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Roche Cobas B221 - User manual

1. Parameter Mean Swr CV Sr CV pH 7 172 0 0037 0 05 0 0054 0 08 PCO 62 3 0 8276 1 33 1 5073 2 42 PO 50 6 4 2084 8 32 5 4278 10 74 Sodium 121 9 0 8432 0 69 1 0952 0 90 Potassium 2 98 0 0333 1 12 0 0352 1 18 Chloride 84 8 0 5243 0 62 0 9029 1 06 ionized Calcium 1 591 0 0170 1 07 0 0217 1 36 Hct 56 8 1 5547 2 74 1 5912 2 80 Lactate 9 3 0 0710 0 76 0 4680 5 01 Glucose 5 5 0 0564 1 02 0 1729 3 13 tHb tHb module 18 7 0 0256 0 14 0 0440 0 24 SO tHb module 100 0 0 0112 0 01 0 0112 0 01 Table A 15 AUTOTROL TS Level 1 n 40 Material AUTOTROL TS Level 2 n 40 Parameter Mean Sur CV S1 CV pH 7 406 0 0022 0 03 0 0043 0 06 PCO 43 1 0 3800 0 88 0 5716 1 33 PO 92 5 2 8967 3 13 3 5631 3 85 Sodium 136 9 0 5024 0 37 0 7705 0 56 Potassium 4 70 0 0303 0 64 0 0414 0 88 Chloride 99 4 0 3950 0 40 0 5617 0 56 ionized Calcium 1 146 0 0141 1 23 0 0178 1 56 Het 41 6 0 3827 0 92 0 7501 1 80 Lactate 1 9 0 0163 0 86 0 0672 3 53 Glucose 2 5 0 0204 0 83 0 1044 4 23 tHb tHb module 14 3 0 0773 0 54 0 0794 0 56 SO tHb module 93 3 0 1776 0 19 0 1855 0 20 Table A 16 AUTOTROL TS Level 2 n 40 Material AUTOTROL TS Level 3 n 40 Parameter Mean Sur CV S1 CV pH 7 567 0 0023 0 03 0 0047 0 06 PCO 22 9 0 2652 1 16 0 4763 2 08 PO 141 8 3 4549 2 44 4 0597 2 86 Sodium 156 3 0 8170 0 52 1 0626 0 68 Potassium 7 03 0 0510 0 72 0 0628 0 89 Chloride 120 3 0 4829 0 40 0 6012 0 50 ionized Calcium 0 599 0 0100 1 67 0 0128 2 13 T
2. Methylene blue 30 mg L MW D K SD n 8 0 01 0 02 4 61 0 20 3 02 0 14 MW I 0 03 3 83 17 63 MW K 0 02 0 77 20 65 Propofol 2uL mL MW I K SD n28 0 00 0 03 00000000000 02 MW I 0 08 eseese 0000000000000 2 MW K 0 08 0 0 o 000000000000 2 Table B 6 Interferences Hb derivates and Bilirubin Roche Diagnostics April 2009 B 16 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Limitations of clinical analysis Limitations of clinical analysis The determined performance data can be influenced by known and unknown factors as described below For details see section Interferences tHb SO on page B 18 and Metabolites on page B 18 General The literature lists various substances which may negatively impact upon the measurement result of the blood and plasma serum sample material A detailed discussion of these phenomena can be found at different places in the technical literature With respect to the cobas b 221 system an attempt was made to identify or evaluate these possible influences But since it is not possible to check all medication or substances the user should be immediately informed with abnormal deviations of the measurement results as with every clinical analysis and evaluate the complete picture of the patient or perform expanded measurements in his own laboratory if necessary Ensure that the selected sample type
3. 53 16 Go to AutoQC home position eene 54 17 Open the AutoQC drawer and remove the ampoule holder 54 18 Go to AutoQC service position eese eene nennen 54 19 Open AutoQC drawer and insert the AutoQC valve clamp 54 20 Go to AutoQC home position eee 55 21 Complete shutdown sse 55 Roche Diagnostics April 2009 A 26 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation Location Roche Diagnostics Installation For best results a suitable level location that is not subject to direct sunlight is required for the instrument When installing an instrument that was stored in a cool room or was transported at low temperatures be aware that condensation may have formed and could cause disturbances to the instrument The instrument must be climatized at room temperature for at least one hour before beginning operation The following conditions must be fulfilled Ambient temperature 15 C to 31 C Ambient air pressure 797 526 mmHg 106 225 70 13 kPa From approx 3000 m above sea level or air pressure lt 526 mmHg 70 13 kPa the specifications for parameter PO are no longer fulfilled and the parameter must no longer be used for evaluation of the clinical decisions After successful installation the parameter must be permanently deactivated
4. Data export to diskette or USB With this function the marked data records are exported to a diskette or an USB storage medium If it is a device with an SN gt 3000 the marked data records are exported to a connected USB storage medium If no USB storage medium is available the marked data records are automatically exported to a diskette If the USB storage medium is full or write protected or if during the read or write process it is disconnected the error message Error exporting data appears Repeated transmission of measuring data Using this function marked data records of the measurement database are exported again via ASTM to a connected LIS HIS system Requirement The format must be changed to ASTM For calibrations and QC measurements only Filter to set the required filter For QC measurements only L J graph use this function to create a Levey Jennings graph of the selected datasets from the QC database QC measurement Accepted using this function the display switches over to the list of the accepted QC measurements QC measurement Rejected using this function the display switches over to the list of rejected QC measurements For Backup Restore only Copy to disk the marked archive s are copied to a disk Copy from disk the archive s saved on disk are copied directly back to the archive overview Restore archive the marked dataset s are reinserted into the curr
5. Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 0 343 0 850 X 10 8 0 957 122 Hitachi Plasma Y 0 053 0 882 X 11 1 0 990 53 Cobas Mira Plasma Y 0 001 0 887 X 11 1 0 981 129 Table A 67 Urea Lactate Unit mmol L Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 0 200 1 000 X 9 5 0 936 136 Hitachi Plasma Y 0 286 1 149 X 0 7 96 0 993 60 Cobas Mira Plasma Y 0 297 1 074 X 3 0 0 968 137 Table A 68 Lactate Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 85 4 Specifications cobas b 221 system Sample throughput Sample throughput Activated installed modules Sample throughput samples hours Syringe Capillary BG tHb SO 31 29 BG COOX 31 29 BG ISE tHb SO 31 28 BG ISE COOX 31 29 BG ISE MSS tHb SO 31 28 BG ISE MSS Glu Lac COOX 30 27 BG ISE MSS Glu Lac Urea COOX 30 27 Table A 69 Sample throughput Measurement times of the samples Roche Diagnostics Activated installed modules Measurement times seconds Total time Until display BG tHb SO 110 66 BG COOX 110 76 BG ISE tHb SO 115 66 BG ISE COOX 110 76 BG ISE MSS Glu Lac tHb SO 115 88 BG ISE MSS Glu Lac COOX 120 88 BG ISE MSS Glu Lac Urea COOX 120 120 Table A 70 Measurement times of the sample
6. For additional information see Chapter 9 Software modes section Buttons on page B 76 April 2009 A 12 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions Measurement and calibration procedure Measurement and calibration procedure Measurement procedure Calibration procedure Oxygen Op PCO pH ISE MSS COOX Roche Diagnostics PO Use of the Clark measurement principle measurement of current generated by the reduction of oxygen PCO Use of the Severinghouse principle potentiometric measurement of the pH change in the electrode caused by CO pH Na K Ca und CI electrodes are potentiometric electrodes Special glasses are used as the sensitive element for pH and Na The potassium and calcium membranes contain special neutral carriers A special ion exchanger is used for chloride membranes Calculation of these variables also requires the use of a reference electrode a permanently contacted chloride electrode in the cobas b 221 system Glucose lactate Glucose oxidizes to form gluconolacton using atmospheric oxygen and the glucose oxidase GOD enzyme lactate oxidizes to form pyruvate using the lactate oxidase enzyme The generated H O is determined amperometrically by using manganese dioxide carbon electrode at 350 mV Urea Urea is broken into ammonia and carbon dioxide through urease Ammonia and carbon dioxide react through hydrolysis with p
7. Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10118 Timing error MSS 10119 An asynchrony occurred between processes and measuring Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10120 Timing error 10121 An asynchrony occurred between processes and measuring Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10123 Comm error D cal 10126 A subprogram did not report back Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10127 Timing error MSS An asynchrony occurred between processes and measuring Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support Table D 1 System stops Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 9 11
8. Sample collection especially for tHb SO and Hct measurement B 5 Sample containers B 7 Capillary tubes B 7 Clot catcher B 8 Roche MICROSAMPLER B 7 Syringes B 7 Sample distribution B 25 Sample handling B 8 Plasma B 9 Pleural fluid B 9 Serum B 9 Sample throughput A 86 Sample types A 87 Sample volumes A 87 Sampling handling Whole blood B 8 Screen PC unit A 19 A 30 Sensor report B 92 Setup B 80 Shutdown A 48 Complete shutdown A 55 Fill the shutdown kit with distilled water A 49 Go to AutoQC home position A 54 A 55 Go to AutoQC service position A 54 Insert shutdown kit into space S2 A 49 Insert shutdown kit into space S3 A 50 Less than 24 hours A 48 Longer than 24 hours A 48 Open AutoQC drawer and insert the AutoQC valve clamp A 54 Open bottle compartment cover and only remove bottle S1 and packs A 49 Open T amp D A 52 Open the AutoQC drawer and remove the ampoule holder A 54 Open the measuring chamber cover and remove the sensors A 50 Release screws at V19 bottle compartment A 53 Remove fill port and sample inlet path glass tube A 52 Roche Diagnostics Remove right FMS tube at VM bottle compartment A 53 Remove shutdown kit from space S2 A 49 Remove shutdown kit from space 3 A 50 Remove the peristaltic pump tubes A 50 Remove the printer p
9. The parameter was successfully calibrated during the current calibration The parameter was not successfully calibrated during the current calibration The parameter was calibrated and is not influenced by the current calibration The parameter was not calibrated and is not intended for the current calibration Roche Diagnostics April 2009 B 68 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Contents Software modes In this chapter all the individual independent software modes analyzer settings data manager and info are described In this chapter Chapter El Software modes geral ii aenea degit 71 User interactions 71 Parametros ia uit hes 73 Display on the Ready screen analyzer mode sss 73 Notation of the measurement input and calculation values 73 DUO e M 76 Analyz r mode eco tecti ete e ee 78 Ready SCteeni seti NN 78 Ryu 79 Quick dec ss ooo edant diede lea ee e RU EE EN E e ERN CHEER 79 QCmedsure ment i eie eise e etii 80 Setup edet teteie eee tele te beetle eee elei Data manager General data manager functions sentent 81 Pati died 83 Measur rmehtts een NIE eee ain ehhh ate 83 Calibrations iii decana eones ie AAA eere deine 84 QCmeasurements da c 84 TAS a 85 Util 85 Backup RES vn ii 85 Protected DB functions
10. a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 A 118 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Oxygen saturation Roche Diagnostics Clinical significance Oxygen saturation is the measured portion of the oxyhemoglobin in total hemoglobin Reference values Adult in arterial blood 95 98 96 in venous blood approx 73 96 Newborn in arterial blood 40 90 96 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Critical values SO lt 80 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 The measurement of SO is used to judge oxygenation usually in connection with other parameters for example PO PCO and hemoglobin For monitoring of patients with possible hypoxia SO Werte gt 90 are acceptable In principle SO measurements are better than estimated values O sa1 however when using SO measurements during the presence of abnormal hemoglobins for example carboxyhemoglobin incorrect results may arise for example assuming a comatose patient with 15 COHb an SO value of 95 may be shown although in reality the level of oxyhemoglobin FO Hb is only 80 100 is the summation of all hemoglobins For this reason the CLSI suggests evaluation of the dyshemoglobins instead of a clinical evaluation of a
11. eeeseeseeeeeeee eene enne nnne nnt nne nn enne enne nn nnn 86 InfQ fe eer nr err IE ett eee eee eec eroe UR 87 Help IAE RABANUS RR ARR AR RR 87 Bald Teele se fave Le RU DG IU RUN D e Re rimis 87 OLOA ini M 88 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 69 9 Software modes cobas b 221 system Contents Roche Diagnostics AN 5 ena dena dana dones etenetie ie tedio de E 88 List otallactiyities ii tit 89 Last Of all warnings etario boe eeetie eee tette tien iens 90 AGO C Status c rre tereti ere deer i A E 90 Versions Miscellaneous reports Parameter report 5nd idiot en ater 91 SENSOL A 92 MICI EC MEER 92 Protected information comicios 92 April 2009 B 70 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Software modes general Software modes general User interface For example For example Roche Diagnostics During measurement calibration or other processes it is possible to conduct database operations perform certain settings or call up general information The software modes which may be run independently are defined as follows Analyzer Place sample measurement system QC measurement calibration quick access which contains commonly used functions Setup Instrument settings Database Data about patients measurements calibrations QC and the i
12. Attention Replace the MSS cassette within 28 days of installation In order to ensure the quality of the measurement results complete a quality control test on 3 level low normal high after each MSS cassette exchange Before exchanging the MSS cassette it is absolutely necessary to prepare a syringe or capillary with whole blood for polarization The blood should have a volume of at least 150 uL contain heparin as an anticoagulant and be stored for less than 24 hours Hold the MSS cassette only at the designated handle and avoid touching the contacts 1 Remove the top cover 2 Open the cover of the MSS module apply force to the right edge of the MC cover with a finger to push it to the left and open up the MC cover Keep the bottle compartment cover closed The following screen appears Changing of MSS sensors EN To change a sensor scan in the sensor barcode To finish this function close the MC cover Reon m SUAE e za Mat change 14 10 System cal 15 02 08 11 2006 1440 CIITTTTTTTTTTTTTTTTTTTITTTTDO Figure C 31 3 Open the contact clip and the locking lever April 2009 C 32 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Unscheduled 4 Push the reference contact RCon see below B or the MSS reference electrode Ref Dummy see below A and the MSS cassette slightly to the lef
13. Blockage or leak e Check Aspirate CAL A Defective mixer valve System gt Utilities gt Fluid actions gt e Defective air valve Fill routines Block leak i D Perform General fluidics test System gt Diagnostics Replace S2 Fluid Pack lt D see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 3004 AQC module error The required position was not reached For instructions see This flag corresponds to the AQC module module stop 20113 on page D 15 20114 stops on page D 15 and 20115 20116 20118 on page D 15 3013 Ref point DI not OK Problem during precalibration Check Aspirate standby solution Possible causes System gt Utilities gt Fluid actions gt e Faulty aspiration of standby solution Fill routines Faulty aspiration of MSS reference Check Fill ref electrode MSS solution System gt Utilities gt Fluid actions gt Fill routines Perform MSS conductivity path test with standby solution System gt Component test gt Control sensors gt Contact paths 3014 Ref point not OK Problem during precalibration Check Aspirate standby solution Possible causes System gt Utilities gt Fluid actions gt e Faulty aspiration of standby solution Fill routines Faulty aspiration of MSS reference Check Fill ref electrode MSS solution System gt Utilities gt Fluid actions gt Fill routines Perform MSS conductivity path test with standby solution System gt Component test g
14. COHb MetHb HHb Bilirubin neonatal mg dL Table A 2 Units of the parameters Material acetat standard solution Level 1 NIST Traceable n 80 Parameter Mean Sur CV S1 CV Sodium 140 0 0 5600 0 40 0 7405 0 53 Potassium 2 02 0 0165 0 82 0 0290 1 44 Chloride ionized Calcium 1 622 0 0155 0 96 0 0205 1 26 Table A 3 Acetat standard solution Level 1 NIST Traceable n 80 Roche Diagnostics April 2009 A 60 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Material acetat standard solution Level 2 NIST Traceable n 80 Performance data Parameter Mean Sur CV Sr CV Sodium 140 1 0 5107 0 36 0 7747 0 55 Potassium 4 00 0 0171 0 43 0 0273 0 68 Chloride z E 2 ionized Calcium 1 166 0 0077 0 66 0 0141 1 21 Table A 4 Acetat standard solution Level 2 NIST Traceable n 80 Material tonometered human whole blood 20 different probands n 80 Parameter Mean Swr CV S1 CV pH 7 441 0 0042 0 06 PCO 18 3 0 3331 1 82 0 6262 3 42 PO 137 9 0 9371 0 68 2 3258 1 69 Sodium 139 5 0 4878 0 35 Potassium 4 58 0 0260 0 57 Chloride 108 4 0 4310 0 40 ionized Calcium 1 181 0 0079 0 67 Hct 43 3 0 3203 0 74 Lactate 11 5 0 1769 1 54 Glucose 1 8 0 0648 3 51 Urea 4 8 0 0529 1 11 tHb tHb module 15 4 0 1461 0 95 SO tHb module 96 6 0 3744 0 39 tHb COOX 14 1 0 0773 0 55 SO COOX 99 9 0
15. Equation A 22 a AO 100 2 Fort unequal 37 C see equation a AO on page A 106 The arterial venous oxygen tension ratio 4 Unit vol Formula data from venous blood available Equation A 23 avDO ctO a ctO v April 2009 A 102 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations RI Shunt A Additional information Roche Diagnostics Parameters and calculations Calculated ctO a and ctO v according to the calculation for ctO for arterial and venous blood for ctO see Equation A 14 on page A 101 Calculation only under the following conditions same patient numbers for both measurements two consecutive measurements sample type is arterial and mixed venous blood The respiratory index is calculated as the ratio of the alveolar arterial oxygen tension gradient to the arterial oxygen tension Unit 96 _ PAO P30 09 Equation A 24 RI PaO Fort unequal 37 C see Equation A 34 on page A 106 The shunt parameter is a measure of the direct mixing of venous blood into the oxygenated blood circulation The Shunt iaa gives the short circuit volume relating to the total volume value In order to determine the shunt Qs Qt two independent measurements are necessary Both measurements must be carried out with the same patient ID The patient ID must therefore be defined as an input value 1 Measur
16. Roche Diagnostics During measurement various patient operator and sample specific data may be entered Ez x s c Result First Name PN IMiddle initial Temperature 37 0 C ws Last w T patients e za Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure B 8 Use the buttons a M to select an entry Press Edit input value to enter data or change existing data A keyboard appears on the screen enter the Patient ID Ifthe patient already exists in the cobas b 221 system database patient specific data appears in the respective lines Scanning in patient and user data is possible by means of a barcode scanner The user must carry out a plausibility check for all barcode data read in and displayed by the instrument If the patient is not yet registered press New patient and the patient related data will be stored The Remark input field is limited to 25 characters If mandatory input fields are defined Setup gt Display amp reports gt Measurement gt Input values they are displayed in a red font An entry must be made in these fields otherwise the measurement values are discarded If a standard value is defined as mandatory input it must be confirmed or edited if necessary April 2009 B 24 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Measuring procedure Sample
17. 03111644180 BP1732 PCO Electrode X 03111679180 BP1733 PO Electrode X 03111695180 BP1734 pH Electrode X 03111717180 BP1735 Reference Electrode X X X X X X X X 03111873180 BP2081 Reference Contact RCon X X X X X X X X 03112071180 BP2258 Sensor Contact SCon X 03260909184 BP2608 Micro Electrode Dummy X X X X X X X X X X 03111849035 BP1959 GLU LAC UREA Cassette 03261085184 BP2500 GLU LAC Cassette X 03260887184 BP2501 GLU Cassette X 03260895184 BP2502 MSS Dummy Sensor 03351262001 Table E 1 X Has to be installed Dummy or electrode has to be used for proper filling of the measuring chamber Roche Diagnostics April 2009 Instructions for Use Revision 10 0 E 5 12 List of consumables cobas b 221 system Order information Solutions Paramenter cr Na K Ca PCO PO pH tHb SO COOX Bili MSS S1 Rinse Solution x X X X X X X X X X 03260917184 S2 Fluid Pack X X X X X X X X X X 03260925184 S3 Fluid Pack A X X X X X X X X X X 03260933184 W Waste Container X X X X X X X X X X 03144054001 Hb Calibrator X X 03110923035 BP1360 Table E 2 X Has to be installed QC material Parameter cr Nat K Ca PCO PO pH tHb SO COOX Bili MSS AUTO TROL PLUS B Level 1 O O O O O O O O O O 03321169001 BP9094 AUTO TROL
18. 2 General descriptions cobas b 221 system System description System description Visual identification For example cobas b 221 lt 6 gt system ivi pdpwd W N B M L C K D J E F G l A Screen PC unit G_S1 Rinse Solution M Input unit B Reverse side H S2Fluid Pack N Measuring chambers C Docking mechanism S3 Fluid Pack O Printer D AutoQC drawer J Bottle compartement cover P Pumps E Barcode scanner K Bottle compartement F W Waste container L COOX module tHb SO module Figure A 3 cobas b 221 lt 6 gt system Roche Diagnostics April 2009 A 18 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions Screen PC unit A Printer A Measuring chamber tHb SO module Roche Diagnostics System description The screen PC unit serves as the graphical user interface All information results error messages alarms warnings etc is displayed on the screen The screen consists of a color LCD that is covered with a touch sensitive film touch screen As sharp objects can damage the touch sensitive film only touch the film using suitable pins and or with your fingers The screen PC unit also contains a diskette drive Low noise thermoprinter with integrated paper cutter manually activated using the Cut key and optional winder The Feed key feeds in the paper With an installed win
19. 9 Software modes cobas b 221 system Data manager Calibrations QC measurements Roche Diagnostics EJ 18 11 2003 18 11 2003 14 14 1Pcal nok Ok Ok Ok nok Ok 18 11 2003 13 08 1P cal Ok Ok Ok Ok Ok Ok 18 11 2003 11 54 1P cal Ok ok Ok ok nok ok 18 11 2003 10 49 1P cal Ok Ok Ok Ok nok Ok Ok 18 11 2003 09 43 1P cal Ok ok Ok ok nok hok nok 18 11 2003 08 38 1P cal ok ok ok ok nok ok Ok Figure B 57 Calibrations that were carried out are listed depending on the definition ofthe display Setup gt Display amp reports gt Calibration gt Calibration database overview Use the buttons Page up down or Up down to select an entry and press the Details button All available information about the selected entries are displayed Material 02 9 2002 AUTO TROL TS 02 9 2002 16 12 AUTO TROL TS 413 90 2 7 408 41 2 1 172 02 9 2002 08 10 AUTO TROL TS 579 547 7 181 56 1 1 604 01 9 2002 21 10 AUTO TROL TS 01 9 2002 01 9 2002 31 8 2002 31 8 2002 AUTO TROL TS AUTO TROL TS AUTO TROL TS AUTO TROL TS Figure B 58 QC measurements that were carried out are listed depending on the definition of the display Set
20. Admission status Admission date STOP gE eel Roche Diagnostics Diet MV e Size e Aate e Weight e Flowrate Insurance code 24h Urine e Patient language ALLEN test Medication Remark Ethnic origin Samples Analyzer active inactive Database active inactive Setup active inactive Info active inactive Aspirate from capillary resp Injection active Aspirate from syringe active User logged on no user logged on Return to the highest level of the Analyzer mode Return to the highest level of the Setup mode Return to the highest level of the Database mode Return to the highest level of the Info mode Back one level used as an enter key to store information or to return to previous screen User stop Move one entry to the left right April 2009 B 76 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes QC lock QC lock Roche Diagnostics User interface Move left to start right to end Move one entry up down Move one page down up Move to bottom top Example for switch button ON Example for switch button OFF April 2009 Instructions for Use Revision 10 0 B 77 9 Software modes cobas b 221 system Analyzer mode Analyzer mode The Analyzer mode contains parameter information e g Ready system settings quick access and the QC measurement The Ready screen is the highest
21. Display on the Ready screen analyzer mode Depending on the settings and the status of the instrument the parameter buttons may have the following appearance Na Parameter activated and ready Parameter temporarily deactivated but calibrated Parameter activated with QC warning Parameter temporarily deactivated with QC warning Parameter not ready not calibrated Y Parameter not ready due to QC lock Parameter not ready due to remote lock Parameter permanently deactivated under Setup a A status report appears after pressing the parameter button b A status report appears after pressing the parameter button Notation of the measurement input and calculation values Measurements depending on configuration PO PCO tHb O Hb Oxygen partial pressure Carbon dioxide partial pressure Negative decadic logarithm of the hydrogen ion activity Sodium ion concentration Potassium ion concentration Chloride ion concentration Calcium ion concentration Hematocrit Total hemoglobin concentration Oxyhemoglobin a Details and calculation see Chapter 5 Theoretical foundations Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 73 9 Software modes cobas b 221 system User interface Roche Diagnostics HHb Desoxyhemoglobin COHb Carboxyhemoglobin MetHb Methemoglobin Bili Bilirubin neonatal SO Functional oxygen saturation Glu Glucose Lac La
22. In patients suffering an extensive blood loss during massive infusion therapy and during complicated surgery especially open heart surgery determination of the hematocrit value with the conductivity method used in the cobas b 221 system can lead to incorrect results Especially with infusions with protein free electrolyte solutions or when hyperosmolar solutions are used the measured hematocrit value can be significantly reduced This artificially reduced hematocrit value may lead to an unnecessary premature decision regarding transfusion If this is the case we recommend either direct measurement of the hematocrit micro centrifugation or PCV or indirect determination via the measurement of the total hemoglobin using the calculated value Hct c To take into account possible influences due to infusion solutions the cobas b 221 system has special correction algorithms for the calculation of patient results These algorithms are particularly optimized with Ringers solution However for those patients receiving infusions other than Ringers or whose hematocrit is pathologically low false hematocrit measurement values cannot be excluded In these instances the aforementioned limitations and evaluation of patient results must be considered Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 117 5 Theoretical foundations cobas b 221 system Clinical significance tHb total hemoglobin concentration Roche
23. QC material Storage conditions in original packaging cobas b 221 lt 1 gt lt 3 gt lt 5 gt system e COMBITROL TS up to 24 months at 2 to 8 C e AUTO TROL TS up to 24 months at 2 to 8 C cobas b 221 lt 2 gt lt 4 gt lt 6 gt system e COMBITROL PLUS B up to 24 months at 2 to 8 C e AUTO TROL PLUS B up to 24 months at 2 to 8 C Stability during operation cobas b 221 lt 1 gt lt 3 gt lt 5 gt system e COMBITROL TS Up to 3 months at room temperature up to 28 C e AUTO TROL TS Up to 3 months at room temperature up to 28 C incl max 1 month in the AutoQC module cobas b 221 lt 2 gt lt 4 gt lt 6 gt system e COMBITROL PLUS B Up to 3 months at room temperature up to 28 C e AUTO TROL PLUS B Up to 3 months at room temperature up to 28 C incl up to 60 days in the AutoQC module Roche Diagnostics April 2009 A 90 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Product data Electrical data Classification Dimensions Weight Acoustic noise level Roche Diagnostics Mains voltage range Frequency Required power Protection class Overvoltage category Contamination level Width Height Depth cobas b 221 system instrument In all operating conditions Product data 100 to 240 VAC 10 permissible tolerance 50 60 Hz 200W II 51 cm 59 cm 60 cm approx 45 kg without wash calibrating solutions and AutoQC min 37 0 dB
24. Roche Diagnostics April 2009 D 38 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages on the measurement report No Message Cause Action 8083 Sample type conflict Detected sample type is invalid e Check sample material Possible causes e Unsuitable sample type used 8084 Invalid sample type A different blood type than arterial or Use arterial or capillary blood as sample capillary blood was used material and set the correct blood type Possible causes e All calculation values calculated from measurement values with arterial blood cannot be output 9000 Calculation error 3 PC calculation error e Contact Technical Support Possible causes e Anunapproved calculation operation occurred 9001 Not activated Parameter is disabled for measurement Enable the parameter gray 9002 Not activated Parameter is not calibrated red X Perform Calibration for Ready Table D 6 Status messages of measuring and calibration values Status messages on the measurement report Messages Causes Out of range Out of range tHb not OK check Hct result Measurement value is outside below the normal range Measurement value is outside above the normal range Indicates at the parameter SO3 that the tHb value is outside the normal range The instrument finds the Hct value to be implausib
25. The sample calibration solution was lt D see Chapter 10 Maintenance section non uniform Aud Changing the MSS cassette Insufficient sample calibration i cobas b 221 lt 5 gt system and solution detected i cobas b 221 lt 6 gt system only on Insufficient wetting of the measuring page C 32 channel Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 23 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 1020 Sample distr error 1 Unable to remove excess sample Perform General fluidics test to isolate the Possible causes eror e Clogging or leaky points during System gt Diagnostics positioning and afterwards contact Technical Support 1021 Sample distr error 2 No solution detected at SS3 although SS2 Perform Wash detected a solution System Wash amp Cleaning Possible causes Ifthe error persists perform General fluidics Clogging test to isolate the error Sample inlet path leaky System gt Diagnostics and afterwards contact Technical Support 1022 Sample distr error 3 Sample excess could not be extracted via Perform Wash transverse channel System Wash amp Cleaning Possible causes If the error persists perform General fluidics Blockage test to isolate the error System Diagnostics and afterwa
26. cobas Life needs answers cobas b 221 system Instructions for Use COBAS COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche 2009 Roche Diagnostics Roche Diagnostics GmbH D 68298 Mannheim Germany www roche diagnostics com cobas b 221 system Revision History Edition notice Copyright Roche Diagnostics Manual Version Software Version Revision date Changes 2 0 1 0 May 2003 Launch 3 0 1 0 June 2003 not delivered 3 1 1 02 July 2003 4 0 2 0 March 2004 5 0 4 0 December 2004 6 0 5 0 November 2005 7 0 5 0 March 2006 cobas Branding 8 0 6 0 December 2006 9 0 7 0 February 2008 10 0 27 0 April 2009 cobas b 221 system In the course of 2006 the Roche OMNIS system was relaunched under the Roche Diagnostics professional IVD user brand cobas Systems with a serial number of 5001 or above are cobas b 221 systems Systems with a serial number up to 5000 are Roche OMNIS systems Every effort has been made to ensure that all the information contained in this manual is correct at the time of printing However Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development Any customer modification to the instrument will render the warranty or service agreement null and void Software updates are done by Roche Service representatives 2009 Roche Diagnostics GmbH all rights reserved The contents of this document may not be rep
27. gt Details where instead of a result an error message appears for the respective parameter Group B The cause is a QC result that exceeds the target value range A cause in Group B can be recognized in the data manager under QC measurements gt Details where a result is available but exceeds the target value range Troubleshooting Group A aspirating or positioning problem 1 Check whether all parameters are calibrated 2 Repeat the QC measurement with same material level combination 3 Inevent of repeat error fan AutoQC module is in use a manual QC measurement with the same material level combination must be carried out Ifthe manual QC measurement shows the same problem continue with Point 4 Ifthe manual QC measurement is OK the fill port and T amp D disk must be cleaned and the ampoule status under Info gt AQC status must be compared with the actual availability of the ampoules in the AutoQC module Repeat the QC measurement with same material level combination Ifthe error persists contact customer service Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 61 7 Quality control cobas b 221 system QC troubleshooting 4 For the affected measurement chamber an internal cleaning must be called up exception MSS measurement chamber Measurement of a blood sample must then be carried out in order to wet the fluid channels 5 Repeat the QC measurement
28. mmHg Measured SO values available k Equation A 13 P50 26 71 0 2P02 1eP0s At which lgQ F3 ig Po EQ F3 x 2 9 uation A 14 B 0 30 100 SO Adult F3 4 172 Fetal F3 4 113 si vw If no measured SO values are available no calculation is possible Roche Diagnostics April 2009 A 100 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Parameters and calculations ctO Oxygen content is the sum of oxygen bound to hemoglobin as O Hb and the amount of oxygen dissolved in the plasma Unit vol X Equation A 15 ctO PO SO tHb 1 39 Um tHb 0 00314 PO At which cobas b 221 system with COOX module X O Hb cobas b 221 system with tHb SO Module X SO Only BG values available X SO c lt D see equation SO on page A 99 If PO is not available ctO is calculated with PO 90 mmHg ctCO B Total concentration of CO in the blood the sum of the total CO in plasma and the red blood cell erythrocyte fluid ERY Unit mmol L ctCO B Equation A 16 0 000768 PCO tHb 14 10 9 7e CO P 1 At which SO PH pay 7 19 0 77 pH 7 4 0 035 1 22 Equation A 17 100 pH egy 7 84 0 06 292 PK y 6 125 Ig 1 10 100 SO or if SO not available SO c Equation A 11 on page A 99 a A correct calculation of the calculated value is possible only after measurement of a whole blood Q sample in the sample type setti
29. o o Islet cell tumours in pancreas Lack of insulin antagonists M Addison Hypopituitarism Sulfon urea therapy Insulin overdose Renal glucosuria very rare April 2009 A 124 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Lactate Roche Diagnostics Clinical significance Normal values e Adult after fasting 4 5 9 mmol L or 74 106 mg dL Adult 1 hour after consumption of 75 g glucose 10 0 mmol L or 180 mg dL Newborns after fasting 2 0 5 5 mmol L or 36 100 mg dL a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Critical values e Glu 22 mmol L or 40 mg dL Glu gt 25 0 mmol L or 450 mg dL a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Lactate acts as an early warning signal for hypoxic states in human tissues for recognition and estimation of the severity and progress of a shock also of septic shock and particularly as a measure for limiting hyperlactataemia The physiological lactate value of blood is 1 0 5 mmol L A lactate rise to up to 5 mmol L in blood with accompanying metabolic acidosis is termed hyperlactataemia A lactate level of over 5 mmol L with causally linked metabolic acidosis is termed lactate acidosis Normal values Adult 0 9 1 7 mmol L or 8 1 15 3 mg dL e Newborns 0 5 2 0 mmol L or 4 5 18 0 mg dL a Cr
30. Calibration ferror persists perform Wetting routine System gt Utilities gt Fluid actions Ifthe error persists perform General fluidics test System gt Diagnostics and afterwards contact Technical Support 1014 Sample pos error 7 Conductivity at BSA sensor is too low Perform MSS polarization Possible causes System gt Utilities follow the instructions on Air bubbles the screen e Poor wetting Insert sufficiently large samples If error cannot be corrected contact Technical Support 1015 Sample pos error 8 Conductivity at lactate sensor is too low Perform MSS polarization Possible causes System gt Utilities follow the instructions on e Air bubbles the screen e Poor wetting Insert sufficiently large samples If error cannot be corrected contact Technical Support 1016 Sample pos error 9 Conductivity at glucose sensor istoolow Perform MSS polarization Possible causes System gt Utilities follow the instructions on e Air bubbles the screen Poor wetting Insert sufficiently large samples If error cannot be corrected contact Technical Support 1017 Sample pos error 10 MSS Conductivity was too low at the Ensure sufficient uniform sample input sensor input after positioning the sample Perform Wetting routine MSS calibration solution in the measuring Tuff System gt Utilities gt Fluid actions chamber e If the error cannot be corrected replace Possible causes MSS cassette
31. Cleaning fill port and sample drip tray sse 8 Cleaning the touch screen e eerte ertet ertet et eriperet ENEE E E EEEE 8 Quarter data dat bate ite bai bae babe be b pa staat 9 Cleaning the LAD disk 2 esee eiii 9 Changing the air filter COOX calibration for instrument versions with COOX module only 10 Sample dependent maintenance procedures sse 13 Exchange of solutions and packs sentent 13 S1 Rinse Solution 2 Fluid Pack 3 Fluid Pack sss 14 Waste Water pe O E aE NE costes 16 Exchange the waste water container W Waste Container 16 1 Empty the W Waste Container ococinininnnnnonincnnnconocnnocanncnonononononononononononononcnos 17 2 Using the empty S1 rinse solution bottle as W waste container 18 Installing the waste water container ccccccnconononanononononanananananananonononananinanananananano 18 Cleaning the modules and tubing paths esse 19 April 2009 Instructions for Use Revision 10 0 C 3 10 Maintenance cobas b 221 system Contents Module cleaning 3 nnnm re bedonerdanadateedantadateetelemas 19 Tubing paths erheben ien ERA 20 Unscheduledi ete tette teretes ferite ferie E taste 22 Exchanging the fill port eeeenetetetntntntntntntntntntntnnnenenes 22 Exchanging the peristaltic pump tubes essen 23 Cleaning the bottle
32. D 4 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Troubleshooting general Troubleshooting general A System stops After use components of the cobas b 221 system including tubing waste container fill port etc contain biological fluids and represent therefore a possible infectious risk Handle these components with care and according to regulations surrounding potentially infectious materials Suitable protective equipment like laboratory clothing protective gloves protective goggles and if necessary mouth protectors must be worn to prevent direct contact with biological working materials In addition a face mask is required if there is a risk of splashes Suitable disinfection and sterilisation procedures must be applied The cobas b 221 system can monitor for air bubbles clots leaks and blockages in the system Should the instrument detect any of these problems an error message will occur in the form of a system stop module stop or status message depending on the issue Depending on the error the font in the error message window changes color e System stop to red Module stop to yellow System warnings and status messages to white For all system stops module stops and status messages for measurement and calibration values a fault analysis and removal suggestions appear directly on the screen This error creates a window outlined in red halting the ana
33. Danger Risque d explosion en cas d utilisation une Observera Enheten anv ndas utrymmen Product complies with FDA radiation performance standards atmosph re contenant des gaz ou produits anesthetiques explosionsfarliga blandningar av anestesigaser 21 CFR subchapter J inflammables In vitro diagnostika Per uso diagnostico in vitro Overhold Seguire le istruzioni d uso M kun anvendes af fagpersonale i CE Uso consentito solo a personale Advarsel Apparatet m udelukkende bnes og repareres af la riparazione dello strumento pu essere eseguita instrueret servicepersonale posed in ambienti con miscele Tween Type cobas b 221 system cobas pee on yP y esplosive di gas anestetici Ta rr Xpo in vitro 6iay cor Kio ji vo AQU C Parag in vivo TE orar Power Rating 100 240 V 50 80 Hz 200 W Bl Germany B Utiliza o reservada apenas a t cnicos especializados Aten o Interven o no equipamento permitida apenas a t cnicos qualificados Aten o Perigo de explos o na presen a de gases e anest sicos inflam veis Diagn stico in vitro Tener en cuenta las instrucciones de uso S lo para uso de personal cualificado Atenci n El equipo s lo deber abrirse y repararse por personal instruido fipoeidonoinan H OIE enmp nerai va eniocevaor ei y vo ond ro exnaeup vo npocuniKd H ouckeur dev NEpieye OTO axoTepik TNC u pn nou unopoov va niakeuaoroUv and To yprjom f 1pocoyrj NiBavde kiv uvoc amp p
34. E E Figure C 37 9 Close the AutoQC drawer April 2009 Instructions for Use Revision 10 0 C 37 10 Maintenance cobas b 221 system Additional maintenance procedures Additional maintenance procedures The listed maintenance procedures may only be performed by the Technical Support or by Roche authorized personnel The components have been tested during development of the instrument to identify worn parts They must be replaced at the annual service to prevent potential malfunctions Yearly service In the course of the yearly service following components have to be replaced cobas b 221 lt 1 gt lt 6 gt system e Sample tube Fill port T amp D tubing set PP pump head PP pump tube e FMS tubing set e Waste separator Bypass nipple e Bacteria filter T amp D disk Tubing set tHb COOX cobas b 221 lt 2 gt lt 4 gt lt 6 gt system only e Cuvette e Cuvette seals e Hemolyzer tube A The tubing paths must also be disinfected annually and the baro value must be checked Replacement every three years Every three years the following components have to be replaced cobas b 221 lt 1 gt lt 6 gt system e Sample tube Fill port T amp D tubing set PP pump head PP pump tube FMS tubing set e Waste separator Roche Diagnostics April 2009 C 38 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Roche Diagnostics Additio
35. Info QC status Ss Cl CEI e L L y EN ES CIA MECO ene cate Warned Material Po AUTO TROL TS 3 21820601 e za Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure B 63 Use this function to determine which material level combination is blocking a parameter Press the Print button to print out the QC Lock Status report Video sequences z Q i If this function is not available contact customer service see Figure B 61 on page B 87 Roche Diagnostics April 2009 B 88 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Info List of all activities Here all the activities are listed that have to be carried out including all the maintenance added under Setup gt Times amp intervals gt Maintenance schedule Press the button Print to print out the list anging Lac sensor Sensor changing 08 11 2006 Waste Replacement of bottle 14 10 08 11 2006 AQC mat D Mat change 19 34 13 11 2006 AQC mat E Mat change 21 11 2006 AQC mat F Mat change 23 11 2006 Replace S2 Replacement of bottle 02 12 2006 Replace S3 Replacement of bottle 04 12 2005 Replace S1 Replacement of bottle 12 12 2006 S AQC mat A Mat change 13 12 2006 K sensor Sensor changing 28 1 2007 m IPOs sensor Sensor changing 28 1 2007 d e az System
36. Ready is not possible and the reason why If required print the list Print remedy the cause and repeat the procedure Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 59 7 Quality control cobas b 221 system QC for Ready without AutoQC module 4 Press the button Perform QC for Ready The following screen appears QC measurement n o STC OK Print Figure B 45 5 Here the respective material level combinations are listed that can remove this lock again 6 Print the list Print and perform a manual QC measurement with the listed QC materials see section Manual QC measurement on page B 51 Roche Diagnostics April 2009 B 60 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control QC troubleshooting QC troubleshooting Description of the current problem After a QC measurement one or more parameters are assessed as not OK QC warning or QC block The affected parameters and the QC material material type level causing the error are listed under Info gt QC status The QC problem can only be solved by a correct QC measurement within the range if the same material level combination is measured Classification of QC problems Group A The cause is an aspirating or positioning problem with the QC sample In this case usually more than one parameter is affected A cause in Group A can be recognized in the data manager under QC measurements
37. Roche Diagnostics April 2009 C 8 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Quarterly Quarterly Cleaning the T amp D disk Activate the following function starting with the top level of the analyzer mode C System gt Wash amp cleaning gt Clean input unit 1 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant see Figure C 1 on page C 8 2 Remove the T amp D cover 3 Clean the fill port with a soft cotton swab moistened with disinfectant 4 Rotate the fill port 90 downward and remove it r n N A Needle Figure C 2 T amp D disk 5 Insert the fill port with the flat side into the slot in the T amp D disk and turn it 90 degrees to the right or left Hold the T amp D disk in place during this process 6 Remove the T amp D disk 7 Cleanand decontaminate the front and back of the T amp D disk A Do not use alcohol for cleaning the T amp D disk 8 Re install the disk in reverse order 9 Re insert the fill port 10 Close the T amp D cover 11 Insert the sample drip tray Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 9 10 Maintenance cobas b 221 system Quarterly Changing the air filter 1 Pullout the air filter using the box tongue see below Figure C 3 Air filter 2 Dispose of the air filter according to local regulations hazardous waste 3 Push in the new air filter accor
38. TPca 1530 08 312008 1518 Figure B 65 Here all the module stops and warnings are listed with their code or it can be found in Chapter 11 Troubleshooting using the respective error code ID Action info Further information is displayed on the errors indicated AQC status E Mat C Level 2 Level 1 Material AUTO TROL PLUS B Lot number Lot number Lot number Level 3 21820601 21820601 21820601 Lot number 21750402 Exp date Exp date Exp date Exp date 31 1 2007 28 2 2003 28 2 2003 26 2 2003 11 Ampoules 11 Ampoules 9 Ampoules 15 Ampoules Details Details Details blue full gray empty Figure B 66 It shows an overview of the mats and the AutoQC material being used Press the Details button to display the ampoule status of the selected mat blue full gray empty Roche Diagnostics April 2009 B 90 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Info Versions Mo cobas b 221 lt 6 gt system PC Microcontroller AVR modules MSS imprint PCO sensor PO sensor pH sensor Print Figure B 67 Here the software versions the instrument serial number the MSS cassette label and the date of insertion of the sensors are listed Press the button Print to print out the list Miscellaneous reports Parameter report Print Figure B 68 Displays the status of the electrodes Roche Diagnostics April 2009 Instructions fo
39. contact Technical Support Table D 4 System warnings Roche Diagnostics April 2009 D 18 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting System warnings No Message Cause Action 30028 Check AQC material At least 1 mat in the AutoQC module If necessary insert a new map contains only two more full ampoules see Chapter 10 Maintenance section Changing of AutoQC mats on page C 35 30029 Check parameter states One or more parameters are not To eliminate this error perform calibrated Calibration for Ready System gt Calibration 30030 Perform manual QC Manual QC measurement is pending e Perform QC measurement measurement 30031 Perform maintenance One or more maintenance processes must Perform maintenance be carried out see Chapter 10 Maintenance 30032 Printer printer lever Printer lever is open Close printer lever opened see Chapter 10 Maintenance section Replacing printer paper on page C 25 30033 Printer No paper No paper available Insert printer paper see Chapter 10 Maintenance section Replacing printer paper on page C 25 30034 HW test error fan Result of the general hardware test Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support and supply the error number 30037 Screen sharing active A service connection was established to This message will be removed af
40. date 31 1 2007 M TEILE ET qe ma Material AUTO TROL PLUS B Level 1 21744302 8 AUTO TROL PLUS B Level 2 21750102 1 3 2175 j C AUTO TROL PLUS e 21750402 0 Delete ea Matchange1410 Systemcal 1502 08112006 1440 Figure B 21 The selected material level combination is assigned to a mat A F by pressing Set EH Press the Back button to save the material assignment Roche Diagnostics April 2009 B 38 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Material setup Inserting the AutoQC mats Starting with the top level of the Analyzer mode insert the ampoule mats in the ampoule holder as follows 1 Pullout the AutoQC drawer The following screen appears a AUTO TROL AUTO TROL AUTO TROL PLUSB PLUSB PLUS B Level 3 Level 2 Level 1 Lot number Lot number Lot number 21750402 21750102 21744302 Exp date Exp date Exp date 31 1 2007 31 1 2007 31 10 2006 0 Ampoules 0 Ampoules 0 Ampoules Details Details Details Refill Refill Refill Fee ga Mat change 1410 System cal 1502 08112008 1440 Figure B 22 2 Take a full mat 20 ampoules from the package 3 Turn the mat so that the necks of the ampoules face down Gently wave but do not shake the mat and ensure that the necks of the ampoules are free of air bubbles Figure B 23 AutoQC Mat 4 Place the mat in the defined position of the ampoule block so that the
41. power supply is connected No reverse compatibility from Variant 2 to Variant 1 possible April 2009 A 22 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions System description Barcode scanner Figure A 9 Barcode scanner Scanning of electrode data type lot expiration date Scanning of patient or user identity Scanning of QC data QC material lot basis expiration date target values etc Scanning of desired alphanumeric code ae Press the button on the underside to activate the scanner A beeping sound and a brief illumination of the LED on the upper side indicate the successful scanning of the barcode For more detailed information please see enclosed manual of the PS2 hand held scanner A included in scope of delivery Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 23 2 General descriptions cobas b 221 system System description Warning and identification labels incl nameplate Usage in vitro In vitro diagnostikum Laboratory Use Suivre les instructions de la notice d utilisation F lj bruksanvisningen t US Electrical Equipment Utilisation r serv e un personnel Endast f r anv ndning av specialister Attention Non reparable par l utilisateur Depannage realisable Varning Enheten far endast ppnas och repareras av utbildad LISTED smiuiement par un tociaiolon quM NS servicepersonal UN i
42. 0613 0 06 O Hb 97 9 0 0684 0 07 COHb 1 4 0 0377 2 79 MetHb 0 7 0 0287 4 10 HHb 0 1 0 0601 Table A 5 Tonometered human whole blood 20 different probands n 80 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 61 4 Specifications cobas b 221 system Performance data Material tonometered human whole blood 20 different probands n 80 Parameter Mean Sur CV St CV 90 pH 7 129 0 0049 0 07 PCO 79 5 1 2629 1 59 1 9644 2 47 PO 40 1 0 3297 0 82 0 5976 1 49 Sodium 142 3 0 7126 0 50 Potassium 4 32 0 0392 0 91 Chloride 105 2 0 5184 0 49 ionized Calcium 1 301 0 0136 1 05 Het 40 4 0 2795 0 69 Lactate 8 7 0 2021 2 33 Glucose 2 3 0 0977 4 31 Urea 4 9 0 0583 1 18 tHb tHb module 15 9 0 1315 0 83 SO tHb module 55 0 0 8839 1 61 tHb COOX 14 1 0 1691 1 20 E SO COOX 67 8 0 2479 0 37 O Hb 66 9 0 3437 0 51 COHb 1 6 0 0549 3 53 MetHb 0 4 0 0504 12 14 HHb 31 5 0 3121 0 99 Table A 6 Tonometered human whole blood 20 different probands n 80 Material human plasma n 80 Parameter Mean Sur CV S1 CV 90 pH 7 670 0 0097 0 13 0 0549 0 72 PCO PO Sodium 140 9 0 7783 0 55 0 9920 0 70 Potassium 3 99 0 0514 1 29 0 0603 1 51 Chloride 106 0 0 4967 0 47 0 7877 0 74 ionized Calcium 1 155 0 0174 1 51 0 0339 2 94 Hct Lactate 2 3 0 0349 1 52 0 1150 5 00 Glucose 5 7 0 0818 1 44
43. 2009 Instructions for Use Revision 10 0 A 57 4 Specifications cobas b 221 system Contents Roche Diagnostics April 2009 A 58 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Performance data Measurement parameters Performance data Parameter specified for specified range PO B Q 0 800 mmHg PCO B Q 4 200 mmHg pH B Q S PF 6 0 8 0 Sodium B Q S A D 20 250 mmol L Potassium B Q S A D 0 2 20 mmol L Chloride B Q S 20 250 mmol L ionized Calcium B Q S A D 0 1 4 0 mmol L 0 4008 16 032 mg dL Hct B Q 10 80 96 Glucose cobas b 221 lt 5 gt system B Q S 0 5 40 mmol L 9 01 720 8 mg dL cobas b 221 lt 6 gt system only Lactate cobas b 221 lt 5 gt system B Q S 0 2 20 mmol L 1 8016 180 16 mg dL cobas b 221 lt 6 gt system only Urea cobas b 221 lt 6 gt system only B Q S 0 5 30 mmol L 3 0028 180 168 mg dL tHb module B Q 3 25 g dL 1 8606 15 505 mmol L SO module B Q 50 100 96 tHb COOX B Q 3 25 g dL SO COOX B Q 0 100 96 HHb COOX B Q 0 100 96 COHb COOX B Q 0 100 96 O Hb COOX B Q 0 100 96 MetHb COOX B Q 0 100 Bilirubin neonatal COOX B Q 3 50 mg dL 51 3 855 umol L Baro 450 800 mmHg Table A 1 Measurement parameters a Due to the current specifications clinically significant deviations in the range 3mmol L can occur compared to other glucose measuring systems Especially in the neo
44. 221 system Status messages of measuring and calibration values No Message Cause Action 6030 COOX HW error A hardware error occured at the COOX see Details of module stop 20068 on module page D 13 20069 on page D 13 und 20071 on page D 13 6031 Neon lamp not OK The light value of the neon lamp is too Perform Internal cleaning low System gt Wash amp Cleaning gt Possible causes Cleaning module select appropriate module Cuvette soiled gt Start internal cleaning Optical fiber damaged Perform Polychromator calibration Polychromator electronics defective System Calibration If the error persists contact Technical Support 6032 Halogen lamp not OK The light value of the halogen lamp is too Perform Internal cleaning low System gt Wash amp Cleaning gt Possible causes Cleaning module select appropriate module Cuvette soiled gt Start internal cleaning Optical fiber damaged Perform Polychromator calibration Polychromator electronics defective System Calibration If the error persists contact Technical Support 7034 Solution exhausted The pH value of the O zero point To correct the error replace S2 Fluid Pack solution is lt 5 see Chapter 10 Maintenance section Possible causes Exchange of solutions and packs on e Solution exhausted page C 13 e Impurity in pack 8036 Ifs not OK The BSA Glu or BSA Lacratiosin CAL3 Perform Calibration for Ready are outsid
45. 4 92 Glucose 5 4 0 0612 1 12 0 1299 2 38 Urea 23 5 0 3307 1 41 0 6664 2 84 tHb tHb module SO tHb module tHb COOX 7 8 0 0317 0 41 0 0599 0 77 SO COOX 72 1 0 0690 0 10 0 1941 0 27 O Hb 46 8 0 0844 0 18 0 2383 0 51 COHb 23 0 0 0371 0 16 0 1043 0 45 MetHb 12 0 0 0180 0 15 0 0513 0 43 HHb 18 1 0 0294 0 16 0 0830 0 46 Bili 6 1 0 0287 0 47 0 0477 0 78 Table A 10 AUTOTROL PLUS B Level 1 n 40 Material AUTOTROL PLUS B Level 2 n 40 Parameter Mean Sur CV S1 CV pH 7 411 0 0031 0 04 0 0047 0 06 PCO 41 0 0 4626 1 13 0 7116 1 74 PO 93 2 2 9752 3 19 5 0160 5 38 Sodium 139 6 0 3827 0 27 0 7718 0 55 Potassium 4 76 0 0131 0 27 0 0250 0 53 Chloride 101 0 0 3290 0 33 0 9795 0 97 ionized Calcium 1 154 0 0064 0 55 0 0138 1 20 Het 38 6 0 2840 0 74 0 6195 1 60 Lactate 1 9 0 0135 0 70 0 0798 4 12 Glucose 2 4 0 0197 0 81 0 1172 4 83 Urea 7 3 0 0538 0 74 0 1939 2 67 tHb tHb module SO tHb module tHb COOX 12 1 0 0715 0 59 0 1182 0 98 SO COOX 89 6 0 1442 0 16 0 1507 0 17 O Hb 74 3 0 2843 0 38 0 3011 0 41 Table A 11 AUTOTROL PLUS B Level 2 n 40 Roche Diagnostics April 2009 A 64 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Performance data Parameter Mean Sur CV Sr CV COHb 11 1 0 1265 1 14 0 1306 1 18 MetHb 6 0 0 0577 0 96 0 0671 1 12 HHb 8 6 0 1001 1 17 0 1041 1 21 Bili 12 4 0 0857 0 69 0 1188 0 96 Table A 11 AUT
46. 6 gt system all ISE parameters except for Hct Hct pH and PCO PO The following calibrations can be performed Calibration for Ready The system automatically selects a calibration which will transfer all selected parameters to the state Ready System calibration 1P calibration 2P calibration Mixing system Calibration of the conductivity system COOX calibration for instruments with COOX module only Fora detailed description of how to do this see Chapter 10 Maintenance COOX calibration for instrument versions with COOX module only on page C 10 Polychromator calibration for instruments with COOX module only Wavelength calibration of polychromator To execute the desired calibration first press the corresponding selection button Activate the calibration by pressing the Start button April 2009 Instructions for Use Revision 10 0 B 67 8 Calibration cobas b 221 system Display of parameters during calibration Display of parameters during calibration A I cc Interrupt Figure B 47 System calibration The already calibrated parameter is also intended for the current calibration The parameter which was not calibrated previously is also intended for the current calibration The parameter is currently being calibrated chances for a successful calibration are very high The parameter is currently being calibrated chances for a successful calibration are very low
47. C 32 After the cleaning perform a polarization of the new MSS cassette Using the function Decontamination all the tubing paths in the instrument can be decontaminated In order to ensure the quality of the measurement results complete a quality control test on 3 level low normal high after the decontamination routine System Wash amp cleaning Decontamination This decontamination is carried out in a similar way to the shut down routine except that deproteinizer is used instead of distilled water The shutdown kit is required for carrying out this function The decontamination procedure must be carried out completely and may not be interrupted Observe the listed sequence while performing the actions April 2009 C 20 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Sample dependent maintenance procedures Processing the actions Manual The corresponding line of the list box contains an instruction which must be performed manually Then press Confirm action Automatic If there is an automatic sequence for any action you can start this by clicking Start process i If an action has been completed successfully manually or automatically this symbol is displayed Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 21 10 Maintenance cobas b 221 system Unscheduled Unscheduled Exchanging the fill port A Dispose of the used
48. Diagnostics QC setup wizard 1 Usingthe Mon Sun buttons select the day of the week on which the AQC measurement is to be carried out 2 Enter starting time and change the number of Repeats 3 Press the Apply QC timing button The entries are saved If when entering the start time there is an overlap with another QC measurement a corresponding message is displayed EN E Ira This time is already in use Mon 07 00 Continue E la Sensor changing 21 12 2007 1P cal 16 19 11 12 2007 15 46 Figure B 35 If no day of the week was selected the QC times cannot be accepted and a corresponding message is displayed At least one day must be selected ining Continue les Sensor changing 21 12 2007 1P cal 16 19 11 12 2007 15 45 Figure B 36 April 2009 Instructions for Use Revision 10 0 B 49 7 Quality control cobas b 221 system QC setup wizard Press this button to exit the QC setup wizard and save the input Press this button to save the input and restart the QC setup wizard Press this button to save the input and switch the display to the section for assigning mats see the section on Assigning the mats on page B 47 AA Other options for starting the QC setup wizard are Q e Pressing the buttons Setup gt QC material gt QC setup wizard Follow the additional instructions on the screen Roche Diagnostics A
49. Fluid Pack for the next calibrations with the aid of the valves VM and V19 Glass tube see Sample inlet path SIP Hematocrit in short Hct is the ratio of the volume of blood cells mainly the red blood corpuscles to the total volume of blood Hemoglobin is the main component of the erythrocytes and serves for transporting oxygen Hemolyzer The sample is exposed to a strong ultrasound field whereby the cell membranes of the erythrocytes are destroyed and the hemoglobin released Heparin salts are the only permissible anticoagulants Input unit Consists of the T amp D module and the sample drip tray ISE Abbrev for ion selective electrode ISE measuring chamber The ISE measuring chamber with its sensors serves for measuring the hematocrit value and the electrolyte values Na K Ca and CI Roche Diagnostics Levey Jennings diagram QC statistical values chart LF Conductivity Linear bracket White plastic part of the peristaltic pump MC Abbrev for measuring chamber Measurement evaluation Before clinical decisions are made on the basis of the results the plausibility of all the measuring results obtained must always be checked by medical specialists thereby taking the clinical situation of the patient into account Measuring chamber cassette serves for transporting the samples and calibration solutions to the waste system after a measurement and or calibration and for adding the reference
50. If this interference applies to the complete module the reference electrode must be replaced lt D see Chapter 10 Maintenance section Changing the reference electrode on page C 29 In the case of individual electrodes they must be checked for air bubbles Carefully tap against the electrode body with a finger nail to release any air bubbles from the membrane see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 Perform Calibration for Ready System gt Calibration Start Stability monitor System gt Diagnostics gt Stability monitor and check Details of the Sensor slope IIf the electrode MSS cassette is defective it is displayed Replace the corresponding electrode or the MSS cassette lt D see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 bzw Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 April 2009 D 28 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 2012 Sensor signal drifting Sensor signal is too high Perform Calibration for Ready Possible causes System gt Calibration Invalid sample type is being used ferror cannot be corrected start e Rinse contaminated Stability monitor Rinse problem during aspiration System gt Diagnostics gt Stability monitor e Air bu
51. Interferences Substance Ca Na K CI Sodium bromide 102 9 mg dL MW DK SD n 16 000 0 000000 2 14 81 3 87 MWD 0000000020000 2 118 38 MW K L 2 p 5000000002000 2e 103 58 Sodium citrate diluted 1000 mg 100 mL MW I K SD n 16 1 05 0 02 60 79 1 36 0 58 0 04 9 MW I 0 01 204 59 3 86 MW K 1 04 143 80 3 95 0 Sodium chloride 140 mmol L MW I K SD n 16 0 19 0 01 37 23 0 45 28 46 4 20 MW I 1 28 179 68 132 59 MW K 1 08 142 40 2 rr 104 13 Sodium chloride diluted 120 mmol L MW D K SD n 16 16 29 0 43 13 72 2 04 MWD b c 158 43 119 86 MW K 142 44 106 14 Sodium chloride diluted 130 mmol L MW I K SD n 16 0 12 0 01 25 73 0 44 20 90 2 75 MW I 1 24 167 99 9 124 35 MW K 1 12 142 26 103 45 Sodium hydrogen carbonate 336 mg 100 mL MW I K SD n 16 0 14 0 01 3245 0 61 700000 MW I 1 00 175 98 ze 00000 MW K 1 14 143 53 50000000 eee ene Table B 3 Interferences pH ISE Roche Diagnostics April 2009 B 12 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Interferences MSS Substance Glu Lac Ascorbic acid 3
52. PLUS B Level 2 O O O O O O O O O O 03321177001 BP9095 AUTO TROL PLUS B Level 3 O O O O O O O O O O 03321185001 BP9096 COMBITROL PLUS B Level 1 O O O O O O O O O O 03321193001 BP9097 COMBITROL PLUS B Level 2 O O O O O O O O O O 03321207001 BP9098 COMBITROL PLUS B Level 3 O O O O O O O O O O 03321215001 BP9099 COOX MSS Verification Material O O O O O O O O O O 03354628001 BP9403 TS MSS Verification Material O O O O O O O O O O 03354601001 BP9407 9 Table E 3 a Only for USA available O Can be used Roche Diagnostics April 2009 E 6 Instructions for Use Revision 10 0 cobas b 221 system 12 List of consumables Accessories Order information Parameter cr Na kt Ca PCO PO pH tHb SO COOX Bili MSS Deproteinizer O O O 03110435180 BP0521 Adapter for Capillaries O O O 03069931001 BP0959 Ampoule Adapter O O 0 03066762001 BP1938 Clot Catcher O O O 03112012180 BP2243 Cleaning Kit for Cl Electrode 03112098035 BP2276 Adapters for Sample Container O O O 03112101180 BP2277 Caps for Roche MICROSAMPLER O O O 03112152180 BP2288 Thermo Printer Paper O O O 03113361180 HP0107 Roche MICROSAMPLER non sterile O O O 03113434035 MC0015 Roche MICROSAMPLER sterile O O O 03113442180 MC0017 Roche MICROSAMPLER O O O with accessories 03113663160 US0600 Roche MICROSAMPLER O O O w o accessories 03113671160 US0601 Capillary Tubes 200 uL O O O 03113477
53. Possible causes Fill routines Reference system not filled Check seat of the electrode Leak in the measuring channel Ifthe error persists replace electrode MSS cassette lt D see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 bzw section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 8078 IfS ADC Interference sensor signal is below ADC Perform Fill reference electrode Tange System gt Utilities gt Fluid actions gt Fill Possible causes routines Reference system not filled Check seat of the electrode Leak in the measuring channel Ifthe error persists replace electrode MSS cassette see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 bzw section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 8080 Interferences 4 Detected sample type is invalid e Check sample material Possible causes Interferences e Unsuitable sample type used 8081 Interferences 5 The calculated COHb value is outside the Check sample material permitted range Possible causes Interferences Unsuitable sample type used 8082 Interferences 6 The calculated SO value is outside the e Check sample material permitted range Possible causes Interferences Unsuitable sample type used Table D 6 Status messages of measuring and calibration values
54. Possible causes If the error persists contact Technical Support Anunapproved calculation operation occurred 5007 Calculation error 2 UC calculation error Remove the affected electrode and reinsert it Possible causes If the error persists contact Technical Support e An unapproved calculation operation occurred 5010 Calculation error 3 UC calculation error COOX Turn the instrument off and on again Possible causes If the error persists contact Technical Support e An unapproved calculation operation occurred 5011 Calculation error 4 UC calculation error 4 COOX Perform Polychromator calibration Possible causes System gt Calibration e An unapproved calculation operation Turn the instrument off and on again occurred If the error persists contact Technical Support 5012 Calculation error 5 UC calculation error 5 COOX Check the cuvette for soiling Possible causes Perform Polychromator calibration e An unapproved calculation operation System gt Calibration occurred Turn the instrument off and on again If the error persists contact Technical Support 6026 ADC error e To correct the error turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 35 11 Troubleshooting cobas b
55. QC material Instrument Figure B 54 For a detailed description see the Reference Manual chapter Software modes section Analyzer gt Setup April 2009 B 80 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Data manager Data manager Use this function to retrieve the following data Patients Instrument QC data Utilities Figure B 55 For a detailed description see the Reference Manual chapter Softwaremodi section Data manager General data manager functions 1 Details all the available detailed information for the selected dataset is displayed and can be edited m 9 Find the function allows to search for datarecords using defined search criteria Sort this function allows to sort the recordings Marker the current datarecord is permanently marked and now has a yellow background to make it more easily visible Mark range use this function to mark a range Tip The marking criterion corresponds to the current sort criterion of the datarecords Print the datasets of a marked range or of a marked line are printed out Delete the datasets of the marked range or the marked line are deleted More additional available functions are displayed ND Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 81 9 Software modes cobas b 221 system Data manager Roche Diagnostics Ri lt x
56. RR Se eb ex eee ee B 63 SOMWATEINOUES ee cc px ticae HA sr ewe urate te B 69 cobas b 221 system 6 Measurement Contents Measurement In this chapter all information necessary for carrying out measurements is described In this chapter Chapter 6 Preanalyti c 5 Sample collection AAA CO O et oreet egere eset ep ee ones es etta 5 Sample acquisition ueseeeeeoeeonneeetertt oreet eter eee 5 Anticoagulants nn eadeseden eadeni da 5 Sample collection especially for tHb SO and Hct measurement 5 Sample collection especially for glucose lactate measurement cobas b 221 lt 5 gt system cobas b 221 lt 6 gt system only sess 6 Sample collection especially for bilirubin measurement cobas b 221 lt 2 gt system cobas b 221 lt 4 gt system cobas b 221 lt 6 gt system nu M aPraNs 6 Sample AA reete eee ee eee ien 7 Syrtes iS 7 Capillary Tubes rakada 7 Roche MIGROSAMPEER dora 7 Clot catcher en AAA A BE 8 Sample DIS ii e ie i ORE TEE RE URS 8 Whole blood erre eee EH eR E YR CH C PR i 8 ISO 05 002 shhh RGR AA LEV EET 9 PA e e eet de ee ai de e D ERR E ERU S 9 Pleu ral fl itd RA det ott ense teda ede NT 9 Interferences a oe Ap REOR a RA hal 10 CEL D SOs C M 10 A uu E 11 MSS raconte n RN tete e edes 13 Hb derivatives and bilirubin es
57. Table A 37 Parameter Lactate mmol L Correlation Slope 0 961 1 041 Intercept t 0 191 Correlation coefficient 0 9989 April 2009 A 76 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Parameter urea mmol L Parameter glucose mmol L Roche Diagnostics Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Performance data Expected value Mean Sur Recovery 0 6 0 83 0 0145 138 8 7 50 7 58 0 0921 101 0 15 00 14 84 0 2328 98 9 22 50 22 13 0 3211 98 4 30 00 29 62 0 5094 98 7 Table A 38 Parameter Urea mmol L Correlation Slope 0 979 1 021 Intercept 0 198 Correlation coefficient 0 9991 Material NIST 965 Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Swr Recovery 5 68 5 56 0 1221 97 9 11 10 11 01 0 2250 99 2 16 36 16 69 0 3826 102 1 Table A 39 Parameter Glucose mmol L Correlation Slope 0 9591 1 0426 Intercept 0 4273 Correlation coefficient 0 9991 April 2009 Instructions for Use Revision 10 0 A 77 4 Specifications cobas b 221 system Performance data Parameter sodium mmol L Material NIST 956a Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Parameter potassium mmol L Roche Diagnostics Expected value Mean Sur Recovery 121 40
58. This module guarantees the fastest possible distribution of the different fluids Tension lever Plexiglass cover on the peristaltic pump tHb calibrator A calibration solution with known tHb value for calibrating the COOX module tHb SO module An optical measuring module for determining the total hemoglobin and the oxygen saturation in the whole blood Tonometered whole blood Whole blood is set with the aid of precision gas to expectancy values to be calculated for PO and PCO Transverse channel serves for optimum thermostatizing and distribution of samples and calibration solutions to the measuring modules Urea Urea diamide of carbonic acid Lat urea pura is an organic compound and is produced as an end product of the metabolism of nitrogen compounds e g amino acids produced in the so called urea cycle and then excreted in the urin Vacuum pump Responsible for washing and drying the tubing with the exception of the measuring chambers Valve V19 Air mixing valve Valve VM Mixing valve for calibration solutions CAL A and CAL B from S2 Fluid Pack W Waste Container Waste container Roche Diagnostics April 2009 E 12 Instructions for Use Revision 10 0 IL Indek nd en rts ve Pl Pe he aad ges F 3 cobas b 221 system Index Index Numerics 1P calibration 1P cal incl O B 66 2P calibration 2P cal B 65 A Abbreviations 8 Accessories A 28 Acid base map B 28 Air
59. Turn amp dock Total hemoglobin Underwriters Laboratories Inc Association of German Electrical Engineers Verband Deutscher Elektrotechniker For writing the measuring calculated and input values see Chapter 9 Softwaremodi gt Parameter on page B 75 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 9 cobas b 221 system Roche Diagnostics April 2009 10 Instructions for Use Revision 10 0 Introduction and specifications A O A amp NN Dae DIODORUS Sas rud etc a ahi eee ERO eke ea A 3 General descrip hons ds Ao SS A 7 Installation and shutdown A ER A 25 SPCCIICAMONS AAA A 57 Theoretical foundations s ecu AAA A 95 cobas b 221 system 1 Safety information Contents Safety information Roche Diagnostics The information provided in this chapter is essential for the safe trouble free operation of the instrument and must be read and understood by the user In this chapter Chapter a Important information amenena r ONON Operating safety information April 2009 Instructions for Use Revision 10 0 A 3 1 Safety information cobas b 221 system Contents Roche Diagnostics April 2009 A 4 Instructions for Use Revision 10 0 cobas b 221 system 1 Safety information Important information Important information These Instructions for Use contain vital warnings and safety information This instrument is intended to be used
60. Wash amp Cleaning calibrated If the error persists contact Technical Support 10050 Error SS3 The optical sample sensor in the Hb Perform Wash again cartridge could not be calibrated System Wash amp Cleaning If the error persists contact Technical Support 10051 ErrorSS4 The optical sample sensor at the input of Perform Wash again the MSS module could not be calibrated System gt Wash amp Cleaning If the error persists contact Technical Support 10052 Error SS6 The optical sample sensor in the middle Perform Wash again of the sample inlet path could not be System Wash amp Cleaning calibrated If the error persists contact Technical Support 10054 Baro sensor error The measured barometric pressure falls Contact Technical Support outside the specified range 10056 Process error additional A subprogram did not report back Press Continue to correct the error 10067 information Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10088 ADC error Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10089 Comm error additional A subprogram did not report back e Press Continue to correct the error 10094 information Ifthe error persists turn the inst
61. a position using Delete 1 Press Set a material level combination is assigned to a mat A F 2 Take a full mat out of the package 3 Tun the mat so that the ampoule necks point down Turn the mat twice do not shake it April 2009 Instructions for Use Revision 10 0 B 47 7 Quality control cobas b 221 system QC setup wizard 9 AQC timing D Roche Diagnostics Ensure that the ampoule necks are free of air bubbles Figure B 33 4 Insert the mat into the previously defined position A F of the ampoule block 5 Close the AQC drawer The ampoule status is automatically set to 20 You cannot change the number of ampoules in the QC setup wizard Ifa lot change has been carried out the AQC times are already defined and are accepted automatically Using this function depending on the newly installed material level combination the start time s for the AutoQC measurement s are defined and or the time is determined After the set time is reached a note appears in the message window System stop ERN EZE AUTO TROL PLUS B Level2 Lot 21460803 Select and apply QC timing LJ time 4 _ _ rae og E aa Sensor changing 21 12 2007 1Pcal 1619 1112207 1528 Figure B 34 All previously defined AQC times are shown in the list April 2009 B 48 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Roche
62. above sea level or air pressure lt 526 mmHg 70 13 kPa the specifications for parameter PO are no longer fulfilled and the parameter must no longer be used for evaluation of the clinical decisions The parameter PO must be permanentely deactivated 2 To deactivate the parameter PO press the following buttons C Setup gt Parameter gt Miscellaneous settings gt Activated deactivated for calibrations 24 Quality control 1 Define the material and if an AutoQC drawer option is available insert the mats before performing a quality control measurement For details see Chapter 7 Quality control 2 Perform quality control tests for all 3 levels low normal high Make sure that the results agree with the target values See Chapter 7 Quality control Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 47 3 Installation and shutdown cobas b 221 system Shutdown Shutdown Less than 24 hours A Longer than 24 hours A Roche Diagnostics Manual Automatic If the cobas b 221 system is not used for a short period of time only lt 24 hours then activate the following function starting with the top level of the analyzer mode System gt Utilities gt Shutdown PC This function allows for switching off the touch screen PC unit and is completed with manually switching off the instrument Follow the instructions on the screen MSS sensors Glu Lac Urea BUN
63. ampoules are no longer visible April 2009 B 39 Roche Diagnostics Instructions for Use Revision 10 0 7 Quality control cobas b 221 system Material setup 5 Press Refill The following question appears NE Is the material from the same lot Details Details Details Refill Fee ga Mat change 14 10 System cal 1502 08112008 1440 Figure B 24 6 Press Yes if the mat is replaced with a new one of the same lot The number of the ampoules is set to 20 AUTO TROL AUTO TROL AUTO TROL PLUSB PLUSB PLUSB Level 3 Level 2 Level 1 Lot number Lot number Lot number 21750402 21750102 21744302 Exp date Exp date Exp date 31 1 2007 31412007 31 10 2006 20 Ampoules 20 Ampoules 20 Ampoules Details Details Details Refill Refill Refill Fee fea Mat change 14 10 System cal 1502 08112008 1440 Figure B 25 7 Incase the mats that are not completely filled press Details By pressing the corresponding key the status of the selected ampoule can be changed and or the ampoules to be measured can be selected blue full gray empty Roche Diagnostics April 2009 B 40 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Material setup ENECICINEEN 1 NNNIIDDTTITSRNNEN m Mat B Materia AUTO TROL TS Level 2 Lot number 21820601 Exp date 28 2 2003 11 Ampoules blue full gray empty DIDBGOBBBHE amp Figure B 26
64. and rinse solution S1 Module stop A certain module is not ready for use Nevertheless the parameters of other modules can still be measured MSS Abbrev for metabolite sensitive sensors MSS cassette is a multi parameter sensor and contains the spots for measuring Glu Lac Urea Bun MSS measuring chamber The MSS measuring chamber with its sensors serves for measuring glucose lactate and urea BUN MSS polarization serves for wetting and preparing the MSS cassette Multirules The valuation of the QC results is based on the Westgard rules and their interpretation for the blood gas analysis The multirule procedure was derived from this It enables malfunctions of the instrument to be detected at an early stage NIST standards define precise sera with certified expected values April 2009 E 10 Instructions for Use Revision 10 0 cobas b 221 system Glossary Patient Trend Diagram Using this diagram the course of individual parameters measuring and calculated values of a patient over an indefinite period of time can be shown and printed out Peristaltic pump see Pumps Plasma Plasma samples are obtained by centrifuging heparinized whole blood whereby cellular cell parts of the blood are separated Pleural fluid Pleural fluid is a serous fluid produced by the pleurae Pleural space The thin space between the two pleural layers is known as the pleural space Plug monitoring Infrared light barri
65. are destroyed during this operation If the instrument is turned on again a new MSS cassette must be inserted See section 19 Open the measuring chamber cover and insert the sensors on page A 40 If the cobas b 221 system will be shut down for longer than 24 hours perform the following procedure Before performing a shutdown Roche Diagnostics recommends decontaminating all surfaces and tube paths lt D see Chapter 10 Maintenance Abschnitt Decontamination on page C 5 Activate the following function starting with the top level of the analyzer mode System gt Utilities gt Put out of operation All solutions and electrodes have to be removed during the shutdown procedure The procedure ends in switching off the instrument Follow the instructions on the screen Observe the listed sequence while performing the actions Processing the actions The corresponding line of the list box contains an instruction which must be performed manually Then press Confirm action If there is an automatic sequence for any action you can start this by clicking Start process April 2009 A 48 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Shutdown v j Upon successful completion this symbol is displayed 1 Open bottle compartment cover and only remove bottle S1 and packs depending on the configuration S2 and S3 1 Open bottle compartment cover and docki
66. chamber A 19 Measuring procedure B 19 Aspirate from syringe B 21 Capillary measurement B 21 Data input B 24 Acid base map B 28 Last patients B 28 Mandatory input B 24 Patient trending map B 27 Result B 26 Sample distribution B 25 Syringe mode B 19 Metabolites B 18 Miscellaneous reports B 91 Module stops D 12 MSS Interferences B 13 MSS cassette General notes on the use of the MSS cassette A 16 Inserting the MSS cassette A 17 MSS cassette removed from the measuring chamber A 16 MSS measuring chamber Incompatible substances A 16 Multirules B 53 Overview of the Multirules B 54 o Operating instructions A 11 Operating safety information A 6 Operator s Manual conventions used 5 find information 5 how to use 5 version 1 Order information E 5 Accessories E 7 Electrodes E 5 April 2009 Instructions for Use Revision 10 0 F 5 Index cobas b 221 system QC material E 6 Solutions E 6 P Parameter Calculation values B 74 Calculation values at the patient s temperature B 75 Display on the Ready screen analyzer mode B 73 Input parameters B 75 Measurements depending on configuration B 73 Notation of the measurement input and calculation values B 73 Parameter icons B 73 Parameter report B 91 Parameters and calculations A 97 Patien
67. cobas b 221 system Installation Accessories Roche Diagnostics The following parts are delivered as standard equipment with the cobas b 221 system 1 barcode scanner 2 Power cords US and European version 1 roll printer paper 2pcs fill port e 1 sample inlet path glass tube e 5 system disks 1 RCon reference contact e lshutdown kit 1dummy electrode 1dummy MSS cassette e 2SCon sensor contact 113mm wrench for screen PC unit 1 Phillips screwdriver 3 pump tubes Not shown in Figure A 12 on page A 29 e lscreen PC unit e 1 power supply e 1 fill port e 2 system disks April 2009 A 28 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown 1 Roll printer paper 1 Dummy electrode 1 Dummy MSS cassette RCon reference contact SCon sensor contact 7 M OO 8 gt 1 Sample inlet path glass tube 2 Power cords US and European version System disks total of 5 pcs 113mm wrench for screen PC unit 1 Phillips screwdriver 1 Barcode scanner K 1 Fill port L 3 Pump tubes M 1 Shutdown kit Installation Figure A 12 Accessories Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 29 3 Installation and shutdown cobas b 221 system Installation Installation 1 Screen PC unit A Roche Diagnostics Ensure that the printed serial number on th
68. compartment 1 Open the bottle compartment cover and the docking mechanism 3 2 Loosen the screws A of the aluminum part of valve V19 approx 2 3 turns y A Screws Figure A 50 Valve V19 3 Close the docking mechanism 3 and the bottle compartment cover 15 Remove right FMS tube at VM bottle compartment 1 Open the bottle compartment cover and the docking mechanism S3 2 Slide the tube out under the tube clip of valve VM Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 53 3 Installation and shutdown cobas b 221 system Shutdown A VM B Tube clip Figure A 51 Valve VM 3 Pressure is removed from the tubes 4 Close the docking mechanism and the bottle compartment cover If available option 16 Go to AutoQC home position Press Start process This action is performed automatically 17 Open the AutoQC drawer and remove the ampoule holder 1 Pullout the AutoQC drawer 2 Remove the AutoQC ampoule holder 3 Remove the already opened ampoules from the mats and dispose of them according to the local guidelines If individual ampoules remain in the white ampoule holder after removing the mats note that these open ampoules may break on removal with the attendant risk of injury Before inserting a new mat remove them all carefully Always wear gloves CAUTION Danger of spilling 4 Leavethe full ampoules in the mats and store them in a refrigerator in accordance
69. contact Technical Support 1006 Irregular sample 1 The measuring chamber is not filled homogeneously Possible causes The sample was irregular e Leak in measuring channel e Air bubbles were detected in the measuring channel e Repeat measurement calibration If the error persists contact Technical Support 1007 Cuvette not empty A sample detection was not possible Possible causes Deposits in the cuvette Light level too low e Perform Internal cleaning System gt Wash amp Cleaning gt Clean module select appropriate module gt Start internal cleaning If the error persists replace PP tube main pump lt D see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 If error cannot be corrected contact Technical Support 1008 Irregular sample 2 The conductivity changed after closing the valve at the measuring chamber input Possible causes Insufficient wetting in the measuring channel Separation of the electrode diaphragm Leaky electrode Perform Wetting routine System gt Utilities gt Fluid actions If error cannot be corrected contact Technical Support 1009 Sample pos error 3 The measuring signal was not constant or the measuring channel was not uniformly filled Possible cause Sample was fragmented Ensure sufficient uniform sample input If the error persists contact Technical Support 1010 Sample pos
70. error 4 The conductivity was too high Possible causes Aspiration problems with standby solution PP tube defective Check PP tube MSS outlet and if necessary replace lt D see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 e Perform Aspirate standby solution System gt Utilities gt Fluid actions gt Fill routines If error cannot be corrected contact Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 21 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 1011 Sample pos error 5 No constant conductivity at sensor input was detected Possible causes Blockage or leak e PP tube MSS outlet defective Check PP tube MSS outlet and if necessary replace see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 Perform Aspirate standby solution System gt Utilities gt Fluid actions gt Fill routines Perform Calibration for Ready System gt Calibration If error persists perform Wetting routine System gt Utilities gt Fluid actions If the error persists perform General fluidics test System gt Diagnostics and afterwards contact Technical Support 1012 Sample pos error 6 Conductivity at sensor input was t
71. fill port in accordance with local regulations hazardous waste Activate the following function starting with the top level of the analyzer mode C System gt Wash amp cleaning gt Clean input unit 1 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant 2 Open the T amp D cover 3 Rotate fill port 90 downward and carefully remove it from the needle A Needle Figure C 16 4 Insert new fill port A Do not bend the needle 5 Close the T amp D cover 6 Reinsert the sample drip tray 7 Close the bottle compartment cover Roche Diagnostics April 2009 C 22 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Unscheduled Exchanging the peristaltic pump tubes cy A B C A Main pump C MSS input pump B MSS output pump Figure C 17 Peristaltic pump When changing the peristaltic pump tubes proceed as follows Activate the following function starting with the top level of the analyzer mode C Quick access gt Maintenance 1 Select the appropriate pump tube to be changed from the list and press Perform 2 Remove the top cover 3 Open the peristaltic pump s clear plastic cover tension lever see below A A Tension lever B Pump head C Linear bracket Figure C 18 Peristaltic pump Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 23 10 Maintenance cobas b 221 system Unscheduled
72. gt Measurement report Starts the printout of the measurement report April 2009 B 26 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Patient trending map Roche Diagnostics Measuring procedure By means of this map the course of individual parameters measurement and calculation values of a patient over any required period standard setting one day can be shown and printed out C I 18 10 2005 PCO 52 0 mmHg PO 1412 mmHg pH 7258 Last Name Hct Out of range First Name Car 1 599 mmol Temperature 440 C K 2 62 mmol FIO 021 Na 114 2 mmol Sample type Blood Ici 73 1 mmol Blood type Unknown tHo Not calibrated Operator ID so Not calibrated Age AF gt 1 year O Hb Not calibrated Patient trending map System cal 15 02 08 11 2006 Map explanation Ca Ha PCO 18 10 2005 00 31 Ca 1 580 mmol 0 0 K 2 62 mmol 0 0 Na 113 5 mmol 0 0 PCO 55 0 mmHg Y 8 10 2005 00 31 18 10 2005 00 39 System cal 15 02 08 11 2006 1440 Mat change 14 10 Figure B 12 Should another start end date and or another start end time be required it can be entered manually see above For reasons of clarity only four parameters can be selected from the selection
73. instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Swr Recovery 89 11 88 59 0 6674 99 4 119 43 115 96 0 9763 97 1 Table A 44 Parameter Chloride mmol L Correlation Slope 0 9032 1 1072 Intercept 8 1053 Correlation coefficient 0 9990 April 2009 Instructions for Use Revision 10 0 A 79 4 Specifications cobas b 221 system Performance data Parameter glucose mmol L Material NIST 909b Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 5 40 5 06 0 0294 93 7 15 00 12 17 0 1239 81 1 Table A 45 Parameter Glucose mmol L Correlation Slope 0 7429 1 3461 Intercept 1 0482 Correlation coefficient 0 9997 Parameter urea mmol L Material NIST 909b Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Swr Recovery 5 51 5 40 0 0248 98 0 Table A 46 Parameter Urea mmol L Parameter tHb g dL SO Material Tonometered whole blood Number of instruments 4 cobas b 221 lt 5 gt systems Parameter Slope intercept Coefficient Range n tHb 0 9892 1 0109 0 0833 0 9904 6 18 g dl 250 SO 0 99999 1 00001 0 856 0 9874 51 7 100 382 Table A 47 Parameter tHb g dL SO Roche Diagnostics April 2009 A 80 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Parameter bilirubi
74. is termed oxyhemoglobin O5Hb The percentage of oxyhemoglobin in comparison to total hemoglobin is termed the oxyhemoglobin fraction FO Hb of the total hemoglobin The oxygen bound in this way forms the largest component in the total blood oxygen content approx 9896 Standard values arterial blood at 37 C Adult 90 95 96 or 0 90 0 95 Newborn 40 90 96 or 0 40 0 90 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Critical values OjHb lt 80 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Deoxyhemoglobin is hemoglobin whose two value iron molecule in the hemogroup is capable of binding an oxygen molecule The sum of deoxyhemoglobin and oxyhemoglobin those derivatives capable of transporting oxygen in the blood are termed function hemoglobin Standard values arterial blood at 37 C Adult 1 4 4 9 96 or 0 014 0 049 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Hemoglobin is capable of binding carbon monoxide to the same ratio as oxygen This means that a hemogroup can bind a carbon monoxide molecule However the hemoglobin molecule has an affinity to carbon monoxide 200 300 times greater than to oxygen This is also the reason why very small quantities of carbon monoxide can cause a fatal concentration of COHb in the blood A concentration of approximately 6 COHb has
75. level of the menu tree available Ready screen Quick e laa Ea Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure B 51 On this screen buttons must be pressed to e activate deactivate all available parameters individually activate deactivate a complete module starta measurement start a QC measurement by pressing the QC measurement button call up additional menus The capillary tube shown indicates required sample size depending on parameters selected Roche Diagnostics April 2009 B 78 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Analyzer mode System The following main menus are available E Utilities Diagnostics Calibrations Figure B 52 For a detailed description see the Reference Manual Chapter Software modes section Analyzer gt System Quick access Use these functions to start the following actions Maintenanc Figure B 53 Fora detailed description see the Reference Manual Chapter Software modes section Analyzer gt Quick access Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 79 9 Software modes cobas b 221 system Setup QC measurement Setup Roche Diagnostics This function helps start a quality control measurement For more detailed information see Chapter 7 Quality control Use this function to make the following settings
76. matches the sample to be measured If the sample and sample type do not match incorrect measurements will result Electrolytes It is well known for example that the potassium value of a patient can vary by up to 2096 from the normal state simply because of the presence of a pressure bandage Hence taking a blood sample while a pressure bandage is present should be avoided In general a local hemolysis caused by pressure should be avoided prior to taking a blood sample Blood gas A whole blood sample is prefered for performing these measurements Contaminating the blood sample with air will significantly distort the measurements The notes and restrictions in the section Preanalytics should be observed in any case see section Preanalytics on page B 5 a Mahoney JJ Wong RJ Van Kessel AL Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas Quality Control Material Clin Chem 39 5 874 879 1993 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 17 6 Measurement cobas b 221 system Limitations of clinical analysis tHb SO Metabolites The cobas b 221 system tHb measurement is sensitive to the sedimentation rate of red blood cells particularly if the sedimentation rate is very high as it may be the case e g with special pathological samples The measurement procedure of the cobas b 221 system is designed so that this effect does not occur during the measurement H
77. material level combination and press Mat a 5 O N If no mat position is available a mat position of the main material that does no longer contain an ampoule must be deleted to find out which mat position can be deleted press Info gt AQC status April 2009 B 42 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Material setup 6 Press Set and the selected material level combination will be assigned to a mat A F EH Press this button to store the assignment 7 Press the Analyzer button to change to the analyzer mode 8 Pullout the AutoQC drawer 9 Take a full mat of the follow up material from the package 10 Turn the mat so that the necks of the ampoules face down Gently wave the mat twice but do not shake it Ensure that the necks of the ampoules are free of air bubbles Make sure there are no air bubbles in the ampoule necks 11 Place the mat in the previously defined position A F of the ampoule block 12 Press Refill 13 Close the AutoQC drawer Q At least one mat of the replacement material must be present in the AutoQC module No QC times should be assigned to the follow up material The defined starting times for the AutoQC measurement s are taken over immediately after the current material has been used up for the follow up material of a new lot 14 Next press the following button C Setup gt QC material gt Change lot 15 Select the material lev
78. of the solutions can also decrease the service life of the electrodes In order to ensure the quality of the measurement results complete a quality control test on 3 levels low normal high after each electrode exchange after each exchange of solutions and packs and after startup of the instrument Additionally complete a quality control test on one level between two automatic 2P calibrations The level have to be alternated low normal high Since the measurements of the instrument depend not only on the correct characteristic function but also on a series of marginal conditions e g pre analysis results obtained from the instrument should be submitted for an expert opinion before taking additional measures based on the supplied measurements Caution refer to accompanying documents Please refer to safety related notes in the manual accompanying this instrument Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 5 1 Safety information cobas b 221 system Operating safety information Operating safety information The instrument has been constructed and tested according to the following European Standards IEC EN 61010 1 e IEC EN 61010 2 101 e IEC EN 61010 2 081 Al It was delivered from the factory in flawless condition with regards to safety features In order to preserve this condition and ensure safe operation the user must respect the notices and warnings that are contained in t
79. on If the error persists contact Technical Support 20097 ADC error tHb Signal acquisition could not be performed due to a hardware error Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 20098 ttHb SO module not ready tHb SO module is not ready Changing the tHb SO module contact Technical Support 20112 SS5 error The optical sample sensor is incorrectly calibrated To correct the error perform Wash AQC System gt Wash amp Cleaning If the error persists contact Technical Support 20113 Module error AQC The required XY position was not reached e Perform Wash AQC System gt Wash amp Cleaning Repeat the AutoQC measurement If the error persists contact Technical Support 20114 Module error AQC The required Z position was not reached e Perform Wash AQC System gt Wash amp Cleaning Repeat the AutoQC measurement If the error persists contact Technical Support 20115 Module error AQC 20116 20118 The required position was not reached e Perform Wash AQC System gt Wash amp Cleaning Repeat the AutoQC measurement If the error persists contact Technical Support 20120 AQC wash error The SS2 detects a bad wash profile of the AQC sample line e Perform Wash AQC System gt Wash amp Cleaning Repeat the AutoQC measurement If the error persists cont
80. only for the specialized purpose described in the instructions The most important prerequisites for use operation and safety are explained to ensure smooth operation No warranty or liability claims will be covered if the machine is used in ways other than those described or if the necessary prerequisites and safety measures are not observed The instrument may be operated only by persons whose qualifications enable them to comply with the safety measures that are necessary during operation of the instrument Suitable protective equipment like laboratory clothing protective gloves protective goggles and if necessary mouth protectors must be worn to prevent direct contact with biological working materials In addition a face mask is required if there is a risk Adjustments and maintenance performed with covers removed and power connected may be attempted only by a qualified technician who is aware of the associated dangers Instrument repairs are to be performed only by the manufacturer or qualified service personnel Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument These items are manufactured especially for use with this instrument and meet the highest quality requirements Operation of the instrument with solutions whose composition is not consistent with that of the original solutions can negatively affect the long term measurement accuracy Deviations in the composition
81. or COOX modul depending on the replace configuration see Chapter 10 Maintenance section Possible causes Exchanging the peristaltic pump tubes on Sample path leaky or clogged page C 23 Cuvette holder is leaky Perform Wash Tubing of main pump is defective System gt Wash amp Cleaning Ifthe error persists perform General fluidics test to isolate the error System gt Diagnostics and afterwards contact Technical Support 1028 Insufficient sample 1 No sample detected in Hb module tHb Repeat measurement calibration check for SO or COOX modul depending on the sufficient and homogeneous sample input configuration If the error persists contact Technical Support Possible causes The sample was irregular Sample was insufficient 1029 Insufficient sample 2 Insufficient sample for BG module was Repeat measurement calibration check for detected sufficient and homogeneous sample input Possible causes If the error persists contact Technical Support The sample was irregular Sample was insufficient 1030 Insufficient sample 3 Insufficient sample for ISE module was Repeat measurement calibration check for detected sufficient and homogeneous sample input Possible causes If the error persists contact Technical Support The sample was irregular Sample was insufficient 1031 Insufficient sample 4 nsufficient sample for MSS module was Repeat measurement calibration check for detected sufficient and homogene
82. parameters for which a measurement QC for Ready is not possible and the reason why If required print the list Print remedy the cause and repeat the procedure Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 57 7 Quality control cobas b 221 system QC for Ready with AutoQC module 4 Press Perform QC for Ready The AutoQC measurement is started for all parameters ready for measurement 5 With the Interrupt QC for Ready key the procedure can be interrupted 6 The measurement results are printed out and stored automatically in the QC database Roche Diagnostics April 2009 B 58 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control QC for Ready without AutoQC module QC for Ready without AutoQC module Parameters will be blocked if one of the adjusted rules is broken and identified accordingly in the Ready screen The function QC for Ready generates a list of the required manual QC measurements material level combination that can remove this lock again Proceeding from the uppermost level of the analyzer mode press the following buttons C QC measurement Figure B 43 1 Press QC measurement for Ready 2 Ifthe parameters are not all ready for measurement the following screen appears QC measurement 12 Status OK Lo Print Figure B 44 3 Here all the parameters are listed for which a measurement QC measurement for
83. path is blocked b Insert new waste container 10043 Separator sens error The optical fluid sensor in the waste separator could not be calibrated Contact Technical Support 10044 Separator error The fluid in the separator could not drain To correct the error stop injection of the sample when acoustic signal or visual indication on the screen occurs Insert new waste container and press Continue If the error persists contact Technical Support 10045 Check Waste fill level Measured waste fill level differs too much from calculated value Check fill level and enter correctly Table D 1 System stops Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 7 11 Troubleshooting cobas b 221 system System stops No Message Cause Action 10046 Waste line blocked The connection from separator into the Insert new waste container waste container is not continuous If the error persists contact Technical Support 10047 VPS error The vacuum pump protection contains Contact Technical Support fluid Vacuum buildup is not possible 10048 Error SS1 The optical sample sensor at the input of Perform Wash again the BG module could not be calibrated System Wash amp Cleaning If the error persists contact Technical Support 10049 Error SS2 The optical sample sensor at theendof Perform Wash again the sample inlet path could not be System gt
84. physiological ion background and pH value as well as a mean physiological buffer capacity of the sample Hemoglobin derivatives and bilirubin As well as the restrictions applicable to determining the blood gases measurement of the Hb derivatives and bilirubin by light absorbing substances in the blood sample e g contrast agent can be disrupted The influence of the most important known interferents was determined during development summarized in section Hb derivatives and bilirubin on page B 16 pH measurements in pleural fluid A Roche Diagnostics Only pH measurement results are specified in pleural fluids Any other measurement results that are output do not conform to specifications April 2009 B 18 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Measuring procedure Measuring procedure QC measurements must be performed in their entirety i e all three QC levels must be measured Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements which may result in incorrect clinical decisions possibly endangering the patient s health Before starting a measurement all parameters must be ready for measurement Depending on the setting the operator ID and a password may be required see Reference Manual chapter Software modes section Setup You have the option of measuring samples from syringes without needles ampoules and ca
85. procedures other than those specified herein may result in hazardous radiation exposure Roche Diagnostics April 2009 A 6 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions Contents General descriptions Roche Diagnostics This chapter contains a general description of the instrument as well as precautionary measures against special dangers and the proper handling of sensors solutions and the MSS cassette In this chapter Chapter A Introduction idad id a a 9 General Dotes Aa as 11 APPIANO Arta td ede e e ADIRE 11 Operating TnStEUCtofis deissat iure estere pere eret te ee e epe eges Important buttons on the screen sanoio T Measurement and calibration procedure Measurement procedure sse netten Calibration procedure et ee GS eee e La edit Measurement evaluation coconcocccnoonnnnnnnononncnnononnananonoonanncnnoonanncn ente tetne nene saia irana Safety instructions for specific dangers sosisini 14 Handling samples ausnar ne oon pierre et ereter eter eteretotet enit inet ina 14 Disposal of waste water bottles packs electrodes and the instrument 14 DECONTAMINATION E 14 Handling solutions da Handling electrodes s General notes on the use of the MSS cassette MSS cassette removed from the measuring chamber Incompatible substances ccccssssesssesssescsssessssssssssssssssssssssscssssssssssssssssssasasssaas Inserting the MSS cas
86. removed sprayed with surface disinfectant and subsequently disinfected using swabs or cellulose Some surfaces require extended soaking to achieve cleaning A Never spray parts that cannot be removed or that are inside the instrument amp see section Decontamination on page C 5 Changing of AutoQC mats Starting with the top level of the analyzer mode 1 Pull out the AutoQC drawer The following screen appears Mat change AUTO TROL AUTO TROL AUTO TROL PLUSB PLUSB PLUSB Level 3 Level 2 Levelt Lot number Lot number Lot number 21750402 21750102 21744302 Exp date Exp date Exp date 31 1 2007 31 1 2007 31 10 2006 11 Ampoules 0 Ampoules 9 Ampoules Refill Refill Refill 08 11 2006 1440 Mat change 14 10 System cal 15 02 Figure C 34 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 35 10 Maintenance cobas b 221 system Unscheduled AO Roche Diagnostics 2 Remove the empty mat from the ampoule holder If individual ampoules remain in the white ampoule holder after removing the mats note that these open ampoules may break on removal with the attendant risk of injury Before inserting a new mat remove them all carefully Always wear gloves If ampoules have expired as specified in the insert sheet dispose of mats in accordance with local regulations CAUTION danger of spilling 3 Take a full mat 20 ampoules from the
87. solutions electrolytes only and the validity of measurements was tested accordingly In order to achieve accurate measurements of recommended aqueous control solutions with regards to deviations from biological samples choose the proper components and make the corresponding corrections in the QC measurement mode The accuracy of measurement values of undefined aqueous solutions cannot be guaranteed e g due to the possibility of interfering components and or missing or insufficient buffer systems and or differences in ionic strength and diffusion potential when compared to biological samples The cobas b 221 system should be switched on at all times If the instrument is switched off for an extended period of time more than 24 hours a shutdown must be performed For additional information see Chapter 3 Installation and shutdown section Installation on page A 27 and Shutdown on page A 48 Prevent any other liquids from entering the instrument except samples and QC material at the fill port In order to ensure the quality of the measurement results complete a quality control test on 3 levels low normal high after each electrode exchange after each exchange of solutions and packs and after startup of the instrument Additionally complete a quality control test on one level between two automatic 2P calibrations The level have to be alternated low normal high For additional information see Chapter 7 Quality co
88. tHb module 15 8 0 0196 0 12 0 0316 0 20 SO tHb module 95 8 0 0469 0 05 0 0596 0 06 Table A 19 AUTOTROL TS Level 5A n 40 Roche Diagnostics April 2009 A 68 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Material MSS Level 1 NIST Traceable n 80 Performance data Parameter Mean Swr CV St CV Lactate 9 4 0 0670 0 71 0 2626 2 78 Glucose 5 7 0 0337 0 60 0 1231 2 18 Urea 4 9 0 0391 0 80 0 1837 3 74 Table A 20 MSS Level 1 NIST Traceable n 80 Material MSS Level 2 NIST Traceable n 80 Parameter Mean Sur CV S1 CV Lactate 1 9 0 0188 0 96 0 0497 2 55 Glucose 2 6 0 0267 1 05 0 0972 3 81 Urea 14 5 0 2263 1 56 0 4100 2 83 Table A 21 MSS Level 2 NIST Traceable n 80 Material human whole blood incl bilirubin Level 1 n 40 Parameter Mean Sur CV S1 CV Bili 8 2 0 1202 1 47 0 6198 7 56 Table A 22 Human whole blood incl bilirubin Level 1 n 40 Material human whole blood incl bilirubin Level 2 n 40 Parameter Mean Sur CV S1 CV Bili 24 1 0 1171 0 49 0 9663 4 01 Table A 23 Human whole blood incl bilirubin Level 2 n 40 Material human whole blood incl bilirubin Level 3 n 40 Parameter Mean Swr CV St CV Bili 44 0 0 1623 0 37 2 1509 4 89 Table A 24 Human whole blood incl bilirubin Level 3 n 40 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 69 4 Specifications cobas b 221 system
89. take up unit Figure C 23 Place printer paper with take up unit optional 8 The paper is automatically pulled into the printer If the paper is pulled in incorrectly open the paper cover open the printer lever and realign the paper close the printer lever and close the paper lid again 9 Close paper lid Roche Diagnostics April 2009 C 26 Instructions for Use Revision 10 0 10 Maintenance Unscheduled cobas b 221 system With take up unit optional 1 Press the paper feed button until the paper is long enough 2 Insert the beginning of the paper in the take up unit according to the instructions on the inside of the paper lid see Figure C 23 on page C 26 D Press the take up unit rods fully onto the holder and rotate until the paper is taut on the rods and Q paper lid so that the entire roll of paper can be taken up During operation the paper should be tautened now and then by turning the take up roller 3 Close printer cover A With an installed take up unit the Automatic Cut function is deactivated Replacement of the electrodes The electrode must be installed in the instrument no later than the imprinted Install before date see section Conventions used in this manual gt Other symbols on page 7 In order to ensure the quality of the measurement results complete a quality control test on 3 level low normal high after each electrode exchange 1 Remove the top co
90. the analysis of QC measurement results B 35 Material setup B 36 Changelot applies only to AutoQC measurements B 42 Inserting the AutoQC mats B 39 materials B 38 QC timing B 41 Recommended QC materials B 34 Multirules B 53 Overview of the Multirules B 54 QC consequences B 55 QC for Ready with AutoQC module B 57 QC for Ready without AutoQC module B 59 QC measurement B 51 AutoQC measurement B 52 Manual QC measurement B 51 QC troubleshooting B 61 Remove the QC lock B 56 QC lock B 56 QC warning B 56 Quick access B 79 R Ready screen B 78 Recalibration without O B 66 Recommended QC materials B 34 Remove the QC lock B 56 QC lock B 56 Automatic correction B 56 Exchange correction B 56 Manual correction B 56 QC warning B 56 Replacement of the electrodes C 27 Reproducibility A 60 Result B 26 Reverse side A 21 Revision History 1 Roche MICROSAMPLER B 7 April 2009 F 6 Instructions for Use Revision 10 0 cobas b 221 system Index S S1 rinse solution C 14 S2 fluid pack C 14 S3 fluid pack C 14 Safety information A 3 Safety instructions for specific dangers A 14 Sample collection B 5 Anticoagulants B 5 Sample acquisition B 5 Sample collection especially for bilirubin measurement B 6 Sample collection especially for glucose lactate measurement B 6
91. the barcode scanner from the packing insert or press the New button and enter the information manually The material code contains the information for the material the proper level lot number expiration date and sample type Roche Diagnostics April 2009 B 36 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Roche Diagnostics a o oe em erem T tnm AUTO TROLPLUSB TROL PLUS B a 2172302 3 Aqueous solutic solution AUTO TROL PLUS B 31 7 0 Aqueous solution AUTO TROL PLUS B 3 2172310 74 Aqueous solution Mat change 14 10 Systemcal 15 02 08112006 1440 Material setup Figure B 19 Press Ranges and read in the additional barcodes for the target values The cobas b 221 system automatically assigns these If no barcode scanner is available the target values can also be entered manually Press Set to edit a previously defined material level combination April 2009 Instructions for Use Revision 10 0 B 37 7 Quality control cobas b 221 system Material setup Material assignment AutoQC materials The selected AutoQC material must be assigned prior to the AutoQC measurement Select the material and level to be assigned and select Mat AA A Y m AUTO TROL PLUS B Level 1 21744302 B AUTO TROL PLUS B Level 2 21750102 AUTO TROL PLUS B Level 3 Lot number 21750402 Exp
92. this chapter Chapter Quality control general eene 33 General OG coricept 252 dede emere eee eee eee eee 33 Important information concerning the analysis of QC measurement results 35 Material setip sioni m 36 Material assignment AutoQC materials sss 38 Inserting the AutoQC mats ssssssseseeeeeeeneetetntntntntntntntntntntntntntnnnntnnnen 39 OC EIDIUTIS a ED UR set red den om d aem eue 41 Setting start Mei be aether hacia saben aden 42 Change lot applies only to AutoQC measurements eee 42 Material setting Material assignment Follow up material 42 OC Seb WIZAT ee eee eere eee eteebele re ee deeem 44 Scanning the material code eee A Abe pegi 45 New OC materials s ee eo t peo e S SA oa 45 Already installed AQC material sse 45 A RR tuti ern eR 45 New OCmatetial 55 5 nh ht ARE REIS 45 Previously installed QC material eee 46 Checking for AutoQC compatibility sess 46 Assigning the mats munici ios 47 A 48 QC mieasuremierit 5 2 rhe er edid eod ide edes eese a asia 5 Manual QC measurement sese eene tnnt sth anar cnn anar a rain rin enne nn inn 51 AutoQC measurement 5 tots ceccca es castdseessdeeseeacdusccancsdacscacccecccasteassdeadeucasuca snes 52 Maa 53 Overview of the Multirules eiai AEA
93. using Urea Calculation values at the patient s temperature User interface PAO Alveolar oxygen partial pressure at patient s temperature RI Respiratory index at patient s temperature AaDO Alveolar arterial oxygen partial pressure at patient s temperature a AO Alveolar arterial oxygen partial pressure ratio at patient s temperature pH pH at patient s temperature Pco PCO at patient s temperature PO PO at patient s temperature Hv Hydrogen concentration at patient s temperature Input parameters R Gas exchange quotient FIO Proportion of inspiratory oxygen tHb e Entered tHb value not measured Hb factor to calculate Hct c from tHb values Additional items e Pract Pat ID Pat ID e Last name e First name Middle initial e Suffix Maiden name e Date of birth Temperature Sample type Blood type e Puncture site e Operator ID e Order ID Date drawn Admission time Discharge date Discharge time Date changed Time changed Specimen ID Sample container Address Billing code Danger code Diagnostic code type Isolation status Marital status Age A F Diagnosis Religion Sex Title Phone no Doctor Accepted by Clinic info Vent mode VT Srate PEEP PIP MAP Ti Te April 2009 Instructions for Use Revision 10 0 B 75 9 Software modes cobas b 221 system User interface Buttons Time drawn Hospital service Ward Department Location
94. which is available in whole blood to buffer strong acids and consists mainly of protein anions and bicarbonate Of the protein anions hemoglobin is the most significant Unit mmol L Equation A 9 BB BE 41 7 0 42 tHb The quantity of oxyhemoglobin in the blood related to the quantity of hemoglobin in the blood which can bind oxygen Unit 96 O Hb suae uico MDC MAb 2 SO is measured No SO data available Measured SO has a higher priority than the calculated SO c No calculation without pH PO or BE Unit 96 Equation A 11 SO c SO PO pH P50 a f BE oum April 2009 Instructions for Use Revision 10 0 A 99 5 Theoretical foundations cobas b 221 system Parameters and calculations At which lgQ 2 9 1gPO amp FI 107 79 F3 Equation A 12 i P50 IgPO 1gPO 0 48 pH 7 4 Ig 0 0013 BE F1 1 661 F2 0 074 F3 4 172 Fetal Psp 21 5 F1 1 3632 F2 0 0533 F3 4 113 Pso The oxygen partial pressure at half saturation P5o is defined as the PO value at which 50 of the hemoglobin is saturated with oxygen The actual P5 value can be calculated from interpolation after measurement of the actual oxygen saturation if a blood sample is tonometered with oxygen so that an oxyhemoglobin of 5096 is achieved pH value 7 4 and PCO 40 mmHg The cobas b 221 system enables the derivation of the P59 from SO PO and pH Unit
95. with same material level combination If the error persists contact customer service Troubleshooting Group B QC result exceeds the target value range 1 Asystem calibration must be carried out for the affected parameters Should parameters of the COOX module be affected a COOX calibration must also be carried out 2 The following points must be checked t must be checked whether the target value ranges under Setup gt QC material gt QC material gt select appropriate material gt Ranges correspond to the target value ranges stated in the package insert fan AutoQC module is in use it must be checked whether the batch number printed on the AutoQC mat corresponds to that under Setup gt QC material gt QC material It must be checked whether before use the QC ampoules have been stored for at least 24 hours at room temperature or in the AutoQC module Inevent of manual QC measurement it must be ensured that the time between opening the ampoules and the QC measurement is kept as short as possible Furthermore it must be ensured that the ampoule adapter is used fan AutoQC module is in use it must be ensured that the AutoQC temperature deviates by less than 5 C from the ambient temperature Check under System gt Component test gt Control sensors gt Temperature control gt AutoQC temperature 3 Repeat the QC measurement with same material level combination Ifthe e
96. with their storage temperature see packaging insert 5 Close the AutoQC drawer 18 Go to AutoQC service position e Press Start process This action is performed automatically 19 Open AutoQC drawer and insert the AutoQC valve clamp 1 Pullout the AutoQC drawer 2 Insert the clamp of the AutoQC valve see below Roche Diagnostics April 2009 A 54 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown 20 Go to AutoQC home position 21 Complete shutdown Roche Diagnostics 3 4 Shutdown A AutoQC valve clamp Figure A 52 AutoQC valve clamp Close the AutoQC drawer Press Start process This action is performed automatically Press the Complete shutdown button Shut down is complete The following screen appears Out of operation ES System Utilities Put out of operation The shutdown procedure is finished Please call the function Shutdown PC and when the display has switched off switch off the analyzer also E as Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure A 53 Shutdown Press the Shutdown PC button Follow the instructions on the screen The PC is booted down Turn off the device Close top cover Remove the transport power cable scanner and if available network connectors April 2009 Instructions for Use Revision 10 0 A 55 3 Installation and shutdown cobas b
97. 0 1695 2 97 Urea 4 8 0 0873 1 81 0 1005 2 08 Table A 7 Human plasma n 80 Roche Diagnostics April 2009 A 62 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Material serum n 80 Performance data Parameter Mean Swr CV Sr CV pH 7 731 0 0120 0 15 0 0334 0 43 PCO PO Sodium 140 2 0 3226 0 23 0 6567 0 47 Potassium 4 18 0 0149 0 36 0 0330 0 79 Chloride 105 2 0 4310 0 41 0 6871 0 65 ionized Calcium 1 098 0 0092 0 84 0 0323 2 94 Hct Lactate 2 3 0 0353 1 53 0 0989 4 30 Glucose 5 1 0 0737 1 45 0 1834 3 62 Urea 5 2 0 0451 0 86 0 1197 2 29 Table A 8 Serum n 80 Material bicarbonate n 80 Parameter Mean Sur CV S1 CV Sodium 137 9 0 7201 0 52 1 0185 0 74 Potassium 2 00 0 0224 1 12 0 0301 1 51 Chloride ionized Calcium 1 605 0 0091 0 57 0 0167 1 04 Table A 9 Bicarbonate n 80 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 63 4 Specifications cobas b 221 system Performance data Material AUTOTROL PLUS B Level 1 n 40 Parameter Mean Swr CV Sr CV pH 7 182 0 0039 0 05 0 0060 0 08 PCO 65 8 0 8109 1 23 1 7861 2 72 PO 55 4 3 6232 6 53 4 5447 8 20 Sodium 121 2 0 6188 0 51 1 1226 0 93 Potassium 2 97 0 0161 0 54 0 0283 0 95 Chloride 84 2 0 4971 0 59 1 6465 1 96 ionized Calcium 1 557 0 0089 0 57 0 0153 0 98 Hct 51 8 0 9534 1 84 1 1250 2 17 Lactate 9 2 0 0821 0 89 0 4539
98. 0 mg 100 mL MW D K SD n 16 0 64 0 41 0 19 0 24 MW 1 3 56 2 64 MW K 4 23 2 86 Dopamine 13 mg 100 mL MW D K SD n 16 2 14 0 26 1 34 0 39 MW 1 2 06 1 47 MW K 4 21 2 81 Dopamine diluted 5 mg dL MW D K SD n 16 1 68 0 23 0 88 0 12 MW 1 2 41 2 10 MW K 4 09 2 98 Dopamine diluted 2 mg dL MW D K SD n 16 0 72 0 32 0 48 0 39 MW 1 4 53 3 40 MW K 5 25 3 88 Gentisic acid 50 mg 100 mL MW D K SD n 16 0 87 0 61 0 52 0 24 MW 1 3 46 3 25 MW K 4 33 3 77 Glycolic acid 10 mg dL MW D K SD n 16 2 2 0 83 0 26 MWD 4 62 MW K 7 3 79 Glycolic acid 50 mg dL MW D K SD n 16 2 1 92 1 05 MWD wenn nena eee 5 67 MW K b c 3 75 Glycolic acid 100 mg dL MW D K SD n 16 0 42 0 16 0 99 1 00 MW 1 3 69 3 13 MW K 4 11 2 14 Glycolic acid 200 mg 100 mL MW D K SD n 16 5 0 81 0 13 MWD 2 09 MW K b e 2 90 Table B 4 Interferences MSS Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 13 6 Measurement cobas b 221 system Interferences Substance Glu Lac Urea Uric acid 20 mg 100 mL MW I K SD n 16 0 46 0 32 Z7 0000000000000 em MW I ATL S S nnn n ne MW K oe ee Uric acid diluted 7 mg 100 mL MW I K SD n 16 040
99. 00314 Q shunt flow Q heart minute volume 0 0 fraction of cardiac output shunted Sa0 arterial oxygen saturation fraction ctO a and ctO v are calculated according to Equation A 14 for arterial and mixed venous blood for ctO see Equation A 14 on page A 101 If no measurement data is available for mixed venous blood then the following is valid Equation A 26 ctO a ctO v 5 15 vol The ionized calcium value standarized to pH 7 40 1 Unit mmol L Equation A 27 nCa pH 7 4 Ca 105074 Blood F5 0 22 Serum plasma F5 0 24 This equation is released for pH 7 2 to 7 6 The anion gap is a calculated parameter used to express the difference in concentrations of major cations and anions in the blood sample 2 Unit mmol L Equation A 28 AG Na K CI cHCO April 2009 A 104 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations pH H t Po AaDo Roche Diagnostics Parameters and calculations pH corrected to patient temperature other than 37 C Unit pH Unit Equation A 29 pH pH 0 0147 0 0065 pH 7 4 t 37 Hydrogen ion concentration at a patient temperature other than 37 ec Hl Unit nmol L Equation A 30 H 10 2 PCO value at a patient temperature which is not 37 eC Unit mmHg Equation A 31 PCO PCO 4 Q9 019 37 PO value at a patient temperature which is not 37 acl
100. 009 Instructions for Use Revision 10 0 3 cobas b 221 system Troubleshooting Part D 11 Troubleshooting Troubleshooting general D 5 System stops D 5 Module stops D 12 System warnings D 16 Status messages of measuring and calibration values D 20 Status messages on the measurement report D 39 Barcode D 40 Appendix Part g 12 List of consumables Order information E 5 Glossary E 9 Index Part n Index F 3 Roche Diagnostics April 2009 4 Instructions for Use Revision 10 0 cobas b 221 system Preface The cobas b 221 system is an analyzer with integrated AutoQC drawer option This manual has detailed descriptions of cobas b 221 system features and general operational concepts specification functions and use of controls operating techniques emergency procedures product labeling and maintenance procedures How to use this manual e Keep this manual in a safe place to ensure that it is not damaged and remains available for use This Instructions for Use should be easily accessible at all times To help you find information quickly there is a table of contents at the beginning of the book and each chapter In addition a complete index can be found at the end Where to find information In addition to the Instructions for Use the following documents are also provided to assist in finding desired information quickly e cobas b 221 system Reference Manual cobas b 221 sy
101. 09 Instructions for Use Revision 10 0 B 65 8 Calibration cobas b 221 system User activated calibrations 1P calibration 1P cal incl O Adjustable every 30 minutes standard 1 hour USA 30 min only adjustable Setup gt Protected setup this area is password protected and is accessible only to authorized personnel or customer service representative Recalibration without O After every measurement User activated calibrations Activation in analyzer mode C System gt Calibration A ee 0 4 i P Pe siatus OK 2P Cal Systern calibration Mixing COOX Polychr Calibration system calibration calibration for Ready Fee ea Matchange i410 Systemcar 1502 08 312008 1440 A Example Instrument with COOX and MSS module Figure B 46 User activated calibrations oe Performing a user activated calibration does not influence the time lapse of automatic Q calibrations Select the parameters to be calibrated It is not possible to select individual parameters instead only functionally coherent groups of parameters can be selected Roche Diagnostics April 2009 B 66 Instructions for Use Revision 10 0 cobas b 221 system 8 Calibration Roche Diagnostics User activated calibrations The following groups can be selected all MSS parameters for instrument versions with MSS module only cobas b 221 lt 5 gt system and cobas b 221 lt
102. 1 0 Sel archives 19 4 2002 00 00 Incr 30 0 K Measurements a Calibrations o 2042002 00 00 Incr 20 0 K 15 QC meas o 2142002 Log data D User entries Free space A gt 0 7 G 69 8 E EN 08 11 2006 1440 Mat change 14 10 System cal 15 02 Figure B 60 For a detailed description see the Reference Manual chapter Software modes section Data manager Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 85 9 Software modes cobas b 221 system Data manager Protected DB functions This area is password protected and only accessible to authorized personnel or customer service Roche Diagnostics April 2009 B 86 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Info Info The following information can be displayed Figure B 61 Help Use this function to retrieve online help information Fill level Lot number 21460809 21461502 Expiration date _ 25 2 2008 08 10 2007 Start date 08 11 2006 08 11 2006 08 11 2006 Time to change 18 11 2006 20 12 2006 20 12 2006 Fill level Figure B 62 This view lists all the data of the solutions such as lot number expiration date expiration date start date the remaining Time to change and fill level Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 87 9 Software modes cobas b 221 system
103. 122 04 0 4136 100 5 141 00 141 37 0 2483 100 3 160 90 160 29 0 3127 99 6 Table A 40 Parameter Sodium mmol L Correlation Slope 0 9719 1 0289 Intercept 4 0475 Correlation coefficient 0 9999 Material NIST 956a Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 6 01 6 04 0 0202 100 6 3 99 4 00 0 0103 100 3 2 03 1 91 0 0209 94 1 Table A 41 Parameter Potassium mmol L Correlation Slope 0 9629 1 0385 Intercept 0 1788 Correlation coefficient 0 9999 April 2009 A 78 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Parameter sodium mmol L Material NIST 909b Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Performance data Parameter potassium mmol L Parameter chloride mmol L Roche Diagnostics Expected value Mean Swr Recovery 120 76 119 96 0 3662 99 3 141 00 144 31 0 4298 102 3 Table A 42 Parameter Sodium mmol L Correlation Slope 0 8311 1 2032 Intercept 25 3383 Correlation coefficient 0 9997 Material NIST 909b Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Swr Recovery 3 42 3 29 0 0162 96 1 6 28 6 56 0 0273 104 4 Table A 43 Parameter Potassium mmol L Correlation Slope 0 8738 1 1444 Intercept 0 6284 Correlation coefficient 1 0000 Material NIST 909b Number of
104. 180 MC0024 BS2 Blood Sampler sterile O O O 03113493035 MC0028 Capillary Tubes 115 uL O O O 03113507035 MG0002 Plastic Capillary Tubes 140 uL O O O 05174791001 Sterile Capillary Holder 05174830001 Caps for Capillary Tubes O O O 03113647035 RE0410 O O O O O O O O Table E 4 a Only for USA available b Only for USA available O Can be used Do not use Roche Diagnostics April 2009 Instructions for Use Revision 10 0 E 7 12 List of consumables cobas b 221 system Order information Parameter Cr Nat K Ca PCO PO pH tHb SO COOX Bili MSS Customer Accessory Kit O O O O O O O O O O for cobas b 221 lt 2 gt lt 4 gt lt 6 gt system 04975626001 Customer Accessory Kit O O O O O O O O O 0 for cobas b 221 lt 1 gt lt 3 gt lt 5 gt system 04977203001 Tabelle E 5 O Can be used Roche Diagnostics April 2009 E 8 Instructions for Use Revision 10 0 cobas b 221 system Glossary Glossary Acid Base Diagram The log PCO pH diagram serves as a basis for showing the rearranged Henderson Hasselbalch equation Alkaline basic Analyzer Software mode for measuring QC measurement system functions calibration quick access AQC Abbrev for AutoQC Arterial blood Blood taken from the artery AutoQC module The AutoQC module is a unit that automatically takes quality control measurements programmed by the user A
105. 221 system Shutdown Roche Diagnostics April 2009 A 56 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Contents Specifications In this chapter the performance data as well as product and environmental data are described In this chapter Chapter n Performance data serenita Eea rete Eee pee ee ek Fore ERE reds a voee ed 59 Measurement parameters sess nnne nnne nnns 59 Reproducibility cional 60 A t boat bte dtaba a eda 70 Correlation to other methods esee eese entente nnns nnn 82 Sample TOUS PU ERE RR RR RR Re e etes 86 Measurement times of the samples sse 86 Sample vol m s uso e eere e E ER IER RII Re eee Is ee d 87 SAMPLE ty POS a M 87 Calibrations tddi 88 Environmental parameters is ee eet reete eret pesetas eire gehn 89 Temperature humidity stability eene 89 Ptod ct dat AAA A e 91 Electrical data be ie eS E AE 91 Clas SICA O10 senres rs a Aa e EAE EE AREA AAEREN 91 Dimensions i215 3 Beda a TEE beg bet dog beo thea eet dave Da ene dado eg 91 A e E mH estis riii n IE 91 Acoustic Noise Level ie hesterna idad 91 Holding points 5o eee tec tide tette ettet eie enne 92 AUTO into edt ood dd od io dd dado dodo dsd id E 92 A fy hei att RN 92 Touch screens Punt 255 AAA AA nda net eiecti bei calor RAE 93 Barcode Scaner st eite ieu REIR 93 Roche Diagnostics April
106. 22e 4 91 Sodium chloride 140 mmol L MW I K SD n 16 0 49 0 17 0 0 2500000000000 2M MW I 4 84 0000000000000 e MW K 5 3300 LL nn nn nnn wenn enn n enn e nee Sodium fluoride 1000 mg 100 mL MW I K SD n 16 0 20 0 39 0 27 0 17 1 37 0 23 MW I 3 45 3 38 2 80 MW K 3 65 3 11 4 17 Paracetamol 150 mg 100mL MW I K SD n 16 2 99 0 59 1614036 MW I 4 79 1 33 4NdK o gt MW K 7 79 3 333 0000000 0 Table B 5 Interferences MSS Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 15 6 Measurement cobas b 221 system Interferences Hb derivatives and bilirubin Substance HHb MetHb Bilirubin Evans blue 5 mg L MW D K SD n 8 0 00 0 02 0 680 005 gt MW 1 0 03 W348 0 ease OT Sad ls MW K 0 02 065 ize I Indocyanine 5 mg L MW D K SD n 8 0 01 0 02 0 00 0 06 2 e MW I 0 03 UNI S L QA Qo MW K 0 02 0 68 0 gt Intralipid 10mg L MW D K SD n 8 0 004002 0000000000022 MW I 0 08 7 00 0 0000000000000 2 MW K 0 08 0 000 0000 2 Lipofundin 10mg L MW I K SD n 8 0 01 0 02 2000000000000 2M MW I 0 02 0 000000000000 2 MW K 0 08 00 o 0000000000000 2 Methylene blue 7 5 mg L MW D K SD n 8 0 00 0 02 1 09 0 05 J i MW I 0 02 0 44 ILL L LLLLSILLLLLOLIGGIQIZQ MW K 0 02 0 65 00 0
107. 3 Fluid Pack Clot catcher Coagulum catcher for use with syringes and capillaries COMBITROL PLUS B QC material for controlling BG ISE Glu Lac Urea BUN COOX Bilirubin COMBITROL TS QC material for controlling BG ISE Glu Lac Hct tHb SO Contact clip The MSS cassette inserted in the measuring chamber slit is pressed into position and thereby firmly positioned COOX module The oximeter module consists of the hemolyzer and the COOX measuring chamber It is an optical sensor module for determining bilirubin Bili total hemoglobin tHb and the hemoglobin derivatives oxyhemoglobin O Hb desoxyhemoglobin HHb carboxyhemoglobin COHb and methemoglobin MetHb Docking mechanism Serves as an interface between the packs or bottles and the fluid channels in the system Dummy electrode A flow through electrode without any measuring function serving as a placeholder April 2009 Instructions for Use Revision 10 0 E 9 Glossary cobas b 221 system Electrodes NIST standards Electrodes are flow through electrodes with a visible sample channel Filling port Enables a sample to be injected or aspirated from syringes Roche MICROSAMPLER capillaries and ampule adapters Fixation lever serves for fixing the sensors in the measuring chamber FMS Fluid mixing system In combination with the main pump this system guarantees the correct mixture of the calibration solutions CAL A and CAL B from the S2
108. 4016 L 0000000000000 e MW I 370 QD jQ LLL MW K 410 0 0 0 000 0 9000000000000 eem Hydroxyurea 0 76 mg 100 mL MW I K SD n 16 0 65 0 31 0 354015 2 MW I 4 21 E RE MW K 4 86 E Hydroxyurea diluted 0 4 mg dL MW I K SD n 16 0 36 0 10 5000000000000 2 MW I ULM S LLL LLLA MW K 410 0 0 0 0 00000 000000000000 eem Potassium oxalate 800 mg 100 mL MW I K SD n 16 0 4A 0 04 2 0 1 24 1 39 MW I 3 64 000000 0c 3 92 MW K 4 08 20 0 000 0 5 16 Sodium bromide 10 mg dL MW I K SD n 16 0 33 40450 2222 0000000000000 e MW I 474 0 0 0 0000000000000 me M 0000000000000 seme MW K OA wenn nnn nner Sodium bromide 20 mg dL MW I K SD n 16 0 96 0 35 0 41 10 23 2 2 MW 1 3 08 1 69 nnn nnn eae MW K 4 04 2 09 gt Sodium bromide 102 9 mg dL MW I K SD n 16 0 59 0 33 20 234 0 13 2 2 MW I 3 58 2 663 2 0 nnn nnaee MW K 4 17 2 86 0 00000000 Table B 5 Interferences MSS Roche Diagnostics April 2009 B 14 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Interferences Substance Glu Lac Urea Sodium citrate 1000 mg 100 mL MW D K SD M 16 24 4 500000000000 0 61 0 07 MWD b bQz 00000 ee 4 29 MW K L 0000000000
109. 5 netetetesse teste dae thes teretes riencia 46 23 Checking the barometer value essen 47 24 Quality control 2e iere eee eee bebe 47 LA A EA AE ANE NN 48 ESA AAA teen teer e orae eee ue eerte oan 48 Longer than 24 hours ien etre iron ta e eee Pe a arana Sii 48 1 Open bottle compartment cover and only remove bottle S1 and packs depending on the configuration 2 and S3 sess 49 2 Fill the shutdown kit with distilled water sees 49 3 Insert shutdown kit into space S2 uoicnacncacouncncnaniennieeienonanui 49 4 Remove shutdown kit from space S2 occccccccocononananannnnananononananananananononananananano 49 5 Insert shutdown kit into space S3 cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only eese ttem ene 50 6 Remove shutdown kit from space 3 cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only 4 edeeteseetetier retentis 50 7 Remove Waste Contain er ia 50 8 Open the measuring chamber cover and remove the sensors 50 9 Remove the peristaltic pump tubes keiserinne 50 10 Remove the printer paper 51 Ls Opet Ets AAA RS 52 12 Remove fill port and sample inlet path glass tube 52 13 Set valves for FMS tubing exchange sse 53 14 Release screws at V19 bottle compartment eere 53 15 Remove right FMS tube at VM bottle compartment
110. 67 COOX lamp error During the measurement or Perform Polychromator calibration polychromator calibration an error System gt Calibration occurred while triggering the neon lamp i sgernng P If the error persists contact Technical Support 20068 COOX HW error The signal acquisition could not be Turn the instrument off wait at least 3 performed due to a hardware error minutes and turn it back on If the error persists contact Technical Support 20069 COOX HW error The supply voltage ofthe COOX module Turn the instrument off wait at least 3 falls outside the specified range minutes and turn it back on If the error persists contact Technical Support 20071 COOX HW error A communications problem occurred at Turn the instrument off wait at least 3 the microcontroller of the COOX minutes and turn it back on module If the error persists contact Technical Support Table D 2 Module stops Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 13 11 Troubleshooting cobas b 221 system Module stops No Message Cause Action 20072 COOX temperature nOk The temperature of the cuvette holder Turn the instrument off wait at least 3 falls outside the specified range minutes and turn it back on If the error persists contact Technical Support 20073 HW test error hemolyzer An error was recognized in a hardware To correct the error perfo
111. 7 Start date 08 11 2006 08 11 2006 08 11 2006 08 11 2006 Time to change 18 11 2006 20 12 2006 20 12 2006 20 12 2006 Fill level 79 8 94 5 87 0 86 5 le aa Mat change 14 10 System cal 1602 08112000 1440 Figure C 10 Always wear gloves Danger of infection 2 Open the docking mechanism hold the waste water bottle by the grip recesses and remove carefully Dispose of the waste water container according to local regulations hazardous waste April 2009 C 16 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Sample dependent maintenance procedures 1 Empty the W Waste Container A Always wear gloves Danger of infection 1 Place the bottle tool on the screw cap A Bottle tool B Screw cap with placed bottle tool Figure C 11 Bottle tool 2 Open the screw cap by pressing the two grips together and rotate them counter clockwise i a a Figure C 12 Open the screw cap 3 When removing the screw cap make sure that the green element inside the container is not moved or removed Figure C 13 Screw cap A Empty the waste water and decontaminate the container according to local regulations hazardous waste Flush the waste water bottle cap with plenty of water Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 17 10 Maintenance cobas b 221 system Sample dependent maintenance procedures 4 Screw the cap bac
112. 7 6 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions Critical values pH 73 uncomplicated parapneumonic effusions e pH lt 7 6 complicated parapneumonic effusions exudative in nature These exudates are caused by pleural empyemas malignant tumors collagenoses tuberculosis esophageal rupture or hemothorax April 2009 Instructions for Use Revision 10 0 A 109 5 Theoretical foundations cobas b 221 system Clinical significance PCO The PCO value of arterial blood is used to assess how well the body eliminates carbon dioxide in relation to the metabolic rate of CO production An arterial PCO below the normal range is termed respiratory alkalosis and indicates hypocapnia a condition caused by increased alveolar ventilation such as hyperventilation An arterial PCO above the normal range is termed respiratory acidosis and indicates hypercapnia a sign of hypoventilation and failure resulting from cardiac arrest chronic obstructive lung disease drug overdose or chronic metabolic acid base disturbances Standard values e Arterial blood 35 45 mmHg Venous blood 41 51 mmHg Critical values e PCO lt 20 mmHg or 2 7 kPa e PCO gt 70 mmHg or 9 3 kPa a Critical Care Testing A Quick Reference Guide by Andrew St John First Editio
113. 90 Location A 27 Maintenance C 3 Additional maintenance procedures C 38 Daily C 7 Checking fill levels C 7 Checking printer paper C 7 Decontamination C 5 Input unit C 5 Recommended disinfectants C 6 Surfaces of the instrument C 6 Touch Screen C 6 Tubing paths C 6 General C 5 Quarterly C 9 Changing the air filter C 10 Cleaning the T amp D disk C 9 COOX calibration for instrument versions with COOX module only C 10 Sample dependent maintenance procedures C 13 Cleaning the modules and tubing paths C 19 Exchange of solutions and packs C 13 Unscheduled C 22 Changing of AutoQC mats C 35 Changing the MSS cassette C 32 Changing the reference electrode C 29 Cleaning the bottle compartment C 25 Cleaning the measuring chambers C 34 Exchanging the fill port C 22 Exchanging the peristaltic pump tubes C 23 Roche Diagnostics Replacement of the electrodes C 27 Replacing printer paper C 25 Surfaces C 35 Weekly C 8 Cleaning fill port and sample drip tray C 8 Cleaning the touch screen C 8 Mandatory input B 24 Manual QC measurement B 51 Material assignment AutoQC materials B 38 Material setup B 36 Measurement B 3 Measurement evaluation A 14 Measurement parameters A 59 Measurement procedure A 13 Use as default setup B 23 Measurement times of the samples A 86 Measuring
114. A Printer cover B Paper lid Figure A 46 Printer cover paper lid 2 Move the printer lever upwards see below A A Printer lever upwards B Printer lever down Figure A 47 Printer lever Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 51 3 Installation and shutdown cobas b 221 system Shutdown 3 Remove the printer paper 4 Move the printer lever down again see above B 5 Close the paper lid and the printer cover 11 Open T amp D Press Start process This action is performed automatically The T amp D disk turns to position 1 12 Remove fill port and sample inlet path glass tube 1 Remove the sample drip tray 2 Remove the T amp D cover 3 Open the T amp D lock and remove the sample inlet path glass tube A T amp D lock B Sample inlet path glass tube Figure A 48 T amp D lock amp sample inlet path 4 Turn the fill port downward by 90 and pull it straight off of the needle A Do not bend the needle Roche Diagnostics April 2009 A 52 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Shutdown F A Fill port B Needle Figure A 49 Fill port 5 Close the T amp D lock again 6 Close the T amp D cover 13 Set valves for FMS tubing exchange e Press Start process This action is performed automatically vie gt Q m Both valves are pushed out 14 Release screws at V19 bottle
115. Diagnostics Hemoglobin is the main component of erythrocytes It serves as the vehicle for transportation of oxygen within the bloodstream and each gram dL of hemoglobin can carry 1 39 mL of oxygen The oxygen combining capacity of the blood is directly proportional to the hemoglobin concentration rather than to the number of red blood cells RBC because some red cells contain more hemoglobin than the others Although oxygen transport is the main function of hemoglobin it also serves as an important buffer in the extracellular fluid Decreased hemoglobin values appear in connection with hemolytical reactions caused by transfusions of untolerated blood but can also be caused by a loss of blood or a number of other factors Increased hemoglobin values found in the blood hemoconcentrations with chronically obstructive pulmonary illnesses ctHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data tHb is used to screen for disease associated with anemia to determine the severity of anemia to follow the response to treatment for anemia and to evaluate polycythemia Normal values arterial blood at 37 C Women 11 7 16 1 g dL Men 12 6 17 4 g dL e Newborn 4 20 g dL a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Critical values tHb lt 70 g L or 7 g dL tHb gt 200 g L or 20 g dL
116. Diagnostics pH 7 35 pH gt 7 45 The pH value of blood serum or plasma may be the single most valuable factor in the evaluation of the acid base status of a patient The pH value is an indicator of the balance between the buffer blood renal kidney and respiratory lung systems and one of the most tightly controlled parameters in the body The causes of abnormal blood pH values are generally classified as primary bicarbonate deficit metabolic acidosis primary hypoventilation respiratory acidosis e primary bicarbonate excess metabolic alkalosis e primary hyperventilation respiratory alkalosis An increase in blood serum or plasma pH alkalosis may be due to increased plasma bicarbonate or a feature of respiratory alkalosis because of an increased elimination of CO due to hyperventilation A decrease of the pH value acidosis in blood serum or plasma may occur due to an increased formation of organic acids a decreased excretion of H ions in certain renal disorders an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids Respiratory acidosis is the result of decreased alveolar ventilation and may be acute as the result of pulmonary edema airway obstruction or medication or maybe be chronic as the result of obstructive or restrictive respiratory diseases Standard values e Arterial blood 7 35 7 45 e Venous blood 7 31 7 41 Critical values e pH 72 pH
117. EE TNO 54 OG consequences nn A it 55 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 31 cobas b 221 system 7 Quality control Contents Remove the OC OG i5 nno erre iere rende iii 56 QC WarDInDg aene Att 56 QC lock Automatic COLTECtION 56 Manual correctior s ea annA A E e eoe 56 Exchange the electrode sauerei teste irat a E EEE EEEE EEA 56 QC for Ready with AutoQC module eese teen 57 QC for Ready without AutoQC module eese 59 OC troubleshooting 5 eise etd de FR RENE ERE RENE ER EH Rene 61 Description of the current problem sse 61 Classification of QC problems renessroniiriiiiiriit corn cn cnn cn anar cnn arranco 61 GTOUP E A eie e IE S epe e e e RAM E E EE 61 Group B uode eg iaa 61 Troubleshooting Group A aspirating or positioning problem 61 Troubleshooting Group B QC result exceeds the target value range 62 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 32 cobas b 221 system 7 Quality control Quality control general Quality control general A QC measurements must be performed in their entirety i e all three QC levels must be measured Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements which may result in incorrect clinical decisions possibly endangering the patient s health Gen
118. H Ca Aspirin Acetylsalicylic acid 100 mg 100 mL MW D K SD n 16 MWD 2 2 2 D bpnmmnm MW K 2 Bovine albumin 6 g 100 mL MW 1 K SD n 16 MWD 2 b Q p bDQue MW K Dobesilate 20 mg 100 mL MW D K SD n 16 MWD MW K b p bu2ee Glycolic acid 50 mg dL MW D K SD n 16 MWD 5 MW K b Q Glycolic acid 100 mg dL MW D K SD n 16 0 94 0 02 MW I 6 93 MW K 7 87 Glycolic acid 200 mg 100 mL MW I K SD n 16 1 08 0 03 MW I 6 56 MW K 7 65 Potassium thiocyanate 23 2 mg 100 mL MW D K SD n 16 MWD b b Dug2hg MW K 5 Potassium thiocyanate 232 mg 100 mL MW D K SD n 16 MWD 5 b b bDpbug Lacf el MW K J Magnesium nitrate 128 2 mg 100 mL MW I K SD n 16 0 26 0 01 MW I 1 24 MW K 0 98 0 16 0 01 1 22 1 06 0 30 0 02 1 34 1 03 0 15 0 00 1 24 1 09 0 31 0 02 1 39 1 09 0 20 0 01 1 29 1 08 1 06 0 02 6 16 5 09 2 25 0 02 6 17 3 91 Table B 2 Interferences pH ISE Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 11 6 Measurement cobas b 221 system
119. HACO E 98 CLCO5 BP EP 98 FO DIA OE A 98 BEN dba ds e iste 99 himc 99 BB Seed A AA 99 m 99 Soros 99 Ne D TE RE EE 100 dio P e 101 SiS Odi A ETT 101 poto ate ceat nto A aute OO 101 CO ut n ites a coetu E 102 DAC uto S EEEE RR Et SEDE 102 Mudo ek Loc M lu tha Apt den eat lente tne 102 AO T 102 Tubo TT 102 A A Er ONE ree e rer Pre rer Er rites 103 SAUS DAA EE RO RO P DEAR 103 A PP A cite ert 104 April 2009 Instructions for Use Revision 10 0 A 95 5 Theoretical foundations cobas b 221 system Contents Roche Diagnostics AC once E ETE EEE ameet 104 DEL aad tn M M ant te Lhe E E cada AERA ARE 105 HT oet um mone aen ud adi 105 BUD MM DM A ANM MR ME RES 105 POS e uM AM D M EAM EM MA DA pad 105 PAO S LL MU MI LM E M LM M T 105 ADO antes diciendo idle jolie dijo 105 UNO urinario int E 106 A A 106 Het O r EE EATER A aaa 106 MECHO a 106 O 106 Beea a e A LU 107 Osmolal aiii aa ERE reed deeds 107 CER AEAEE A ES 107 Heart Min t yol me Q si iii 108 P E ING Ox 31 nin en ERE nie aie ioitalit 108 Bibli graphy NN 108 Clinicalsignificabee v e tee e Eee a ee etre ne eere 109 O RNR O e REE ST CE I Ed 109 O heey cals Sree ote wh 110 O E ONE 110 SOSA a 111 FACON did ia 112 Chloride std eee eee eiae E 114 Ionized calcitim A eterne e redeo ep Rosae dade espe a e ede eaa 115 Hematocrit cete estes n ise n eee Ure Ee Ede IT T EXE EINE dede EN 117 tHb to
120. OOX O Hb HHb COHb MetHb e Bilirubin neonatal The following configurations are available cobasb221 1 system BG pH tHb SO cobas b 221 lt 2 gt system BG pH COOX Bili cobas b 221 lt 3 gt system BG pH ISE Hct tHb SO cobas b 221 lt 4 gt system BG pH ISE Hct COOX Bili cobasb221 5 system BG pH ISE Hct MSS tHb SO e cobas b 221 6 system BG pH ISE Hct MSS COOX Bili a are no longer manufactured or offered Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 9 2 General descriptions cobas b 221 system Introduction Roche Diagnostics During the measurement or calibration or other processes it is possible to conduct database operations perform certain settings or call up general information at the same time For details see Chapter 9 Software modes The individual mutually independent software modes are defined as follows Analyzer Measuring QC measurement system calibration commonly used functions quick access Setup Instrument settings Database Data about patients measurements calibrations QC and the instrument Info April 2009 A 10 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions General notes Application area Operating instructions Roche Diagnostics General notes The instrument has been tested for measuring parameters in whole blood serum plasma and dialysis
121. OOX values are available or not April 2009 Instructions for Use Revision 10 0 A 107 5 Theoretical foundations cobas b 221 system Parameters and calculations Heart minute volume Q P F Index Bibliography Roche Diagnostics Unit vol Q ctO A ctO v Equation A 44 a amp 0 4 amp 1 39 tHb 1 5 SaO arterial oxygen saturation fraction Ration PaO FIO H Unit mm Hg Equation A 45 P F Index PaO PAO PaO 0 00314 2 Clinical and Laboratory Standards Institute Blood gas an pH related measurements CLSI document C46 A Approved Guideline 2001 M ller Plathe Oswald S ure Basen Haushalt und Blutgase Breuer B ttner Stamm Stuttgart New York Georg Thieme Verlag 1982 Burtis Carl A Ashwood Edward R Tietz Textbook of Clinical Chemistry 4 Edition W B Saunders Company 2006 Thomas Lothar Labor und Diagnose Indikation und Bewertung von Laborbefunden f r die medizinische Diagnostik 5 Auflage Frankfurt am Main TH Books Verl Ges 2000 Thode J Fogh Andersen N Wimberley P D Moller Sorensen A Siggaard Andersen O Relation between pH and ionized calcium in vitro and in vivo man Scand J clin Invest 43 Suppl 165 79 82 1983 April 2009 A 108 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Clinical significance Clinical significance pH Roche
122. OTROL PLUS B Level 2 n 40 Material AUTOTROL PLUS B Level 3 n 40 Parameter Mean Sur CV S1 CV pH 7 571 0 0027 0 04 0 0050 0 07 PCO 20 3 0 3114 1 53 0 5568 2 74 PO 144 2 5 3745 3 73 6 5040 4 51 Sodium 158 9 0 5680 0 36 0 8495 0 53 Potassium 6 97 0 0343 0 49 0 0514 0 74 Chloride 119 0 0 4810 0 40 1 0305 0 87 ionized Calcium 0 546 0 0041 0 76 0 0078 1 43 Hct 26 9 0 4193 1 56 0 4298 1 60 Lactate 0 8 0 0103 1 29 0 0562 7 02 Glucose 21 0 0 1298 0 62 0 4006 1 91 Urea 2 1 0 0202 0 94 0 0757 3 53 tHb tHb module 7 z 5 7 SO tHb module tHb COOX 20 4 0 1940 0 95 0 2357 1 15 SO COOX 97 5 0 1396 0 14 0 1400 0 14 O Hb 92 5 0 3581 0 39 0 3617 0 39 COHb 3 3 0 1564 4 75 0 1565 4 75 MetHb 1 9 0 0773 4 13 0 0809 4 32 HHb 2 4 0 1244 5 23 0 1249 5 25 Bili 21 6 0 1621 0 75 0 1690 0 78 Table A 12 AUTOTROL PLUS B Level 3 n 40 Material AUTOTROL PLUS B Level 4B n 40 Parameter Mean Sur CV S1 CV pH 7 418 0 0014 0 02 0 0050 0 07 PCO 41 3 0 2720 0 66 0 6088 1 48 PO 96 4 5 0118 5 20 8 9120 9 24 Sodium 140 6 0 3242 0 23 0 5710 0 41 Potassium 4 77 0 0135 0 28 0 0220 0 46 Chloride 101 6 0 3679 0 36 0 9279 0 91 ionized Calcium 1 104 0 0048 0 43 0 0092 0 83 Hct 36 7 0 3883 1 06 0 5049 1 38 Lactate 5 6 0 0304 0 54 0 1607 2 85 Table A 13 AUTOTROL PLUS B Level 4B n 40 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 65 4 Specifications cobas b 221 system Performance data
123. Parameter Mean Sur CV Sr CV Glucose 1 4 0 0204 1 45 0 1026 7 26 Urea 13 1 0 2512 1 91 0 7169 5 46 tHb tHb module SO tHb module tHb COOX 6 4 0 0265 0 41 0 1241 1 93 SO COOX 62 7 0 2002 0 32 0 2514 0 40 O Hb 36 5 0 1973 0 54 0 2474 0 68 COHb 27 6 0 0869 0 32 0 1091 0 40 MetHb 14 2 0 0414 0 29 0 0518 0 36 HHb 21 7 0 0690 0 32 0 0866 0 40 Bili 4 2 0 0146 0 34 0 0707 1 67 Table A 13 AUTOTROL PLUS B Level 4B n 40 Material AUTOTROL PLUS B Level 5B n 40 Parameter Mean Sur CV S1 CV pH 7 412 0 0033 0 04 0 0061 0 08 PCO 41 4 0 3787 0 91 0 7924 1 91 PO 94 7 3 1077 3 28 3 2578 3 44 Sodium 139 4 0 7465 0 54 0 8404 0 60 Potassium 4 76 0 0365 0 77 0 0339 0 71 Chloride 102 1 0 7601 0 74 1 3617 1 33 ionized Calcium 1 119 0 0062 0 56 0 0103 0 92 Hct 38 0 1 4404 3 79 1 4027 3 69 Lactate 12 9 0 1628 1 26 0 5348 4 14 Glucose 25 4 0 1913 0 75 0 5098 2 00 Urea 26 4 0 4122 1 56 2 5774 9 75 tHb tHb module SO tHb module tHb COOX 23 0 0 2175 0 94 0 3139 1 36 SO COOX 98 1 0 1568 0 16 0 1744 0 18 O Hb 94 2 0 4087 0 43 0 4554 0 48 COHb 2 5 0 0852 3 37 0 1053 4 16 MetHb 1 4 0 0397 2 77 0 0519 3 62 HHb 1 8 0 0675 3 83 0 0837 4 75 Bili 24 1 0 2629 1 09 0 2728 1 13 Table A 14 AUTOTROL PLUS B Level 5B n 40 Roche Diagnostics April 2009 A 66 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Material AUTOTROL TS Level 1 n 40 Performance data
124. Performance data Linearity Tonometered whole blood Aqueous Solutions NIST standards Hematocrit Human whole blood incl bilirubin Parameter PO mmHg Roche Diagnostics Whole blood was tonometered at 37 C to various level of gravimetrically prepared gases with CO and O concentrations certified to 0 03 absolute by the manufacturer Expected and observed values for PCO and PO were corrected to 760 mmHg Expected values for the aqueous solutions are based on weighted samples NIST standards are precise serums with accredited target values Measurement results of the hemofuge which is representing the Golden Standard for hematocrit measurements are used as expected values for hematocrit results Expected bilirubin values for human whole blood incl bilirubin are based on weighted samples Material tonometered whole blood Number of instruments 4 cobas b 221 systems Measurements per measuring point and instrument 5 Expected value Mean Sur Recovery 55 39 55 66 0 4860 100 5 83 83 83 45 0 4982 99 5 103 55 103 16 0 9034 99 6 216 97 218 54 1 9437 100 7 Table A 25 Parameter PO mmHg Correlation Slope 0 9904 1 0097 Intercept 0 857 Correlation coefficient 0 9998 April 2009 A 70 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Parameter PCO mmHg Parameter pH pH units Roche Diagnostics Material Tonometered whole blood Number of instru
125. RAM 40 GB Harddisk 1 44 MB integrated at the right side of the screen TFT LCD screen 10 4 inch 640 x 480 pixel April 2009 Instructions for Use Revision 10 0 A 93 4 Specifications cobas b 221 system Barcode scanner Barcode scanner Roche Diagnostics Type Reading speed Resolution Reading distance Reading width Preprogrammed code types MT 9060 4 Wedge PS2 hand scanner with integrated decoder up to 45 scans s 0 1 mm up to5cm up to 8 cm China Postal Code Codabar Code 39 Code 128 EAN 8 EAN 13 EAN 128 Interleaved 2 of 5 UPC A UPC E a Further available barcode types can be programmed in accordance with the enclosed manual of the PS2 hand held scanner included in scope of delivery April 2009 A 94 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Contents Theoretical foundations Roche Diagnostics This chapter contains the formulae for calculation values factors and unit conversion as well as the clinical significance of measurement parameters In this chapter Chapter 5 Parameters and calculations ccccsscssescessessessessescsscescsssescssesscesesaessessesaessessesseeaseaseaees 97 Conversion table for units eese eene eene nnne nn nnne nn enne nn ennt 97 A ORE OS eMe bee p Re ER EE IESS 97 Standard values and ranges eee sete rrt 97 GU ATOMS bita dite Oasis 98 PP H E 98 C
126. Rinse Solution expired Insert new S1 Rinse Solution 10029 S1 expired SI Rinse Solution expired Insert new S1 Rinse Solution 10032 Microcontroller communications error A communications problem occurred at the microcontroller Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 10033 COOX communications error A communications problem occurred at the microcontroller Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 10034 AQC communications error A communications problem occurred at the microcontroller Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 10039 Vacuum reduction not ok Low pressure reduced insufficient V13 does not open Press Continue to correct the error If the error persists contact Technical Support 10040 Vacuum error Vacuum buildup is insufficient To localize the error perform General fluidics test System gt Diagnostics e Start Vacuum pump test System gt Component test gt Aggregats If the pump output is more than 20 over or under the reference value contact Technical Support 10041 Waste error 1 The waste system is leaking s Insert new waste container 10042 Waste error 2 The waste ventilation
127. Roche Diagnostics 4 Push the linear bracket white plastic part upwards see below A 5 Remove the complete tubing set tubing holder and tubing of the corresponding pump see below B A Move linear bracket upwards B Remove tubing set Figure C 19 Peristaltic pump 6 Check if the five rollers are easily moveable In case of malfunction contact customer service 7 Place the tube around the corresponding rolling wheel Check that the tubing set is correctly orientated the grip end must be pointing upwards see above B 8 Close the clear plastic cover tension lever The tubing holder is then pressed into the sealer 9 Close the top cover The tubes may drip a little after being disconnected Remove excess fluids with a clean absorbent cloth The peristaltic pump tubes are also replaced during the annual service see section Additional maintenance procedures on page C 38 April 2009 C 24 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Cleaning the bottle compartment 1 Open the bottle compartment cover The bottle exchange image appears on the display Lot number 21460909 21461502 21462001 Expiration date 25 2 2008 08 10 2007 12 11 2007 Start date 08 11 2006 08 11 2006 08 11 2006 08 11 2006 Time to change 18 11 2006 20 12 2006 20 12 2006 20 12 2006 Fill l
128. See section 23 Checking the barometer value on page A 47 e Avoid direct sunlight vibration and strong electromagnetic fields electric motors transformers X ray equipment cellular phones A stable and level work surface max 1 incline with bottles installed Relative humidity 20 to 8596 e Atleast 10 cm free space around the instrument for air circulation and electrical connections e Correct voltage 100 to 240 VAC 410 After setting up the cobas b 221 system at a location that meets the necessary conditions the following steps must be performed to ensure the instrument is ready for operation e First check the instrument and the accessories for completeness and damage The completeness of the delivery can be checked through comparison with the delivery packing slip If anything is missing inform the Roche representative immediately If the delivery has suffered damage despite careful packing inform the transportation company immediately Retain the packing material and products as evidence for the damage claim Handle the instrument only at the specified holding points risk of injury Take care when lifting weight of the instrument without wash calibrating solutions and AutoQC is approx 45 kg See illustration on the outer packaging and in Chapter 4 Specifications section Holding points on page A 92 April 2009 Instructions for Use Revision 10 0 A 27 3 Installation and shutdown
129. Start internal cleaning Ifthe error persists optimize the cleaning interval Setup gt Time amp Intervals gt Maintenance timing gt BG cleaning change interval and or sample counter or contact Technical Support 2022 Ref drift alarm IIn the Ready state drifting of the sensor Perform Fill reference electrode signal was detected at the reference System gt Utilities gt Fluid actions gt electrode Fill routines Possible causes e Perform Calibration for Ready Reference system fault due to bubbles System gt Calibration Docki hanism for S2 Fluid Pack i b M ER LE VPE Check S2 docking mechanism for soiled ME c contamination and if necessary clean it Ifthe error persists replace reference electrode see Chapter 10 Maintenance section Changing the reference electrode on page C 29 2023 Sensitivity drift 1 point sensitivity drifts Perform Calibration for Ready Possible causes System gt Calibration The sensor did not finished the start up period and the 1 point sensitivity highly increases Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 30 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 2024 Air bubble detected Before washing out the sample the Perform General fluidics test conductivity value was not detected as Syst
130. SulfHb 0 if SulfHb is not measured April 2009 A 106 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations BEsct Osmolality OER ww Roche Diagnostics Parameters and calculations Base deviation at actual oxygen saturation Unit mmol L BE 1 0 0143 tHb 1 63 tHb 9 5 pH 7 4 2426 cHCO Equation A 40 0 2 tHb 1 2 100 Unit mOsm kg P Equation for blood plasma serum Osm 1 86 Na Glu Urea 9 Equation A 41 Equation for aqueous solution acetate bicarbonate Equation A 42 Osm 2 Na K 3 Ca Mg Glu Urea Default values e K 43 mmol L Ca 2 1 25 mmol L Mg 2 0 6 mmol L e Glu 4 5 mmol L e Urea 5 mmol L Explanation Na if no measurement value is available no osmolality is calculated K if no measurement value is available the default value is used for the calculation Ca ifno measurement value is available the default value is used for the calculation Mg the default value is used for the calculation Urea if no measurement value is available the default value is used for the calculation Glu if no measurement value is available the default value is used for the calculation Oxygen extraction ratio Unit 96 _ ctO 5 ctO4 ani Equation A 43 OER ctO Xa for ctO see Equation A 14 on page A 101 Different calculation depending on whether C
131. This function can also be used when full ampoules are removed from the mat for manual measurement 8 Repeat the procedure for all mats 9 Close the AutoQC drawer QC timing Depending on the selected material level this function is used to select the start time s for the AutoQC measurement s and or the time for performing a manual QC measurement After reaching the set time a note appears in the instruction window Press the following buttons C Setup gt Times amp intervals gt QC timing WEA a 00 00 03 00 06 00 09 00 12 00 15 00 18 00 21 00 00 00 gt Time Material level Type 4 08 19 AUTO TROLPLUSBL1 ma Figure B 27 A little marker QC on the time scale indicates the defined start time s and for a better coordination with the QC timing a little marker on the time scale also indicates Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 41 7 Quality control cobas b 221 system Material setup Setting start time s New Edit Delete Copy daily profile Paste daily profile the defined calibration intervals Small red colored point System calibration small green colored triangle 2P calibration Select the day from the Day of Week list on which the QC measurement should be performed Enter start time material and measurement repeats Press Use another material to define the material used for a possible measurement repeat Press Repea
132. Troubleshooting cobas b 221 system System stops No Message Cause Action 10128 Timing error An asynchrony occurred between processes and measuring Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected Print Mesurement reports Quick access gt Last measurement and contact Technical Support 10130 Timing error COOX An asynchrony occurred between processes and measuring e Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected Print Mesurement reports Quick access gt Last measurement Print Sensor report Info gt Miscellaneous reports and contact Technical Support 10155 AQC drawer open The AutoQC drawer is open e Close the AQC drawer If the error persists in case of closed AutoQC drawer cover with displayed Mat change screen contact Technical Support 10160 File error 10261 A file check resulted in an error Perform a new SW update System gt Utilities gt Communication 10288 Program error 10389 A communications error occurred as part of the programming of the module processors e To correct the error turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technica
133. UTO TROL PLUS B AutoQC material for controlling BG ISE Glu Lac Urea BUN COOX Bilirubin AUTO TROL TS AutoQC material for controlling BG ISE Glu Lac Het tHb SO Barcode scanner PS2 hand held scanner with integrated decoder for simple input of QC data electrode data patient or user identity BG Abbrev for blood gas BG measuring chamber The BG measuring chamber with its sensors serves for measuring the pH value and blood gas values PO and PCO Bilirubin is a yellow decomposition product of the red blood pigment hemoglobin or more exactly that of the hemoglobin share Bottle compartment The bottle compartment contains the W Waste Container the S1 Rinse Solution bottle the S2 Fluid Pack with the solutions for BG and ISE and the S3 Fluid Pack with the solutions for Glu Lac and Urea BUN only cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system The bottle compartment also contains the necessary Roche Diagnostics Acid Base Diagram Dummy electrode docking mechanisms for transporting the fluids into or out of the system Bottle tool serves for emptying the W Waste Container and for degassing the 1 Rinse Solution BUN Abbrev for blood urea nitrogen Bypass nipple Connection between the sample inlet path and the transverse channel Calibration for Ready A calibration is selected to bring all the activated parameters into the Ready condition Clip Plastic fastener on S2 Fluid Pack and S
134. Unit mmHg 549 107 00 95 40 071 E 97210 PO 9 2 30 PO PO 10 t 37 Equation A 32 Alveolar oxygen partial pressure at a patient temperature other than 37 equi Unit mmHg Equation A 33 PAO P otal PH 0 FIO PACO no for PAO lt PO otherwise PAO PO with PH O 47 o 9257 0001 G 37 0 37 O Alveolar oxygen partial pressure at a patient temperature other than 37 aci Unit mmHg Equation A 34 AaDO t PAO PaO April 2009 Instructions for Use Revision 10 0 A 105 5 Theoretical foundations cobas b 221 system Parameters and calculations a A0 RI Hct c MCHC BO Roche Diagnostics Arterial alveolar oxygen partial pressure ratio at the patient s temperature Unit _ Pao Equation A 35 a AO 100 ei 2 Respiratory index corrected to patient temperature other than 37 ac Tu Unit 96 _ PAO PaO PaO Equation A 36 RI 100 Hct as a function of tHb 4l Equation A 37 Hct c tHb 100 Default value of F 3 00 input range 2 70 to 3 30 Only measured tHb is permitted Mean corpuscular hemoglobin concentration Units g Hb dL Ery Equation A 38 MCHC tHb 100 Hct Only displayed as a calculated value if both values are measured Oxygen capacity 1 Unit vol COHb MetHb SulfHb Equation A 39 BO tH is ao 100
135. a samples older than 1 hour must be re centrifuged in order to remove fibrin clumps that may have formed The procedure for handling pleural fluids is the same as for plasma samples April 2009 Instructions for Use Revision 10 0 B 9 6 Measurement cobas b 221 system Interferences Interferences tHb SO Roche Diagnostics The measuring module and measuring sensors were tested with respect to their interference stability with the given chemical substances and pharmaceuticals Respective concentrations of the interference substances were added to the whole blood samples as suggested by the CLSI and then measured again D Control serum interference substance K Control serum MV Mean value SD Standard deviation Substance tHb SO Indocyanin green 5 mg L MV D K SD n 4 3 834015 9222 n MV I 19 0 nnn nnn nnnnnn MV K 15 60 1 11 11 Intralipid 10 g L MV D K SD n 4 2934017 se MV I 17 2300 essene MV K 15 00 manne enna nanan Methylene blue 30 mg L MV D K SD n 4 0 mn 25 20 1 47 MVD ooo cM 75 73 MV K rs 99 90 Lipofundin 10 g L MV D K SD n 4 1 33 0 25 00 2220 sssr MV 1 16 30 1 1111 111 MV K 14 98 000 Table B 1 Interferences tHb SO module April 2009 B 10 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement pH ISE Interferences Substance p
136. able A 17 AUTOTROL TS Level 3 n 40 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 67 4 Specifications cobas b 221 system Performance data Parameter Mean Sur CV Sr CV Hct 22 9 0 5431 2 37 0 5799 2 53 Lactate 0 8 0 0316 4 02 0 0446 5 68 Glucose 21 3 0 6006 2 82 0 7883 3 70 tHb tHb module 8 3 0 0122 0 15 0 0319 0 39 SO tHb module 93 3 0 0355 0 04 0 0450 0 05 Table A 17 AUTOTROL TS Level 3 n 40 Material AUTOTROL TS Level 4A n 40 Parameter Mean Sur CV S1 CV pH 6 880 0 0054 0 08 0 0076 0 11 PCO 87 5 1 3229 1 51 2 4825 2 84 PO 22 7 3 6828 16 23 5 1660 22 77 Sodium 88 0 0 5162 0 59 0 8391 0 95 Potassium 8 94 0 0584 0 65 0 1029 1 15 Chloride 67 8 0 5941 0 88 1 3054 1 93 ionized Calcium 2 543 0 0272 1 07 0 0452 1 78 Hct 75 8 0 8202 1 08 1 0158 1 34 Lactate Glucose Urea tHb tHb module 11 0 0 0206 0 19 0 0281 0 26 SO tHb module 88 2 0 0303 0 03 0 0450 0 05 Table A 18 AUTOTROL TS Level 4A n 40 Material AUTOTROL TS Level 5A n 40 Parameter Mean Sur CV S1 CV pH 7 730 0 0042 0 05 0 0061 0 08 PCO 9 2 1 3769 15 03 1 4213 15 51 PO 253 6 6 0686 2 39 8 7795 3 46 Sodium 174 5 0 8890 0 51 1 2891 0 74 Potassium 2 00 0 0250 1 25 0 0346 1 73 Chloride 130 3 0 7821 0 60 1 1922 0 91 ionized Calcium 0 403 0 0065 1 61 0 0109 2 70 Het 22 0 0 6997 3 18 0 7713 3 50 Lactate Glucose Urea tHb
137. act Technical Support 20122 AQC pos error 20141 The required position was not reached e Perform Wash AQC System Wash amp Cleaning Repeat the AutoQC measurement If the error persists contact Technical Support 20142 AQC temperature nOk The temperature of the AQC module is outside the specified range Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support Table D 2 Module stops Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 15 11 Troubleshooting cobas b 221 system System warnings System warnings No Message Cause Action 30005 Cl electrode is contaminated defective Perform the following troubleshooting options step by step until the warning disappears 1 Press System gt Wash amp Cleaning gt Cleaning modules gt Start internal cleaning System gt Wash amp Cleaning gt Cleaning modules gt Start external cleaning Replace Cl electrode lt D see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 30008 Pack S2 level is low S2 Fluid Pack will be empty in the next 12 to 24 hours If necessary insert a new S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 30009 Pack S3 level is low S3 Fluid Pack will be empty in the next 12 to 24 hours If necessary in
138. alled one with the same lot number is being scanned There is the ability to scan in up to 4 different materials If this number is reached you first have to delete an existing AQC material Setup gt QC material gt Delete A corresponding prompt appears on the screen Already installed AQC material AQC material with the same lot number AQC material with different lot number Scanning ranges New QC material Roche Diagnostics If the barcode of a previously installed QC material with the same lot number is scanned the procedure is continued and a corresponding information message is displayed If the barcode for a previously installed AQC material with a different lot number is scanned in after you press the Continue button you can choose between two options e Carry out lot change automatically e see Change lot applies only to AutoQC measurements on page B 42 Do not carry out lot change Allows you to review or discard your entries Exits the QC setup wizard The following screen appears April 2009 Instructions for Use Revision 10 0 B 45 7 Quality control cobas b 221 system QC setup wizard Figure B 30 As soon as a valid range is scanned the corresponding module is marked and the Continue button appears This allows continuation of the process without having entered all ranges Previously installed QC material In this case the system checks whe
139. already be found in the blood of moderate smokers Concentrations of 10 2096 in the blood cause headaches and a slight shortage of breath A concentration of 30 40 causes weakness and visual faults A concentration of 40 5096 causes tachypnoea tachycardia ataxia and fainting A concentration of 50 7096 leads to seizures coma and restricted heart and lung functions Higher concentrations are usually fatal Clinical diagnoses require CO oxymetry as the calculated oxygen saturation of blood gas and acid alkali measurements is confusingly high April 2009 Instructions for Use Revision 10 0 A 121 5 Theoretical foundations cobas b 221 system Clinical significance Methemoglobin MetHb Roche Diagnostics Small quantities of carbon monoxide are generated in the body by the conversion of haem into biliverdin This production of small quantities of endogenous carbon monoxide is increased by hemolytic anaemia Standard values arterial blood at 37 C e Nonsmoker 0 5 1 5 or 0 005 0 015 e Smoker 8 0 9 0 or 0 080 0 090 a Labor und Diagnose Lothar Thomas 5th expanded edition 2000 Page 490 Critical values e COHb gt 15 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Methemoglobin is created through oxidation of two to three value hemoglobin iron This reduces the oxygen binding capacity as Fe cannot bind oxygen reversibly This hemoglobin oc
140. anism S3 2 Tighten the screws on valve V19 approx 2 3 rotations see Figure A 17 Q 7 Use the delivered screwdriver VM V19 A Screws on valve V19 Figure A 17 Valve V19 and VM 3 To return to the installation window close the docking mechanism and the bottle compartment cover 11 Insert right FMS tube at VM bottle compartment 1 Open the bottle compartment cover and the docking mechanism S3 2 Slide the tube under the tube clip of valve VM ul A VM B V19 Figure A 18 Valve VM 3 Close docking mechanism and bottle compartment cover Roche Diagnostics April 2009 A 34 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation 12 Insert fill port and sample inlet path glass tube Pull out the sample drip tray Remove the T amp D cover and the unit cover Insert the fill port started from the 6 o clock position as shown below gt e O N Push the fill port straight onto the insert needle A Do not bend the insert needle during this process A Needle Figure A 19 Insert needle 5 Rotate the fill port 90 clockwise and upwards until it snaps into place Figure A 20 6 Open the T amp D lock see Figure A 21 on page A 36 A 7 Insert the glass tube into the guides fasten it and check it for a correct position see Figure A 21 on page A 36 C see Figure A 21 on page A 36 D Roche Diag
141. aper A 51 Remove Waste container A 50 Set valves for FMS tubing exchange A 53 Software version 1 Software modes B 69 Analyzer mode B 78 Ready screen B 78 General B 71 Info B 87 User interface B 71 Solutions Handling solutions A 15 Specifications Touch screen PC unit A 93 SN 1500 A 93 SN 1500 A 93 SN 5000 A 93 Standard values and ranges A 97 Status messages of measuring and calibration values D 20 Status messages on the measurement report D 39 Symbols 5 Syringe mode B 19 Syringes B 7 System B 79 System calibration B 65 System description A 18 Barcode scanner A 23 Bottle compartment A 20 COOX module A 20 Input unit A 20 Interfaces A 22 Measuring chamber A 19 Power supply A 21 Printer A 19 Pumps A 20 Reverse side A 21 Screen PC unit A 19 tHB SO module A 19 Visual identification A 18 Warning and identification labels incl nameplate A 24 System stops D 5 System warnings D 16 T T amp D disk Cleaning C 9 April 2009 Instructions for Use Revision 10 0 F 7 Index cobas b 221 system Temperature humidity stability A 89 tHb SO Interferences B 10 tHB SO module A 19 Theoretical foundations A 95 Touch screen Cleaning C 8 Troubleshooting D 3 Barcode D 40 Module stops D 12 Status messages of measuring and ca
142. aste container or enter correct fill level 10020 Rinse bottle empty The transponder on the S1 Rinse Solution Insert new S1 Rinse Solution bottle indicates an empty bottle see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 10021 Flap S1 Docking mechanism for S1 Rinse Close mechanism Solution is open 10022 uC Reset Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 10023 Power fail A power fail occured The instrument will be ready for operation after warmup 10024 No wash water container Insert 1 Rinse Solution Table D 1 System stops Roche Diagnostics April 2009 D 6 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting System stops No Message Cause Action 10025 Check date and time Check date and time in the Setup mode and perform any necessary changes Setup gt Times amp intervals gt Act time date 10026 Bypass wash error 2 Sample sensor S52 detects insufficient water during wash process Perform Wash again System gt Wash amp Cleaning If the error persists contact Technical Support 10027 SD wash error 2 Sample sensor SS2 detects not enough water during wash process Perform Wash again System gt Wash amp Cleaning If the error persists contact Technical Support 10028 S1 on board time expired On board time of S1
143. ation A 5 QC measurement B 51 Operating safety information A 6 Multirules B 53 QC consequences B 55 2 General descriptions Remove the QC lock B 56 Introduction A 9 QC for Ready with AutoQC module B 57 General notes A 11 QC for Ready without AutoQC module B 59 Measurement and calibration procedure A 13 QC troubleshooting B 61 Measurement evaluation A 14 Safety instructions for specific dangers A 14 8 Calibration Handling solutions A 15 Calibration general B 65 Handling electrodes A 15 Automatic calibrations B 65 General notes on the use of the MSS cassette A 16 User activated calibrations B 66 System description A 18 Display of parameters during calibration B 68 3 Installation and shutdown 9 Software modes Installation A 27 Software modes general B 71 Shutdown A 48 User interface B 71 Analyzer mode B 78 4 Specifications Setup B 80 Performance data A 59 Data manager B 81 Sample throughput A 86 Info B 87 Measurement times of the samples A 86 Sample volumes A 87 Sale types A 87 Maintenance Part Ic Calibrations A 88 Environmental parameters A 89 10 Maintenance Product data A 91 Maintenance general C 5 AutoQC A 92 Decontamination C 5 Printer A 92 Daily C 7 Touch screen PC unit A 93 Weekly C 8 Barcode scanner A 94 Quarterly C 9 Sample dependent maintenance procedures C 13 5 Theoretical foundations Unscheduled C 22 Parameters and calculations A 97 Additional maintenance procedures C 38 Clinical significance A 109 Roche Diagnostics April 2
144. ature BG ISE 37 0 2 C MSS Glu Lac Urea BUN 30 0 2 C e Relative humidity 20 to 8596 Storage conditions in original packaging Temperature BG ISE 15 to 30 C MSS Glu Lac Urea BUN 2 to 8 C e Relative humidity 20 to 8596 not condensed Transportation conditions in original packaging Temperature BG ISE 5 to 40 C over a period of 3 days MSS Glu Lac Urea BUN 5 to 35 C over a period of 5days Humidity 20 to 85 96 not condensed over a period of 3 days Shock resistance 30g Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 89 4 Specifications cobas b 221 system Environmental parameters Solutions Operating conditions Ambient temperature 15 to 35 C e Relative humidity 20 to 8596 Storage conditions in original packaging Temperature S1 rinse Solution 2 to 30 C 24 months S2 fluid Pack 2 to 30 C 18 months S3 fluid Pack 2 to 25 C 18 months Relative humidity 20 to 85 a storage time contains also transportation time and the storage time in Mannheim Transportation conditions in original packaging Temperature 2 to 35 C over a period of 7 days e Relative humidity 20 8596 e Shock resistance 30g Stability during operation Solutions Description with 15 31 C ambient temperature weeks e Si Rinse Solution Wash solution 6 e S2 Fluid Pack Calibration solution BG ISE 6 e S3 Fluid Pack Calibration solution Glu Lac Urea BUN 6
145. ature limitation The conditions necessary to preserve the product s shelf life before opening In Vitro Diagnostic Medical Device Manufacturer according to In Vitro Diagnostic guidelines 98 79 EG Catalogue number Serial number model plate Caution consult accompanying documents Please consult instructions for use a DIN EN 980 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements b DIN EN ISO 780 Packaging Pictorial marking for the handling of goods Roche Diagnostics April 2009 6 Instructions for Use Revision 10 0 cobas b 221 system Other symbols Roche Diagnostics Description GOR srenuelo STERILE R Biological risk according to the standard IEC EN 61010 2 101 a Instrument Biological risk according to the standard DIN EN ISO 980 Consumables Do not use if package damaged Do not reuse Fragile Handle with care Handle with care Valid only for Roche MICROSAMPLER Method of sterilization using ethylene oxide Valid only for BS2 Blood Sampler Method of sterilization using irradiation a IEC EN 61010 2 101 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment b DIN EN ISO 980 Medical devices Symbols to be used with medical device
146. ays the appropriate information The use of an expired fluid pack can lead to calibration errors Insert a new pack which has not expired Never use expired bottles packs Procedure starting from the analyzer mode 1 Open the bottle compartment cover The following screen appears vee mes 9 9 a Lot number 21460909 21461502 21462001 Expiration date 25 2 2008 08 10 2007 12 11 2007 Start date 08 11 2006 08 11 2006 08 11 2006 08 11 2006 Time to change 18 11 2006 20 12 2006 20 12 2006 20 12 2006 Fill level 79 8 94 5 87 0 86 5 Mat change 14 10 System cal 15 02 08 11 2006 1440 A cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only Figure C 7 2 Open the docking mechanism and pull out the bottles packs to be exchanged Dispose of the bottles packs according to local regulations hazardous waste Remove packs rubber sealings 3 Insert the new bottle or the new pack in the corresponding position until it stops 4 The cobas b 221 system recognizes the correct bottle or the correct packs and verifies the expiration date 5 Ifthe bottle has passed the expiration date the screen displays a warning 6 Close the docking mechanism and the bottle compartment cover The solutions are automatically aspirated upwards detection in the flap 7 Anew QC measurement with all three level low no
147. ays wear gloves For more detailed information about decontamination see Chapter 10 Maintenance Roche Diagnostics April 2009 A 14 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions Handling solutions Handling solutions Store the cobas b 221 system wash calibrating solutions according to the specified packaging requirements The temperature of the solutions should be adapted to the ambient temperature before use The shelf life of the solutions is limited Please read the bottle label and the packaging for the correct storage temperature and the maximum shelf life DO NOT FREEZE If frozen the solution s concentration may change and cause calibration errors Do not use damaged fluid packs S2 and S3 Do not mix the individual components For Storage specifications see Chapter 4 Specifications Handling electrodes Store the electrodes according to the packaging specifications The shelf life of the electrodes is limited Please read the label and the packaging for the correct storage temperature and the maximum shelf life e CAUTION Installation note for the PCO electrode A Insert the electrode into the measuring chamber within 5 minutes of opening the ALU PE packaging A special protective gas atmosphere designed to condition the PCO electrode during storage is found inside the ALU PE packaging This gas atmosphere ensures immediate potential stabilit
148. bas b 221 system 11 Troubleshooting System stops No Message Cause Action 10471 T amp D error An error occured at the T amp D module Clean the T amp D disk the fill port and the plug control see Chapter 10 Maintenance Press Initialization System gt Component test gt Aggregates gt T amp D module If the error persists contact Technical Support 10472 Transponder error S1 The transponder data of the rinse bottle could not be read To correct the error remove and reinsert the S1 Rinse Solution Insert new S1 Rinse Solution If the error persists contact Technical Support 10488 HW test error An error was recognized in a hardware component Perform General hardware test System gt Diagnostics If the error persists turn the instrument off and contact Technical Support 10489 Remote lock Instrument locked by cobas bge link To remove lock press Continue Log on as a user with the privileg Remote unlock For more information on user management see Reference Manual chapter Software modes section Sicurity 10491 QC setup wizard active The instrument was locked by starting the QC setup wizard The message is removed after finishing the QC setup wizard see Chapter 7 Quality control 10492 Data transfer active The device was locked by starting the data e transfer The message is removed after finis
149. bbles at the membrane in the edis and check Details of the Sensor slope internal electrolyte of the electrodes e A Interference signals in the measuring If the electrode MSS cassette is defective it is channel during measurement displayed Replace the corresponding acquisition electrode or MSS cassette Interference signals via reference lt D see Chapter 10 Maintenance section electrodes during measurement Replacement of the electrodes on acquisition page C 27 or Changing the MSS cassette cobas b 221 5 system and cobas b 221 lt 6 gt system only on page C 32 Check electrode for air bubbles Carefully tap against the electrode body with a finger nail to release any air bubbles from the membrane If error cannot be corrected replace electrode see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 Ifthe error persists perform Aspirate Rinse System gt Utilities gt Fluid actions gt Fill routines f necessary replace S1 Rinse Solution see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 2016 Signal too high The first sampling value of the O zero Perform Wetting routine for BG point calibration is gt 60 mV System gt Utilities gt Fluid actions Possible causes Ifthe error cannot be corrected perform e An air bubble falsifies the calibration Aspirate solution O2 zero Non uniform O2 zero point solution System gt Utilities gt Fluid actions gt F
150. ble substances The following substances may not be introduced into the MSS measuring chamber under any circumstances since they would immediately destroy the MSS sensors or severely impact their functionality Deproteinizer NaOCl e QO zero point solution Cleaning solution e Na electrode conditioning solution e Rinse additive Solutions containing heavy metals Ag Hg Au etc e g Thiomersal Cleaning solutions containing detergent e g washing material or liquid detergents All solutions for disinfections e g high percentage alcohol glutaric dialdehyde cresol etc Solutions with pH values that deviate greatly from neutral e g pH value of 6 0 and 9 0 The use of anticoagulants other than those approved by Roche Diagnostics approved heparin salts such as EDTA citrate NH4 heparin and glycolysis inhibitor such as NaF and oxalate can lead to erroneous results Roche Diagnostics April 2009 A 16 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions General notes on the use of the MSS cassette Inserting the MSS cassette vie mv 7 Hold the MSS cassette only at the designated handle and avoid touching the contacts For a detailed description see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 17
151. cal 1502 06 112006 1442 A A Warning window for pending maintenance Figure B 64 DA The warning window will always display the oldest message 0 see Figure B 64 Make sure that the tasks displayed on the screen are executed properly and immediately as any additional pending warnings or information can otherwise not be visualized accordingly Sm Sensor changing Q The sensors must be replaced without delay as soon as the specified time for sensor replacement has been reached MSS sensors must be replaced no later than after 28 days Sensors that remain in the instrument after an alarm will suffer decreased performance which can result in longer calibration times and deviating measurement values The time stated for changing a sensor is a standard value as from the time of insertion of a new sensor or a new electrode During operation this value is adjusted to the respective state of the sensor electrode and thus becomes more and more exact NL MSS cassette Q The sensors for the parameters glucose lactate and urea are listed separately in the List of all activities but refer to one sensor these sensors however are not changed separately but together with an MSS cassette Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 89 9 Software modes cobas b 221 system Info List of all warnings Ready 102 Te x Y Action info e fea Matchange ast
152. cal blood e g blood from newborns taken from earlobes and heels The clot catcher coagulate trap which is placed on the top of the syringe or capillary prevents blood clots and tissue particles from entering the cobas b 221 system Clot catchers are not suitable for measurements in Aspiration from syringe mode Withdraw whole blood samples using heparinized syringes capillaries or the Roche MICROSAMPLER and analyze the samples as soon as possible after sampling Remove air bubbles from the sample collection container immediately after the sampling procedure Immediately after withdrawing the sample with syringes thoroughly mix the sample with anticoagulant This can be done by rolling the sample between both hands or shaking Properly label the samples following the standard documentation procedure Samples that are measured within 15 minutes may be retained at room temperature e Ifunable to measure samples within 15 minutes place them temporarily in ice water Complete the measurement within 30 minutes but not after more than 60 minutes Samples with a PO level above 200 mmHg 26 kPa should be collected in a glass container if the measurement can not be performed within 15 minutes If unable to measure samples immediately store the sample at room temperature for no longer than 30 minutes When using capillaries analyze samples for tHb SO Hct glucose and lactate measurements immediately after sampling t
153. cal medical specialist who will take the patient s clinical condition into consideration before any clinical decisions are reached based on the test results In order to ensure the quality of the measurement results complete a quality control test on 3 levels low normal high after each electrode exchange after each exchange of solutions and packs and after startup of the instrument Additionally complete a quality control test on one level between two automatic 2P calibrations The level have to be alternated low normal high For detailed information see Chapter 7 Quality control Safety instructions for specific dangers Handling samples While handling samples all necessary regulations concerning hygiene must be observed Dangerous pathogenic agents could be present For more detailed information see Chapter 6 Measurement Disposal of waste water bottles packs electrodes and the instrument Dispose of waste water bottles packs electrodes and the instrument according to local and or labor regulations biologically contaminated hazardous waste Decontamination The purpose of this decontamination is to minimize risk when handling items that were in contact with biological samples Roche recommends following a decontamination procedure in addition to regulations specific to the laboratory These decontamination procedures should be performed periodically to minimize the risk of infections A Alw
154. cal working materials In addition a face mask is required if there is a risk Suitable disinfection and sterilization procedures must be applied The purpose of this procedure is to minimize the risk of infections when replacing items that were in contact with blood Perform these decontamination procedures regularly Roche recommends following a decontamination procedure in addition to regulations specific to the laboratory Use only liquid disinfectant such as protein remover Roche deproteinizer or an alcohol based about 7096 surface disinfectant Do not spray disinfectant directly onto the instrument because this could cause malfunctions in the electronics Do not use any type of bleaching agent Exception Roche Deproteinizer Do not attempt to decontaminate any part of the instrument before shutting it down and unplugging it from the power source Before plugging the instrument back in and turning it on always wait 15 minutes to allow the disinfectant to evaporate Danger of fire and explosion For safety reasons only authorized technical service personnel may decontaminate the power pack Regularly decontaminate the following parts of the instrument Input unit consisting of T amp D module incl fill port and the sample drip tray Touch screen e Surfaces of the instrument Tubing paths see Cleaning fill port and sample drip tray on page C 8 see Quarterly on page C 9 see Exchanging t
155. compartment cocococininononnonocononocononanonononononononononononononononononanenos 25 Replacing printer Paper i e neenieeetetetetiten tente tente tette tente ion iet decis 25 With take up unit optional ocococacacaninaninancncnnononononononononononononono ieie 27 Replacement of the electrodes santana cocaina citaba 27 Changing the reference electrode sees 30 Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only 32 Cleaning the measuring chambers eee 34 Ser M 35 Changing of AUtONDCMAtS miii itte eee 35 Additional maintenance procedures sse eene 38 Dye deu c 38 Replacement every three years desnatada 38 Roche Diagnostics April 2009 C 4 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Maintenance general Maintenance general A Decontamination Input unit Roche Diagnostics After use components of the cobas b 221 system including tubing waste container fill port etc contain biological fluids and therefore represents a possible infectious risk Handle these components with care and according to regulations surrounding potentially infectious materials Suitable protective equipment like laboratory clothing protective gloves protective goggles and if necessary mouth protectors must be worn to prevent direct contact with biologi
156. concentrations of calcium in serum occur during e disturbances to the hormonal regulation of primary and tertiary hyperparathyreoidism increased release from the bones o osteolysis through bone metastasis o plasmocytome o paraneoplastic symptom through ectopic production of parathormone or similar substances or prostaglandin E2 April 2009 Instructions for Use Revision 10 0 A 115 5 Theoretical foundations cobas b 221 system Clinical significance Roche Diagnostics o long lasting immobilization vitamin D intoxication within the scope of therapeutic measures e sarcoidosis Reduced calcium level in serum will be noticed as a result of insufficient calcium reabsorption o undernourishment o mal absorption syndrome o vitamin D3 deficiency o deficiency of 1 25 dihydroxycholecalciferol o chronic kidney insufficiency o hypoparathyreoidism o hypomagnesium greatly decreased concentration of albumen in the serum Note ionized calcium is in the normal range o nephrotic syndrome cirrhosis of the liver acute pancreatitis Normal values Adult 1 12 1 32 mmol L e Child 1 10 1 50 mmol L Critical values Ca lt 0 82 mmol L or 3 28 mg dL e Ca gt 1 55 mmol L or 6 20 mg dL a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 A 116 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Clinica
157. conjugated bilirubin the serum bilirubin concentration increases post natum reaches approx 100 umol L 6 mg dL as maximum for full term newborns on the 3rd to 5th day and then drops down to the standard level in the 2nd to 3rd week Higher bilirubin concentrations occur particularly in premature newborns and the icterus remains for a longer time hyperbilirubin anemia in newborns Higher bilirubin concentrations are very important in newborns since the blood brain barrier is not completely developed yet and bilirubin may enter the brain Bilirubin acts toxic on nerve cells so that high bilirubin values in the first ten days after birth can lead to brain damage or death Depending upon the bilirubin concentration or whether the newborn is a healthy full term one or a premature one icterus neonatorum is treated with photo therapy or with exchange transfusions or with both options Normal values Premature birth Umbilical cord lt 2 0 mg dL or lt 34 2 umol L e 0 1 day 8 0 mg dL or 137 0 umol L 1 2 days lt 12 0 mg dL or lt 205 0 pmol L e 3 5 days lt 16 0 mg dL or lt 274 0 umol L a Tietz Textbook of Clinical Chemistry 3 Edition 1999 page 1803 Normal values normal birth Umbilical cord lt 2 0 mg dL or lt 34 2 umol L 0 1 day 1 4 8 7 mg dL or 24 0 149 0 pmol L 1 2 days 3 4 11 5 mg dL or 58 0 197 0 pmol L e 3 5 days 1 5 12 0 mg dL or 26 0 205 0 pmol L a Tietz Textbook
158. creen BG Utt iuste ete eee tede etie 30 2 POWELSUDDply cio cita idiota 31 3 Attach power cord and barcode scanner see 31 A 31 itecto M 32 6 Select lang age nite ee 32 7 Set the date and time one dedere 32 8 Cal intervals EAN 33 9 Set valves for FMS tubing exchange eociconononononcncnnonaninananonanananananananananananananano 33 10 Fix screws at V19 bottle compartment eciccconnoncnnnnnnnnoninnonananinncnanananicncnos 34 11 Insert right FMS tube at VM bottle compartment 34 12 Insert fill port and sample inlet path glass tube 35 13 Insert printer Paper coser ret t RR IE RA MPO dead 37 14 Insert peristaltic p mptubeScnminninannans ds 39 15 Go to AutoQC service position 39 16 Open the AutoQC drawer and remove the AutoQC valve clamp 40 17 Go to AutoQC home position eene 40 18 Open AutoQC drawer and insert ampoule holder 40 19 Open the measuring chamber cover and insert the sensors 40 20 Open bottle compartment cover and insert Waste container amp packs 44 21 Complete installation sese 46 22 Perform MSS polarization cobas b 221 lt 5 gt system and April 2009 Instructions for Use Revision 10 0 A 25 3 Installation and shutdown cobas b 221 system Contents cobas b 221 6 system only
159. ct Group 10 Intercharacter Delay read the barcode labeled as 500uS B011 If the error persists contact Technical Support April 2009 D 40 Instructions for Use Revision 10 0 Appendix 12 Vest Of consumables Soa AA E CES WO auus E 3 MEC I FE E 9 cobas b 221 system 12 List of consumables Contents List of consumables In this chapter all nessary consumables and order numbers are listed In this chapter Chapter 12 Order information 5 5 2 nc20ncoDoBhoiucnaosoncgonogongch elei edes 5 Blectrodes 5 2e de Bnet nds beph nei bivio 5 Solutions 3 3 noh ndnonootedip on o eO n DO E P REUS 6 OG material ainia laicidad dadas llana did 6 ACCESSOTIES zinimiissoitiiminieiu poi realidad idis 7 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 E 3 12 List of consumables cobas b 221 system Contents Roche Diagnostics April 2009 E 4 Instructions for Use Revision 10 0 cobas b 221 system 12 List of consumables Order information Order information To measure the respective parameter following products are required Electrodes Parameter cr Na K Ca PCO PO pH tHb SO COOX Bii MSS Chloride Electrode X 03111571180 BP1729 Sodium Electrode X 03111598180 BP1730 Potassium Electrode X t t 03111628180 BP1731 Calcium Electrode X
160. ctate Urea BUN Urea Baro Air pressure Calculation values H Hydrogen ion concentration cHCO Bicarbonate concentration in plasma ctCO P Total CO2 concentration in plasma ctCO B Total carbon dioxide concentration in blood BE Base excess of blood BE Base excess of blood at current oxygen saturation BEecf Base excess of the extracellular fluid BB Buffer bases ctO Total oxygen concentration pH Standard pH value cHCO3 4 Standard bicarbonate concentration in plasma PAO Alveolar oxygen partial pressure RI Respiratory index nCa Standardized ionized calcium pH 7 4 Qs Qt Shunt quotient between both oxygen concentration differences Qt Difference of oxygen concentration between alveolar and mixed venous blood P50 Oxygen partial pressure at 50 oxygen saturation calculated with SO as measurement value FO Hb Fractional oxygen saturation SO Oxygen saturation SO3 c Functional oxygen saturation calculated with P50 as input value AaDO Alveolar arterial oxygen partial pressure a AO Alveolar arterial oxygen partial pressure ratio avDO Arterial venous oxygen level difference AG Anion Gap MCHC Middle corpuscular hemoglobin concentration Osm Osmolality OER Oxygen extraction ratio April 2009 B 74 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Roche Diagnostics Hct c Hct calculated from tHb P F Index Ratio PaQ FIO BO Oxygen capacity BUN Urea calculated
161. curs increasingly in large amounts in chronic hypoxaemia and in residential areas Methemoglobin is also formed by a number of organic and anorganic oxidation agents and pharmaceuticals MetHb also occurs in patients with inherited structural abnormalities of hemoglobin Concentrations of up to 20 are usually tolerable concentrations of 30 40 cause headaches nausea and cyanosis Concentrations above 40 require therapy normally intravenous treatment with methylene blue which occurs as the activator of NADPH dehydrogenase In patients with known enzyme deficiencies concentrations of MetHb of up to 70 can occur Standard values arterial blood at 37 C Adult lt 0 8 or lt 0 008 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Critical values e MetHb gt 30 96 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 A 122 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Total bilirubin neonatal Clinical significance Neonatal bilirubin occurs in newborns By increasing this primarily unconjugated bilirubin the so called jaundice in newborns Icterus neonatorum occurs which is created due to transitional immaturity of the transport e g ligandin and coupling systems UDP glucuronic transferase in the liver In newborns it leads to a significant enteral backresorption of un
162. cuum No regulated vacuum could be build up Perform test function Vacuum system during aspiration process System gt Component test Control sensors Possible causes If the error persists contact Technical Support e Vacuum system defective Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 26 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 2004 Repro not OK Sensor signal cannot be reproduced Possible causes Measuring channel contaminated Bubbles on the diaphragm in the inside electrolyte of the electrode Interference signals in the measuring channel during measurement value acquisition Interference signals via the reference electrode during measured value acquisition Sensitivity loss of the electrode Perform Calibration for Ready System gt Calibration If error cannot be corrected perform Wetting routine System gt Utilities gt Fluid actions Check electrode for bubbles carefully tap against the electrode body with a finger nail to release any air bubbles from the membrane If error cannot be corrected replace the electrode see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 If the sample channel is visibly soiled perform Internal cleaning System gt Wash amp Cleaning gt Clean
163. d Roche Diagnostics April 2009 A 40 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation The following screen appears Figure A 31 Changing of electrodes 2 Openthelocking lever see Figure A 34 on page A 42 3 Follow the instructions on the screen If there are air bubbles between the contact pin and the membrane there will not be effective electrical conduction Result calibration and measurement errors i Check the internal electrolyte of the electrodes for possible air bubbles see below 4 Remove any air bubbles Remove air bubbles by holding the electrode vertically and by tapping lightly with a fingernail against the electrode body see below A Free of air bubbles Figure A 32 Electrode 5 Insert the electrodes beginning at the right and proceeding left according to the color code 6 Push all electrodes slightly to the right so that they are lined up together without gaps Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 41 3 Installation and shutdown cobas b 221 system Installation gt Insertion of the reference electrode 1 Insert the reference electrode As NW E o Figure A 33 Reference electrode 2 Insert the reference tube into the upper tube guide channel of the left locking lever and into the tube holder of the cover hinge Close the locking lever see bel
164. der the Automatic Cut function is deactivated Underneath the top cover are the BG and depending on the configuration ISE measuring chamber with the electrodes the MSS measuring chamber with the MSS cassette and the tHb SO or COOX module The electrodes are flow through electrodes with a visible sample channel Figure A 4 tHb SO module The tHb SO module is an optical sensor module for determining the level of total hemoglobin tHb and oxygen saturation SO in whole blood April 2009 Instructions for Use Revision 10 0 A 19 2 General descriptions cobas b 221 system System description COOX module Pumps Input unit Bottle compartment Roche Diagnostics The COOX module consists of the hemolyzer and the COOX measuring chamber The measurement is based on the principle of spectral photometry Depending on the configuration up to three peristaltic pumps transport the sample and the operating fluids inside the instrument The sample insertion as well as the aspiration of solutions is carried out via input unit which consists of the following T amp D module T amp D disk T amp D tubing set with wash water jet e Plug control Fill port Sample drip tray Behind the bottle compartment cover are the S1 Rinse Solution bottle the S2 Fluid Pack the W Waste Container and depending on the configuration S3 Fluid Pack cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only A
165. des o CUSHING syndrome o Aldosterone producing suprarenal gland carcinoma o overdose of mineral corticoids o renal tubular acidosis displacement between intracellular and extracellular potassium o severe alkalosis o insulin therapy for diabetic coma potassium substitution required Normal values Adult 3 5 4 5 mmol L Newborn 3 7 5 9 mmol L e Child 3 4 4 7 mmol L Critical values e K 2 8 mmol L K 62 mmol L a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 Instructions for Use Revision 10 0 A 113 5 Theoretical foundations cobas b 221 system Clinical significance Chloride Roche Diagnostics Chloride is the most important anion in bodily fluids Chloride is located like sodium mostly in the extracellular area Erythrocytes represent the highest intracellular content The concentration of chloride in serum like the level of sodium is held constant within tight limits in healthy people Chloride is glomerulary filtered in the kidneys and is tubularly reabsorbed by passively following the sodium Chloride may be exchanged for bicarbonates during disturbances to the acid base status causing chloride to adopt the additional task in addition to maintaining the isotones in the extracellular area of working with sodium to regulate the acid base status Changes to the chloride and sodium concentrations in serum usually occur i
166. ding to the figure see Figure C 3 on page C 10 9 The exchange may be performed less frequently in clean lab operations and at room temperature significantly below the maximum permissible operating temperature COOX calibration for instrument versions with COOX module only A This calibration must always be performed following a manipulation of the cuvette but not later Q than every 3 months To calibrate the COOX module enter the tHb calibrator or a blood sample whose tHb values are exactly known To avoid injury protect your hands with gloves and tissues when breaking open the ampoule Never reuse the ampoule and the capillary 1 Take the ampoule out of the package 2 Carefully shake the ampoule 3 Gently tap the head of the ampoule with your fingernail to remove any liquid from the top 4 Breakopen the ampoule Completely insert the ampoule adapter into the ampoule or fill the sample into a capillary 5 Activate the following function starting with the top level of the analyzer mode C System gt Calibration gt COOX calibration 6 To start the calibration press Start The following screen appears Roche Diagnostics April 2009 C 10 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Quarterly gt Calibration ae X x tHb calibrator gt Figure C 4 7 tHb target value g dL enter the desired target value using the keyboa
167. disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate CAL 1 2 Insert a new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30023 Prep of CAL 2 not ok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate CAL 2 2 Inserta new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30024 Prep of CAL 3 not ok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate CAL 3 2 Insert a new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30025 Prep of CAL 4 not ok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate CAL 4 2 Insert a new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning
168. distribution This function can be used to monitor the sample distribution during measurement see below Measurement ze p 1 EN Sample distribution Sample distribution Figure B 10 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 25 6 Measurement cobas b 221 system Measuring procedure Result Roche Diagnostics Input values Select report Print After the measurement is completed and all data is entered the results are displayed on the screen and printed out Pco 44 8 mmHg PO 160 7 mmHg pH 7 389 Hct 69 4 Ca 1 906 mmol L K 0 37 mmol L Na Out of range cr Out of range tHb Interferences 4 SO Interferences 4 Glu In progress Lac Not calibrated Urea Not calibrated H 41 8 nmol L BE 0 0 mmol L cHCO 7 1 nmol L ls aa Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure B 11 A subsequent correction of the input values is still possible after the conclusion of the measurement by pressing the Input values button Ifa connection to an ASTM host and the function Send immediately Setup gt Interfaces gt ASTM is activated the input values cannot be corrected after the measurement is finished see Reference Manual chapter 2 Description of system components section ASTM Select one of the predefined forms Setup gt Display amp reports gt Measurement
169. docking mechanism open 20087 MSS temperature nOk The temperature ofthe MSS measuring Turn the instrument off wait at least 3 20089 chamber falls outside the specified range minutes and turn it back on If the error persists contact Technical Support 20091 No pack S3 Insert new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 20092 ADC error cond MSS A hardware error occured during Turn the instrument off wait at least 3 initialization minutes and turn it back on If the error persists contact Technical Support Table D 2 Module stops Roche Diagnostics April 2009 D 14 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Module stops No Message Cause Action 20093 ADC error MSS Signal acquisition could not be performed due to a hardware error Turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 20094 Transponder error S3 The transponder data ofthe S3 Fluid Pack could not be read To correct the error remove and reinsert S3 Fluid Pack If the error persists replace S3 Fluid Pack 20095 S3 on board time expired e Insert new S3 Fluid Pack 20096 tHb SO temp error The temperature of the tHb SO module falls outside the specified range Turn the instrument off wait at least 3 minutes and turn it back
170. e S2 Fluid Pack see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 20032 BG temperature nOk The temperature of the BG measuring Turn the instrument off wait at least 3 20035 chamber falls outside the specified range minutes and turn it back on If the error persists contact Technical Support 20037 ADC error BG Signal acquisition could not be Turn the instrument off wait at least 3 performed due to a hardware error minutes and turn it back on If the error persists contact Technical Support 20048 ISE temperature nOk The temperature of the ISE measuring Turn the instrument off wait at least 3 20051 chamber falls outside the specified range minutes and turn it back on If the error persists contact Technical Support 20053 ADC error ISE The signal acquisition could not be Turn the instrument off wait at least 3 performed due to a hardware error minutes and turn it back on If the error persists contact Technical Support 20065 COOX lamp error An error occurred during control ofthe Perform Polychromator calibration halogen lamp System gt Calibration If the error persists contact Technical Support 20066 COOX lamp error During the measurement or Perform Polychromator calibration polychromator calibration an error System gt Calibration occurred while triggering the neon lamp R sgernng P If the error persists contact Technical Support 200
171. e module is not calibrated and transferred to an alarm state A recalibration should be performed By pressing Accept the calibration values are accepted and used for calculating the layer thickness of the cuvette If the calculated thickness layer and the corresponding reference value do not fall within the specified internal limits the COOX module is failed and the calibration needs to be repeated April 2009 C 12 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Sample dependent maintenance procedures Sample dependent maintenance procedures Exchange of solutions and packs In order to ensure the quality of the measurement results complete a quality control test on 3 level low normal high after each exchange of solutions These solutions should be exchanged depending on the rate of measurement and or the onboard stability The screen displays the appropriate information A A B A Rubber sealings B cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only Figure C 6 Solutions and packs Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 13 10 Maintenance cobas b 221 system Sample dependent maintenance procedures S1 Rinse Solution S2 Fluid Pack S3 Fluid Pack A gt gt Roche Diagnostics Depending on the rate of measurement and or the onboard stability this fluid packs should be exchanged every 6 weeks The screen displ
172. e rear of the screen PC unit is the same as the unit serial number on the nameplate Unscrew the fixing nut from the screen Place the screen PC unit on the swivel arm At the base of the swivel arm place the brake packet and lock nut on the shaft and tighten using the 13 mm wrench provided in the accessories A B C D A Screen PC unit C Fixing nut B Swivel arm D Brake packet Figure A 13 Swivel arm of the Screen PC unit Connect the cable to the screen and push it into the cable routing bar April 2009 A 30 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation 2 Power supply 1 Place the power supply including the two adapter connectors on the holder and position them A Screw B Holder Figure A 14 Power supply 2 Tighten the screw 3 Attach power cord and barcode scanner 1 Connect the power cord 2 Connect the barcode scanner and if necessary the network connection to the appropriate port on the rear side of the cobas b 221 system 4 Switch on Switch the instrument on and wait until the program has completely loaded and started Before starting the installation you must set the language in which the unit is to be operated the date and the time Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 31 3 Installation and shutdown cobas b 221 system Installation 5 Installation ww Manual Aut
173. e the range System Calibration Possible causes Ifthe error cannot be corrected replace Interference correction not possible MSS cassette see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 8061 Interferences 1 The calculated tHb value is invalid Check sample material and if necessary Possible c ses reenter the sample Interferences If the error persists contact Technical Support e Unsuitable sample type used 8062 Interferences 2 The calculated Hb derivatives are invalid Check sample material and if necessary Possible causes reenter the sample Interferences If the error persists contact Technical Support Unsuitable sample type used 8063 Interferences 3 The calculated value of Bilirubin is e Check sample material invalid If the error persists contact Technical Support Possible causes Interferences Unsuitable sample type used Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 36 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 8070 IfS repro not OK Non reproducible sensor signal at Perform Wetting routine MSS interference sensor System gt Utilities gt Fluid actions Possible causes Kann der Fehler nicht behoben we
174. easurement results from arterial blood are issued only for the set blood types arterial and capillary Hydrogen ion concentration Unit nmol L Equation A 3 H 199 PH Bicarbonate concentration in plasma D Unit mmol L Equation A 4 cHCO 0 0307 PCO 10 PH 6 105 Total concentration of CO in plasma the sum of dissolved CO and bicarbonate Unit mmol L Equation A 5 ctCO P cHCO 0 0307 PCO Fractional oxygen saturation 1 Unit O Hb Equation A 6 FO Hb UG a all not listed equations are not realized Roche Diagnostics April 2009 A 98 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations BE BEecf BB SO COOX module tHb SO module SO c E Roche Diagnostics Parameters and calculations The base deviation of the blood results from a calculation to determine the titratable base of the blood which in principle is measured by titration of the blood with a strong acid or base to a pH of 7 4 with PCO 40 mmHg at 37 c Unit mmol L Equation A 7 BE 1 0 014 tHb 1 43tHb 7 7 pH 7 4 24 8 cHCO For BE see Equation A 40 on page A 107 The base deviation of extracellular fluid is a quantity that reflects only the non respiratory components of acid base balance Unit mmol L Equation A 8 BE 16 2 pH 7 4 24 8 cHCO The buffer base is the concentration of buffering anions
175. ee eene nn nnne 16 Limitations of clinical analysis eene 17 General e ee geaess 17 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 3 6 Measurement cobas b 221 system Contents Roche Diagnostics Ble Ctroly tes c a sioisn 17 Hic cm ERE 17 E a e E EEI PEA Oeo OBSS eee ettet Metabolites Hemoglobin derivatives and bilirubin pH measurements in pleural fluid seen Measuring procedure riscos 19 SAP Dabo ien Po ie PSP SERA e e RES 19 Capillary measurement sajinise eter a KE a eset eter adas asas 21 ION ii AAA RERO RR DUO rugas 21 Use as default SUP etr e ee e e e ems 23 Datadnput eu RR NA 24 Mandatory input 3 eee ettet tese ua Per Idoia 24 East patients sac Tanta rs 28 POC mode Point of care mode esses eese nnne 29 April 2009 B 4 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Preanalytics Sample collection A Sample acquisition A Anticoagulants Preanalytics Follow the usual applicable safety precautions when drawing blood samples When handling blood samples there always exists the danger of transmission of HIV hepatitis B and C viruses or other pathogens transmissible by blood Employ suitable blood sampling techniques in order to reduce risk to personnel Suitable protective equipment like laboratory clothing protective glov
176. een Contact Technical Support calibration solution and sample The sample was not aspirated or aspirated too late Possible causes Deposits or blockage in measuring chamber 1003 Ref sol asp error No reference solution was detected Perform Fill Reference Electrode Possible causes System gt Utilities gt Fluid actions gt Fill e Blockage or leaks in reference system routines Ifthe error persists replace S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this error cannot be corrected contact Technical Support 1004 Ref sol pos error Conductivity level could not be Check the electrode seating maintained Perform Calibration for Ready Possible causes System gt Calibration Detachment of electrode membrane If this error cannot be corrected contact Leaking electrodes Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 20 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 1005 End of sample detected SS1 detects the end of the sample but the measuring chamber is not yet filled Possible causes Irregular sample Insufficient sample Improper sample Repeat the measurement calibration check for sufficient and homogeneous sample input If the error persists
177. el combination to which a replacement material of a new lot must be assigned Y Y For this material level combination main material at least one QC measuring time must be Q defined so that a follow up material can be assigned 16 In the New lot number window select the lot of the replacement material 17 Press Select new lot number the new lot becomes the follow up material of the current material EH Press this button to store the assignment Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 43 7 Quality control cobas b 221 system QC setup wizard QC setup wizard This chapter describes the software supported setup of QC material step by step AE Y To start the QC setup wizard the user must have the right to change QC materials Otherwise the Q start is refused with the message Insufficient user privileges see Reference Manual chapter 3 Setup section Security Starting with the top level of the analyzer mode 1 Open the AQC drawer Start QC setup wizard Figure B 28 2 Press Yes Following screen appears Figure B 29 To execute follow the additional instructions on screen for completing the other fields Roche Diagnostics April 2009 B 44 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control QC setup wizard Scanning the material code New QC material The system determines whether a new QC material or a previously inst
178. em Diagnostics ressure stable pou if error occurs contact Technical Support Possible causes e Replace PO electrode e PO electrode has not filled bubble Replace PCO electrode free Leaky sample path in BG 2028 Mean not OK Measurement value of calibration is Perform module related system calibration outside the expected range System gt Calibration gt System calibration Possible causes e Ifseveral electrodes are affected replace Electrode limit exceeded S2 Fluid Pack or S3 Fluid Pack nur cobas b 221 lt 5 gt system cobas b 221 lt 6 gt system lt D see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 With PO electrode check barometer System gt Component test gt Control sensors gt Barometer Ifthe error persists replace electrode MSS cassette see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 2029 ADC gt gt gt gt gt Sensor signal is above the measuring Perform Fill reference electrode Tange System gt Utilities gt Fluid actions gt Fill Possible causes routines Reference system not filled Check seat of the electrode Leaky empty electrode Perform General fluidics test System Diagnostics Ifthe error persists replace electrode MSS cassette see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 2030 ADC Sensor signal is below the measuring Perform Fill reference elec
179. ement with blood type mixed venous 2 Measurement with blood type arterial Select blood type arterial The desired value for Qs Qt is determined The same patient ID must be used as for the first measurement With a combination of arterial and venous blood the Qs Qt value cannot be determined Samples from patients with other patient ID can be measured between the two Qs Qt partial measurements The period between the two Qs Qt partial measurements is not limited by the instrument The internal calculation procedure requires the following measurement and calculation values e tHb SO arterial e PO arterial e PAO e ctO arterial In order to obtain these measurement and calculation values the blood type arterial must be selected April 2009 Instructions for Use Revision 10 0 A 103 5 Theoretical foundations cobas b 221 system Parameters and calculations nCa AG Roche Diagnostics Furthermore the internal calculation procedure requires the following calculation value ctO mixed venous To produce this computing value the blood type mixed venous must be selected In order to be able to select the blood type it must be defined as an input value Setup gt Display amp Reports gt Measurement gt Input value Unit 100 1 39 tHb 1 5202 100 PAO PaO 0 00314 Equation A 25 Q Qi Eto a ctO v 1 39 tHb 1 s PAO PaO 0
180. ements of all level T total number of individual measurements per level L Level QC measurement value of one level and one parameter mean value taken from the insert sheet or calculated based on at least 20 and no more than 100 individual measurements standard deviation Description QC measurement value m is outside x 20 QC measurement value m is outside x 30 Two of three QC measurement values are outside x 26 Observation time period 1 series within run Nr 3 4 2596 2 QC measurement values m are outside x 20 Observation time period 2 series NL22 5 61g 6 QC measurement values m are outside x lo Observation time period 3 series Nr gt 6 6 9m 9 QC measurement values m are on the same side as the mean value Observation time period 5 series Ny 29 25D range Defined target values ranges Table B 7 Multirules Mo Z The Multirule process is applied after each individual measurement Q Multirules are only applied to the corresponding control material e g COMBITROL TS Roche Diagnostics April 2009 B 54 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control QC consequences QC consequences By default the QC consequence QC lock should be assigned to all parameters Press the following buttons to set or check the assigned QC consequences C Setup gt Parameter gt Miscellaneous settings gt QC lock QC warning Mat chan
181. emoglobin loaded with oxygen in the functional hemoglobin is determined by the PO and is defined as oxygen saturation SO The oxygen affinity of hemoglobin is primarily dependent on five factors temperature pH PCO concentration of 2 3 DPG and the hemoglobin type A limitation of the oxygen transport from the lung to hemoglobin inadequate circulation or shunt can cause a reduction of PO and oxygen saturation and finally a decrease in oxygen transport to tissue Clinically it is important to make a distinction between hypoxia lack of oxygen in tissue and cyanosis reduced oxygen content in blood through an abnormally high concentration of deoxyhemoglobin or the formation of nonfunction hemoglobin derivatives Cyanosis occurs when the capillary content of deoxyhemoglobin exceeds 5 g 100 mL April 2009 A 120 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Oxyhemoglobin 05Hb Desoxyhemoglobin HHb Carboxyhemoglobin COHb Roche Diagnostics Clinical significance This situation can occur when the arterial hemoglobin is not saturated or the oxygen acceptance of tissue is too high Comparable degrees of cyanosis occur at concentrations of 1 5 MetHb dL blood Abnormally high MetHb concentrations generally result from drug and chemical reactions Methemoglobin anaemia rarely occurs at birth When each hemogroup of hemo molecule is bound to an oxygen molecule the hemoglobin
182. ensitive sample Transport of the sample container protected from light e Avoid direct sunlight Samples should be analyzed immediately after collection Roche Diagnostics April 2009 B 6 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Sample containers vw Syringes A Capillary tubes Roche MICROSAMPLER A Preanalytics We recommend using the sample containers offered by Roche Diagnostics If using another manufacturer s product with liquid heparin as a clot inhibitor the collection container should not be larger than required for the blood volume This will minimize the effects of the clot inhibitor on the thinning of the blood Plastic syringes are normally used but there are cases when the use of plastic syringes is not appropriate for example when PO values are expected to be outside the normal range If very high PO values are expected the sample should be analyzed as quickly as possible after the sampling Use only heparinized syringes Improper use of syringes with liquid heparin will affect the parameters especially the ISE parameters Depending on instrument configuration capillary tubes must have a minimum volume of 115 uL 140 uL or 200 uL Capillary tubes with ceramic sealing caps should not be used because the fracture that forms when opening the capillary can damage the fill port of the cobas b 221 system Only glass capillary tubes with heat poli
183. ent database Backup now a full databank backup is started April 2009 B 82 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Patients Measurements Roche Diagnostics Data manager Patient data that were entered are listed depending on the definition of the display Setup gt Display amp reports gt Patient database gt Patient database overview Use the buttons Page up down or Up down to select an entry and press the Details button All available information about the selected entry are displayed For a detailed description see the Reference Manual chapter Software modes section Data manager 7 776 1592003 09 36 1285 24 2 1408 7 569 0 564 7 02 160 4 121 0 7 567 Mat change 14 10 08 11 2006 1440 System cal 15 02 Figure B 56 Measurements that were carried out are listed depending on the definition of the display Setup gt Display amp reports gt Measurement gt Sample database overview Use the buttons Page up down or Up down to select an entry and press the Details button All available information about the selected entry are displayed Fora detailed description see the Reference Manual chapter Software modes section Data manager April 2009 Instructions for Use Revision 10 0 B 83
184. entration in serum occurs during e decreased excretion through the kidneys o acute and chronic kidney insufficiency especially pronounced with oliguria and anuria o Aldosterone deficiency with suprarenal gland insufficiency M ADDISON o dosage of potassium saving diuretic o oral potassium substitution with possibly unknown mild limitation of kidney functions displacement between intracellular and extracellular potassium o severe insulin deficiency o intoxication with heart glycosides o severe acidosis o each 0 1 reduction of the blood pH results in a rise in potassium of 0 4 to 1 2 mmol L serum o malignant hyperthermia Reales of potassium on massive cell destruction o hemolytic crisis o transfusions with cold or very cold blood o cytostatic therapy for leukemia and others o burns o severe soft tissue injuries Hypokalemia is observed during gastrointestinal potassium losses laxative abuse o massive diarrhea o fistulas in the area of the gastrointestinal tract o villous papillary adenoma o VERNER MORRISON syndrome pancreatic cholera e increased renal excretion April 2009 A 112 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Roche Diagnostics Clinical significance o primary hyperaldosteronism CONN syndrome o secondary hyperaldosteronism cirrhosis of the liver caused by decreased aldosterone breakdown o therapy with loop diuretics and thiazi
185. er Roche Diagnostics April 2009 C 18 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Sample dependent maintenance procedures Cleaning the modules and tubing paths Module cleaning Automatic BG cleaning External cleaning Roche Diagnostics If required an internal cleaning procedure is automatically carried out during the 2P calibration and a system calibration which similarly includes a 2P calibration The instrument is delivered with the following standard settings for automatic internal cleaning Measuring module Samples Cycle BG 500 never ISE 200 never COOX und tHb SO 20 never MSS never Table C 1 If the automatic BG cleaning is activated internal instrument data such as the measuring frequency and drift behavior of the sensors is used to automatically select an optimum cleaning interval see Reference Manual chapter 3 Setup section Times amp intervals gt Maintenance schedule An additional external cleaning with deproteinizer should only be carried out if the measuring chamber is contaminated protein deposits or if components of the sample path must be exchanged Activate the following function starting with the top level of the analyzer mode System Wash amp cleaning Cleaning modules Mat change 14 10 System cal 15 02 08112006 1440 Figure C 15 April 2009 Instructions for Use Revision 10 0 C 19 10 Mai
186. er for detecting plugged or unplugged sample containers Polychromator Light is refracted and focused on the surface of a photosensitive receiver CCD PP Abbrev for peristaltic pump Printer A low noise thermoprinter with integrated paper cutter and optional paper winder Pumps The transport of the sample and the operating fluids is effected by means of up to three peristaltic pumps depending on the design main pump MSS output pump MSS input pump QC Abbrev for quality control QC material see AUTO TROL PLUS B AUTO TROL TS COMBITROL PLUS B COMBITROL TS Quality control The known target areas of the QC materials are compared with the QC results of the instrument RCon Abbrev for reference contact This is used for the Glu Lac or Glu instrument type and replaces the reference electrode and dummy electrode Roche Diagnostics Patient Trend Diagram System warnings Ready screen Main window of the analyzer mode Reference electrode The reference electrode serves as a counter electrode of the measuring electrodes Due to the reference solution its signal remains constant irrespective of the composition of the sample S1 Rinse Solution Wash solution S2 Fluid Pack Calibration solutions BG ISE S3 Fluid Pack Calibration solutions Glu Lac Urea BUN Sample drip tray Prevents dirtying the bottle compartment Sample inlet path SIP Glass tube Serves for transporting fluids from the T amp D d
187. er value A 47 Complete installation A 46 Fix screws at V19 bottle compartment A 34 Go to AutoQC home position A 40 Go to AutoQC service position A 39 Insert fill port and sample inlet path glass tube A 35 Insert peristaltic pump tubes A 39 Insert printer paper A 37 Insert right FMS tube at VM bottle compartment A 34 Instrument location A 27 Open AutoQC drawer and insert ampoule holder A 40 Open bottle compartment cover and insert Waste container amp packs A 44 Open the AutoQC drawer and remove the AutoQC valve clamp A 40 Open the measuring chamber cover and insert the sensors A 40 Perform MSS polarization A 46 Power supply A 31 Quality control A 47 Screen PC unit A 30 Select language A 32 Set the date and time A 32 Switch on A 31 Interfaces A 22 April 2009 F 4 Instructions for Use Revision 10 0 cobas b 221 system Index Interferences B 10 Hb derivatives and bilirubin B 16 MSS B 13 pH ISE B 11 tHb SO B 10 ISE nterferences B 11 L Language A 32 Last patients B 28 Limitations of clinical analysis B 17 Blood gas B 17 Electrolytes B 17 General B 17 Hemoglobin derivatives and bilirubin B 18 Metabolites B 18 pH measurements on pleural fluid B 18 tHb SO B 18 Linearity A 70 List of all activities B 89 List of all warnings B
188. eral QC concept Roche Diagnostics always strives to ensure the highest quality standards for its products This quality awareness is the result of a sense of responsibility toward the customer and the well being of the patient The quality control is an important element of this claim Aqueous blood gas electrolyte QC materials such as COMBITROL TS AUTO TROL TS etc are offered to ensure that the cobas b 221 system provides measurements of high quality to protect customers or its patients In order to ensure the quality of the measurement results complete a quality control test on 3 levels low normal high after each electrode exchange after each exchange of solutions and packs and after startup of the instrument Additionally complete a quality control test on one level between two automatic 2P calibrations The level have to be alternated low normal high For example 2P calibration interval 12 hours 24 hours ML poet Ieee Ms i N pot N 2P Cal Level1 gt 2P Cal Level 2 2P Cal Level3 gt 2P Cal Levell 4 A L Figure B 17 Roche Diagnostics The automatic system calibration includes a complete 2P calibration Complete at least two quality control tests on different level once daily or more often in accordance with local regulations Run quality control tests ideally prior to sample measurements A qualit
189. erence tube into the upper tube guide channel of the left locking lever and into the tube holder of the cover hinge Close the locking lever A Locking lever Figure C 29 Insert the reference electrode 8 Connect the white connector on the end of the tube to the measuring chamber cassette see below April 2009 C 30 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Unscheduled A Connector B Measuring chamber cassette Figure C 30 Insert the reference electrode 2 9 Scan the barcode of the exchanged reference electrode located on the inner packaging or enter the barcodes manually with the help of the keyboard 10 Close the measuring chamber and top cover 11 A conductivity calibration is performed following a warm up phase 12 A new QC measurement with all three level low normal high must be performed after every exchange of a reference electrode Make sure that the results agree with the target values see Chapter 7 Quality control Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 31 10 Maintenance cobas b 221 system Unscheduled Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only A Roche Diagnostics The MSS cassette must be installed in the instrument no later than the imprinted Install before date see section Conventions used in this manual gt Other symbols on page 7
190. ersonal Danger Risque d explosion en cas d utilisation dans une Observera Enheten far inte anv ndas i utrymmen med inflammables mS Pe In vitro diagnostika Per uso diagnostico in vitro Overhold Seguire le istruzioni d uso M kun anvendes af fagpersonale Uso consentito solo a personale Advarsel Apparatet m udelukkende bnes og repareres af la riparazione dello strumento pud essere eseguita instrueret servicepersonale solo dal costruttore o dal personale di es qualificato adage Type cobas b 221 system cobas ue ambient con miscele cluginsionsegtige blandinger af annetesigas yp y esplosive di gas anestetici Tia 77 xprjor in vitro Giayvcor ko Lovo AKDAOUSHOTE T prins SH Para in vitro M vo poe st ale che a npoaonkb Power Rating 100 240 V 50 80 Hz 200W Bid Germany Bee Aten o Perigo de explos o na presen a de gases e anest sicos inflam veis fipoei amp onainan H cuo enmp nerai va eniocevaor ei y vo and ro exnadeyu vo npooorik H cuokeur Gev MEPI XE OTO XXoTEpIKD TNCU PN nou pnopoov va niokguacroUv and ro POT fipocoyrj NiBavde xiv uvoc amp prjEns av Ae roupyci napoucia eoplexrov avac amp rrkax rj aepiaw For invitro diagnostic use Diagn stico in vitro Eod FH BARRE ORK KAW Follow the instructions for use Tener en cuenta las instrucciones de uso AKER ERAOKRAACT For professional use S lo para uso de personal cualificado ER RRRASLROUAOR TAMERS ELT parts inside nj Atenc
191. es protective goggles and if necessary mouth protectors must be worn to prevent direct contact with biological working materials In addition a face mask is required if there is a risk Gudelines and additional information about handling blood samples are provided in CLSI document M29 A3 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guidelines 3rd edition 2005 and other documents Only qualified personnel may perform the collection of blood needed for analytical purposes The puncture site may never be squeezed Mixing the blood sample with tissue fluid may lead to the premature onset of clotting despite sufficient heparinization of the sample collection containers Incorrect sample collection or the use of an unsuitable sample collection container may lead to errors and discrepancies in the measurement values For detailed information about drawing blood and storing and handling blood samples refer to CLSI Document H11 A4 Procedures for the collection of arterial blood specimens Approved Standard Fourth Edition 2004 and other documents The only clot inhibitors that may be used for analyses in the cobas b 221 system are heparin salts Other clot inhibitors such as EDTA citrate oxalate fluoride and ammonium based materials have significant influence on the blood s pH and other parameters and may not be used for this reason Sample collection especially for tHb SO and Hct
192. etup gt Times amp intervals gt Cal intervals amp timing ES EN A a A A S D A A 335 731 333 353 00 00 03 00 06 00 09 00 12 00 15 00 18 00 21 00 00 00 Pay os e za Mat change 14 10 System cal 15 02 08 11 2006 1440 System calibration e 06 00 2P calibration v 1P calibration aaa Figure A 16 Cal intervals Use this function to enter the automatic calibration times and intervals for system 1 point and 2 point calibrations The time scale uses markers to show the selected interval for the 2P calibration and the start time for the system calibration Intervals System calibration Every 8 12 or 24 hours Enter the Start time of a system calibration to which all calibrations are oriented 2P calibration Every 4 8 or 12 hours 1P calibration All 30 or 60 minutes USA only every 30 minutes 9 Set valves for FMS tubing exchange Press Start process This action is performed automatically E C Valve V19 is pushed in to prevent the tube from being pinched while the aluminum part is Q tightened Valve VM is pushed out a Fluid Mixing System Mixing of calibration solution A and B in a certain ratio Roche Diagnostics April 2009 A 33 Instructions for Use Revision 10 0 3 Installation and shutdown cobas b 221 system Installation 10 Fix screws at V19 bottle compartment 1 Open the bottle compartment cover and the docking mech
193. evel 79 8 94 5 87 0 86 5 Mat change 14 10 System cal 15 02 08 112006 1440 Unscheduled Figure C 20 2 Open the docking mechanism and pull out all the bottles or packs 3 Clean the bottle compartment with a cloth moistened with disinfectant e g disinfectant containing 7096 alcohol 4 Reinsert the bottle or packs see Exchange of solutions and packs on page C 13 5 Close the docking mechanism and the bottle compartment cover Replacing printer paper paper roll Q 2 The printer paper is heat sensitive on one side only Observe the correct insertion of the thermal 1 Open the printer cover O N Open the paper lid Remove the empty paper roll rollers If necessary cut the paper at a right angle Ensure the paper has a clean leading edge to help start the paper through the 5 Place the new paper roll into the holder so that the roll feeds from the bottom Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 25 10 Maintenance cobas b 221 system Unscheduled 6 Ensure that the printer lever is in the down position see below only visible with opened paper cover Figure C 21 Printer lever 7 Feedin the beginning of the paper according to the instructions on the inside of the paper lid see below A Paper lid B Printer lever Figure C 22 Place printer paper without
194. filter Changing the air filter C 10 Analyzer mode B 78 Data manager B 81 QC measurement B 80 Quick access B 79 Ready screen B 78 Setup B 80 System B 79 Application area A 11 AQC status B 90 Aspirate from syringe B 21 Auflistung Verbrauchsmaterialien E 3 Automatic calibrations B 65 1P calibration 1P cal incl O B 66 2P calibration 2P cal B 65 Recalibration without O5 B 66 System calibration B 65 AutoQC Specifications A 92 AutoQC materials Material assignment B 38 AutoQC measurement B 52 Barcode D 40 Barcode scanner A 23 A 31 Specifications A 94 Bottle compartment A 20 Brands 2 Buttons B 76 C Cal intervals amp timing A 33 Calibration A 88 B 63 B 65 1P calibration 1P cal incl O B 66 Automatic calibrations B 65 Display of parameters during calibration B 68 Recalibration without O5 B 66 System calibration B 65 User activated calibrations B 66 Roche Diagnostics Calibration procedure A 13 Calibrations Automatic calibrations 2P calibration 2P cal B 65 Capillary measurement B 21 Capillary tubes B 7 Change lot applies only to AutoQC measurements B 42 Changing of AutoQC mats C 35 Changing the air filter C 10 Changing the MSS cassette C 32 Changing the reference electrode C 29 Checking fill levels C 7 Checking printer paper C 7 Chloride A 114 Cleani
195. ge 14 10 System cal 15 02 08 11 2006 1440 Figure B 40 Description of the QC consequences QC Warning through a warning the respective parameter will be marked in the Ready screen but remains ready for measurement The measurement protocol now displays q and q QC warning if the QC warning is activated and the paramter is in the QC Warning status broken The parameter will be identified accordingly in the Ready screen QC lock the parameter will be blocked if one of the adjusted rules is A status report appears after pressing the parameter button Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 55 7 Quality control cobas b 221 system Remove the QC lock Remove the QC lock QC warning QC lock Automatic correction Manual correction A NL vw Exchange the electrode Roche Diagnostics Proper execution of a QC measurement using the same material level combination removes the warning Using the QC for ready function the required AutoQC measurements are carried out with the corresponding material level combination which can remove this lock Proper execution of a QC measurement using the same material level combination removes the block A manual correction is only allowed if the same material level combination is no longer available In this case repeat the QC measurement with a new material level combination of a different lot and ana
196. he fill port on page C 22 April 2009 Instructions for Use Revision 10 0 C 5 10 Maintenance cobas b 221 system Decontamination Touch Screen see Cleaning the touch screen on page C 8 Surfaces of the instrument see Surfaces on page C 35 Tubing paths e see Cleaning the modules and tubing paths on page C 19 Recommended disinfectants A Do not use any type of bleaching agent Exception Roche Deproteinizer Surfaces 70 alcohol surface decontaminant Tubing paths Protein remover Roche deproteinizer Potential dangers Due to the alkaline and oxidizing character of this preparation we cannot rule out local irritation to the skin eyes and mucous membranes First Aid measures o After inhalation breath fresh air drink large amounts of water o After skin contact wash with generous amounts of water remove contaminated clothing o After eye contact rinse eyes with generous amounts of water contact an eye doctor o After drinking drink large amounts of water avoid vomiting contact a doctor Roche Diagnostics April 2009 C 6 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Daily Daily Checking fill level Press C Info gt Fill level to check the fill level of the solutions S1 rinse solution S2 Fluid Pack S3 Fluid Pack and the waste container W Waste Container on a daily basis Exchange empty bottles bottles whose usage date has exp
197. hese Instructions for Use This equipment is a Class I laser product and it complies with FDA Radiation Performance Standards 21 CFR Subchapter J only valid for cobas b 221 lt 1 gt system cobas b 221 lt 3 gt system and cobas b 221 lt 5 gt system with tHb SO module This instrument is classified under the protection class I according to IEC EN 61010 1 The instrument meets the conditions for overvoltage category II The instrument meets the conditions for contamination level 2 Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide If objects or liquids enter the internal areas of the instrument remove the instrument from its power supply and allow an expert to check it thoroughly before using it again The instrument is suitable for long term operation indoors e The power cord must be plugged into a grounded power receptacle When using an extension cord make sure it is properly grounded e Any rupture of the ground lead inside or outside the instrument or a loose ground connection may result in hazardous operating conditions for the operating personnel Intentional disconnection of the grounding is not permitted The instrument is not suitable for operation with a direct current power supply Use only the original power plug delivered with the cobas b 221 system The use of controls or adjustments or performance of
198. hing the data transfer Table D 1 System stops Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 11 11 Troubleshooting cobas b 221 system Module stops Module stops This error creates a message in yellow in the error window upper right hand corner on the display screen This error is not a system stop These errors identify individual issues affecting only a specific module of the analyzer and not the entire analyzer operation No Message Cause Action 20000 SD temperature nOk The temperature of the sample Turn the instrument off wait at least 3 distributor falls outside the specified range minutes and turn it back on If the error persists contact Technical Support 20016 FMS volume error The calibration solution is aspirated into To localize the error the BG measuring chamber in the e Perform Aspirate CAL B ified time E System gt Utilities gt Fluid actions gt Fill routines Perform General fluidics test System gt Diagnostics After removing possible faults perform the calibration Mixing system System gt Calibration Install a new S2 Fluid Pack see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 Replace pump tube of main pump see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 If the error persists contact Technical Support 20017 FMS error The mixture ratio falls
199. hysiological pH to form ammonia or bicarbonate ions The ammonia ions can be determined using a potentiometrical ammonia ion selective electrode This measurement requires a reference electrode such as those used in ion selective electrodes tHb SO Light absorption in whole blood is measured at four different wavelengths the sample is subjected to light radiation and the dispersed light is also evaluated COOX The hemoglobin derivatives and the total bilirubin neonatal are determined spectrophotometrically based on the Lambert Beer law Hematocrit Measurement of the sample s conductivity in the ISE measuring chamber tHb and SO was calibrated when the instrument was manufactured Ambient air and a zero point solution are used to calibrate oxygen are calibrated using two solutions mixed under different conditions thereby avoiding the gas supply which is required by other instruments The calibration is carried out with four Glu Lac or five solutions Urea BUN whose weighing concentrations form the basis for measured value determination Determining the hemoglobin derivatives and the total bilirubin neonatal are carried out spectral photometrically using a cuvette April 2009 Instructions for Use Revision 10 0 A 13 2 General descriptions cobas b 221 system Measurement evaluation Measurement evaluation The validity of the test results from the cobas b 221 system must be carefully examined by a clini
200. i n El equipo s lo deber abrirse y repararse por personal instruido ATA MAL A SR TINEO APU ORN TETO LEO Danger Cuidado No utilizar el equipo en espacios donde pueda haber fred D Ed TOL LM COMARBI TC RED flammable anesthetics or gases mezclas inflamables de gases anest sicos SRRAERERER In vitro Diagnosticum Voor in vitro diagnostisch gebruik Acid A REA rentas Goed nota nemen van ae EE ORFEBRE zum Gebrauch durch Uitsluitend voor Des Gerit epi aes pre Sh DRERGR RAR RA ANSE TIERE UE ERR ge ffnet und repariert werden Achtung Das Ger t darf nicht in R umen mit explosions fahigen Gemischen von An sthesiegasen betrieben werden servicepersoneel geopend en gerepareerd worden Let op Het apparaat mag niet gebruikt worden in ruimten met explosieve mengsels van anesthesiegassen Figure A 11 cobas b 221 lt 2 gt system cobas b 221 lt 4 gt system and cobas b 221 lt 6 gt system Roche Diagnostics April 2009 A 24 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Contents Installation and shutdown Roche Diagnostics In this ch apter the software guided installation and shutdown of the instrument are described step by step The sequence of the steps described must be strictly followed In this chapter Chapter Ej O odia 27 IS 27 Pulli M HR 28 Installation 5 dotata si o de e ag oae ee plo dE drin 30 Te S
201. ild Critical values e Na 120 mmol L e Na 160 mmol L a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 Instructions for Use Revision 10 0 A 111 5 Theoretical foundations cobas b 221 system Clinical significance Potassium Roche Diagnostics About 97 of potassium within the organism is intracellular Transport into the cells is regulated by the Na K ATPase localized in the cell membrane Only about 3 of the potassium is contained in the extracellular fluid Potassium is glomerularly filtered and most of it about 9096 is reabsorbed in the proximal tubule and in Henle s loop Reabsorption or excretion in the distal tubulus is influenced especially by aldosterone and the blood pH value Due to the high intracellular concentration of potassium the serum potassium values do not always reflect the potassium level of the organism Therefore the data obtained from the serum may be interpreted only with careful consideration of the patient s clinical situation and acid base status Consider the following examples diabetic coma during which the flow of potassium into the cell is reduced due to the lack of insulin and acute intoxication with heart glycosides with accompanying inhibition of the Na K ATPase membrane In both cases exists despite a more or less greatly increased serum potassium level intracellular potassium deficiency Increased potassium conc
202. ill e PO electrode defective routines f necessary replace S2 Fluid Pack lt D see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 Ifthe error persists replace PO electrode lt D see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 29 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 2021 Drift alarm A drifting of the sensor signal was Perform Calibration for Ready detected in the Ready state System gt Calibration Possible causes e Start Stability monitor Electrode drifts are exceeding the System gt Diagnostics gt Stability monitor ified limit val SL DUM cm M and check Details of the Sensor slope Invalid sample type is being used Wetting problems e If the electrode MSS cassette is defective it is displayed Replace the corresponding I f PO MTS 4 electrode or the MSS cassette contamination possible 2 see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 bzw Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 In case of PO drift Perform Internal cleaning System gt Wash amp Cleaning gt Cleaning module select BG module gt
203. ion 10 0 A 73 4 Specifications cobas b 221 system Performance data Parameter chloride mmol L Parameter pH pH units Roche Diagnostics Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 24 86 25 84 0 5081 103 9 93 20 93 08 0 2241 99 9 149 34 146 85 0 3541 98 3 194 98 190 16 0 6110 97 5 239 86 232 04 1 0721 96 7 Table A 32 Parameter Chloride mmol L Correlation Slope 0 959 1 043 Intercept 2 908 Correlation coefficient 0 9999 Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Swr Recovery 6 20 6 24 0 0022 100 7 6 87 6 89 0 0024 100 2 7 38 7 38 0 0023 100 1 7 70 7 67 0 0023 99 7 8 00 7 97 0 0035 99 7 Table A 33 Parameter pH pH units Correlation Slope 0 960 1 042 Intercept 0 293 Correlation coefficient 1 0000 April 2009 A 74 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Performance data Parameter CO mmHg Material tonometered aqueous solution Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 10 00 11 36 0 1389 113 6 20 00 20 59 0 1962 103 0 60 00 57 57 0 6557 95 9 120 00 114 24 1 5521 95 2 180 00 175 37 2 4358 97 4 Table A 34 Pa
204. ion lever The tubing holder is then pressed into the sealer see below B A Place the tubing set B Close the tension lever Figure A 28 Peristaltic pump AutoQC module option The installation with an AutoQC module optional must be performed by a Roche Diagnostics Q Service Representative 15 Go to AutoQC service position Press Start process This action is performed automatically Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 39 3 Installation and shutdown cobas b 221 system Installation 16 Open the AutoQC drawer and remove the AutoQC valve clamp 1 Pullout the AutoQC drawer 2 Pullthe key of the AutoQC valve up and out see below A AutoQC valve clamp Figure A 29 AutoQC valve clamp 3 Close the AutoQC drawer 17 Go to AutoQC home position Press Start process This action is performed automatically 18 Open AutoQC drawer and insert ampoule holder 1 Pullthe AutoQC drawer out again A without ampoule holder B with ampoule holder Figure A 30 AutoQC drawer 2 Insert the AutoQC ampoule holder 3 Close the AutoQC drawer 19 Open the measuring chamber cover and insert the sensors 9 BG ISE measuring chamber 1 Open the measuring chamber cover push the right edge of the MC cover to the left with a finger and open up the MC cover y Y In each case open only the relevant measuring chamber Q Keep the bottle compartment cover close
205. ired and full waste water bottle see section Exchange of solutions and packs on page C 13 or section Waste water on page C 16 Checking printer paper Check daily to be sure that sufficient paper is available and exchange it if necessary I E i Y Y The printer paper is heat sensitive on one side only Please make sure that you insert the paper roll Q correctly Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 7 10 Maintenance cobas b 221 system Weekly Weekly Cleaning fill port and sample drip tray A Handle these parts with care danger of injury Always wear gloves Danger of infection Activate the following function starting with the top level of the analyzer mode C System gt Wash amp cleaning gt Clean input unit A B C D A T amp D cover C Fill port B T amp D disk D Sample drip tray Figure C 1 Input unit 1 Pullout the sample drip tray and clean it with a cloth moistened with disinfectant 2 Reinsert the sample drip tray 3 Clean the fill port with a soft cotton swab moistened with disinfectant Cleaning the touch screen Activate the following function starting with the top level of the analyzer mode C System gt Wash amp cleaning gt Clean screen The keys on the screen are deactivated for 30 seconds A Clean only with a moist cloth for example one that is soaked with disinfectant Do not use water and sprays
206. isc via the needle to the sample distribution block transverse channel Sample throughput Number of samples per hour Sample volume limit is the maximum volume aspirated from a sample container SCon Abbrev for sensor contact By means of the conductivity contact this electrode supports the monitoring for filling the measuring chambers with fluid In addition it measures the temperature in the measuring chamber Screen PC unit Serves as a graphic user interface AII the information results operating instructions alarms warnings etc is displayed on the screen The screen consists of a color LCD that is covered with a touch sensitive film touch screen SO Oxygen saturation System calibration This is carried out every 8 12 or 24 hours standard and consists of wave length calibration of the polychromator internal cleaning automatic conditioning of the Na electrode calibration of the mixing system and the 2 point calibration ofall the parameters System stop When this error occurs a window is displayed with a red outline the instrument stops System warnings Warning or indication that does not require any direct action April 2009 Instructions for Use Revision 10 0 E 11 Glossary cobas b 221 system T amp D module W Waste Container T amp D module The T amp D Turn and Dock serves for sample input for aspirating solutions from S1 2 3 and the QC material from the AutoQC module
207. itical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Critical values e Lac gt 3 4 mmol L or 31 0 mg dL a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 Instructions for Use Revision 10 0 A 125 5 Theoretical foundations cobas b 221 system Clinical significance Urea BUN Roche Diagnostics Urea is the most important catabolic product of the protein metabolism It indicates a limited or insufficient kidney function reduced or nonexistant filtration in cases of shock heart failure hypertonia dehydration tumours etc The urea value is also an important parameter for monitoring the protein supply in patients with malfunctioning kidneys and for monitoring the therapy of dialysis patients with kidney failures Normal values Adult Urea 2 1 7 1 mmol L or 13 0 43 0 mg dL BUN 6 0 20 0 mg dL e Newborns Urea 1 0 5 0 mmol L or 6 0 30 0 mg dL BUN 2 9 14 0 mg dL a Labor und Diagnose Lothar Thomas 5th expanded edition 2000 Page 385 Critical values e Urea gt 16 7 mmol L or 100 0 mg dL a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 A 126 Instructions for Use Revision 10 0 Operation VD ON DW Measurement cae ernest a EH SOS Be ar o E Vp io Ew hos B 3 Quality Ven FOL ss exea eite sees E MEAS LC EP PENES B 31 CONDIATON s ce eia BUE ek
208. k onto the container The cap must be screwed shut until completely closed 1 q A Replace waste water container and the screw cap after approx 5 uses Dispose of the waste water container according to applicable local codes and regulations hazardous waste 2 Using the empty S1 rinse solution bottle as W waste container Remove the sticker from the empty bottle of S1 rinse solution i Q This sticker may not be reused discard immediately S1 Rinse Solution cobas b 221 Roche OMNI S 1850 mL REF No 0 3260917184 cobas W Waste Container Store at FORINVITRO 25 DIAGNOSTIC USE ids cobas b 121 2 C Al 1 MEL iz Il Roche OMNI C cobas b 221 Roche OMNI S REF No 0 3144054001 FOR IN VITRO DIAGNOSTIC USE 50 C EIS eh re at A Remove the S1 sticker from the bottle at this B Pull off the sticker beginning from the D W sticker on the bottle of S1 location lower right corner arrow until the sticker Waste is completely visible C W sticker Figure C 14 Sticker Installing the waste water container 1 Push the bottle to the position for waste water W until it engages 2 Close the docking mechanism 3 The fill level monitoring feature recognizes the waste container as Empty If the waste water container to be used is not empty Press Waste fill level and enter the fill level a scaling on the container label gives an approximate value 4 Close the bottle compartment cov
209. kalosis K Chronic respiratory alkalosis L Mixed met acidosis amp resp alkalosisose N Normal area PCO kPa 20 40 60 80 100 120 H motit Meas values PCO 44 80 mmHg pH 7 39 Print Mat change 14 10 system cal 15 02 08112006 1440 oo 10 0 20 0 30 0 40 0 50 0 60 0 70 0 80 0 90 0 100 0 PCO mmHg Figure B 13 There is also the possibility of displaying and printing out an acid base trend diagram in the data manager Fora detailed description refer to the Reference Manual chapter 4 Data manager section Measurement The last patients whose samples have been measured are listed here Measurement PatlD 2 Schneider Schuster 1236 M ller 1235 Maier 1234 Mustermann 1233 Schuster 1232 Schumann Sch ller Mat change 14 10 System cal 15 02 08 11 2006 Figure B 14 April 2009 B 28 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Measuring procedure POC mode Point of care mode The POC mode is a user interface simplified to suit the needs of POC users with very restricted user rights Before the POC mode is activated the newly created POC profile in the profile management must be assigned to a POC user user profile see Reference manual chapter 3 Setup section Security C Setup gt Security gt Instrument functions Pe fife gt Setup Security Inst
210. l Support 10416 Hardware conflict 10419 A defective module was detected within the scope of the module communications To correct the error turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support and supply the error number Turn the instrument off 10424 Hardware error 10452 A defective module was detected within the scope of the module communications To correct the error turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support and supply the error number Turn the instrument off 10456 EEPROM error 10468 The EEPROM data of a module processor are incorrect Tocorrect the error turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support and supply the error number Turn the instrument off 10469 Vacuum ADC error A communications problem occured at the vacuum board To correct the error turn the instrument off wait at least 3 minutes and turn it back on If the error persists contact Technical Support 10470 Transponder error An antenna of the transponder receiving circuit defective Contact Technical Support and supply the error number Turn the instrument off Table D 1 System stops Roche Diagnostics April 2009 D 10 Instructions for Use Revision 10 0 co
211. l significance Hematocrit The Hct is the cellular volume portion of the blood which is occupied by the red blood cells in relation to the volume of the whole blood The Hct can be expressed as percentage or fraction Reduced Hct values are an indication for anemia together with a simultaneous reduction of ctHb and RBC of leukemia hypothyroidism cirrhosis acute massive blood loss and with hemolytic reactions due to transfusions with incompatible blood incompatibility with certain chemicals infectious and physical agents Increased Hct values can be associated with polycythemia erythrocytosis and heavy loss of water and with shock The cobas b 221 system offers the user a direct measured hematocrit Hct using conductivity method and a calculated Hct c which is derived from the patient total hemoglobin result The use of Hct or Hct c must carefully be examined by medical professional who will evaluate the patients clinical situation before any treatment decisions are made Normal values arterial blood at 37 C e Women 0 34 0 45 or 34 45 96 Men 0 34 0 48 or 34 48 96 e Newborn 3 7 weeks 0 36 0 46 or 36 46 96 a Clinical Laboratory Diagnostics use and assessment of clinical laboratory results edited by Lothar Thomas M D Edition 1998 Critical values Hct 0 20 or 20 96 Hct gt 0 60 or 60 96 a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001
212. labels labelling and information to be supplied Part 1 General requirements The following symbols are listed as additional information Symbol Description INSTALL BEFORE IRRITANT REIZEND IRRITANT IRRITANTE bijtend RETANDE IRRITAMENT epefhu nio X1 R36 37 38 S26 37 Electrodes This date indicates the limit of the maximum storage time of an electrode The electrode must be installed in the instrument no later than the imprinted date If the installation takes place on the imprinted date it still falls within the specifications The calculation of the Install before date is based on the production date of the elctrode Danger symbol Irritant on the label and the packaging of S2 Fluid Pack Rating Although not corrosive momentary longer lasting or repeated contact with skin or mucous membrane may result in inflammation Danger of sensitization during contact with skin when classified with R 43 Caution Avoid contact with eyes and skin do not inhale vapors April 2009 Instructions for Use Revision 10 0 7 cobas b 221 system Roche Diagnostics Abbreviations Description Invisible Laser Radiation Avoid direct radiation to eyes Laser Class 3R according to EN 60825 1 P0 5mW A 635 850 nm Store upright Gr ner Punkt in Germany Protective gloves protective goggles and suitable protective clothing must be worn The following abbreviatio
213. le Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 39 11 Troubleshooting cobas b 221 system Barcode Barcode Roche Diagnostics If problems occur reading in with the PS2 hand held scanner included in the scope of delivery carry out the following steps 1 Make sure your scanner firmly connects with the interface connector of the instrument Inspect in detail the condition of the cable e g by looking for broken areas or loose cable parts Check the voltage supply by inspecting whether LED light is visible continuously or flash light only Additionally the scanner prompts a trigger tone when reading a barcode Use the test function on the instrument to read in a barcode with known characters In case the characters are transmitted and displayed correctly the barcode scanner will indicate this by a flash light and a trigger see Reference manual chapter Software modes section Component test In case of a problem the characters are transmitted and or displayed incorrectly or even not transmitted So proceed with the next step Unplug the barcode cable from the instrument Re plug the barcode cable Repeat step 4 for checking again the functionality If still not ok proceed with the next step Set the scanner by using the barcode manual to default Take the barcode scanner programming manual select Group 1 read the barcode labeled as Default A001 Sele
214. lectrolytes a also used for pH measurements in the pleural fluid c with approximate physiological ion matrix and buffer capacity April 2009 Instructions for Use Revision 10 0 A 87 4 Specifications cobas b 221 system Calibrations Calibrations Calibrations Time intervals Duration without MSS Duration with MSS min min System calibration every 24 hours 11 Glu Lac 15 5 alternatively 8 12 or 24 hours Glu Lac Urea 17 1P calibrations every 30 minutes 1 6 3 3 alternatively 1 hour 2P calibrations every 12 hours 6 2 11 4 alternatively 4 8 or 12 hours Warm up phase when turning ON 32 43 Warm up phase power failure 1 minute 2 5 2 5 Electrode exchange as needed 25 50 Table A 73 Calibrations a incl calibration Roche Diagnostics April 2009 A 88 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Environmental parameters Environmental parameters Temperature humidity stability Instrument Operating conditions e Ambient temperature 15 to 31 C e Ambient air pressure 526 797 mmHg 70 13 106 225 kPa e Relative humidity 20 85 Measuring chamber temperature BG amp ISE 37 0 2 C MSS 30 0 2 C COOX 37 0 5 C tHb SO 37 C 35 to 37 5 C Storage and transportation conditions Temperature 20 to 50 C Humidity 20 to 85 not condensed e Shock resistance 30g Electrodes Operating conditions Temper
215. lever Figure A 25 Insert printer paper without take up unit Figure A 26 Insert printer paper with take up unit optional 6 The paper is automatically pulled into the printer 7 Close paper lid With take up unit optional 1 Press the paper feed button until the paper is long enough 2 Insert the beginning of the paper in the take up unit according to the instructions on the inside of the paper lid see Figure A 26 on page A 38 JENA Press the take up unit rods fully onto the holder and rotate until the paper is taut on the rods and Q paper lid so that the entire roll of paper can be taken up During operation the paper should be tautened now and then by turning the take up roller 3 Close printer cover A With an installed take up unit the Automatic Cut function is deactivated Roche Diagnostics April 2009 A 38 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation 14 Insert peristaltic pump tubes 1 Open the peristaltic pump s clear plastic cover tension lever 2 Push the linear bracket white plastic part upwards see below A B Cc A Tension lever B Pump head C Linear bracket Figure A 27 Peristaltic pump 3 Place the tubing set around the corresponding rolling wheel see below A Check that the tubing set is correctly orientated the grip end must be pointing upwards see below B 4 Close the clear plastic cover tens
216. libration general The cobas b 221 system uses a technology for simultaneous calibration of PCO pH Nat K Ca and CI which requires only two aqueous solutions contained in 2 Fluid Pack Oxygen O is calibrated with ambient air and a zero point solution The MSS calibration is carried out with the solutions contained in S3 Fluid Pack for instrument versions with MSS module only cobas b 221 lt 5 gt system und cobas b 221 lt 6 gt system The COOX calibration is carried out by entering a tHb calibrator whose exact values are known for instrument versions with COOX module only Automatic calibrations System calibration 2P calibration 2P cal Roche Diagnostics The following calibrations are automatically initiated and performed by the analyzer Every 8 12 or 24 hours default which includes the following e Wavelength calibration of polychromator for instruments with COOX module only Cleaning with internal cleaning solution Automatic conditioning of the Na electrode every 24 hours Calibration of the mixing system 2 point calibration of all parameters The user can set a permanent start time for the system calibration This enables completion of calibration tasks while the cobas b 221 system is not in use or when the workload in the laboratory or station is smaller see Reference manual chapter Software modes section Setup Adjustable 4 8 and 12 hours standard April 20
217. libration values D 20 System stops D 5 System warnings D 16 Troubleshooting general D 5 Tubing paths C 20 U Use as default setup B 23 User interface B 71 Buttons B 76 User activated calibrations B 66 V Versions B 91 Video sequences B 88 W Warning and identification labels incl nameplate A 24 Waste water C 16 Exchange the waste water container W Waste Container C 16 Roche Diagnostics April 2009 F 8 Instructions for Use Revision 10 0
218. librations 5 Check the internal electrolyte of the electrodes for possible air bubbles see below A 6 Remove any air bubbles Hold the electrode vertically and tap lightly with a fingernail against the electrode body see below B A Free of air bubbles B Remove air bubbles Figure C 25 Electrode 7 Insert the new electrode according to the color code 8 Push all electrodes slightly to the right so that they are lined up together without gaps 9 Close the locking lever 10 Scan the barcodes located on the inner packaging of each electrode or enter the barcodes manually with the help of the keyboard 11 The replaced electrode is shown slightly lower than the others displayed on the screen 12 Read the next actions their duration and the sensor data Roche Diagnostics April 2009 C 28 Instructions for Use Revision 10 0 10 Maintenance cobas b 221 system Unscheduled Changing of ISE electrodes omes enm f Sensor dt Warmup 12 min Signature Na 21512301 Calibration 7 min Revision 0 Install by 25 12 2009 le aa Mat change 14 10 Systemcal 15 02 08112006 1440 Operator ID Figure C 26 13 Close the measuring chamber and then the top cover 14 A calibration is performed following a warm up phase 15 After completing the calibration perform a quality control measurement on all 3 level low normal high 16 Make sure that the results ag
219. list see above from which the map is then made In order to obtain a clear representation the result of the first measurement in the observation period of the respective parameter is standardized to 100 and is thus the basis for the trend curve If only one parameter was selected the representation takes place in absolute values and in the adjusted unit As soon as a further parameter is selected changes the representation on the 100 standardization of the respective parameter Furthermore when only one parameter is selected the display is in absolute values and in the configured unit As soon as another parameter is selected the display switches to 100 scaling of the relevant parameter The Patient trending map can be called up either immediately after measurement or later in the data manager April 2009 Instructions for Use Revision 10 0 B 27 6 Measurement cobas b 221 system Measuring procedure Acid base map Last patients Roche Diagnostics If PCO and pH measurements are available the diagram can be displayed and printed Measurement Map explanation A Metabolic acidosis B Mixed met amp resp acidosis C Acute respiratory acidosis D Mixed ac amp chr resp acidosis E Chronic respiratory acidosis F Mixed met alkalosis amp resp acidosisose G Metabolic alkalosis H Mixed resp amp met alkalosis t Acute respiratory alkalosis J Mixed ac amp chr resp al
220. lyze it as described under Important information concerning the analysis of QC measurement results see section Important information concerning the analysis of QC measurement results on page B 35 To ignore the result violates the accepted QC rules Press the following buttons to unlock the QC lock Setup gt Parameter gt Miscellaneous settings gt Remove QC lock To remove a QC lock the correct parameter must be selected A calibration changing electrodes and or changing an MSS cassette do not remove a QC lock see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 April 2009 B 56 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control QC for Ready with AutoQC module QC for Ready with AutoQC module Parameters will be blocked if one of the adjusted rules is broken and identified accordingly in the Ready screen The function QC for Ready generates a list of the required manual QC measurements material level combination that can remove this lock again Proceeding from the uppermost level of the analyzer mode press the following buttons C QC measurement Figure B 41 1 Press QC for Ready When all parameters are ready for measurement the AutoQC measurement is started automatically 2 Ifthe parameters are not all ready for measuring the following screen appears Print Figure B 42 3 Here a list is given of all the
221. lyzer An error message in red is also displayed in the error window upper right hand corner on the display screen The error window will remain until corrective action is taken No Message Cause Action 10001 Flap W Docking mechanism for waste is open Close mechnism If the error persists contact Technical Support 10002 Out of operation The instrument has been taken out of Perform installation procedure operation lt D see Chapter 3 Installation and shutdown section Installation on page A 27 10003 Warmup The instrument warms up after power on Wait until the warmup is finished and or power fail perform installation procedures if necessary see Chapter 3 Installation and shutdown section Installation on page A 27 10004 Economy mode The instrument is in automatic or manual To return to the ready mode press Exit economy mode Table D 1 System stops Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 5 11 Troubleshooting cobas b 221 system System stops No Message Cause Action 10005 Comm error PC uC Communications between PC and microcontroller is interrupted Turn the instrument off and on again If the error persists contact Technical Support 10006 Download error The download process to the Turn the instrument off wait at least 3 microcontroller failed min
222. max 51 8 dB April 2009 Instructions for Use Revision 10 0 A 91 4 Specifications cobas b 221 system AutoQC Holding points Take care when lifting weight of the instrument without wash calibrating solutions and AutoQC is approx 45 kg Figure A 54 Holding points AutoQC Number of ampoules Printer Type Resolution Full graphics Printing speed Paper width Paper length Roche Diagnostics 6 mats each with 20 ampoules Thermal printer with integrated paper cutter and optional take up unit 8 dots mm 864 dots line max 20 mm sec 111 mm about 50m April 2009 A 92 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Touch screen PC unit SN lt 1500 PC Memory Hard disk Floppy disk drive Screen type Format Resolution SN gt 1500 PC Memory Hard disk Floppy disk drive Screen type Format Resolution SN gt 5000 PC Memory Hard disk Floppy disk drive Screen type Format Resolution Roche Diagnostics Touch screen PC unit AMD 5x86 Single Board PC 133 MHz 32 MB RAM 2 GB Harddisk 1 44 MB integrated at the right side of the screen TFT LCD screen 10 4 inch 640 x 480 pixel GEODE GXII 200 MHz 128 MB RAM 20 GB Harddisk 1 44 MB integrated at the right side of the screen TFT LCD screen 10 4 inch 640 x 480 pixel GEODE GXII 200 MHz 128 MB
223. measurement Roche Diagnostics Whole blood especially for the analysis of tHb SO and Hct must be thoroughly mixed immediately before analysis in order to achieve consistent distribution of red blood cells and plasma before insertion of the sample Carefully rotate the sample about two axis using your hand or a mechanical device or insert a metal disk or ball in the syringe before collecting the sample Shortly before using the sample carefully shake the syringe The up and down motion of the disk or ball inside the syringe cylinder ensures consistent mixing Refer to CLSI document C46 A Blood gas and pH analysis related measurements Approved Guideline 2001 April 2009 Instructions for Use Revision 10 0 B 5 6 Measurement cobas b 221 system Preanalytics Sample collection especially for glucose lactate measurement cobas b 221 lt 5 gt system cobas b 221 lt 6 gt system only Glucose Patient preparation 12 hr fasting period for blood glucose Optimal postprandial blood sampling is 1 hr after ingestion of food Samples should be analyzed immediately after collection since the sample metabolism causes a decrease in the glucose concentration within a few minutes of sample collection If immediate analysis is not possible the blood sample must be centrifuged immediately and the excess serum or plasma must be separated by pipette Plasma and serum samples collected in this manner and stored under refrige
224. ment Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 13 193 1 106 X 0 9 0 948 108 Radiometer 715 Y 2 143 1 028 X 1 4 0 972 107 Table A 62 Sodium Potassium Unit mmol L Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 6 Y 0 126 1 020 X 1 4 96 0 986 131 Radiometer 725 Y 0 323 1 083 X 10 6 96 0 989 98 Table A 63 Potassium Roche Diagnostics April 2009 A 84 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Calcium Unit mmol L Performance data Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 0 039 1 024 X 0 8 0 941 108 cobas b 121 System Y 0 036 1 042 X 1 3 96 0 962 140 Radiometer 725 Y 0 096 1 073 X 1 1 0 981 98 Table A 64 Calcium Chloride Unit mmol L Comparison instrument Slope and intercept Bias Corr coeff r No of samples cobas b 121 System Y 12 459 1 118 X 0 7 96 0 960 139 Radiometer 725 Y 17 100 0 800 X 4 0 96 0 965 98 Table A 65 Chloride Glucose Unit mmol L Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 0 461 1 034 X 3 9 0 938 134 Radiometer 715 Y 0 867 1 201 X 15 2 96 0 986 107 Hitachi Plasma Y 1 207 1 127 X 4 9 96 0 990 60 Cobas Mira Plasma Y 0 807 1 121 X 0 4 0 946 135 Table A 66 Glucose Urea Unit mmol L
225. ments 4 cobas b 221 systems Measurements per measuring point and instrument 5 Performance data Expected value Mean Sur Recovery 14 90 13 78 0 1141 92 5 39 74 37 78 0 3911 95 1 119 43 117 09 1 3505 98 0 Table A 26 Parameter PCO mmHg Correlation Slope 0 9898 1 0103 Intercept 1 225 Correlation coefficient 0 9999 Material Tonometered whole blood Number of instruments 4 cobas b 221 systems Measurements per level and instrument 5 Expected value Mean Sur Recovery 7 52 7 52 0 0050 100 7 32 7 32 0 0042 100 6 98 6 99 0 0066 100 1 Table A 27 Parameter pH pH units Correlation Slope 0 9825 1 0178 Intercept 0 133 Correlation coefficient 0 9998 April 2009 Instructions for Use Revision 10 0 A 71 4 Specifications cobas b 221 system Performance data Parameter Hct 90 Parameter sodium mmol L Roche Diagnostics Material human whole blood traceable to golden standard micro centrifuge Number of instruments 4 cobas b 221 systems Measurements per level and instrument 5 Expected value Mean Sur Recovery 11 00 11 72 0 4146 106 5 24 00 23 60 0 1804 98 3 36 00 36 51 1 0171 101 4 48 00 49 73 1 0046 103 6 68 00 68 16 0 2210 100 2 78 00 77 80 0 3925 99 7 Table A 28 Parameter Hct Wo Correlation Slope 0 997 1 003 Intercept 0 620 Correlation coefficient 0 999 Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measureme
226. mg dL 9 008 mg dL 1 4007 mg dL 6 0056 mg dL 2 mmol L BUN 17 1 pmol L 1 mmol kg 0 155 mmol Hb L Ery 1 3333 mbar 39 37x10 Inch in Hg 0 4464 mmol L 0 6202 mmol L 2 8014 mg dL BUN 0 1333 kPa Table A 74 Temperature Conversion table for units Equation A 1 Equation A 2 Standard values and ranges Roche Diagnostics T F 2 x T C 32 T C 2 x T F 32 Parameter Standard value Possible range tHb 15 0 g dL 1 0 26 0 g dL 150 g L 1 260 g L 9 0 mmol L 1 0 16 0 mmol L FiO 0 21 0 10 1 00 R Respiratory quotient 0 84 0 70 2 00 Patient s temperature 37 0 C 2 0 44 0 C 98 6 F 35 6 111 0 F Hb factor 3 0 2 7 3 3 Table A 75 Standard values and ranges April 2009 Instructions for Use Revision 10 0 A 97 5 Theoretical foundations cobas b 221 system Parameters and calculations Equations Ht cHCO ctCO P FO Hb All literature data stated in this section e g are stated afterwards in the section Bibliography The validity of calculated results from the cobas b 221 system must be carefully examined by a clinical medical specialist who will take the patient s clinical condition into consideration before any clinical decisions are reached based on the calculated results especially if one of the according measurement results exceeds its critical range Calculated values that require m
227. module select appropriate module gt Start internal cleaning If the error concerns the parameter s pH Urea or several ISE parameters perform Fill reference electrode System gt Utilities gt Fluid actions gt Fill routines If the error persists replace reference electrode see Chapter 10 Maintenance section Changing the reference electrode on page C 29 2009 Recal not OK Signal difference occurring during Perform Calibration for Ready recalibration of PCO was too large System Calibration Possible causes If the error persists replace electrode Invalid sample type used see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 27 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message 2011 Sensorsignal instabil Table D 6 Roche Diagnostics Cause Sensor signal cannot be reproduced Possible causes Invalid sample type is being used e Measuring channel contaminated e Air bubbles at the membrane in the internal electrolyte of the electrodes Interference signals in the measuring channel during measurement acquisition Interference signals via reference electrodes during measurement acquisition Status messages of measuring and calibration values Action
228. n mg dL Roche Diagnostics Material human whole blood incl bilirubin Number of instruments 2 cobas b 221 systems Measurements per level and instrument 3 Performance data Expected value Mean Sur Recovery 6 00 6 86 0 0928 114 33 14 00 14 55 0 1417 103 93 28 00 26 28 0 1901 93 86 44 00 41 52 0 0920 94 36 Table A 48 Parameter Bilirubin mg dL Correlation Slope 0 9038 1 1064 Intercept t1 514 Correlation coefficient 0 9996 April 2009 Instructions for Use Revision 10 0 A 81 4 Specifications cobas b 221 system Performance data Correlation to other methods pH Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 6 Y 0 063 1 009 X 0 007 0 990 134 Radiometer 725 Y 0 496 0 933 X 0 003 0 990 99 pH meter Y 0 9963 X 0 0 999 20 Table A 49 pH a pleural fluid pH measuring instrument temperature corrected PO Unit mmHg Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 6 Y 0 643 1 031 X 1 6 96 0 987 136 Radiometer 725 Y 4 433 1 013 X 6 6 0 996 137 Table A 50 PO PCO Unit mmHg Comparison instrument Slope and intercept Bias Corr coeff r No of samples cobas b 121 System Y 1 452 1 038 X 0 4 96 0 988 129 Radiometer 55 Y 0 301 1 000 X 1 2 96 0 992 144 Table A 51 PCO tHb cobas b 221 system with tHb SO module Unit g dL Comparison instrume
229. n parallel Exceptions to this occur during disturbances to the acid base status caused by the previously mentioned exchange of chloride for bicarbonates as well as during massive chloride loss with gastric juices during extended periods of vomiting hypochloremic alkalosis Normal values Adult 98 107 mmol L Newborn 98 113 mmol L a Tietz Textbook of Clinical Chemistry 3 d Edition 1999 Critical values e Cl 75 mmol L e Cl 126 mmol L a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 April 2009 A 114 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations lonized calcium Roche Diagnostics Clinical significance Approximately 99 of calcium in the human body is localized in bone substance mostly in the form of hydroxylapatite About 1 of the cations are located in the extracellular area Only very small amounts exist intracellularly the calcium ions here act especially as activators for numerous enzymes and play a role in the effect mechanism of hormones It is possible to exchange calcium in the extracellular fluid for that in bones In addition hydroxylapatite serves as a reserve holder from which calcium can be rapidly mobilized when needed Calcium is present in plasma in 3 forms e About 50 are ionized and biologically active e about 40 are bound to proteins especially albumin and e about 10 are prese
230. n 2001 The PO value in arterial blood is one of the main factors in calculating arterial oxygenation Values below the normal range arterial hypoxia are normally caused by blockages in the lung and respiratory tract as well as in the blood circulatory system for example bronchial obstruction vascular disturbances lessened cardiac function increased need for oxygen anatomical cardiac defect lower level of inspired O In general PO values over 100 mmHg do not contribute significantly to the oxygen level because with a normal hemoglobin concentration of 80 100 mmHg PO a saturation level of 9796 has already been achieved Standard values e Arterial blood 80 mmHg Venous blood 30 40 mmHg Critical values e PO lt 40 mmHg or 5 3 kPa a Critical Care Testing A Quick Reference Guide by Andrew St John First Edition 2001 Roche Diagnostics April 2009 A 110 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Sodium Roche Diagnostics Clinical significance The fast majority of sodium in organisms is located in the extracellular area about 97 96 Even with greatly varying supply with nourishment the sodium concentration in serum is subject to strong regulation In the kidneys sodium is glomerularly filtered and most of this about 60 70 96 is reabsorbed in the proximal tubule The most important function of the sodium is to maintain constant osmolarity in the ext
231. nEns av Aeroupyel napoucia eiplexrov avaicen roy r aepiow BOROBIA BARNES RNA AMI KRAOKMAACT ER RRRABLRUAORT HA RICOe ELT ANTENA MBA LEV SDR TIRA ARES S MB CUTS LEO Danger Possible explosion hazard if used in the presence of Cuidado No utilizar el equipo en espacios donde pueda haber REM DIED FOLD RBH COMA TK RSV flammable anesthetics or gases mezclas inflamables de gases anest sicos SRATFRERRA In vitro Diagnosticum Voor in vitro diagnostisch gebruik RAH SMA RA pms Se Goed nota nemen van EE DATE AFAR zum Gebrauch Uitsluitend voor gebruik personeel Das Gare deaf Gur s fan Le aor BR REPE BMURB SUE SAA TIERMUES IS ge ffnet und repariert werden en gerepareerd worden Achtung Das Ger t darf nicht in R umen mit explosions f higen Let op Het apparaat mag niet gebruikt worden in ruimten met Gemischen von An sthesiegasen betrieben werden explosieve mengsels van anesthesiegassen Figure A 10 cobas b 221 lt 1 gt system cobas b 221 lt 3 gt system and cobas b 221 lt 5 gt system with tHb SO module Usage in vitro In vitro diagnostikum Laboratory Use Suivre les instructions de la notice d utilisation F lj bruksanvisningen t US Electrical Equipment Utilisation r serv e un personnel Endast f r anv ndning av specialister Attention Non reparable par l utilisateur Depannage realisable Varning Enheten far endast ppnas och repareras av utbildad LISTED exclusivement par un technicien qualifi servicep
232. nal maintenance procedures Bypass nipple e Bacteria filter T amp D disk Tubing set tHb COOX e Sample distributor cartridge Measuring chamber cartridge e Hb cartridge e Waste tubing VP tubing set cobas b 221 lt 2 gt lt 4 gt lt 6 gt system only e Cuvette e Cuvette seals e Hemolyzer tube The tubing paths must also be disinfected annually and the baro value must be checked April 2009 Instructions for Use Revision 10 0 C 39 10 Maintenance cobas b 221 system Additional maintenance procedures Roche Diagnostics April 2009 C 40 Instructions for Use Revision 10 0 Troubleshooting D IL DRONDIeSDOOLID Lesson tug mena e qub Ute San ele D 3 cobas b 221 system 11 Troubleshooting Contents Troubleshooting In this chapter all fault messages their causes and remedies are described These are also displayed directly on the instrument screen All messages are arranged according to info number In this chapter Chapter 1 Troubleshooting general NA tede tede eter e etse Module stops tddi SCA inici Status messages of measuring and calibration values esses 20 Status messages on the measurement report s sese 39 Barcode S schist ah entend ed e OU EE a ORE DNE NR 40 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 3 11 Troubleshooting cobas b 221 system Contents Roche Diagnostics April 2009
233. natal field we therefore recommend carrying out a comparative blood measurement relative to a known reference system or to adapt the correlation table refer to the Reference Manual chapter Setup section Correlation For any questions concerning this matter contact the local Roche organization Roche Diagnostics nO gt o ux Whole blood Aqueous QC material Serum or plasma Dialysis solutions containing acetate Dialysis solutions containing bicarbonate PF Pleural fluid can be measured in serum plasma mode a with approximate physiological ion matrix and buffer capacity April 2009 Instructions for Use Revision 10 0 A 59 4 Specifications cobas b 221 system Performance data Reproducibility Within Run Swr and Total Precision ST was determined from 2 runs per day with 2 replicates per run for 20 days on four cobas b 221 systems The mean value is the measured value of the corresponding parameter for which Syr and Sy are representative resp have been determined Parameter Unit pH pH units PCO mmHg PO mmHg Sodium mmol L Potassium mmol L Chloride mmol L ionized Calcium mmol L Het Lactate cobas b 221 lt 5 gt system mmol L cobas b 221 lt 6 gt system only Glucose cobas b 221 lt 5 gt system mmol L cobas b 221 lt 6 gt system only Urea cobas b 221 lt 6 gt system only mmol L tHb tHb module g dL SO tHb module tHb COOX g dL SO COOX 96 O Hb
234. ng blood PH Standard pH value of the blood is defined as the pH value of a blood sample which has been equilibrated at 37 C with a gas mixture having a PCO 40 mmHg Unit pH unit Equation A 18 pH 0 8262 0 01296 tHb 0 006942 BE lg 0 025 PCO pH Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 101 5 Theoretical foundations cobas b 221 system Parameters and calculations cHCO0 PAO AaDO a A0 avDO Roche Diagnostics Standard bicarbonate of the blood defined as the plasma bicarbonate concentration in blood which has been equilibrated at 37 C with a gas mixture having a PCO 40 mmHg Unit mmol L Equation A 19 cHCO s 10 PB 6022 The alveolar oxygen partial pressure is used to calculate several parameters used for oxidation and breathing 1 Unit mmHg Equation A 20 PAO P otal 47 FIO PACO FIO me PACO PaCO alveolar PCO for PAO gt PO otherwise PAO PO For t unequal 37 C see Equation PAO on page A 105 The alveolar arterial oxygen partial pressure gradient PAO PaO is the difference between the alveolar oxygen partial pressure as calculated above and the measured oxygen partial pressure of arterial blood 1 Unit mmHg Equation A 21 AaDO PAO PaO Fort unequal 37 C see equation AaDO on page A 105 Arterial alveolar oxygen partial pressure ratio Unit 96 PaO
235. ng fill port and sample drip tray C 8 Cleaning the bottle compartment C 25 Cleaning the measuring chambers C 34 Cleaning the modules and sample paths Module cleaning C 19 Cleaning the modules and tubing paths C 19 Tubing paths C 20 Cleaning the T amp D disk C 9 Cleaning the touch screen C 8 Clinical significance A 109 A 114 PO A 110 Glucose A 124 Hematokrit A 117 Hemoglobin derivatives and bilirubin A 120 Carboxyhemoglobin COHb A 121 Methemoglobin MetHb A 122 Oxyhemoglobin O Hb A 121 Total bilirubin A 123 Ionized calcium A 115 Lactate A 125 Oxygen saturation A 119 PCO A 110 pH A 109 Potassium A 112 Sodium A 111 tHb total hemoglobin concentration A 118 Urea BUN A 126 Contact addresses 2 Conversion table for units A 97 COOX calibration for instrument versions with COOX module only C 10 COOX module A 20 Copyright 1 Correlation to other methods A 82 April 2009 Instructions for Use Revision 10 0 F 3 Index cobas b 221 system D Data input B 24 Data manager B 81 Calibrations B 84 General data manager functions B 81 Instrument B 85 Measurements B 83 Patients B 83 QC measurements B 84 Utilities B 85 Backup Restore B 85 Protected DB functions B 86 Date and Time A 32 Decontamination A 14 C 5 Input unit C 5 Recommended disinfectants C 6 S
236. ng mechanism and remove bottle S1 and the packs 52 and S3 A Do not remove the waste container 2 Close docking mechanism and bottle compartment cover 2 Fill the shutdown kit with distilled water Fill the shutdown kit about halfway with distilled water Figure A 43 Shutdown kit 3 Insert shutdown kit into space S2 1 Open bottle compartment cover and docking mechanism 2 and insert the shutdown kit into space S2 2 Close docking mechanism and bottle compartment cover 3 Perform Washing of the tubes 4 Remove shutdown kit from space S2 1 Open bottle compartment cover and docking mechanism S2 and remove the shutdown kit 2 Close docking mechanism and bottle compartment cover 3 Perform Emptying of the tubes Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 49 3 Installation and shutdown cobas b 221 system Shutdown 5 Insert shutdown kit into space S3 cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only 1 Open bottle compartment cover and docking mechanism 3 and insert the shutdown kit into space S3 Close docking mechanism and bottle compartment cover Perform Washing of the tubes 6 Remove shutdown kit from space S3 cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only 1 7 Remove Waste container Open bottle compartment cover and docking mechanism S3 and remove the shutdown kit Close docking mechanism and bottle c
237. nostics April 2009 Instructions for Use Revision 10 0 A 35 3 Installation and shutdown cobas b 221 system Installation A T amp D lock C Insert the glass tube into the guides B Glass tube D Fasten and check for correct position Figure A 21 Glass tube 8 Close the T amp D lock again Check the correct positioning of the sample inlet path to the bypass nipple see below A Bypass nipple Figure A 22 T amp D lock 9 Close the T amp D cover 10 Insert the sample drip tray Roche Diagnostics April 2009 A 36 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown 13 Insert printer paper Roche Diagnostics Installation The printer paper is heat sensitive on one side only Observe the correct insertion of the thermal paper roll A B A Printer cover B Paper lid Figure A 23 Printer 1 Open the printer cover and the paper lid 2 3 4 Cut the start of the paper so that it is straight Place the paper roll into the holder Make sure that the printer lever is in the down position see below A Printer lever down position Figure A 24 Printer lever April 2009 Instructions for Use Revision 10 0 A 37 3 Installation and shutdown cobas b 221 system Installation 5 Insert the beginning ofthe paper according to the instructions on the inside of the paper lid see below A Paper lid B Printer
238. ns are used Abbreviation Definition 2 ANSI QC ao gt DIL DNS EC e g EN FMS Hct HIV HW American National Standards Institute Automatic Quality Control Blood gas Abbr for blood urea nitrogen Clinical Laboratory Improvement Amendments Clinical and Laboratory Standards Institute Conductivity Canadian Standards Association Decibel weighted against the A frequency response curve This curve approximates the audible range of the human ear Diluent Domain Name Server European community exempli gratia for example European standard Fluid mixing system Hematrocrit Human immunodeficiency virus Hardware April 2009 8 Instructions for Use Revision 10 0 cobas b 221 system Abbreviation Definition I ie ISE IVD LCD LIS LJ MAC MC MSDS MSS MV PP QC RCon REF SIP SDC S1 S2 S3 SCon SD SO T amp D tHb UL VDE id est that is to say Ion selective electrode In vitro Diagnostic Directive Liquid cristal display Laboratory Information System Levey Jennings Media Access Control Measuring chamber Material safety data sheet Metabolite sensitive sensor Mean value Peristaltic pump Quality control Reference contact Reference solution Sample inlet path Sample distributor cartridge 1 Rinse Solution S2 Fluid Pack S3 Fluid Pack Sensor contact Standard deviation Oxygen saturation
239. nstrument Info Top level of the analyzer mode Ready A Current status of the analyzer mode Direct call up of the video sequences B Status line offered C AutoQC act deact J Required sample volume display varies D Network connection act deact according to activated deactivated modules E Pending maintenance K Software modes Info setup analyzer F Type and time of next calibration database G Current date L Error instruction window H Current time M active Figure B 48 Ready screen Screen sharing a remote monitoring and remote maintenance software is active April 2009 Instructions for Use Revision 10 0 B 71 9 Software modes cobas b 221 system User interface A service connection was established to the instrument See the screen sharing symbol in the status line A Screen sharing a remote monitoring and remote maintenance software is active Figure B 49 For example User defined parameter groups C Setup gt Parameter gt User defined parameter groups This function helps to define three parameter groups Fora detailed description see the Reference Manual chapter 3 Setup section User defined parameter groups Ready 1D i ES Eae Le vel ce E peras 59 Figure B 50 Roche Diagnostics April 2009 B 72 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Parameters icons User interface
240. nt Deviation of mean values No of samples OMNI 9 0 3 96 abs 129 Radiometer 725 0 2 96 abs 131 Table A 57 MetHb COHb cobas b 221 system with COOX module Unit 96 For values less than 3 596 Comparison instrument Deviation of mean values No of samples OMNI 9 0 7 96 abs 130 Radiometer 725 0 1 96 abs 132 Table A 58 COHb Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 83 4 Specifications cobas b 221 system Performance data SO cobas b 221 system with COOX module Unit 96 Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 6 Y 0 100 1 000 X 0 1 96 abs 0 967 132 Radiometer 725 Y 17 341 0 824 X 0 5 96 abs 0 988 132 Table A 59 SO Bilirubin cobas b 221 system with COOX module Unit mg dL Comparison instrument Slope and intercept Bias Corr coeff r No of samples Hitachi TBil Y 0 127 0 968 X 3 7 96 abs 0 986 85 Beckman LX 20 tBil Y 0 537 1 060 X 1 4 96 abs 0 980 76 Kodak Vitros tBil Y 0 119 0 988 X 2 4 96 abs 0 984 73 Radiometer Y 0 327 1 044 X 10 5 96 abs 0 974 82 Table A 60 Bilirubin Hct Unit 96 Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 0 182 1 003 X 0 4 abs 0 918 137 cobas b 121 System Y 0 689 1 040 X 0 6 96 abs 0 946 141 Table A 61 Hct Sodium Unit mmol L Comparison instru
241. nt Slope and intercept Bias Corr coeff r No of samples Radiometer 725 Y 0 581 1 083 X 2 0 96 0 814 96 Table A 52 tHb SO cobas b 221 system with tHb SO module Unit 96 Comparison instrument Slope and intercept Bias Corr coeff r No of samples cobas b 121 System Y 10 066 0 903 X 1 1 96 abs 0 991 130 Radiometer 715 Y 3 969 1 037 X 0 4 0 904 102 Table A 53 SO Roche Diagnostics April 2009 A 82 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications tHb cobas b 221 system with COOX module Performance data Unit g dL Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 9 Y 0 100 1 000 X 1 0 96 0 980 135 Radiometer 700 Y 0 200 1 000 X 1 1 0 977 125 Table A 54 tHb O Hb cobas b 221 system with COOX module Unit 96 Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 6 Y 2 394 0 971 X 0 3 96 abs 0 986 132 Radiometer 725 Y 14 492 0 846 X 0 1 96 abs 0 986 132 Table A 55 O Hb HHb cobas b 221 system with COOX module Unit 96 Comparison instrument Slope and intercept Bias Corr coeff r No of samples OMNI 6 Y 0 069 0 987 X 0 1 abs 0 986 132 Radiometer 725 Y 0 316 0 816 X 0 5 96 abs 0 980 132 Table A 56 HHb MetHb cobas b 221 system with COOX module Unit 96 For values less than 1 396 Comparison instrume
242. nt in complex bonds with citrate phosphate bicarbonate lactate and others Protein bonding is dependent on the concentration of albumen in plasma and on the pH level of the blood With lower total albumen and an acidic pH level fewer calcium ions are bound causing the ionized proportion to increase This also explains why despite a low level of calcium in serum during severe acidosis due to chronic kidney insufficiency tetanic reactions do not occur The portion of calcium suitable for ultrafiltration ionized and complex bound is glomerularly filtered in the kidneys and up to 95 99 reabsorbed in the proximal and distal tubule A small portion of the calcium can also be excreted via the intestine The regulation of calcium exchange is closely related to the regulation of the phosphate level Therefore the concentrations of both substances in serum and the excretion with urine should always be seen and judged in relationship to each other The level of calcium in plasma is decisive for calcium phosphate exchange Three hormones play roles in the regulation They affect the maintenance of the extracellular calcium concentration via the reabsorption of calcium ions from the intestine the release or storage processes in bones and the extent of the renal excretion Parathormone and 1 25 dihydroxycholecalciferol lead to an increase of the calcium concentration in plasma Calcitonin reduces the level of calcium Increased
243. ntenance cobas b 221 system Sample dependent maintenance procedures ww Tubing paths Roche Diagnostics BG ISE COOX or tHb SO module ISE module the frequency of the cleaning process depends on the lab specific type of sample physiological pathological fetal blood BG module should be cleaned only on demand in the following scenario e visible blood clot in the BG module e low PO QC recoveries due to microscopic bacterial contamination of the PO electrode 1 Activate the corresponding module and press Start external cleaning 2 The external cleaning agent is inserted like a sample syringe or capillary via the fill port 3 Each external cleaning must be followed by a wetting using whole blood or serum press System gt Utilities gt Fluid actions gt Wetting routines 4 Pressing Start internal cleaning to carry out a cleaning using the internal cleaning solution MSS module cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only This cleaning should be performed with every exchange of the cassette but not more than once per month e g obstruction 1 Activate the MSS module and press Start external cleaning 2 The external cleaning agent is inserted like a sample syringe or capillary via the fill port 3 Insert a new MSS cassette using the correct procedure e see Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page
244. ntrol With Software V 6 0 onwards using cobas bge link the instrument can be monitored from one location any disturbances can be remedied and the analytical quality monitored cobas bge link is a remote monitoring and remote maintenance software for Roche Point of Care analyzers see Figure A 2 on page A 12 April 2009 Instructions for Use Revision 10 0 A 11 2 General descriptions cobas b 221 system General notes A A service connection was established to the instrument See the screen sharing symbol in the status line SP aa a Sensor changing 06 12 2007 1P cal 15 13 11 12 2007 14 13 A A Screen sharing Symbol B Screen sharing active Figure A 2 Confirm the message with OK either on the instrument or on the PC The screen sharing symbol is added in the status line To avoid multiple operation of the instrument the message Screen sharing active is displayed with a yellow background in the error and message window of the instrument As long as the screen sharing symbol is displayed in the status line the service connection is active In order to prevent multiple operation of the instrument no buttons on the screen should be pressed Important buttons on the screen Roche Diagnostics Buttons Description Analyzer active inactive Database active inactive EM M Setup active inactive Ea EB Info active inactive
245. nts per level and instrument 15 Expected value Mean Sur Recovery 19 85 21 25 0 4979 107 1 91 52 92 44 0 3018 101 0 153 49 154 83 0 3808 100 9 205 66 208 30 0 5619 101 3 258 42 262 68 1 6465 101 6 Table A 29 Parameter Sodium mmol L Correlation Slope 0 988 1 012 Intercept 0 365 Correlation coefficient 0 9999 April 2009 A 72 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Parameter potassium mmol L Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Performance data Parameter ionized Calcium mmol L Roche Diagnostics Expected value Mean Sur Recovery 0 23 0 26 0 0159 115 0 3 12 3 12 0 0114 100 0 5 11 5 13 0 0144 100 4 9 96 10 16 0 0378 102 0 14 71 15 19 0 0624 103 3 19 36 20 15 0 0757 104 1 Table A 30 Parameter Potassium mmol L Correlation Slope 0 960 1 042 Intercept 0 109 Correlation coefficient 0 9999 Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 0 10 0 09 0 0042 92 0 0 80 0 76 0 0067 94 7 1 25 1 19 0 0055 95 2 2 50 2 39 0 0122 95 7 4 00 3 86 0 0225 96 5 6 00 5 84 0 0347 97 4 Table A 31 Parameter ionized Calcium mmol L Correlation Slope 0 975 1 026 Intercept 0 024 Correlation coefficient 0 9999 April 2009 Instructions for Use Revis
246. o ensure correct and accurate measurement results Despite proper sampling procedures errors can arise in the blood gas analysis e due to insufficient mixing of the sample after sampling and before the measurement e due to ambient air contamination caused by air bubbles that are not removed after sampling dueto changes in metabolism in the sample April 2009 B 8 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Serum Plasma Pleural fluid Roche Diagnostics Preanalytics After the appearance of spontaneous clotting process the sample in a centrifuge to separate the cellular solid components and the fibrin from the watery serum Transfer the serum to a suitable sample container and seal If it is necessary to store the sample close the sample container tightly and cool it to 4 8 C If a sample has been cooled warm it to room temperature 15 33 C before analysis Plasma samples are obtained by centrifuging heparinized whole blood during which the cellular components of the blood are removed from plasma Complete the analysis as quickly as possible If immediate lactate analysis is not possible the blood sample must be centrifuged immediately in a cooled centrifuge If it is necessary to store the sample close the sample container tightly and cool it to 4 8 C If a sample has been cooled warm it to room temperature 4 15 33 C before analysis Plasm
247. of Clinical Chemistry 3 Edition 1999 page 1803 Critical values e Bilirubin gt 15 0 mg dL or gt 256 5 pmol L a Tietz Textbook of Clinical Chemistry 3 Edition 1999 page 1846 a Total bilirubin unconjugated free and conjugated form Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 123 5 Theoretical foundations cobas b 221 system Clinical significance Glucose Roche Diagnostics Glucose detection is an important test to monitor hyperglycemia or hypoglycemia Hyperglycaemia is an increased blood sugar concentration blood sugar level gt 130 mg dL or 7 2 mmol L The most common forms of diabetes mellitus are Type II diabetes Insulin independent diabetes ZNIDDM adult diabetes Frequency 8096 Type I diabetes Insulin dependent diabetes IDDM juvenile diabetes Frequency 2096 During operative intervention hyperglycaemia caused by hypoxia can cause serious acidosis If the blood sugar level drops below 40 mg dL this state is termed hypoglycaemia This can be caused by one of the following circumstances Reduced glucose supply Reduction in hepatic gluconeogenesis o o o o Congenital metabolism defect Terminal cirrhosis of the liver Alcohol toxication Poisoning Malabsorption Dumping syndrome gastrectomy Fasting Increased peripheral use of glucose Physical activity Endogenous hyperinsulinism o o o
248. omatic 6 Select language 7 Set the date and time When carrying out the installation follow the on screen instructions Installation must be carried out completely and may not be interrupted Observe the listed sequence while performing the actions If the automatic first installation is unsuccessful you must carry out the installation process manually To do this press the following buttons System gt Utilities gt Installation Processing the actions The corresponding line of the list box contains an instruction which must be performed manually Then press Confirm action If there is an automatic sequence for any action you can start this by clicking Start process d If an action has been completed successfully manually or automatically this symbol is displayed 1 Press the following buttons Setup gt Instrument gt Language If the current language is English Instrument gt Language 2 Select the language Press the following buttons C Setup gt Times amp Intervals gt Act time date Roche Diagnostics HH MM A HH MM am pm H MM am pm HH MM am pm Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure A 15 Act time date April 2009 A 32 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation 8 Cal intervals amp timing e Press the following button C S
249. ompartment cover Perform Emptying of the tubes Open bottle compartment cover and docking mechanism W Remove the waste water container W Waste Container Close docking mechanism and bottle compartment cover 8 Open the measuring chamber cover and remove the sensors 1 2 5 Remove the top cover and open all measuring chamber covers Open the measuring chamber cover push the right edge of the MC cover to the left with a finger and open up the MC cover Open the locking levers and the contact clip MSS measuring chamber Sequentially remove the electrodes and the MSS cassette from the measuring chambers Close the locking lever the contact clip and all the measuring chamber covers 9 Remove the peristaltic pump tubes 1 2 Roche Diagnostics Open the peristaltic pump s clear plastic cover tension lever see below A Tension lever B Pump head C Linear bracket Figure A 44 Peristaltic pump Push the linear bracket white plastic part upwards see below A April 2009 A 50 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Shutdown 3 Remove the complete tubing set tubing holder and tubing of the corresponding pump see below B A Push the linear bracket upwards B Remove the tubing set Figure A 45 Peristaltic pump 4 Close the tension lever 10 Remove the printer paper 1 Open the printer cover and the paper lid A B
250. oo low Possible causes Blockage No fluid in measuring chamber PP tube MSS outlet defective Check PP tube MSS outlet and if necessary replace see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 Perform the fill routine Aspirate standby solution System gt Utilities gt Fluid actions gt Fill routines Perform Calibration for Ready System gt Calibration If error persists perform Wetting routine System gt Utilities gt Fluid actions If the error persists perform General fluidics test System gt Diagnostics and afterwards contact Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 22 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 1013 Sample sep error 2 MSS No air packet was detected between Check PP tube MSS outlet and if necessary calibration solution and sample The replace sample was not aspirated or aspirated too see Chapter 10 Maintenance section late Exchanging the peristaltic pump tubes on Possible causes page C 23 Deposits or blockage in measuring Perform Aspirate standby solution channel System gt Utilities gt Fluid actions gt Fill PP tube MSS outlet defective routines Perform Calibration for Ready System gt
251. or System gt Utilities gt Fluid actions gt Possible causes Fill routines e Aspiration of MSS standby solution Check Fill ref electrode MSS not ok System gt Utilities gt Fluid actions gt e Aspiration of MSS reference solution Fill routines not ok Jo Perform MSS conductivity path test with standby solution System gt Component test gt Control sensors gt Contact paths 8075 IfS ADC error To correct the error turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 37 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 8076 IfS mean not OK Calibration end value of an IfS is outside Replace S3 Fluid Pack the range see Chapter 10 Maintenance section Possible causes Exchange of solutions and packs on e Problems with transponder of page C 13 S3 Fluid Pack Ifthe error persists replace MSS cassette e see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 8077 IfS ADC gt gt gt gt gt nterference sensor signal is above ADC Perform Fill reference electrode range System gt Utilities gt Fluid actions gt
252. orm Calibrationfor Ready System gt Calibration Ifthe error persists contact Technical Support 1037 No sample detected 8 No sample detected in hemolyzer Perform Hemolyzer test Possible causes System gt Component test gt Aggregates gt Sample path leaky or blocked Hemolyzer Ifthe error persists perform General fluidics test to isolate the error System Diagnostics and afterwards contact Technical Support 1038 No sample detected 9 No rinse solution from the Hb module Perform Wash detected tHb SO or COOX module System gt Wash amp Cleaning dependi th figurati epen ns on fhe corifiguratioti If the error persists perform General fluidics Calibration y test to isolate the error Possible causes i System gt Diagnostics Sample path leaky or blocked ua cca ME and afterwards contact Technical Support 1050 No sample in SIP No sample detected in the sample inlet Perform Wash path at 582 or 56 System Wash amp Cleaning Possible causes Ifthe error persists perform General fluidics e No sample was inserted test to isolate the error System Diagnostics and afterwards contact Technical Support 1051 No AQC sample detected No sample was detected at SS5 Perform Wash AQC Possible causes System Wash amp Cleaning Sample path leaky or blocked Ifthe error persists perform General fluidics test to isolate the error System gt Diagnostics and afterwards contact Technical Support 1052 No va
253. ous sample input Possible causes With noncalibrated sensors perform fill i routine Aspirate CAL 2 3 4 e The sample was irregular e Sample was insufficient System gt Utilities gt Fluid actions gt Fill routines Perform Calibration for Ready System gt Calibration If the error persists contact Technical Support 1032 Sample distr error 5 No calibration solution 1 CAL 1 Check PP tube main pump detected e Perform Aspirate CAL 1 Possible causes System gt Utilities gt Fluid actions gt e Blockage or leak Fill routines Tubing of main pump is defective Tfthis error cannot be corrected replace main pump tube see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 If the error persists contact Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 25 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 1036 Insufficient sample 5 Insufficient sample for MSS module was Repeat the measurement calibration check detected for sufficient and homogeneous sample Possible causes input e With noncalibrated sensors perform fill The sample was irregular routine Aspirate CAL 2 3 4 Sample was insufficient System gt Utilities gt Fluid actions gt Fill routines Perf
254. outside the To localize the error specified range Perform Aspirate CAL B CAL A System gt Utilities gt Fluid actions gt Fill routines Perform General fluidics test System gt Diagnostics After removing possible faults insert a new S2 Fluid Pack see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 If the error persists contact Technical Support 20018 Pack S2 empty Inserta new S2 Fluid Pack see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 20019 Flap S2 Docking mechanism for S2 Fluid Packis Close the docking mechanism open Table D 2 Module stops Roche Diagnostics April 2009 D 12 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Module stops No Message Cause Action 20020 No pack S2 e Insert the S2 Fluid Pack see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 20021 ADC error cond BG ISE A hardware error occured during mixture Turn the instrument off wait at least 3 calibration minutes and turn it back on If the error persists contact Technical Support 20022 Transponder error S2 The transponder data of the S2 Fluid Pack To correct the error remove and reinsert could not be read S2 Fluid Pack Ifthe error persists replace S2 Fluid Pack see Chapter 10 Maintenance Exchange of solutions and packs on page C 13 20023 S2 on board time expired e Insert th
255. ow A A Locking lever Figure A 34 Insertion of the reference electrode 3 Connect the white connector on the end of the tube to the measuring chamber cassette see below A B A Connector B Measuring chamber cassette Figure A 35 Insertion of the reference electrode 2 4 Scanthe barcodes located on the inner packaging of each electrode or enter the barcodes manually with the help of the keyboard 5 Close the measuring chamber cover Roche Diagnostics April 2009 A 42 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown 1 A Roche Diagnostics Installation MSS measuring chamber for instrument versions with MSS module only Hold the MSS cassette only at the designated handle and avoid touching the contacts 1 Open the cover of the MSS measuring chamber apply force to the right edge of the MC cover with a finger to push it to the left and open up the MC cover Keep the bottle compartment cover closed Y OOAD Open the contact clip and the locking lever Depending on the MSS parameter configuration insert the MSS reference electrode Ref dummy see Figure A 36 A or the reference contact RCon see Figure A 36 B and the MSS cassette close the contact clip and the locking lever A Ref dummy for Glu Lac Urea B RCon Glu or Glu Lac C Locking lever D Contact clip Figure A 36 MSS measuring chamber Read in the barcode of the packaging Close
256. owever this assumes an extensive and proper rolling of the sample container to avoid this type of sedimentation in the sample see section Preanalytics on page B 5 The most important influence in glucose lactate determination is the treatment of the sample until the measurement due to the glycolysis in the erythrocytes of the blood sample Detailed information about the correct treatment of samples are listed in the section Preanalytics on page B 5 The following principle holds Perform metabolite measurements from heparinized whole blood as quickly as possible or centrifuge the sample as quickly as possible for plasma extraction and immediately pipette off the supernatant of the sample The cobas b 221 system metabolite measurement is performed with an active interference correction As such the glucose or lactate measurement features an additional integrated sensor that largely eliminates any possible occurring interferences endogenously e g uric acid or exogenously e g actetylsalicylic acid To achieve the highest possible perfection in interference compensation the compensation sensor with the actual biosensors is adjusted daily as part of the system calibration The influence of the most important known interferents was determined during development summarized in section MSS on page B 13 In spite of these interference compensation sensors a metabolite determination is only possible with samples with an approximate
257. package 4 Turn the mat so that the necks of the ampoules face down Gently wave but do not shake the mat and ensure that the necks of the ampoules are free of air bubbles Figure C 35 AutoQC mat 5 Place the mat in the defined position A F of the ampoule block so that the ampoules are no longer visible 6 Press Refill The following question appears Mat change Is the material from the same lot le faa Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure C 36 7 Press Yes if the mat is replaced with a new one of the same lot The number of the ampoules is set to 20 April 2009 C 36 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Roche Diagnostics Unscheduled Press No if the new mat was not inserted from the same batch In this case the material has to be newly defined See Chapter 7 Quality control section Material setup on page B 36 8 Incase the mats are not completely filled press Details By pressing the corresponding key the status of the selected ampoule can be changed see below and or the ampoules to be measured can be selected This function can also be used when full ampoules are removed from the mat for manual measurement Mat change a SS m SEE i p Mat B Material AUTO TROL TS Level 2 Lot number 21820601 Exp date 28 2 2003 11 Ampoules blue full gray empty a E El El El El e
258. pillaries Syringe mode Improper heparinization of syringes with liquid heparin may cause erroneous results ISE parameters are particularly susceptible 1 Securely attach the syringe to the fill port If the position of the syringe is correct the T amp D disk will be backlit in green Figure B 1 E a Using syringe with an excentric tapered tip make sure that the tapered tip is in lower position while Q attaching the syringe to the fill port For details see Figure B 2 on page B 20 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 19 6 Measurement cobas b 221 system Measuring procedure AA Roche Diagnostics Figure B 2 2 The following screen appears EN Sc Inject sample Aspirate sample slowly Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure B 3 3 Inject the sample slowly until the signal sounds Do not press the Aspirate sample button or the sample will spill out danger of infection 4 Detach the syringe after the message Remove sample container appears 5 The measurement starts April 2009 B 20 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Measuring procedure Capillary measurement A Only glass capillary tubes with heat polished ends or the plastic capillary tubes offered by Roche Diagnostics may be used in order to prevent damage to the inst
259. pril 2009 A 20 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions System description Reverse side E n D B C A Power supply D Air filter B Main power switch and connector E Interfaces C Warning and identification labels Figure A 5 Reverse side Power supply This unit also contains the main power switch and the connector A Power supply B Main power switch OFF C Main power switch ON Figure A 6 Power supply Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 21 2 General descriptions cobas b 221 system System description Interfaces A Roche Diagnostics Only data processing units manufactured according to the standards IEC 950 UL1950 may be attached to the interface connections A B Cc D E F A Power supply D Ext keyboard barcode scanner B Service connector E RS232 C RS232 F 10BaseT Figure A 7 Interfaces without USB gt N cal IA M SERVICE A A Power supply D RS232 B Service connector E USB C Ext keyboard barcode scanner F 10BaseT Figure A 8 Interfaces with USB e Variant 2 2x RS 232 interfaces COM 1 and COM 2 SN lt 1500 see Figure A 7 on page A 22 e Variant 1 1x RS 232 interface COM 1 and 1x USB SN gt 1500 see Figure A 8 on page A 22 1x 10BaseT Ethernet RJA5 Ext keyboard barcode scanner PS 2 DIN 6 pin female connector e 1 service connector Power
260. pril 2009 B 50 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control QC measurement QC measurement In order to ensure the quality of the measurement results complete a quality control test on 3 levels low normal high after each electrode exchange after each exchange of solutions and packs and after startup of the instrument Additionally complete a quality control test on one level between two automatic 2P calibrations The level have to be alternated low normal high see General QC concept on page B 33 Manual QC measurement 1 Press the following buttons starting with the top level of the analyzer mode C QC measurement AO Roche Diagnostics Figure B 37 2 Activate the corresponding QC material and the selected level for example level 1 3 Remove the ampoule of the corresponding level of the desired QC material from the packaging or of the AutoQC material from the mat 4 Gently tap the head of the ampoule with your fingernail to remove any liquid from the top 5 Break open the ampoule To avoid injury protect your hands with gloves and tissues when breaking open the ampoule Use the control material within 30 seconds of opening Never reuse the ampoule It is recommended to use an ampoule adapter April 2009 Instructions for Use Revision 10 0 B 51 7 Quality control cobas b 221 system QC measurement 6 Insert the adapter see belo
261. r 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30014 Prep of CAL A not ok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate CAL A 2 Insert a new S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30017 Prep of O2 zero not ok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and startAspirate O2 zero point solution 2 Insert a new S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30018 Prep of Na cond notok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate Na conditioning solution 2 Insert a new S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30019 Prep of clean sol notok Perform the following troubleshooting options step by step until the warning disappears l Press S
262. r Use Revision 10 0 B 91 9 Software modes cobas b 221 system Info Sensor report 70 58 mv 1431 10 mv OK 947 36 mV 144 65 mv 470 97 mv 1 16 mv 219 30 mv Print Figure B 69 Displays the current status of the electrodes sensors Press the Print button to print out the sensor report Status report Pressing Print status report information about the instrument and a multitude of settings will be printed Protected information This area is password protected and only accessible to authorized personnel or customer service Roche Diagnostics April 2009 B 92 Instructions for Use Revision 10 0 Maintenance c 10 Maintenance ueesnso Na s cab A Ma i C 3 cobas b 221 system 10 Maintenance Maintenance Roche Diagnostics Contents In this chapter all maintenance work is described that is necessary for trouble free operation of the instrument In this chapter Chapter 10 Maintenance enla 5 Decontamination oedtetioa etra id e OE GOOD DIG OD aded editos 5 Input unit oria pnie eean UE epe eei ed 5 TOUCHSCREEN 2 anale il 6 Surfaces of the instrument ener eitis 6 Tubo Datis tte to nat ta tai 6 Recommended disinfectants iA 6 IDEM M M A 7 Checking fill level tit etit tenete tre tee eer n te tete ierra 7 Checking printer paper nnne peteret teer tpe pepe eeepc ce 7 Weekly eee eee eee dd 8
263. racellular fluid For that reason the level of sodium and water are always closely interrelated However in pathological operations there may be marked tissue hypo or hyperhydration with values in the standard range Conversely an increased respectively a decreased sodium concentration is found in serum due to a loss or gain of water when there is a normal level of sodium An increased sodium level in serum occurs when there is e a decreased supply of liquid e increased loss of water through the kidneys o central diabetes insipidus o renal diabetes insipidus o osmotic diuresis e g mannitin fusions through the intestine o infection deseases especially dysentery and cholera excessive supply of hypertonic saline solution infusion therapy dosed too high increase of aldosterone induced sodium reabsorption o primary hyperaldosteronism CONN syndrome o secondary hyperaldosteronism Reduced sodium level in serum occurs following e excessive supply of liquid without sufficient absorption of sodium e excessive water supply with normal level of sodium in the organism for example congestive heart failure e disturbance of sodium reabsorption caused by aldosterone deficiency o suprarenal gland insufficiency M ADDISON o adrenogenital syndrome with saline loss aldosterone insufficiency with high grade enzyme defect Standard values Adult 135 148 mmol L 134 144 mmol L 138 144 mmol L Newborn Ch
264. rameter CO mmHg Correlation Slope 0 961 1 041 Intercept t 0 865 Correlation coefficient 0 9994 Parameter 0 mmHg Material tonometerd aqueous solution Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 600 00 550 24 8 2594 9 7 300 00 278 07 3 7131 92 7 140 00 140 25 0 5353 100 2 60 00 60 29 0 2923 100 5 10 00 11 71 0 4329 117 1 Table A 35 Parameter O mmHg Correlation Slope 0 908 1 101 Intercept 6 609 Correlation coefficient 0 9995 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 75 4 Specifications cobas b 221 system Performance data Parameter glucose mmol L Parameter lactate mmol L Roche Diagnostics Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 0 80 0 80 0 0309 100 5 10 00 10 91 0 1274 109 1 20 00 20 21 0 3101 101 0 30 00 29 97 0 4377 99 9 40 00 38 12 0 8833 95 3 Table A 36 Parameter Glucose mmol L Correlation Slope 0 919 1 088 Intercept 1773 Correlation coefficient 0 998 Material aqueous solution NIST traceable Number of instruments 4 cobas b 221 systems Measurements per level and instrument 15 Expected value Mean Sur Recovery 0 50 0 45 0 0064 89 8 5 00 5 00 0 0420 99 9 10 00 10 11 0 0873 101 1 15 00 14 84 0 0920 98 9 20 00 19 07 0 2818 95 3
265. ration are suitable for glucose analysis for up to 24 hours Lactate Patient preparation Collection after physical rest at least 2 hours Even minor physical activities will lead to an increase in lactate concentration Samples should be analyzed immediately after collection since the sample metabolism causes an increase in the lactate concentration within a few minutes of sample collection If immediate analysis is not possible the blood sample must be centrifuged immediately in a cooled centrifuge and the excess serum or plasma must be separated by pipette Plasma and serum samples collected in this manner and stored under refrigeration are suitable for lactate analysis for up to 24 hours There are significant arteriovenous differences depending on forearm activity and oxygenation of the forearm muscle Immediately following the collection of the sample the protein in the sample must be removed using ice cold perchloric acid If glycolysis inhibitors are used heparin blood can be processed without removing the protein Such a sample is stable up to 2 hours after collection Otherwise the supernatant lactate concentration after centrifugation remains constant for 24 hours if stored under refrigeration Sample collection especially for bilirubin measurement cobas b 221 lt 2 gt system cobas b 221 lt 4 gt system cobas b 221 lt 6 gt system only Whole blood especially for the analysis of bilirubin must be treated as a light s
266. rd ex Take the target value for the tHb calibrator from the label of the tHb calibrator recommended by Q Roche Diagnostics 8 Theunitis standard g dL and can be changed if necessary 9 Cuvette replaced Press Yes after a cuvette was replaced otherwise press No 10 Sample type It is possible to select between tHb calibrator and Blood as calibration solution 11 The target value for blood must be a known setpoint 12 Attach the ampoule adapter see below A or the capillary see below B filled with tHb calibrator to the fill port follow the instructions on the screen 3 gt 4 A Ampoule adapter B Capillary Figure C 5 Ampoule adapter Capillary The COOX calibration is carried out After the measurement the result is displayed In ideal circumstances the tHb i value should be identical with the tHb m measurement Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 11 10 Maintenance cobas b 221 system Quarterly A Roche Diagnostics If the cuvette has been replaced no calibration value appears just the comment COOX calibration performed In event of error repeat the COOX calibration This function allows for the introduction of tightened limits in your own estimation In general values in the range of 20 of the setpoint can be accepted in accordance with the adjustability of the module If the calibration values are not acceptable press Reject Th
267. rdance with applicable regulations or repeat the measurement Call up the QC statistics in the QC database to aid in the analysis see Chapter 9 Software modes section QC measurements on page B 84 The analysis can be automated by activating additional multirules lt D see section Multirules on page B 53 If the result of the repeated measurement is greater than target value 2SD but less than target value 3SD the parameter is not locked but must not be used for further patient measurements A To eliminate the error replace the electrode and or contact customer support Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 35 7 Quality control cobas b 221 system Material setup Material setup Ej d Take the lot expiration date sample type and target values ranges as well as the corresponding Q barcodes from the text included in the recommended QC material The QC material must be defined prior to the QC measurement Q 7 Select the QC material according to the instrument version The barcode scanner facilitates easy entry of the required information Press the following buttons C Setup gt QC materials gt QC materials SS I INSECTO EN EN II Setup QC material e aa Mat change 14 10 System cal 1502 08 112000 1440 Figure B 18 To define a new QC material read in the material code with
268. rden MSS Unsuitable sample type is being used Kassette tauschen lt D see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 8071 IfS calculation error 1 UC calculation error 1 on interference Remove and reinsert S3 Fluid Pack 8072 2 sensor Possible causes An unapproved calculation operation occurred 8073 IfS sensor signal unstable Interference sensor signal cannot be If this interference applies to the complete reproduced module replace reference electrode Possible causes lt D see Chapter 10 Maintenance section Unsuitable sample type is being used Changing the reference electrode on e Measuring channel contaminated page C 29 Interference signals in the measuring Perform Calibration for Ready channel during measurement System gt Calibration acquisition gt Iferror cannot be corrected start Interference signals via reference M Stability monitor electrodes during measurement acquisition System gt Diagnostics gt Stability monitor and check Details of the Sensor slope Ifthe cassette is defective it is displayed and should be replaced lt D see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 8074 IfS ref point not OK Problem at reference point of standby Check Aspirate standby solution solution at interference sens
269. rds contact Technical Support 1023 Sample distr error 4 SS4 did not detect solution e Perform Wash Possible causes System gt Wash amp Cleaning Blockage Ifthe error persists perform General fluidics test to isolate the error System gt Diagnostics and afterwards contact Technical Support 1024 No sample detected 1 SS3 and SS2 did not detect a sample Insert sufficient sample amount repeat Possible causes measurement No more sample available for the Hb If the error persists contact Technical Support module 1025 No sample detected 2 ISE No constant conductivity of the Ensure sample entry is free of air bubbles sample was detected Repeat measurement Possible causes If the error persists contact Technical Support Fragmented sample in sample distributor 1026 No sample detected 3 ISE No constant conductivity of the Ensure sample entry is free of air bubbles sample was detected Repeat measurement Possible causes If the error persists contact Technical Support Fragmented sample in sample distributor Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 24 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 1027 No sample detected 4 No sample detected in Hb module tHb Check PP tube main pump and if necessary SO
270. rected replace S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 2036 Interference The sensitivity of the sensor is too low sensitivity Possible causes e Sensor worn out Replace MSS cassette see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 Ifthe error cannot be corrected replace S3 Fluid Pack lt D see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 2040 Cuvette not OK Check of layer thickness outside the expected range Possible causes e Cuvette is contaminated ncorrect target value Perform Poylchromator calibration System gt Calibration Perform COOX calibration System gt Calibration 2041 Ref point not OK Reference point is outside the expected range Possible causes Sample feeding clogged Perform Wash System Wash amp Cleaning Ifthe error persists perform General fluidics test to isolate the error System gt Diagnostics and afterwards contact Technical Support 2042 Wavelength not OK 1 One specific wavelength is outside the expected range Perform Poylchromator calibration System gt Calibration If the error persists contact Technical Support Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 32 In
271. ree with the target values see Chapter 7 Quality control Changing the reference electrode The reference electrode must be installed in the instrument no later than the imprinted Install before date see section Conventions used in this manual gt Other symbols on page 7 In order to ensure the quality of the measurement results complete a quality control test on 3 level low normal high after each electrode exchange ON LS a Figure C 27 Reference electrode 1 Remove the top cover and open the measuring chamber cover I NE In each case open only the relevant measuring chamber Q Keep the bottle compartment cover closed The following screen appears April 2009 C 29 Roche Diagnostics Instructions for Use Revision 10 0 10 Maintenance cobas b 221 system Unscheduled Roche Diagnostics oO a e QQ N Changing of ISE electrodes p x EE To change a sensor scan in the sensor barcode To finish this function please close the MC cover Eu oran serrana Z CI Operator ID e aa Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure C 28 Open the locking lever Remove the reference electrode Remove the white connector from the measuring chamber cartridge Insert the new reference electrode Attach the white connector at the end of the tube to the measuring chamber cartridge Insert the ref
272. ringe or capillary with whole blood for polarization The blood should have a volume of at least 150 uL contain heparin as an anticoagulant and be stored for less than 24 hours MSS polarization Interrupt 7 Please insert syringe or capillary filled with sample material min 150 pl e za Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure A 42 MSS polarization 2 The blood sample is inserted via fill port similar to a measurement see Chapter 6 Measurement 3 The MSS cassette is subsequently exposed to liquid polarized and heated 4 A system calibration is carried out 5 If after inserting the cassette the automatic polarization was not successful and the MSS sensors are not calibrated you must manually polarize the MSS cassette To do this press the following buttons C System gt Utilities gt MSS polarization 6 Follow the instructions on the screen Roche Diagnostics April 2009 A 46 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation 23 Checking the barometer value C System gt Component test gt Control sensors gt Baro sensor 1 Ifthe barometer value deviates by more than 4 mbar from the value indicated by a precision barometer it will be necessary for Technical support to calibrate the barometer A wrong barometer value leads to wrong PO measurement results Important From approx 3000 m
273. rm component of the hemolyzer General hardware test System Diagnostics If the error persists turn the instrument off and contact Technical Support 20080 PP error The pump performance of the MSS To correct the error check PP tube MSS output pump falls outside the specified output and if necessary replace Tange see Chapter 10 Maintenance section Exchanging the peristaltic pump tubes on page C 23 Perform MSS system calibration System gt Calibration 20081 MSS pol running The MSS polarization phase is not The sensor will be operational after the system finished yet calibration which is automatically performed 20082 MSS pol not ok The blood sample required for MSS To correct the error repeat the polarization could not be positioned MSS polarization follow the instructions on the screen System gt Utilities 20083 MSS pol not ok The MSS polarization was canceled To correct the error repeat the MSS polarization follow the instructions on the screen System Utilities 20084 HW test error MSS An error was recognized in a hardware To correct the error perform component of the MSS measuring General hardware test chamber System Diagnostics If the error persists turn the instrument off and contact Technical Support 20085 Pack S3 empty Insert a new S3 Fluid Pack lt D see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 20086 Flap S3 Docking mechanism for S3 Fluid Packis Close
274. rmal high must be performed after every exchange of solutions and packs April 2009 C 14 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Sample dependent maintenance procedures 8 Make sure that the results agree with the target values see Chapter 7 Quality control Q 2 To prevent spilling of the S1 rinse solution If your facility is 3000 m above sea level or higher deaerate the bottle before inserting to avoid splashing the S1 rinse solution 1 Place the bottle tool see below A on the screw cap of the S1 rinse solution see below B A Bottle tool B Bottle tool on the screw cap Figure C 8 Bottle tool 2 Press the grips together and press the transparent disk downward see below A 3 Rotate the transparent disk clockwise and stop when you notice a resistance after a short distance see below B A B Figure C 9 Deaerate bottle S1 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 15 10 Maintenance cobas b 221 system Sample dependent maintenance procedures Waste water Exchange the waste water container W Waste Container Roche Diagnostics 1 Openthe bottle compartment cover The bottle exchange image appears on the display eS C E m Gifs z gt a 4 Lt TE Lot number 21460909 21461502 21462001 Expiration date 25 2 2008 08 10 2007 12 11 200
275. roduced in any form or communicated to any third party without the prior written consent of Roche Diagnostics While every effort is made to ensure its correctness Roche Diagnostics assumes no responsibility for errors or omissions which may appear in this document Subject to change without notice April 2009 Instructions for Use Revision 10 0 1 cobas b 221 system Brands COBAS COBAS B LIFE NEEDS ANSWERS ROCHE OMNI AUTOQC ROCHE MICROSAMPLER COMBITROL and AUTO TROL are trademarks of Roche Contact addresses Manufacturer Roche Diagnostics GmbH ud D 68298 Mannheim Germany www roche com Edition Revision 10 0 April 2009 First edition May 2003 REF No 03261395001 Roche Diagnostics April 2009 2 Instructions for Use Revision 10 0 cobas b 221 system Table of contents Revision Histor Edition notice i Operation Part B Copyright Brands 6 Measurement Contact addresses Preanalytics B 5 Edition Interferences B 10 Table of contents Limitations of clinical analysis B 17 Preface Measuring procedure B 19 How to use this manual Where to find information 7 Quality control UU A El ad ua UU YU Y NN DN RR Re Conventions used in this manual Quality control general B 33 General QC concept B 33 Introduction and specifications Important information concerning the analysis of QC measurement results B 35 Material setup B 36 1 Safety information QC setup wizard B 44 Important inform
276. rror persists internal cleaning of the affected measurement chamber must be carried out exception MSS measurement chamber For this measurement chamber a wetting routing must then be called up 4 Repeat the QC measurement with same material level combination Ifthe error persists the affected electrode sensor must be replaced If all ISE parameters are affected simultaneously the reference electrode must be replaced If the problem cannot be solved successfully the Customer Service must be notified Roche Diagnostics April 2009 B 62 Instructions for Use Revision 10 0 cobas b 221 system 8 Calibration Contents Calibration In this chapter all automatic and user activated calibrations are described In this chapter Chapter Ej Calibration general Automatic calibrations System calibration 2P calibration 2P CA 51 1P calibration 1P cal incl O5 4 ettet 52 Recalibration without O seunenoccsciiriicsiiir iiitide n A 52 User activated calibrations oo ccecsscsscssssscsscsscsscsscseeseeseesecsecsessesessessecsessessessesaeeaeeases 52 Display of parameters during calibration sse 54 Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 63 8 Calibration cobas b 221 system Contents Roche Diagnostics April 2009 B 64 Instructions for Use Revision 10 0 cobas b 221 system 8 Calibration Calibration general Ca
277. rument see Capillary tubes on page B 7 in the section Sample containers 1 Insert the capillaries or the Roche MICROSAMPLER into the fill port If the position of the capillary is correct the T amp D disk will be backlit in green Figure B 4 2 Press the Aspirate sample button see Figure B 3 on page B 20 3 Detach the capillaries or the Roche MICROSAMPLER after the message Remove sample container appears 4 The measurement starts Aspirate from syringe This option is activated in the Setup mode A ImL syringes cannot be used for the software mode Aspirate from syringe 9 A minimum fill height of 15 mm is required see Chapter 4 Specifications section Sample volumes Table A 72 page A 87 Press the following buttons C Setup gt Instrument gt Switch gt Aspirate from syringe This option is now also displayed at the top level of the analyzer mode Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 21 6 Measurement cobas b 221 system Measuring procedure Roche Diagnostics poe ff Quick Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure B 5 ME EN 1 Pressing or turns the T amp D disk to the corresponding position 2 Securely attach the syringe to the fill port If the position of the syringe is correct the T amp D disk will be backlit in green i Figure B 6 3 Press the Aspirate sample bu
278. rument functions Calibration data amp instrurnent data read Calibration data amp instrument data edit Remote unlock Instrument amp interface settings read Ez Instrument amp interface settings edit v Security settings read E Security settings edit 8 Patient data amp measurement data read EJ Patient data amp measurement data edit 8 QC data read e QC data edit Ex 9 Delete all m 33 Sensor changing 15 11 2006 1P cal 14 55 08 11 2006 14 58 Figure B 15 POC mode In the POC mode there is no possibility for interrupting any actions started Persons registered as POC users are able to call up the functions offered on the Ready screen all the functions under Info and if available also the video sequences Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 29 6 Measurement cobas b 221 system Measuring procedure All parameters All parameters Figure B 16 Ready screen at POC mode Roche Diagnostics April 2009 B 30 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Contents Quality control For safety reasons quality control measurements must be carried out on a daily basis In this chapter all steps are described that are necessary for a successful QC measurement In
279. rument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support 10095 Timing error An asynchrony occurred between e Press Continue to correct the error 10097 processes and measuring Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected contact Technical Support Table D 1 System stops Roche Diagnostics April 2009 D 8 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting System stops No Message Cause Action 10098 Timing error COOX An asynchrony occurred between Press Continue to correct the error measurement processes and measuring Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected Print Mesurement reports Quick access gt Last measurement e Print Sensor report Info gt Miscellaneous reports and contact Technical Support 10099 Timing error 10112 An asynchrony occurred between processes and measuring Press Continue to correct the error Ifthe error persists turn the instrument off wait at least 3 minutes and turn it back on If this error cannot be corrected Print Mesurement reports Quick access gt Last measurement and contact Technical Support 10113 Comm error additional 10117 information A subprogram did not report back
280. s April 2009 A 86 Instructions for Use Revision 10 0 cobas b 221 system 4 Specifications Sample volumes ww Sample volumes The minimum sample volume requirement is dependent on Hct concentration in the sample Activated installed modules Typical sample volume Typical sample volume Max sample volume uL uL volume limitation by the sample sensor pL BG tHb SO or COOX 88 102 111 BG ISE tHb SO or COOX 112 128 148 BG ISE MSS tHb SO or COOX 172 186 210 Table A 71 a typical sample volume for Hct lt 45 Sample volumes b typical sample volume for 45 lt Hct lt 75 if a sample with high Hct is expected the sample volume for high Hct is recommended c The sample volume limitation is the maximum volume of sample which is aspirated from the container Q Sample types Roche Diagnostics The volume limitation by the sample sensor depends on INSTALLED modules regardless whether they are activated or deactivated The actual required sample volume depends on the used sample container Activated installed modules Sample container Minimum level BG ISE MSS tHb SO or COOX 1 mL syringe 300 uL 3 mL syringe 700 uL 5 mL syringe 1mL 200 uL capillary 186 uL Table A 72 Sample container Whole blood Serum Plasma Dialysis solutions containing acetate and bicarbonate Recommended QC material b only for e
281. sert a new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 30010 Rinse level is low S1 Rinse Solution will be empty in the next 12 to 24 hours If necessary insert a new S1 Rinse Solution see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 30011 Waste is nearly full The waste bottle will be full in the next 12 to 24 hours If necessary replace and or empty the bottle see Chapter 10 Maintenance section Waste water on page C 16 Table D 3 System warnings Roche Diagnostics April 2009 D 16 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting System warnings No Message Action 30012 Prep of rinse not ok Perform the following troubleshooting options step by step until the warning disappears 1 Press System gt Component test gt Aggregates gt Vacuum pump If a defect is detected contact Technical Support 2 Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate rinse 3 Insert a new S1 Rinse Solution If this does not remove the warning contact Technical Support 30013 Prep of CAL B not ok Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Aspirate CAL B 2 Insert a new S2 Fluid Pack see Chapte
282. sette inane e DO Ge OUR C UG C Beeren iere idees 17 System descrIDtIODT 5 oce NEEE ENEE ERE NE HE Re Re se Ee Ree Re RENE on 18 Visualadent fication saiun Eniri a E PRCeR PROCERES 18 SETE PAUL A RR a Printer uestes Measuring chamber tHb SO module 2 rete traitant ttt pen e ttr nite rne eere ri uada AUN deed deed eee een PUMP dias Input utt dat April 2009 Instructions for Use Revision 10 0 A 7 2 General descriptions cobas b 221 system Contents Roche Diagnostics Bottle compartment iaoiai ina r A adas 20 Reverse SIde aided e E Eae e to ees tu a a S 21 P wers pply sz AR AA A ES 21 Id lo AE O AE 22 Barcode scanner Warning and identification labels incl nameplate 24 April 2009 A 8 Instructions for Use Revision 10 0 cobas b 221 system 2 General descriptions Introduction Introduction Figure A 1 cobas b 221 system The cobas b 221 system is an analyzer with integrated AutoQC drawer option Depending on combination and configuration the following parameters can be measured in whole blood serum plasma acetate and bicarbonate containing dialysis solutions and QC materials e pH Blood gas BG PO PCO e Electrolyte ISE Na K CI Ca Hematocrit Hct Metabolite MSS Q z Urea BUN only cobas b 221 lt 6 gt system Total hemoglobin tHb e Oxygen saturation SO5 e Hemoglobin derivative C
283. shed ends or the plastic capillary tubes offered by Roche Diagnostics may be used in order to prevent damage to the instrument When using stirring rods like those offered by a few manufacturers remove these rods before inserting the sample in order to avoid clogging the sample path of the cobas b 221 system The Roche MICROSAMPLER was developed for the technical facilitation of taking samples of arterial blood The Roche MICROSAMPLER which consists of two capillary tubes 220 uL in a plastic container is ideally suited to a traumatic arterial blood collection Each laboratory should document the permissibility of sample containers that are used These products vary from manufacturer to manufacturer and sometimes from lot to lot The use of sample containers or clot inhibitors other than those manufactured by Roche Diagnostics may lead to adulteration of the samples and errors and differences in the measurement values Roche developed a specialized sample collection container for this purpose and recommends its use for this reason a isa trademark of Roche Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 7 6 Measurement cobas b 221 system Preanalytics Clot catcher A Sample handling Whole blood Glass capillary tubes Plastic capillary tubes A Roche Diagnostics To prevent a blockage of the sample path the use of a clot catcher is recommended for measuring criti
284. single SO value a Indicative for a decreased level of oxygen in blood b COHb c COHb MetHB SulfHb April 2009 Instructions for Use Revision 10 0 A 119 5 Theoretical foundations cobas b 221 system Clinical significance Hemoglobin derivatives and bilirubin e HHb 25 ma O2Hb a COHb Te MetHb EN EN Bilirubin scaled by 1 2 20 A 15 4 A 10 54 0 r T 450 550 i 600 650 700 I B A z L mmol cm B Wavelength nm Figure A 55 Absorption spectrum of the Hb derivatives and Bilirubin Roche Diagnostics Each hemoglobin molecule consists of four hemo groups each containing an iron atom This iron atom can either exist as two value reduced or three value oxidized iron In the two value state each iron atom of the deoxygenized hemoglobin HHb can be in the reversible molecular oxygen O5Hb or carbon monoxide COHb With methemoglobin MetHb three value iron can be in the hydroxyl ions cyanide and sulfur components On account of their capability to transport oxygen HHb and O Hb is termed functional hemoglobin Carboxyhemoglobin methemoglobin or sulfhemoglobin are nonfunctional hemoglobin types The amount of hemoglobin loaded with oxygen in the total hemoglobin is termed the oxyhemoglobin fraction FO Hb and is used to estimate the amount of oxygen in the tissue with tHb and PO to calculate the oxygen content The amount of h
285. stem Short Instruction Conventions used in this manual Visual cues are used to help locate and interpret information in this manual quickly This section explains formatting conventions used in this manual Symbols Helping to locate and interpret information in this manual the following symbols are used Symbol Used for Procedural step List item c Cross reference e Call up of screen slo Q Note Roche Diagnostics April 2009 Instructions for Use Revision 10 0 5 cobas b 221 system Symbol Used for Caution A All sections passages that are marked with this symbol describe procedures and or indicate conditions or dangers that could damage or lead to a malfunction in the cobas b 221 system and which therefore should never be attempted and contain information that must be observed to avoid potential injuries to patients users and third parties Risk of infection A All sections and parts of texts that are marked with this symbol describe procedures that may involve risk of infection IVD symbols The symbols are used in accordance with DIN EN 980 and DIN EN ISO 780 Symbol Description C Conformit Europ enne This product complies with the requirements in the guideline for In Vitro Diagnostic 98 79 EC Lot designation Use by The product should not be used after expiry of the specified date If a day is not indicated apply the last day of the respective month Temper
286. structions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 2043 Hemolysis not OK 1 Hemolyzer is not ready Perform Hemolyzer test System gt Component test gt Aggregates gt Hemolyzer 2044 Hemolysis not OK 2 Hemolyzer power is outside the expected Visually check the drying operation range 2070 Sensor signal unstable tHb sensor signal is disturbed Perform Internal cleaning Possible causes System gt Wash amp Cleaning gt Cleaning Irregular sample module gt tHb SO module gt Start internal Sample feeding is leaking or clogged cleaning Ifthe error persists perform General fluidics test to isolate the error System gt Diagnostics e Replace S1 Rinse Solution lt D see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If the error persists contact Technical Support 2071 Measuring path dirty The absolute limits of water calibration Perform Internal cleaning are outside the specified range System gt Wash amp Cleaning gt Possible causes Cleaning module select appropriate e Contaminated or defective sensor module gt Start internal cleaning repeat as necessary e Replace S1 Rinse Solution see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If the error persists contact Technical Support 3000 D2 D3 not performed MSS s
287. t Control sensors gt Contact paths Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 D 34 Instructions for Use Revision 10 0 cobas b 221 system 11 Troubleshooting Status messages of measuring and calibration values No Message Cause Action 3022 Conductivity not OK Conductivity calibration was not exited correctly Print out Sensor report and check the error messages for conductivity with calibration solution CAL B or A Info gt Miscellaneous reports 3033 0P not OK Oy zero calibration was not exited Perform Aspirate O zero point solution correctly System gt Utilities gt Fluid actions gt Fill Possible causes routines e Aspireate O zero not ok Check fill port and the T amp D disc for soiling Soiling or leak see Chapter 10 Maintenance e Replace S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 4003 Calibration pending 1 Sensor reinserted no calibration values Perform Calibration for Ready available System gt Calibration 4008 Calibration pending 2 Calibration is pending or was canceled Perform Calibration for Ready System gt Calibration 4024 Calibration pending 3 Sensor is or was deactivated Perform Calibration for Ready System gt Calibration 5006 Calculation error 1 UC calculation error Remove bottles packs and reinsert them
288. t in the direction of the arrow and remove the MSS cassette A Glu Lac Urea C Locking lever B Glu or Glu Lac D Contact clip Figure C 32 MSS measuring chamber Insert the new MSS cassette and close the locking lever and the contact clip Read in the barcode from the packaging of the MSS cassette Close the measuring chamber and top cover on Oo QC Follow the instructions on the screen The prepared blood sample is inserted into the fill port similar to a measurement see Chapter 6 Measurement 9 The MSS cassette is subsequently exposed to liquid polarized heated and calibrated 10 If the automatic polarization was not successful and the MSS parameters are not calibrated a manual polarization must be performed 11 Activate the following function starting with the top level of the analyzer mode Roche Diagnostics April 2009 Instructions for Use Revision 10 0 C 33 10 Maintenance cobas b 221 system Unscheduled C System gt Utilities gt MSS polarization MSS polarization Interrupt Please insert syringe or capillary filled with sample material min 150 pl Figure C 33 12 Follow the instructions on the screen 13 A new QC measurement must be performed with all three level low normal high after every exchange of the MSS cassette Make sure that the results agree with the target values see Chapter 7 Quality control Cleaning the measuring chambers 1 Remove the top co
289. t trending map B 27 Performance data A 59 Correlation to other methods A 82 Linearity A 70 Measurement parameters A 59 Reproducibility A 60 pH Interferences B 11 Pleural fluid B 9 pH measurements B 18 POC mode Point of care mode B 29 Power cord A 31 Power supply A 21 A 31 Preanalytics B 5 Printer A 19 Checking printer paper C 7 Insert printer paper A 37 Remove the printer paper A 51 Replacing printer paper C 25 Specifications A 92 Product data A 91 Acoustic Noise Level A 91 Classification A 91 Dimensions A 91 Electrical data A 91 Holding points A 92 Weight A 91 Pumps A 20 Q QC consequences B 55 QC for Ready with AutoQC module B 57 QC for Ready without AutoQC module B 59 QC lock B 56 Automatic correction B 56 Exchange correction B 56 Manual correction B 56 QC measurement B 51 B 80 Roche Diagnostics AutoQC measurement B 52 Manual QC measurement B 51 QC status B 88 QC timing B 41 QC troubleshooting B 61 Classification of QC problems B 61 Description of the current problem B 61 Troubleshooting Group A aspirating or positioning problem B 61 Troubleshooting Group B QC result exceeds the target value range B 62 QC warning B 56 Quality control E 5 General B 33 General QC concept B 33 Important information concerning
290. table control material e g COMBITROL TS AUTO TROL TS The Multirule procedures produce the best results when 3 QC measurements with randomly selected level are completed per series time between two 2 point calibrations A minimum of 2 QC measurements series or 6 QC measurements 3 series is required The QC concept expects Multirules rule 1 and 2 to be activated Press the following buttons to check the settings C Setup gt Parameters gt Miscellaneous settings gt Multirules ELMO PCO Check rule 4 Check rule 6 Mat change 14 10 system cal 15 02 08 11 2006 1440 Figure B 39 Select additional desired rules in the right part of the window and assign it to the cor responding parameter which is listed in the left part of the window under Parameter The activation of range 2SD automatically deactivates all other rules rules 1 6 a James O Westgard et al A Multi Rule Shewhart Chart for Quality Control in Clinical Chemistry Clinical Chemistry Vol 27 No 3 1981 b Elsa F Quam BS Lorene K Haessig BS Marlene J Koch BS A Comprehensive Statistical Quality Control Program for Blood Gas Analyzers Journal of Medical Technology 2 1 January 1985 April 2009 Instructions for Use Revision 10 0 B 53 7 Quality control cobas b 221 system Multirules Overview of the Multirules a time between two 2 point calibrations number of individual measur
291. tal hemoglobin concentration eese tnter 118 Oxygen saturation ak 119 Hemoglobin derivatives and bilirubin esee 120 Oxyhemoglobin OF fttt udine dean 121 Des xyhemoselobin HD arenai ve ertet tte tede OO 121 Carboxyhemoglobin GOD etd ettet tton 121 Methemoglobin MetHb eese eene eenennnnenenene 122 Total bilirubin neonatal conconccncnoccoccononnnononncononncononncnncononn con oonconcoroncnnonnos 123 Gl cose AA NN 124 Lactate eR hihi rrr ee er eer UPON PER aer APER esneevetynessnebunevuvetaceversreeaess 125 Urea BUN 5 23 TN 126 April 2009 A 96 Instructions for Use Revision 10 0 cobas b 221 system 5 Theoretical foundations Parameters and calculations Conversion table for units Parameters and calculations The cobas b 221 system provides an array of useful parameters which are calculated from the measurement values of each sample Refer to the following table for an explanation of the symbols used in the equations Unless otherwise noted all measured values used in the equations are no longer valid at 37 C ctO avDO ctCO Ca tHb Glucose Lactate BUN Urea Urea BUN Bilirubin Osmolality MCHC Air pressure PCO PO 1 vol96 mmol L 1 g dL mmol L mmol L mmol L mmol L mmol L Urea 1 mg dL 1 mOsm kg 1 g Hb dL Ery 1 mmHg 1 mmHg 1 mL dL 4 008 mg dL 10 g L 18 02
292. tandby solution was not aspirated Check Aspirate standby solution Possible causes System gt Utilities gt Fluid actions gt e Faulty aspiration of standby solution Fill routines e Faulty aspiration of reference solution Check aspiration of reference solution System gt Utilities gt Fluid actions gt Fill routines Perform Calibration for Ready System gt Calibration 3001 FMS volume error Time out error during aspiration of e Check Aspirate CAL B calibration solution System gt Utilities gt Fluid actions gt Fill Possible causes routines Blockage or leak Perform General fluidics test System gt Diagnostics Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 33 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 3002 Temperature error The module temperature is outside the Check the temperature signals permitted range If the temperature is outside the specified range Possible causes for a long period of time inform Poor heating contact Technical Support e Fan failure Heating failure e Air filter heavily soiled or covered 3003 FMS error Incorrect deviation from specified value To isolate error check Aspirate CAL B and measurement value of FMS System gt Utilities gt Fluid actions gt Possible causes Fill routines
293. tant information concerning the analysis of QC measurement results on page B 35 April 2009 B 34 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Important information concerning the analysis of QC measurement results Important information concerning the analysis of QC measurement results Ensure that Multirules rule 1 and 2 are activated and the QC consequence QC lock was assigned to the parameters see section Multirules on page B 53 G see section QC consequences on page B 55 The evaluation depends upon which SD areas are featured in the QC measurement results Measured value is within the target value range 2SD The parameter is acceptable The QC measurement results are within 25D from the target value and the parameter is remains activated for measurements Measured value is outside the target value range 3 SD Consequence A QC lock is assigned to the parameter The QC measurement result is not acceptable The parameter is locked for additional measurements and may only be released for further patient measurements after the cause of the lockout has been determined and the error has been corrected see section Remove the QC lock on page B 56 Measured value is larger than target value 2SD but smaller than target value 3 SD Consequence A QC warning is assigned to the parameter The user must now analyze the QC measurement results in acco
294. ter screen the instrument The Screen sharing sharing was finished indicator will be displayed in the status line Table D 5 System warnings Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 19 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values Status messages of measuring and calibration values These messages define causes that affect the measurement values and or calibration values of the analyzer No Message Cause Action 1000 Sample pos error 1 The conductivity is not constant If discoloration can be detected by sample Possible causes material in the internal electrolyte of the electrode it must be replaced Blockage or leak P e Separation of electrode membrane lt D see Chapter 10 Maintenance section Leaking electrodes Replacement of the electrodes on page C 27 Ifthe error persists perform General fluidics test to isolate the error System gt Diagnostics and afterwards contact Technical Support 1001 Sample pos error 2 The conductivity is too low Ifthe error persists replace S2 Fluid Pack Possible causes lt D see Chapter 10 Maintenance section Blockage Exchange of solutions and packs on e No fluid in measuring chamber page C 13 Perform General fluidics test to isolate the error System Diagnostics and afterwards contact Technical Support 1002 Sample sep error 1 No air packet was detected betw
295. the measuring chamber cover Close the top cover Prepare a syringe or capillary with whole blood for polarization Having completed the installation process the unit requests a blood sample The blood should have a volume of at least 150 uL contain heparin as an anticoagulant and be stored for less than 24 hours April 2009 Instructions for Use Revision 10 0 A 43 3 Installation and shutdown cobas b 221 system Installation 20 Open bottle compartment cover and insert Waste container amp packs A Ruber sealings B cobas b 221 lt 5 gt system and cobas b 221 6 system only Figure A 37 Waste container amp packs 1 Open the bottle compartment cover 2 Open the corresponding docking mechanism 3 Insert an empty waste water bottle and a S1 Rinse Solution bottle A Remove packs rubber sealings 4 Push the two packs into the appropriate location in accordance with the labeling on the docking mechanisms until the packs lock Using the transponder attached to the bottle packs the instrument automatically recognizes the corresponding bottle or packs E A Lot number 21460909 21461502 21462001 Expiration date 25 2 2008 08 10 2007 12 112007 Start date 08 11 2006 08 11 2006 08 11 2005 08 11 2006 Time to change 18 11 2005 20 12 2006 20 12 2006 20 12 2006 Fill level 798 945 87 0 865 A cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system onl
296. ther the ranges have already been assigned If this information is missing the range is scanned the corresponding module is marked and the Continue button appears L rs Changes to existing ranges cannot be made using the QC setup wizard Checking for AutoQC compatibility After all ranges are set the QC material is checked for AutoQC compatibility AutoQC compatible materials e AUTO TROL TS e AUTO TROL PLUS B The following QC materials do not meet these requirements e COMBITROL TS COMBITROL TS COMBITROL PLUS e COMBITROL PLUS B Roche Diagnostics April 2009 B 46 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Assigning the mats Roche Diagnostics QC setup wizard Figure B 31 If the QC material is not AutoQC compatible it will still be installed successfully In this case press the Exit QC wizard button to exit the setup wizard You can scan more QC materials e See Figure B 30 on page B 46 For AutoQC compatible materials the process continues and checks whether an AutoQC module is installed The scanned QC material now has to be assigned a position in the AutoQC module Assign material Insert mat Close AQC drawer A AUTO TROL PLUS B Level 2 21460803 31 03 2008 20 Ampoules Set Set Set Set Set Set Figure B 32 All previously assigned mats are displayed If no position is available you first have to delete
297. trode range System gt Utilities gt Fluid actions gt Fill Possible causes routines Reference system not filled Check seat of the electrode Leaky empty electrode Perform General fluidics test System Diagnostics Ifthe error persists replace electrode MSS cassette lt D see Chapter 10 Maintenance section Replacement of the electrodes on page C 27 Table D 6 Status messages of measuring and calibration values Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 31 11 Troubleshooting cobas b 221 system Status messages of measuring and calibration values No Message Cause Action 2031 Conditioning not OK Na electrode was not conditioned Possible causes e S2 Fluid Pack docking mechanism is leaking T amp D leaking during aspiration of conditioning solution e Perform Aspirate Na cond solution System gt Utilities gt Fluid actions gt Fill routines Perform Conditioning System gt Utilities gt Fluid actions Insert a new S2 Fluid Pack Ifthe error persists perform General fluidics test System Diagnostics and correct the leak 2035 Linearity not OK The sensitivity of the sensor is too low Possible causes e Sensor worn out Replace the MSS cassette lt D see Chapter 10 Maintenance section Changing the MSS cassette cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only on page C 32 Ifthe error cannot be cor
298. ts to define the number 0 3 of QC measurements to be repeated Change or modify start time material and measurement repeats Press Use another material to define the material used for a possible measurement repeat Delete the marked entry from the list The start time s will be copied to a cache see Paste daily profile Select another day of the week and press Paste daily profile the cached entry will be entered for the new day of the week Change lot applies only to AutoQC measurements By means of this function a follow up material of a new lot can be assigned to a current Material Level Combination main material The defined starting times for the AutoQC measurement s are thus taken over immediately after the current material has been used up for the follow up material of a new lot This means there is no interruption of the AutoQC measurements First define the new material follow up material assign the material and insert the mats Material setting Material assignment Follow up material Roche Diagnostics The follow up material has the same material name and QC level but a different batch number Press the following buttons Setup gt QC Material gt QC Material 1 Read in the material code from the package insert using the barcode scanner or press the New button and manually enter the information Press the Ranges button Read in the other barcodes for the target values Select the
299. tton 4 The sample is aspirated from the syringe 5 Detach the syringe after the message Remove sample container appears 6 The measurement starts April 2009 B 22 Instructions for Use Revision 10 0 cobas b 221 system 6 Measurement Measuring procedure Use as default setup It is possible to set either the Capillary mode or Aspirate from syringe as standard measurement method Press the following buttons C Setup gt Instrument gt Switches 1 Press Activate aspirate from syringe 2 Activate Use as default setup SS Cl INTI Auto patient ID Figure B 7 3 Activate Capillary mode aspirate with capillary or inject sample or Activate aspirate from syringe as the standard setting Depending on which mode has been selected as the standard setting the T amp D disk turns to the position intended for it at the end of a measurement The following setting combinations are possible Capillary mode Switch between Activate aspirate from syringe and Capillary mode Standard setting Activate aspirate from syringe For the next measurement Capillary mode can be switched to Standard setting Capillary mode For the next measurement Activate aspirate from syringe can be switched to Roche Diagnostics April 2009 Instructions for Use Revision 10 0 B 23 6 Measurement cobas b 221 system Measuring procedure Data input gt Mandatory input
300. up gt Display amp reports gt QC measurement gt QC database overview Use the buttons Page up down or Up down to select an entry and press the Details button All available information about the selected entry are displayed April 2009 B 84 Instructions for Use Revision 10 0 cobas b 221 system 9 Software modes Data manager Instrument NENCCTIIENNN EJ 2 520 2 AQC c cover error System stop on 23 5 2002 08 36 AQC cover error System stop off 23 5 2002 08 36 AQC cover error System stop on 235 2002 08 35 Warmup System stop off 23 5 2002 08 30 Warmup System stop on 235 2002 08 30 MC cover BG System stop off 23 5 2002 08 30 MC cover BG System stop on Figure B 59 Stored instrument data are listed depending on the definition of the display Setup gt Display reports gt Instrument database gt Instrument database overview Use the buttons Page up down or Up down to select an entry and press the Details button All information about the selected entry are displayed Utilities Backup Restore Use this function to perform a data backup Database Measurements 104 Calibrations 2076 QC meas 34 Log data 22605 User entries 0 14 4 2002 15 4 2002 00 00 Incr 0 16 4 2002 00 00 Incr 20 0 K o 17 4 2002 00 00 Incr 30 0K 1 18 4 2002 00 00 Incr 20 0K 0 23
301. urfaces of the instrument C 6 Touch Screen C 6 Tubing paths C 6 Disposal of Bottles A 14 Electrodes A 14 Instrument A 14 Packs A 14 Waste water A 14 E Edition 2 Edition notice 1 Electrodes Handling electrodes A 15 Environmental parameters A 89 Temperature humidity stability A 89 Equations A 98 Exchange of solutions and packs C 13 S1 rinse solution S2 fluid pack S3 fluid pack C 14 Waste water C 16 Exchange the waste water container W Waste Container C 16 Exchanging the fill port C 22 Exchanging the peristaltic pump tubes C 23 F Filllevels B 87 Checking fill levels C 7 G General notes A 11 General QC concept B 33 Glossary E 9 Roche Diagnostics H Handling electrodes A 15 Handling samples A 14 Handling solutions A 15 Help B 87 Hemoglobin derivatives and bilirubin B 18 How to Use This Manual 5 Important information A 5 Info B 87 AQC status B 90 Filllevels B 87 Help B 87 List of all activities B 89 List of all warnings B 90 Miscellaneous reports B 91 Parameter report B 91 Protected information B 92 Sensor report B 92 Status report B 92 QC status B 88 Versions B 91 Video sequences B 88 Input unit A 20 Installation A 27 A 30 A 32 Attach power cord and barcode scanner A 31 Cal intervals amp timing A 33 Checking the baromet
302. utes and turn it back on If the error persists contact Technical Support 10008 No waste container Waste container is missing Insert container If the error persists contact Technical Support 10009 Actuator bus current An error was recognized in a hardware Perform General hardware test to correct the overload component error System Diagnostics If the error persists turn the instrument off and contact Technical Support 10010 Valve bus current overload An error was recognized in a hardware Perform General hardware test to correct the component error System Diagnostics If the error persists turn the instrument off and contact Technical Support 10012 uC memory overrun A microcontroller memory overflow was Turn the instrument off wait at least 3 detected minutes and turn it back on If the error persists contact Technical Support 10016 Bottle compartment cover Close the bottle compartment cover open If the error persists contact Technical Support 10017 Bypass wash error 1 Sample sensor SS2 detects not enough air Perform Wash again during wash process System Wash amp Cleaning If the error persists contact Technical Support wash water jet is plugged 10018 SD wash error 1 Sample sensor SS2 detects not enough air Perform Wash again during wash process System Wash amp Cleaning If the error persists contact Technical Support wash water jet is plugged 10019 Waste container full Insert empty w
303. ver and open the measuring chamber cover 2 Remove all electrodes see Replacement of the electrodes on page C 27 3 Clean the measuring chamber with a cloth moistened with disinfectant e g disinfectant containing 7096 alcohol 4 Reinsert the electrodes 5 Close the measuring chamber cover and top cover DA Do not scan a barcode Instead perform the following calibrations Q BG ISE calibrating the mixing system 2P calibration MSS system calibration see Chapter 8 Calibration section User activated calibrations on page B 66 Roche Diagnostics April 2009 C 34 Instructions for Use Revision 10 0 cobas b 221 system 10 Maintenance Unscheduled Surfaces Do not attempt to decontaminate any part of the instrument before shutting it down and unplugging it from the power source Before plugging the instrument back in and turning it on always wait 15 minutes to allow the disinfectant to evaporate Danger of fire and explosion For safety reasons only authorized customer service personnel may decontaminate the power pack Regularly decontaminate all outer surfaces of the instrument including all covers e g printer cover bottle compartment cover top cover T amp D cover with the disinfectant according to the lab specific regulations Very dirty surfaces should first be cleaned with a swab or paper towel that has been soaked in distilled water All removable covers e g instrument cover can be
304. ver and open the measuring chamber cover of the corresponding measurement module apply force to push the right edge of the MC cover to the left with a finger and open up the MC cover Yat In each case open only the relevant measuring chamber Q Keep the bottle compartment cover closed The following screen appears Changing of ISE electrodes EH EN To change a sensor scan in the sensor barcode To finish this function please close the MC cover BEHEBH Operator ID e aa Mat change 14 10 System cal 15 02 08 11 2006 1440 Figure C 24 Roche Diagnostics April 2009 C 27 Instructions for Use Revision 10 0 10 Maintenance cobas b 221 system Unscheduled 2 Open the locking lever 3 Take the appropriate electrode move it to the left and remove it Dispose the electrode s according to local regulations hazardous waste gt 4 Ifnecessary clean the measuring chamber with a cloth moistened with disinfectant e g disinfectant containing 70 alcohol ps If a new electrode is not available insert a dummy electrode instead SCon and the reference electrode may not be replaced with a dummy electrode Ifan electrode is replaced by a dummy electrode it must be immediately deactivated permanently for measurements and calibrations under Setup gt Parameters gt Miscellaneous settings To do so deactivate the switch Activated for ca
305. w A or the filled capillary see below B into the fill port A Ampoule with adapter B Capillary Figure B 38 Manual QC measurement 7 Press the Aspirate sample button 8 Detach the ampoule adapter or the capillaries after the message Remove sample container appears 9 The measurement starts 10 If the user does not reject the results they are printed and automatically saved in the QC database For details about the Database see Chapter 9 Software modes section Data manager on page B 81 and or Reference manual chapter Softwaremodi AutoQC measurement The AutoQC measurement can be performed in programmed or manual mode Setup gt Times amp intervals gt QC timing For this purpose press QC measurement in the analyzer mode and activate the corresponding AutoQC material e g AUTO TROL TS and the selected level e g Level 1 Start the AutoQC measurement by pressing Start AutoQC Roche Diagnostics April 2009 B 52 Instructions for Use Revision 10 0 cobas b 221 system 7 Quality control Multirules Roche Diagnostics Multirules The evaluation of QC results is based on the Westgard rules and their interpretation for blood gas analysis The Multirule process was derived from these rules It permits early detection of random and systematic errors associated with the measuring device and its operation The Multirules procedure can only be applied in connection with a sui
306. y Figure A 38 Changing of bottles and packs Roche Diagnostics April 2009 A 44 Instructions for Use Revision 10 0 cobas b 221 system 3 Installation and shutdown Installation A A cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only Figure A 39 Bottle compartment 5 Close the docking mechanism and the bottle compartment cover By a To avoid splashing the S1 Rinse Solution deaerate the bottle at about 3000 m above sea level or Q higher before inserting it 6 Place the bottle tool on the screw cap of the S1 Rinse Solution see below A Bottle tool B Screw cap with placed bottle tool Figure A 40 Screw cap 7 Press the grips together and press the transparent disk downward see below A 8 Rotate the transparent disk clockwise and stop when you notice a resistance after a short distance see below B A B Figure A 41 Open bottle Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 45 3 Installation and shutdown cobas b 221 system Installation 21 Complete installation 1 Press the Complete installation button Automatic sequences take place and the unit warms up 2 Installation is complete If a power failure occurs during installation the installation starts anew with the next restart Actions which were performed successfully are discarded 22 Perform MSS polarization cobas b 221 lt 5 gt system and cobas b 221 lt 6 gt system only 1 Prepare a sy
307. y control program includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results April 2009 Instructions for Use Revision 10 0 B 33 7 Quality control cobas b 221 system General QC concept Colour code of the ampoules Roche Diagnostics The following control material is recommended For BG ISE Glu Lac Hct tHb SO cobas b 221 lt 1 gt system cobas b 221 lt 3 gt system cobas b 221 lt 5 gt system e COMBITROL TS AUTO TROL TS AutoQC material For BG ISE Glu Lac Urea BUN COOX bilirubin cobas b 221 lt 2 gt system cobas b 221 lt 4 gt system cobas b 221 lt 6 gt system e COMBITROL PLUS B AUTO TROL PLUS B AutoQC material Level 1 red marking line Level 2 yellow marking line e Level 3 blue marking line The target areas listed in the package text should be taken as 2 SD areas SD standard deviation e g for PO 25D 12 mmHg 1SD 6 mmHg The QC measurement results within the target value range 2SD are acceptable If QC measurement results fall outside the target value range 3SD the parameter must be locked see section Important information concerning the analysis of QC measurement results on page B 35 QC measurement results that are greater than the target value 2SD but less than the target value 3SD cause QC warning and must be treated accordingly see sectionImpor
308. y during insertion of the electrode into the measuring chamber and immediate readiness for measuring the first 2 point calibration If more than 5 minutes elapse after opening the ALU PE packaging the level of gas conditioning could be lost and the time required for the first time calibration could be increased For Storage specifications see Chapter 4 Specifications Roche Diagnostics April 2009 Instructions for Use Revision 10 0 A 15 2 General descriptions cobas b 221 system General notes on the use of the MSS cassette General notes on the use of the MSS cassette For instrument versions with MSS module only Attention MSS cassette may only be brought into contact with liquids in the cobas b 221 system while electrodes are changed Replace the MSS cassette within 28 days of installation V After initial contact with liquids the MSS cassette may no longer be removed from the instrument Q It may lead to the destruction of the enzyme sensors Storage At 2 8 C maximum of 2 weeks at room temperature MSS cassette removed from the measuring chamber Once an MSS cassette is exposed to liquid it must not be allowed to dry out under any circumstances since this would destroy the enzymes The enzymes are equipped with a special protectant prior to shipping for transportation purposes This protectant is washed out inside the instrument during the warm up phase and MSS polarization Incompati
309. ystem gt Utilities gt Fluid actions gt Fill routines and start Aspirate cleaning solution 2 Insert a new S2 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30020 Prep of standby not ok Perform the following troubleshooting options step by step until the warning disappears 1 Press System gt Utilities gt Fluid actions gt Fill routines and startAspirate standby solution 2 Check MSS sensor for correct fit 3 Insert a new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support Table D 4 System warnings Roche Diagnostics April 2009 Instructions for Use Revision 10 0 D 17 11 Troubleshooting cobas b 221 system System warnings No Message Action 30021 Prep of Ref MSS not ok only if Urea is installed Perform the following troubleshooting options step by step until the warning disappears l Press System gt Utilities gt Fluid actions gt Fill routines and start Fill ref electrode MSS 2 Insert a new S3 Fluid Pack see Chapter 10 Maintenance section Exchange of solutions and packs on page C 13 If this does not remove the warning contact Technical Support 30022 Prep of CAL 1 not ok Perform the following troubleshooting options step by step until the warning

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