Bayer HealthCare Rapidlab 800 manuale d’uso

     2000 Bayer Corporation. All rights reserved. 115701 Rev C., 4/2000[...]

No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Bayer Corporation. The Rapidlab 800 system is for In V itro Diagnostics Use. Certain and Ready Sensors are trademarks of Bayer Corporation. APV is a servicemark of Bayer Corporation. Cidex is a trademark of Johnson[...]

                     ?[...]

                  ?[...]

                 [...]

                    [...]

                ?[...]

                 [...]

                   ?[...]

                      ?[...]

              [...]

               ?[...]

                       [...]

    [...]

           This manual is to be used with the Bayer Diagnostics 840, 844, 845, 850, 854, 855, 860, 864, and 865 systems. The manual provides the information and procedures necessary to operate and [...]

          Use this section to identify the sections in this manual that describe the 800 system and the tasks associated with operating and maintaining the system.  ?[...]

                obtain service and technical information and order supplies Appendix B, Service and Supplies      Appendix C,[...]

          The Operator ’ s Manual uses the following text and symbol conventions throughout the document.   Bold B[...]

       This section describes the symbols that may appear on the exterior of the system. The symbols provide you with the location of certain components and with warnings for proper operation.  [...]

    [...]

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                     ?[...]

                 [...]

                  ?[...]

     [...]

       The Rapidlab 800 Operator ’ s Manual accompanies the 800 series systems— base models 840, 850, 860—and base models with the oximetry module— models 844, 854, 864— and base models with the CO-ox module— models 845, 855, 865.[...]

      The 850 and 860 systems report the following parameters:  calcium ion concentration adjusted to pH 7.4 [Ca ++ (7.4)]  anion gap (AnGap) In addition, the 844, 845, 854, 855, 864, and 865 systems report the following parameters:  hematocrit  he[...]

      The 800 system offers advanced features for analyzing samples, managing patient results and QC data, and customizing the system. These features are designed to enhance operator safety , to enhance ease of use, to enhance reliability , and to red[...]

         maintenance and troubleshooting low maintenance Ready  Sensors reduced number of system parts and system complexity waste system designed for biosafety automatic, reagent-path cleaning cycle expanding system capa[...]

         The following series of illustrations show the exterior controls and components of the 800 system. The 860, 864, and 865 systems have five reagent bottles, and the 840, 844, 845, 850, 854, and 855 sys[...]

               Reagent Pump Sample Entry Reagent Bottles Keypad Screen Measurement Module Door Latch Sample Pump Waste Pump Measure[...]

               CO-ox Pump CO-ox Module Sample Chamber Hemolyzer[...]

          Power Input Fuse Compartment Diskette Eject Button Diskette Drive Air Filter Cover[...]

            Contrast Knob Lamp Cover Keyboard Port Parallel Port Paper Spool Bar Code Scanner Port Serial Port 3 Serial Port 1 Serial Port 2 Network Port Air Filter Co[...]

              F2 F1 F3 F4 F5 ? – . 123 456 7890 Enter Home Help CIBA - CORNING Contrast Knob Arrow Keys F-keys Help Key Home Key Enter Key Numeric Keys Screen Paper Spool Key Paper[...]

       The 800 system components consist of the following functional groups:  base model measurement module  CO-ox model measurement module  fluidic components  electronic components ?[...]

           Spacer pH Sensor Reference Sensor Release Tab Measurement Module Tubing Measurement Block Preheater pCO 2 Sensor Sample [...]

          Lactate Sensor pH Sensor Reference Sensor Spring-Loaded Latch Measurement Module Tubing Preheater pO 2 Sensor pCO 2 Sensor Sample Ground[...]

        The hemoglobin content is measured in the sample chamber , which is located between the fiber optics and the polychromator . After passing through the hemolyzer , the sample moves to the sample chamber where it[...]

       The reagent delivery components include the reagents, the gases, and the solenoid valves that direct the movement of reagents, ambient air , and gases through the system. The opening and closing of the 1 1 solenoid valve[...]

        The five fluid detectors in the base model sense the presence, type, and continuity of fluids in the system. Fluid detectors 1, 1A, and 2 are associated with the measurement block. These detectors ensure tha[...]

      The hemolyzer uses ultrasonic sound vibrations to rupture red blood cell membranes and release hemoglobin molecules. These vibrations also rupture other cells in the sample, reducing the light scattering from whole cells that can interfere[...]

        Preamplifier (Preamp) Amplifies the signal from each sensor and sends those signals to the premux PC board for selection Premultiplexer (Premux) Selects the channel to be read and provides [...]

       The user interface, shown in Figure 1-10, consists of components that you use to direct system activities and obtain operating status information.    ?[...]

        Y ou use the system keys to direct system activities and to move through the software. The 800 system has the following keys:    Analyze Analyze starts analysi[...]

        paper spool winds the paper on the paper spool F-keys F1 accesses the function that appears in the F-key labels on the screen above each key; the labels can vary with each screen  [...]

       Y ou use F-keys to access functions that appear on the screen above each key . The F-key labels can vary with each screen. The following keys are some of the more commonly used F-keys.         [...]

       Screen elements are the components on the screen that enable you to interact with the system software.          [...]

      Sensor icons appear in the status area of the screen. Each sensor is represented by a box containing the sensor label. The CO-ox module is represented by the tHb icon in the sensor bar . The sensor icons indicate the current status of each sensor inst[...]

         The Menu mode lets you perform infrequently required functions. Y ou access the Menu mode by pressing Menu. The system displays the Menu screen with the first option in the Main Menu highlighted. Use the arrow keys [...]

                         ?[...]

        Use menu codes to quickly select menu options from the Main Menu on the Menu screen. T o use menu codes, you press the numeric key for the menu option instead of using arrow keys and pressing Enter . NOTE: For menu codes t[...]

        Use the Help program to get information about your 800 system. Y ou can access Help when the system is inactive or when the system is performing an operation, such as an analysis, a wash, or a calibration. When you access [...]

    This section describes sample requirements, collection procedures, and handling techniques for pH, blood gas, and electrolyte analysis. For a detailed review of sample requirements, refer to NCCLS Document C2[...]

      The following limitations apply to the 850 and 860 systems:  A void hemolyzed samples, because they falsely elevate potassium levels due to intra-erythrocyte potassium levels.  A void samples with elevated levels of salicylates, salicylate deriv[...]

     expired gas Expired gas samples may be obtained using a 10 mL syringe. When used in conjunction with blood gas samples, expired gas samples provide an assessment of gas exchange and oxygena[...]

         CAUTION: Do not use clay-capped capillary tubes because the cut edges of a capillary tube can damage the sample port. Use only fire-polished capillary tubes to prevent damage to the sample port. NOTE: T o p[...]

  T o minimize the errors these conditions can cause, use correct storage and handling techniques. Y ou can minimize errors due to metabolic changes by analyzing samples as soon as possible after collection. This is particularly important for p O 2, glucose, and [...]

         Refer to Emptying the W aste Bottle in Section 3 for detailed instructions for handling the waste bottle and its contents. BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommen[...]

   This section describes the active ingredients, the intended use, the storage, and the handling instructions and the preparation instructions for the reagents used on the 800 systems. W ear safety glasses, gloves, and laboratory coat whe[...]

         Cal G/L 10 mmol/L glucose 2.0 mmol/L lactate salts surfactant buffer Cleaning Solution 1 cleaning compound Cleaning Solution 2 cleaning compound Conditioner ammonium bifluoride[...]

      The reagents used on the 800 systems have the following intended uses:    7.3/CO-ox Zero 7.3 reagent provides the calibration point for the [...]

        This section describes the storage instructions for the reagents used on the 800 systems. CAUTION: Discard any reagent that is frozen. Do not thaw and use. The reagent composition is irreversibly altered [...]

      CAUTION: Discard any reagent that is frozen. Do not thaw and use. The reagent composition is irreversibly altered when the reagent is frozen. Handle and prepare the reagents[...]

        The 800 system requires two gases to calibrate the p CO 2 and p O 2 sensors, Cal Gas and Slope Gas. Cal Gas provides the calibration point for both p CO 2 and p O 2 sensors during one- and two-point ca[...]

   Calibration is the process of testing and adjusting the electronic signal from a sensor in response to a known concentration of a calibration solution or of a gas standard. Calibration establishes a relationship between the ele[...]

      Flexible time performs calibrations at various intervals. The system uses an algorithm to determine the number of minutes between calibrations. This algorithm is based on sensor status and the change in drift values from previous calibrations. Calibra[...]

  The system displays a status message indicating that a one-point metabolite calibration is due at the completion of the sample analysis. The glucose sensor is inactive until the calibration is successfully completed. Y ou cannot defer this calibration. Second, [...]

        The system displays calibration results on the screen and updates them continuously until the parameters reach endpoint. The system then adjusts the values to match the theoretically expected res[...]

     Y ou can view , print, and transmit stored calibration data using the Recall option. Y ou cannot edit calibration data. Y ou can search for the data by calibration type or calibration da[...]

        Quality control (QC) procedures are part of an overall quality assurance program. Quality control testing evaluates system performance for imprecision and inaccuracy to ensure that results of patient samples[...]

  T o monitor system performance and to chart any trends, Bayer Diagnostics recommends that you analyze controls as follows:             pH, p O 2 , [...]

      Quality control limits are established by calculating the mean and standard deviation (SD) from multiple measurements of the QC material. 5 T ypical QC limits use ± 2 SD or ± 3 SD where there is approximately a 95.5% probability that a result is wit[...]

    expected (target) range for each parameter , the measurement limits above and below the mean where the majority of the QC samples are expected to fall action range for each parameter , the measuremen[...]

          The system can automatically transmit QC results to an LIS or a data management system when analysis is complete. Refer to Selecting Automatic T ransmission of [...]

     Statistical summary reports present the month-to-date and lot-to-date mean, standard deviation, coefficient of variation, and number of samples for each QC file. Y ou can print a stat[...]

         Calibration verification is the measurement of calibration materials to verify that the calibration of the system has remained stable throughout the patient reportable range estab[...]

  Y ou can also obtain correlation data by parallel testing of patient samples that span the reportable ranges on the new system and on the existing system or method. Results from the new system are plotted against the existing system or method. T ypically , line[...]

        The following system sequence diagrams illustrate the flow of liquids and gases through the 800 system. Figure 1-12 identifies the components of the system sequence diagrams for the base model with a C[...]

       Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean Cal G/L 5 CO H SC 1. The sample door closes and determines the sample type and the probe extends accordingly . The waste and sample pumps start, and the sample moves [...]

      Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean Cal G/L 5 CO H SC 3. The sample pump moves the sample to fluid detector 2, pauses for one second, and then moves the sample until the trailing edge is detected at fluid detector 1. The CO-ox sam[...]

     7.3 6.8 Wash Clean Cal G/L Cal Slope Ambient Air 1 5 H SC 1a 2 43 R CO S W •••••••••••••••••••• ••••••••••••••••• •• •••••••••••••••• • • • •••?[...]

        The following steps describe the activities that take place when you initiate a wash sequence by selecting W ash or Cancel. Cal Slope Ambient Air 11 a 2 43 R S W ••••••• •• ••••• 7.3 6.[...]

     Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••• ••••••••••••••••• •• ••••••••••••••• • • • ••••• 7.3 6.8 Wash Clean Cal G/L 5 CO H S[...]

         The following steps describe the activities that take place during a one-point calibration. Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••?[...]

     Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 3. After the wash segment moves through the measurement module, the Cal gas and diverter valves open and Cal gas flows into the inner sample port. The sample pump aspirates the Cal gas at a controlled[...]

      Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••• •• ••••••••••••••••• •• ••••••••••••••• • • • ••••• 7.3 6.8 Wash[...]

     Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 9. When the measurement completes, the reagent pump starts and moves the remaining foam wash to the inner sample port. The reagent pump stops, the waste pump starts, and the wash moves from the sample[...]

          The following steps describe the activities that take place during a two-point calibration. Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••[...]

     Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 3. After the wash segment moves through the measurement module, the Cal gas and diverter valves open and Cal gas flows into the inner sample port. The sample pump aspirates the Cal gas at a controlled[...]

      Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••••••• •••••••••••••• •• ••••• 7.3 6.8 Wash Clean 5 CO H SC 6. The reagent and sample pumps remain on. Th[...]

     Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 9. A small amount of foam wash is moved to the measurement module to remove the 7.3 reagent. The reagent pump then moves three 6.8 reagent pre-segments and a main segment to the inner sample port. The[...]

      Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 12. The probe extends and the main segment moves until the trailing edge is at fluid detector 1. The pumps stop and the analytes are measured. Cal Slope Ambient Air 11 a 2 43 R S W •[...]

     Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••••••• ••••••••••• •••••••••••••••••••• •• ••••••••••••••••••[...]

     [...]

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                    [...]

                    [...]

        The 800 system indicates that it is ready to analyze samples when the following conditions exist:  Ready screen appears  sample door is open  Analyze key is lit Do not attempt to analyze samples if [...]

      If the system detects bubbles when the sample is in the measurement module, the Bubbles Detected in Sample message box appears. Look at the sample in the measurement module to see where the bubble is located because bubbles may affect the results of all [...]

      Y ou may have to type a password before you can analyze samples and access certain menus. If your system requires a password, a prompt appears, as shown in Figure 2-1.   [...]

         The following tables list the minimum volumes required by each system to analyze syringe samples:    [...]

    2. Press  . The system aspirates the sample. 3. When prompted, remove the sample device. 4. T ype the required information in the Patient Information screen and then press  .  Y ou can scan the patient ID and the accession number[...]

          The following table lists the minimum volumes required by each system to analyze capillary tube samples:  [...]

      T o ensure the accuracy of the CO-ox measurement, close the CO-ox cover before pressing Analyze. 2. Press  .         there is sufficient sample volume the system automatically aspirates the samp[...]

        Do not move the sample backward after it touches the reference sensor . The potassium and chloride values will be affected. 6. When prompted, turn the sample pump clockwise until the leading edge of the sample fills the[...]

       Use this procedure to analyze samples when the sample volume is too small for routine analysis. The system determines when a sample volume is too small for routine syringe or capillary analysis and prompts you to m[...]

              3. Select   and press  .  If the sample de[...]

    8. T ype the required information in the Patient Information screen and press  when you finish. Refer to Entering Patient Sample Data , page 2-27, if you need more information to complete this screen.   Do not move the sample backward aft[...]

          Use this procedure to determine the total hemoglobin content and available hemoglobin derivatives for a sample on an 844, 845, 854, 855, 864, and 865 systems. Y ou can anal[...]

        Since pH samples are frequently capillary tubes with insufficient sample volume, the system requires you to move the sample manually to the measurement module. If the sample device is a syringe that contains su[...]

              3. Select   and press  . 4. Press  .  Ensure tha[...]

    7. When prompted, remove the sample device. 8. T ype the required information in the Patient Information screen and then press  . Refer to Entering Patient Sample Data , page 2-27, if you need more information to complete this screen. Results appear on the screen and [...]

           The following table lists the minimum volumes required by each system to analyze vacuum tube samples :   [...]

      T o ensure the accuracy of the CO-ox measurement, close the CO-ox cover before pressing Analyze. 3. Press  . 4. When prompted, remove the aspiration adapter . 5. T ype the required information in the Patient Information screen [...]

          Use this procedure to analyze expired gas samples. During this procedure, you inject the gas into the system. The minimum sample volume requirement is 10 mL. BIOHAZARD: [...]

    6. When prompted, remove the sample device. 7. T ype the required information in the Patient Information screen and then press  . Refer to Entering Patient Sample Data , page 2-27, if you need more information to complete this screen. Results appear on the screen and [...]

              Use this procedure to analyze a patient sample at an 840, 850, or 860 system and combine the [...]

    If the patient ID entered at the 800 system and the 270 CO-oximeter do not match, the Patient ID Mismatch message box appears.         you want to combine the 270 results with the 800 system results a. Press  ?[...]

           Use this procedure to combine an arterial blood sample with a venous or mixed venous blood samples to create an a-v studies report.  ?[...]

    1. Analyze the arterial, and the venous or mixed venous samples you want to use for a-v studies. 2. Select the first patient sample for a-v studies: a. Select  . b. Select    and press  . c. Select  [...]

      9. Press  to create the a-v study results. The Patient Data Search Log screen appears. 10. Select the sample used for a-v studies and press  . The Patient Data Search Result screen appears. 1 1. Press  ?[...]

        Use this procedure to enter data in the Patient Information screen. The Patient Information screen appears on the screen during sample analysis after you remove the sample device. Figure 2-15 shows the[...]

      4. Enter data in all required fields. 5. Press  . The Patient Information screen closes. If you want to make changes to the Patient Information screen during analysis, press    . The Patient Inf[...]

       Use this procedure when you want to measure specific parameters for a single patient sample. After the sample is analyzed, the system restores the default panel for your system. Different panels are availa[...]

          This section provides an overview of the Patient Sample Results screen and the printed sample report. Figure 2-17 shows the results screen. Y our screen may appear differen[...]

      # The patient sample contains substances that may interfere with glucose or lactate measurement. ? Optical measurements indicate that the CO-oximeter results should be reviewed. See T r oubleshooting Patient Results in Section [...]

      The following table describes the messages that may appear in patient sample reports on the roll printer:   ****** = Not in Calibration The sensor is out of calibration. ------ ↑ or ------ ↓ = [...]

      COox Cover Open During Meas The cover on the CO-ox module was open while the system was analyzing the sample. COox Sample Chamber T emp Error The CO-ox module sample chamber temperature is ± 0.35 ° C of range and cannot ac[...]

        Sample T emperature Out of Range The measurement module temperature is not in range at the end of measurement sequence. __ Sent Appears when you press Send at the end of analysis. [...]

        Use this procedure to recall patient sample data and results stored in the system. When the system locates patient sample data, you can edit data, print reports, and transmit the data to an LIS or a[...]

                from the earliest date to a specific date leave the Analysis Date From field blank, and type the specified date in the Analysis Date T o field. from a specific date to the present date ty[...]

                   ?[...]

      If no patient sample results are recalled, the system prompts you to ensure the accuracy of the search criteria or to enter new search criteria.     Use this procedure to edit pat[...]

    If you change the patient ID to match another existing patient ID, the Duplicate Patient ID message box appears.         Continue accept the patient ID and return to the Patient Information screen. Cancel return to the Patient Information sc[...]

         The 800 systems accept QC samples from a syringe or from an aspiration adapter . When you perform routine QC analysis, all parameters available on your system are analyzed. Y ou can specify a pa[...]

             Sample Port Aspiration Adapter QC Sample   T o ensure the accuracy of the CO-ox[...]

      7. Perform the required action.          Accept accept the results into the QC file and update the statistics. Reject store the results in the appropriate QC file, but the system does not update the statistics. D[...]

     Ensure that the calibration reagents and quality control materials are not expired or deteriorated. V isible signs of deterioration include color changes or cloudiness of the reagents or quality control materials.  Ensure that you followed the operating procedures recommen[...]

               use the keypad or keyboard type the File Number and press  . use the optional bar code scanner scan the bar code label on the QC ampule. NOTE: T o ensure accurate sample identificati[...]

       Use this procedure to recall the current month’ s QC sample data and statistics. When the system locates the QC sample data, you can edit the data, print reports, and transmit the data to an LIS or data management system. Y ou can[...]

      3. T ype the search criteria and press  after you complete each field.             for a selected date type the date in both Analysis Date fields. from ear[...]

    5. Select the report that you want to view and press  . The QC Data Search Result screen appears.         [...]

         Use this procedure to edit QC data that you recall. Y ou can edit QC data in the following ways:  move a QC report to a different file.  change the Accept, Reject, or Discard status. 1. Use the procedure[...]

          Use this procedure to print or transmit data from the QC Data Search Criteria Log screen or the QC Data Search Result screen. 1. Locate the sample you want as desc[...]

               ↓ the result is below the lower limit of the target range. ↑↑ the result is above the upper limit of the action range. ↓↓ the result is below the lower limit of th[...]

        Use this procedure to print statistical summary reports for the current month’ s QC data. The statistical summary report includes QC samples analyzed to date. Y ou can print s[...]

      5. Press  to return to the Ready screen.       Use this procedure to view and print Levey-Jennings charts of the current mont[...]

       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 QUALITY CONTROL LEVEY-JENNINGS CHART April 10 1994 16:25 System 850-1001 QC ID 473841 LEVEL 1 Lot 331302 E[...]

      If the QC Data Search Log contains samples from more than one file and you choose to view a Levey-Jennings chart, the chart that appears is for the file number of the sample that you selected on the log. The following symbols appear on Levey-Jennings [...]

          Y ou can perform calibrations from either the Analyze mode or the Menu mode. All calibrations available on the 840, 850, and 860 are also available on sys[...]

            Y ou can perform calibrations from either the Analyze mode or the Menu mode. All calibrations available on the 840, 850, and 860 are a[...]

        Use this procedure to calibrate the tHb slope for the CO-ox module. Y ou can perform this calibration from either the Analyze mode or the Menu mode. 1. Initiate the tHb slope calibration[...]

      Press Cancel to interrupt a calibration. The system starts a wash and the W ash screen appears. The system returns to the Ready screen at the end of the wash. The maximum time between tHb slope calibrations is 90 days. One day before a tHb slope calib[...]

        Use this procedure to calibrate the internal atmospheric pressure sensor to a barometer in your laboratory . 1. Access the Barometer Calibration screen from the Menu screen: a. Select[...]

        Press  to interrupt a calibration. If you interrupt an automatic calibration, the system will attempt to start the calibration again in 90 seconds. Y ou can de[...]

       Y ou can print calibration data and send the data to an LIS or a data management system. Y ou cannot edit calibration data. 1. Access the Recall Calibration Data screen from the Menu screen: a. Select  [...]

                     ?[...]

                 [...]

          2-POINT CALIBBRATION REPORT APR 12 1994 13:02 SYSTEM 860-1001 Sequence no 433 Calibration Date APR 12 1994 Calibration Time 11:42 [...]

    The following result flags can appear on printed reports:          * the measurement did not reach endpoint. ↑ the calibration is above the upper drift limit. ↓ the calibration is below the lower drift limit[...]

     [...]

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                  ?[...]

                   ?[...]

                  ?[...]

     [...]

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        Use this procedure to view pending maintenance tasks and record completed maintenance tasks in the maintenance log. 1. Access the Maintenance Schedule screen from the Menu screen: a. Press 2 Mainten[...]

           Use this procedure to print a Maintenance Schedule Report from the Maintenance Schedule screen. The report lists all the maintenance tasks fo[...]

        Use this procedure to view and print the list of completed maintenance tasks for the current or the previous month. 1. Access the Maintenance Log screen from the Menu screen: a. Press 4 Data Reca[...]

        The daily maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted. If your laboratory analyzes more than 30 samples per day , perform daily maintenance more frequently . [...]

    NOTE: Do not insert swabs into the sample port or spray anything into the measurement module. 1. Rinse the exterior surfaces with reagent-quality water . NOTE: Bayer Diagnostics recommends using reagent-quality water in accordance with NCCLS guidelines. Refer to the W ater Qua[...]

          Check the amount of paper on the roll. A pink line on the paper indicates that the roll is nearly empty . Replace the paper if the roll is empty or nearly empty as described in R[...]

     2. Compare the displayed atmospheric pressure to your laboratory’ s barometer reading.              correct press Done . incorrect a. T [...]

           The twice weekly maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted. If your laboratory analyzes more than 30 samples per day , perform twice we[...]

       The weekly maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted. If your laboratory analyzes more than 30 samples per day , perform weekly maintenance more frequently . Use this procedur[...]

      5. Insert an aspiration adapter into the sample port and insert the other end into the deproteinizer vial, or decant the deproteinizer into a syringe and insert the syringe into the sample port. 6. Press Analyze . 7. When prompted, remove the adapter [...]

    NOTE: If your system has a CO-ox module, follow the procedure described for the appropriate base model. For example, information identified for an 860 also applies to an 865. 1. Access the Condition screen from the Menu screen: a. Select 2 Maintenance and press Enter . b. S[...]

      9. Press Ye s to perform a two-point calibration. 10. Analyze a minimum of two levels of quality control material to verify sensor performance. Press CANCEL to stop conditioning. The system performs a wash and then displays the Calibrate System messag[...]

           Use this procedure to ensure that the sensors contain fill solution to the levels described in Figure 3-5. ?[...]

                    [...]

      The monthly maintenance schedule is based on the expiration date of the opened reagents.     Effective cleaning is accomplished [...]

      NOTE: Do not remove or tighten the cap that contains the reagent septum. Removing or tightening the cap damages the integrity of the reagent septum. 4. Remove the plug from the cap of the new cleaning solution bottle. 5 . Insert the cleaning solution [...]

    3. W rite the date installed in the space provided on the new reagent bottles. NOTE: Do not remove or tighten the cap that contains the reagent s e pt um . Removing or tightening the cap damages the integrity of the reagent septum. 4. Remove the plugs from the caps of the n[...]

        Perform the following procedures every 2 months. The bimonthly maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted. If your laboratory analyzes more than [...]

    4. Remove the plugs from the caps of the new reagent bottles. 5. Insert the new reagent bottles into position on the reagent manifold. 6. Push the bottles to ensure that they fit tightly on the reagent fittings. 7. Press Reset Levels . The Reset Levels screen appears. 8. Se[...]

                 [...]

    1 1. Connect the sample tubing to the sample tubing connector on the measurement module. 12. Press Continue . A wash sequence starts. When the wash sequence sequence finishes, a message box appears prompting you to perform a two-point calibration. 13. Press Ye s to perform [...]

        Perform the following procedures every 3 months. The quarterly maintenance described in this section is based on analyzing 30 samples per day . If your laboratory analyzes more than 30 samp[...]

        Sample Chamber Sapphire Window Mounting Pin Cam Bubble T rap 4. Remove the gasket and support: a. Slide your finger under the flat metal support of the gask[...]

      a. Fill a syringe with reagent-quality water . b. Attach a capillary adapter or a piece of 0.016-inch diameter sample tubing to the syringe. c. Attach the tubing or capillary adapter to the port and flush the water through the port. 7. Clean the glass[...]

    12. Inspect the tubing. a. If the tubing is damaged, or is stretched or loose at the connection, replace the tubing as described in Replacing the CO-ox Sample T ubing on page 3-37. b. If there is an obstruction in the tubing, remove the sample tubing. c. Push a 0.016-inch d[...]

         Materials required:  lint-free tissue or lint-free swabs  reagent-quality water  dilute cleaning solution (do not use bleach, alcohol, or abrasive powder)  hemolyzer gasket BIO[...]

    d. Lay the anvil on its side. e. Remove the gasket and discard it according to your laboratory biohazard protocol. 3. Clean the hemolyzer and the anvil: a. Clean the hemolyzer with a lint-free tissue soaked in mild cleaning solution. b. W ipe the surface with a lint-free ti[...]

        Perform the following procedures every 6 months. The semiannual maintenance described in this section is based on analyzing 30 samples per day . If your laboratory analyzes more than 30 [...]

    4. Reinstall the air filter cover: a. Align the two pins, located inside the air filter cover , underneath the holes. b. Push the cover up until it snaps it into place. 5. Press Home to return to the Ready screen.    [...]

            Materials required:  measurement module tubing BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended [...]

    5. Replace the measurement module tubing: a. Remove the tubing from the connector at the spring-loaded latch in the measurement block as shown in Figure 3-20.    ?[...]

                ?[...]

          Materials required:  CO-ox sample tubing BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precautions when working with biohazardous mate[...]

      l. Disconnect the sample tubing from the CO-ox pump. m. Connect one end of the replacement tubing to the outlet on the sample chamber and the other end to the CO-ox pump. 3. Replace the waste tubing: a. Disconnect the waste tubing from the CO-ox pump.[...]

       Perform the following procedures every 12 months. These procedures are based on analyzing 30 samples per day . If your laboratory analyzes more than 30 samples per day , perform this maintenance more frequently . Use thi[...]

                    [...]

             f. Place the left tubing cuf f under the left side of the platen.  Do not st[...]

                    [...]

    6. Press Continue . A wash sequence starts. When the wash sequence finishes, a message box appears prompting you to perform a two-point calibration. 7. Press No . 8. Calibrate the reagent pump from the Menu screen: a. Select 3 T roubleshooting and press Enter . b. Select 1 [...]

              Perform the following procedure annually . This schedule is based on analyzing 30 samples per day . If your laboratory analyzes more[...]

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          Materials required:  10% solution of household bleach NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent-qualit[...]

      NOTE: The waste bottle is disposable and can be autoclaved before you discard it. The waste bottle is not reusable after autoclaving. Cover the waste bottle with the cap provided and discard the bottle according to your laboratory protocol or infectio[...]

           Use this procedure to clean the reference sensor and to remove bubbles at the electrode tip and in the passage between the electrode co[...]

                ?[...]

          Materials required:  0.022 inch diameter clot-removal line (to fit through a 0.030 inch ID pathway) 1. Stop the system from the Menu screen: a[...]

      6. Ensure that the O-ring is in place. Replace the O-ring if it is worn or damaged. CAUTION: Do not remove or return the sensors to the measurement module without first discharging static buildup. T ouch the inner surface of the module frame to discha[...]

        Use this procedure to clean the roller cages for the reagent, sample, or waste pumps. Materials required:  10% solution of household bleach NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:1[...]

                  ?[...]

    9. Press Continue . A wash sequence starts. When the wash sequence finishes, a message box appears prompting you to perform a two-point calibration. 10. Press Ye s to perform a two-point calibration.    ?[...]

      6. Clean the fitting with a swab moistened with a 10% solution of household bleach. 7. Rinse the fitting with reagent water and dry thoroughly . Ensure that the O-ring is in place on the back of the reagent fitting. 8. Reinstall the fitting into the a[...]

        Materials required:  10% solution of household bleach NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent quality water .  reagent water  lint-free swabs BIOHAZARD: Refer to [...]

      NOTE: Ensure that the three O-rings are in place. 7. Reinstall the sample port, matching the tab on the sample port to the notch in the retainer ring. 8. Push the tab on the retainer ring away from you until it locks in place. 9. Reinstall the sample [...]

    8. Remove the paper from the printer . 9. Reconnect the power cord to the power supply and allow the system to warm up. 10. Reinstall the printer paper as described in Replacing the Printer Paper , page 3-66. 1 1. V erify the printing quality as described in Roll Printer T [...]

      3. Deproteinize the sample path: a. Prepare the deproteinizer as directed on the package. b. Select 2 Maintenance and press Enter . c. Select 1 Deproteinize and press Enter . d. Invert the deproteinizer vial several times to mix. e. Insert an aspirati[...]

    8. Perform a two-point calibration from the Menu screen:  Glutaraldehyde may cause excessive drift to the K + and Ca ++ sensors. Repeat calibrations until the system performs a successful calibration. a. Select 1 Calibration and press Enter . b. Select [...]

      NOTE: If your system has a CO-ox module, follow the procedure described for the appropriate base model. For example, information identified for an 860 also applies to an 865. CAUTION: Do not remove or return the sensors to the measurement module witho[...]

    W ear safety glasses, gloves, and a laboratory coat when handling bleach. 4. Perform the cleaning cycle: a. Press Ye s . b. Insert an aspiration adapter into the sample port and immerse the other end in the 10% bleach solution. c. Press Analyze . d. When prompted, remove th[...]

           Use this procedure to manually initiate the cleaning sequence. The system automatically initiates the cleaning sequence every 24 hours at 02:[...]

       Use this procedure to stop the system when you perform maintenance activities such as replacing components. Stopping the system discontinues all fluidic activities such as calibrations and sample analyses. CAUTION: Becau[...]

           The 800 system collects workload data and provides month-to-date and year-to-date workload statistics reports. The workload statisti[...]

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            W ear safety glasses, gloves, and a laboratory coat when handling the reagents. 1. At the Re[...]

      9. Perform a two-point calibration. a. Press Calibrate . b. Select T wo-point and press Enter . c. Press Start Calibration . Perform two-point calibrations after changing the calibration reagents to ensure that the reagents are acceptable and the syst[...]

                c. Push th[...]

       Gently guide the paper against the left edge of the spool when you wind paper on the spool. If the right edge of the paper roll is uneven, the paper can jam. ?[...]

         Materials required:  reference electrode refill  hex tool  lint-free tissue BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precautions when wo[...]

                    [...]

        Materials required:  reference sensor replacement kit  hex tool  lint-free tissue BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precauti[...]

      c. Slowly fill the electrode compartment by gently squeezing the container until the KCl fill solution enters the KCl reservoir .    ?[...]

    5. Fill the KCl reservoir in the new sensor: a. Remove the reservoir cap with the hex tool and set it aside as shown in Figure 3-45.       [...]

        Do not overtighten the reservoir cap. Overtightening can deform the gasket and cause leaks. e. Reinstall the reservoir cap and hand-tighten. 6. Continue with Reinstalling a Sensor , page 3-89. ?[...]

    CAUTION: Do not touch the internal electrode wire. The wire is fragile and is easily damaged. 3. Use the hex tool to remove the internal electrode from the cassette you are replacing. 4. Discard the cassette according to your laboratory protocol. 5. Stand the internal elect[...]

                     ?[...]

          Materials required:  reference electrode internal replacement kit  hex tool  lint-free tissue BIOHAZARD: Refer to Appendix A, Pr otecting Y ourse[...]

              [...]

                ?[...]

                 [...]

            pH pH 840, 850, 860 Na + Na + , K + , Cl – , Ca ++ 850, 860 K + Na + , K + , Cl – , Ca ++ 850, 86[...]

      CAUTION: Do not touch the internal electrode wire. The wire is fragile and is easily damaged. 3. Unscrew the internal electrode and carefully set it aside on a lint-free tissue as shown in Figure 3-57. ?[...]

              7. Insert the internal electrode [...]

      CAUTION: Do not remove or return the sensors to the measurement module without first discharging static buildup. T ouch the inner surface of the module frame to discharge static buildup. 2. Remove the sensor as shown in Figure 3-59: a. Push up the lat[...]

    e. Screw the internal electrode into place, ensuring that you do not cross-thread the electrode. f. T ap the front face of the sensor with your knuckle to remove bubbles. g. W ipe any excess fill solution from the exterior of the sensor with a lint-free tissue. 5. Ensure th[...]

      g. Allow the system to warm up. h. Press Exit T est . 1 1. When the temperature is stable, perform a two-point calibration: a. Select 1 Calibration and press Enter . b. Select 2 T wo-point and press Enter . The Ready screen appears when the calibratio[...]

      Do not remove or return the sensors to the measurement module without first discharging static buildup. T ouch the inner surface of the module frame to discharge static buildup. 2. Remove the biosensors as shown in Figure 3-60: ?[...]

                 [...]

    12. V erify biosensor performance by completing two successful two-point calibrations. 13. Analyze a minimum of two levels of quality control material to verify sensor performance.    Use this procedure to reinstall t[...]

      10. Analyze a minimum of two levels of quality control material to verify sensor performance. After the sensor temperature equilibrates, remove the sensor and inspect for bubbles. Remove any bubbles that are present.  [...]

    a. Using a valve wrench, close the gas tank by turning the valve stem fully clockwise.  Do not remove the yoke screw before releasing the gas from the regulator . Gas under pressure can cause bodily injury and property damage. b. Disconnect the gas regu[...]

                  ?[...]

      Do not turn the needle valve too hard or damage can occur . h. Carefully turn the needle valve adjustment knob counterclockwise until until it stops. i. Listen carefully for any gas leaks. j. Check the gas line for good gas flow . k. V isuall[...]

      9. Perform a gas two-point calibration from the Menu screen: a. Select 1 Calibration and press Enter . b. Select 4 Gas T wo-point and press Enter . Perform two-point calibrations after changing the calibration reagents, including the gas standards, to[...]

    4. Disconnect the tubing from the gas regulator and discard the tubing. 5. Connect one end of the new tubing to the fitting on the regulator . 6. Connect the other end of the tubing to the fitting on the reagent manifold. NOTE: The average main tank pressure is 2200 psi. Th[...]

          Use this procedure to replace the roller cage for the reagent, sample, waste, or CO-ox pump. Materials required:  reagent water  lint-free tissue  roller cage BIOHAZARD: Refer to[...]

                   ?[...]

           Materials required:  sample port BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precautions when working with biohazardous materials. [...]

         Materials required:  sample probe BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precautions when working with biohazardous materials. 1. Stop the system [...]

                   ?[...]

    a. Select 2 Maintenance and press Enter . b. Select 7 Stop System and press Enter . 2. Ensure that the sample probe is fully retracted. 3. Remove the old capillary seal: a. Grasp the top of the capillary seal and pull it toward the right and out of the sample port, as sh[...]

            Materials required:  measurement module lamp 1. Shut down the system from the Menu screen: a. Select 7 System Utilities and press Enter . b.[...]

    8. Pinch the ends of the clamp and pull it away from the bracket. 9. Remove the old lamp from the clamp and discard it. CAUTION: A void touching the lamp with your fingers. 10. Place a new lamp in the clamp with the front of the lamp facing the system. 1 1. Pinch the end[...]

      b. Select 7 Stop System and press Enter . 2. Allow the lamp to cool for at least 5 minutes.  Ensure that the lamp has been of f for at least 5 minutes to allow sufficient time for it to cool. 3. Remove the lamp cover from the C[...]

    b. Select 3 Measurement and press Enter . c. Select 2 COox Optics and press Enter . The COox Optics T est screen appears. 13. Press Start T est . 14. Check the screen for the message, Lamp test passed. 15. Press Exit T est . 16. Press Exit Menu  17. Perform a one-poin[...]

      3. Disconnect the power cord from the side panel of the system. 4. Remove the air filter cover . 5. W ith a small, flat-blade screwdriver , gently pry open the fuse compartment door at the top, as shown in Figure 3-72. 6. Remove the fuse holders fr[...]

    12. Reconnect the power cord to the power source and allow the system to warm up for at least 15 minutes. A wash sequence starts. When the wash sequence finishes, a message box appears prompting you to perform a two-point calibration. 13. Press No . 14. V erify the syste[...]

     [...]

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                     ?[...]

                      ?[...]

                 [...]

     [...]

          Use this procedure to review and print Status Event Log messages. The Status Event Log stores most diagnostic codes (D codes) and system messages from the last 72 hours of operation. The D code[...]

        System messages provide information about the operating status of the system and can appear in the status area of the screen, in the Status Event Log, or on printed reports. T able 4-1 describes each system message. [...]

        COox Sample Chamber T emp Error Appears when the CO-ox sample chamber temperature is not in range. The system cannot accept tHb sample measurement requests. See T r oubleshooting System Mes[...]

         Interfering Substance: Glu Appears when the system detects substances in the sample that may interfere with glucose measurement. See T roubleshooting System Messages, page 4-1 18. NOTE:[...]

        No Sample Device Detected Appears when you press Analyze, the sample door closes, and no device is detected in the sample port. See T r oubleshooting System Messages, page 4-120. No W aste [...]

     [...]

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         This section describes the 800 system diagnostic codes (D codes) and messages, the conditions that cause them, and possible solutions. D codes identify changes in the system operation that requi[...]

                Sensor drift is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: p O 2 p CO 2  ?[...]

                  Sensor drift is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: pH K + Ca ++ Cl – Na + [...]

      Perform the Measurement T est as described on page 4-70. Check the diverter valve to verify that the valve is working by performing the V alves test as described on page 4-62. Replace the affected sensor as described in Replacing the Measur ement or Sample [...]

           Sensor drift is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: Glu Lac   If D co[...]

           The tHb slope is beyond predefined limits during the calibration. Qualifiers: tHb  Ensure the target value entered for the tHb slope is correct [...]

               Sensor slope is beyond predefined limits during a two-point calibration. Qualifiers: p O 2 p CO 2   If D codes also exist [...]

                   Sensor slope is beyond predefined limits during a two-point calibration. Qualifiers: pH K + Ca ++ Cl – Na +  ?[...]

           Sensor slope is beyond predefined limits during a one- or two-point calibration. Qualifiers: Glu Lac   If D codes also exist for [...]

           The tHb slope is beyond predefined limits during the calibration. Qualifiers: tHb  Ensure the target value entered for the tHb slope is correct for the reag[...]

               Sensor offset is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: p O 2 p CO 2   If [...]

                   Sensor offset is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: pH K + Ca ++ Cl – Na + ?[...]

           Sensor offset is beyond predefined limits during a two-point calibration. Qualifiers: Glu Lac   If D codes also exist for reag[...]

                Sensor does not reach stable reading within predefined time limit. Qualifiers: p O 2 p CO 2   If D codes also exist fo[...]

                  Sensor does not reach stable reading during predefined time limit. Qualifiers: pH K + Ca ++ Cl – Na +  ?[...]

            Sensor does not reach stable reading during predefined time limit. Qualifiers: Glu Lac   If D codes also exist for reagent pr[...]

           Sample door detector cannot determine whether the sample door is open or closed.  Check that your hand does not prevent the door [...]

             Fluid detector 1 (FD1) does not detect the sample during the predefined time limit.  Check the sample entry components for obstruc[...]

            Fluid detector 2 (FD2) does not detect the sample during the predefined time limit.  Check the sample position in the measurement modu[...]

           Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifiers: FD1 FD1A FD2  Check the sample path in the measurement modu[...]

          Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifiers: FD3 FD4  Perform a wash. Observe the fluid as it moves through [...]

           Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifier: FD5  Check the CO-ox sample path for obstructions. If you se[...]

         An internal communication problem between the system processors has occurred. Qualifiers: 1 3    1[...]

           The barometer detects atmospheric pressure beyond predefined limits.  Check that the system barometer is functioning properly:[...]

           Fluid detector 3 (FD3), fluid detector 4 (FD4), or both detectors do not detect reagent. Qualifiers: 7.3 6.8 W ash C1/C2 Cal G/L [...]

            Fluid detector 1 (FD1), fluid detector 2 (FD2), or both detectors do not detect fluid during a one-point or a two-point calibration. Qualifiers: 7.3 [...]

          The wash did not completely clean the sample path due to low volume or poorly segmented flow .   If a D23 or D24 code [...]

           The probe detector cannot determine the position of the sample probe.  Check to see if the probe is bent. If the probe is bent replace it as [...]

         The system detects an error in the electronics system. Qualifiers: 1 2 4 5 6 7 8 9 10 1 1 12 13   [...]

           The system detects an error in the temperature control system. Qualifiers:1 2 3 4 5 6 7 8 9 10 1 1 Every 15 minutes, the system enables the temperature control and reevalu[...]

           The system detects an open connection in the glucose biosensor .  Check that the biosensor is installed correctly with the contacts ali[...]

            The system detects an open connection in the lactate biosensor .  Check that the biosensor is installed correctly with the contacts[...]

          The system detects a transmission error in port 1, 2, 3, or the bar code scanner port, which is caused by a faulty cable connection or by the failure of the communications electr[...]

          The system detects an error in the CO-ox optical measurement system. Qualifiers: 2 3 4 7 9    2 Perform[...]

            Fluid detector 5 (FD5) does not detect the sample during the predefined time limit.  Ensure the sample volume is sufficient for the sa[...]

            The CO-ox sample chamber does not detect the sample during the predefined time limit.  Ensure the sample volume is sufficient for t[...]

         The CO-ox module detects lamp levels that are inadequate for sample analysis.  Perform the Lamp On/Off T est as described in CO-ox Optics T est , page 4-75. Remove the[...]

           The system detects an error in the electronics system. Qualifiers: 1 2 3 4 5 6 7 8 9 10 1 1 12    ?[...]

                1 testing occurs at power-up initialization and before each zero and slope calibration. The  12V is checked before and after every sample measurement. A GO pulse is sent[...]

                 7 testing occurs at power-up initialization. Communications between the microstepper controller and the CPB are monitored for the response time to a command from the mi[...]

          The system detects an error in the temperature control system. Every 15 minutes, the system enables the temperature control and reevaluates the error condition. If the problem th[...]

            Fluid detector 5 (FD5), the CO-ox sample chamber , or both do not detect reagent. Qualifiers: 7.3 W ash  Check the expi[...]

     Perform the Pump Functions T est as described in Pump Functions T est , page 4-58. If the D code reappears, contact your Service Representative.[...]

            The wash did not completely clean the CO-ox sample path due to low volume or poorly segmented flow .  ?[...]

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          This section describes how to use the 800 system diagnostic tests to check the functions of the system components. Access the tests from the T roubleshooting menu or by pressing T roubles[...]

         Roll Printer T ests the ability of the roll printer to print all characters. Bar Code Scanner T ests the ability of the bar code scanner to read a test pattern.    [...]

     5. Perform the appropriate action.            test another reagent repeat steps 2 through 4. return to the Menu screen press Exit T est .  6. Press Exit Menu .   [...]

      3. Check the screen for the message, Reagent pump flow rate acceptable, to verify that the flow rate is within the acceptable range.             acceptable press Exit T est . unaccep[...]

                     ?[...]

      c. Attach another piece of test tubing to a two-way connector , attach the connector to the outlet tubing for the appropriate pump, and place the test tubing in the graduated cylinder .         [...]

     c. Attach another piece of test tubing to the waste tubing connector on the CO-ox pump tubing, and place the test tubing in the graduated cylinder . 6. Select the pump and speed to test and press Enter . 7. Prime the tubing: a. Press Start T est . b. Allow reag[...]

      1 1. Reinstall the reagent, sample, or waste pump tubing: a. Disconnect the test tubing and the two-way connectors from the pump tubing. b. Reinstall the pump tubing:  reagent pump tubing to the connectors at position 1  sample pump tubing to the conn[...]

        V ent controls the flow of ambient air into the manifold Clean controls the flow of Cleaning Solution G/L controls the flow of Cal G/L Reagent Bypass diverts the W ash G/L Zero Reagent in the reagent manifold when the f[...]

      5. Perform the appropriate action.            test another valve repeat steps 2 through 4. return to the Menu screen press Exit T est .  6. Press Exit Menu . When you use the left arrow key t[...]

     d. Press Stop T est . Ensure that the bubbles stop flowing from the adapter . 4. Check the flow of Slope Gas: a. Select Slope Gas and press Enter . b. If required, push down the sample door halfway open, insert an aspiration adapter into the sample port, and im[...]

          Use this procedure to test the ability of the fluid detectors to detect the presence of fluids and to detect whether the fluids are clear or opaque. Y ou can also test fluid detectors 1, 1A, and 2 with [...]

     4. T est the fluid detectors with whole blood: a. Select Whole Blood and press Enter . b. Insert a sample device containing a whole blood sample into the sample port. c. Press Start T est . d. Remove the sample device when prompted. e. Check the screen for the [...]

                       [...]

     5. If the system does not correctly recognize the sample device, calibrate the sample door: a. Press Calibrate Door . b. Insert the door calibration gauge. Use a Bayer Diagnostics 1 mL syringe size. c. Press Start T est . d. Remove the sample device when prompt[...]

      4. Perform the appropriate action.            T emperature control system on message a. Press Stop T est . b. Look at the status area to see if the D38 code has disappeared. c. Allow the system [...]

                 K + 29.0 to 126.0 mV 15 to 90 Cl – 29.0 to 126.0 mV 15 to 90 Ca ++ 29.0 to 126.0 mV 2[...]

                TB1, p O 2 /p CO 2 T est/Blank Sensor  TB2, pH/Na + T est/Blank Sensor  TB3, K + /Ca ++ /Cl – T est/Blank Sensor  TB4, Glu[...]

          Lac A 17.602 to 42.398 nA sample ground/temperature 36.840 to 37.373 ° C  d. Press Stop T est . e. Perform the appropriate action.     [...]

      d. T ake a reading of the actual sensor output signal. e. W ait 100 seconds, and take another reading. value = (reading 1 – reading 2) / 100 seconds f. Calculate the resulting value and then compare the resulting value to the expected value: ?[...]

         Y ou can use this procedure to test the operation of the CO-ox lamp and to display the integration time for the last CO-ox zero calibration. 1. Access the CO-ox Optics T est from the Menu screen: a. Select 3 T ro[...]

      b. Select 4 Communications and press Enter . The External Loopback T est screen appears as shown in Figure 4-1 1.         [...]

     CAUTION: Do not attempt to print without paper in the printer . Damage to the printer can occur . 1. Access the Roll Printer T est from the Menu screen: a. Select 3 T roubleshooting and press Enter . b. Select 5 Roll Printer and press Enter . 2. Press Start T e[...]

     [...]

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            Use this procedure to remove obstructions from the sample entry components. Perform the steps in sequence unti[...]

      4. Remove obstructions from the sample probe using the clot-removal line from the probe clot removal kit: a. Disconnect the sample tubing from the sample probe. b. Push a 0.016-inch diameter clot-removal line through the sample probe until the line comes ou[...]

            Capillary Seal Drip Tray Sample Door Retainer Ring Sample Port Clot-removal Line Mount O-ring 7. Inspect[...]

            BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazards , for recommended precautions when working with [...]

      Use wash reagent that has not expired and has not been open longer than 60 days. Do not install the wash reagent bottle that you use for this procedure on the system. d. If the obstruction is not removed, fill the syringe with fresh wash r[...]

        T ouch the inner surface of the module frame to discharge static buildup before removing or returning sensors. g. Dry thoroughly and reinstall each sensor , ensuring that the O-rings are in place.  [...]

              Remove the gas sensors from the measurement module. Clot-removal Line Push the sprin[...]

                Grasp the tab on the reference sensor and pull it up[...]

            BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazards , for recommended precautions when working with biohazard[...]

       Do not move the obstruction into the hemolyzer , sample chamber, or sample connector .            in the CO-ox sample tubing that connects the hemolyze[...]

     3. Inspect the sample connector for obstructions: a. Disconnect the tubing from the sample connector . b. Remove the sample connector . c. Push a clot-removal line through the sample connector to remove obstructions.  If the obstruction is [...]

      5. Inspect the sample chamber and bubbletrap for obstructions:            near the sample chamber outlet a. Disconnect the CO-ox sample tubing from the sample connector . b.[...]

                not removed a. Remove the sample chamber . NOTE: Hold the sample chamber by the edges. b. Disconnect the bubble trap from the sample chamber . c. Push a clot-removal [...]

           Use this procedure to disconnect the CO-ox sample path from the base model. Y ou can continue to measure the remaining parameters. BIOHAZARD: Refer to Appendix[...]

     5. Align the sample connector with the guide pin and slide the “Y” prongs into the slot at the bottom of the face plate. The straight path is on top when the CO-ox sample path is disconnected. 6. Reinstall the screw . 7. Reconnect the base model sample tubi[...]

        This section describes information about observed problems that are not usually associated with diagnostic codes (D codes), that appear as system messages requiring operator intervention, or t[...]

           ↑ or  ↓ or Out of Range message The result is above (up arrows) or below (down arrows) the limits of the system’ s me[...]

           Proficiency test results are not as expected System requires cleaning or maintenance, or reagents or controls are outdated, deteriorated, or incorrectly han[...]

        Use this table if you observe unexpected or out-of-range patient results.     [...]

            ↑ or  ↓ or Out of Range message The result is above (up arrows) or below (down arrows) the limits of the system’ [...]

          ? is printed next to the CO-oximeter results on reports Optical measurements indicate that the CO-oximeter results should be reviewed. Results may still be clin[...]

           ? is printed next to the CO-oximeter results on reports       is successful is not successful ?[...]

       Use this table if you observe fluid leaks in or under the 800 system.      Sample drips out of sample port 1. Ensure that you do n[...]

         Use this table if you observe problems with fluids flowing too slowly , erratically , or not at all.     ?[...]

          Insufficient wash solution is flowing through the sample port 1. Check the level of wash reagent and install a new bottle of Bayer Diagnostics wash reagent i[...]

           Sample path is obstructed The fluid flow is insuf ficient due to obstructions in the sample path. 1. Check for obstructions in the sample entry component[...]

          During the first 24 hours following installation, the glucose or lactate biosensors measure a large negative slope value during calibration. The biosensors m[...]

          Use this table if you observe fluids with cloudiness, color changes, or particulate matter .    ?[...]

       Use this table if you observe problems with the supply and delivery of Cal or Slope Gas.      Leaking or hissing of gas 1. Locate the so[...]

           Salt deposits appear in measurement module 1. Check the reference sensor for leaks. T ighten cap if required and clean any deposits with a swab moistened[...]

        Use this table if you observe problems with bar codes or the bar code scanner .      The bar [...]

         Use this table if you observe electronic problems.      The system does not r[...]

           Use this table if you observe problems with the roll printer .      P[...]

          Use this table if you observe problems with the reagent pump, sample pump, or waste pump.     [...]

           Measurement module temperature error message The measurement module temperature is outside the 37.0 ± 0.5 ° C range. The system cannot accept sample analy[...]

          Use this table to troubleshoot system messages that appear during analysis mode functions. The system messages are listed in the status area of the Analysis Mode h[...]

           Excessive Bubbles in COox Sample Excessive Bubbles in COox tHb Slope Excessive Bubbles in Zero The system detects a non-continuous fluid in the CO-ox sample[...]

            If Blood, Question Data Optical measurements indicate that the CO-ox results should be reviewed. A question mark (?) is printed next to the CO-ox result[...]

           If Blood, Question Data       is successful is not successful    go to step 5. a.[...]

            Insufficient Sample There is not enough sample to fill the measurement block. Y ou can manually position the sample for measurement. See Analyzing Micr [...]

           Meas Module T emperature Error The measurement module temperature is outside the 37.0 ± 0.5 ° C range. The system cannot accept sample analysis requests. [...]

           No Sample Device Detected No sample device is detected in the sample port after you press Analyze and the sample door closes. 1. Ensure that you use prop[...]

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                      ?[...]

                    [...]

         This section describes the procedures for defining or changing 800 system setup parameters. T able 5-1 describes many of the tasks that you can do in setup and lists the setup menu option you select to perform each [...]

                 control various system functions such as beeper volume, auto move capillaries, auto send results, and reporting resolution System Setup and Systems Options sel[...]

             Previous Screen return to the frame or screen from which you entered the present screen. If you press this key after you make changes to the current screen, a message appears prompting you to save your changes. Press Y es to s[...]

     1. Access the System Information screen from the Menu screen: a. Press 8 Service Setup and press Enter . b. Press 1 System Information and press Enter . The System Information screen appears, as shown in Figure 5-1. [...]

       T emperature temperature of the patient tHb total hemoglobin value of the patient Source origin of the patient sample Draw Date date sample was drawn Draw T ime time sample was drawn F I O 2 fraction of inspired air V entil[...]

                     ?[...]

        Use this procedure to customize a panel that the system will use to analyze a patient sample. Y ou can define up to 5 customized panels. The system measures only the parameters listed in the panel. Y ou can cho[...]

         Use this procedure to select the panel that the system will use to analyze a patient sample. Y ou can select default panels from a predefined list or from any defined custom panel[...]

           855 All Parameters pH/Blood gas CO-ox pH/lytes Blood gas/lytes pH/Ca ++ pH, p O 2 , p CO 2 , Na + , K + , Cl – , Ca ++ , tHb, F O 2 Hb, F COHb, F MetHb, F HHb pH, p O 2 , p[...]

     1. Access the Select Default Panels screen from the Menu screen: a. Select 6 System Setup and press Enter . b. Select 4 Panels and press Enter . c. Select 1 Default Panel and press Enter . The Select Default Panel screen appears, as shown in Figure [...]

                    [...]

           c tHb g/dL g/L, mmol/L 840, 850, 860 pH pH H + nmol/L 840, 850, 860 O 2 SA T , F I O 2 , sO 2 , Hct, Hb Fractions % decimal[...]

     If you change parameter units for pH after the system has started to collect data, QC statistics are still computed in the current units.      Use this procedure to define the values for c tHb and p 50[...]

                      3. C[...]

         tHb c tHb O 2 Cap BO 2 AaDO 2 p O 2 (A–a)(T) a/A p O 2 (a/A)(T)  1. Access the Parameter Names screen from the Menu screen: a. Select 5 Operating Setup and press Enter . b. Select 5 Parameter Names and press Enter . The[...]

     NOTE: The default values for the action range are equal to the measurement range. If you use the default action range values, the system does not flag action range results but instead indicates that the results are out of measurement range. Change t[...]

           FO 2 Hb % 94.0 – 97.0  –99.9 – 999.9 FCOHb % 0.5 – 1.5  –99.9 – 999.9 FMetHb % 0.0 – 1.5  –99.9 – 999.9 FHHb % 0.0 – 5[...]

      Use this procedure to select automatic printing, number of copies, and printer type for the following reports:  patient sample reports  QC reports  calibration reports[...]

                 [...]

        Use this procedure to do the following:  Select the report format that the system uses to print the patient sample results.  Select the report formats[...]

   Y ou can select a report format for the roll printer and, if a line printer is connected, for a line printer . 3. Y ou can print a copy of a report to view the format and create lines of information to appear in the header of the report:  [...]

         Use this procedure to turn the roll printer on and off. When you turn the roll printer off, it is of f for all reports. Y ou cannot turn the roll printer on for a specific r[...]

        Use this procedure to turn the paper spool on or off. The paper spool automatically winds the roll printer paper as the reports print. The default value is On. 1. Access the Printing Options screen [...]

      Use this procedure to select sample analysis and menu functions for password protection. When you password protect sample analysis or menu functions, operators must en[...]

  3. Select the functions that you want to protect and press Enter . Any combination of menu options can be password protected. The password protection default value for all functions is off. 4. Press Done . 5. Define the appropriate passwords.   ?[...]

    The first operator password has a default value of 12345. T o ensure that there is always at least one active operator password, you can edit the default password, but you cannot delete it. [...]

  Operator IDs can contain 1 to 13 alphanumeric characters and can include spaces. Operator passwords can contain 1 to 8 alphanumeric characters, can include spaces, and are case sensitive. If you enter an operator ID without an operator password, the system does not accept [...]

                 [...]

       Use this procedure to change the date and time. T able 5-10 lists the date and time formats that you can use.     ?[...]

   2. Change the date and time.              Date a. Move the cursor to the Date field. b. T ype the month, date, and year in the selected format. Press Enter after[...]

        Use this procedure to change the time when the system performs the automatic cleaning of the reagent manifold. Auto Clean occurs once every 24 hours. The default time is 0200. On the first day of[...]

   b. Press 2 Maintenance T asks and press Enter . The Maintenance Setup screen appears, as shown in Figure 5-19.       ?[...]

         Use this procedure to define the number of patient samples that can be stored on your hard disk. Y ou have the option of maximizing your patient sample [...]

        Use this procedure to adjust the beeper volume. Y ou can select a high, medium, or low volume. The default value is high. 1. Access the System Options screen from the Menu sc[...]

      Use this procedure to control the way the system moves capillary samples to the measurement module. Y ou can choose to move the samples manually or to have the system [...]

        Use this procedure to select automatic transmission of patient sample results directly to an LIS, HIS, or data management system. Y [...]

     Use this procedure to define the number of significant digits reported for certain primary parameters. T able 5-13 lists the parameters that have high and low resolution options. The default valu[...]

                 [...]

  1. Access the System Options screen from the Menu screen: a. Press 6 System Setup and press Enter . b. Press 5 Systems Options and press Enter . The System Options screen appears, as shown in Figure 5-25.   [...]

      Use this procedure to define correlation coefficients. Correlation coef ficients allow you to adjust the patient results from an 800 system to match the pa[...]

  1. Access the Correlation Coef ficients screen from the Menu screen: a. Select 5 Operating Setup and press Enter . b. Select 8 Correlation and press Enter . The Correlation Coefficients screen appears, as shown in Figure 5-26.  [...]

       Use this procedure to print the setup report. The setup report contains a record of the setup options selected on your 800 system. Bayer Diagnostics recommends that you print the se[...]

     This section describes procedures for the following QC options:  creating new QC setup files  editing QC files  turning QC Auto Identity on and off  turning Auto Accept QC on and off  turning QC Auto Send[...]

       Use this procedure when you first create a new QC file. The system uses QC files to store results from QC sample analyses. Y ou can use this QC information to create reports summarizing QC resu[...]

  6. Press Ye s . The QC File Setup screen appears with all data fields empty , as shown in Figure 5-28.           ?[...]

   9. Press Done . A message appears prompting you to set up another QC file.             save your entries and create another QC file Ye s . The QC File screen appears. Contin[...]

      Use this procedure to edit QC setup information in an existing QC file under one of the following circumstances:  When you change QC lots, you want to replace the old QC file information with the new lot informat[...]

                   ?[...]

                    6. Perfor[...]

   8. Press Done when you finish. A message appears prompting you to set up another QC file.             save changes and edit another QC file Ye s . The QC File screen reappea[...]

       Use this procedure to control the way QC results are assigned to a QC file. T able 5-19 describes the options for assigning QC results.  ?[...]

         Use this function if you are connected to an LIS or data management system and you want the 800 system to automatically accept Q[...]

  5. Define another setup function or press Exit Menu to return to the Ready screen.        Use this procedure to control transmission of QC results dir[...]

        Use this procedure to print a QC setup report for any QC file. 1. Access the QC File screen from the Menu screen: a. Select 5 Operating Setup and press Enter . b. Select 1 QC Setup[...]

     This section describes procedures for the following calibration options:  changing drift limits  changing calibration gas values  selecting calibration frequency and Auto Repeat ?[...]

   1. Access the Calibration Drift Limits screen from the Menu screen: a. Select 5 Operating Setup and press Enter . b. Select 6 Calibration Setup and press Enter . c. Select 1 Drift Limits and press Enter . The Calibration Drift Limits screen appears, a[...]

                CO 2 2.00 – 7.90% 5.00% (C[...]

         Use this procedure to select the frequency at which automatic calibrations occur and to direct the syste[...]

  c. Select 2 Cal Intervals and press Enter . The Cal Intervals screen appears with the cursor in the Calibration Frequency frame, as shown in Figure 5-37.       ?[...]

       Use the following procedures to configure the 800 system for any of the following external devices:  270 CO-oximeter  800 series compatible ticket printer[...]

  2. Select the appropriate serial port, press Enter , and then press Done . Refer to T able 5-25 to determine which port to select for your device. The Device Selection screen appears, as shown in Figure 5-39. If the port already has a device assigned, that device is select[...]

            ?[...]

  5. Press Done when you finish. Y ou are prompted to configure another port.          want to configure another device Ye s . The Port Selection screen appears. do not want to configure another device No . The Menu screen appe[...]

      Bayer Diagnostics Service Representatives use the Service Setup menus to enter various types of system and service information, such as the system model number , the serial number[...]

     This section provides the following procedures for managing 800 system data files using the disk utilities:  back up and restore data files  archive QC data  view and print archived QC data  install system s[...]

      Use this procedure to copy the previous month’ s QC files and statistics from the hard disk to a diskette. The system copies all QC files at the same time. Y ou can archive the previous month’ s QC d[...]

  If you do not insert a diskette, the No Diskette in Diskette Drive message box appears. If you insert an unformatted diskette, the Cannot W rite to Diskette message box appears.         you want to continue to archive insert a formatted [...]

        Use this procedure to view QC data from archive diskettes. Y ou can also print the following QC reports from archive diskettes:  Levey-Jennings Chart  QC Sample Report  QC St[...]

  7. Perform one of the following tasks.            view the report results select the QC sample you want and press Enter . print a Levey-Jennings, QC sample, or statistical summary report press Reporting Options[...]

   If you type invalid data in a field and press Done the system displays either the Invalid Entry or Invalid Range message box. Press OK and type a valid entry in the field. If there is no QC data found for the search criteria you entered, the No QC Dat[...]

              [...]

   If you do not insert a diskette, the No Diskette in Diskette Drive message box appears. If you insert an unformatted diskette, the Cannot W rite to Diskette message box appears.         you want to continue with the[...]

  4. Complete the restore process.         a message appears prompting you to insert the next diskette a. Remove the diskette from the diskette drive. b. Insert another backup diskette and press Continue . the Restore Finished screen appea[...]

   If you want to cancel the restore process, press Cancel . When prompted, press Ye s and remove the diskette from the diskette drive. Format Disk Previous Screen Menu Done   Use this procedure to in[...]

  4. Press Continue to proceed. The following message appears: The system identifies the diskette and displays the Install Identification message box:      ?[...]

   6. After the system copies the software files, the Install Identification message box appears.         you have more program diskettes to install the Insert Next Diskette message appears on the Install Identificatio[...]

  9. Restart the system: a. W ait at least 10 seconds after disconnecting the power cord. b. Reconnect the power cord into the power source. The system restarts. After a few moments, the system starts initializing. When initializing is complete, a screen for Analyze Mode app[...]

                 [...]

    The Copy Files option allows you to copy patient data files stored on your system to a diskette in a format that can be imported into PC applications, such as spreadsheets and databases. Y ou can then use these applications for data manageme[...]

         Blank No exceptions 1 Blood gas and CO-ox sample temp out of range 2 Blood gas sample temp out of range 3 CO-ox sample temp out of [...]

     This section describes procedures to place the 800 system in standby and to shut down the system. Standby is an inactive state that disables the automatic calibration functions to reduce reagent consumption. During S[...]

   3. Exit standby .              automatically Do nothing. The system automatically exits standby at the scheduled date and time. manually Press Exit Standby[...]

        Use this procedure to shut down the system before you perform service and to restart the system when finished. 1. Access the Shutdown screen from the Menu screen: a.[...]

  [...]

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..[...]

                   ?[...]

                ?[...]

                   ?[...]

             ?[...]

        This appendix summarizes the established guidelines for handling laboratory biohazards. The summary is based on the guidelines developed by the National Institutes of Health (NIH) and the Centers for Disease[...]

    Dispose of contaminated materials according to your laboratory’ s biohazard control procedures.  Keep your work area disinfected.  Disinfect tools and other items that have been near any part of the instrument sample path or waste area with 1[...]

       This appendix provides the following service and supply information:  addresses and communication numbers for obtaining service and technical information and for ordering supplies and accessories  system warranty and [...]

   Bayer OY Suomalaistentie 7 FIN 02270 Espoo, Finland + 35 89 88 78 87 Bayer Medical Ltd. Unosawa T okyu Building 3 F1–19–15, Ebisu Shibuya–Ku T okyo 150–0013, Japan 81.3.3440.4881 Bayer Diagnostics T our Horizon 52, quai de Dion Bouton 92807 Putea[...]

  Bayer Puerto Rico Inc. Diagnostics Division V ictoria Industrial Park Building #1 Carolina, Puerto Rico 787 752–8989 Bayer T aiwan Company Limited Diagnostics Division 8/F No. 109 Sec. 2 Keelung Road T aipei, T aiwan R.O.C. 886–2–23777520 Baye[...]

          Bayer Diagnostics and its authorized distributors provide customers who acquire new Bayer Diagnostics systems[...]

       Customers, with some exceptions, may also request warranty service to be delivered outside of normal business hours, including evenings, weekend [...]

     Bayer Diagnostics or its authorized distributors will provide warranty service to customers during the warranty period, which includes appropriate parts, travel to the location of the system, and on[...]

        Bayer Diagnostics warrants to all customers that service will be performed in a professional manner consiste[...]

      Use T able B-1 and T able B-2 to find the supply or accessary you need to order .    ?[...]

     673702000 T est/Blank Sensor K + /Ca ++ /Cl – (TB3) 673396000 T est/Blank Sensor Ref (TB5) 477832000 T icket Printer 478736000 Fuse Kit 477570000 Clot Removal Kit 673703000 Aspirati[...]

      013895701 Reagent Fitting Kit (Septum Probe) 673708000 Lamp Bulb (incandescent) 014073002 9-pin Cable-Matching Connector 013899001 Loopback Connector 013902701 O-ring Kit 013903701 Blan[...]

      478498000 Reference Sensor Refill (cassette, fill solution, O-rings) 013174001 Retainer , Sample Port 013186001 Sample Port 013199001 Front Cover 477833000 Analysis Report T icket[...]

              473120000 CO-oximeter Sl[...]

    This appendix lists all references for this manual. 1. National Committee for Clinical Laboratory Standards. Blood Gas Pre–Analytical Considerations: Specimen Collection, Calibration and Controls, Approved Guideline; NCCLS Document C–27A (V ol. 13, No. 6); April 1993. 2. D[...]

   14. Moran R, Cormier A. The blood gases: pH, p O 2 , p CO 2 . Clin Chem News 1988; 14(4/5): 10–12. 15. Severinghaus JW , Bradley AF . Electrodes for blood p O 2 and p CO 2 determination. J Appl Physiol 1968; 13:515–520. 16. Shapiro BA, Harrison RA, C[...]

   31. Burritt MF , Cormier AD, Maas AHJ, Moran RF , O’Connell KM. Methodology and clinical applications of ion-selective electrodes. Proceedings of an international symposium. Danvers (MA): The Electrolyte/Blood Gas Division of the American Association of Clinical Chemistry , 1987. 32. Aberman A, Cavanille [...]

   48. Shapiro BA, Harrison RA, Cane RD, Kozlowski–T emplin R. Clinical application of blood gases. 4th ed. Chicago: Y ear Book Medical Publishers, 1989: 143. 49. Shapiro BA, Harrison RA, Cane RD, Kozlowski–T emplin R. Clinical application of blood gase[...]

       This section provides information about making the connection between an 800 series system and the following external devices:  270 CO-oximeter  800 series compatible ticket printer  bar code scanner  Bayer Diag[...]

        Use this procedure to connect an 800 system to a 270 CO-oximeter . Materials Required:  800 to 270 interface cable (part number 0141 17701) T o prevent electrical sh[...]

  f. Press ENTER to confirm your selection. g. Select the transmission specifications as shown in T able D-1.     ?[...]

   NOTE: Always use serial port 1 for the ticket printer . 3. Connect the 9-pin connector of the interface cable to serial port 1 on the 800 system. Refer to Figure D-1. 4. Connect the 25-pin connector to the printer . 5. T ighten the hold down screws on th[...]

  T o prevent electrical shock and damage to either system, disconnect the 800 system and the data management system from the AC power source before installing the cable. Refer to Shutting Down and Restarting the System in Section 5 for the procedure [...]

           Use this procedure to connect an 800 system to a laboratory information system (LIS) or hospital[...]

     This appendix provides the following information about the 800 series systems:  system specifications  limitations  reference methods  840 system performance characteristics  850 system performance characteristics[...]

     T able E-1 lists the specifications for the 800 system.    ?[...]

  T able E-2 lists the units, reporting ranges, and display resolutions for the pH and blood gas parameters measured by the 800 system.       ?[...]

        Lactate mg/dL mmol/L 0.0 – 270.3 0.00 – 30.00 0.1 0.01 AnGap mmol/L –5.0 – 50.0 0.1  T able E-4 lists the units, reporting r[...]

       c tO 2 (a-v) mL/dL mL/L mmol/L 0.0 – 20.0 0 – 200 0.0 – 9.0 0.1 1 0.1 c tO 2 ([a-v]/a)) % decimal fraction 0 – 100 0.00 – 1.00 1 [...]

        % –99.9 – 999.9 0.1 F MetHb fraction –0.999 – 9.999 0.001 % –99.9 – 999.9 0.1 F HHb fraction –0.999 – 9.999 0.001 % –[...]

       p O 2 (A–a)(T) mmHg kPa 0 – 800.0 0 – 106.67 0.1 0.01 p O 2 (a/A)(T) % decimal fraction 0 – 100 0.00 – 1.00 1 0.01 RI(T) % decima[...]

   T able E-8 lists the units, reporting ranges, and display resolutions for the parameters that can be entered into the 800 system.     [...]

    The following reference methods were used for the 800 systems.    pH IFCC reference method , * also referenced by NCCLS document C–27A. 1 p [...]

    Bayer Diagnostics cannot guarantee system performance when any of the following situations occur . Specific terms of warranty , service, and contract agreements may be invalidated if any of these situations occur . ?[...]

      All performance data presented in this section were generated using 840 systems. The system used default correlation factors, and performed calibr[...]

   Precision on aqueous calibration verification materials was estimated using three 840 systems. At least seven runs per instrument were made over five days. T wo replicates of each control level were analyzed in each run. T able E-10 summarizes the res[...]

  T able E-1 1 through T able E-13 summarize the results of the 840 system whole blood and expired gas recovery precision testing.        ?[...]

                 [...]

          Capillary 18 0.68 71.7 71.3 100.6 Microcapillary 24 2.24 71.0 71.3 99.5 Microsyringe 24 0.33 71.4 71.3 100.1 Expired Gas 24 0.17 7[...]

           4 Syringe 24 0.97 150.5 149.7 100.5 Capillary 18 0.86 150.2 149.7 100.3 Microcapillary 24 2.00 151.8 149.7 101.4 Microsyringe [...]

      All performance data presented in this section was generated using 850 systems. The system used default correlation factors, and performed calibra[...]

           2 71 133.0 0.21 0.86 3 72 154.5 0.36 1.58 K + 1 72 2.42 0.007 0.023 2 71 4.96 0.017 0.036 3 72 7.71 0.022 0.087 Cl – 1 72 79.2 0.35 0.57 2 71 101.7 0.2[...]

           p O 2 1 44 25.8 1.39 1.97 4 44 237.7 2.99 5.78 Na + 1 44 102.4 0.34 1.31 4 44 167.2 0.48 1.43 K + 1 44 2.04 0.059 0.073 4 44 16.87 0.170 0.235 Cl – 1 44 1[...]

   T able E-16 through T able E-22 summarize the results of the 850 system whole blood, expired gas, and electrolyte recovery and precision testing.     ?[...]

                 [...]

           Capillary 24 1.20 71.7 71.3 100.6 Microcapillary 18 1.36 71.1 71.3 99.7 Microsyringe 18 0.55 70.5 71.3 98.9 Expired Gas 18 0.4[...]

          4 Syringe 18 2.65 149.6 149.7 99.9 Capillary 22 0.83 150.0 149.7 100.2 Microcapillary 18 0.98 150.0 149.7 100.2 Microsyringe 18 0.[...]

                  ?[...]

                 [...]

                 [...]

                 [...]

       All performance data presented in this section was generated using 860 systems. The system used default correlation factors, and performed cal[...]

     Thiocyanate 80 mg/dL Bilirubin (Direct) 30 mg/dL Bilirubin (T otal) 34 mg/dL Creatinine 30 mg/dL Hydroxybutyrate 200 mg/dL Lactate 100 mg/dL Urea 500 mg/dL Uric Acid 10[...]

   T able E-25 lists substances that interfere with the glucose measurement.       [...]

         T o test for interferences, serum was spiked with a potentially interfering substance up to the test concentration shown in the following[...]

      Bilirubin (Direct) 30 mg/dL Bilirubin (T otal) 35 mg/dL Creatinine 30 mg/dL Glucose 1000 mg/dL Hydroxybutyrate 200 mg/dL Urea 500 mg/dL Guaiacol 5 mg/dL Pyruvate 9 [...]

  Refer to Sample Collection Devices and Anticoagulants in Section 1 for the specific requirements on sample handling and anticoagulants.     ?[...]

            2 241 43.0 0.89 1.41 3 185 23.0 0.64 0.81 p O 2 1 387 61.7 1.79 2.17 2 316 103.5 1.46 2.66 3 236 152.3 1.89 4.51 Na + 1 387 1 12.7 0.25 0.62 2 316 135.1[...]

          2 177 0.99 0.01 1 0.049 3 170 0.52 0.008 0.033  * WRSD = within-run standard deviation  T otSD = total standard deviation  Performance determined wi[...]

            For testing syringe, capillary , microsyringe, and microcapillary modes, blood was collected in[...]

          Capillary 48 0.004 7.507 7.502 100.1 Microcapillary 36 0.005 7.529 7.526 100.0 Microsyringe 48 0.004 7.503 7.500 100.0 pH/L yte 36[...]

           Capillary 23 0.44 50.3 49.9 100.8 Microcapillary 24 0.71 49.9 49.9 100.0 Microsyringe 24 0.54 49.8 49.9 99.7 Expired Gas 18 0.[...]

          3 Syringe 24 1.19 84.9 85.6 99.2 Capillary 24 0.61 85.4 85.6 99.7 Microcapillary 24 0.80 84.8 85.6 99.0 Microsyringe 24 1.08 85.2 [...]

           pH/L yte 21 0.42 1 17.8 1 19.1 98.9 148.7 Syringe 24 0.63 149.2 149.9 99.5 Capillary 24 0.44 149.0 149.7 99.5 Microcapillary 3[...]

                 [...]

                 [...]

                 [...]

                 [...]

              [...]

       All performance data presented in this section was generated using the 800 system CO-ox modules. The system performed recommended tHb sl[...]

  T able E-41 lists substances that were found not to interfere using the criteria stated in T able E-40.      ?[...]

              Fetal Hemoglobin at 80% tHb COHb MetHb HHb –0.9 g/dL +3.1% –1.1% –2.6% Carboxymethylcellulose tH[...]

           F COHb 1 96 52.64 0.18 0.35 2 96 32.03 0.16 0.30 3 96 9.52 0.35 0.39 F MetHb 1 96 5.05 0.13 0.23 2 96 4.70 0.14 0.24 3 96 4.07 0.19 0.30 F HHb 1 96 36.52 0.[...]

               Syringe 66 92.18 0.90 0.39 F COHb Capillary 72 4.23 –0.43 0.33 Syr[...]

                ?[...]

  [...]

     This appendix contains examples of the patient sample reports that you can print on the roll printer , the line printer , and the 800 series compatible ticket printer . The examples display all parameters, patient sample data fields, temperature corrected values, [...]

       .................................................................................................................... ........................................[...]

        Roll Printer Report B displays temperature corrected values next to the original values, and it does not display reference ranges. Figure F-2 shows an example of Roll Printer Report B. ?[...]

       Roll Printer Report C is similar to Roll Printer Report B, except that it lists blood gas and CO-oximeter values separately . Figure F-3 shows an example of Roll Printer Report C. ?[...]

        Roll Printer Report D provides a four-column layout of parameters. Figure F-4 shows an example of Roll Printer Report D.     ................[...]

       Roll Printer Report E is similar to Report C, except that it includes the pH value with the blood gas values. Figure F-5 shows a sample of Roll Printer Report E. ?[...]

       This section contains examples of the patient sample reports that you can print on a line printer . The examples include all possible parameters, patient sample data fields, temperature corrected values, entered values, and CO-oximeter[...]

       Line Printer Report A is the default line printer report. It includes the CO-oximeter values with the oxygen status values. Figure F-6 shows an example of Line Printer Report A. [...]

        Line Printer Report B lists blood gas and CO-oximetry values separately . Figure F-7 shows an example of Line Printer Report B.     .........[...]

       Line Printer Report C is similar to Report B, except that it includes the pH value with the blood gas values. Figure F-8 shows an example of Line Printer Report C. ?[...]

      This section contains an example of the patient sample report you can generate from the 800 series compatible ticket printer . The ticket printer report displays only 45 lines of data. Y ou can define the data that appears on the [...]

         ............................................................................................ .................[...]

     The 800 system provides a setup option, Defining Corr elation Coefficients, that you can use to adjust the slope and intercept values to correlate results from an 800 system with results from another analyzer or methodology . Before changing t[...]

   7. Perform a linear regression analysis of the duplicate pairs of results a. The regression should be performed by a computer capable of calculating the regression by the Deming method. The debiased slope and offset provided by this method is the recomme[...]

    Y our 800 system should be installed by an authorized Bayer Diagnostics representative. Use the following procedure to install your 800 system yourself only if you are located in a region where Bayer Diagnostics Field Service Representatives do not perform installation. [...]

   2. Inspect the packing case and report any damage to the shipper . Notify your Bayer Diagnostics representative at installation. 3. Cut the shipping straps and open the packing case. 4. Remove the installation tray and set it aside. 5. Carefully lift the[...]

                  ?[...]

        Power Input Fuse Compartment Door Air Filter Cover Fuse Compartment Door Notch Voltage Selection Bobbin Window Voltage Bobbin 100 VA[...]

  Refer to the table below to identify the correct fuses for the voltage you use.        100/120V 4A Slo Blo 5 x 20 mm 220/240V 2A Slo Blo 5 x 20 mm  g. Install the fuses as shown in Figure H-3. h. Slide the fuse holder(s) back[...]

               ?[...]

        Second Stage Pressure Gauge Main Tank Pressure Gauge Needle Valve Adjustment Knob Gas Tank i. Connect one end of a length of black tubing to the regulator fitting on the slop[...]

   21. Install the reagents:  Do not tighten or remove the bottle cap or attempt to mix the contents of one bottle with another . The bottle caps are adjusted to ensure proper reagent flow . a. Remove the plugs from the reagent bottle c[...]

  24. Install the reference sensor: a. Open the measurement module door by pushing up on the latches located on the lower corners to release the door , and then lifting the door up. b. Push the spring-loaded latch to the right. c. V erify that the O-rings are in place on both sides of the sensor . d. V e[...]

   30. V erify that the sensors are installed in the following order:                                 ?[...]

  e. Pull the paper from under the platen and push it through the slot in the printer cover . f. Push the printer lever down. 35. Close the printer cover: a. Pull up the paper spool. b. Insert the paper into the paper slot on the spool and turn three or four rotations. Press Paper Advance if there is [...]

    If the temperature is outside of the range, verify that the power has been on for at least 30 minutes. 40. Access the Barometer screen from the Menu screen: a. Select 1 Calibration and press Enter . b. Select 8 Barometer and pres[...]

  48. V erify sensor performance by completing two successful two-point calibrations. The Ready screen appears when the calibration finishes. 49. Analyze QC material and verify acceptable results. 50. Replace the front cover .    [...]

     ambient operating barometric pressure 400 – 825 mmHg (53.0 – 110.0 kPa) system dimensions height 30.3 cm (11.94 inches) when installed 47.8 cm (18.81 inches) width 17.35 cm (6.83 inc[...]

  8. Carefully remove the foam end caps from the module. 9. Remove the plastic bag surrounding the module. 10. Remove any tape used to secure parts during shipment.     If you are installing the CO-ox module to an operational 800 series sy[...]

               ?[...]

            This procedure refers to right and left as you are looking at the rear of system. NOTE: Placing a piece of paper under the CO-ox module will allow for easier [...]

   9. Open the hydraulic walls and lock the counterbalance hinges. 10. Tighten the two screws in the alignment bosses on the CO-ox module chassis to the chassis receptacles of the 800 base model. 1 1. Install the two plugs retained from the 800 base mode[...]

  NOTE: Ensure that the waste tubing is positioned through the hole on the CO-ox module fluid detector . 5. Connect the waste tubing to the 800 base model manifold. 6. Connect the sample tubing to the sample connector .     [...]

   2. Plug the power cord into the AC power receptacle. At startup, the system proceeds through a series of initial tests and then displays Initializing in the banner . Any errors incurred during initialization are posted to the status log. 3. Access the[...]

   lint-free tissue and swabs  aspiration adapter  test/blank sodium or pH sensor (TB2)  glucose test/blank sensor (TB4)  lactate test/blank sensor (TB4)  reference test/blank sensor (TB5)  valve wrench BIOHAZARD: Refer to Appendix A for recommended precautions when working with b[...]

     Prolonged exposure to the 10% bleach solution damages the reference sensor membrane. Y ou must replace the reference sensor with a test/blank ref sensor (TB5) while you complete the cleaning procedure. Do not substitute[...]

        1. Remove all the reagent bottles from the system and perform a prime sequence. 2. Access the Prime screen from the Menu screen: a. Select 2 Maintenance and press Enter . b. Select[...]

       Drip Tray Sample Door Retainer Ring Mount Sample Port O-ring 4. Grasp the sample port and drip tray and pull it to the right to remove it. [...]

  NOTE: Do not insert swabs into the sample port or spray anything into the measurement module. 2. Rinse the exterior surfaces with reagent water . 3. Clean spills around any of the roller cages, if required: a. Remove the roller cage as described in Replacing a Roller Cage in Section 3. b. Clean the [...]

        Compressed gas tanks require cautious handling. T o prevent damage and possible personal injury , refer to Replacing the Gas T anks in Section 3, for more detailed precautions. 1. Remove th[...]

  g. When each gas tank is completely vented and the pressure is zero, label the container Empty , and dispose of the tanks according to your laboratory protocol. Bayer Diagnostics recommends that you remove the valve stems before disposal. 2. Pack the 800 system in the original shipping carton. If th[...]

  [...]

     The measurement technology used for the 800 critical blood analytes systems is based on electrochemical, biochemical and optical phenomena. Electrochemistry involves the measurement of current or voltage occurring in an electrochemical cell. The cel[...]

     Voltmeter Sample Solution Reference Electrode Measuring Electrode Liquid Junction Each electrode, which acts as a half-cell with a half-cell potential, contain[...]

  System sensors are designed to measure a specific substance in a sample. T o better understand the ability of a sensor to measure specific substances, consider ion-selective electrode (ISE) technology . Many of the sensors, like the pH sensor , are designed with this technology [...]

   E cell = (E ref elmt + E memb ) – (E ref + E lj ) where E cell = electrochemical cell potential E ref = reference electrode half-cell potential E ref elmt = potential of the ISE inner reference element E memb = potential of the ISE membrane E lj = liqu[...]

  I = 1/2 ∑ m * z 2 where I = ionic strength of the solution z = the charge number of the ions in solution m = concentration of the ion (mol/L) The activity coefficient generally decreases with increasing ionic strength. 10 Using an established convention, the activity of ions t[...]

   The reference sensor contains a silver (Ag) wire, coated with a layer of silver chloride (AgCl) and an ion permeable polymer , surrounded by a saturated potassium chloride (KCl) solution. By ensuring that the concentration of Cl – remains unchanged in [...]

  The electrochemical cell contains two electrodes: the anode, which is positively charged and the cathode, which is negatively char ged. The measuring electrode, which is frequently composed of platinum(Pt) or another noble metal, can be either the anode or the cathode. Each elec[...]

        The notation of pH expresses the hydrogen ion activity in a solution as the negative logarithm of the hydrogen ion concentration. The hydrogen ion is actually the determinant of th[...]

  pH is clinically significant as a means of determining acid-base disturbances. Acid-base disorders can result in several pathologic conditions. An acid-base disorder resulting initially from ventilatory dysfunction is called a primary respiratory acidosis or alkalosis, while a d[...]

   The levels of HCO 3 – , H 2 CO 3 , and dissolved CO 2 play a major role in maintaining the pH in blood. This relationship is best described through the Henderson-Hasselbalch equation:        S[...]

     The p CO 2 sensor is based upon the electrode described by Severinghaus and Bradley . 15 It is a complete electrochemical cell that consists of a measuring electrode and an internal reference electrode. The measuring electrode, which is a pH e[...]

   Since it is not possible to measure intra-cellular oxygen tension ( p O 2 ), arterial p O 2 has become a standard for clinical evaluation of arterial oxygenation status. Measurement of p O 2 (A), which indicates the oxygen tension in arterial blood, r[...]

     Sample Path Cathode Contact Anode Contact A constant voltage, called a polarizing voltage, is maintained between the anode and the cathode. As dissolved oxygen from the sample passes through the membrane int[...]

      Potassium, Chloride, and Calcium Sensor Sample Path Silver/Silver Chloride Wire Electrolyte Solution Silver/Silver Chloride Wire[...]

     Sodium (Na + ) is the most abundant cation in the extracellular space in the body . It is the major determinant of extracellular osmotic regulation and plays a central role in determining body fluid volume. The[...]

   Most potassium is excreted by the kidney , which is the major regulator of potassium output in the body . Actually , the kidney is better at conserving sodium and excreting potassium so in cases where potassium intake stops, the kidney requires time t[...]

  Hypochloremia is usually seen in states of hyponatremia. However in pyloric stenosis, chloride levels are usually proportionally lower than sodium levels. Hyperchloremia is seen in cases of excessive administration of chloride and in renal failure. Additionally , because the [...]

   In critical care situations, especially where large amounts of blood are being transferred, ionized calcium levels should be monitored closely . Transfused blood typically contains citrate as an anticoagulant that can bind ionized calcium and affect i[...]

  A number of factors influence the level of blood glucose. Dietary intake has a direct effect of glucose concentration. Blood levels of glucose will fluctuate depending on nutritional condition and the time of day when a sample is taken. Insulin, a hormone produced by speciali[...]

       The glucose and lactate biosensors are complete electrochemical cells that incorporate amperometric technology to measure glucose or lactate concentration in samples.[...]

  The loss of electrons in the oxidation of H 2 O 2 creates a current flow that is directly proportional to the lactate concentration in the sample. In the lactate sensor , lactic acid from the sample interacts with the lactate oxidase on the surface of the measuring electrode [...]

   Hyperlipemia can result in artificially increased methemoglobin values. 42, 43 High bilirubin concentrations can falsely increase oxyhemoglobin values. Hyperlipemia and administration of fat emulsions can increase total hemoglobin values. Samples froz[...]

   Methemoglobin (MetHb), which is sometimes known as hemoglobin Hi, is hemoglobin whose iron is oxidized to its ferric state (FE(1 1 1) and is unable to bind oxygen. High methemoglobin concentrations, a condition called methemoglobinemia,[...]

   The CO-oximeter (CO-ox) module detects and indicates concentrations of sulfhemoglobin greater than 1.5%.     Hemoglobin derivatives have charac[...]

   the polychromator—which consists of coupling lenses, entrance slot, collimating mirror , grating camera mirror , and the diode array Light from the lamp passes through the lenses, a series of filters, and the fiber optic coupler to the sample chamber . The light is coup[...]

   where pK, which is the dissociation constant describing the ability to release hydrogen ions , equals 6.105 for normal plasma, and 0.0307 is a combination of CO 2 solubility in plasma and a factor for converting mmHg to mmol/L. The equation can be fur[...]

    Base excess is an empirical expression that approximates the amount of acid or base required to titrate one liter of blood back to a normal pH of 7.40. The base excess in blood with a pH of 7.40, a p CO 2 of 40 mmHg (5.33 kPa), a total hemoglob[...]

   Oxygen saturation can be directly measured or it can be estimated using the relationship described by Kelman 24 and Thomas 25 : O 2 SA T = × 100 N 4 – 15N 3 + 2045N 2 + 2000N N 4 – 15N 3 + 2400N 2 – 31,100N + (2.4 × 10 6 ) where N = p O 2 × 1[...]

  Oxygen content is determined, using NCCLS recommendations, 26 from the following relationship: c tO 2 = F O 2 Hb × 1.xx × c tHb + 0.00314 × p O 2 where c tHb is expressed in g/dL. If F O 2 Hb is unavailable, oxygen content is derived from estimated oxygen saturation (O 2 S[...]

       The oxygen capacity of hemoglobin (BO 2 or O 2 CAP ) is the maximum amount of oxygen that the hemoglobin in a given quantity of blood can carry . This value represents t[...]

  sO   i  7  i  0 K    [( p O 2 S – 27.5)  ( p O  S  27.5)] i K   51.87074 K   129.8325 K   6.82836 8 K   –223.7881 K   –27.953 K   258.5009 K   21.84175 K   –1 19.2322   [...]

       All measurements and calculations are based upon a standard temperature of 37.0 ° C. During sample analysis, you can enter the actual patient temperature value, w[...]

  The 800 system does not report alveolar oxygen tension, but uses the p O 2 (A) value to calculate the alveolar-arterial oxygen tension dif ference and the arterial-alveolar oxygen tension ratio.     ?[...]

       Ionized calcium values are dependent upon sample pH. The calcium value adjusted to pH of 7.40 reflects the true ionized calcium concentration of blood normalized to pH 7.40. Calcium[...]

      When mixed venous blood gases from the pulmonary artery are combined with arterial blood gas measurements, the results frequently clarify the cardiopulmonary status and assist in determining [...]

      The a-v extraction index ( c tO 2 ([a-v]/a)) aids in the interpretation of the arterial-venous oxygen content difference and can indicate inadequate oxygen content in arterial blood or inadequat[...]

  The system determines the physiologic shunt using the following equation: 32 Qst/Qt(T) = c tO 2 (c)- c tO 2 (a) c tO 2 (c)- c tO 2 (v) where c tO 2 (c) = [1.39 x c tHb x (1 - FCOHb - F MetHb)] + (0.00314 x A); A = [( F I O 2 /100) x (pAtm - pH2O)] - {pCO 2 x [ 1.25 - (0.25 x [...]

     As with all diagnostic tests, each laboratory should establish its own reference ranges for the diagnostic evaluation of patient results. Bayer Diagnostics recommends that the reference ranges listed belo[...]

      Appendix J provides Maintenance Checklist charts for you to record maintenance activities performed on the 800 system. Make photocopies of these charts as necessary and record your maintenance activities according to the mainte[...]

  [...]

                                                           [...]

                             [...]

                   ?[...]

                                                           [...]

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Reagent W ater Quality Introduction Water quality is an important consider- ation in the laboratory because it can significantly affect the outcome of laboratory procedures and the measure- ment of patient samples. This bulletin provides an overview of reagent water quality guidelines as specified by the National Committee for Clinical Laboratory[...]

The quality of the reagent water you produce depends on the quality of the water you start with (source water), and the performance of your water purification system. To produce the type of water you require, you may need a purification system that uses a combination of methods. For example, if you want to produce Type I water, you need a system [...]

References 1. National Committee for Clinical Laboratory Standards. Preparation and testing of reagent water in the clinical laboratory. 2nd ed. Villanova (PA): NCCLS; 1991 Aug. 37 p. (NCCLS Document C3-A2). 2. Tietz, Norbert W. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B. Saunders Company; 1987. 1010 p. 3. Kaplan, Lawrence A. Pes[...]

107060 Rev. C 10/99 Manufactured by: Bayer Corporation East Walpole, MA 02032-1597 USA Bayer Argentina S.A. Division Diagnósticos Buenos Aires, Argentina Bayer Australia Limited Diagnostics Business Group Scoresby, Victoria 3179, Australia Bayer Austria GesmbH GB Diagnostika A-1164 Wien, Austria Bayer Diagnostics 1050 Bruxelles, Belgium Bayer S.A.[...]

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   Accept The F-key that lets you store QC results in a QC file and update the statistics in the QC file. accession number A number , not assigned by the 800 system, used to identify a sample. The number is usually assigned by the hospital or laboratory to cross reference the analysis for billin[...]

    Auto Send The system setup option that automatically sends patient or QC sample results to a laboratory information system (LIS) or data management system. Backup The Disk Utilities menu option that copies all the system files to di[...]

   check box A box next to each option in a list of options that indicates whether the option is chosen. If the option is chosen, the box is filled in. If the option is not chosen, the box appears empty . Y ou can select more than one option from a list of options with check boxes. Clear Entry T[...]

    Data Recall The menu option that lets you access stored data, such as patient, quality control, and calibration data, and workload statistics. D code A diagnostic code, which appears in the status area of the screen, that you use as[...]

   External Loopback The Communications menu option that performs an external communications loopback test. This test verifies the internal communications through the serial ports and external cables. File 13 A storage file containing QC data that Bayer Diagnostics field service engineers use du[...]

    fluidic system The subsystem responsible for the movement of fluids in the 800 system, including tubing, pumps, fluid detectors, waste system, solenoid valves, and reagents. frame The boxed area on a screen that displays information[...]

   Levey-Jennings chart A visual representation of measured QC values used to detect results that fall outside of the established control limits and to observe trends or shifts in control values. LIS Laboratory information system. A computer system that is used for data management in one or more[...]

    Operating Setup The Menu screen option that lets you define QC setup, reference and action ranges, patient data entry , report formats, measurement units, parameter names, printing options, calibration setup, printing options, and c[...]

   platen The component in a pump that, in conjunction with the roller cage, applies pressure to the tubing to move liquids through the system with a pumping action. The pumping action seals the tubing to prevent a vacuum from reaching the measurement module. power supply The component that acce[...]

    reagent A substance that the system uses because of its chemical or biological activity to detect or measure the analytes present in a patient sample, to analyze a QC sample, to calibrate the system, or to wash system tubing. rea[...]

   required fields Patient data entry fields in which you must enter a value. For example, if the Patient T emp field is a required field, you must enter a patient temperature in the field before you can access the next screen. Y ou define required fields in Setup. Restore The Disk Utilities [...]

    Security Options The System Setup Menu option that lets you define passwords for the system and for Menu mode. sensor A device designed to detect a particular analyte in a sample. The pH and the p CO 2 sensors are examples. senso[...]

   system message A message that appears in the status area of the screen that describes the status of certain system operations. System Options The System Setup menu option that lets you define system options. The options include Reporting Resolution, Beeper V olume, Auto Move Capillary Samp[...]

    waste detector The component beneath the waste bottle that detects the presence of the waste bottle and detects the amount of liquid in the bottle to prevent waste overflow . work area The area on the screen that displays the scr[...]

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  ?, 2-31, 2-32, 4-99, 4-1 16 ?=If Blood, Question Data, 4-7 to 4-9 #, 2-31, 2-32, 4-98, 4-1 18 –––––– ↑ , 2-30, 2-32, 4-95, 4-98 –––––– ↓ , 2-30, 2-32, 4-95, 4-98 *, 2-30, 2-32, 4-97 ******, 2-30, 2-32 **Empty**, 2-30, 2-32, 2-40, 4-95, 4-98, 4-1 16, 4-1 18, E-8, I-36 ↑ , 2-30, 2-32[...]

     bicarbonate ion, I-25 biohazards, 2-3 meaning of warning, xviii protecting yourself from, A-1 waste disposal, 1-38 bubbles detecting before measurement, 2-3 detecting during measurement, 2-4 effect on results, 2-4 Bubbles Detected in Sample, 4-1 14 [...]

 intended use, 1-41 storing, 1-42 conditioning the sensors, 3-14 CO-ox cover , close before analyzing sample, 2-6 CO-ox Cover is Open message, 4-6 CO-ox Cover Open During Meas message, 2-33, 4-6 CO-ox Cover Open During Zero message, 4-6 CO-ox measurement, insufficient sample volume, 2-8 CO-ox module integration time (zero calib[...]

     managing, 5-67 to 5-82 data management system configuring an 800 system for , 5-62 connecting to an 800 system, D-4 date and time changing, 5-31 to 5-32 selecting a format, 5-31 Date and T ime Setup screen, 5-31 default passwords menu options, 5-30 [...]

 glucose and lactate biosensors, measurement principles, lactate biosensor , I-20 glucose biosensor , interfering substances, E-28 to E-30  Help key , 1-24 Help program, 1-32 hematocrit, I-31 hemolyzer anvil, 3-30 cleaning, 3-30 disassembling (illustration), 3-30 hepatitis B virus (HBV), A-1 hex tool (illustration), 3-73 Hom[...]

     temperature range (warning), 4-1 12, 4-1 19 Measurement Module Door Open message, 4-8 Measurement Module T emp Error message, 2-33 Measurement Module T emp W arning message, 2-33 measurement test, 4-55, 4-70 to 4-74 printing stored signals, 4-70 tes[...]

 fields, 5-6 screen, 2-27 patient sample analysis canceling, 2-4 capillary samples, 2-8 to 2-29 inserting (illustration), 2-8 moving automatically , 5-37 moving manually , 2-9 sample volume requirements, 2-8 combining results with 270 CO-oximeter results, 2-22 to 2-29 CO-ox only , sample volume requirements, 2-14 CO-ox only sam[...]

     QC Data Search Result screen, 2-47 QC file information, 5-45 QC File Information form, screen, 2-43 QC File Information form (screen), 2-43 QC File Setup (Ranges) screen, 5-47 QC File Setup screen, 5-46 QC files, 1-52 creating new QC files, 5-46 edi[...]

 troubleshooting, 4-1 1 1 turning on or off, 5-24 roll printer test, 4-56, 4-76  sample chamber cleaning, 3-26 to 3-29 removing (illustration), 3-27 replacing. See cleaning sample chamber gasket (illustration), 3-27 sample connector (illustration), 4-92 sample count, 5-5 sample devices, 1-35 identifying, 2-3 sample entry com[...]

     reference sensor internal electrode (illustration), 3-78 reservoir cap from reference sensor (illustration), 3-70 sample ground/temperature sensor (illustration), 3-49 replacing glucose and lactate biosensors, 3-86 to 3-89 measurement sensors, 3-[...]

  temperature/ p Atm test, 4-55, 4-69 tHb See also CO–ox module measurement principles, I-22 tHb measurement values, 5-15 tHb slope analyze mode, 2-57 menu mode, 2-57 tHb Slope Calibration Due message, 4-9 tHb Slope Calibration screen, 2-57 ticket printer configuring an 800 system for , 5-62 connecting to an 800 system,[...]