Test CEF Insert Test Card Expiration Date 36 11 7606 Lot Hr 7570511 TP _ Insert the test RFID card Confirm the data of the Fill the test cartridge with the alin supplied with the testing kit test to be calibrated with calibration material according i The confirmation menu T to the instructions on the appears calibration kit s package insert Insert the cartridge and touch a The calibration will be per formed automatically Note the calibration applies only to the respective test
9. and closes automatically Do not try to open or close the panel manually e The panel protects the analysis system from dust dirt and humidity Empty the panel s cartridge chamber after every analysis and keep it closed when the machine is not in use e If an error message appears on the screen during an analysis please consult the Troubleshooting section on page 25 NOT OK When handling a test cartridge e Do not use test cartridges after their expiration date or when the test cartridges have not been stored in accordance with the regulations N e Do not use the test cartridge if the packaging is damaged or if fluids have leaked e The test cartridge must reach room temperature 15 30 C 59 86 F before use e Never allow a test cartridge to remain at room temperature for a long period as this may affect its stability and lead to inaccurate test results e Use gloves when handling and disposing of the test cartridges patient samples and sample collection equipment because they pose a potential biohazard e Do not re use the test cartridges e Use only test cartridges that have been approved or specified by the manufacturer Test cartridges that have been approved by the manufacturer are listed in Eurolyser Diagnostica s product list This product list can be obtained from the Downloads page at www eurolyser com See the package insert that comes with all test cartridges suitable for use with the Eurolyser smart laboratory pho
10. d before such leakage current can be measured smart user manual engl ED 41201 revD1 27 04 2010 page 10 of 29 G Bonecker GETTING STARTED N If the device is not used according to the instruction manual then the provided levels of safety will be lowered How to switch ON the EUROLYSER smart laboratory photometer 4 The machine is switched on by plugging the power cable into the socket This launches the device s automatic start up and warm up processes Please wait for these to be completed approximately 5 minutes Do not open the testing panel manually The automatic start up and warm up processes Warm up menu 2 Interrupting the 3 Start up menu warm up process optional Skip Harnup SMaPtisac Insert Card 62 65 7667 SMartisas Harnup in process eS The automatic start up procedure starts as soon as the device is connected to the power supply The machine is warmed up to its proper working temperature in approx I5 minutes If you want to interrupt the warm up process just touch warm up A submenu appears press w to interrupt However if you don t want to interrupt the process press As soon as the entire progress bar turns gray and the initialization of the optical unit is completed in a few more seconds the start up menu appears The instrument is now operational smart user manual engl ED 41201 revD1 27 04 2010 page 11 of 29 G Bonecker GETTING STARTED Configuring t
11. er instead of the patient data Prepare the test just like a patient sample and start the analysis The result is displayed Record the result according to your laboratory s quality guidelines The result will be saved in the instrument s memory just like a patient s results Verify that the result lies within the mandatory limits for the control material according to the control material s package insert To analyze a patient sample Insert the RFID card from the testing kit into the machine Prepare a test cartridge and a patient sample according to the instructions on the testing kit insert Enter the required patient data Insert the test cartridge into the analyzer and start the analysis The result will be displayed The result will be saved in the instrument s memory Export the result to an optional external computer or print the result with an optional external printer Be sure to follow the detailed instructions for the analysis processes that are provided in the following sections and to comply with the information provided on the package insert enclosed with each testing kit smart user manual engl ED 41201 revD1 27 04 2010 page 15 of 29 G Bonecker TESTING PROCEDURES Operating safety precautions When operating the laboratory photometer e Use only your fingertip to operate the touch screen Do not use pens or any other objects that may scratch or damage the screen e The testing panel opens
12. fied range Perform a test using a control from a new lot If the above instructions have been followed but the control results are still not within the permitted A range contact your local Eurolyser smart laboratory photometer supplier for assistance before proceeding with tests on any patient samples Frequency of QC testing Control testing is recommended when a new shipment of testing kits is about to be used a new lot is about to be used e if its possible that the test cartridges have not been properly stored e if an unexpected patient result is obtained when new personnel is being trained to use the equipment if local regulations require more frequent control testing than described above then the number of control tests performed must comply with these regulations smart user manual engl ED 41201 revD1 27 04 2010 page 19 of 29 G Bonecker CALIBRATION If control testing with the proper control materials produces results that are outside the prescribed ranges then the instrument must be calibrated The instrument is set to perform either an automatic calibration using a calibration kit or a manual Li calibration by entering a factor You ll need the proper calibration kit to perform an automatic calibration The kits differ depending on the type of test being performed Please follow the instructions in the calibration kit s package insert Performing an automatic calibration Start up menu 2
13. ge the value in the HCT default input menu 9 Default gender menu Default x Last used female male child Select which gender is to be used as the standard default Last used means that the gender last used will always be selected 12 HCT default input menu Her male CCE t Js Le La 2 Ls Enter the hematocrit value and confirm it by pressing If no value is given the analyzer uses the value 40 by default Completely turning off the instrument can only be accomplished by disconnecting it from the power supply It is not necessary to switch the analyser off every day When the instrument is in start screen mode the power safe function dims the screen after it has been idle for 10 minutes Touching the screen will re illuminate it to its customary level of brightness smart user manual engl ED 41201 revD1 27 04 2010 page 14 of 29 G Bonecker TESTING PROCEDURES Overview of the testing and measuring procedures Allow the ERS test cartridge to come to room temperature before use If the smart laboratory photometer has been disconnected from the power supply plug it in soon enough for it to be at the proper operating temperature when it is needed How to run a control test if necessary Insert the RFID card from the testing kit into the slot on the front of the machine Prepare the control serum according to the instructions on the control package insert Enter the lot numb
14. he photometer You can configure your Eurolyser smart laboratory photometer according to your needs before you begin using it To go to the configuration menu follow these steps Start up menu 2 Settings menu 3 Configuration menu SMaPtisas Door open Door close Calibration Language Insert Card 82 65 7667 Interface ms 4 Lt Settings Date Time Jii J Ji veti fi Touch C to go to el Touch Settings to go to ian Touch the setting you want to configure and confirm it with the Settings menu the Settings Configuration v4 menu 4 Language menu 5 Interface menu 6 Interface printer menu Language Printout x English Disable Automatic German x On request Touch the preferred language Select the interface you want If a printer is connected and contri it wih ae to configure Choose Printer Disable printouts will never to configure transmission to a be provided connected printer Choose Automatic the results will Host to configure be printed out after every transmission to a host e g a measurement PC On request printouts will only be provided on demand 7 Interface host menu 8 Date menu 9 Date detail menu Transfer to Host Date Day 1 31 i2 A a6 81 7087 Honth 4 42 i Year 6 99 K L a eane A Au STRESE Tie Date Format DD HH Y Y x On request BF 24 32 EA If a host e g a PC is Touch to go to the Date Touch to go to the Date connected
15. he sample and the reagent are mixed automatically within the machine The photometer unit performs the analysis with either one or two light diode s The absorption of light rays is measured during this process and the measured value is then converted into the test result using mathematical methods This result is then displayed on the touch screen Optionally the results can be exported to an external personal computer an HIS or they can be printed out using an external printer When the user confirms the result the testing panel opens automatically and the ERS cartridge can then be removed and discarded After this procedure the instrument is ready to perform the next analysis Manufacturer s calibration The Eurolyser smart laboratory photometer is manufactured according to the highest quality standards in order to yield safe and accurate testing results Every instrument is inspected during the manufacturing process using the EU stipulated reference methods smart user manual engl ED 41201 revD1 27 04 2010 page 8 of 29 G Bonecker PICTOGRAMMS TOUCH BUTTONS The touch screen symbols and their functions Tapping one of these symbols on the touch screen activates the described function Every symbol that can appear while using the instrument is described here Reac cil Start the analysis Opens the menu so the user can make additional testing entries Selects one entry line or one value higher OO wX Down Selects one entr
16. ing kit being used If the above instructions have been followed but the control results are still not within the permitted range contact your local Eurolyser smart laboratory photometer supplier for assistance before performing the next test on a patient s sample Performing a manual calibration Start up menu 2 Settings menu 3 Calibration options menu SMartisas Door open Calibration Door close Calibration Insert Card 62 65 7667 Settings J Touch C to go to Touch Calibration to go Select Test kit to go to the Settings menu to the Calibration options the Calibration options menu menu smart user manual engl ED 41201 revD1 27 04 2010 page 21 of 29 G Bonecker CALIBRATION 4 Calibration options menu 5 Password menu 6 Manual calibration menu Calibration Passuord Hanual Calibration T 7 JL JLs bon ae als Calibration Date 34 81 2007 Factor z 166 noe Enter the password The data of the testing To perform a manual The default setting is kit to be calibrated is calibration touch 3010 displayed Manual Confirm it with Confirm it with W 7 Detail entry menu Factor 166 Honth 41 417 1 E Year 68 99 T s x Change the factor according to the difference from the target value of a control serum Confirm it with W Example of how to determine the manual calibration factor The calibration factor can be determined empirically by analysing a control
17. ls Interface parameters Parameter Value Value Data bits e Data format Data is transmitted in blocks of data sets One data set contains the data from one analysis Data sets consist of data fields A data field consists of an identifier 7 characters and its respective value or text Data fields are concluded with one carriage return and line feed Data sets are concluded with three carriage returns and line feeds Data Fields mimes on OO Times aa Cd Patre aammcyyyy ates oe 022007 USB Interface The USB interface emulates the serial interface O smart user manual engl ED 41201 revD1 27 04 2010 page 24 of 29 Bonecker ERROR INFORMATION AND TROUBLESHOOTING Error messages and possible causes Error message Cause Correction Invalid card A wrong defective or expired Use a new testing kit RFID card A defective RFID module Contact your dealer No test results are stored Perform the test Invalid calibration The calibration values are outside Repeat the calibration with a new the prescribed range testing kit or a new calibrator An error occurred during If the problem recurs contact calibration your dealer Tests expired The test cartridge has passed its Use a cartridge from a new testing expiration date kit that has not expired Calibration required The calibration interval has been Perform a new calibration exceeded The test cartridge is
18. mart USER MANUAL EURO Eurolyser Diagnostica GmbH Bayernstrasse la 5020 Salzburg Austria smart user manual engl ED 41201 revD1 27 04 2010 page 1 of 29 G Bonecker SYMBOLS AND ABBREVIATIONS The following symbols and abbreviations are used in the product labeling and instructions for the Eurolyser laboratory photometer Symbol Abbreviation Explanation Conforms with the European directive 98 79 EC on in vitro diagnostic medical devices VD In vitro diagnostic medical device sa Catalogue number Order number A m mn Lot number O Serial number The contents are sufficient to perform lt n gt number of tests Best used by Temperature limitations Manufacturer Date of production Sterile Warnings and precautions see accompanying documents Operator s action i a ERS T Refer to the user s manual and follow the instructions Do not dispose with household waste ERS Testing Cartridge Light Emitting Diode Personal Computer Identification Hospital Information System Liquid Crystal Display Alternating Current Direct Current Radio Frequency Identification C gt C ERSTC ae HS AC RAID Tablet smart user manual engl ED 41201 revD1 27 04 2010 page 2 of 29 G Bonecker TABLE OF CONTENTS Introduction Intended use of the EUROLYSER smart laboratory photometer 5 About this user s manual 5 Inspecting the package conte
19. nd confirm the incorrect entry use entry use selection with w smart user manual engl ED 41201 revD1 27 04 2010 page 17 of 29 G Bonecker TESTING PROCEDURES Analyzing a patient s sample contd 7 Sample type menu 8 Hematocrit menu for all tests 9 Start analysis menu 5 let H t it I t Cartrid anpletype Eng ocr i nsert Cartridge Sr aoe EE a2 Blood x _ gt Touch Serum or Blood Enter the hematocrit and confirm the value and confirm it with hn a selection with vd Fully insert the test cartridge into the analyzer Touch 7 P The panel closes and the test is performed automatically If you do not enter a value the analyzer uses a default value of 40 The instrument displays the following information during the automatic testing process no user input necessary 10 Mixing I Incubating 12 Measuring Heasurenent Heasurenent Heasurenent Hixing 1 sec Incubating 4 sec Heasuring 57 sec e Be sure to handle the test cartridge according the instructions on the package insert N e Be sure the test cartridge is properly sealed before you insert it into the analyzer e Be sure the test cartridge is fully inserted into the proper opening in the analyzer e Use ONLY manufacturer approved test cartridges otherwise serious damage to the smart photometer or inaccurate test results may occur e Do not attempt to open or close the panel manually Viewing and processing the test
20. nts 5 System Description Description of the Eurolyser smart laboratory photometer 6 How to operate the Eurolyser smart laboratory photometer 7 Screensaver 8 Indicator lights 8 How the Eurolyser smart laboratory photometer works 8 Manufacturer s calibration 8 Touch Screen Pictograms The touch screen symbols and their functions 9 Additional symbols and special characters 9 Getting Started The proper placement of the smart laboratory photometer 10 Connecting the power supply lO Connecting the optional equipment 10 How to switch on the photometer I The automatic start up and warm up processes Configuring the photometer 12 Setting the normal values and the units using a CRP test as demonstration 13 How to switch off the photometer 14 Testing Procedures Overview of the testing and measuring procedures I5 Operating safety precautions l6 Analyzing a patient s sample I7 Viewing and processing the test results 18 Quality Control Choosing quality control QC materials 19 Handling the QC control materials 19 Frequency of QC testing 19 Calibration Performing an automatic calibration 20 Performing a manual calibration 2l Example of how to determine the manual calibration factor 22 Performing an instrument calibration 23 Interface Description Serial interface 24 USB interface 24 Troubleshooting Error messages and possible causes 25 Service information 26 smart user manual engl ED 41201 revD1 27 04 201
21. o operate the Eurolyser smart laboratory photometer The smart laboratory photometer is operated solely by means of the touch screen All the basic operating steps are displayed as symbols An overview of these symbols can be found in Table and Table 2 To activate a symbol touch or tap it with a finger In order to perform a test the RFID card enclosed in the testing kit must first be inserted into the laboratory photometer This card contains all the data needed to perform the routine tests No analysis can be started without the RFID test card The ERS cartridge is inserted into the slot in the front of the machine the testing panel then opens automatically After entering all the requested data and activating the START button on the touch screen the panel closes automatically and the testing procedure begins After the analysis is completed the panel opens again automatically and the test cartridge can then be removed The panel prevents ambient light dust dirt and humidity from entering the laboratory photometer during the testing process and when the machine is not in use e Do not open the panel manually e Use only your fingers to touch the screen Do not use pens or other hard or sharp objects Commands Information 2 Touch Buttons 3 RFID Card 4 Testing Panel closed Figure 3 smart user manual engl ED 41201 revD1 27 04 2010 page 7 of 29 G Bonecker INTRODUCTION Screensaver The screensaver
22. ory photometer dealer for technical assistance Before asking for assistance please have the following information ready e the serial number of your smart laboratory photometer the test type the test lot number the control lot number e the control results obtained so far a description of the problem including any of the smart s error messages smart user manual engl ED 41201 revD1 27 04 2010 page 26 of 29 G Bonecker TECHNICAL SPECIFICATIONS Eurolyser smart laboratory photometer Photometer resolution Reproducibility Linearity Temperature control Display Buffer battery Fuse Dimensions Weight Communications interface Tolerance conditions Work surface Power supply Manufacturer Type Mains adapter Input Output Power usage Options Thermo printer Interface Mains adapter Barcode reader scanner Reading area Max resolution Mains adapter IP rating smart user manual engl ED 41201 revD1 27 04 2010 0 0001 ABS lt 1 5 CV at OD 0 1000 3 0000 OD better than 1 5 and 0 01 OD Electrical temperature control of the photometer unit to 37 C 2 C Standard LCD display with back light and integrated touch panel BR2032 2 5 amperes self healing 260 x 145 x 140 cm H x Bx T 3 5 kg unpackaged RS232 USB Work space 15 28 C relative humidity 10 90 Transport Storage 0 50 C relative humidity 5 95 A dry clean level su
23. re fluctuations e Direct sunlight e Vibrations e g from centrifuges and dishwashers e Electromagnetic radiation e g from mobile phones Connecting the power supply Connect the power cable to the power supply unit Insert the plug from the power supply unit into the power socket on the back of the machine Figure 4 Plug the power cable into the wall socket Always connect to the proper supply voltage The power supply voltage must comply with the N regulations cited in the technical specifications on page 27 The instrument is to be operated only using the power supply unit provided RS232 socket Socket for an optional printer 2 RS232 socket PC connection 3 USB socket PC connection 4 Power socket Connects to the power supply Figure 4 Connecting optional equipment The following optional devices which are not included in the standard delivery package can be connected to the instrument An external printer for optional test result printouts An external barcode scanner A PC for the transfer of test data into an HIS or laboratory software We recommend the DPU 414 from SEIKO as an optional printer as described in the Technical specifications section on page 27 N Connect optional equipment only when the instrument is switched off Please note that attaching optional equipment e g a printer can increase the amount of leakage current All optional equipment must be connecte
24. results The smart laboratory photometer can store up to 100 patient and control results in its memory When this capacity is exceeded the oldest results are deleted in chronological order The following parameters are saved from each test Single result menu 2 Remove cartridge menu 3 Overall result menu Remove Cartridge Hane Huster Hans ID 1672 Sex male Samp le Serum mj bT CRP 68 86 mg dl Fange 6 66 1 186 Time 67 19 Hane Huster Hans ID 1672 CRP 6 66 mgfdl Range 6 66 1 16 Saga lt em The analyser automatically To scroll through the menu The result is shown Touch opens the testing panel touch gt gt or lt lt Touch i to print it out Touch Remove the test ala to print the result Th Th H j i a K to export rae an LIS ha nu i en touch Eh to send it close the panel The main or PC or touch 9 P electronically Touch i to display the Pe ee Nee delete the result You can data Touch to close the j Touch to go to return to the main menu smartuse menu and end the test with the overall result menu QUALITY CONTROL A quality control program should be performed on a regular basis to verify the Eurolyser smart laboratory photometer is working properly and providing reliable results Data integrity can only be assured when controls and GCLP practices are used routinely The frequency of performing QC differs from laboratory to laboratory please comply with your national quality control
25. rface Avoid direct sunlight Alternatively Mascot Globtek 992 GTM21097 5012 A separate AC to DC mains adapter with double insulation 00 230V AC 50 60 Hz 90 264V AC 47 63 Hz I2 V DC 3A 12V DC 4 17A Max 30 VA Max 30 VA Seiko DPU 414 Serial 100 240 VAC Datalogic Touch65 63mm 0 10mm 4mils 100 240 VAC IP Safety Class Il page 27 of 29 G Bonecker DECLARATION OF CONFORMITY CE Declaration of conformity with IVD directives The Eurolyser SMART laboratory photometer is in compliance with all provisions in the directive 98 79 EC on In Vitro Diagnostic medical technology products and is CE marked as conforming to standards Safety standards The Eurolyser SMART laboratory photometer has been tested and conforms to the safety standards IEC EN 61010 1 IEC EN 61010 2081 and IEC EN 61010 2 I01 as well as to the EMC standard IEC EN 61326 smart user manual engl ED 41201 revD1 27 04 2010 page 28 of 29 G Bonecker MANUFACTURER DATA ul EUROLYSER DIAGNOSTICA GmbH Bayernstrasse I la 5020 Salzburg AUSTRIA Tel 43 662 432100 Fax 43 662 432100 50 www eurolyser com Contact Gerhard Bonecker MBA smart user manual engl ED 41201 revD1 27 04 2010 page 29 of 29 G Bonecker
26. serum N The target value of the control serum is e g 3 6mg l 6 4mg l The measured value of the control serum is e g 8 00 mg l In this case the instrument produces a result that is too high so that means that the calibration factor must be decreased the default value is 100 Decrease the calibration factor by 5 units The default value is 100 so set the new factor at 95 and repeat the measurement of the control serum If the result is still outside the control serum s specified range then decrease the factor by another 5 units and repeat the procedure smart user manual engl ED 41201 revD1 27 04 2010 page 22 of 29 G Bonecker CALIBRATION Performing an instrument calibration Start up menu SMaPtisac Door open Door close 3 Calibration options menu Calibration Calibration Insert Card 62 63 2660 Settings m Ta o ct 5 0a lt uv 3 D 5 W Touch C to go to Touch Calibration to go Select Instrument to the Settings menu to the Calibration options perform an instrument menu calibration 4 Password menu 5 Factor and Offset input menu Passuord EE l ze le Offset B Ba T a i KED d Enter the password Enter the factor and the The default setting is offset accordingly 3010 Confirm them with W Confirm it with 4 smart user manual engl ED 41201 revD1 27 04 2010 page 23 of 29 G Bonecker INTERFACE DESCRIPTION SERIAL INTERFACE Interface signa
27. tometer and follow all instructions regarding e the proper temperature a cartridge must have before a test is performed e the exact amount of the sample volume fil e the regulations for the proper storage of the test cartridges e the stability of the test cartridges and their expiration date e the sequence of the testing procedures smart user manual engl ED 41201 revD1 27 04 2010 page 16 of 29 G Bonecker TESTING PROCEDURES Analyzing a patient s sample Start up menu 2 Main menu 3 Input menu Hane SmMartisas Smartisas ID 15 Test CRP mg dl Sex nale Insert Card 62 65 2667 Sanpletype Serum Remaining Tests 36 Vv Expiration Date 36 63 7666 Lot Hr 66275967 Take the provided RFID The analyser automatically Touch The ABC menu card out of the testing kit reads the card displays the appears To navigate within package and insert it into ag ot isc uae of tests the input menu use and the analyzer the expiry date and lot a number I T Touch eae ial The panel opens automatically and the input menu appears fil To leave a menu or to cancel an entry touch Xx 4 ABC menu 5 Numeral menu 6 Input menu Gender Control a pe x male child ee ooeooon oan female Control DOBRA eE i Enter the name and Enter the patient ID and Touch Male Female W confirm the entry with confirm it with To Child or Control To delete an delete an incorrect a
28. y line or one value lower Pai a i Tlm Pa ka a E Opens an entry or value so it can be edited ror x ma O X Delete Deletes the last character entered Oe fe O Come C A Opon Shows which elementis selected O Opo eme Stars the selected operation OOOO SB Prinwer Starts pring Starts data transmission Selects the results menu machina dha ca a Recycle bin Go to the delete menu Settings Go to the settings menu Table 2 Additional symbols and special characters Additional symbols or special characters that can appear on the touch screen during operation are described here These symbols and special characters provide additional information only and cannot be activated by touching Symbol Name Function T gt mf Insert cartridge Command to insert the test cartridge mj gt Tt Remove cartridge Command to remove the test cartridge Table 3 OQ smart user manual engl ED 41201 revD1 27 04 2010 page 9 of 29 3 Bonecker GETTING STARTED The proper placement of the smart laboratory photometer least 10 cm of table surface and clearance on each side and that the machine can be easily disconnected from the power source Acclimate the instrument to the ambient room temperature before operating it in Place the machine on a dry clean stable and level surface Make sure that the instrument has at The instrument can be damaged by e Condensing humidity and water e Heat and large temperatu
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