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User Manual - E-vet

1. and buttons 15 Default sample type menu 16 Specie menu 17 HCT default input menu Default le Hemat it eTau ia ocrl lt lt LS Last used O PipetteSy OC Cat O Pipette20pu a Young cat mimm mim mim maian FE EE L X v x Select which type of sample Select which specie s HCT should Enter the hematocrit value and should be marked by default Last be changed VA confirm it by pressing SAS used means the sample type last used will be selected Note Additionally to the pre defined species one can add up to 10 more free defined species 3 Note If more than one test is used on the solo you will have to select the test you want to edit the default settings solo user manual ED 43204 revD1 06 07 2012 Page 20 of 40 Eurolyser Diagnostica GmbH 18 Operator menu 19 Default operator menu Operator Operator Delete All Q Disable Delete C Enable Select Operator to change the Select Disable if you want to default settings for operator input disable selecting an operator see 14 Touch Delete All to when performing a test Select delete all currently saved Enable to use operators when operators Touch Delete to delete performing a test Accept new a single operator settings with How to switch OFF the analyzer Completely turning off the instrument can only be accomplished by disconnecting it from the ta power supply It is not ne
2. INTRODUCTION Intended use of the Eurolyser solo laboratory photometer About this user s manual Inspecting the package contents SYSTEM DESCRIPTION Description of the Eurolyser solo laboratory photometer How to operate the Eurolyser solo laboratory photometer Screensaver Indicator lights How the Eurolyser solo laboratory photometer works Manufacturer s calibration PICTOGRAMMS TOUCH BUTTONS The touch screen symbols and their functions Additional symbols and special characters GETTING STARTED The proper placement of the solo laboratory photometer Connecting the power supply How to switch ON the Eurolyser solo laboratory photometer Connecting optional equipment Connecting a barcode scanner Using a barcode scanner The automatic start up and warm up processes Configure the Eurolyser solo photometer Setting the normal values and the units using a T4 test as demonstration How to switch OFF the analyzer TESTING PROCEDURES Overview of the testing and measuring procedures Operating safety precautions Analyzing a patient s sample Viewing and processing the test results solo user manual ED 43204 revD1 06 07 2012 Page 4 of 40 Eurolyser Diagnostica GmbH jo WO WO 10 10 11 12 12 12 13 13 14 14 15 16 19 21 22 22 23 24 26 QUALITY CONTROL Choosing quality control QC materials Handling the QC control materials Frequency of QC testing CALIBRATION
3. 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 Start the testing entries Opens the menu for additional testing entries U selects one entry line or one value higher Selects one entry line or one value lower a a eet anemyoesneninemas OS em ome E S e ps p gt Start the analysis Starts the test analysis E Starts data transmission Displays the photometer data of the last test ma Go to the next page H C C lm gt gt gt a gt Menu backward Go to the previous menu Recycle bin Go to the delete menu Settings Go to the settings menu SS Sortdown Moves sorts an entry one level down Table 2 solo user manual ED 43204 revD1 06 07 2012 Page 10 of 40 Eurolyser Diagnostica GmbH 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 Insert cartridge Command to insert the test cartridge Remove cartridge Command to remove the test cartridge Table 3 solo user manual ED 43204 revD1 06 07 2012 Page 11 of 40 Eurolyser Diagnostica GmbH GETTING STARTED The proper placement of the solo lab
4. Performing an automatic calibration Performing a manual calibration Example of how to determine the manual calibration factor Performing an instrument calibration CLEANING INSTRUCTIONS Cleaning the Touch Display Cleaning the Door Cartridge Area Cleaning the Exterior INTERFACE DESCRIPTION Serial Interface USB Interface ERROR INFORMATION AND TROUBLESHOOTING Error messages and possible causes Service information TECHNICAL SPECIFICATIONS Eurolyser solo laboratory photometer Power supply Options DECLARATION OF CONFORMITY SHUT DOWN AND WASTE MANAGEMENT MANUFACTURER DATA solo user manual ED 43204 revD1 06 07 2012 Page 5 of 40 Eurolyser Diagnostica GmbH 27 27 27 28 29 29 30 31 32 33 33 33 33 34 34 34 35 35 36 37 37 37 37 38 39 40 INTRODUCTION Intended use of the Eurolyser solo laboratory photometer The Eurolyser solo laboratory photometer is for in vitro diagnostic clinical chemistry use only The solo 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 solo laboratory photometer The user s manual also explains how the photometer works describes t
5. cartridge blocks the bolt Use the correct ERS cartridge and because the wrong ERS cap is cap being used Repeat the test using a new cartridge Measurement overflow The photometric measurement value is outside the measuring range e g if a cold cartridge has been used Blank Error The photometric measurement Repeat the test after restarting the value is outside the measuring instrument Tepe evar Th without the cartridge on instrument possibly been selected Linearity error The reaction of kinetic test is not Repeat the test using a new linear e g if a cold cartridge has sample and a new cartridge been used if wrong sampletype was set if wrong samplevolume was used or if a cartridge with integrated capillary was not used correctly Mix error Instrument fails to perform test due Please contact your local dealer contact your to possible hardware error Coagulation aror dealer cartridge Mmana volume error The provided sample volume is not Repeat the test using a new correct e g pipetting error cartridge with correct sample volume Cartridge temperature error The cartridges temperature is too Repeat the test and refer to the low for a proper test package inserts for proper cartridge use solo user manual ED 43204 revD1 06 07 2012 Page 35 of 40 Eurolyser Diagnostica GmbH If the problem persists after the corrective actions are taken contact your local solo laboratory photometer dealer for tech
6. menu T4 Unit g dl C nmol l x i v Confirm the selection T4 with vi Touch the selected unit and confirm it with vi This description is only an example as the configuration of the Eurolyser laboratory photometer models varies depending on the tests used 1 Note If only one test is used on the solo the test selection menu will be skipped solo user manual ED 43204 revD1 06 07 2012 Page 19 of 40 Eurolyser Diagnostica GmbH 9 Configuration menu 10 Input menu 11 Default specie menu Language Norm Values Species Operator Additional Date Time Input HCT Interface Units Sampletype Order ite aia Touch nput to reach the input Select which values to change Select which additional specie is menu from the Input menu to be added with Additional Choose Order to change the order of the specie 12 Additional specie menu 13 Specie entry menu 14 Specie order menu Specie 01 DJ 62 Puppy dog al Q Species1 C Species3 a nme pa wy 5 Hamst OC Species2 m Species4 o6 W C 7 Guinea pig 08 Ferret 9 Reptile m 10 Bird v x i V Select which specie entry should Enter the species name and Select which entry should be be edited and confirm with AS confirm the entry with SA To edited by browsing with the delete an incorrect entry use cursor buttons Change the order up or down with the
7. Globtek GTM21097 5012 A separate AC to DC mains adapter with double insulation 90 264V AC 47 63 Hz 12V DC 4 17A Seiko DPU 414 Serial 100 240 VAC Datalogic Touch65 63mm 0 10mm 4mils 100 240 VAC Page 37 of 40 Eurolyser Diagnostica GmbH DECLARATION OF CONFORMITY Declaration of conformity with IVD directives The Eurolyser solo 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 solo laboratory photometer has been tested and conforms to the safety standards IEC EN 61010 1 IEC EN 61010 2 081 and IEC EN 61010 2 101 as well as to the EMC standard IEC EN 61326 solo user manual ED 43204 revD1 06 07 2012 Page 38 of 40 Eurolyser Diagnostica GmbH SHUT DOWN AND WASTE MANAGEMENT For proper waste management according to the directive 2002 96 EG please contact your local dealer Used cartridges need to be disposed with the laboratory waste and according to its correct regulations Before shutting down the solo laboratory photometer for the purpose of a repair or dispense it is needed to make sure there is no cartridge left within the solo laboratory photometer For the purpose of delivering the solo laboratory photometer it is also required to protect the photometer with its original delivered packaging and packaging inserts solo user manual ED 43204
8. after their expiration date or when the test cartridges have not been stored in accordance with the regulations Do not use the test cartridge if the packaging is damaged or if fluids have leaked e The test cartridge must reach room temperature 18 28 C 64 4 82 4 F before use e Use gloves when handling and disposing of the test cartridges patient samples and sample collection equipment because they pose a potential biohazard e Use the test cartridge only once e Only use the test cartridges that are specified and approved by the manufacturer See the package insert that comes with all test cartridges suitable for use with the Eurolyser solo laboratory photometer 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 e the regulations for the proper storage of the test cartridges solo user manual ED 43204 revD1 06 07 2012 Page 23 of 40 Eurolyser Diagnostica GmbH Analyzing a patient s sample 1 Startup menu solo Insert Card 22 09 2011 2 Main menu solo Test T4 yug dl Remaining Tests 16 Expiration Date 2012 11 24 Lot No oie Take the provided RFID card out of the test package and insert it into the instrument 4 Input menu 3 Operator input menu Operator oo New P wie The instrument automatically reads the card displays the type of test number of tests the ex
9. ally The instrument displays the following information during the automatic testing process Varies by test type 11 Mixing 12 Incubating 13 Measuring Measurement Measurement Measurement Mixing 5 sec Incubating 12 sec Measuring 56 sec e Be sure to handle the test cartridge according the instructions on the package insert e Be sure the test cartridge is properly sealed before you insert it into the analyzer N 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 solo photometer or inaccurate test results may occur e Do not attempt to open or close the door manually solo user manual ED 43204 revD1 06 07 2012 Page 25 of 40 Eurolyser Diagnostica GmbH Viewing and processing the test results The solo laboratory photometer can store up to 250 patient and control results in its memory When this Capacity is exceeded the oldest results are overwritten in chronological order 1 Single result menu 2 Remove cartridge menu 3 Overall result menu Remove Cartridge T4 0 31 g dl ID 3 y _ Name 3 Holder John ID 3 T4 56 pg dl ee Holder John Range 0 30 3 50 Specie Dog Sample Pipette5yu Range 0 30 3 50 Date 28 07 2011 13 15 The result is shown Touch to The instrument automatically To scroll through the results print it Touch a gt to export opens the door Remove the t
10. art up menu 2 Settings menu 3 Calibration options menu solo Door open calibration Calibration e lt Insert Card 22 09 2011 Door close Service Om Settings About ir Eri S Testkit Instrument X Touch to go to the Settings Touch Calibration to go to the Select Test kit to go to the menu Calibration options menu Calibration options menu 4 Calibration options menu 5 Calibration card menu 6 Calibration data menu Calibration Calibration Calibration Insert Calibrator Card Test T4 Expiration Date 20 08 2012 Lot No 1901 T4 80 pg dl Auto Manual x x wy x To perform an automatic The instrument asks you to insert The instrument reads the calibration touch Auto the calibration RFID card calibration data from the card supplied with the calibration kit Confirm it with AS solo user manual ED 43204 revD1 06 07 2012 Page 29 of 40 Eurolyser Diagnostica GmbH 7 Insert test card menu 8 Confirmation menu 9 Start analysis menu Calibration Calibration Insert Cartridge Insert Test Card Test T4 Expiration Date 24 09 2012 Lot No 9101 D KA x Insert the test RFID card Confirm the data of the test to be Fill the test cartridge with the supplied with the test kit The calibrated with AS calibration material according to confirmation menu appears the instructions on the calibration kit s package insert Insert the cartridge and touc
11. atient sample Insert the RFID card from the test kit into the instrument Prepare a test cartridge and a patient sample according to the instructions on the test 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 test kit solo user manual ED 43204 revD1 06 07 2012 Page 22 of 40 Eurolyser Diagnostica GmbH 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 If an error message appears on the screen during an analysis please consult the Troubleshooting section on page 35 The door protects the analysis system from dust dirt and humidity Empty the door s cartridge chamber after every analysis and keep it closed when the instrument is not in use The door opens and closes automatically Do not try to open or close the door manually When handling a test cartridge Do not use test cartridges
12. ccordingly Confirm them with 1 Note If only one test is used on the solo the test selection menu will be skipped solo user manual ED 43204 revD1 06 07 2012 Page 32 of 40 Eurolyser Diagnostica GmbH CLEANING INSTRUCTIONS Cleaning the Touch Display Clean the touch display with a clean lint free cloth moistened with water i Do not use any liquid except of water when cleaning the touch display To avoid damage do not spill liquid onto the display Cleaning the Door Cartridge Area Clean the door with a clean lint free cloth moistened with isopropyl alcohol Wipe down the surface The cartridge area may be cleaned with a cotton swab moistened with isopropyl alcohol Cleaning the Exterior Do not clean the touch panel with isopropyl alcohol Refer to Cleaning the Touch Display on how to clean the touch panel The exterior may be cleaned with a clean lint free cloth moistened with isopropyl alcohol Wipe down the exposed surfaces solo user manual ED 43204 revD1 06 07 2012 Page 33 of 40 Eurolyser Diagnostica GmbH INTERFACE DESCRIPTION Serial Interface Interface signals Interface parameters 9600 Default Baud rate 115200 Data bits Bo 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 fi
13. cessary to switch the instrument off every day When the instrument is in T 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 T I solo user manual ED 43204 revD1 06 07 2012 Page 21 of 40 Eurolyser Diagnostica GmbH TESTING PROCEDURES Overview of the testing and measuring procedures Allow the ERS test cartridge to reach room temperature before use If the solo 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 test kit into the slot on the front of the instrument Prepare the control serum according to the instructions on the control package insert Enter the lot number 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 Export the result to an optional external computer or print the result with an optional external printer Verify that the result lies within the mandatory limits for the control material according to the control material s package insert To analyze a p
14. e testing procedure begins After the analysis is completed the door opens again automatically and the test cartridge can then be removed The door prevents ambient light dust dirt and humidity from entering the laboratory photometer during the testing process and when the instrument is not in use e Do not open the door manually N Use only your fingers to touch the screen Do not use pens or other hard or sharp objects 1 Commands Information 2 Touch Buttons 3 RFID Card 4 Door closed Figure 3 solo user manual ED 43204 revD1 06 07 2012 Page 8 of 40 Eurolyser Diagnostica GmbH Screensaver The screensaver 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 instrument is connected to the power source The instrument may be left plugged in indefinitely How the Eurolyser solo laboratory photometer works The Eurolyser solo 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 solo 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 maintenance free The instrument is equipped with an RFID ca
15. e 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 power source Figure 2 describes the main exterior parts of the solo laboratory photometer rear view Figure 2 solo user manual ED 43204 revD1 06 07 2012 1 RS232 socket 2 USB socket 3 RS232 socket 4 Power socket Page 7 of 40 PC connection PC connection Socket for an optional printer or and barcode scanner Connects to the power supply Eurolyser Diagnostica GmbH How to operate the Eurolyser solo laboratory photometer The solo 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 1 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 test 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 door opens automatically once a test is initiated by pressing the E button The ERS cartridge is inserted into the slot in the front of the instrument After entering all the requested data and activating the button on the touch screen the door closes automatically and th
16. elds are concluded with one carriage return and line feed Data sets are concluded with three carriage returns and line feeds Data Fields C Name Spy Sid E e E moraer froe OOOO Sorenson oe O species ree OOOO eceng m4 2 48 pg SAG 100 mg dl Range 0 00 1 00 times hhimm T bates fad mm yyyy Pare 0 USB Interface The USB interface emulates the serial interface solo user manual ED 43204 revD1 06 07 2012 Page 34 of 40 Eurolyser Diagnostica GmbH ERROR INFORMATION AND TROUBLESHOOTING Error messages and possible causes Error message Cause Correction Invalid card A wrong defective or expired Use a new test kit A defective RFID module Contact your dealer Calibration failed The calibration values are outside Repeat the calibration with a new the prescribed range test kit or a new calibrator An error occurred during If the problem reocurrs contact calibration your dealer expiration date that has not expired exceeded Door blocked The test cartridge is blocking the Reposition the test cartridge or door because the cartridge has not tighten the cap on the cuvette been inserted completely or the cuvette has not been capped firmly enough Wrong cap The wrong ERS cap is being used Use the correct ERS cartridge and Missing cap or the ERS cap is missing Missing cartridge or the cartridge is missing or an already used cartridge is inserted Bolt blocked The test
17. est touch gt or lt lt Touch to it to an HIS or PC or touch VA to cartridge and discard it Touch print the result s touch a gt gt gt display the photometric data a to close the door The main to send the result s Remove the cartridge and touch menu appears electronically Touch IT to delete AS to close the menu and end the result s Touch to return the test If you do not remove the to the main menu cartridge before accepting the result the Remove cartridge menu will appear e Whenever the transmission of the operator id lot number and serial number is activated in the appropriate settings menu pp 16 17 they will be transfered to the printer or a host system automatically and can be viewed on printouts or the computer host system solo user manual ED 43204 revD1 06 07 2012 Page 26 of 40 Eurolyser Diagnostica GmbH QUALITY CONTROL A quality control program should be performed on a regular basis to verify the Eurolyser solo 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 regulations Choosing quality control QC materials The authorized manufacturers of the solo test cartridges also supply control materials These control kits contain control materials which allo
18. h J The calibration will be performed automatically Note the calibration applies only to the respective test kit being used N If the above instructions have been followed but the control results are still not within the permitted range contact your local Eurolyser solo laboratory photometer supplier for assistance before performing the next test on a patient s sample Performing a manual calibration 1 Start up menu 2 Settings menu 3 Calibration options menu solo Door open Calibration Calibration eae al Insert Card 22 09 2011 Door close Service Settings About ri eS S Testkit Instrument x lt Touch gt to go to the Settings Touch Calibration to go to the Select Test kit to go to the menu Calibration options menu Calibration options menu solo user manual ED 43204 revD1 06 07 2012 Page 30 of 40 Eurolyser Diagnostica GmbH 4 Calibration options menu 5 Password menu 6 Manual calibration menu selina a lt x Calibration Manual Calibration Test T4 Calibration Date 14 09 2011 Factor 100 To perform a manual calibration Enter the password The default The data of the test kit to be touch Manual setting is 3010 Confirm it with calibrated is displayed Confirm it with 7 Detail entry menu Factor 30 8 a s a pan Change the factor according to the difference from the target va
19. he quality assurance system and assists you in troubleshooting any errors or problems When not used according to the user s manual the protection of the solo laboratory photometer may be influenced We recommend that you familiarize yourself with these instructions before operating the Eurolyser solo laboratory photometer some of the information in this user s manual is marked with following symbols Operator s action fhr 2 Warnings and precautions see accompanying documents Ti Refer to the user s manual and follow the instructions Inspecting the package contents When unpacking the solo laboratory photometer check the contents against the list below and examine the components for signs of shipping damage The solo package contains the Eurolyser solo laboratory photometer Mains adapter Power cable User s manual lf 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 solo user manual ED 43204 revD1 06 07 2012 Page 6 of 40 Eurolyser Diagnostica GmbH SYSTEM DESCRIPTION Description of the Eurolyser solo laboratory photometer Figure 1 shows the main exterior parts of the solo laboratory photometer front view Figure 1 Do not open the door manually 1 Touch Display 2 RFID Card Adapter 3 Door 4 LED The main user interfac
20. lue of a control serum Confirm it with vi To delete an incorrect entry use lt Example of how to determine the manual calibration factor A The calibration factor can be determined empirically by analysing a control serum 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 value is too high the calibration factor must be decreased the default value is 100 Decrease the calibration factor by 5 units The default value is 100 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 decrease the factor by another 5 units and repeat the procedure solo user manual ED 43204 revD1 06 07 2012 Page 31 of 40 Eurolyser Diagnostica GmbH Performing an instrument calibration 1 Start up menu 2 Settings menu 3 Calibration options menu solo Door open Calibration Calibration Insert Card 22 09 2011 Door close Service Settings About a Testkit Instrument x Touch xt to go to the Settings Touch Calibration to go to the Select nstrument to perform an menu Calibration options menu instrument calibration 4 Password menu 5 Test selection menu 6 Factor and Offset input menu Enter the password The default Confirm the selection T4 with vi Enter the factor and the offset setting is 3010 Confirm it with a
21. mat Touch eee to goto the Time confirm the selected date with DD Day input or Time format menus To MM Month navigate within the screen use YYYY Year vy and 19 Time input menu 20 Time format menu Hour 23 Sr Time Format a5 minnin mim ESEARS Ox Vv x ies nies nie aie Touch the digits to enter the time Select either the 12 hour time and confirm your selection with format 1 12 AM PM or the 24 hour time format 0 23 solo user manual ED 43204 revD1 06 07 2012 Page 18 of 40 Eurolyser Diagnostica GmbH Setting the normal values and the units using a T4 test as demonstration 1 Configuration menu 2 Test selection menu 3 Limits menu Language Norm Values peers Interface Units C Dog O Cat Date Time Input C Puppy C Young cat KA x Touch Norm Values to change Confirm the selection of T4 with Select the specie you want to edit the norm values AS with SA 4 Limits detail menu 5 Limits change menu 6 Configuration menu T4 g dl Lower limit Dog 1 00 lt _ lt Va Language Norm Values Lower limit 7 8 9 Interface Units T4 g dl Upper limit 4 5 6 Date Time Input ej Edit the according limits by Enter the desired value by Touch Units to change the units pressing the e e e Button pressing the number buttons 7 Test selection menu 8 Units selection
22. nical assistance Before asking for assistance please have the following information ready e the serial number of your solo laboratory photometer e the test type e the test lot number e the control lot number e the control results obtained so far e adescription of the problem including any of the solo s error messages solo user manual ED 43204 revD1 06 07 2012 Page 36 of 40 Eurolyser Diagnostica GmbH TECHNICAL SPECIFICATIONS Eurolyser solo laboratory photometer Photometer resolution Reproducibility Linearity Temperature control Display Buffer battery Fuse Dimensions Weight Communications interface Tolerance conditions Work surface Power usage Power supply Manufacturer Type Mains adapter Input Output Options Thermo printer Interface Mains adapter Barcode reader scanner Reading area Max resolution Mains adapter solo user manual ED 43204 revD1 06 07 2012 0 0001 ABS lt 1 5 CV at 1 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 color 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 unpackagedq RS232 USB Work space 18 28 C relative humidity 10 85 Transport Storage 0 50 C relative humidity 5 85 A dry clean level surface Avoid direct sunlight 12V DC 2A
23. nterface host transfer menu 11 Password menu 12 Interface host option menu Transfer to Host Operator Baud Disable Lot No On request Serial No L ex If a host e g a PC is connected The service password is required Select Operator Lot No or Serial Disable data will never be to change interface host options No to define if they should be transmitted included in the transfer to a host Automatic the results will be or not by choosing Disable or transmitted to the host after every Enable Select Baud to change measurement the baud rate when transferring to On request data will only be a host transmitted upon request solo user manual ED 43204 revD1 06 07 2012 Page 17 of 40 Eurolyser Diagnostica GmbH 13 Interface host baudrate menu 14 Date time menu 15 Date detail menu Date Day 1 31 20 s CXY 20 09 2011 Month 1 12 9 Year 99 11 Date Format DD MM YYYY L Select the desired baud rate for Touch eee to go to the Date Touch e es to change the transferring to a host detail and Time detail menus selected entry Use hd or to navigate on the screen 16 Day date menu 17 Date format menu 18 Time detail menu Day 1 31 Date Format Hour 23 2 Minute 59 Tolls 2 v nn vvvv YYYY MM DD sae i as mm pb vvvy alfe o S min L XI v Touch the desired digits and Select your preferred date for
24. oratory photometer Place the instrument on a dry clean stable and level surface Make sure that the instrument has Jta atleast 10 cm of table surface and clearance on each side and that the instrument can be easily wv disconnected from the power source Acclimate the instrument to the ambient room temperature before operating it The instrument can be damaged by Condensing humidity and water Heat and large temperature fluctuations Direct sunlight Vibrations e g from centrifuges and dishwashers Electromagnetic radiation Connecting the power supply Connect the power cable to the power supply unit oll Insert the plug from the power supply unit into the power socket on the back of the instrument 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 regulations cited in the technical specifications on page 37 The instrument is to be operated only using the power supply unit provided 1 RS232 socket Socket for an optional printer or and barcode scanner 2 USB socket PC connection 3 RS232 socket PC connection 4 Power socket Connects to the power supply Figure 4 solo user manual ED 43204 revD1 06 07 2012 Page 12 of 40 Eurolyser Diagnostica GmbH How to switch ON the Eurolyser solo laboratory photometer The instrument is switched on by plugging the power cable into the socket This launches the
25. ory photometer supplier for assistance before proceeding with tests on any patient samples solo user manual ED 43204 revD1 06 07 2012 Page 27 of 40 Eurolyser Diagnostica GmbH Frequency of QC testing Control testing is recommended when e anew shipment of test kits is about to be used e anew lot is about to be used e if it s possible that the test cartridges have not been properly stored e if an unexpected patient result is obtained e when new personnel is being trained to use the equipment e if local regulations require more frequent control testing than described above then the number of control tests performed must comply with these regulations solo user manual ED 43204 revD1 06 07 2012 Page 28 of 40 Eurolyser Diagnostica GmbH CALIBRATION All test kits that are made for the Eurolyser solo photometer are calibrated by the manufacturer during production A calibration of the photometer therefore is not necessary Nevertheless the instrument offers the opportunity to do a specific calibration if the operator wishes to The instrument is set to perform either an automatic calibration using a calibration kit or a manual calibration by entering a factor TT 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 1 St
26. piry date and lot number Touch Df the door opens automatically 5 ABC menu Name Mustermann MA The first time when performing a test you will be prompted to input an operator Choose New to define an operator All saved operators will be shown in this menu whenever you perform another test 6 Numeral menu tec 2 x marere Touch eesse The ABC menu appears To navigate within the input menu use and 7 Input menu Specie Control O Cat Young cat Touch Control or the desired specie and confirm the selection with Had Enter the name and confirm the entry with va To delete an incorrect entry use lt 8 Sample type menu not for all tests Sampletype Pipette20u C Pipette5u Touch Pipette20yu or Pipette5u and confirm the selection with 1 Note This menu only appears once the operator input is enabled p 21 solo user manual ED 43204 revD1 06 07 2012 Page 24 of 40 Enter the patient ID and confirm it with AS To delete an incorrect entry use lt 9 Hematocrit menu not for all tests sampletypes Hematocrit 40 Enter the hematocrit value and confirm it with Eurolyser Diagnostica GmbH 10 Start analysis menu Insert Cartridge f T Fully insert the test cartridge into the analyzer Touch C4 the door closes and the test is performed automatic
27. rd reader module RFID cards are necessary for performing any testing procedures They are included in the test 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 The sample and the reagent are mixed automatically within the instrument 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 computer an HIS or they can be printed out using an external printer After the test process the door opens automatically and the ERS cartridge can then be removed and discarded After confirming the result the instrument is ready to perform the next analysis Manufacturer s calibration The Eurolyser solo laboratory photometer is manufactured according to the highest quality standards in order to yield safe and accurate testing results Every instrument is inspected and calibrated during the manufacturing process using the EU stipulated reference methods solo user manual ED 43204 revD1 06 07 2012 Page 9 of 40 Eurolyser Diagnostica GmbH
28. revD1 06 07 2012 Page 39 of 40 Eurolyser Diagnostica GmbH MANUFACTURER DATA ul EUROLYSER DIAGNOSTICA GmbH Bayernstrasse 11a 5020 Salzburg AUSTRIA Tel 43 662 432100 Fax 43 662 432100 50 www eurolyser com Contact Gerhard Bonecker MBA solo user manual ED 43204 revD1 06 07 2012 Page 40 of 40 Eurolyser Diagnostica GmbH
29. rface cable order number SZ0405 has to be interconnected The barcode reader can handle barcodes up to 16 digits 1 RS232 socket 2 USB socket 3 RS232 socket 4 Power socket Figur 5 Using a barcode scanner 1 Start up menu 2 Operator menu solo Test T4 g dl Remaining Tests 16 Expiration Date 2012 11 24 Lot No 9101 O gt i ow te First start a test by touching When you reached the operator Di menu you will be able to scan the operator with the barcode scanner The operator will be created automatically 1 Note This menu only appears once the operator input is enabled p 21 solo user manual ED 43204 revD1 06 07 2012 Page 14 of 40 Socket for an optional printer or and barcode scanner PC connection PC connection Connects to the power supply 3 Operator insert menu After you reached the operator insert menu you will also be able to scan the operator with the barcode scanner Eurolyser Diagnostica GmbH 4 Insert menu 5 ID insert menu 15 John Dog When you reached the insert It is also possible to use the menu you will be able to scan the barcode scanner while being ID with the barcode scanner inside the ID insert menu Data will be put automatically into the ID field Note One can either use the barcode scanner in the operator menu and insert menu or within the operator insert menu and ID in
30. sert menu The automatic start up and warm up processes 1 Warm up menu 2 Interrupting the warm up process 3 Start up menu optional solo Skip warmup solo Warmup in process Insert Card 22 09 2011 fo The automatic start up procedure starts as soon as the instrument is connected to the power supply The instrument is warmed up to its proper working temperature in approx 15 minutes If you want to interrupt the warm up process just touch Warmup in process A submenu appears i press v to interrupt However if you don t want to interrupt the process press As soon as the entire progress indicator gets full and the initialization of the optical unit is completed in a few more seconds the start up menu appears The instrument is now operational solo user manual ED 43204 revD1 06 07 2012 Page 15 of 40 Eurolyser Diagnostica GmbH Configure the Eurolyser solo photometer You can configure your Eurolyser solo laboratory photometer according to your needs before you begin using it To go to the configuration menu follow these steps 1 Start up menu 2 Settings menu 3 Configuration menu solo Door open Calibration Language Norm Values Insert Card 22 09 2011 Door close Service Interface Units Settings About Date Time Input Le e 2 Touch gt to go to the Settings Touch Settings to go to the Touch the setting you want to menu Settings Configuration men
31. solo user manual ED 43204 revD1 06 07 2012 solo User Manual EURO Eurolyser Diagnostica GmbH BayernstraBe Ila 5020 Salzburg AUSTRIA Tel 43 662 432100 Fax 43 662 432100 50 Page 1 of 40 Eurolyser Diagnostica GmbH 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 In vitro diagnostic medical device Catalogue number Order number O Lot number Serial number The contents are sufficient to perform lt n gt number of tests Best used by Temperature limitations Relative humidity limitations Manufacturer Date of production TERIL Sterile Warnings and precautions see accompanying documents Operator s action Refer to the user s manual and follow the instructions Do not dispose with household waste ERS Testing Cartridge Light Emitting Diode Personal Computer LED solo user manual ED 43204 revD1 06 07 2012 Page 2 of 40 Eurolyser Diagnostica GmbH oo Identification HIS Hospital Information System LCD Liquid Crystal Display Alternating Current Radio Frequency Identification Table 1 solo user manual ED 43204 revD1 06 07 2012 Page 3 of 40 Eurolyser Diagnostica GmbH TABLE OF CONTENTS SYMBOLS AND ABBREVIATIONS TABLE OF CONTENTS
32. tr Instrument s automatic start up and warm up processes Please wait for these to be completed if approximately 15 minutes N Do not open the door manually Connecting optional equipment The following optional devices which are not included in the standard delivery package can be connected to the instrument e An external printer for optional test result printouts e An external barcode scanner e 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 37 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 connected before such leakage current can be measured If the instrument is not used according to the instruction manual then the provided N levels of safety will be lowered solo user manual ED 43204 revD1 06 07 2012 Page 13 of 40 Eurolyser Diagnostica GmbH Connecting a barcode scanner To install the Datalogic Touch 65 barcode reader Order number SZ0400 please connect the RS232 cable to the outer RS232 socket at the analyzer see illustration Always connect the power supply to the barcode scanner correctly before using it lf a printer should be installed simultaneously an adapter barcode printer inte
33. u configure 4 Language menu 5 Interface menu 6 Interface printer menu Printer Printout Host Options Touch the preferred language Select the interface you want to Select Printout for further and confirm it with i configure Choose Printer to configuration regarding printouts configure transmission to a of test result s Select Options to connected printer Choose Host configure whether Operator Lot to configure transmission to a No or Serial No should be host e g a PC included in the printout or not solo user manual ED 43204 revD1 06 07 2012 Page 16 of 40 Eurolyser Diagnostica GmbH 7 Interface printout menu 8 Interface printer option menu 9 Interface host menu Pr aneelre Operator Transfer jamasan Disable Lot No Options on request Serial No MA If a printer is connected Select Operator Lot No or Serial Select Transfer for further Disable printouts will never be No to define if they should be configuration regarding transfer of provided included in the printout or not by test result s Select Option to Automatic the results will be choosing Disable or Enable configure whether Operator Lot printed out after every No or Serial No should be measurement included in the transfer and which On request printouts will only be baud rate is used when provided on demand transferring to a host The service password to change the settings is required 10 I
34. w you to assess the measuring accuracy of the instrument Ensure the measuring methods are compatible with the Eurolyser solo 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 Ti Consult the package insert that comes with each control kit for detailed instructions on the storage and handling of the control materials Follow the instructions in the Analyzing a patient s sample sections pp 24 25 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 lf one or more controls tested are 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 lf one or more control results are still outside the specified 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 r the permitted range contact your local Eurolyser solo laborat

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