BioSystems A-15 Analyzer - Frank`s Hospital Workshop
Contents
1. 10 Technical specifications 11 3 1 Behaviour limitations and criteria 14 4 Instrument care and maintenance 15 4 1 General recommendations Lecce 15 4 2 Changing the lamp 15 4 3 Changing an optical filter eese sees 15 4 4 Cleaning the dispensing system esse 16 4 5 Cleaning the semi disposable reactions rotor 16 40Removing resiguUe ERR o 17 4 7 List of consumables accessories and spares 17 9 56 19 6 Troubleshooting guide ee 19 7 PREVENTIVE MAINTENANCE eere eene nn 20 8 Supplementary information crees eee e 21 8 1 List of uses and applications ee 21 8 2 Limitations to Warranty oo 21 8 3 Requesting components and perishables 21 8 4 Technical assistance 21 8 5 Table of symbols units 21 8 6 Additional te2. 0 003 Ato 1 0A CV 0 3 96 0 005 Ato 2 5 A CV 0 2 0 003 Aat 340 nm 0 002 A at 505 nm 0 005 A to 0 1 A 596 0 015 Ato 0 5 A 396 0 02 Ato 1 0 A 296 0 04 Ato 2 0 A 296 0 05 Ato 2 5 A 296 at 340 nm 405 nm 505 nm 915 BioSystems MINIMUM COMPUTER REQUIREMENTS Pentium IV processor or higher Windows 98 or higher 256 Mb RAM 50 Mb free hard disk space CD ROM VGA monitor minimum screen resolution 800x600 Mouse RS 232 serial channel connector or USB The insulation level of the A15 analyser communications channel is reinforced the insulation of the communications channel of the computer has also been reinforced CHECKED REQUIREMENTS OF THE CODE BAR READER Reading Speed 200 readings second Reading Width 80mm Resolution 0 1mm Light Source Visible red LED of 660 nm Sensor Linear CCD of 2160 elements Input Voltage 5VDC Interface Keyboard PS 2 and AT USB RS232C POWER REQUIREMENTS Input voltage 115 230 V AC 50 60 Hz Power 150 VA Electrical installation category overvoltage category The mains power point must be approved and have an earth connection and cable with a minimum section of 1 5 ATMOSPHERIC CONDITIONS Interior use Height lt 2500 Temperature 10 C 35 C Relative humidity 75 Contamination level 2 Reinforced insulation is that which ensures protection that is equal to or higher than double that provided by the main
3. The communications cable is not connected Check the cable is connected to the RS232 PC port of the analyser The computer does not function adequately Reboot the computer and launch the user programme Check communications with the test utility of the PC Analyser communications channel The analyser or the computer hangs 1 Another instrument is interfering with its functioning Check the analyser and the computer are not near centrifuges or equipment with motors or electromagnets that generate strong electromagnetic interference In this case position the analyser at a distance from said equipment The computer is running other programmes The computer must be dedicated fully to the analyser while itis in operation No other programme can be used while the analyser is working 3 The computer is unstable Reboot the computer and launch the user programme If the unstable functioning persists check that the computer complies with minimum requirements The programme has been incorrectly installed Reinstall the user programme Other programmes have been installed on the computer and are causing the instability of the user programme Uninstall all programmes and reinstall the user programme It is highly recommended that the computer is used exclusively for controlling the analyser The results of the analyses are wrong 1 The fluid system is not being supplied correctly Check the system liquid container filt
4. dd mm aa h m s The export file has one line per test applied to each patient The export file has one line per test applied to each patient 22 and the fields are separated by a tab and have the size shown in the table Sample export file PAC1234 AT SER 1214717 U L 19 09 2005 12 19 46 PAC1234 GLUCOSE SER 2613174 mg dL 19 09 2005 12 19 46 8 6 2 Password working You can create three types of user with different access levels e Operator is the user with a lower level of access to the application He can only do working sessions reports of current and historical results and validate quality control results In the screens of programming of techniques and contaminations he can look up programming values but he can not modify any parameter He can not delete results or alarms This user has total access to the rack and profile programming and to the analyser s configuration except for changes of filters He can change his own password Whenever you want you can change the user by means of the option Change of user from the User menu Each user is capable of changing his password All these options can be reached from the user menu Supervisor is the user with a medium access level This user has got the same privileges as the operator user s and in addition he has got permissions to modify the programming of techniques in the calibration parameters and the control values He can create a restricted n
5. The dispensing system should be cleaned with washing solution at the start and end of each working day to ensure that it is completely free from air bubbles and is perfectly clean Once the wash has been performed the analyser asks the user to replace the container with system liquid and it automatically performs a wash and rinse of the dispensing system with system liquid With the initial wash the system is ready for working in optimum conditions during the entire working day offering maximum performance With the final wash the analyser cleans the needle at the end of the working day keeping it in optimum condition for future working days The user can also wash the dispensing system whenever he wishes by means of the Dispensing System Wash tool on the user programme while the analyser is in standby mode It is also appropriate to clean and check the filters of the system liquid container at least once every 3 months If the needle is obstructed by solid residue and needs cleaning with the metal cleaning rod supplied with the analyser it can be disassembled for cleaning out of the analyser For this the Disassemble dispensing needle utility on the user programme must be used It is also recommendable to periodically clean the outside surface of the needle with a piece of cotton or a soft cloth dampened with alcohol When handling the needle always wear laboratory gloves The needle must be replaced if it noticeably deteriorat
6. insulation The main insulation is that whose failure could lead to the risk of electric shock EN 61010 1 COMPLIANCE WITH DIRECTIVES AND APPLIED STANDARDS Directive 98 79 CE related with n Vitro Diagnostic products e EN 61010 2 101 2002 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for vitro diagnostics IVD medical equipment e UNE EN 61326 1999 A1 2000 A2 2003 A3 2005 ERR 2002 Electromagnetic equipment for measurement control and laboratory use ECM requirements e UNE EN 55022 2000 A1 2002 CORR 2002 Radiated emisions class B continous interference class B e UNE EN 61000 3 2 2002 Harmonic current e UNE EN 61000 3 3 1997 Corr 1999 A 1 2002 Fickers e UNE EN 61000 4 2 1997 A1 1999 A2 2001 e UNE EN 61000 4 3 2003 A1 2004 Radiated inmunity e UNE EN 61000 4 4 1997 A1 2001 A2 2002 Fast transient Burst e UNE EN 61000 4 5 1997 A1 2001 Surge transients e UNE EN 61000 4 6 1998 A1 2001 Conducted inmmunity e UNE EN 61000 4 11 1997 A1 2001 Voltage disp short interruptions and voltage variations inmmunity UNE EN 22233 1992 ISO 2233 1986 Packaging Complete filled transport packages and unit loads Conditioning for testing UNE EN 24180 2 1992 ISO 4180 1980 Complete filled transport packages General rules for the compilation of 13 Installation and maintenance manual performance test schedules UNE E
7. on unpacking the analyser Visually check that none of them has been apparently damaged during transport Analyser Unpacking instructions sheet Instrument Release Certificate Boxes of accessories Empty washing solution container with lid oS c 15 BioSystems Content of the box of accessories Racks of samples 3 3 3 Rack of reagents 3 Reactions rotor 5 Bottles of concentrated washing solution 1 bottle of 100mL 5 Bottle of concentrated system liquid 11 6 Empty 50 ml bottles 10 7 Empty 20 ml bottles 10 8 User manual 9 Installation and maintenance manual 10 CD ROM with User programme 11 Network connection cables European and American 12 Serial channel cable for connection to the computer 13 Fuses 14 Metal rod for cleaning the needle 15 2 mm Allen key Sample wells 1000 PINE Installation and maintenance manual 1 3 Identification of the main components The main parts of the analyser are identified and numbered in the following figures and their associated lists 1 Label showing brand and model 1 Power point 2 Rack tray 2 Switch 3 Sample racks 3 Fuses 4 Reagent racks 4 Identification label 5 Arm protector cover 5 Fans 6 Reactions rotor and reading 6 RS 232 serial connections PC and USB auxiliary 7 Needle washing station connection 8 Operating arm 7 Back cover 9 Rotor cover 8 Hydro pneumatic elevators for the main cover 10 LED status indicator 9 Ba
8. 8 6 1 LIMS Communications opecifications for the A15 programme communication with a computer management system LIMS Laboratory Information Management Systems software This section explains how to perform bidirectional communication from the A15 analyser to a centralised computer management system This communication establishes a system for programming work sessions with the A15 and for exporting the concentration results obtained with the analyser Communication is by copying flat text documents into a system folder To make the communication the computer must have a network connection with the central system in order to be able to make copies of the documents The following folders show the locations of the documents in order to be able to make the communication C Program files A15 installed Folder where the application is C Program files A15 lmport Folder where the document for import is copied C Program files A15 Export Folder where all the export documents are stored C Program files A15 Memo Folder where the memorised sessions are stored Import process To import a work session to the A15 analyser program a flat text document must be copied into the mport folder with the name import txt On the screen for entering New samples the Import session button is activated to load the import file samples when there is a new import document in the Import folder A15 Entering of New Samples Configurat
9. do so by the analyser It is recommendable to restart the work session daily by means of the Restart session button For each sample you wish to analyse select the sample class and type from the ntroduction of New Samples screen If desired introduce the patient code Select the profiles and tests to be performed Add the sample to the list of samples by clicking on the Add Arrow gt button Patient details can be introduced if desired while the analyser performs the analysis Click on the Position button to access the Samples and Reagents Positioning screen Click on the Position Reagents Automatically and Position Samples Automatically buttons for the analyser to position all the elements required on the rack tray automatically Click on the OK button Place the bottles of reagents and the tubes of samples physically on the tray of the analyser in keeping with the configuration shown by the computer Place the bottle of distilled water and if necessary the bottles with washing solution and saline solution 10 Click on the Start button to start the analyser working and to display the Monitor 11 Each time you wish to introduce new samples for analysis click on the New Sample button on the Monitor and repeat steps 7 to 10 If the analyser is still carrying out preparations click on the Sampling Stop button to physically introduce the new samples or reagents in the analyser Once in position click on the Continue but
10. fitting 50 ml bottle with top 10 units 20 ml bottle with top 10 units Bottle of concentraded washing solution 100mL Bottle of concentrated system liquid 1L Samples wells 1000 Detachable needle 20 ml 50 ml reagents rack 13 mm tube sample rack 15 mm tube sample rack Paediatric well samples rack Set of 2A F fuses European network cable American network cable Serial channel cable for connection to PC 6 V 10W halogen lamp Lamp holder fastening system 340 nm filter unit 405 nm filter unit 505 nm filter unit 535 nm filter unit 560 nm filter unit 600 nm filter unit 635 nm filter unit 670 nm filter unit Covered filter unit Reactions rotor cover Filter cover AC13198 AC13199 AC12222 AC12223 Operating arm fastening for transport Height adjustable leg Metal rod for cleaning the needle 2 mm Allen key Installation and maintenance manual 5 Quick use guide The basic routine operation method of the analyser can be summarised in the following instructions 1 Check that the waste container is empty and that the fast fitting of said container is correctly connected Fill the system liquid container Fit a reactions rotor Boot up the computer and launch the user programme From the Monitor screen click on the Warm up button to switch on the analyser and start it up The initial wash is performed with washing solution place the corresponding container in position when required to
11. is securely in place Do not touch the lamp bulb with your fingers To handle the lamp use the wrapping cutting it at the terminal end and squeezing it until they come out f Putthe lamp holder back in place Put the tab in position and fasten the screw g Putthe rotor cover back h The lamp does not require any adjustment but it can be placed in the analyser in two possible positions by turning it 180 around its longitudinal axis The programme itself requires the user to place the lamp in the two possible positions and check in which of the two maximum light intensity is obtained in the optical System 4 3 Changing an optical filter Installation and maintenance manual a Access the Filter Drum Configuration screen of the user programme Indicate which filter is to be changed position 1 9 and click on the Change filter button b Remove the rotor cover c Remove the filter drum cover by simply pulling on it d Remove the top filter using a pair of fine pliers e Position the new filter by pressing down until it is correctly in place f Donotleave the position free without putting a filter holder in place If no filter is required in this position put a covered filter holder in place g Place the filter drum cover and the optics cover back in position Put the rotor cover back h If itis different introduce the wavelength of the new filter that has been installed 4 4 Cleaning the dispensing system
12. its proper recycling To this end the manufacturer facilitates its elimination 3 Technical specifications PLEASE NOTE 9915 BioSystems The manufacturer accepts no liability for damage caused by incorrect use of the apparatus GENERAL SPECIFICATIONS Automatic random and continual access analyser aimed at giving results per patient with direct photometric reading over a reactions rotor Preparation cycle time 24 5 up to 150 prep h Warm up time 25 mins Reading time for each preparation Every 24 s up to 10 mins Size 840x670x615mm 33 17 x 26 8 x 24 2 length x depth x height Weight 45 kg 100 Ib REAGENTS AND SAMPLES TRAY Positions for racks 4 Capacity of the sample racks 24 Maximum number of samples 72 913 mm 215 mm sample tubes max height 100 mm 13 mm paediatric well Capacity of the reagent racks 10 Maximum number of reagents 30 20 ml and 50 ml reagent bottles Possible configurations Sample racks Reagent racks Number of samples 1 3 24 2 2 48 3 1 72 DISPENSING SYSTEM NEEDLE Detachable tip Vertical length 110 mm Capacity level detection Self adjustment of position NEEDLE THERMOSTATATION SYSTEM Actuator 1 Resistive Control PID Thermostatation time 15s Dispensation temperature 3 C Trueness 0 5 Repeatability 0 5 Number of reagents 30 20 10 Installation and maintenance manual DISPENSING PUMP Ceramic piston with PTFE graphite seal Piston diameter Displac
13. location or atmospheric conditions etc together with internal manipulation of the instrument by personnel not authorised by BioSystems or the use of unoriginal consumables and spares tubes fuses etc shall invalidate the warranty 8 3 Requesting components and perishables If any of the components of the analyser deteriorate of if any of the perishable materials are required always use original BioSystems material The List of consumables accessories and spares section lists all the components that may be occasionally required To purchase said components please contact your usual distributor and order each element using its corresponding code This will simplify work and minimise errors 8 4 Technical assistance Please contact your usual distributor for information about Training for using the analyser After sales Service Request Protocol User programme updates 8 5 Table of symbols and units TABLE OF SYMBOLS AND UNITS serial number FUS Fuse F Fast V Hz VA A Voltage Frequency Apparent power Current 20 In Vitro Diagnostic Medical Device Consult Instructions for Use Serial number Batch code Catalogue number LOT REF 1860858 Temperature limitation Irritant R36 38 Irritating to eyes and skin 1526 In case of contact with eyes rinse imme diately with plenty of water and seek medical advice 8 6 Additional technical information
14. INSTALLATION AND MAINTENANCE MANUAL English TEUS00024 03 ING August 2006 D 5 BioSystems TABLE OF CONTENTS Ds MOPS UNG E EE 5 1 1 UNPACKING cece ce 5 Mee LISTOI CONTE MIS ascents ae eso EENE 5 1 3 Identification of the main components 6 2 acl RR 7 2 1 Warnings and precautions es 7 2 2 c 7 2 3 Opening the main 7 2 4 Unblocking the operating 7 2 5 Installing the waste and system liquid containers 8 2 6 Installing the reagent and sample racks 8 2 7 Installing the reactions rotor eese eee 8 2 8 Connection to mains and start up ee 8 2 9 Connection to the computer 9 2 10 Installing the user programme on the computer 9 2 11 Installation of a code bar reader 10 2 12 Preparation before operation 10 r e WINS Lo p iex Te een sane 10 2 14 Handling storage and reshipment
15. Installing the waste and system liquid containers On the left of the analyser are the waste and system liquid containers The system liquid container with its lid and blue mark is at the front i e in the position nearest to the user and the waste container with its lid and red mark is at the back The positions of these two containers cannot be swapped over To fill the system liquid container unscrew the lid extract the tubes and the lid and remove it from the analyser Fill the container to the top with distilled water approximately 3000 ml add 6 ml of concentrated system liquid and shake the liquid gently To empty the waste container disconnect the fitting and remove it from the analyser The quick coupling fitting of the waste container has a valve which is closed when it is disconnected to avoid the spillage of waste If during the functioning of the analyser said tube is not correctly con nected the needle washing station cannot be emptied and the waste is emptied to the outside of the analyser through the drainage points The user must make sure that the fitting is correctly connected by pressing it until it clicks Also prepare the washing solution container with the lid marked in green Add 15 ml of concentrated washing solu tion to the container filled with distilled water approximately 3000 ml 2 6 Installing the reagent and sample racks The analyser has a tray with 4 positions for reagent and samp
16. N 22247 1992 ISO 2247 2000 Packaging Complete filled transport packages and unit loads Vibration tests at fixed low frequency UNE EN 22248 1992 ISO 2248 1985 Packaging Complete filled transport packages Vertical impact test by dropping MAXIMUM SIZE OF ANALYSER Closed cover Length 840 mm Depth 670 mm Height 615 mm Opened Cover Length 840 mm Depth 670 mm Height 1025 mm The manufacturer reserves the right to modify any technical specification without prior notice 3 1 Behaviour limitations and criteria The A15 analyser is optimised for working with the BioSystems A15 reagents line The programmed manufacturing techniques correspond to measurement procedures that use these reagents and which have been deeply and fully studied and validated to guarantee optimum performance of the reagent analyser system However other reagents can be used whose measurement procedures are compatible with the specifications of the instrument with the consequent loss in performance if the adjustment is not made correctly In this case BioSystems cannot guarantee the performance of the system Updated information about the measurement procedures with BioSystems reagents can be obtained from your distributor or directly from the BioSystems website The use of accessories and spares that are not BioSystems original parts may seriously alter the functioning of the analyser as well as your personal safety It also implies to
17. TestID size gt 16 chars TestID DOES NOT exist in test programmed Type indicated is NOT programmed for the test indicated Installation and maintenance manual Export process Once it has been reset an export document is automatically generated in the Export folder EXPAuto DateSession txt This document is automatically deleted after one week If the user wishes to export a specific work session he she can use the Export results button which generates a document called Exp aa mm dd hh mm txt 15 Past Reports Configuration Programming Work Session Current State Historical Reports Users Utilities EXIT 0 8690 e Accept Calibrator Abs 24 02 2004 12 06 32 1 00092 Delete Export Results Blank Abs 23 02 2004 15 17 38 0 0006 Referencerange 8173 3275 Result date Extraction UAL 24 02 2004 11 34 01 UL 24 02 200411 3802 U L 24 02 2004 114348 Ua 24 02 2004 11 51 50 ALT BILIRUBIN DIRECT BILIRUBIN TOTAL CK CREATININE GT Factor UCOSE IRON FERROZINE LDH SLEEPING 05 03 2004 14 45 For example Exp 2005 01 28 14 24 txtfile exported on 28 01 2005 at 14 24 Said document has the following format U Urgent patient N Normal patient No of characters CSF Cerebrospinal liquid WBL Whole Blood PLM Plasma Alphanumeric string any character except Alphanumeric string any character allowed
18. check that they are not close to centrifuges or equip ment with motors or electromagnets that may cause strong electromagnetic interference In this case position the analyser at a distance from said equipment The A15 analyser has been designed for working within the 115 V 230 V 50 or 60 Hz range with a maximum power of 150 VA The analyser automatically adapts to the mains voltage which does not need to be manually selected Working outside the voltage range may cause incorrect functioning of the equipment and damage to it The cat egory of the electrical installation overvoltage category must be Il To connect the analyser proceed as follows a Check that the switch at the back is in off position 0 b Connect the mains cable first to the apparatus and then to the mains Place the switch in on position 1 y Mz VAmax FUS AJI CLASS wszx sso wo m It is recommended you always leave the switch on unless maintenance work or breakdown repairs are to be carried out The power consumption of the analyser in this posi tion is minimal In this way the analyser can be started up or switched off from the user programme 2 9 Connection to the computer The computer must be dedicated fully to the analyser while itis in operation No other programme can be used while the analyser is working With the computer turned off con nect the supplied RS 232 cable to the COM1 B of the ana dV 5 BioSystems
19. chnical information 21 1 Unpacking The A15analyzer is a precision instrument For this reason special care must be taken with its installation and location It is very important to connect the apparatus and the associated computer to an appropriate electrical system It must be as exclusive as possible and it must be earthed We recommend you read this chapter carefully before installing the apparatus Non fulfilment of the instructions given in this chapter may jeopardise the safety and functioning of the equipment 1 1 Unpacking On receiving the instrument check that the packaging is in perfect condition and that the sealing is intact Open the box and carefully take out the contents Follow the indications on the unpacking instructions sheet The instrument weighs 45 kg and needs a minimum of two people to move it When lifting it keep your back straight to avoid injury Grip it below the base never by the top or by the housing or any other of its elements The base of the analyser has two areas on each side especially designed for gripping it while moving it It is recommendable to use mechanical means such as a fork lift for transporting the analyser Do not throw the packaging ma terial away since it may be necessary for ensuring safe transport if the analyser is reshipped or moved in a vehicle 1 2 List of contents The following is a list of the elements the user should find
20. data sheets that are at the user s disposal through the distributor For removing mixtures with waste samples the general criteria based on good laboratory practice must be applied These criteria must be familiar with the personnel of a clinical laboratory and set forth in the current legislation of the country where the instrument is installed If user can not D 5 BioSystems guarantee a correct cleaning of the rotor we advise not to reuse it 4 7 List of consumables accessories and spares If any of the components of the analyser deteriorate of if any of the perishable materials are required always use original BioSystems material The following table shows lists of components that may be required To purchase said components please contact your usual distributor and order each element using its corresponding code This will simplify work and minimise errors DESCRIPTION User Manual Installation and maintenance manual CODE AC13188 AC11485 AC11486 BO13189 113190 BO13191 BO13192 BO11493 BO11494 BO13416 BO11524 AC10770 AC13193 AC11501 AC11502 AC11503 AC11504 FU13194 CA10455 CA10456 110466 LA13195 ZO13196 111563 111564 111565 111490 111491 111566 111567 111568 111498 AC13197 AC13200 User program CD Reactions rotor 10 units Reactions rotor fastening screw System liquid container with top system liquid container filters Washing solution container with top Waste container with lid and
21. e U SER PAC1234 T15 U SER PAC1234 GLUCOSE T15 Import file error control The programme checks that the information in the Import txt file is correct and generates a file Errors txt in the IMPORT folder if it detects an error in syntax or incompatibility with the tests programmed in the application If an error is found in the import document the Import errors button is enabled A15 Entering of New Samples Configuration Programming Work Session Current State Historical Reports Users Utilities EXIT Sample Data Class Normal M snmplus Type SER j Samples sent Patients Blanks and Calibrators Controls Test ALBUMIN MICROALB Patient code Patient Profile No of Samples 12 Tests amp Profiles ACP ALBUMIN ALP AMP ALP DEA ALT AMYLASE DIRECT AMYLASE EPS BILIRUBIN DIRECT BILIRUBIN TOTAL CALCIUM ARSENAZO CHE CHOL HDL DIRECT CHOL LDL DIRECT CHOLESTEROL Patient Data SLEEPING 05 03 2004 13 18 Import errors List of errors Line maximum length of 41 Check the size of all fields characters and or tabs Incorrect CLASS U Urgent N Normal Incorrect TYPE SER URI CSF WBL PLM T15 Diameter 15 T13 Diameter 13 PED Paediatric Reduce PatientID size Reduce TestID size Check programmed test Check Types programmed for the test Incorrect tube Incorrect PatientID size gt 16 chars Incorrect
22. ement Dispensing volume Resolution Fuzziness Dispensing speed Programmable reagent volume Programmable sample volume NEEDLE WASHING SYSTEM oystem liquid consumption oystem liquid container volume Waste container volume Waste and water level control per capacitive detection REACTIONS ROTOR AND READING WELL ROTOR oemi disposable extractible methacrylate rotor Number of wells Accepted reaction volumes Light path length ROTOR THERMOSTATATION SYSTEM Actuators Control Working temperature Trueness Stability OPTICAL SYSTEM 6 V 10 W halogen lamp Wavelength selection with compensated interferential filters 8mm 2omm 3 ul 1250 ul 0 126 ul lt 1 up to 3 ul max 880 ul s 10 ul 440 ul 3 ul 40 ul approx 1 2 ml per preparation 3000 ml 3000 ml 120 200 ul 800 ul 6mm 4 Peltier cells PID 3 C 0 2 0 1 Detection system with silicon photodiode and 20 bit AD integrator converter Measurement range Heading speed Maximum number of filters Base configuration of the filter drum Wavelength precision Bandwidth Digital resolution Base line stability Repeatability of the reading system 1 SD 505 nm with filter movement Optical repeatability between wells bichromatic at 0A Accuracy from 0 05 Ato 2 5A 1 readings 9 340 405 505 535 560 600 635 670 nm 2nm 10 2nm 0 0001 A max 0 004 A in 30 mins at 505 nm 0 0005 A to 0 1 A CV 0 5 95
23. ers If they are obstructed replace them with new filters Switch on and start up the analyser or manually wash the fluid system with washing solution from the utilities screen The dispensing needle is obstructed or incorrectly installed Detach the needle clean it and reinstall it If noticeably deteriorated replace it with a new one The reactions rotor is dirty or in poor condition Replace it with a new one The reagents are incorrectly positioned Check that the physical configuration of the reagents on the racks of the analyser is exactly as shown in the user programme Contamination problems of the sample well You have to bear in mind that it may be a transfer from a reagent to the sample well during a list This transfer is not likely to affect the stability of a sample constituent The best way to detect this problem is doing a good internal quality control such as doing the quality control before and after the list If you find a case as the one described the solution is separating a sample aliquot to use only with the reagent suspected to cause contamination 7 PREVENTIVE MAINTENANCE A weekly preventive maintenance is advisable 1 Carry out an outer cleaning of the needle In order to access the needle use the program option Remove dosing needle And with a piece of cotton soaked in 70 alcohol clean the outer part of the needle At the same moment with a brush of bristles clean the L shaped metallic
24. es 4 5 Cleaning the semi disposable reactions rotor When the reactions rotor is completely full the user must change it for one that is empty clean and dry The reactions rotors can be reused if they are carefully cleaned immediately after use The procedure is as follows e Remove the reagents from the rotor wells and rinse abundantly with running water e mmerse the material in a 5 wash solution Extr n Merck for 30 minutes Rinse thoroughly with running water Deproteinize the rotor by adding a 396 nitric acid solution for 5 minutes Rinse thoroughly with distilled water e Immerse in distilled water for 30 minutes and allow to dry at room temperature only deproteinize the rotor when tests for ions such as magnesium calcium etc are required Organic solvents alcohol benzene or alkaline solutions must not be used They must be left to dry completely before being reused High temperatures must not be used during drying The rotors must be rejected if they are noticeably deteriorated The optical status of a rotor must be verified by means of the Heactions rotor verification utility on the user programme The useful lifetime of each rotor depends drastically on its use and care 4 6 Removing residue The correct and safe way of removing the residue of the reagents is common practice in clinical laboratories If there are any doubts about a BioSystems reagent this information will be given in the safety
25. f accessories and spares that are not BioSystems original parts may seriously alter the functioning of the analyser as well as your personal safety It also implies total loss of warranty for the analyser To prepare the system liquid you must always use dis tilled water never tap water Automatic pre diluting of the samples must be done with saline solution To keep the analyser in perfect working order and obtain optimum per formance the entire dispensing system must be washed with BioSystems washing solution and system liquid on beginning and ending each working day These washes are performed automatically by the analyser During start up the A15 analyser automatically performs all the checks required for correct functioning and no manual adjustment is necessary If for any reason user interven tion is necessary the analyser issues the corresponding alert through the computer 2 13 Transport The instrument weighs 45 kg and needs a minimum of two people to move it For easy transport four people are rec ommended When lifting it Keep your back straight to avoid injury Grip it below the base never by the top or by the housing or any other of its elements The base of the ana lyser has two areas on each side especially designed for gripping it while moving it It is best to transport the ana lyser using mechanical means 2 14 Handling storage and reshipment Although thanks to its elaborate design the analyser is
26. i disposable reactions rotor e Never use detergents or abrasive products for cleaning the surface of the analyser Use only a damp cloth with water and pH neutral soap f Ifareagent or corrosive product spills or solashes onto the apparatus clean it with a damp cloth and soap immediately If necessary protect your hands with appropriate laboratory gloves g All the elements of the analyser have drainage conduits leading to the exterior to enable the elimination of any liquid spilled and to prevent the apparatus from flooding If the spillage is significant the liquid spilled onto the table through the drainage conduits and the analyser must be adequately cleaned h When not in use close the main cover of the analyser to protect it from dust 4 2 Changing the lamp The analyser is fitted with a 6 V 10 W halogen lamp with an estimated average lifetime of 1 000 hours It is recommended that you change the lamp every year even though its lifetime has not run out When the lamp needs to be changed access the Change lamp utility of the user programme and follow the steps indicated by the programme itself To replace the lamp proceed as follows a Remove the rotor cover b Loosen the screw that holds the fastening tab of the lamp holder c Push the tab back d Remove the lamp holder loosen the Allen screw and take out the lamp e Insert the new lamp pushing the terminals to the back Tighten the Allen screw until the lamp
27. ion Programming Work Session Current State Historical Reports Users Utilities EXIT 0 8900 Sample Data Class Normal X Type SER New Samples Patients i Blanks and Calibrators Controls Test Samples sent Patient code Class Patient Profile e No of Samples Tests amp Profiles ALBUMIN ALP AMP ALP DE ALT AMYLASE DIRECT AMYLASE EPS Apo A Apo B 50 AST BILIRUBIN DIRECT BILIRUBIN TOTAL CALCIUM ARSENAZO CHE CHOL HDL DIRECT CHOL LDL DIRECT CHOLESTEROL Patient Data Import Session SLEEPING 11 02 2004 10 46 Sample class Sample Type Patient identifier Technique identifier Test tube type The import file must contain one row per test and the fields must be separated by a tab ASCII code 09 U Urgent Patient N Normal Patient SER Serum URI Urine CSF Cerebrospinal liquid WBL Whole Blood PLM Plasma Alphanumeric string any character except Alphanumeric string any character allowed PED Paediatric tube T13 Tube 13 T15 Tube 15 D 5 BioSystems The size of the Patient identifier and Test identifier fields must be a maximum of 16 characters The other fields must have the exact size indicated in the table Sample import file We have a patient PAC1234 considered urgent for ALT and GLUCOSE tests The sample is SERUM type and is placed in a DIAMETER 15 tub
28. le racks To position a rack in the analyser place it on one of the tray positions push it to the back and gently lower it by holding it by the front tab until it is in position 2 7 Installing the reactions rotor Remove the rotor cover and extract the rotor fastening screw Introduce the reactions rotor in the heater channel holding itby the top tabs and trying not to touch the channel walls It has only one position and must fit perfectly in the sup port Screw back up the rotor fastener and put the rotor cover in place The cover also has only one position Its position has a detector which tells the analyser it is in place The analyser also detects the presence of the reac tions rotor If the analyser detects that the cover or rotor are not in position it does not take optical readings and gives alerts the user 2 8 Connection to mains and start up It is very important to connect the apparatus and the asso ciated computer to an appropriate electrical system It must be as exclusive as possible and it must be earthed The analyser and the computer must have the same earth con nection It is best to use the Uninterruptible Power Supply UPS for the analyser and the control computer We rec ommend you use a 1000 VAUPS with voltage stabilisation sine wave output and an input separation transformer If any anomaly is observed in the functioning of the analyser or the computer programme hangs or sporadic reboots occur
29. lyser and a series channel of the computer The connec tors have 9 pins COM 1 Main communications port A USB connection B RS 232 connection COM 2 Auxiliary communications port 2 10 Installing the user programme on the computer The user programme must be used on a compatible PC with the following minimum requirements Pentium IV processor or higher Windows 98 or higher 256 Mb RAM 50 Mb free hard disk space CD ROM VGA monitor minimum screen resolution 800x600 Mouse RS 232 serial channel connector or USB To install the programme proceed as follows a Boot up the computer Installation and maintenance manual b Insert the CD ROM c The installation programme launches automatically Fol low the indications given If it does not launch automati cally click on Start select Run and type CD HOM drive letterXSetup e g D Setup 2 11 Installation of a code bar reader The user manual section 2 2 6 1 explains how to introduce a patient s code This code can also be introduced by a code bar reader The reader is directly connected to the computer In order to install the reader you should follow the installation instructions of the code bar reader manu facturer 2 12 Preparation before operation The analyser is optimised for working with BioSystems consumables and reagents The use of reagents by other commercial brand names is possible but certain features may be affected The use o
30. no objects obstructing the air output of the venti lators 2 atthe back and 1 on the base Leave a minimum space of 10 cm between the back of the analyser and the wall or the nearest object The surface must be sufficiently robust and rigid to support the weight of the analyser 45 kg and the force resulting from the rapid movements of the dV 5 BioSystems operating arm To adapt the analyser to the surface and level it correctly the front right leg is adjustable 2 3 Opening the main cover Lift the cover gently upwards by the front The hydro pneu matic hinge system enables the cover to be opened easily and it stays open while the user works with the different elements of the analyser To close it simply lower it gently to its lowest position The cover has an open sensor which tells the analyser that it is open In this case the operating arm does not carry out any preparation and stays in the parked position to avoid injury to the user 2 4 Unblocking the operating arm To avoid damage during transport the arm is immobilised by 1 screw and two foamm pipes These elements must be removed for the arm to move freely Simply unscrew it using your fingers no tools are required as indicated on the unpacking instructions sheet Keep these screws and the pipes next to the analyser so they can be repositioned if it has to be moved using a transport vehicle or reshipped Installation and maintenance manual 2 5
31. part inside the instrument You can 19 D 5 BioSystems access through the origin hole of system XY see the following photograph 2 Carry out the following 3 steps one after the other Use button NSL New System Liquid of the screen Monitor e Remove the tubes from the System Liquid bottle and carry out a cycle of NSL In order to empty all the tubes e Place the tubes in a bottle with Washing Solution and carry out a cycle of NSL e Place the bottle with System Liquid and carry out the last cycle of NSL This process is used to avoid the air bubble formation that alter the analytical results or that affect the dosing system 3 It is also recommended to carry out an extra washing cycle once in a while with button NSL between two consecutive lists 4 Carry out a weekly washing with Sodium Hypochlorite to the 1 596 to avoid the obstruction of the needle Use the utility Utilities Wash dosing system Installation and maintenance manual 8 Supplementary information 8 1 List of uses and applications The A15 analyser has been designed for biochemical analyses It is optimised to function with the line of A15 Reagents by BioSystems For further information about all the measurement procedures available please contact your usual distributor This information is also available on the BioSystems website 8 2 Limitations to warranty Any misuse dropping negligence power conditions out of tolerance inappropriate
32. robust and durable it must be remembered that it is a pre cision instrument and as such must be handled with spe cial care and attention If the analyser is to be stored for long periods it is recom mended that you completely clean all the fluid circuits with the corresponding utility on the user programme first with washing solution and then with system liquid The fluid sys tem tubes must be left filled with system liquid The sys tem liquid container must be emptied and the waste con tainer must also be emptied and washed It is recommended that you throw away the used reaction rotors and use new rotors when you restart the analyser The analyser must be duly protected from dust and other environmental aggres sors such as direct sunlight or excessive humidity If the analyser is to be reshipped or moved using a trans port vehicle it is important to block the operating arm and use the original packaging to ensure that the apparatus is not damaged To package the instrument follow the indica tions on the unpacking instructions sheet The special waste container crossed out symbol indicates that the product in question is subject to the selec tive waste collection principle as established in European Union Directive WEEE Waste Electrical and Electronic Equipment Once the instrument s lifetime is completed it becomes waste and as established in the directive the said waste must be separated from domestic waste for
33. se 11 Needle self adjustment sensor 10 General cover 12 System liquid container 13 Waste container 14 System liquid tubes 15 Waste tubes 16 Grommet 17 Adjustable leg 2 Installation With a view to guaranteeing optimum functioning of the analyser follow the installation instructions given in this chapter carefully 2 1 Warnings and precautions The A15 analyser has been designed and constructed ex clusively for professional use The user must be adequately trained for work in a clinical analysis laboratory and to use an in vitro diagnostic analyser Read this manual carefully together with the User Manual and take heed of all the warnings and precautions set forth in said manuals The manufacturer accepts no liability for damage caused by incorrect use of the apparatus Warning The user must check that the arm is completely in parked position before raising the cover of the analyser 2 2 Location The analyser must be located in a dry non corrosive at mosphere Relative humidity must not be higher than 75 It is recommended that room temperature is below 28 Avoid positioning it in draughts Furthermore the instru ment must not be near sources of electromagnetic radia tion such as motors or centrifuges or heat sources or receive direct intense sunlight or artificial light It must be placed on a flat spacious surface minimum of 110 cm x 60 cm with particular being taken to ensure that there are
34. tal loss of warranty for the analyser If problems exist in the power supply the use of uninterruptible power supply UPS is recommended In this way time problems are avoided and the equipment is protected from possible anomalies D 5 BioSystems 4 Instrument care and maintenance To achieve optimum functioning of the A15 analyser throughout its useful lifetime minimum maintenance norms must be followed This chapter sets forth these norms together with instructions for replacing different parts of the apparatus 4 1 General recommendations a The analyser fluid system must always work using the system liquid never with distilled water only This liquid must be prepared by adding 6 ml of concentrated system liquid to the container filled with distilled water approx 3000 ml b The analyser automatically washes its fluid system at the start and the end of the working day In this way optimum instrument performance is ensured This liquid must be prepared by adding 15 ml of concentrated washing solution to the container washing solution lid marked in green filled with distilled water approximately 3000 ml c On ending the working day once the analyser has been switched off always empty the waste container d Never leave a full reactions rotor in the analyser Once the analyses have finished remove it from the analyser immediately If you wish to reuse the rotor proceed as indicated in the section Cleaning the sem
35. ton 12 Once the analysis is over display and print out the reports from the Results Reports screen 13 Remove the reactions rotor from the analyser If you wish to reuse the rotor proceed as indicated in the section Cleaning the semi disposable reactions rotor 18 14 From the Monitor switch off the analyser using the Shutdown button 15 The final wash is performed with washing solution place the corresponding container in position when required to do so by the analyser 16 When the analyser is off empty the waste container 6 Troubleshooting guide Through the Monitor screen of the user programme the analyser continually informs the user of all the incidences that occur by means of alarms and alerts The Alarms and alerts section of the user manual sets forth the main alarms and alerts shown by the analyser requiring user intervention together with their possible cause and solution The following describes some additional anomalies and incidences together with their possible causes and solutions If any of the problems persist contact the Technical Assistance Service The analyser does not start 1 The analyser is not connected to the mains Check that the network cable is correctly connected to the instrument and to the mains The switch at the back is off Turn the switch at the back of the instrument on 1 The safety fuses have jumped Replace the 2 fuses on the back cover of the instrument
36. umber of new techniques that is defined at the moment of creating such user and that it is a default setting of 5 He can also modify the programming of contaminations and change the analyser s filters He can change his own password Administrator is the user with total access to the analyser s functions He can create new users as much at supervisor as at operator level eliminate or modify users When ios Utilidades SALIR Programaci n Sesi n Trabajo Estado Actual Hist ricos Usuar Configuraci n OSICA Crear nuevo usuario SLEEPING 05 03 2004 14 15 creating supervisor users he has to indicate the maximum number of new techniques that can create He can activate or deactivate Work Without Passwords option within the Configuration menu The administrator can only be the Technical Assistance Service When users are created the access is limited to different parts of the program When starting the program an identification of the user is requested by the user name and a password and then the program will automatically restrict the different parts of the program depending on the access level permitted 23 D 5 BioSystems
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