Biolyte 2000 Quick User Manual
Contents
1. 1 Press Status key to change the Status Screens or press the Enter key to print all status information 2 The Status Screen 1 Figure 35A shows the last conducted calibration slopes of each sensor The analysis test number will auto count from 1 to 10 000 lt lt STATUS gt gt Press ENTER to print 10 06 12 Na K CLs Li Fi 35A Status 1 Slope NC 50 00 50 00 OFF EEDD Stas Screen Analysis test number 1 3 The Status Screen 2 Figure35B shows voltage values of each sensor that has been selected All signals change per second lt lt STATUS gt gt Press ENTER to print 10 06 12 Na 120 55 mV K 12 54 mV Cl 123 45 mV AIR 880 45 mV Next auto calibration time 109 min Figure35B Status Screen 2 b procedure All signals change per second lt lt STATUS gt gt Press ENTER to print Calibration flow rate Analysis flow rate Remaining reagent Figure35C Status Screen 3 5 Press Escl key to quit the Status Screen Flowpath Function Key Press Flowpath key in the Main Screen System will prime air into the analyzer until S line electrode train and W line are empty Once empty screen will display to the Flowpath Screen 1 Figure36 lt lt FLOWPATH gt gt 11 20 51 gt gt Press FLOWPATH key to continue Figure36 Flowpath Screen 1 Either press Flowpath key again while in the Flowpath Screen 1 to prime all fluids into the tubing and return t2. There are two modes of calibration build in Biolyte 2000 Manual Calibration and Auto calibration Manual Calibration To initiate a manual calibration on the Biolyte 2000 press Calibrate key in the Main Screen Auto Calibration The Biolyte 2000 automatically initiates a calibration sequence 30 minutes after POWER ON and approximately every 2 hours thereafter or 2 hours after the last manual calibration To set two point calibration interval see Setting Two point Calibration Interval Maintenance Introduction Maintenance includes both daily and periodic maintenance procedures as well as component replacement non routine maintenance and instrument shutdown start up procedures The daily maintenance procedures should be performed before operating the instrument for the first time each day The periodic maintenance procedures should be also performed according to users scheduled timetables Biolyte 2000 Quick User Manual Revision 0 14 Maintenance Function Biolyte 2000 s maintenance functions shall be operated as described below Input 6 and press Enter key in the Menu Screen to enter the Maintenance Screen Figure42 shows the Maintenance Screen MAINTENANCE gt gt Input No 1 10 06 12 Condition 2 Clean flow path Figure42 Maintenance Screen Reagent info 4 Prime Probe adjustment 6 Cal pump freguency Input 1 46 and press Enter key to select functio
3. Schlauchpumpe Warnung IleptotaAtiuc c Pump IIpoei oro non Pompa peristaltica Warning Pompe p ristaltique Avertissement FUSE T2 H250 Fuse Specification Pojistka Fuse Specification Fuse IIpo urypap amp c Fusibile Specification Fuse Sp cification Biolyte 2000 Quick User Manual Revision 0 22
4. Alarm ON System will alarm when error occurred if it were set ON Table 8 Description of the Message Message Description Ref Means assay concentration is less than reference low limit Ref Means assay concentration is greater than reference high limit Pan Means assay concentration is less than panic low limit Pan Means assay concentration is greater than panic high limit Drift Means E 0 drift is greater than E 0 drift limit NC Means the electrode isn t calibrated Operation Biolyte 2000 Guick User Manual Revision 0 Introduction It includes two parts software description software screen and analysis operation procedures Most display screens and operation procedures are described in this chapter Main Screen Push the Power Switch to ON position to turn the Biolyte 2000 on Power Switch is located at the backside of the Biolyte 2000 see Figure23 After system initiated the screen will change to the Main Screen System Initial 11 20 45 gt gt Setting the flow rate 10 06 12 lt lt CONDITION Na gt gt 10 06 12 gt gt Pull the sampler out then press ENTER key to start gt gt Press ESC key to quit lt lt CONDITION FLOW PATH gt gt 10 06 12 gt gt Pull the sampler out then press ENTER key to start gt gt Press ESC key to quit lt lt CALIBRATION gt gt 10 06 12 Remaining 48 sec Rinse STD A Nat ON K ON amp Cl ON Li OFF 19
5. 6 If operation option ID input is set ON ID must be input If ID is not input when Analyze key is pressed system will show Figure 31 lt lt SAMPLE DATA gt gt OC run control 105206312 You must input ID Figure31 Analysis Warning Screen gt gt Press any key to continue 7 Figure32 shows 4 screens of the Analysis Screen Biolyte 2000 Quick User Manual Revision 0 11 lt lt ANALYSIS gt gt 10 06 12 Remaining 48sec Rinse STD A Na ON K ON CLS ON Li OFF lt lt ANALYSIS gt gt 10 06 12 Next auto calibration time 109 min Na 120 55 mV K 12 54 mV Cb 123 45 mV AIR 880 45 mV Figure32 Analysis Screen lt lt ANALYSIS gt gt 10 06 12 Calibration flow rate 1 6 sec Analysis flow rate 1 6 sec Remaining reagent 100 lt lt ANALYSIS gt gt 10 06 12 Na K Cl Li Slope NC 50 00 50 00 OFF Analysis test number 1 During analysis procedure press Status key to switch between the four Analysis Screens Once sample analysis is finished the printer will automatically print the results During printing an Analysis Concentration Screen Figure33 will appear Once printing is finished the system remains in the Analysis Concentration Screen for 5 seconds or otherwise press any key to automatically return to the Analysis Screen lt lt ANALYSIS gt gt 10 06 12 Item conc Item conc Na NC K 3 12 mmol L C
6. Products previously sold or shipped WHEN ENCOUNTERING ANY QUESTION ARISING FROM DIFFERENT LANGUAGE VERSIONS THE ENGLISH VERSION WILL BE THE PRINCIPAL REFERENCE IF YOU NEED MORE DETAILED INFORMATION PLEASE REFER TO BIOLYTE 2000 REFERENCE MANAUL ALL THE DATA REPORTED FROM BIOLYTE ARE FOR CLINICAL REFERENCE IF ABNORMAL CLINICAL DATA OCCUR THE USERS ARE SUGGESTED TO TAKE FURTHER STUDIES AND EVALUATION OF THESE DATA TO ENSURE CLINICAL SAFETY Assistance from this warranty is available through BioCare Corporation s Customer Service Center during normal business hours Monday through Friday Customer Service Center BioCare Corporation Tel 886 3 2616678 Fax 886 3 2616679 E mail service biocare com tw Biolyte 2000 Quick User Manual Revision 0 19 Warning Messages A E ne 10 11 12 13 The Biolyte 2000 is for indoor use only Do not use the Biolyte 2000 in a manner not specified by BioCare Corporation Do not use the Biolyte 2000 with flammable substances The Biolyte 2000 should not be mounted on a surface of flammable material Take any possible hazards of explosion implosion or release of toxic or flammable gases arising from the materials being heated away from the Biolyte 2000 Use only a fuse and a power supply cord with the same type and rating as specified in the Appendix II User has the responsibility for carrying out appropriate decontamination eg scrubbing with 75 alcohol if hazardous material is
7. TD 2 Sequence tt Acc 4 Diluted urine Yes Name start set change char Figure29B Sample Data Screen for Urine 1 System will clear error message of last analysis and begin calculating analysis time when users press Analyze key 2 Calibration must be done before analysis procedure If the selected electrode statuses are NC the screen will show Figure 30 Press any key to quit analysis procedure lt lt ANALYSIS gt gt 10 06 12 gt gt No calibration data gt gt Please run calibration first Figure30 NC Analysis Screen gt gt Press any key to continue 3 Table 10 shows description options of the Sample Data Screen Table 10 Description Options of the Sample Data Screen Option Description ID 10 characters number or letter Sequence 0 999 auto count by system Acc Accession 0 9999999999 Diluted urine Press Ente key to select Yes or No 20 characters letter 1 PD Patient Name A EI key to move cursor then input information if Press 4 desired To input alphabets under the ID and Patient Name options press and L key to select the desired alphabet 4 If barcode reader has been installed users can read bar code of ID or Acc by barcode reader when the cursor is at position of ID or Acc When read data is out of range system will alarm 5 Press Analyze key to return to analysis procedure
8. The Resolution Set Option lets users specify the number of decimal places that the Biolyte 2000 reports for sodium potassium chloride and lithium results Figure14 shows the Resolution Set Screen with the alternate resolution values 1 The flowchart on the left side of this page is the step by step procedure for Setting Resolution Values lt lt RESOLUTION SET gt gt 08 30 32 NA H23 pi AR Figurel4 Resolution Set Screen 3 Cl 123 4 Li 1 23 gt gt Press Enter key to change 123 12 3 2 Usel JD keys to move the cursor and press Enter key to change the number of decimal places 3 After setting the resolution values press Esc key twice to return to the Menu Screen Table 5 Resolution Options for Analytes Resolution Analyte 1 mmol L 0 1 mmol L 0 01 mmol L Na X X K X X cr X X Li X Setting Two point Calibration Interval The 2 Pt Calibration Setup Option lets users specify the two point calibration interval for Biolyte 2000 Figure15 shows the 2 Pt Calibration Setup Screen 1 The flowchart on the left side of this page is the step by step procedure for setting two point Calibration Interval lt lt 2 PT CALIBRATION SETUP gt gt 11 20 51 Calibration interval 2 hour Figure 15 2 Pt Calibration Setup Screen gt gt Range 1 12 hour 2 Input the number 1 12 and press Enter key to set the two point calibration interval 3 After
9. can press JSamp Type key in the Main Screen Figure25 shows the Sample Type Set Screen lt lt SAMPLE TYPE gt gt Input No 1 11 20 51 1 Serum Plasma 2 Whole blood Figure25 Sample Type Set Screen 3 Urine 4 CSF gt gt Sample Type Serum Plasma gt gt Sample Type Serum Plasma means the selected sample type at present Input 1 4 and press Enter key to change sample type or press Esc key to return to the Main Screen When sample type is changed the calibration status of Biolyte 2000 will change to NC Recalibrate must be done before proceeding to analysis procedure When sample type change to urine system will display the HELP FOR URINE SAMPLE screen for analyze urine sample analyses Figure26 V VVWV lt lt HELP FOR URINE SAMPLE gt gt 11207351 1 Dilute one part urine sample with two parts diluent Part No 1030072 2 Use diluted sample to run ANALYZE Figure26 Help for Urine Sample Screen Calibrate Function Key Users can press Calibrate key in the Main Screen Figure27 shows 4 screens of the Calibration Screen lt lt CALIBRATION gt gt 10 06 12 Remaining 48sec Rinse STD A Na ON K ON El ON Li 2 OFF lt lt CALIBRATION gt gt 10 06 12 Next auto calibration time 109 min Na 156 42 mV K 12 54 mV ee sree ay BIB ROPBODOIONV Figure27 Calibration Screens lt lt CAL
10. if left uncorrected or as corrective actions in response to inappropriate or incorrect procedures Cleaning the Sample Inlet Port See Cleaning the Sample Inlet Port in the earlier section Cleaning the Probe The probe cleaning procedure is recommended when a gradual increase in flow times is observed This cycle takes place with the sampler in the manual position During the probe cleaning cycle Cleaning Solution is aspirated from a sample cup into the electrode carrier At the end of the cycle the Cleaning Solution flushes into the waste bottle Complete the following steps to clean the probe Pull the sampler up to the manual position Fill the sample cup with 1ml of CLEANING SOLUTION Part No 1030012 See Clean Flow Path in the earlier section of this chapter for details Recondition the flow path with serum see Daily Maintenance Procedures and recalibrate before proceeding to control and specimen assays Replacing the Reagent Pack Replace the reagent pack and septum when the reagent pack has expired or is empty Note 1 All fluids in tubing are infectious thus must be handled with care Wear gloves if necessary 2 Septum must be replaced together with the reagent pack Replacing the reagent pack and RMS 1 When the reagent pack has expired or is empty system will show Figure49A and start emptying all standard solutions IA lt lt CHANGE REAGENT PACK gt gt 10 06 12 Reagent pack has expired gt gt Emptying
11. set the panic values After setting the panic values press Esc key 3 times to return to the Menu Screen Tf the input number is larger than 1000 Biolyte 2000 will alarm and return to the previous value Tf the analysis data is out of the range of panic values Biolyte 2000 will automatically mark lt Pan or gt Pan The Resolution of the panic values depends on Resolution Set HN t Setting Offsets Values The Offsets option lets users enter slope and intercept values for each analytical parameter so that users can correlate results from the Biolyte 2000 with other instruments in users lab Figure21 shows the Offsets Screen 1 The flowchart on the left side of this page is the step by step procedure for Setting Offsets lt lt OFFSETS gt gt 11 20 51 lt Serum gt Slope Int Slope Int Figure 21 Offsets Screen Nat 1 00 0 00 K 1 00 0 00 Cl 1 00 40 00 Lit 1 00 0 00 2 Press Samp Type key to change sample types Note Serum indicates for both serum and plasma samples and WB indicates for whole blood samples Use KID IAI keys to move the cursor Input the number of slope or intercept Press Enter key to change the sign of intercept After setting the slope and intercept press Esd key 3 times to return to the Menu Screen Table 6 shows the range of slope amp intercept ANA Table 6 Range of Slope and Intercept Sl
12. the septum counterclockwise 1 4 turn and remove it from the sampler as shown in Figure50 left 12 Discard the old septum 13 Slide the new septum over the probe and turn it clockwise 1 4 turn to lock it into place as shown in Figure50 right 14 Connect the A line and B line to the new septum 15 Insert the tubing harness straws into the appropriate bottles of the reagent pack Figure50 Replacing the Septum A Septum 16 Press Calibrate key to start full priming and system will show Figure49E lt lt CHANGE REAGENT PACK gt gt 10 06 12 New reagent pack Figure49E Change Reagent Pack Screen 5 gt gt Full priming 17 After full priming system will do auto calibration 18 Close the analyzer door Installation of Thermal Paper This section does not only explain installation of thermal paper but also explain the replacement of thermal paper Users can install replace thermal paper according to the following procedures 1 Open the printer cover 2 Gently remove the old roll of paper 3 Install a new roll of paper into the chamber 4 Insert the tip of the thermal paper into the paper inlet of the printer 5 Press the ON LINE key on the top of the Biolyte 2000 once to turn off the ON LINE light indicator then press the Feed key several times until the tip of the paper roll goes out through the outlet 6 Pull the paper and center it 7 Press the ON LINE key once to turn on the ON LIN
13. uso diagnostico in vitro Pour le Diagnostic In Vitro mn European Conformity Evropsk shody European Conformity Evponaikr Evuu ppoon Conformita europea Conformit europ enne Manufactured by Vyroben Hergestellt durch Katackev Letoal ad Prodotto da Fait par Authorized Representative Opravn ny zastupce Authorized Representative EvtoA050y0c Rappresentante autorizzato Repr sentant autoris Catalog Number Katalogov c slo Katalog Zahl Apis kaTad yov Numero di catalogo Catalog Number Lot Number slo ar e Lot Nr ApWu cs zopc oc Numero di lotto Num ro de lot Use by YY Y Y MM DD Pouzit RRRR MM DD Verwendung von JJJJ MM DD Xpnjon and EEEE MM HH Uso da parte di AAAA MM DD L utilisation de AAAA MM JJ K b E HE Temperature Limit Mezn teplota Temperaturgrenze Oepuoxpoo o Opto Temperatura limite Limite de temp rature Biolyte 2000 Quick User Manual Revision 0 21 Consult Instructions for Use Konzultovat N vod k pouziti Consult Instructions for Use 2vuBovlevtelte tic o ny ec xphons Consultare le istruzioni per l uso Consulter les instructions d utilisation Biological Risks Biologick rizika Biologische Risiken BioAoytkot kivdvvot Rischi biologici Risques biologiques Grounding Uzemn n Erdung T e oon Messa a terra Grounding gt 6B E Peristaltic Pump Warning Peristaltick Cerpadla Upozorn n
14. 1 20 51 FER nee HOP DOW High Figure 19 Reference Set Screen 1 Na 136 146 LETRAS SO 5 0 Sa CL 98 106 4 Li 0 50 1 20 Press lSamp Type key to change sample types Note lt Blood gt means serum plasma or whole blood Use LD JAI EF keys to move the cursor Input the number 0 00 999 and press Enter key to set the reference values After setting the reference values press Esc key 3 times to return to the Menu Screen If the input number is larger than 1000 Biolyte 2000 will alarm and return to the previous value Tf the analysis data is out of the range of the reference values Biolyte 2000 will automatically mark lt Ref or gt Ref The resolution of the reference values depends on Resolution Set SOV eRe Qk Setting Panic Values The Panic Set Option lets users define the panic values of Biolyte 2000 Figure20 shows the Panic Set Screen 1 The flowchart on the left side of this page is the step by step procedure for Setting Panic Values lt lt PANIC SET gt gt 11 20 51 lt Blood gt Low High Low High lue Bo 200 DUM E Figure 20 Panic Set Screen 3 K 60 200 4 Li 0 10 Note 1 lt Blood gt means serum plasma or whole blood 2 Only the panic values of serum plasma and whole blood can be set 2 Use KID IAIE keys to move the cursor Biolyte 2000 Quick User Manual Revision 0 7 Input the number 0 00 999 and press Enter key to
15. 99 05 04 lt lt Biolyte gt gt 11120351 Sample Type Serum Plasma Status Na K Cl Ready Figure23 From System Initial Screen to Main Screen Table 9 describes the status in the Main Screen Table 9 Status Description in the Main Screen Status Description Parameter ready Indicates that the electrode s is ready and analysis can proceed Not ready Must perform calibration before proceeding to analysis Flow path Must perform Flow Path procedure before proceeding to other options In the Main Screen users can use the waiting function keys as following Start Standby Samp Type Calibrate Analyze Menu QC Status Flowpath Start Standby Function Key Users can press Start Standby key in the Main Screen Figure24 shows the Standby Screen lt lt STANDBY gt gt Figure24 Standby Screen gt gt Press START key to continue 1 In the Standby Screen users only can use Start Standbyl function key 2 Under the Standby Mode during auto calibration no calibration is carried out instead system will rinse STD A for 5 seconds and REF for 2 seconds 3 After pressing the Start Standby key system will run flush procedure and then return to the Main Screen Note After a power failure when the electricity return reload back to the previous standby or normal mode Biolyte 2000 Quick User Manual Revision 0 Samp Type Function Key Users
16. Biolyte 2000 Quick User Manual id BioCare Corporation BioCare 4F No 12 Lane 5 Sec 2 Nanshan Rd Lujhu Township Taoyuan County Taiwan Tel 886 3 2616678 Fax 886 3 2616679 Biolyte 2000 Quick User Manual Revision 0 1 Preface Intended Use The Biolyte 2000 is intended for in vitro diagnostic use by healthcare professionals in the quantitative determination of sodium potassium chloride or lithium option in whole blood serum and plasma sodium potassium and chloride in whole blood serum plasma urine and CSF All the data reported from the Biolyte 2000 are for clinical reference If abnormal clinical data occur further studies and evaluation of these data are suggested to ensure clinical safety Intended Audience The Biolyte 2000 Quick User Manual is written for healthcare professionals who operate the Biolyte 2000 Users do not need prior experience with BioCare products but should have been trained on the instrument by BioCare s designated personnel This manual simply describes the Biolyte 2000 and explains how to test samples with them If you need more detailed information please refer to Biolyte 2000 reference manaul Technical Assistance For technical assistance call BioCare Corporation s Customer Service Center at 886 3 2616678 Description Installing the Biolyte 2000 Users must complete the following steps to install the Biolyte 2000 Some procedures may not apply to all instruments Un
17. E light indicator 8 Close the printer cover Tf the printer fails to print after a new roll of paper is installed investigate the following causes O Tf the loose end feeds from the top of the roll the roll of paper is installed upside down Remove the roll turn it around and install it so the loose end feeds from the bottom of the roll O The printer paper is jammed Check that the part number of the paper Part No 5020097 is correct for the Biolyte 2000 s printer O After installing the thermal paper check the ON LINE light indicator If the ON LINE light indicator is off press the ON LINE Key once to turn on the ON LINE light indicator If the above mentioned are checked and none of them is the cause of the printer failure power off the Biolyte 2000 and try power on again Biolyte 2000 Quick User Manual Revision 0 17 Shutdown Use the following shutdown procedures to prevent salt buildup in the flow path when the Biolyte 2000 is turned off or unplugged Note All fluids in tubing are infectious Thus they must be handled with care Wear gloves if necessary Open the analyzer door 2 Remove A B and R straws from their reagent bottles in the reagent pack Leave the W tubing in the waste container Wipe each straw dry as it is lifted out of the bottles to prevent cross contamination 3 Leave A B and R straws exposed to the air 4 From the Menu Screen press 6 to access the Maintenance Screen 5 Select the Prime f
18. IBRATION gt gt 10 06 12 Calibration flow rate 1 6 sec Analysis flow rate 1 6 sec o Remaining reagent 100 lt lt CALIBRATION gt gt 10 06 12 Na K CIs Li Slope 50 00 50 00 50 00 OFF Analysis test number 1 System will start to calculate calibration time when Calibrate key has been pressed During calibration procedure press Status key to switch between the four Calibration Screens At the end of calibration system will set and calculate next auto calibration time Tf calibration procedure is interrupted system will rinse the flow path with STD A and REF At the end of calibration system will printout Figure28 AE Biolyte 2000 Quick User Manual Revision 0 10 1999 04 28 133237312 Na 50 0 50 7 66 8 NC lt 1 Figure28 Printout of Calibration Item STD A mV STD B mV lt lt 2 Na 120 55 75 26 K 56 28 98 58 CL 123 45 78 02 1 NC Means that the sensor is not calibrated 2 MV Print must be set ON in the Operation Option for system to print this message Analyze Function Key Users can press Analyze key in the Main Screen Figure29A and Figure29B show the Sample Data Screen SAMPLE DATA gt gt OC run control 10 06 12 E 3 d GRUD A Figure29A Sample Data Screen for Serum Plasma cya Whole Blood and CSF Name lt start set change char SAMPLE DATA gt gt OC run control 10 06 12
19. all standard solutions Figure49A Change Reagent Pack Screen 1 gt gt Press ESC key to quit Biolyte 2000 Quick User Manual Revision 0 16 lt lt CHANGE REAGENT PACK gt gt 10 06 12 Reagent pack has expired Figure49B Change Reagent Pack Screen 2 Please disconnect tubing A B R then press ENTER key to empty tubing 3 Open the analyzer door 4 Remove A B and R straws from their reagent bottles in the reagent pack Leave the W line in the waste bottle Wipe each straw dry as it is lifted out of the bottles to prevent cross contamination Leave A B and R straws exposed to the air 5 Press Enter key to empty tubing and system will show Figure49C lt lt CHANGE REAGENT PACK gt gt 10 06 12 Reagent pack has expired Emptying tubing gt gt Press ESC key to quit Figure49C Change Reagent Pack Screen 3 6 After emptying all tubing system will show Figure49D lt lt CHANGE REAGENT PACK gt gt 10 06 12 Reagent pack has expired gt gt Please replace a new reagent pack then press CALIBRATE key to start Figure49D Change Reagent Pack Screen 4 7 Remove the W straw from the waste bottle Wipe it dry with a tissue 8 Turn off the power then remove the old reagent pack and the old RMS 9 Place the new reagent pack onto the fluids deck and plug the new RMS into the RMS port Replacing the septum 10 Disconnect the A line and B line from the old septum 11 Turn
20. ate or time is invalid system will display a warning message Invalid on line 1 of LCD see Figure17 lt lt DATE TIME SET gt gt Invalid 11 08 08 KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK KKK KK 1999 02 30 15 46 20 Figure 17 Date Time Set Invalid Screen KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK KKK 5 Users must reset if Invalid appears Setting Results Printer The Results Set Option lets users define the reference values panic values and offsets values Figure18 shows the Results Set Screen 1 The flowchart on the left side of this page is the step by step procedure for accessing the Results Set Screen RESULTS SET gt gt Input No 1 120351 Figure 18 Results Set Screen Reference set 4 Printer OFF Panic set Offsets 2 Input 1 4 and press Enter key to select function or press Esc key twice to return to the Menu Screen 3 The default value of printer is OFF Please input 4 and press Enter key to turn printer on 4 Printer OFF function is designed for end user who is able to analyze samples if the printer is defective This is a temporary action please replace related parts as necessary Setting Reference Values The Reference Set Option lets users define the reference values of Biolyte 2000 Figure19 shows the Reference Set Screen 1 The flowchart on the left side of this page is the step by step procedure for Setting Reference Values lt lt REFERENCE SET gt gt 1
21. atory should establish and maintain its own reference intervals based on its patient population Table 3 Reference Intervals Serum Urine 24hr Whole Blood CSF Sodium 136 146 mmol L 60 220 mmol day 136 146 mmol L Potassium 3 5 5 0 mmol L 1 0 10 0 mmol day 3 5 5 0 mmol L Chloride 98 106 mmol L 60 200 mmol day 98 106 mmol L 118 132 mmol L Lithium 0 5 1 20 mmol L Display Range for Analytes The following display ranges are used by the Biolyte 2000 to check for result range errors low or high if the concentration of an analyte falls outside the range for a specimen sample type the specimen cannot be tested for that analyte Table 4 Display Range by Sample Type Analytes Serum Plasma Whole Blood CSF Urine Sodium 60 200 mmol L 40 400 mmol L Potassium 1 0 10 0 mmol L 3 300 mmol L Chloride 60 200 mmol L 60 200 mmol L 40 400 mmol L Lithium 0 1 5 0 mmol L Biolyte 2000 Quick User Manual Revision 0 5 Set Up Introduction The Biolyte 2000 s Set Up options let users define the instrument s operating parameters to accommodate users laboratory s testing needs To access the Set Up Screen Figurel1 from the Menu Screen Figurel1 input 1 and press Enter key SETUP gt gt Input No 1 10 06 12 Test select 2 Units setting Resolution set 4 2 Pt cal setup Date Time set 6 Results settings Figure 11 Set Up Screen Set Up Options in Menu Selecting Electrodes Use this function to
22. cording to the instructions that appear later Cleaning the Sample Inlet Port 1 Pull the sampler up to the manual position 2 Clean the sample inlet port with a cotton swab moistened with deionized water Note If whole blood is analyzed freguently clean the sample inlet port more often Conditioning Na Electrode Press Menu key and input 6 Input 1 and press Enter key to select function to do conditioning Na electrode Conditioning the Flow Path with Serum Press Menu key and input 6 Input 1 and press Enter key to select function to do the flow path with serum Checking Slope amp Flow Time Calibrate the instrument if electrode conditioning has just been performed Calibration is initiated by pressing Calibrate key Checking the Electrode Slope Press Status key repeatedly until the Status Screen 3 Figure35C appears This screen displays the slope of the last calibration Checking the Flow Time Flow time measures the time it takes for fluid to travel from the tip of the probe to the air detector Press Status key repeatedly until the Status Screen 2 Figure35B appears This screen displays the flow times during the last calibration and analysis cycles as well as their acceptable ranges Periodic Maintenance Periodic maintenance procedures must be performed according to users scheduled timetables to assure optimal instrument performance Unless otherwise indicated the flow path maintenance cycle must be initiated be
23. ctrodes inside Pump Sampler Probe inside Fluids Deck Electrode Carrier The electrode carrier Figure8 houses the analytical components that measure analyte concentrations in a sample electrodes a reference electrode a spacer and an air detector Each measuring electrode quantities a specific analyte It includes the measuring Figure8 Electrode Carrier Electrode Carrier Measuring Electrodes During an analysis or calibration fluid fills the electrode carrier and each electrode generates an electrical potential or current in proportion to the amount of its specific analyte in the fluid Then the microprocessor calculates the concentration of each analyte in the fluid based on the output of each electrode Reference Electrode The reference electrode supplies a continuous electrical potential in contrast to a measuring electrode The reference electrode s potential varies with each particular sample Because electrical potential can only be measured in comparison to a known voltage the Biolyte 2000 uses constant voltage supplied by the reference electrode to measure the potential produced by each measuring electrode Air Detector The air detector is located below the potassium electrode and has 2 functions it verifies the presence of air or fluid in the electrode train The microcomputer monitors the air detector so that it knows when to stop the pump from aspirating a fluid once it fills the electrode train Wh
24. e power input module is located where the power cord connects to the Biolyte 2000 8 Confirm the availability of appropriate fuse for the required voltage See Table 1 below for the fuse that is required for the Biolyte 2000 Power Switch cm OFF Position c Fuse Socket Power Input Module Figurel Power Input Module and Fuse Socket y A Fuse Requirement 100 240 0 6 2 0A SB T2 0A 250V _ __ Press the Locking Lever Down to Open Position Assembling and Installing Electrode gt 9 Remove the electrodes and electrode carrier from the packing material 10 Place the electrode carrier on the table with the locking lever pointing towards the installer Press the locking lever down to its Open position see Figure 2 Figure2 Open Position 11 Insert each electrode into the electrode carrier as follows A Insert the electrode with the pins facing up and to the left side of the electrode Note that the gasket placement of each electrode except for the spacer will be towards the top B Align the lip of the electrode to the guide rails at the side of the electrode train Slide in the electrodes from the bottom towards the top of the electrode train C Install the electrode in the following order Spacer Reference Electrode Chloride Electrode or Lithium Electrode Sodium Electrode Potassium Electrode and Air Detector see Figure 3 D The electrode
25. een System will enter the Menu Screen Input 5 and press Enter key to run diagnostic procedures Then press B and press Enter key in the Diagnostic Screen to access the Air Detector Test function Flow Path Check For troubleshooting purposes the flow path has been divided into the following 6 sections W line Check S line Electrode Carrier Check Probe Check A line amp B line Check R line Check Septum Check DO OS If you have determined the exact location of a flow problem troubleshoot only that section of the flow path in which the problem originates If you have been unable to locate the source of the problem troubleshoot the flow path in the recommended order to avoid duplicating steps Investigate and correct each section completely before proceeding to the next one Discontinue the flow path check as soon as the flow problem has been eliminated Warranty of Products The Products manufactured by BioCare Corporation hereinafter called BioCare are warranted against defects in materials and workmanship prior their expiration date The Instrument of Products is covered by a Warranty Period of 12 months warranty from the date of delivery BioCare s liability under this warranty is limited at the option of BioCare for repair or replacement of the product Item expendable through normal use is not covered by this warranty All warranty repair or replacement of parts shall be limited to instrumen
26. en the air detector takes a reading during an analysis it knows whether it is detecting air or fluid The air detector is an optical sensor that can detect air and fluids Keypad The keypad Figure9 is located on the left front side of the Biolyte 2000 and contains both numeric and function keys AU 00O fs Figure9 Keypad 4 990 ds S Calibrate cupa ac Esc Enter Analyze Table 2 The Function Keys Key Function Analyze Initiates a specimen analysis or restart an interrupted analysis Calibrate Initiates a 2 point calibration Delete characters on an input screen Enter A select highlighted number of data initiates sequences and selects options The Enter key transfers data from the screen to the microcomputer Esc Aborts procedures and calls up the previous screen Accesses the Main Screen Interrupts an analysis Flowpath Begins and ends a flow path maintenance sequence Menu Displays the Main Screen from the sensor Status Screen QC Accesses QC functions Samp Type Displays the Sample Type Set Screen Status Displays the Full Sensor Status Screen and the Biolyte 2000 Status Screen Biolyte 2000 Quick User Manual Revision 0 Start Standby Makes the screen of Biolyte into Standby Mode Press again to return to Main Screen Liquid Crystal Display LCD The Biolyte 2000 uses 40 characters 4 lines LCD screen The Biolyte 2000 s main screen is sh
27. fore the start of any maintenance procedures The flow path maintenance cycle purges the flow path of fluid and holds the instrument in an idle state while it is being serviced Flow Path Maintenance Cycle To initiate the Flow Path Maintenance Cycle press the Flowpath key once in the Main Screen Or users can use Prime function and select ATR to empty flow path Replacing the W line Figure43 shows the location of the W line W line Biolyte 2000 Quick User Manual Revision 0 15 Replacing the R line Figure44 shows the location of the R line R line K Replacing the S line Figure45 shows the location of the S line S line Replacing the A line B line Figure46 shows the location of the A line and B line O 3 A A ton e pom li Ref Waste StdB StdA PORE Replacing the Probe Ly Figure47 shows the location of Probe B line Probe Electrode Spacer with the W port inserted through the top hole of the electrode carrier Reference Electrode with the R port pointing to the right gt Chloride Electrode or Lithium Electrode Sodium Electrode Replacing the Electrodes Figure48 shows the Electrode Carrier Potassium Electrode Air Detector Non routine Maintenance Non routine maintenance procedures are performed in response to trends in instrument operation that may generate error codes
28. l 100 2 mEq L Li OFF Figure33 Analysis Concentration Screen 10 11 gt Unit and resolution depend on Set Up set gt OFF Means that sensor is not being selected Tf the analysis procedure is interrupted system will rinse the flow path with STD A and REF At the end of analysis system will print results as shown in Figure34 Note For QC analysis press loc instead of Analyze key 1 2 3 4 1999 04 28 13723712 lt lt Analysis gt gt Figure34 Printout of Analysis SAMPLE ID A122113994 Access tt 1221159940 Name S M WU Sequence 1 Analyze Date 1999 04 28 Analyze Time 13 24 10 Sample Type Serum Plasma Item Concentration Message 1 Na NC E Q K 3 12 mmol L l 100 2 mEq L Drift K xGo mm x 4 Item STD A mV Sample mV Na 7120755 cU 26 K 56 28 98 58 Cl 123 45 78 02 Message Print must be set ON in the Operation Option for system to print this message NC Means that the sensor is not calibrated Drift Means that the voltage of STD A taken during analysis is too large compared with the voltage of STD A during calibration MV Print must be set ON in the Operation Option for system to print this message Biolyte 2000 Guick User Manual Revision 0 12 Status Function Key The Status Screen can call up in any screen by pressing the Status key Figure 35A B C shows the Status Screens
29. n or press Esc key to return to the Menu Screen Table 11 shows the description of Maintenance Options Table 11 Description of Maintenance Options Option Description Condition Running procedures for conditioning sodium electrode and flow path Clean flow path Running procedures for cleaning flow path Reagent info Showing the information of the reagent pack Prime Running procedures for priming the selected solution or air Probe adjustment Adjusting the probe position Cal pump freguency Calibrating pump freguency Daily Maintenance The following maintenance procedures must be performed before users use Biolyte 2000 for the first time each day Check the reagent pack level Clean the sample inlet port Condition Na electrode Condition the flow path with serum Check the slope and flow time eeeee Note 1 BioCare recommends conditioning Na electrode and flow path before daily operation Users must calibrate the instrument if electrode conditioning has just been performed 2 All fluids in tubing are infectious thus must be handled with care Wear gloves if necessary Perform the following steps to complete the daily maintenance procedures Checking the Reagent Pack Level Press Status Key repeatedly until the Status Screen 2 appeared Figure35B This screen shows the amount of the most consumed fluid that is left in the reagent pack When it shows that the reagent pack is empty replace the reagent pack ac
30. nd a full description of the circumstances giving rise to the claim Before any Products are returned for repair and or adjustment written authorization from BioCare or its authorized representative for the return and instruction as to how and where these Products should be returned must be obtained Any Products returned to BioCare for examination shall be sent freight prepaid via the means of transportation indicated as acceptable to BioCare BioCare reserves the right to reject any warranty claim not promptly reported and any warranty claim on any item that has been altered or has been returned by non acceptable means of transportation When any product is returned for examination and or inspection or for any other reason the customer shall be responsible for all damage resulting from improper packing or handling and for loss in transit notwithstanding any defector nonconformity in the product In all cases BioCare has the sole responsibility for determining the cause and nature of the failure BioCare s determination with regard thereto shall be final If it has been found that the Products has been returned without cause and is still serviceable the customer will be notified and the Products returned at its expense in addition a charge for testing and examination may be made to the Products so returned BioCare reserves the right to change alter modify or improve any of its Products without any obligation to make corresponding changes to any
31. nger tightens the locking screw onto the sampler arm lt Probe Figure5 Install the Probe Installing the Tubing 21 Connect 1 end of the S line Sample Tubing to the down side of the electrode carrier and thread the other end to the probe 22 Loosen the pump Insert the W line Waste Tubing into the pump The yellow collar must be detained at the left pump bracket Fasten the pump Connect the W line to the top of the electrode carrier Thread the W line into place inside of the waste valve Attach the fitting on the reagent harness 23 Connect the R line Reference Tubing to the left hand side of the electrode carrier Thread the R line into place inside of the reference valve Attach the fitting on the reagent harness 24 Connect the A line STD A Tubing and B line STD B Tubing to the septum Attach the fitting on the reagent harness lt er Cp E J FLU Figure6 Install tubing Installing the Reagent pack 25 Unscrew the bottle caps of all reagents and the waste bottle 26 Place a reagent pack half way onto the fluid deck 27 Insert the tubing harness straws into the appropriate bottles 28 Push the reagent pack all the way in 29 Check all tubing connections Incorrect installation may result in backward flow and contamination of reagent packs 30 Plug the RMS into the RMS port See Figure7 for the location of the RMS port Powering on the Instrument 31 Insert the female end of the power cord in
32. o the Main Screen Figure 3 1 or system will automatically prime all fluids after one hour of idling Before priming all fluids into the tubing system will beep 10 times once per second and display the Flowpath Screen 2 Figure37 To stay at flowpath mode or empty tubing press Esq key during these 10 seconds lt lt FLOWPATH gt gt 11 20 51 Figure37 Flowpath Screen 2 gt gt Press ESC key to stay at flowpath mode gt gt Press FLOWPATH key to continue Menu Function Key Press Men key in the Main Screen to enter Menu Screen Figure38 shows the Menu Screen MENU gt gt Input No 1 1172001 Setup 2 Operation Data 4 Software version Diagnostic 6 Maintenance Figure38 Menu Screen ON and press Enter key to select function or press Esd to return to the Main Screen Input 1H Software Version E Diagnostic When Menu key was pressed in the Main Screen system will enter the Menu Screen Input n and press Ente key in the Menu Screen to enter the Software Version Screen Figure 39 shows the Software Version Screen lt lt SOFTWARE VERSION gt gt 10 06 12 Main program version Figure39 Software Version Screen Test program version Biolyte 2000 Quick User Manual Revision 0 13 Biolyte 2000 Operation This prologue contains shortcut instructions for running samples The Biolyte 2000 is a sophisticated instrument with many operating functi
33. ons and convenient user features This chapter explains in detail how to operate the Biolyte 2000 However the Biolyte 2000 is also designed to accommodate users need to run analyses quickly and simply without using all of the offered functions The following operation shortcuts allow users to analyze samples quickly without altering the instrument s set up parameters Shortcut Procedures The shortcut procedures are as shown on Figure40 ON Electrodes Selecting Analysis Mode Set Sample Type Figure40 Shortcut Procedures Note The Shortcut Procedures are for reference use only For more detailed information please refer to the respective sections in this Reference Manual Power On See Powering on the Instrument Description Figure1 Selecting Electrodes See Selecting Electrodes Set Up Figure12 Set Sample Type See Samp Type Function key Set Up Figure25 Selecting Analysis Modes There are 2 analysis modes build in Manual Mode and Semi Auto Mode User can position the arm straight to operate Semi Auto Mode lift up the arm to operate Manual Mode The instrument has auto sensor to distinguish the 2 modes automatically Figure 41A 41B DOO UuUtut SS SS Figure41A Semi Auto Mode Figure41B Manual Mode A Note Place the sample cup carefully to avoid any possible spills when using the Semi Auto Mode Calibration Press Calibrate key in the Main Screen to run calibration procedures
34. ope Intercept 0 8 1 2 18 0 0 7 1 3 10 0 0 8 1 2 10 5 0 7 1 3 1 0 Setting Operation Options The Operation Options allow users to set the analysis result and alarm option Figure 22 shows the Operation Screen 1 The flowchart on the left side of this page is the step by step procedure for Setting Operation Options lt lt OPERATION gt gt 11 20 51 1 Patient copy 0FF 2 ID required OFF Figure 22 Operation Screen 3 Calib print ON 4 MV print OFF 5 Mess print ON 6 Alarm ON Use PJA keys to move the cursor and press Enter key to switch the operation options ON or OFF After setting the operation options press Esd key to return to the Menu Screen Table 7 shows the description of the operation options Table 8 shows the description of the message Une Do Table 7 Description of the Operation Options Option Default Set Description Patient copy OFF Biolyte 2000 will print two analysis results if it were set ON ID required OFF Users must input ID before analysis procedure if it were set ON Calib print ON Biolyte 2000 will print the calibration result after calibration if it were set ON MV Print OFF Biolyte 2000 will print results of analysis amp calibration including voltage of signals if it were set ON Mess Print ON 1 Biolyte 2000 will print results including worry message if occurred if it were set ON 2 Table 2 3 shows the worrying messages
35. own in Figure10 1999 05 04 lt lt Biolyte gt gt 115207304 Sample Type Serum Plasma Status Not ready Figure 10 Main Screen The main screen contains the following information the currents date and time sample type and status Acceptable Samples The following chart lists acceptable sample types for the different parameters measured PARAMETER _ SPECIMEN MATRIX Sodium Serum plasma whole blood or urine Potassium Serum plasma whole blood or urine Chloride Serum plasma whole blood urine or CSF Lithium Serum plasma whole blood Sample Handling Requirement Because the specimens have biohazard and infect users have to wear glove during all analysis process Proper sample handling is critical to ensure that values obtained accurately reflect the in vivo state Ensure that all samples have been obtained and stored following consistent clinically accepted protocols The following is a discussion of general guidelines in reference to sample collection handling requirements for the Biolyte 2000 The NCCLS Approved Guideline on Procedures for the Handling and Processing of Blood Specimens indicates that serum or plasma should be physically separated from contact with cells as soon as possible to a maximum time limit of 2 hours from the time of collection It is also recommended that a contact time of less than 2 hours be established for serum or plasma sample intended for potassium analysis Reference Intervals Each labor
36. packing the Biolyte 2000 and accessory boxes Confirming voltage range Assembling and installing electrodes Installing the septum Installing the probe Installing the tubing Installing the reagent pack Powering on the instrument Preparing the printer Conditioning electrodes and flow path Performing instrument calibration VVVVVVVVVVV The Biolyte 2000 weighs approximately 26 lbs 12 kg without reagent pack BioCare recommends that at least 1 person help to remove the instrument from its shipping carton and place it on the counter Complete the following steps to install and assemble the instrument Unpacking the Biolyte 2000 and Accessory Boxes 1 Inspect the boxes for any shipping damage Contact BioCare if necessary 2 Put the box facing up Open the top lid of the carton box Take out the accessory box 3 Open the accessory box and check its contents with the enclosed packing list before proceeding with the installation Contact BioCare if users are missing users parts 4 Remove the top foam end cap Gently remove the Biolyte 2000 from the carton box and place it on the counter 5 Remove the reference manual and the power cord from the carton box Confirming Voltage Range 6 The power input module permits the Biolyte 2000 to run at 0 6A 100 240VAC 7 Confirm that the voltage of users laboratory is in the range of Biolyte 2000 s specification Turn the instrument around in order to view the backside Th
37. ransport fluids throughout the Biolyte 2000 When multiple error codes occur resolve the flow problems before troubleshooting the remaining error codes In most cases the accompanying errors are resolved along with the flow problems Error codes that remain unresolved after flow problem has been corrected must be investigated individually Do not replace any flow path components until you resolved the flow problems unless instructed to do so during the flow path check Troubleshooting Procedure The recommended troubleshooting procedure consists of a series of steps that are designed to resolve a malfunction in the most direct and logical way The following approach is used 1 Eliminate obvious causes 2 Troubleshooting individual error codes and groups of error codes by first eliminating flow problems Then resolve any remaining error codes Proceed as follows to troubleshoot malfunction 1 First eliminate all obvious problems that may have caused the malfunction a Investigate and correct if necessary the following possibilities Unplugged electrode O Disconnected tubing or septum O Empty reagent pack O Incorrectly connected reagent pack b Perform a calibration to determine if all calibration errors have disappeared If the calibration errors have disappeared perform an analysis to determine if the analysis errors have also been resolved d Ifresolved the troubleshooting procedure is now completed If either calibration or analy
38. s are keyed so users cannot install them upside down Biolyte 2000 Quick User Manual Revision 0 2 Note Make sure there is a sealing gasket between each of the electrodes in the carrier gt Electrode Spacer with the W port inserted through the top hole of the electrode carrier gt Reference Electrode with the R port pointing to the right Chloride Electrode or Lithium Electrode Figure3 Electrode Carrier with Installed Electrode Sodium Electrode vv v Potassium Electrode Air Detector v 12 Engage the locking lever at the bottom of the carrier to secure all the electrodes in the carrier The lever should be in its Closed position 13 Align the connector pins on the electrode and the electrode carrier with the receptacles on the instrument 14 Gently push the electrode carrier into place on the Biolyte 2000 pressing from the bottom and the top simultaneously Installing the Septum 15 Remove a septum from the reagent pack 16 Lift the sampler to the manual position and install the septum into the bayonet lock located on the under surface of the sampler Turn the septum clockwise 1 4 turn to lock it in place A Figure4 Install the Septum Septum Installing the Probe t 17 Open the analyzer door 18 Unscrew the locking screw from the top of the sampler arm 19 Insert the long end of the probe through the sampler arm and into the septum 20 Slip the locking screw over the short end of the probe Fi
39. setting the two point calibration interval press Esc key twice to return to the Menu Screen 4 If the input number is larger than 12 Biolyte 2000 will alarm and return to the previous value Biolyte 2000 Quick User Manual Revision 0 6 Setting Date and Time The Biolyte 2000 displays the date and time on each screen and on every printout Users must enter the date and time when the instrument is first powered up users can change it at any time The internal clock has a battery that will maintain the correct date and time during long power outages Figure 16 shows the Date Time Set Screen Complete the following steps to change the date and time Note The Biolyte 2000 displays time in military units i e 1 00PM 13 00 1 The flowchart on the left side of this page is the step by step procedure for Setting Date and Time lt lt DATE TIME SET gt gt 11 08 08 CK CK CK CK CK CK AAA AAA AAA AAA AAA AAA Ck Ck Ck AAA A Figure 16 Date Time Set Screen SE 1999 03 30 15 46 20 i KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK ckckckckck On the Date Time Set screen a blinking cursor appears next to the first date field 2 At the cursor input a digit Once input cursor automatically jumps to the next digit 3 Use UD keys to move the position of cursor to the desired place and use numerical key to input date or time Then at the end of the input press Esc key twice to return to the Menu Screen 4 When the input d
40. sis errors codes persist proceed to Step 2 to continue o 2 Troubleshoot individual error codes Refer to numerical list of error codes in Error Codes Table see Biolyte 2000 Reference Manual If a flow problem is suspected you will be instructed to perform the flow path check at appropriate time Special emphasis will be given to flow path components that are the most likely cause of the flow problem Refer to flow path check later in this chapter for detailed instruction on how to perform this procedure After the corrective action in each step has been completed perform a calibration or analysis or both to determine if the errors have been resolved If the proceeding troubleshooting procedure failed to resolve the Biolyte 2000 s malfunction call BioCare Customer Service Center Indicator of Flow Related Problem The Biolyte 2000 monitors flow during every calibration and analysis cycle and provides the following useful flow indicators O Flow times O Air and fluid readings These flow indicators can help you to determine if a problem is flow related Flow Times Press Status key repeatedly to view the last calibration and analysis flow rate A calibration or analysis flow time of zero indicates that no calibration or analysis has been performed since the instrument was powered down therefore data is unavailable Biolyte 2000 Quick User Manual Revision 0 18 Air and Fluid Readings E Press Menu key in the Main Scr
41. spilt on or inside the Biolyte 2000 To prevent shock hazard disconnect power supply before cleaning of the unit Before using any cleaning or decontamination method except those recommended by BioCare Corporation users should check with BioCare Corporation that the proposed method will not damage the Biolyte 2000 Do not use the service program which is for service engineers only When the Biolyte 2000 alarms or there is any error message shown stop operating and check The electromagnetic environment should be evaluated prior to operation of the device Use of this instrument in a dry environment and don t use this instrument in close proximity to sources of strong electromagnetic radiation as these may interfere with the proper operation User s should ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended This equipment complies with the emission and immunity requirements described in this part of the EN 61326 series Description of IEC Letter Symbols Description Symbol Description Voltage Power On Alternating Current O Power Off Current Protective Conductor Attention Consult Terminal Accompanying Documents Biolyte 2000 Quick User Manual Revision 0 20 Labels on the Biolyte 2000 IVD For In Vitro Diagnostic Use K diagnostick mu pouZit in vitro F r die In vitro Diagnostik Tua In Vitro Auryvoocixi Xpnon Per
42. t malfunction which in the sole opinion of BioCare is due or traceable to defects in the original materials or workmanship All obligations of BioCare under this warranty shall cease in the event of abuse accident alteration misuse or neglect of the Products In warranty repair or replacement all parts are warranted for only the remaining unexpired portion of the original Warranty Period applicable to the repaired or replaced parts After expiration of the applicable Warranty Period the customer will be charged at the current prices for parts labor and transportation Reasonable care must be used to avoid hazards to the Products BioCare expressly disclaims responsibility for loss or damage caused by the use of its ways other than in accordance with proper operating procedures EXCEPT AS STATED HEREIN BioCare MAKES NO WARRANTY EXPRESSED OR IMPLIED OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE Statements made by any person including representatives of BioCare which are inconsistent or in conflict with the terms of this warranty shall not be binding upon BioCare unless specified in writing and approved by BioCare All claims under this warranty must be made promptly after the occurrence of circumstances giving rise thereto and must be received by BioCare or its authorized representative within fifteen 15 days after the instrument malfunction Such claims should include the Products serial number the date of purchase a
43. to the Power Input Module plug receptacle Please position the equipment properly to prevent that it is difficult to operate the disconnecting service Plug the other end of the cord into a wall socket 32 Switch the power button ON It is located on top of the Power Input Module The instrument is now powered on 33 The instrument screen should now display the system initialization procedure Preparing the Printer 34 Install the printer paper Conditioning Electrodes and Flow Path Biolyte 2000 Quick User Manual Revision 0 35 Perform the conditioning procedure for the sodium electrode 36 Perform the conditioning procedure for the flow path Performing Instrument Calibration _ 37 From the Menu Screen press 6 to access the Maintenance Screen Select the Prime option Select the Full Prime option then press Enter key to initiate a full prime of all fluids 38 Press Calibrate key to initiate a manual calibration Repeat procedure at least one more time Main Components The Biolyte 2000 s Main Components Figure7 include tubing and flow controller to aspirate fluids an electrode carrier to analyze samples and several communication devices to receive and display information The Biolyte 2000 also includes a replaceable reagent pack that contains all of the reagents to calibrate the instrument and analyze samples Printer Figure7 Main Component Waste Valve Reference Valve Electrode Carrier Ele
44. turn ON or OFF each electrode Figurel2 shows the Test Select Screen 1 The flowchart on the left side of this page is the step by step procedure for Selecting Electrodes lt lt TEST SELECT gt gt 11 20 51 1 Na ON 2 K ON a 3 Cl ON A Lit OFF Figurel2 Test Select Screen gt gt Press Enter key to change ON OFF 2 Use LID IEI keys to move the cursor and press Enter key to turn ON or OFF the test electrode 3 After setting the test electrode press Esc key twice to return to the Menu Screen Selecting Units of Measurement The Units Setting Option lets users select the units of measurement for the analysis report of each test Figurel3 shows the Units Setting Screen which lists all of the system tests and the units of measurement that users can select for each one 1 The flowchart on the left side of this page is the step by step procedure for Selecting Units of Measurement lt lt UNITS SETTING gt gt 08 30 32 Figurel3 Units Setting Screen 1 Nat mmol L 2 K mmol L 32 Ol mmol L 4 Li mmol L gt gt Press Enter key to change mmol L mEg L 2 Use OD keys to move the cursor and press Enter key to change the units of measurement 3 After setting the units of measurement press Escl key twice to return to the Menu Screen Note Only Na and K can be set to mmol L or mEq L Setting Resolution Values
45. unction Then select the Full Prime option 6 Press Enter key to purge fluids from all the tubes 7 At the conclusion of the full prime cycle immerse the ends of A B and R straws into a beaker of deionized water 8 Press Enter key to fill the tubes with deionized water 9 At the conclusion of the prime cycle remove the straws from the beaker of water and leave them exposed to air 10 Perform 2 full prime cycles with air to purge all water from the tubing 11 At the conclusion of the second full prime cycle remove the W straw from the waste bottle and wipe the straw 12 Tf the reagent pack has a reasonable of reagent left tape the holes on top of the bottles or cover them with parafilm to prevent evaporation of the fluids 13 Release the collars of the W line from the pump bracket 14 Close the analyzer door 15 Switch the power button OFF and unplug the Biolyte 2000 Troubleshooting Introduction It describes troubleshooting procedure for the Biolyte 2000 and provides instructions on how to use error codes and the Diagnostics Screen Troubleshooting Theory The most efficient troubleshooting procedures focus on the simplest and fastest way to resolve error codes Since most error codes are due to flow problem in the Biolyte 2000 s flow path it is logical to investigate flow problems first It is helpful while troubleshooting to view the system as a whole and to consider how the flow path components interact to t
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