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Bayer HealthCare Rapidlab 800 Operator's Manual
Bayer HealthCare Rapidlab 800 Operator's Manual

Bayer HealthCare Rapidlab 800 Operator's Manual

Rapidlab 800 series diagnostycs systems

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2000 Bayer Corporation.
All rights reserved.
115701 Rev C., 4/2000

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Summary of Contents for Bayer HealthCare Rapidlab 800

  • Page 1 2000 Bayer Corporation. All rights reserved. 115701 Rev C., 4/2000...
  • Page 2 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 Vitro Diagnostics Use. Certain and Ready Sensors are trademarks of Bayer Corporation.
  • Page 15 800 series systems. The Bayer Diagnostics 800 system document set includes the following: Rapidlab 800 Operator’s Manual Rapidlab 800 Quick Reference Guide Rapidlab 800 Interface Specification Manual These documents are designed to meet the needs of:...
  • Page 16 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. review system features and Section 1, Learning About the System capabilities and the theory and principles of operation identify 800 series system Section 1, Learning About the System components, including the...
  • Page 17 obtain service and technical Appendix B, Service and Supplies information and order supplies Appendix C, References interface external devices, Appendix D, Connecting to External Devices such as a CO-oximeter or a laboratory information system review system performance Appendix E, Performance Characteristics characteristics Appendix F, Printed Reports install the system...
  • Page 18 This is the abbreviation used for systems with a CO-oximeter module attached. Procedural notes appear after many of the procedures in the Rapidlab 800 Operator’s Manual. They explain conditions that can happen when a procedure is not performed as intended. They also contain brief explanations about how to handle an unexpected situation or how to discontinue a process.
  • Page 19 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. This symbol warns you of a possible burn hazard for the lamp. Wait at least 5 minutes after the lamp has been off to allow sufficient time for it to cool.
  • Page 27 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. These systems are used for the determination of pO...
  • Page 28 The 850 and 860 systems report the following parameters: calcium ion concentration adjusted to pH 7.4 [Ca anion gap (AnGap) In addition, the 844, 845, 854, 855, 864, and 865 systems report the following parameters: hematocrit hemoglobin oxygen saturation (sO oxygen content of hemoglobin [ctO oxygen capacity of hemoglobin (O partial pressure of oxygen at 50% saturation (p50)
  • Page 29 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 reduce maintenance. analyzing samples fully automated sampler that controls sample delivery with a technique-independent sample entry automated sample entry that minimizes exposure to the...
  • Page 30 maintenance and low maintenance Ready Sensors troubleshooting reduced number of system parts and system complexity waste system designed for biosafety automatic, reagent-path cleaning cycle expanding system advanced on-board data management capabilities bidirectional communication with your information systems and Chiron Diagnostics data management systems combined results with an optional CO-ox full-page reports (8.5 x 11 inches) with an optional line...
  • Page 31 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 systems have four reagent bottles. Keypad Measurement Module Window Analyze Key...
  • Page 32 Keypad Reagent Pump Measurement Module Door Latch Measurement Module Analyze Key Sample Entry Reagent Bottles Gas Tubing Screen Sample Pump Waste Pump Reagent Manifold Measurement Module Door Latch Waste Bottle...
  • Page 33 CO-ox Pump Sample Chamber Hemolyzer CO-ox Module...
  • Page 34 Diskette Eject Button Diskette Drive Air Filter Cover Fuse Compartment Power Input...
  • Page 35 Paper Spool Bar Code Scanner Port Serial Port 1 Serial Port 2 Serial Port 3 Contrast Knob Lamp Cover Network Port Parallel Port Keyboard Port Air Filter Cover Base Model Interface...
  • Page 36 Contrast Knob Screen F-keys Help Home CIBA-CORNING Help Key Home Key – Enter Paper Spool Key Enter Key Paper Advance Key Arrow Keys Numeric Keys Printer...
  • Page 37 The 800 system components consist of the following functional groups: base model measurement module CO-ox model measurement module fluidic components electronic components The following illustrations show the measurement module components. Table 1-1 describes these components and their functions. Preheater The preheater warms the sample to 37 C. Sensors The sensors detect analytes present in the sample and form the actual sample path.
  • Page 38 Measurement Block Preheater Sensor Sensor Sample Ground/ Temperature Sensor pH Sensor Reference Sensor Measurement Block Preheater Sensor Sensor Sample Ground/ Temperature Sensor pH Sensor K + Sensor Ca ++ Sensor Measurement Module Door Latch Measurement Module Door Release Spring-Loaded Latch Na + Sensor Cl –...
  • Page 39 Measurement Block Preheater Sensor Sensor Sample Ground/ Temperature Sensor Glucose Sensor Lactate Sensor pH Sensor K + Sensor The CO-ox module is connected to the base model, which supplies power to the module. The 844, 854, and 864 systems analyze samples for tHb and FO 845, 855, and 865 systems anlayze samples for tHb, FO FCOHb.
  • Page 40 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 is warmed to 37 C. The fluidic components move fluids, gases, and samples through the 800 system.
  • Page 41 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 11 solenoid valves allow the fluids and gases to pass through the system. The solenoid valves are located in the reagent manifold.
  • Page 42 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 that the sample is positioned correctly for accurate measurement. Detectors 3 and 4, located in the reagent manifold, sense the presence of the reagents in the system.
  • Page 43 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 with hemoglobin analysis in the sample chamber. All CO-ox module samples pass through the hemolyzer before entering the sample chamber.
  • Page 44 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 programmable gain; the premux board then sends the signal to the DAS PC board.
  • Page 45 The user interface, shown in Figure 1-10, consists of components that you use to direct system activities and obtain operating status information. Contrast Knob Screen F-keys Help Home CIBA-CORNING Help Key Home Key – Enter Paper Spool Key Enter Key Paper Advance Key Arrow Keys Numeric Keys...
  • Page 46 You use the system keys to direct system activities and to move through the software. The 800 system has the following keys: Analyze Analyze arrows Enter Help Help Home Home numeric paper advance starts analysis move the cursor in the direction of the selected arrow accepts selected options and moves from field to field;...
  • Page 47 paper spool F-keys You can use an IBM AT compatible, 101-key, alpha-numeric keyboard to operate an 800 system. Use the following keys on the keyboard to simulate the system keys on the 800 system keypad: Analyze Roll Printer Paper Advance Help Home Home...
  • Page 48 You 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. Previous Screen return to the frame or screen from which you accessed the current screen.
  • Page 49 Screen elements are the components on the screen that enable you to interact with the system software.
  • Page 50 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 installed on the system.
  • Page 51 The Menu mode lets you perform infrequently required functions. You 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 to move up and down a menu to highlight the option you want. As you highlight an option in the Main Menu, another menu appears to the right.
  • Page 53 Use menu codes to quickly select menu options from the Main Menu on the Menu screen. To use menu codes, you press the numeric key for the menu option instead of using arrow keys and pressing Enter. NOTE: For menu codes to work properly, begin only when the cursor is in the Main Menu.
  • Page 54 Use the Help program to get information about your 800 system. You 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 help during an operation, the Help screen appears and the operation continues in the background.
  • Page 55 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 C27–A, Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls. Since blood gases are typically the most sensitive of the parameters measured by the 800 system, the requirements and procedures described in this section are based on techniques appropriate to pH and blood gas analysis.
  • Page 56 The following limitations apply to the 850 and 860 systems: Avoid hemolyzed samples, because they falsely elevate potassium levels due to intra-erythrocyte potassium levels. Avoid samples with elevated levels of salicylates, salicylate derivatives such as – ibuprofen, and bromide (Br ), because they falsely elevate chloride levels.
  • Page 57 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 oxygenation status. capillary blood Capillary blood, when carefully collected under the proper conditions, resembles arterial blood and can be used for blood gas studies if the sample limitations are understood.
  • Page 58 Do not use clay-capped capillary tubes because the cut edges of a CAUTION: capillary tube can damage the sample port. Use only fire-polished capillary tubes to prevent damage to the sample port. NOTE: To prevent hemolysis and maintain sample integrity, Bayer Diagnostics recommends using capillary tubes that do not contain mixing fleas.
  • Page 59 To minimize the errors these conditions can cause, use correct storage and handling techniques. You can minimize errors due to metabolic changes by analyzing samples as soon as possible after collection. This is particularly important for pO glucose, and lactate values, because the sample consumes oxygen and glucose, and lactate is rapidly formed during storage.
  • Page 60 Refer to Emptying the Waste Bottle in Section 3 for detailed instructions for handling the waste bottle and its contents. Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. The waste bottle is disposable. You can autoclave the waste bottle before discarding it, but you cannot use it after autoclaving.
  • Page 61 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. Wear safety glasses, gloves, and laboratory coat when handling the reagents. All reagents described in this section are for in vitro diagnostic use only. Bayer Diagnostics cannot guarantee the performance of the system when any of the following occur: Reagents other than those recommended are used.
  • Page 62 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 (NH CO-oximeter Slope dyes and viscosity adjuster Deproteinizer 0.1N hydrochloric acid proteolytic enzyme Material Safety Data Sheets (MSDS) can be obtained by contacting Bayer Diagnostics Customer Service.
  • Page 63 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 one- and two-point pH and electrolyte calibrations and the zero calibration for the CO-ox module. 7.3 reagent is buffered to a pH of 7.382 at 37 C and is NIST traceable.
  • Page 64 This section describes the storage instructions for the reagents used on the 800 systems. Discard any reagent that is frozen. Do not thaw and use. The reagent CAUTION: composition is irreversibly altered when the reagent is frozen. Do not use any reagents beyond the expiration date. The expiration date NOTE: for Bayer Diagnostics reagents indicates the last month of valid use for unopened reagents.
  • Page 65 Discard any reagent that is frozen. Do not thaw and use. The reagent CAUTION: composition is irreversibly altered when the reagent is frozen. Handle and prepare the reagents used on the 800 systems as follows: 7.3/CO-ox Zero 7.3/CO-ox Zero is ready to use. Invert the bottle several times to mix thoroughly before use.
  • Page 66 The 800 system requires two gases to calibrate the pCO and Slope Gas. Cal Gas provides the calibration point for both pCO and two-point calibrations. Cal Gas contains 5.00 0.03 mol% carbon dioxide and 12.00 0.03 mol% oxygen balanced with nitrogen. Cal Gas is NIST traceable. Slope Gas provides the slope point for pCO calibrations.
  • Page 67 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 electrical output of a sensor and the concentration of the analyte measured by the sensor. Electronic drift and normal sensor aging can cause variations in electronic signals.
  • Page 68 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. Calibrations are performed at intervals necessary to avoid excessive drift to the sensor that is experiencing the fastest rate of drift.
  • Page 69 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. You cannot defer this calibration. Second, after completing the calibration, the system sets a 5 minute timer. If no samples are run within this period, the system performs another metabolite recal at the end of 5 minutes.
  • Page 70 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 results. The screen displays the measured and the drift values for each calibrated parameter. If a sensor does not reach endpoint within 90 seconds, the parameter value appears on the screen with asterisks and the message D5 No Endpoint.
  • Page 71 You can view, print, and transmit stored calibration data using the Recall option. You cannot edit calibration data. You can search for the data by calibration type or calibration date and time.
  • Page 72 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 are accurate and reliable. Imprecision is a measure of random error and variability. Random errors are sporadic and do not show trends or shifts of values around the mean.
  • Page 73 To monitor system performance and to chart any trends, Bayer Diagnostics recommends that you analyze controls as follows: pH, pO , pCO one sample of control at least once during each eight–hour shift using at least two levels of control during each day of testing.
  • Page 74 Quality control limits are established by calculating the mean and standard deviation (SD) from multiple measurements of the QC material. 2 SD or 3 SD where there is approximately a 95.5% probability that a result is within the 2 SD range and approximately a 99.7% probability that a result is within the 3 SD range when the system is performing as expected.
  • Page 75 expected (target) for each parameter, the measurement limits above and below range the mean where the majority of the QC samples are expected to fall action range for each parameter, the measurement limits above and below the mean requiring immediate action sample results the results for each parameter, the QC sequence number, and the analysis date and time...
  • Page 76 The system can automatically transmit QC results to an LIS or a data management system when analysis is complete. Refer to Selecting Automatic Transmission of QC Results in Section 5 to use this option. You can view, edit, print, and transmit stored QC data using the recall option. You can search for the data by file number, lot, level, analysis date, and analysis time.
  • Page 77 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. You can print a statistical summary report for each current QC file using the recall option. Refer to Recalling QC Data in Section 2. At 0200 on the first day of the month, the system automatically prints a final statistical summary report for each QC file.
  • Page 78 Calibration verification is the measurement of calibration materials to verify that the calibration of the system has remained stable throughout the patient reportable range established for your system. performance in the clinically significant range, calibration verification periodically checks the upper and lower limits of the reportable range where patient results occasionally fall.
  • Page 79 You 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. Typically, linear regression and least squares evaluation are used to compare results.
  • Page 80 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 CO-ox module. The legend in Figure 1-12 describes the conventions used in the diagrams. Small Tubing Reagent...
  • Page 81 1 1a Wash Clean Cal G/L 1 1a Wash Clean Cal G/L 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 to fluid detector (FD) 1 and 1A.
  • Page 82 1 1a Wash Clean Cal G/L 1 1a Wash Clean Cal G/L 1 1a Wash Clean Cal G/L 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 sample moves through the hemolyzer and the sample chamber.
  • Page 83 • • • • • • • • • • • • • • • • • • • • • • • • • • • Wash Clean Cal G/L 1 1a Wash Clean Cal G/L 6. After all of the foam wash is removed, the reagent pump starts, the wash bypass, and vent valves open, and the remaining solid wash segment moves to the inner sample port.
  • Page 84 The following steps describe the activities that take place when you initiate a wash sequence by selecting Wash or Cancel. 1 1a • • • • • • • • • • • • Wash Clean Cal G/L 1 1a Wash Clean 1.
  • Page 85 • • • 1 1a • • • • • • • • • • • • • • • • • • • • • • • • • Wash Clean Cal G/L 1 1a Wash Clean Cal G/L 3.
  • Page 86 The following steps describe the activities that take place during a one-point calibration. 1 1a • • • • • • • • • • • • • • • • • • Wash Clean 1 1a • • • •...
  • Page 87 1 1a Wash Clean 1 1a • • • • • • • • • • • • • • • • • • • Wash Clean 1 1a • • • • • • • • • • • • • • • • • • • • • • • • •...
  • Page 88 • • • 1 1a • • • • • • • • • • • • • • • • • • • • • • • • • • • Wash Clean 1 1a Wash Clean 1 1a •...
  • Page 89 1 1a Wash Clean 1 1a • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Wash Clean 1 1a Wash Clean 9.
  • Page 90 The following steps describe the activities that take place during a two-point calibration. 1 1a • • • • • • • • • • • • • • • • • • Wash Clean 1 1a • • • •...
  • Page 91 1 1a Wash Clean 1 1a Wash Clean 1 1a • • • • • • • • • • • • • • • • Wash Clean 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.
  • Page 92 1 1a • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Wash Clean 1 1a • • • • • • • • • • •...
  • Page 93 1 1a Slope Ambient Air Wash Clean 1 1a Slope • • • • • • • • • • • • • • • • • • • • • • • • Ambient Air • • • • • Wash Clean 1 1a •...
  • Page 94 1 1a Wash Clean 1 1a • • • • • • • • • • • • • • Wash Clean 1 1a Wash Clean 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.
  • Page 95 1 1a • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •...
  • Page 101 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 the system is not ready. The system aspirates all samples except expired gas samples. Aspiration reduces exposure to biohazardous materials and increases precision: by sampling the correct volume for each analysis by ensuring precise sample heating before sample analysis...
  • Page 102 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 the measured parameters. continue with analysis.
  • Page 103 You 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. 1. Type your password in the password field. 2. Press and then press If you type the password incorrectly, a message box appears.
  • Page 104 The following tables list the minimum volumes required by each system to analyze syringe samples: 090 L 844, 845 140 L 110 L 854, 855 160 L 125 L 864, 865 175 L The system automatically aspirates the sample. If you want the system to analyze a different set of parameters for the sample, press Change Parameters to select another panel.
  • Page 105 2. Press The system aspirates the sample. 3. When prompted, remove the sample device. 4. Type the required information in the Patient Information screen and then press You can scan the patient ID and the accession number fields if your system uses the bar code option feature.
  • Page 106 The following table lists the minimum volumes required by each system to analyze capillary tube samples: 090 L 844, 845 140 L 110 L 854, 855 160 L 125 L 864, 865 175 L If an 844, 845, 854, 855, 864, or 865 detects insufficient sample in the NOTE: measurement module, the system analyzes the sample as a microsample.
  • Page 107 To ensure the accuracy of the CO-ox measurement, close the CO-ox cover before pressing Analyze. 2. Press there is sufficient the system automatically aspirates the sample and moves it sample volume to the measurement module. the system prompts a. Look to see if the sample has reached point A. If not, you to move the sample b.
  • Page 108 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 reference sensor, as shown in Figure 2-5. Ensure that the trailing edge of the sample remains in contact with the sample ground/temperature sensor.
  • Page 109 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 move the sample manually. The following table lists the minimum volumes required by each system to analyze a sample: 840, 844, 845 55 L...
  • Page 110 3. Select If the sample device is a syringe, the system tries to move the sample automatically for routine analysis. If the syringe contains sufficient volume, the system analyzes the sample automatically. 4. Press The Position Sample Manually message box appears. 5.
  • Page 111 8. Type 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 after it touches the reference sensor.
  • Page 112 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. You can analyze syringe or capillary samples. The minimum sample volume requirement is 100 L. If the system detects an insufficient volume, the analysis cannot be performed.
  • Page 113 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 sufficient volume for analysis, the system positions the sample automatically. The following table lists the minimum sample volumes required by each system to determine pH: 840, 844, 845 35 L...
  • Page 114 3. Select and press 4. Press Ensure that the trailing edge of the sample remains in contact with the sample ground/temperature sensor. 5. Turn the sample pump clockwise until the leading edge of the sample fills the reference sensor, as shown in Figure 2-11. Sample Ground/ Temperature Sensor 6.
  • Page 115 7. When prompted, remove the sample device. 8. Type 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 are continuously updated until analysis is complete.
  • Page 116 The following table lists the minimum volumes required by each system to analyze vacuum tube samples 090 L 844, 845 140 L 110 L 854, 855 160 L 125 L 864, 865 175 L If you want the system to analyze a different set of parameters for the sample, press Change Parameters to select another panel.
  • Page 117 To 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. Type 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 form.
  • Page 118 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. Refer to Appendix A , Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. 1.
  • Page 119 6. When prompted, remove the sample device. 7. Type 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 are continuously updated until analysis is complete.
  • Page 120 Use this procedure to analyze a patient sample at an 840, 850, or 860 system and combine the results with results from a sample analyzed at a 270 CO-oximeter that is connected to one of these systems. Refer to Appendix D, Connecting to External Devices, for information about connecting the 270 CO-oximeter to an 800 base model.
  • Page 121 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 a. Press the 270 results with appears. the 800 system results b. Type the patient ID and press you do not want to press combine the 270...
  • Page 122 Use this procedure to combine an arterial blood sample with a venous or mixed venous blood samples to create an a-v studies report. To complete a-v studies successfully, ensure that the samples meet the following requirements: The difference between analysis times of the two samples at the 800 system must be less than 60 minutes.
  • Page 123 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 and press The Patient Data Search Criteria screen appears. 3.
  • Page 124 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. 11. Press to view the a-v study results. The a-v results are not automatically sent to the LIS.
  • Page 125 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 default Patient Information screen. The Patient Information screen may appear differently on your system. NOTE: Certain fields may not appear because they were turned off.
  • Page 126 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 Information screen reappears. Make your changes to the fields and press If you do not complete all required fields before you press Done, a message box appears prompting you to complete the required data entry fields.
  • Page 127 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 available for each system. 1. Press The Parameter Panels menu appears, as shown in Figure 2-16. Select a parameter.
  • Page 128 This section provides an overview of the Patient Sample Results screen and the printed sample report. Figure 2-17 shows the results screen. Your screen may appear differently depending on your system and how parameters were defined in setup. The following table describes the symbols seen in patient sample reports: ****** The sensor is out of calibration.
  • Page 129 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 Troubleshooting Patient Results in Section 4. Figure 2-18 shows an example of a printed report. Your printed report may appear differently depending on your system and how parameters were defined in setup.
  • Page 130 The following table describes the messages that may appear in patient sample reports on the roll printer: ****** = Not in The sensor is out of calibration. Calibration ------ or ------ = Out of The result is above or below the measurement range. Range: ____ * = D5 No Endpoint: __ The sensor did not reach a stable reading within the...
  • Page 131 COox Cover Open During The cover on the CO-ox module was open while the Meas system was analyzing the sample. COox Sample Chamber The CO-ox module sample chamber temperature is Temp Error 0.35 C of range and cannot accept sample analysis requests.
  • Page 132 Sample Temperature The measurement module temperature is not in range at Out of Range the end of measurement sequence. __ Sent Appears when you press Send at the end of analysis.
  • Page 133 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 data management system. 1. Access the Patient Data Search Criteria screen from the Menu screen: a.
  • Page 134 from the earliest date leave the Analysis Date From field blank, and type the to a specific date specified date in the Analysis Date To field. from a specific date type the start date in the Analysis Date From field, and type to the present date nothing in the Analysis Date To field.
  • Page 135 5. Edit, print, or transmit the appropriate patient reports. 6. Press when you finish. Done more than one sample the Done Options message box appears. is found Select Next Record and press that appears on the log. Select Previous Record and press previous report that appears on the log.
  • Page 136 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 patient information that you recall. You can edit patient information in the following ways: Change the sample temperature or the hemoglobin value and recalculate the results.
  • Page 137 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. return to the Patient Information screen without accepting the patient ID. Cancel Use this procedure to print or transmit data from the Patient Data Search Log screen or the Patient Data Search Result screen.
  • Page 138 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. You can specify a panel of parameters to analyze for each sample. Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials.
  • Page 139 Sample Port To ensure the accuracy of the CO-ox measurement, close the CO-ox cover before pressing Analyze. 4. Press 5. When prompted, remove the sample device. The QC File Information screen appears. you already the QC File Information screen is complete. Continue with scanned the step 7.
  • Page 140 7. Perform the required action. accept the results into the QC file and update the statistics. Accept Reject store the results in the appropriate QC file, but the system does not update the statistics. discard the results. Discard The system stores the results in QC File 14. The system does not update the statistics.
  • Page 141 Ensure that the calibration reagents and quality control materials are not expired or deteriorated. Visible signs of deterioration include color changes or cloudiness of the reagents or quality control materials. Ensure that you followed the operating procedures recommended in this manual. Ensure that you handled and sampled the quality control materials according to the procedures recommended by the manufacturer.
  • Page 142 use the keypad or type the File Number and press keyboard use the optional scan the bar code label on the QC ampule. bar code scanner NOTE: ampule bar codes only after selecting Quality Control (QC) from the Sample Type screen or when the QC File Information form is displayed.
  • Page 143 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. You can recall QC data for the previous month by archiving the previous month’s QC data and then viewing the data.
  • Page 144 3. Type the search criteria and press for a selected date type the date in both Analysis Date fields. from earliest date to leave the Analysis Date and Analysis Time fields blank. the present date from the earliest date leave the Analysis Date From field blank, and type the to a specific date specified date in the Analysis Date To field.
  • Page 145 5. Select the report that you want to view and press The QC Data Search Result screen appears. 6. Use this screen to edit, print, or transmit QC reports; to view and print Levey-Jennings Charts; and to print statistical summary reports. When a CO-ox module is attached, you press parameters.
  • Page 146 Use this procedure to edit QC data that you recall. You 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 described in Recalling QC Data, page 2-45, to locate the QC sample you want to edit.
  • Page 147 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 described in Recalling QC Data, page 2-45. 2. Press print a QC sample report transmit a QC sample report to an LIS or data management system...
  • Page 148 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 the action range. - - - the result is above the upper limit of the measurement range. - - - the result is below the lower limit of the measurement range.
  • Page 149 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. You can print statistical summary reports for the previous month by archiving the previous month’s QC data and then printing statistical summary reports for the archived data.
  • Page 150 5. Press to return to the Ready screen. Use this procedure to view and print Levey-Jennings charts of the current month’s QC data. You can print Levey-Jennings charts for the previous month by archiving the previous month’s QC data and then printing Levey-Jennings charts of the archived data.
  • Page 151 Y-axis shows measured values 88.3 78.3 68.3 58.3 48.3 Rejected Values Accepted Values Upper Target Limit (+2SD) The Levey-Jennings chart for the previous month displays only the data points for QC samples remaining in the file. The Levey-Jennings chart for the current month displays only the data points for QC samples analyzed to date.
  • Page 152 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 charts: The results are accepted.
  • Page 153 You 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 systems with the CO-ox module—the 844, 845, 854, 855, 864, and 865. 1. Press The Calibration Type menu appears, as shown in Figure 2-31.
  • Page 154 You 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 systems with the CO-ox module—the 844, 845, 854, 855, 864, and 865. 1. From the Menu screen, select The Calibration menu appears, as shown in Figure 2-32.
  • Page 155 Use this procedure to calibrate the tHb slope for the CO-ox module. You can perform this calibration from either the Analyze mode or the Menu mode. 1. Initiate the tHb slope calibration procedure. Analyze mode a. Press b. Select Menu mode a.
  • Page 156 Press Cancel to interrupt a calibration. The system starts a wash and the Wash 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 calibration is scheduled, a status message appears on the screen indicating that a calibration is due.
  • Page 157 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 and press b. Select and press 2. Type the correct atmospheric pressure and press The acceptable range for atmospheric pressure is 400 –...
  • Page 158 Press to interrupt a calibration. If you interrupt an automatic calibration, the system will attempt to start the calibration again in 90 seconds. You can delay calibrations for up to 30 minutes beyond the scheduled time. After 30 minutes, the system starts the required calibration.
  • Page 159 You can print calibration data and send the data to an LIS or a data management system. You cannot edit calibration data. 1. Access the Recall Calibration Data screen from the Menu screen: a. Select and press b. Select 2. Select a calibration type and press 3.
  • Page 160 The system uses two sequence numbers for two-point calibrations. Only one number appears in the log. 5. Perform the appropriate task at the Calibration Data Search Log. view the data for a calibration print a calibration report transmit the results to an LIS or a data management system select the report you want and press...
  • Page 161 6. Perform the appropriate task at the Calibration Data Search Result screen. print the calibration report transmit the results to an LIS or a data management system a. Press b. Press . The calibration report prints, as shown in Figure 2-36. a.
  • Page 162 2-POINT CALIBBRATION REPORT SYSTEM 860-1001 Sequence no Calibration Date Calibration Time CAL POINT ....... . . 7.382 35.4 85.0...
  • Page 163 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. - - - the result is above the upper limit of the measurement range. - - - the result is below the lower limit of the measurement range.
  • Page 173 Use this procedure to view pending maintenance tasks and record completed maintenance tasks in the maintenance log. Menu Code 1. Access the Maintenance Schedule screen from the Menu screen: a. Press 2 Maintenance b. Press 4 View Schedule The Maintenance Schedule screen appears as shown in Figure 3-1. Tasks due for the current date appear at the top of the scroll list.
  • Page 174 Use this procedure to print a Maintenance Schedule Report from the Maintenance Schedule screen. The report lists all the maintenance tasks for the system model. The tasks are sorted by frequency. Tasks due for the current date appear at the top of the report. The Due field displays the date on which the task is due next.
  • Page 175 Use this procedure to view and print the list of completed maintenance tasks for the current or the previous month. Menu Code 1. Access the Maintenance Log screen from the Menu screen: a. Press 4 Data Recall b. Press 3 Maintenance Log The Maintenance Log screen appears as shown in Figure 3-2.
  • Page 176 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. Materials required: 10% solution of household bleach NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent quality water.
  • Page 177 Do not insert swabs into the sample port or spray anything into the NOTE: 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 Water Quality Technical Bulletin included at the back of this manual.
  • Page 178 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 Replacing the Printer Check the fluid volume in the waste bottle. Empty the waste bottle if it is at or near the waste full line as described in Menu Code 1.
  • Page 179 2. Compare the displayed atmospheric pressure to your laboratory’s barometer reading. correct incorrect press Done a. Type the correct atmospheric pressure and press Enter b. Press to save the new atmospheric Done pressure and return to the Ready screen. c. Perform a gas two-point calibration.
  • Page 180 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 weekly maintenance more frequently. Use this procedure to verify the performance of the glucose and lactate biosensors. Materials required: High G/L ampule aspiration adapter...
  • Page 181 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 procedure to clean the sample path with deproteinizer once a week or every 210 samples.
  • Page 182 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 or syringe. 8.
  • Page 183 If your system has a CO-ox module, follow the procedure described for NOTE: the appropriate base model. For example, information identified for an 860 also applies to an 865. Menu Code 1. Access the Condition screen from the Menu screen: a.
  • Page 184 9. Press 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 message box. The main tank pressure must be higher than 300 psi.
  • Page 185 Use this procedure to ensure that the sensors contain fill solution to the levels described in Figure 3-5. – pH, K , Cl , and Ca Reference The pO NOTE: though they have fill solution. Slight discoloration of the fill solution in the pO and pCO sensors is normal.
  • Page 186 3. Verify that the reference sensor fill solution is not below the fill line. Refer to Filling the Reference Sensor, page 3-69. Do not remove or return the sensors to the measurement module CAUTION: without first discharging static buildup. Touch the inner surface of the module frame to discharge static buildup.
  • Page 187 The monthly maintenance schedule is based on the expiration date of the opened reagents. Effective cleaning is accomplished by alternating Cleaning Solution 1 (C1) and Cleaning Solution 2 (C2) each month. C1 is on your system replace it with C2. C2 is on your system replace it with C1.
  • Page 188 Do not remove or tighten the cap that contains the reagent septum. NOTE: 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 bottle into position on the reagent manifold. 6.
  • Page 189 3. Write the date installed in the space provided on the new reagent bottles. Do not remove or tighten the cap that contains the reagent septum. NOTE: Removing or tightening the cap damages the integrity of the reagent septum. 4. Remove the plugs from the caps of the new reagent bottles. 5.
  • Page 190 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 30 samples per day, perform bimonthly maintenance more frequently. Use this procedure to discard and replace the 6.838 Buffer and Wash G/L Zero reagents if they are opened and installed on the system for 60 days.
  • Page 191 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.
  • Page 192 5. Disconnect the tubing from the sample probe as shown in Figure 3-11. 6. Discard the tubing according to your laboratory’s biohazard protocol. 7. Orient the new sample tubing as shown in the diagram on the system. 8. Connect the new sample tubing to the sample probe. 9.
  • Page 193 11. 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 to perform a two-point calibration.
  • Page 194 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 samples per day, perform this maintenance more frequently. Materials required: lint-free tissue or lint-free swabs lens paper reagent quality water dilute cleaning solution (do not use bleach, alcohol, or abrasive powder)
  • Page 195 Sample Chamber Mounting Sapphire Window 4. Remove the gasket and support: a. Slide your finger under the flat metal support of the gasket. b. Lift the gasket and support from the sample chamber. Mounting Pin Holes Outlet Inlet Gasket Gasket Support CAUTION: Do not touch the optical zone (front or back area enclosed by the gasket) of the sample chamber with your fingers.
  • Page 196 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.
  • Page 197 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 Tubing on page 3-37. b. If there is an obstruction in the tubing, remove the sample tubing. c.
  • Page 198 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 BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a.
  • Page 199 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.
  • Page 200 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 samples per day, perform this maintenance more frequently. Materials required: air filter 1.
  • Page 201 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 to return to the Ready screen. Home Materials required: CO-ox air filter 1.
  • Page 202 Materials required: measurement module tubing BIOHAZARD: recommended precautions when working with biohazardous materials. 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.
  • Page 203 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. b. Remove the tubing from the spacer. c. Disconnect the tubing from the connector at position 3 on the reagent manifold.
  • Page 204 7. Close the measurement module door. 8. Press Continue A wash sequence starts. When the wash sequence finishes, a message box appears prompting you to perform a two-point calibration. 9. Press to perform a two-point calibration.
  • Page 205 Materials required: CO-ox sample tubing BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System 2. Replace the CO-ox sample tubing as shown in Figure 3-22: Sample Chamber a.
  • Page 206 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. b.
  • Page 207 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 this procedure to replace the tubing on the sample pump, the waste pump, the reagent pump, and the CO-ox module pump.
  • Page 208 a. Perform the appropriate step. sample pump tubing waste pump tubing CO-ox pump tubing 3. Replace the reagent pump tubing as shown in Figure 3-23: a. Select the replacement tubing that has the tubing collar. b. Grasp the left tubing cuff and pull it away from the platen. c.
  • Page 209 f. Place the left tubing cuff under the left side of the platen. Do not stretch the tubing. g. Place the tubing around the outside of the rollers. h. Hold the right tubing cuff below the right side of the platen and turn the roller cage clockwise to gently work the new tubing between the platen and roller cage.
  • Page 210 a. Disconnect the tubing from the reagent manifold. b. Grasp the left tubing cuff and pull it away from the platen. c. While holding the tubing, turn the roller cage clockwise and gently pull the tubing away from the platen and the roller cage. d.
  • Page 211 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 Menu Code 8. Calibrate the reagent pump from the Menu screen: (from the Main Menu) a.
  • Page 212 Perform the following procedure annually. This schedule is based on analyzing 30 samples per day. If your laboratory analyzes more than 30 samples per day, perform this maintenance more frequently. Materials required: reagent manifold vent filter 1. Remove the old reagent manifold vent filter from the reagent manifold vent inlet and discard it.
  • Page 215 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 tissue or swabs BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for recommended precautions when working with biohazardous materials. Wear safety glasses, gloves, and a laboratory coat when performing this procedure.
  • Page 216 The waste bottle is disposable and can be autoclaved before you discard it. NOTE: 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 infection control policy.
  • Page 217 Use this procedure to clean the reference sensor and to remove bubbles at the electrode tip and in the passage between the electrode compartment and the KCl reservoir. Materials required: reagent water lint-free swab BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1.
  • Page 218 6. Tap the front face of the sensor with your knuckle to release any bubbles. 7. Clean any salt deposits on the reference sensor with a lint-free swab moistened with deionized water and dry it thoroughly. 8. Ensure that the O-rings are in place on both sides of the sensor. 9.
  • Page 219 Materials required: 0.022 inch diameter clot-removal line (to fit through a 0.030 inch ID pathway) Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System 2. Push up the latches on the measurement module door and lift the door. 3.
  • Page 220 6. Ensure that the O-ring is in place. Replace the O-ring if it is worn or damaged. CAUTION: without first discharging static buildup. Touch the inner surface of the module frame to discharge static buildup. NOTE: If the sensor does not insert easily into the measurement module, slide the remaining sensors to the right to create more space.
  • Page 221 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) 1:10 with reagent-quality water. reagent water lint-free tissue and swabs BIOHAZARD: recommended precautions when working with biohazardous materials.
  • Page 222 Wear safety glasses, gloves, and a laboratory coat when handling bleach. 6. Clean the roller cage: a. Clean the rollers with a lint-free tissue moistened with a 10% solution of household bleach. b. Clean the interior surface of the roller cage with a lint-free swab moistened with the bleach solution.
  • Page 223 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 to perform a two-point calibration. Materials required: 10% solution of household bleach Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent NOTE: quality water.
  • Page 224 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 appropriate position on the reagent manifold, and turn clockwise one-quarter turn.
  • Page 225 Materials required: 10% solution of household bleach Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent NOTE: quality water. reagent water lint-free swabs BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a.
  • Page 226 Ensure that the three O-rings are in place. NOTE: 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.
  • Page 227 8. Remove the paper from the printer. 9. Reconnect the power cord to the power supply and allow the system to warm 10. Reinstall the printer paper as described in 3-66. 11. Verify the printing quality as described in Roll Printer Test in Section 4. Materials required: glutaraldehyde aspiration adapter...
  • Page 228 Menu Code 3. Deproteinize the sample path: a. Prepare the deproteinizer as directed on the package. b. Select c. Select d. Invert the deproteinizer vial several times to mix. e. Insert an aspiration adapter into the sample port and insert the other end into the deproteinizer.
  • Page 229 Menu Code 8. Perform a two-point calibration from the Menu screen: (from the Main Menu) Repeat calibrations until the system performs a successful calibration. a. Select b. Select 9. Analyze a minimum of two levels of quality control material to verify sensor performance.
  • Page 230 If your system has a CO-ox module, follow the procedure described for NOTE: the appropriate base model. For example, information identified for an 860 also applies to an 865. Do not remove or return the sensors to the measurement module CAUTION: without first discharging static buildup.
  • Page 231 Wear safety glasses, gloves, and a laboratory coat when handling bleach. 4. Perform the cleaning cycle: a. Press b. Insert an aspiration adapter into the sample port and immerse the other end in the 10% bleach solution. c. Press d. When prompted, remove the adapter. e.
  • Page 232 Use this procedure to manually initiate the cleaning sequence. The system automatically initiates the cleaning sequence every 24 hours at 02:00. Menu Code 1. Access Auto Clean from the Menu screen: a. Select 2 Maintenance b. Select 6 Auto Clean To interrupt the Auto Clean sequence at any time, press The Auto Clean sequence takes 10 minutes.
  • Page 233 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: Because no fluids reach the sensors while the system is stopped, stopping the system for a prolonged period of time may affect the performance of the sensors.
  • Page 234 The 800 system collects workload data and provides month-to-date and year-to-date workload statistics reports. The workload statistics report includes the total cycle count of all patient samples, calibrations, and QC samples performed by the system. The yearly statistics are reset every January 1 after the system performs the first sample analysis or calibration.
  • Page 237 Wear safety glasses, gloves, and a laboratory coat when handling the reagents. 1. At the Ready screen, press The Reagent Levels screen appears. 2. Remove the reagent bottle from the reagent manifold, as shown in Figure 3-37. 3. Write the date installed in the space provided on the new bottle. Do not remove or tighten the cap that contains the reagent septum.
  • Page 238 9. Perform a two-point calibration. a. Press Calibrate b. Select Two-point and press c. Press Start Calibration Perform two-point calibrations after changing the calibration reagents to ensure that the reagents are acceptable and the system is functioning properly. You can analyze quality control materials with the new reagents and compare the results with the previous QC results after the system is recalibrated.
  • Page 239 c. Push the paper under the platen until it comes out the front side. d. Pull the paper from under the platen and push it through the slot in the printer cover. e. Push down the printer lever. Pull up the paper firmly as you close the cover to ensure that the paper does not jam under the cover.
  • Page 240 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. b. Insert the paper into the paper slot on the spool and turn the spool three or four rotations away from you.
  • Page 241 Materials required: reference electrode refill hex tool lint-free tissue Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b.
  • Page 242 4. Add KCl fill solution to the KCl reservoir to the fill line, as shown in Figure 3-42. Do not overtighten the reservoir cap. Overtightening can deform the CAUTION: gasket and cause leaks. 5. Reinstall the reservoir cap and hand-tighten. 6.
  • Page 243 Materials required: reference sensor replacement kit hex tool lint-free tissue Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b.
  • Page 244 c. Slowly fill the electrode compartment by gently squeezing the container until the KCl fill solution enters the KCl reservoir. Do not touch the internal electrode wire. The wire is fragile and is easily damaged. 4. Install the internal electrode in the sensor: a.
  • Page 245 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. b. Partially fill the KCl reservoir as shown in Figure 3-46. c. Tap the front face of the sensor with your knuckle to release any bubbles. d.
  • Page 246 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 Materials required: reference electrode refill kit hex tool lint-free tissue Menu Code 1. Stop the system from the Menu screen: a.
  • Page 247 Do not touch the internal electrode wire. The wire is fragile and is CAUTION: 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.
  • Page 248 b. Partially fill the KCl reservoir as shown in Figure 3-50. c. Tap the front face of the sensor with your knuckle to release any bubbles. d. Gradually fill the KCl reservoir with KCl fill solution up to the fill line. Do not overtighten the reservoir cap.
  • Page 249 Materials required: reference electrode internal replacement kit hex tool lint-free tissue Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b.
  • Page 250 4. Discard the internal electrode according to your laboratory protocol. 5. Empty the KCl fill solution from the cassette. 6. Add 3 drops of KCl fill solution to the electrode compartment and then drain the compartment. 7. Fill the electrode compartment in the new cassette as shown in Figure 3-53: a.
  • Page 251 CAUTION: Do not touch the internal electrode wire. The wire is fragile and is easily damaged. 8. Use the hex tool to remove the new internal electrode from its container. 9. Insert the internal electrode into the compartment and screw it into place with the hex tool, ensuring that you do not cross-thread the electrode.
  • Page 252 c. Tap the front face of the sensor with your knuckle to release any bubbles. d. Gradually fill the KCl reservoir with KCl fill solution to the fill line. Do not overtighten the reservoir cap. Overtightening can damage the gasket and cause leaks. e.
  • Page 253 – BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System Do not remove or return the sensors to the measurement module CAUTION: without first discharging static buildup.
  • Page 254 Do not touch the internal electrode wire. The wire is fragile and is CAUTION: easily damaged. 3. Unscrew the internal electrode and carefully set it aside on a lint-free tissue as shown in Figure 3-57. 4. Empty the fill solution remaining in the sensor. NOTE: Refer to Table 3-1 to determine the appropriate fill solution to use.
  • Page 255 7. Insert the internal electrode into the electrode compartment and screw it into place, ensuring that you do not cross-thread the electrode. 8. Continue with If you need to replace the reference sensor, refer to Sensor, page 3-71. If you need to replace the glucose or lactate biosensors, refer to Glucose and Lactate Materials required: appropriate sensor...
  • Page 256 Do not remove or return the sensors to the measurement module CAUTION: without first discharging static buildup. Touch 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 latches on the measurement module door and lift the door. b.
  • Page 257 e. Screw the internal electrode into place, ensuring that you do not cross-thread the electrode. f. Tap the front face of the sensor with your knuckle to remove bubbles. g. Wipe any excess fill solution from the exterior of the sensor with a lint-free tissue.
  • Page 258 g. Allow the system to warm up. h. Press Menu Code 11. When the temperature is stable, perform a two-point calibration: (from the Main Menu) a. Select b. Select The Ready screen appears when the calibration finishes. 12. Analyze a minimum of two levels of quality control materials to verify sensor performance.
  • Page 259 Do not remove or return the sensors to the measurement module without first discharging static buildup. Touch the inner surface of the module frame to discharge static buildup. 2. Remove the biosensors as shown in Figure 3-60: a. Push up the latches on the measurement module door and lift the door. b.
  • Page 260 a. Align the contacts on the biosensor with the contacts in the measurement module. b. Snap the body of the biosensor down into place. The contacts must be flush with the biosensor. c. Press the tab on the spring-loaded latch down to release the latch. d.
  • Page 261 12. Verify 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 the reference sensor after completing any of the following procedures: Filling the Reference Sensor, page 3-69.
  • Page 262 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. Use this procedure to replace a gas tank or cylinder when the main tank pressure falls below 300 psi.
  • Page 263 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 regulator from the gas tank by unscrewing the yoke screw.
  • Page 264 4. Install the new gas tank: a. Check the gas tank label to verify that you are installing the correct gas: Bayer Diagnostics Cal Gas contains 5% CO Bayer Diagnostics Slope Gas contains 10% CO b. Place the gas tank into its final position and secure the tank. c.
  • Page 265 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. Visually check for leaks by applying soapy water around all connections, as shown in Figure 3-63, and watching for bubbles.
  • Page 266 Menu Code 9. Perform a gas two-point calibration from the Menu screen: (from the Main Menu) a. Select b. Select Perform two-point calibrations after changing the calibration reagents, including the gas standards, to ensure that the reagents are acceptable and the system is functioning properly.
  • Page 267 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. The average main tank pressure is 2200 psi.
  • Page 268 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 Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1.
  • Page 269 6. Clean the roller cage shaft with a lint-free tissue moistened with reagent water and dry thoroughly. 7. Place the new roller cage on the shaft. 8. Turn the roller cage on the shaft until the roller cage stops. 9. Press the roller cage down until the cage snaps into place. 10.
  • Page 270 Materials required: sample port Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System 2.
  • Page 271 Materials required: sample probe Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System 2.
  • Page 272 3. Install the new probe: Insert the probe slowly to avoid bending the shaft. a. Push the sample probe into the opening in the sample port and place the probe tab in the slot. b. Connect the sample tubing to the new sample probe. c.
  • Page 273 a. Select and press 2 Maintenance b. Select and press 7 Stop System 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 shown in Figure 3-69.
  • Page 274 Materials required: measurement module lamp Menu Code 1. Shut down the system from the Menu screen: a. Select 7 System Utilities b. Select 3 Shutdown c. Press You must wait at least 1 minute before you disconnect the power cord, CAUTION: and then wait at least 10 seconds before you reconnect the power cord.
  • Page 275 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: 10. Place a new lamp in the clamp with the front of the lamp facing the system. 11.
  • Page 276 b. Select 2. Allow the lamp to cool for at least 5 minutes. sufficient time for it to cool. 3. Remove the lamp cover from the CO-ox module. 4. Remove the lamp connector, as shown in Figure 3-71. 5. Remove the old lamp from the lamp housing and discard it. 6.
  • Page 277 b. Select c. Select The COox Optics Test screen appears. 13. Press Start Test 14. Check the screen for the message, Lamp test passed. 15. Press Exit Test 16. Press Exit Menu Menu Code 17. Perform a one-point calibration from the Menu screen: (from the Main Menu) a.
  • Page 278 3. Disconnect the power cord from the side panel of the system. 4. Remove the air filter cover. 5. With 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 from the compartment. 7.
  • Page 279 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.
  • Page 287 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 codes and system messages listed in the Status Event Log can help you determine what recent events may have contributed to an existing system problem.
  • Page 288 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. Table 4-1 describes each system message. 1-pt Cal Pending Appears 5 minutes before a one-point calibration is due and in __ Min counts down until the calibration starts.
  • Page 289 COox Sample Appears when the CO-ox sample chamber temperature is not in Chamber Temp range. The system cannot accept tHb sample measurement Error requests. See Troubleshooting System Messages, page 4-114. COox Sample Appears when the CO-ox sample chamber temperature is not in Temp Out of Range range at the end of measurement sequence.
  • Page 290 Interfering Appears when the system detects substances in the sample that Substance: Glu may interfere with glucose measurement. See Troubleshooting System Messages, page 4-118. NOTE: Repeated, unexpected occurrence of this message may indicate sensor failure. See Troubleshooting Patient Results, page 4-98.
  • Page 291 No Sample Device Appears when you press Analyze, the sample door closes, and no Detected device is detected in the sample port. See Troubleshooting System Messages, page 4-120. No Waste Bottle Appears when the waste bottle is not installed. Detected __ Not Sent Appears when you press Do Not Send at the end of analysis.
  • Page 295 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 require corrective action. Some D codes also contain a qualifier after the message. The qualifier indicates a specific condition related to the D code.
  • Page 296 Sensor drift is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: pO If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct this D code. If a D2 for pCO period and no drift occurs for pO out of range, replace the sensor.
  • Page 297 Sensor drift is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: pH If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct this D code. If more than one sensor has excessive drift, check the reference sensor for KCl leaks as described in Cleaning the Reference Sensor and Removing Bubbles in Section 3.
  • Page 298 Perform the Measurement Test as described on page 4-70. Check the diverter valve to verify that the valve is working by performing the Valves test as described on page 4-62. Replace the affected sensor as described in Replacing the Measurement or Sample Ground/ Temperature Sensors in Section 3.
  • Page 299 Sensor drift is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: Glu Lac If D codes also exist for reagent problems such as D23, D24, D29, or D50, correct these problems first, then correct this D code. Check the expiration dates and the levels of the reagents.
  • Page 300 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 slope reagent used. If required, re-enter the value and repeat the tHb slope calibration. Deproteinize the sample path as described in Deproteinizing the Sample Path in Section 3.
  • Page 301 Sensor slope is beyond predefined limits during a two-point calibration. Qualifiers: pO If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct this D code. Perform a gas two-point calibration. Ensure that the gas tank pressures are greater than 300 psi.
  • Page 302 Sensor slope is beyond predefined limits during a two-point calibration. Qualifiers: pH K If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct this D code. Perform a two-point calibration. Check the expiration dates and the levels of the reagents.
  • Page 303 Sensor slope is beyond predefined limits during a one- or two-point calibration. Qualifiers: Glu Lac If D codes also exist for reagent problems such as D23, D24, D29, or D50, correct these problems first, then correct this D code. Perform a two-point calibration. Check the expiration dates and the levels of the reagents.
  • Page 304 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 reagent used. If required, re-enter the value and repeat the calibration. Ensure the slope reagent is appropriate for the instrument. Check that the sample chamber is tightly in place.
  • Page 305 Sensor offset is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: pO If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct the D4. Perform a gas two-point calibration. Check for cracks or leaks in the sample tubing.
  • Page 306 Sensor offset is beyond predefined limits during a one-point or a two-point calibration. Qualifiers: pH K If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct the D4. Perform a two-point calibration. Check the expiration dates and the levels of the reagents.
  • Page 307 Sensor offset is beyond predefined limits during a two-point calibration. Qualifiers: Glu Lac If D codes also exist for reagent problems such as D23, D24, D29, or D50, correct these problems first, then correct the D4. Check that the biosensors are installed in the correct order and are aligned, the O-rings are in place, and the spring-loaded latch is closed as described in Removing and Checking the Sensors on page 4-65.
  • Page 308 Sensor does not reach stable reading within predefined time limit. Qualifiers: pO If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct the D5. If a D5 for pCO result is out of range, replace the sensor. Ensure measurement module door was not opened during measurement.
  • Page 309 Sensor does not reach stable reading during predefined time limit. Qualifiers: pH K If D codes also exist for reagent problems such as D23, D24, or D29, correct these problems first, then correct the D5. Perform a two-point calibration. Deproteinize the sample path and condition the sensors as described in Deproteinizing the Sample Path and Conditioning the Sensors in Section 3.
  • Page 310 Sensor does not reach stable reading during predefined time limit. Qualifiers: Glu Lac If D codes also exist for reagent problems such as D23, D24, D29, or D50, correct these problems first, then correct the D5. Perform a metabolite two-point calibration. Perform the Measurement Test for the affected biosensor as described in Measurement Test, page 4-70.
  • Page 311 Sample door detector cannot determine whether the sample door is open or closed. Check that your hand does not prevent the door from closing. Check that the door is installed correctly. Perform the Sample Entry Test as described on page 4-67. If the D code reappears, contact your Service Representative.
  • Page 312 Fluid detector 1 (FD1) does not detect the sample during the predefined time limit. Check the sample entry components for obstructions and the sample path for blood clots. If obstructions are found press Stop as prompted in the message box. Remove them as described in Removing Obstructions from the Sample Entry Components page 4-79.
  • Page 313 Fluid detector 2 (FD2) does not detect the sample during the predefined time limit. Check the sample position in the measurement module. not positioned in the measurement module present in the measurement module Check the measurement module for obstructions and remove them as described in Removing Obstructions from the Measurement Module, page 4-82.
  • Page 314 Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifiers: FD1 FD1A FD2 Check the sample path in the measurement module for obstructions or leaks. Ensure that O-rings are in place on the sensors and that the sensors are aligned correctly as described in Removing and Checking the Sensors on page 4-65.
  • Page 315 Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifiers: FD3 FD4 Perform a wash. Observe the fluid as it moves through the system for sufficient wash flow, wash segments, and no leaks at the sample port. Perform the Fluid Detector Test as described on page 4-66. If the D code reappears, contact your Service Representative.
  • Page 316 Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifier: FD5 Check the CO-ox sample path for obstructions. If you see any obstructions, remove them as described in Removing Obstructions from the CO-ox Sample Path, page 4-87. Check the sample tubing that goes through FD5 for cracks, leaks, and discoloration.
  • Page 317 An internal communication problem between the system processors has occurred. Qualifiers: 1 3 If the D code reappears, contact your Service Representative. Shut the system down and restart as described in Shutting Down and Restarting the System in Section 5. Disconnect the CO-ox sample path as described in Disconnecting the CO-ox Sample Path, page 4-92.
  • Page 318 The barometer detects atmospheric pressure beyond predefined limits. Check that the system barometer is functioning properly: Menu Code 1. From the Menu screen, select 2. Select 3. Press 4. Check the screen to verify whether the atmospheric pressure (pAtm) is within the range of 400 to 825 mm Hg (53 to 110 kPa) and that the reading is stable.
  • Page 319 Fluid detector 3 (FD3), fluid detector 4 (FD4), or both detectors do not detect reagent. Qualifiers: 7.3 6.8 Wash C1/C2 Cal G/L For the 7.382 Buffer, 6.838 Buffer, Wash G/L Zero and Cal G/L reagents, check the expiration dates and the levels. Ensure that the reagent bottles are installed properly and in the correct location.
  • Page 320 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 6.8 Wash Cal G/L If a D23 code also exists, correct that problem first, then correct the D24.
  • Page 321 The wash did not completely clean the sample path due to low volume or poorly segmented flow. If a D23 or D24 code also exists, correct these problems first, then correct the D29. Perform a wash. Ensure that the bottle is installed properly. Check the level of Wash/Zero reagent.
  • Page 322 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 described in Replacing the Sample Probe in Section 3. Check the sample port, the probe mount, and the capillary seal for obstructions, and ensure that the capillary seal is installed correctly.
  • Page 323 The system detects an error in the electronics system. Qualifiers: 1 2 1, 2, 4, 5, 8, 9, 11 6 or 7 If the D code reappears, contact your Service Representative. 10 11 12 13 perform the Measurement Test as described on page 4-70. If the measurement test does not remove the D35, shut the system down and restart it as described in Shutting Down and Restarting the System in Section 5.
  • Page 324 The system detects an error in the temperature control system. Qualifiers:1 Every 15 minutes, the system enables the temperature control and reevaluates the error condition. If the problem that caused the condition has been corrected, the system clears the D38 condition automatically.
  • Page 325 The system detects an open connection in the glucose biosensor. Check that the biosensor is installed correctly with the contacts aligned, and the spring-loaded latch is closed as described in Removing and Checking the Sensors on page 4-65. Check the levels of the reagents. Ensure that the reagent bottles are installed properly and in the correct location.
  • Page 326 The system detects an open connection in the lactate biosensor. Check that the biosensor is installed correctly with the contacts aligned, and the spring-loaded latch is closed as described in Removing and Checking the Sensors on page 4-65. Check the levels of the reagents. Ensure that the reagent bottles are installed properly and in the correct location.
  • Page 327 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 electronics. Qualifiers: 1 Ensure that the cable is firmly connected to the 800 system and to the external device.
  • Page 328 The system detects an error in the CO-ox optical measurement system. Qualifiers: 2 If the D code reappears, contact your Service Representative. Perform a pH/Lytes one-point calibration. Replace the 7.3 Buffer/CO-ox zero reagent. Check that the area around the sample chamber is free from lint or dust. Prime and perform a pH/Lytes one-point calibration.
  • Page 329 Fluid detector 5 (FD5) does not detect the sample during the predefined time limit. Ensure the sample volume is sufficient for the sample type. Check the sample entry components for obstructions and the sample path for blood clots. Remove them as described in Removing Obstructions from the Sample Entry Components, page 4-79.
  • Page 330 The CO-ox sample chamber does not detect the sample during the predefined time limit. Ensure the sample volume is sufficient for the sample type. Ensure the sample is red. Check the CO-ox sample path for leaks or cracks. If you find cracks or leaks, replace the tubing as described in Replacing the CO-ox Sample Tubing in Section 3.
  • Page 331 The CO-ox module detects lamp levels that are inadequate for sample analysis. Perform the Lamp On/Off Test as described in CO-ox Optics Test, page 4-75. Remove the lamp cover from the CO-ox module and visually verify that the lamp is on. If the lamp is not on, replace it as described in Replacing the CO-ox Lamp in Section 3.
  • Page 332 The system detects an error in the electronics system. Qualifiers: 1 2 1, 2, 3, 5, 8, 11 Menu Code 4, 7, 9, 12 If the D code reappears, contact your Service Representative. 10 11 12 perform the CO-ox Lamp On/Off test, and then perform a one-point calibration.
  • Page 333 testing occurs at power-up initialization and before each zero and slope calibration. The every sample measurement. A GO pulse is sent to the CMB. PWRGOOD is polled to determine if the power supplies are within range. . testing occurs at power-up initialization and before each zero and slope calibration.
  • Page 334 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 microstepper controller. The test steps are: Reset the microstepper controller. Enable microstepper controller. Wait 100 S for a response from the controller. If no response, the controller is not operating correctly.
  • Page 335 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 that caused the condition has been corrected, the system automatically clears the D77 condition.
  • Page 336 Fluid detector 5 (FD5), the CO-ox sample chamber, or both do not detect reagent. Qualifiers: 7.3 Wash Check the expiration dates and levels of the 7.3/COox Zero and the Wash/Glu Zero. Ensure that the reagent bottles are installed properly and in the correct location.
  • Page 337 Perform the Pump Functions Test as described in Pump Functions Test, page 4-58. If the D code reappears, contact your Service Representative.
  • Page 338 The wash did not completely clean the CO-ox sample path due to low volume or poorly segmented flow. If a D78 also exists, correct that problem first, then correct the D79. Perform a wash. Ensure that the Wash/Glu zero reagent bottle is installed properly. Check the level of reagent.
  • Page 341 This section describes how to use the 800 system diagnostic tests to check the functions of the system components. Access the tests from the Troubleshooting menu or by pressing Troubleshooting describes the function of each test. Fluidics Functions Tests the ability of the reagent components to deliver the reagents to the fluid detectors in the reagent manifold and the measurement module.
  • Page 342 Roll Printer Tests the ability of the roll printer to print all characters. Bar Code Scanner Tests the ability of the bar code scanner to read a test pattern. Use this procedure to test the ability of the reagent components to deliver reagents to the fluid detectors in the reagent manifold and the measurement module.
  • Page 343 5. Perform the appropriate action. test another reagent repeat steps 2 through 4. return to the Menu press screen 6. Press Exit Menu Use this procedure to test the flow rate of the reagent pump and to calibrate the reagent pump, if necessary. 1.
  • Page 344 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 unacceptable a. Press b. Check the screen for the message, Pump calibration complete. c. Press 4.
  • Page 345 2. Test the pump electronics: a. Select the pump and speed to test and press b. Press Start Test . The pump turns on. When you select the reagent pump, the waste pump also turns on. c. Check the screen for the message, Pump current acceptable, to verify that the pump electronics are functioning correctly.
  • Page 346 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. test the reagent pump test the sample pump test the waste pump Two-Way Connector Tubing...
  • Page 347 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 7. Prime the tubing: a.
  • Page 348 11. 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 connectors at position 4 waste pump tubing to the connectors at position 5 12.
  • Page 349 Vent controls the flow of ambient air into the manifold Clean controls the flow of Cleaning Solution controls the flow of Cal G/L Reagent Bypass diverts the Wash G/L Zero Reagent in the reagent manifold when the foam wash valve is off, preventing a pressure buildup Diverter directs the flow of reagent into either the calibration passage or the wash passage of the sample port...
  • Page 350 5. Perform the appropriate action. test another valve return to the Menu screen 6. Press Exit Menu When you use the left arrow key to exit the Troubleshooting menu and enter the Main menu, the system performs a wash. Use this procedure to test the flow of Cal Gas and Slope Gas. Refer to Figure 4-7 as you perform this procedure.
  • Page 351 d. Press Stop Test Ensure that the bubbles stop flowing from the adapter. 4. Check the flow of Slope Gas: a. Select Slope Gas b. If required, push down the sample door halfway open, insert an aspiration adapter into the sample port, and immerse the other end in the water. c.
  • Page 352 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. You can also test fluid detectors 1, 1A, and 2 with whole blood by inserting a sample device containing whole blood into the sample port.
  • Page 353 4. Test the fluid detectors with whole blood: a. Select and press Whole Blood b. Insert a sample device containing a whole blood sample into the sample port. c. Press Start Test d. Remove the sample device when prompted. e. Check the screen for the message, FD1, FD1A, FD2, FD5 acceptable, to verify correct fluid detector function.
  • Page 354 2. Test the positions of the sample door and the sample probe: a. Select and press Automatic b. Press Start Test c. Check the screen for the message, Sample entry module acceptable, to verify that the sample door and sample probe function correctly. d.
  • Page 355 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 Test d. Remove the sample device when prompted. e.
  • Page 356 4. Perform the appropriate action. Temperature control system on message Temperature control system off message 5. Press Exit Test Use this procedure to test the measurement electronics. You can: print stored signals from the last successful two-point calibration test the sensor circuit without a sensor and with a test/blank sensor 1.
  • Page 357 29.0 to 126.0 mV – 29.0 to 126.0 mV 29.0 to 126.0 mV Glu I –5.35 to +16.45 nA Glu A –5.35 to +16.45 nA Lac I –5.35 to +16.45 nA Lac A –5.35 to +16.45 nA 217.1 to 443.3 mV –203.2 to +126.6 mV –0.300 to +0.360 nA 35.2 to 141.0 mV...
  • Page 358 TB1, pO /pCO TB2, pH/Na Test/Blank Sensor TB3, K TB4, Glucose/Lactate Test/Blank Sensor Menu Code 1. Access the Measurement Test from the Menu screen: a. Select 3 Troubleshooting b. Select 3 Measurement Touch the inner surface of the module frame to discharge static CAUTION: buildup before removing or returning sensors.
  • Page 359 Lac A sample ground/temperature d. Press Stop Test e. Perform the appropriate action. is within the expected value is not within the expected value The measurement test, which requires approximately 8 minutes to complete, can effectively evaluate measurement system failures. 4.
  • Page 360 d. Take a reading of the actual sensor output signal. e. Wait 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: –...
  • Page 361 You 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 Test from the Menu screen: a. Select 3 Troubleshooting b. Select 3 Measurement c.
  • Page 362 b. Select 4 Communications The External Loopback Test screen appears as shown in Figure 4-11. 2. Select the appropriate port and press Attach the loopback connector to the cable matching connector, if your cable requires one. 3. Attach the loopback connector as follows. the 800 system a.
  • Page 363 Do not attempt to print without paper in the printer. Damage to the CAUTION: printer can occur. Menu Code 1. Access the Roll Printer Test from the Menu screen: a. Select 3 Troubleshooting b. Select 5 Roll Printer 2. Press Start Test 3.
  • Page 367 Use this procedure to remove obstructions from the sample entry components. Perform the steps in sequence until you locate and remove the obstructions. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for recommended precautions when working with biohazardous materials.
  • Page 368 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 out of the sample port. 5.
  • Page 369 Mount O-ring Retainer Ring Capillary Seal Sample Port Clot-removal Line 7. Inspect the mount for obstructions and clean if necessary. 8. After removing any obstructions, reinstall the sample port: Ensure that the three O-rings are in place on the mount. a.
  • Page 370 Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Stop the system from the Menu screen: a. Select 2 Maintenance b. Select 7 Stop System 2. Open the measurement module door: a.
  • Page 371 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 reagent and inject the wash reagent into the sensor sample path.
  • Page 372 Touch 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. To avoid damage to Ca attempt to push the clot-removal line through these sensors. –...
  • Page 373 Preheater Connector for Sample Tubing Clot-removal Line Push the spring-loaded latch to the right. d. Connect the sample tubing to the preheater. e. Reinstall the gas sensors, ensuring that the O-rings are in place. 7. Remove obstructions from the path through the latch, as shown in Figure 4-19: without first discharging static buildup.
  • Page 374 Grasp the tab on the reference sensor and pull it up and out of the measurement module. Push the spring-loaded latch to the right. d. Connect the measurement module tubing to the latch. e. Reinstall the reference sensor, ensuring that O-rings are in place. 8.
  • Page 375 Refer to Appendix A, Protecting Yourself from Biohazards, for BIOHAZARD: recommended precautions when working with biohazardous materials. Do not use a needle on the syringe that you use to introduce reagent water NOTE: or air into the CO-ox sample tubing. Using a needle may damage the CO-ox sample tubing.
  • Page 376 Do not move the obstruction into the hemolyzer, sample chamber, or sample connector. in the CO-ox sample a. Remove the piece of sample tubing that contains tubing that connects the hemolyzer and bubble trap b. Push a clot-removal line, less than 0.020 mm or the sample chamber and CO-ox pump c.
  • Page 377 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 in the preheater, see Removing Obstructions from the Measurement Module for instructions.
  • Page 378 5. Inspect the sample chamber and bubbletrap for obstructions: near the sample chamber outlet near the sample chamber inlet a. Disconnect the CO-ox sample tubing from the sample connector. b. Manually turn the CO-ox pump clockwise. c. Move the obstruction just into the sample tubing that connects the sample chamber to the CO-ox pump.
  • Page 379 not removed in the bubble trap 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 8. Perform a one-point calibration from the Menu screen: a.
  • Page 380 Use this procedure to disconnect the CO-ox sample path from the base model. You can continue to measure the remaining parameters. BIOHAZARD: recommended precautions when working with biohazardous materials. Menu Code 1. Turn the CO-ox parameters off: a. Select b. Select c.
  • Page 381 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.
  • Page 382 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 that are not cleared by a diagnostic test. Use the appropriate subsections to troubleshoot the following: results reagents sensors and CO-ox...
  • Page 383 The result is above (up arrows) or below (down arrows) the limits of the system’s measurement range, as described Out of Range message in Appendix E, Performance Characteristics. 1. Verify the manufacturer’s control values and ascertain 2. Check for sample movement during measurement. 3.
  • Page 384 Proficiency test System requires cleaning or maintenance, or reagents or results are not controls are outdated, deteriorated, or incorrectly handled. as expected 1. Perform all required maintenance and cleaning. 2. Ensure that reagents, controls, and unknown samples 3. Check all quality control results. 4.
  • Page 385 Use this table if you observe unexpected or out-of-range patient results. The patient sample result is The result is inconsistent with the patient’s diagnosis, not as expected current treatment, or past history including previous measurements on that patient, or is inconsistent with other values on the same specimen.
  • Page 386 The result is above (up arrows) or below (down arrows) the limits of the system’s measurement range, as described Out of Range message in Appendix E, Performance Characteristics. 1. Check the source and result, and ascertain whether a 2. Check for sample movement during measurement. 3.
  • Page 387 ? is printed next Optical measurements indicate that the CO-oximeter to the CO-oximeter results results should be reviewed. on reports Results may still be clinically valid. When reporting CO-oximeter results, consider the patient’s history and clinical condition to determine acceptability of results. To troubleshoot an If Blood, Question Data message, determine whether the problem is with the sample type, the patient sample, or the system.
  • Page 388 ? is printed next 4. Review the last calibration. to the CO-oximeter results on reports is successful is not successful 5. Obtain and analyze a new sample from the patient. 6. If the message reappears, the problem may be with the 7.
  • Page 389 Use this table if you observe fluid leaks in or under the 800 system. Sample drips out of 1. Ensure that you do not inject the sample into the sample port 2. Ensure that the syringe is fully seated in the sample 3.
  • Page 390 Use this table if you observe problems with fluids flowing too slowly, erratically, or not at all. Insufficient wash solution is flowing to clean the sample path 1. Check the level of wash reagent and install a new bottle of Bayer Diagnostics wash reagent if required.
  • Page 391 Insufficient wash solution is flowing through the sample port No waste is flowing out of the waste outlets into the waste bottle 1. Check the level of wash reagent and install a new bottle of Bayer Diagnostics wash reagent if required.
  • Page 392 Sample path is obstructed Air bubbles in fluid in sample path The fluid flow is insufficient due to obstructions in the sample path. 1. Check for obstructions in the sample entry components as described in Removing Obstructions from the Sample Entry Components, page 4-79. 2.
  • Page 393 During the first 24 hours following installation, the glucose or lactate biosensors measure a large negative slope value during calibration. The biosensors measure an equal, but positive slope valve during the next calibration. Erratic sample flow The shift in slope value is due to bubbles trapped in the glucose or lactate biosensor.
  • Page 394 Use this table if you observe fluids with cloudiness, color changes, or particulate matter. A reagent is cloudy or The reagent may be outdated or deteriorated. has particulate matter 1. Remove the reagent, and then prime the lines to purge all reagent from the system.
  • Page 395 Use this table if you observe problems with the supply and delivery of Cal or Slope Gas. Leaking or hissing of 1. Locate the source of the leak by listening closely for hissing around the regulators and gas tubing. Apply soapy water around the regulator or the gas fittings on the reagent manifold and look for bubbles.
  • Page 396 Salt deposits appear 1. Check the reference sensor for leaks. Tighten cap if in measurement required and clean any deposits with a swab moistened in module reagent water. 2. Clean deposits in measurement module and on all sensors with swabs moistened in reagent water. 3.
  • Page 397 Use this table if you observe problems with bar codes or the bar code scanner. The bar code scanner Faulty scanning technique, poor bar code print quality, or loose works intermittently cable connection to the port on the 800 system. 1.
  • Page 398 Use this table if you observe electronic problems. The system does not 1. If your system has a keyboard, check the keyboard to see if respond to input from it is working, and ensure that Num Lock is turned off. the keypad 2.
  • Page 399 Use this table if you observe problems with the roll printer. Printer is not printing 1. Ensure the thermal paper is feeding correctly and that it is at all not reversed. Refer to Replacing the Printer Paper in Section 3. 2.
  • Page 400 Use this table if you observe problems with the reagent pump, sample pump, or waste pump. Pump is not operating 1. Inspect the pump tubing and replace if required. correctly 2. Clean the roller cage and shaft as described in Cleaning the Roller Cages in Section 3.
  • Page 401 Measurement module The measurement module temperature is outside the temperature error 37.0 message requests. 1. Ensure the measurement module door is closed. 2. Wait at least 15 minutes for the system to warm up. 3. Perform the Temperature/pAtm Test, as described in Section 4.
  • Page 402 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 home screen. Bubbles Detected in The system detects a non-continuous fluid in the measurement Sample module sample path.
  • Page 403 Excessive Bubbles in The system detects a non-continuous fluid in the CO-ox sample COox Sample path. Excessive Bubbles in 1. Ensure that you use proper sampling technique, as COox tHb Slope described in Analyzing . . . Samples in Section 2. Analyze the sample again or perform a pH/lytes one-point Excessive Bubbles in calibration.
  • Page 404 If Blood, Question Optical measurements indicate that the CO-ox results should be Data reviewed. A question mark (?) is printed next to the CO-ox results on reports. Results may still be clinically valid. When reporting CO-ox results, consider the patient’s history and clinical condition to determine acceptability of results.
  • Page 405 If Blood, 4. Review the last calibration. Question Data is successful is not successful 5. Obtain and analyze a new sample from the patient. 6. If the message reappears, the problem may be the result of the patient’s clinical condition. Analyze a sample from a different patient.
  • Page 406 Insufficient Sample There is not enough sample to fill the measurement block. You can manually position the sample for measurement. See Analyzing Microsamples, Steps 5-11, in Section 2. 1. Ensure that the sample volume is sufficient for the sampling device used and the tests requested. 2.
  • Page 407 Meas Module The measurement module temperature is outside the Temperature Error 37.0 requests. 1. Ensure that the measurement module door is closed. 2. Wait at least 15 minutes for the system to warm up. 3. Perform the Temperature/pAtm Test, as described in Section 4.
  • Page 408 No Sample Device No sample device is detected in the sample port after you press Detected Analyze and the sample door closes. 1. Ensure that you use proper sampling technique, as described in Analyzing . . . Samples in Section 2. 2.
  • Page 413 This section describes the procedures for defining or changing 800 system setup parameters. Table 5-1 describes many of the tasks that you can do in setup and lists the setup menu option you select to perform each task. create and edit QC files define the number of patient samples stored on the system select Auto ID and Auto Accept for...
  • Page 414 control various system functions such as beeper volume, auto move capillaries, auto send results, and reporting resolution select maintenance functions such as record, view, or schedule maintenance tasks configure the 800 systems for a 270, a printer, a bar code scanner, an LIS, or a data management system define passwords to protect operations and menu access...
  • Page 415 Previous return to the frame or screen from which you entered the present Screen screen. If you press this key after you make changes to the current screen, a message appears prompting you to save your changes. Press Yes to save changes. Press No if you do not want to save your changes.
  • Page 416 1. Access the System Information screen from the Menu screen: a. Press 8 Service Setup b. Press 1 System Information The System Information screen appears, as shown in Figure 5-1. 2. Press when you finish viewing the screen. Menu 3. Define another setup function or press Use this procedure to select the fields you want to use in the Patient Information screen.
  • Page 417 Temperature temperature of the patient total hemoglobin value of the patient Source origin of the patient sample Draw Date date sample was drawn Draw Time time sample was drawn fraction of inspired air Ventilator Flow flow rate setting on the patient’s ventilator Respiratory Rate respiration rate per minute of the patient partial pressure of oxygen at which hemoglobin is 50% saturated...
  • Page 418 2. Define another setup function or press 3. Select the fields you want to change: make a field a. Move to the On/Off check box for the field you want. appear or not b. Press appear the field is on. The default value is On. If you turn a field off, it does not appear on the Patient Information screen.
  • Page 419 Use this procedure to customize a panel that the system will use to analyze a patient sample. You can define up to 5 customized panels. The system measures only the parameters listed in the panel. You can choose to have a parameter not appear on the panel by turning the parameter off. If you select a parameter to be off, the system does not measure or NOTE: calculate results during analysis, and the parameter name does not appear on the...
  • Page 420 Use this procedure to select the panel that the system will use to analyze a patient sample. You can select default panels from a predefined list or from any defined custom panels. The system measures only the parameters listed in the panel. The system default is All Parameters.
  • Page 421 All Parameters pH/Blood gas CO-ox pH/lytes Blood gas/lytes pH/Ca All Parameters pH/Blood Gas pH/Blood Gas/lytes pH/lytes/metabolites pH/Ca All Parameters pH/Blood gas CO-ox pH/lytes/metabolites pH/Ca pH/Blood gas/lytes/ metabolites All Parameters pH/Blood gas CO-ox pH/lytes/metabolites pH/Ca pH/Blood gas/lytes/ metabolites – pH, pO , pCO , Na , Cl...
  • Page 422 1. Access the Select Default Panels screen from the Menu screen: a. Select 6 System Setup b. Select and press 4 Panels c. Select 1 Default Panel The Select Default Panel screen appears, as shown in Figure 5-4. 2. Select the appropriate panel and press Custom panels are listed as Panels 1–5.
  • Page 423 2. Select the parameters. a. Move to the frame that contains the appropriate parameter. b. Select the parameter that you want and press c. Repeat steps a and b for each parameter you want to change. d. Press to access the second screen of parameters. Next Screen e.
  • Page 424 ctHb g/dL SAT, F , sO Hct, Hb Fractions mmol/L Glucose mg/dL Lactate mmol/L 1. Access the Units and Values screen from the Menu screen: a. Select 5 Operating Setup b. Select and press 4 Units/Values The Units and Values screen appears, as shown in Figure 5-6. 2.
  • Page 425 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 ctHb and p50 that the system uses when no value is entered or measured, and to define the value for the O and ctO (a-v), which are constants supplied by the system.
  • Page 426 3. Change the appropriate parameter values: a. Move to the field you want to change. b. Type in the new value and press c. Repeat steps a and b for each parameter value you want to change. 4. Press when you finish. Done 5.
  • Page 427 ctHb AaDO (A–a)(T) (a/A)(T) 1. Access the Parameter Names screen from the Menu screen: a. Select 5 Operating Setup b. Select 5 Parameter Names The Parameter Names screen appears, as shown in Figure 5-8. 2. Select Option 1 Option 2 3.
  • Page 428 The default values for the action range are equal to the measurement range. NOTE: 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 the action range values to have the system flag action range results.
  • Page 429 94.0 – 97.0 FCOHb 0.5 – 1.5 FMetHb 0.0 – 1.5 FHHb 0.0 – 5.0 * Tietz NW ed. Fundamentals of clinical chemistry. 3rd ed. Philadelphia: WB Saunders, 1987; 864-891. Weisberg HF. Acid-Base pathophysiology in the neonate and infant. Annals of Clinical and Laboratory Science 1982;...
  • Page 430 Use this procedure to select automatic printing, number of copies, and printer type for the following reports: patient sample reports QC reports calibration reports You select options separately for each type of report. Table 5-9 lists the available report printing options. Roll Printer Lets you turn the roll printer on or off.
  • Page 431 2. Select the type of report required. 3. Press Done The second Printing Options screen appears. 4. Select the printing options you want from this screen. Press selections. Refer to Table 5-9 for the list of options. 5. Press Done A message appears prompting you to set up another report.
  • Page 432 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 for roll and line printers. Print a copy of each report format. Create four lines of information to appear at the top of each report. You need an alphanumeric keyboard to type the information.
  • Page 433 You can select a report format for the roll printer and, if a line printer is connected, for a line printer. 3. You can print a copy of a report to view the format and create lines of information to appear in the header of the report: print a report a.
  • Page 434 Use this procedure to turn the roll printer on and off. When you turn the roll printer off, it is off for all reports. You cannot turn the roll printer on for a specific report type. The default value for the roll printer is On. 1.
  • Page 435 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 from the Menu screen: a. Press 5 Operating Setup b.
  • Page 436 Use this procedure to select sample analysis and menu functions for password protection. When you password protect sample analysis or menu functions, operators must enter a password to access the protected function. Select the Sample Analysis option to password protect the system from unauthorized use.
  • Page 437 3. Select the functions that you want to protect and press 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. Sample Analysis for define the operator passwords, as described in Defining password protection Operator Passwords, page 5-27.
  • Page 438 The first operator password has a default value of 12345. To ensure that there is always at least one active operator password, you can edit the default password, but you cannot delete it. If you want to define only one operator password for all operators to use, enter the password you want and leave the Operator ID field blank.
  • Page 439 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 the entry.
  • Page 440 You must enter values into both the Supervisor Password and the Menu Password fields. If you do not use or uniquely define one or the other password, you can enter the default password. The default for both passwords is 12345. 3.
  • Page 441 Use this procedure to change the date and time. Table 5-10 lists the date and time formats that you can use. Date MM/DD/YY DD/MM/YY YY/MM/DD Time HH:MM (24-hour clock) 1. Access the Date and Time Setup screen from the Menu screen: a.
  • Page 442 2. Change the date and time. Date a. Move the cursor to the Date field. b. Type the month, date, and year in the selected format. Press Enter Time field. Time a. Move the cursor to the Time field. b. Type the hour and minutes in the format, HH:MM. You can enter 0 –...
  • Page 443 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 the month, the system also prints out final statistical summary reports of the previous month’s QC data at the time of the Auto Clean.
  • Page 444 b. Press 2 Maintenance Tasks The Maintenance Setup screen appears, as shown in Figure 5-19. 2. Enter the start date for recording the maintenance tasks. Tasks become due on midnight of the scheduled date. For example, weekly tasks are due every 7 days after the start date, monthly tasks are due every fourth week after the start date.
  • Page 445 Use this procedure to define the number of patient samples that can be stored on your hard disk. You have the option of maximizing your patient sample database and storing up to 5,000 samples on your hard disk or minimizing the database by reducing the number of stored samples.
  • Page 446 Use this procedure to adjust the beeper volume. You can select a high, medium, or low volume. The default value is high. 1. Access the System Options screen from the Menu screen: a. Press 6 System Setup b. Press 5 Systems Options The System Options screen appears, as shown in Figure 5-21.
  • Page 447 Use this procedure to control the way the system moves capillary samples to the measurement module. You can choose to move the samples manually or to have the system move them automatically. The system moves capillary samples automatically to the measurement module.
  • Page 448 Use this procedure to select automatic transmission of patient sample results directly to an LIS, HIS, or data management system. You can use this option only if your 800 system is connected to an LIS or data management system. Refer to Selecting Automatic Transmission of QC Results, page 5-55, for the procedure to define auto send for QC results.
  • Page 449 Use this procedure to define the number of significant digits reported for certain primary parameters. Table 5-13 lists the parameters that have high and low resolution options. The default value is high. nmol/L mmHg mmHg High nmol/L mmHg mmHg 1. Access the System Options screen from the Menu screen: a.
  • Page 450 2. Select and press High 3. Press Done 4. Define another setup function or press screen. The option that you select for the Reporting Resolution is saved with each patient and QC sample. If you recall the sample data later and have changed the resolution, the system prints the report using the resolution selected when the sample was saved.
  • Page 451 1. Access the System Options screen from the Menu screen: a. Press 6 System Setup b. Press 5 Systems Options The System Options screen appears, as shown in Figure 5-25. 2. Move to the Report with Cal Drift frame. 3. Select and press 4.
  • Page 452 Use this procedure to define correlation coefficients. Correlation coefficients allow you to adjust the patient results from an 800 system to match the patient results from another system. You can specify correlation coefficients for slope and offset (y-intercept). Refer to Appendix G, Correlation Adjustment, for the procedure to determine correlation coefficients.
  • Page 453 1. Access the Correlation Coefficients screen from the Menu screen: a. Select 5 Operating Setup b. Select and press 8 Correlation The Correlation Coefficients screen appears, as shown in Figure 5-26. 2. Type the slope and offset values you want for each parameter. 3.
  • Page 454 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 setup report when you change a setup parameter or value. The report is a record of your setup definitions which can be used later when you want to make another change.
  • Page 455 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 on or off printing a QC setup report Each QC file can store the following information: file identification information results for the last 150 QC samples...
  • Page 456 Use this procedure when you first create a new QC file. The system uses QC files to store results from QC sample analyses. You can use this QC information to create reports summarizing QC results. NOTE: If you have an existing QC file and want to change to a new lot of QC material, refer to Editing QC File Setup, page 5-49.
  • Page 457 6. Press The QC File Setup screen appears with all data fields empty, as shown in Figure 5-28. 7. Complete the form. the keypad type the low and high target limits for each parameter. Press Enter after you complete each field. the optional bar scan the target range bar code for each parameter from QC code scanner...
  • Page 458 9. Press Done A message appears prompting you to set up another QC file. save your entries and create another QC file save your entries and you do not want to create another file return to the QC File Setup (ranges) screen If you press Done before you complete both the low and high fields for a parameter, a message appears telling you the empty field is an invalid range.
  • Page 459 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 information. You want to change the high and low range values for a parameter. If you are creating a QC file for the first time, refer to Creating New QC Files, page 5-46.
  • Page 460 4. Perform one of the following options. change to a new type the new QC file information in the fields or, if you use QC lot the optional bar code scanner, scan the new QC file information. Continue with step 5. edit the ranges for continue with step 5.
  • Page 461 6. Perform one of the following options. changing to a new QC type the high and low target limits for each parameter. Press NOTE: QC information, scan the QC Parameter bar codes. editing a portion of the move to the field requiring change, press existing QC file ranges and type the new data.
  • Page 462 8. Press when you finish. Done A message appears prompting you to set up another QC file. save changes and edit another QC file save the entries and you do not want to edit setup function or press another file screen.
  • Page 463 Use this procedure to control the way QC results are assigned to a QC file. Table 5-19 describes the options for assigning QC results. The system automatically determines the appropriate QC file to assign QC sample results, by comparing the QC sample results for pH and pCO these parameters.
  • Page 464 Use this function if you are connected to an LIS or data management system and you want the 800 system to automatically accept QC results. When you use Auto Accept with Auto Send, the 800 system accepts all QC samples and sends them to the connected LIS or data management system.
  • Page 465 5. Define another setup function or press screen. Use this procedure to control transmission of QC results directly to an LIS or data management system. This option is available only if your 800 system is connected to an LIS or data management system. Refer to Defining Automatic Transmission of Results, page 5-38, for the procedure to define patient sample auto send.
  • Page 466 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 b. Select c. Select 2. Select the file number that you want to print. 3. Press Print QC Setup The QC Setup report prints.
  • Page 467 This section describes procedures for the following calibration options: changing drift limits changing calibration gas values selecting calibration frequency and Auto Repeat Use this procedure to enter the drift limits allowed during calibrations. Drift is the difference between the value expected from a known calibrant and the actual value measured during the calibration.
  • Page 468 1. Access the Calibration Drift Limits screen from the Menu screen: a. Select 5 Operating Setup b. Select 6 Calibration Setup c. Select 1 Drift Limits and press The Calibration Drift Limits screen appears, as shown in Figure 5-35. 2. Move to the field that you want to change. The number you enter establishes a range above and below the expected value.
  • Page 469 2.00 – 7.90% 5.00% 5.00 – 98.00% 12.00% 1. Access the Calibration Gas Values screen from the Menu screen: a. Select 5 Operating Setup b. Select 6 Calibration Setup c. Select and press 3 Gas Values The Calibration Gas Values screen appears, as shown in Figure 5-36. 2.
  • Page 470 Use this procedure to select the frequency at which automatic calibrations occur and to direct the system to repeat calibrations automatically whenever the drift is out of limits. There are two calibration frequency options: fixed time and flexible time. Table 5-24 describes the Calibration Frequency and Auto Repeat options. Fixed Time Lets you schedule one- and two-point calibrations to occur at regular intervals.
  • Page 471 c. Select and press 2 Cal Intervals The Cal Intervals screen appears with the cursor in the Calibration Frequency frame, as shown in Figure 5-37. 2. Select the options you want. Calibration Frequency One-point, Two-point, or tHb Slope Interval Auto Repeat Metabolite Recal 3.
  • Page 472 Use the following procedures to configure the 800 system for any of the following external devices: 270 CO-oximeter 800 series compatible ticket printer Bayer Diagnostics data management systems bar code scanner line printer laboratory or hospital information system Table 5-25 lists the ports you can use with each device. Serial port 1 the ticket printer.
  • Page 473 2. Select the appropriate serial port, press Refer to Table 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 selected. If required, press and select another port.
  • Page 474 4. Select the parameters according to the communication requirements for the device you are connecting. Table 5-26 describes each of the communication parameters. protocol the set of conventions that governs the format and timing of the information transferred between the 800 system and the LIS, HIS, or data management system baud rate speed at which data is sent or received when devices are...
  • Page 475 5. Press when you finish. Done You are prompted to configure another port. want to configure another device do not want to . The Menu screen appears. You can define another setup configure another function or press device want to return to the Cancel last field edited When the system establishes the connection to an external device, the Device...
  • Page 476 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, and the service contact. You can view the system information, but you cannot change any of the information. Refer to Viewing System Information on page 5-5 for the procedure to view the system information.
  • Page 477 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 software copy patient data files to a diskette in a CSV file format When you backup or archive, use DOS-formatted, 3.5-inch diskettes.
  • Page 478 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. You can archive the previous month’s QC data one or more times during the current month.
  • Page 479 If you do not insert a diskette, the No Diskette in Diskette Drive message box appears. If you insert an unformatted diskette, the Cannot Write to Diskette message box appears. you want to continue insert a formatted diskette and press to archive you do not want to press...
  • Page 480 Use this procedure to view QC data from archive diskettes. You can also print the following QC reports from archive diskettes: Levey-Jennings Chart QC Sample Report QC Statistical Summary You cannot edit or restore archived QC data. NOTE: 1. Access the View Archived QC Data screen from the Menu screen: a.
  • Page 481 7. Perform one of the following tasks. view the report results print a Levey-Jennings, QC sample, or statistical summary report 8. Press to print a Levey-Jennings, QC sample, or statistical Reporting Options summary report. 9. Select the report you want to print. Levey-Jennings Chart QC Sample Report QC Statistical Summary...
  • Page 482 If you type invalid data in a field and press Invalid Entry or Invalid Range message box. Press field. If there is no QC data found for the search criteria you entered, the No QC Data message box appears. Press accurate.
  • Page 483 2. Perform one of the following tasks. back up the system select data copy the trace log select 3. Press . The Backing Up message box appears prompting you to insert a Done diskette. 4. Insert an IBM-formatted diskette in the diskette drive and press The Writing to diskette message box appears while the system performs the backup.
  • Page 484 If you do not insert a diskette, the No Diskette in Diskette Drive message box appears. If you insert an unformatted diskette, the Cannot Write to Diskette message box appears. you want to continue with insert a formatted diskette and press the backup you do not want to continue press...
  • Page 485 4. Complete the restore process. a message appears a. Remove the diskette from the diskette drive. prompting you to b. Insert another backup diskette and press insert the next diskette the Restore Finished Continue with step 5. screen appears 5. Press and the remove the diskette.
  • Page 486 If you want to cancel the restore process, press and remove the diskette from the diskette drive. Format Disk Previous Screen Menu Use this procedure to install or update operating software on your 800 system. You update system files using program diskettes that contain new system software. To protect against data loss, always back up files before installing new CAUTION: software.
  • Page 487 4. Press to proceed. Continue The following message appears: The system identifies the diskette and displays the Install Identification message box: Do not remove the diskette. 5. Press to proceed using the diskette the system just read. Continue The system copies the software files from the diskette to the hard disk:...
  • Page 488 6. After the system copies the software files, the Install Identification message box appears. you have more program diskettes to install the Last Diskette message appears on the Install Identification message box instruction line If the Last Diskette message does not appear after the system reads the last program diskette, it is likely that at least one of the program diskettes was not installed.
  • Page 489 9. Restart the system: a. Wait 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 appears. The software version number appears on the System Information screen with the date and time of installation.
  • Page 490 Use this screen to define the criteria for the patient data files you want to copy. The system locates only the files that meet the criteria you specify. For example, if you want to copy patient data files from a specific period, type in the start date in the Analysis Date From field and the end date in the Analysis Date To field.
  • Page 491 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. You can then use these applications for data management and analysis.
  • Page 492 Blank No exceptions Blood gas and CO-ox sample temp out of range Blood gas sample temp out of range CO-ox sample temp out of range Bubbles detected in blood gas and CO-ox sample Bubbles detected in blood gas sample Bubbles detected in CO-ox sample Blank No exceptions Entered value...
  • Page 493 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 Standby, the system continues to perform purge sequences to maintain the integrity of the sensors, and it performs the Auto Clean sequence.
  • Page 494 3. Exit standby. automatically manually After the system exits standby, it performs the required calibrations and returns to the Ready screen. If you turn off the power while the system is in standby, the system returns to standby when you turn on the power. If the system is scheduled to perform an automatic calibration while in standby, the calibration starts when the system exits standby.
  • Page 495 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. Select 7 System Utilities b. Select 3 Shutdown and press 2. Press A message appears on the screen and on the roll printer, prompting you to wait before you disconnect the power.
  • Page 503 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 Control and Prevention (CDC) and Guideline M–29A from the National Committee for Clinical Laboratory Standards (NCCLS): Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood and Tissue, Approved Guideline.
  • Page 504 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 15% v/v bleach. Do not eat, drink, smoke, or apply cosmetics while in the laboratory. Do not mouth pipet any liquid, including water.
  • Page 505 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 service delivery policy information a list of the system supplies that you are most likely to order For technical assistance contact your local authorized representative.
  • Page 506 Bayer OY Suomalaistentie 7 FIN 02270 Espoo, Finland + 35 89 88 78 87 Bayer Diagnostics Tour Horizon 52, quai de Dion Bouton 92807 Puteaux Cedex, France 01 49 06 56 00 Bayer Vital GmbH & Co. KG Geschäftsbereich Diagnostics Siemensstraße 3D–35463 Fernwald, Germany...
  • Page 507 Bayer Puerto Rico Inc. Diagnostics Division Victoria Industrial Park Building #1 Carolina, Puerto Rico 787 752–8989 Bayer (Pty) Ltd. Healthcare Division 27 Wrench Road Isando 1600, South Africa 27 11 921–5048 Química Farmacéutica Bayer, S.A. División Diagnósticos Calabria, 268 08029 Barcelona, España + 34 93 495.65.00 Bayer AB Drakegatan 1...
  • Page 508 Bayer Diagnostics and its authorized distributors provide customers who acquire new Bayer Diagnostics systems with a one-year comprehensive, but limited, warranty. This limited warranty is designed to protect customers from the cost associated with repairing systems that exhibit malfunctions due to defects in materials and/or workmanship during the warranty period.
  • Page 509 Customers, with some exceptions, may also request warranty service to be delivered outside of normal business hours, including evenings, weekend days, or nationally observed holidays by contacting the Bayer Diagnostics location or authorized distributor. Warranty service performed at these times is subject to a surcharge unless the customer has purchased a service product option that provides warranty service outside normal hours.
  • Page 510 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-site labor during normal business hours. In addition, Bayer Diagnostics or its authorized distributors will provide warranty service during the warranty period only, and system repairs, labor, or replacement parts, as provided during the original warranty period, will not extend the original warranty period.
  • Page 511 Bayer Diagnostics warrants to all customers that service will be performed in a professional manner consistent with the industry. If the system is not performing according to its specifications, Bayer Diagnostics will, at its option, repair or replace the system. This is the customer’s sole and exclusive remedy for breach of warranty.
  • Page 512 Use Table B-1 and Table B-2 to find the supply or accessary you need to order. 115701 Manual, Rapidlab 800 Operator’s 115713 Manual, Rapidlab 800 Quick Reference Guide, English 115716 Manual, Rapidlab 800 Quick Reference Guide, Spanish 115719 Manual, Rapidlab 800 Quick Reference Guide, French...
  • Page 513 673702000 Test/Blank Sensor K 673396000 Test/Blank Sensor Ref (TB5) 477832000 Ticket Printer 478736000 Fuse Kit 477570000 Clot Removal Kit 673703000 Aspiration Adapter Kit 858040001 Power Cord, US 858071001 Power Cord, International 111399 Kit Bar Code Scanner LS4004 110889 Bar Code Scanner (LS4004) 110890 Cable, Bar Code Scanner (LS4004) 858086001...
  • Page 514 013895701 Reagent Fitting Kit (Septum Probe) 673708000 Lamp Bulb (incandescent) 014073002 9-pin Cable-Matching Connector 013899001 Loopback Connector 013902701 O-ring Kit 013903701 Blank 3.5-inch Diskette, Preformatted 673356000 Waste Bottle Kit 476267000 pH Ready Sensor 476247000 Ready Sensor 476246000 Ready Sensor 476270000 Potassium Ready Sensor 476266000 Sodium Ready Sensor...
  • Page 515 478498000 Reference Sensor Refill (cassette, fill solution, O-rings) 013174001 Retainer, Sample Port 013186001 Sample Port 013199001 Front Cover 477833000 Analysis Report Ticket 477434000 Cal Calibration Gas (5% CO 477438000 Slope Calibration Gas (10% CO 823736001 Gas Tank Seal 478740000 Sample Ground/Temperature Sensor 013662001 Waste Nozzle (waste outlet cover) 014117701...
  • Page 516 473120000 CO-oximeter Slope (10 pack) 570017 CO-ox Air Filter 570051 CO-ox Pump Tubing 014801001 CO-ox Pump Tubing Connector 570019 CO-ox Sample Tubing Kit 570050 CO-ox Lamp 570018 CO-ox O-ring/Gasket Kit (for hemolyzer and sample chamber) 673700000 Clot Removal Kit (tubing diameter <0.022mm) 570049 Sample Chamber 106371...
  • Page 517 This appendix lists all references for this manual. National Committee for Clinical Laboratory Standards. Blood Gas Pre–Analytical Considerations: Specimen Collection, Calibration and Controls, Approved Guideline; NCCLS Document C–27A (Vol. 13, No. 6); April 1993. Douglas IHS, McKenzie PJ, Leadingham I, Smith G. Effect of halothane h. on pO electrode.
  • Page 518 14. Moran R, Cormier A. The blood gases: pH, pO 14(4/5): 10–12. 15. Severinghaus JW, Bradley AF. Electrodes for blood pO J Appl Physiol 1968; 13:515–520. 16. Shapiro BA, Harrison RA, Cane RD, Templin R. Clinical application of blood gases. 4th ed.
  • Page 519 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 JM, Trotter J, Erbeck D, Weil MH, Shubin H. An equation for the oxygen hemoglobin dissociation curve.
  • Page 520 48. Shapiro BA, Harrison RA, Cane RD, Kozlowski–Templin R. Clinical application of blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989: 143. 49. Shapiro BA, Harrison RA, Cane RD, Kozlowski–Templin R. Clinical application of blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989: 140. 50.
  • Page 521 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 Diagnostics data management system line printer laboratory information system (LIS) hospital information system (HIS) Figure D-1 identifies the various ports available on the 800 system.
  • Page 522 Use this procedure to connect an 800 system to a 270 CO-oximeter. Materials Required: 800 to 270 interface cable (part number 014117701) To prevent electrical shock and damage to either system, disconnect the 800 system and 270 CO-oximeter from the AC power source before installing the cable.
  • Page 523 f. Press to confirm your selection. ENTER g. Select the transmission specifications as shown in Table D-1. baud rate 9600 parity even stop bit data bits modem control h. Press to confirm the selections. ENTER The display shows the port number and the device connected to the port. i.
  • Page 524 Always use serial port 1 for the ticket printer. NOTE: 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. Tighten the hold down screws on the connectors. 6.
  • Page 525 To 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 to disconnect the 800 system. 1.
  • Page 526 Use this procedure to connect an 800 system to a laboratory information system (LIS) or hospital information system (HIS). Materials Required: LIS or HIS to 800 system interface cable and 9-pin, cable-matching connector (supplied with the LIS or HIS) if you are converting from a 200 series system, 9-pin to 25-pin cable adapter (part number 014118001) To prevent electrical shock and damage to either system, disconnect the 800 system and Data Management system from the AC power source before...
  • Page 527 This appendix provides the following information about the 800 series systems: system specifications limitations reference methods 840 system performance characteristics 850 system performance characteristics 860 system performance characteristics CO-ox module performance characteristics...
  • Page 528 Table E-1 lists the specifications for the 800 system. ambient operating 15 – 32 C temperature ambient operating 5 – 85%, non-condensing relative humidity power rating 400VA voltage requirements 100V/120V (85V to 132V) 50/60Hz 220V/240V (170V to 264V) 50/60Hz ambient operating 400 –...
  • Page 529 Table E-2 lists the units, reporting ranges, and display resolutions for the pH and blood gas parameters measured by the 800 system. 6.000 – 8.000 nmol/L mmHg mmHg pAtm mmHg Table E-3 lists the units, reporting ranges, and display resolutions for the electrolyte parameters measured or calculated by the 850 and 860 systems.
  • Page 530 Lactate mg/dL mmol/L AnGap mmol/L –5.0 – 50.0 Table E-4 lists the units, reporting ranges, and display resolutions for the oxygenation parameters calculated by the 800 system or calculated from a sample analyzed on the 800 system and a connected CO-oximeter. mmHg mL/dL mL/L...
  • Page 531 (a-v) mL/dL mL/L mmol/L ([a-v]/a)) decimal fraction mL/min L/min mmol/mi mL/min L/min mmol/mi Table E-5 lists the units, reporting ranges, and display resolutions for parameters measured by the 800 system CO-ox module. g/dL mmol/L fraction –0.999– 9.999 –99.9 – 999.9 fraction –0.999–...
  • Page 532 –99.9 – 999.9 FMetHb fraction –0.999– 9.999 –99.9 – 999.9 FHHb fraction –0.999– 9.999 –99.9 – 999.9 CAP) mL/dL mL/L mmol/L mmHg (Hb) mL/dL mL/L mmol/L Table E-6 lists the units, reporting ranges, and display resolutions for the temperature corrected and respiratory parameters calculated by the 800 system. pH(T) 6.000 –...
  • Page 533 (A–a)(T) mmHg (a/A)(T) decimal fraction RI(T) decimal fraction Qsp/Qt(T) decimal fraction Qsp/Qt(est, T) decimal fraction Table E-7 lists the units, reporting ranges, and display resolutions for the metabolic parameters calculated by the 800 system. – mmol/L 0 – 99.9 – mmol/L 0 –...
  • Page 534 Table E-8 lists the units, reporting ranges, and display resolutions for the parameters that can be entered into the 800 system. Temperature decimal fraction ctHb g/dL mmol/L Flow L/min Resp Rate b/min mmHg L/min * The 800 system converts Fahrenheit values to centigrade values. 10.0 –...
  • Page 535 The following reference methods were used for the 800 systems. IFCC reference method Tonometered whole blood as described in NCCLS document C21–A. Gases used are traceable to NIST Certified Reference Material SRM series 1701. Method described in NCCLS document C29 for the NIST Certified Reference Material SRM 956 using flame photometry.
  • Page 536 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. Reagents other than those recommended are used. Expiration dates of reagents have been exceeded. Reagents are not used according to Bayer Diagnostics recommendations.
  • Page 537 All performance data presented in this section were generated using 840 systems. The system used default correlation factors, and performed calibrations using the default settings recommended by Bayer Diagnostics for optimum performance. All reported values were corrected to 760 mmHg. The operating environment during the collection of this data was normal room temperature (about 23 C).
  • Page 538 Precision on aqueous calibration verification materials was estimated using three 840 systems. At least seven runs per instrument were made over five days. Two replicates of each control level were analyzed in each run. Table E-10 summarizes the results of the 840 system precision for CVM levels 1 and 4.
  • Page 539 Table E-11 through Table E-13 summarize the results of the 840 system whole blood and expired gas recovery precision testing. Syringe Capillary Microcapillary Microsyringe pH Only Syringe Capillary Microcapillary Microsyringe pH Only Syringe Capillary Microcapillary Microsyringe pH Only * WRSD = within-run standard deviation 0.002 7.251 7.251...
  • Page 540 Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe 0.08 14.0 14.3 0.32 13.6 14.3 0.34 14.0 14.3 0.13 14.3 14.3 0.10 14.5 14.3 0.14 21.6 21.4...
  • Page 541 Capillary Microcapillary Microsyringe Expired Gas * WRSD = within-run standard deviation Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas 0.68 71.7 71.3 2.24 71.0 71.3 0.33 71.4 71.3 0.17 71.1 71.3 0.21 28.2...
  • Page 542 Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas * WRSD = within-run standard deviation 0.97 150.5 149.7 0.86 150.2 149.7 2.00 151.8 149.7 0.80 150.6 149.7 0.25 150.4 149.7 1.20 377.9 377.9 2.40 379.0 377.9 4.08 380.7 377.9 3.22...
  • Page 543 All performance data presented in this section was generated using 850 systems. The system used default correlation factors, and performed calibrations using the default settings recommended by Bayer Diagnostics for optimum performance. All reported values were corrected to 760 mmHg. The operating environment during the collection of this data was normal room temperature (about 23 C).
  • Page 544 – * WRSD = within-run standard deviation TotSD = total standard deviation Precision on aqueous calibration verification materials was estimated using four 850 systems. As many as seven runs per instrument were made over seven days. Two replicates of each control level were analyzed in each run. Table E-15 summarizes the results of the 850 system precision for CVM levels 1 and 4.
  • Page 545 – * WRSD = within-run standard deviation TotSD = total standard deviation For testing syringe, capillary, microsyringe, and microcapillary modes, blood was collected in heparinized vacuum tubes. It was tonometered at 37.0 C to each of three levels to prepare samples for pH analysis, and five levels to prepare samples for pCO and pO analysis.
  • Page 546 Table E-16 through Table E-22 summarize the results of the 850 system whole blood, expired gas, and electrolyte recovery and precision testing. Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes * WRSD = within-run standard deviation 0.002 7.194 7.193...
  • Page 547 Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe 0.28 14.0 14.3 0.08 14.7 14.3 0.20 14.5 14.3 0.14 14.1 14.3 0.14 14.5 14.3 0.12 21.3 21.4...
  • Page 548 Capillary Microcapillary Microsyringe Expired Gas * WRSD = within-run standard deviation Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas 1.20 71.7 71.3 1.36 71.1 71.3 0.55 70.5 71.3 0.49 71.0 71.3 0.16 28.2...
  • Page 549 Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas * WRSD = within-run standard deviation 2.65 149.6 149.7 0.83 150.0 149.7 0.98 150.0 149.7 0.62 149.4 149.7 0.31 149.5 149.7 1.40 377.4 377.9 2.41 377.5 377.9 5.50 378.9 377.9 5.51...
  • Page 550 Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes * WRSD = within-run standard deviation 0.25 115.6 115.5 0.29 115.6 115.5 0.47 115.1 115.1 0.42 115.4 115.3 0.43 121.0 120.9 0.49 150.9 151.0 0.46 150.9 151.2 0.80...
  • Page 551 Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes * WRSD = within-run standard deviation 0.071 1.89 1.90 0.050 1.89 1.88 0.092 1.88 1.83 0.043 1.79 1.83 0.029 1.95 1.95 0.020 3.49 3.51 0.034 4.14 4.14 0.037...
  • Page 552 Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes * WRSD = within-run standard deviation 0.007 0.78 0.76 0.011 0.79 0.77 0.025 0.80 0.75 0.014 0.72 0.74 0.016 0.78 0.76 0.012 1.87 1.84 0.017 1.85 1.82 0.010...
  • Page 553 Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes Syringe Capillary Microcapillary Microsyringe pH/Lytes * WRSD = within-run standard deviation 99.6 99.7 99.5 99.8 100.2 100.5 100.5 100.8 100.4 99.6 99.9 99.8 99.7 99.8 100.2...
  • Page 554 All performance data presented in this section was generated using 860 systems. The system used default correlation factors, and performed calibrations using the default settings recommended by Bayer Diagnostics for optimum performance. All reported values were corrected to 760 mmHg. The operating environment during the collection of this data was normal room temperature (about 23 C).
  • Page 555 Thiocyanate 80 mg/dL Bilirubin (Direct) 30 mg/dL Bilirubin (Total) 34 mg/dL Creatinine 30 mg/dL Hydroxybutyrate 200 mg/dL Lactate 100 mg/dL Urea 500 mg/dL Uric Acid 10 mg/dL * Interference by dopamine and structurally related drugs is dependent on glucose concentration. However, even at high glucose concentrations, therapeutic levels of dopamine do not interfere with the glucose measurement.
  • Page 556 Table E-25 lists substances that interfere with the glucose measurement. Sodium Fluoride 1000 mg/dL each Acetominophen 2 mg/dL Sodium Fluoride/ 1000 mg/dL each Potassium Oxalate * Increased reported glucose values by the amount shown. 25 mg/dL (1.4 mmol/L) 7 mg/dL (0.4 mmol/L) 25 mg/dL (1.4 mmol/L)
  • Page 557 To test for interferences, serum was spiked with a potentially interfering substance up to the test concentration shown in the following tables. The interference was calculated by comparing the spiked sample to an unspiked sample immediately preceding it. To evaluate the interference from fluoride/oxalate, the blood was drawn in grey-top tubes and compared to the lactate recovery in heparinized blood.
  • Page 558 Bilirubin (Direct) 30 mg/dL Bilirubin (Total) 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 mg/dL Theophylline 9 mg/dL Penicillamine 25 mg/dL Isoniazid 2 mg/dL Uric Acid 10 mg/dL The following anticoagulants were found not to interfere with lactate recovery at the indicated concentrations but they cannot be used on the 860 system due to potential interferences on other sensors or analytes.
  • Page 559 Refer to Sample Collection Devices and Anticoagulants in Section 1 for the specific requirements on sample handling and anticoagulants. Sodium Fluoride 1000 mg/dL Sodium Fluoride/ 1000 mg/dL Potassium Oxalate Acetominophen 2 mg/dL Quality control materials and calibration verification materials were analyzed on the 860 systems.
  • Page 560 – Lactate 43.0 0.89 1.41 23.0 0.64 0.81 61.7 1.79 2.17 103.5 1.46 2.66 152.3 1.89 4.51 112.7 0.25 0.62 135.1 0.21 0.50 151.3 0.40 0.77 2.68 0.014 0.020 5.04 0.014 0.022 7.34 0.033 0.050 119.5 0.57 1.14 100.0 0.34 0.74 77.6 0.41...
  • Page 561 * WRSD = within-run standard deviation TotSD = total standard deviation Performance determined with metabolite recal on. Refer to Glucose Biosensor Calibration, in Section 1 for information on performance with recal off. Table E-30 summarizes the results of the 860 system precision for CVM levels 1 and 4.
  • Page 562 For testing syringe, capillary, microsyringe, and microcapillary modes, blood was collected in heparinized vacuum tubes. It was tonometered at 37.0 C to each of three levels to prepare samples for pH analysis, and five levels to prepare samples for pCO and pO analysis.
  • Page 563 Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe 0.004 7.507 7.502 0.005 7.529 7.526 0.004 7.503 7.500 0.003 7.507 7.507 0.20 14.5 14.3 0.15 14.4 14.3 0.19 14.3...
  • Page 564 Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas * WRSD = within-run standard deviation Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas 0.44 50.3 49.9 0.71 49.9 49.9 0.54 49.8 49.9 0.62 49.4 49.9 0.52 71.3...
  • Page 565 Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas Syringe Capillary Microcapillary Microsyringe Expired Gas * WRSD = within-run standard deviation 119.4 Syringe Capillary Microcapillary Microsyringe 1.19 84.9 85.6 0.61 85.4 85.6 0.80 84.8 85.6 1.08 85.2 85.6 0.09 85.4...
  • Page 566 pH/Lyte 148.7 Syringe Capillary Microcapillary Microsyringe pH/Lyte 171.5 Syringe Capillary Microcapillary Microsyringe pH/Lyte * WRSD = within-run standard deviation 0.42 117.8 119.1 0.63 149.2 149.9 0.44 149.0 149.7 0.98 147.1 147.4 0.58 148.3 148.4 0.57 148.4 148.6 0.38 172.1 171.6 1.25 171.6 171.2...
  • Page 567 Syringe Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe pH/Lyte * WRSD = within-run standard deviation 0.043 1.37 1.39 0.095 1.34 1.38 0.145 1.67 1.73 0.032 1.53 1.62 0.060 1.66 1.66 0.028 3.75 3.73 0.027 3.72 3.69 0.027...
  • Page 568 0.69 Syringe Capillary Microcapillary Microsyringe pH/Lyte 1.66 Syringe Capillary Microcapillary Microsyringe pH/Lyte 2.38 Syringe Capillary Microcapillary Microsyringe pH/Lyte * WRSD = within-run standard deviation 0.008 0.70 0.69 0.016 0.72 0.70 0.017 0.71 0.69 0.009 0.71 0.69 0.013 0.71 0.68 0.014 1.67 1.65 0.011...
  • Page 569 Syringe Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe pH/Lyte * WRSD = within-run standard deviation 99.7 100.4 99.1 100.2 99.2 98.9 100.3 100.2 99.4 99.5 99.8 100.1 99.6 99.5 100.2...
  • Page 570 Syringe Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe pH/Lyte Syringe Capillary Microcapillary Microsyringe pH/Lyte * Performance determined with metabolite recal on. Refer to Glucose Biosensor Calibration in Section 1 for information on performance with recal off. WRSD = within-run standard deviation 102.8 107.9 101.2...
  • Page 571 1.75 Syringe Capillary Microcapillary Microsyringe pH/Lyte 2.81 Syringe Capillary Microcapillary Microsyringe pH/Lyte 3.94 Syringe Capillary Microcapillary Microsyringe pH/Lyte * WRSD = within-run standard deviation 0.030 1.69 1.61 0.062 1.83 1.79 0.089 1.65 1.73 0.028 1.75 1.70 0.075 2.11 1.90 0.046 2.83 2.89 0.074...
  • Page 572 All performance data presented in this section was generated using the 800 system CO-ox modules. The system performed recommended tHb slope procedures, and calibrations using the default settings recommended by Bayer Diagnostics for optimum performance. The operating environment during collection of this data was normal room temperature (about 23 C).
  • Page 573 Table E-41 lists substances that were found not to interfere using the criteria stated in Table E-40. Indocyanine Green 5 mg/L Lipid equivalent to 3% intralipid Bilirubin 20 mg/dL Fetal Hemoglobin at 21% Table E-42 lists substances that showed interference using the criteria stated in Table E-40.
  • Page 574 Fetal Hemoglobin at 80% Carboxymethylcellulose Quality control materials were analyzed on the 800 series CO-ox module. The results are presented here. Precision on aqueous quality control materials was estimated using four 800 systems. One run per instrument was made over a eight day period. Three replicates of each control level were analyzed in each run.
  • Page 575 FCOHb FMetHb FHHb * WRSD = within-run standard deviation TotSD = total standard deviation For testing syringe and capillary modes, blood was collected in heparinized vacuum tubes. It was tonometered at 37 C and/or adjusted chemically. Three levels of tHb were prepared by separating the red cells from the plasma and recombining appropriately.
  • Page 576 Syringe FCOHb Capillary Syringe FMetHb Capillary Syringe FHHb Capillary Syringe * WRSD = within-run standard deviation Capillary Syringe Capillary Syringe FCOHb Capillary Syringe FMetHb Capillary Syringe FHHb Capillary Syringe * WRSD = within-run standard deviation 92.18 0.90 4.23 –0.43 4.24 –0.45 3.81 –0.95...
  • Page 577 Capillary Syringe Capillary Syringe FCOHb Capillary Syringe FMetHb Capillary Syringe FHHb Capillary Syringe * WRSD = within-run standard deviation 21.04 0.21 20.72 0.19 90.03 –0.73 92.31 –1.21 6.56 0.53 4.48 0.95 3.41 –0.08 3.21 –0.01 0.00 0.27 0.00 0.28 0.21 0.22 0.24 0.64...
  • Page 579 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, entered values, and CO-oximeter values for the 800 series systems.
  • Page 580 PATIENT SAMPLE REPORT SYSTEM xxx-xxxx SYSTEM xxx-xxxx Sequence no xxxxx Acc no xxxxx Source xxxxxxxx Pt name xxxxxxxxxxx Patient ID xxxxxxxxxxx Patient Data Birthdate xxx xx xxxx Age xxx Syringe Sample ....... . . ACID/BASE 37 C -act -std...
  • Page 581 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. PATIENT SAMPLE REPORT System xxx-xxxx System xxx-xxxx Sequence no xxxxx Acc no xxxxx Source xxxxx...
  • Page 582 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. PATIENT SAMPLE REPORT SYSTEM xxx-xxxx SYSTEM xxx-xxxx Sequence no xxxxx Acc no xxxxx Source xxxxxxxx Patient ID xxxxxxxxxxx...
  • Page 583 Roll Printer Report D provides a four-column layout of parameters. Figure F-4 shows an example of Roll Printer Report D. PATIENT SAMPLE REPORT SYSTEM xxx-xxxx Sequence No xxxxx Acc No xxxxx Source xxxxxxxx Patient ID xxxxxxxxxxx Patient Data Birthdate xxx xx xxxx Age xxx SYRINGE SAMPLE .
  • Page 584 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. PATIENT SAMPLE REPORT SYSTEM xxx-xxxx Sequence no xxxxx Acc no xxxxx Source xxxxxxxx Patient ID xxxxxxxxxxx Patient Data...
  • Page 585 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 values for 800 systems. The examples include the following reports: Line Printer Report A Line Printer Report B Line Printer Report C...
  • Page 586 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. PATIENT SAMPLE REPORT Patient ID xxxxxxxxxxx Physician ID xxxxxxxxxxx Patient and Location xxx Birthdate xxx xx xxxx Sample Data...
  • Page 587 Line Printer Report B lists blood gas and CO-oximetry values separately. Figure F-7 shows an example of Line Printer Report B. PATIENT SAMPLE REPORT Patient ID xxxxxxxxxxx Physician ID xxxxxxxxxxx Patient and Location xxx Birthdate xxx xx xxxx Sample Data Age xxx Sex x BLOOD GAS 37 C...
  • Page 588 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. PATIENT SAMPLE REPORT Patient ID xxxxxxxxxxx Physician ID xxxxxxxxxxx Location xxx Patient and Birthdate xxx xx xxxx...
  • Page 589 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. You can define the data that appears on the report by selecting the parameters and data entry fields in Setup. Do not use the optional hospital header lines and delete some parameters in Setup to limit the report length to 45 lines.
  • Page 590 PATIENT SAMPLE REPORT Hospital Header Line 1 Hospital Header Line 2 Displays hospital Hospital Header Line 3 name and address. Hospital Header Line 4 SYSTEM xxx-xxxx Sequence no xxxxx Acc no xxxxx Source xxxxxxxx Analysis Time Draw Time Operator ID Patient ID Location Patient Data...
  • Page 591 The 800 system provides a setup option, Defining Correlation 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 these values, you must simultaneously analyze a range of samples on the 800 system and on a reference analyzer.
  • Page 592 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 recommended process for method comparison.
  • Page 593 Your 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. For detailed information about the software, refer to Learning About the System in Section 1 and Operating the System in Section 2.
  • Page 594 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 packing case up and off of the system. If you anticipate relocating your system, do not discard the packing case.
  • Page 595 13. Rotate the system so that the right side panel faces you. 14. Install the fuses as required for your system your system has no voltage bobbin, it uses a universal power supply suitable for 100V to 240V your system has a voltage bobbin a.
  • Page 596 e. Check the system fuses. f. Pull one of the fuse holders out of the fuse compartment, as shown in Figure H-3. Voltage Selection Bobbin Fuse Compartment Fuse Holder Fuse compartment door in open position. Fuse 120 VAC 100 VAC Voltage Bobbin Fuse Compartment Door Notch...
  • Page 597 Refer to the table below to identify the correct fuses for the voltage you use. 100/120V 4A Slo Blo 220/240V 2A Slo Blo g. Install the fuses as shown in Figure H-3. h. Slide the fuse holder(s) back into the fuse compartment. Make sure that the arrow on the end of the holder points to your right, as indicated by the arrows printed inside the compartment.
  • Page 598 f. Attach the gas regulators to the gas tanks with the regulator nipple engaging the opening in the tank valve. g. Attach and tighten the yoke screws firmly. h. Attach and tighten the tubing adapter fittings into each needle valve. Ensure that the needle valve is fully open.
  • Page 599 Second Stage Pressure Gauge Needle Valve Adjustment Knob i. Connect one end of a length of black tubing to the regulator fitting on the slope gas tank (10% CO j. Connect the tubing attached to the slope gas tank to the slope connector on the reagent manifold.
  • Page 600 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 caps. b.
  • Page 601 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.
  • Page 602 30. Verify that the sensors are installed in the following order: 31. Close the measurement module door. 32. Install the reagent pump tubing: a. Disconnect the right side of the tubing from right positions 1 and 2. b. Remove the tubing cuff from the right side of the platen. c.
  • Page 603 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.
  • Page 604 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 and press 1 Calibration b. Select and press 8 Barometer The Barometer Calibration screen appears.
  • Page 605 48. Verify 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. Refer to Appendix A for recommended precautions when working BIOHAZARD: with biohazardous materials.
  • Page 606 ambient operating 400 – 825 mmHg (53.0 – 110.0 kPa) barometric pressure system dimensions height 30.3 cm (11.94 inches) when installed 47.8 cm (18.81 inches) width 17.35 cm (6.83 inches) when installed 70.3 cm (27.66 inches) depth 50.8 cm(20.0 inches) weight 7.9 kg (17.5 lbs) when installed 36.5 kg (82 lbs) flat-blade screwdriver #2 [15.24 cm (6 inches) minimum shank length]...
  • Page 607 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 system, perform the following procedure to shut down the system.
  • Page 608 3. Open the 800 base model, secure the spring locks, access and remove the right side panel by loosening the captive screws mounted on the interior floor of the chassis. Do not remove the screws. Retain the side panel. Slide the base model to the edge of the work surface to access the front plug.
  • Page 609 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 movement on the work surface. 1. Move the CO-ox module close to the right side of the 800 base model. 2.
  • Page 610 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. 11. Install the two plugs retained from the 800 base model to the right side wall. Ensure that the new adhesive dots are in place.
  • Page 611 Ensure that the waste tubing is positioned through the hole on the CO-ox NOTE: module fluid detector. 5. Connect the waste tubing to the 800 base model manifold. 6. Connect the sample tubing to the sample connector. This procedure refers to right and left as you look at the front of system. 1.
  • Page 612 2. Plug the power cord into the AC power receptacle. At startup, the system proceeds through a series of initial tests and then displays in the banner. Any errors incurred during initialization are Initializing posted to the status log. 3. Access the Service Setup screen from the Menu screen: a.
  • Page 613 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 Refer to Appendix A for recommended precautions when working BIOHAZARD: with biohazardous materials. Exposure to bleach damages the glucose and lactate biosensor CAUTION: membranes.
  • Page 614 Prolonged exposure to the 10% bleach solution damages the reference sensor membrane. You must replace the reference sensor with a test/blank ref sensor (TB5) while you complete the cleaning procedure. Do not substitute a new reference sensor. Do not remove or return the sensors to the measurement module without first discharging static buildup.
  • Page 615 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 b. Select 3 Prime and press 3. Select and press All Reagents 4.
  • Page 616 Mount O-ring Retainer Ring 4. Grasp the sample port and drip tray and pull it to the right to remove it. The sample port and the drip tray are one piece. Wear safety glasses, gloves, and a laboratory coat when handling the reagents.
  • Page 617 Do not insert swabs into the sample port or spray anything into the NOTE: 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.
  • Page 618 Compressed gas tanks require cautious handling. To prevent damage and possible personal injury, refer to Replacing the Gas Tanks in Section 3, for more detailed precautions. 1. Remove the gas tanks, as shown in Table H-4: a. Using a valve wrench, close each gas tank by turning the valve stem clockwise.
  • Page 619 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 the original carton is no longer available, contact your Service Representative for a replacement shipping carton.
  • Page 621 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 cell consists of two or more electrodes that interact with a chemical in solution and are connected to an electrical system.
  • Page 622 Voltmeter Measuring Electrode Each electrode, which acts as a half-cell with a half-cell potential, contains an inner reference element immersed in an internal electrolyte solution. The measuring electrode is designed to respond to changes in the concentration of the specific analyte being measured in the sample solution.
  • Page 623 System sensors are designed to measure a specific substance in a sample. To 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. For the purpose of measuring a variety of analytes in solution, sensors must have the ability to measure specific analytes in solution.
  • Page 624 = (E ) – (E cell ref elmt memb where = electrochemical cell potential cell = reference electrode half-cell potential = potential of the ISE inner reference element ref elmt = potential of the ISE membrane memb = liquid junction potential In this equation, the reference electrode potential and the potential of ISE inner reference element are constant;...
  • Page 625 I = 1/2 m * z 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. Using an established convention, the activity of ions that are measured by sensors can be expressed in terms of concentration.
  • Page 626 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 solution, the reference sensor maintains a constant electrical potential.
  • Page 627 The electrochemical cell contains two electrodes: the anode, which is positively charged and the cathode, which is negatively charged. The measuring electrode, which is frequently composed of platinum(Pt) or another noble metal, can be either the anode or the cathode. Each electrode is attached to an external voltage source as shown in Figure I-4.
  • Page 628 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 the acidity of blood or plasma. Normal cellular metabolism requires an exacting environment where hydrogen ion concentration must be maintained within narrow limits.
  • Page 629 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 disorder due to renal or gastrointestinal inadequacy is referred to as metabolic acidosis or alkalosis.
  • Page 630 – The levels of HCO , and dissolved CO the pH in blood. This relationship is best described through the Henderson-Hasselbalch equation: – Substituting HCO as the base and dissolved CO equation reads as follows: Taking the equation further, pH is seen as being proportional to the acid-base relationship: Although other acids and bases are present in the blood, the H relationship is sensitive and dynamic and typically reflects other acid-base...
  • Page 631 The pCO sensor is based upon the electrode described by Severinghaus and Bradley. It is a complete electrochemical cell that consists of a measuring electrode and an internal reference electrode. The measuring electrode, which is a pH electrode, is surrounded by a chloride bicarbonate solution. A membrane permeable to gaseous CO separates this solution from the sample.
  • Page 632 Since it is not possible to measure intra-cellular oxygen tension (pO ), arterial pO has become a standard for clinical evaluation of arterial oxygenation status. Measurement of pO (A), which indicates the oxygen tension in arterial blood, reflects the pressure or driving force for moving oxygen from one location to the next due to pressure differential;...
  • Page 633 Anode Contact Cathode Contact Sample Path 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 into the electrolyte solution, it is reduced at the cathode. –...
  • Page 634 Electrolyte Solution Silver/Silver Chloride Wire Potassium, Chloride, and Calcium Sensor The recognition mechanism in the ISE is the membrane. Each sensor has a membrane selective for the specific substance that it measures. To understand this concept more clearly, take the case of the potassium sensor. The potassium sensor membrane is designed as a charge separator.
  • Page 635 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 kidneys are the primary regulator of sodium and consequently water volume;...
  • Page 636 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 to adjust and stop excreting potassium. Two hormones, insulin and aldosterone can affect the extracellular level of potassium.
  • Page 637 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 chloride level remains fairly constant, it is valuable in the calculation of the anion gap.
  • Page 638 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 its level in the blood. Although total calcium levels may increase, ionized calcium may decrease and lead to cardiac and neuromuscular malfunction.
  • Page 639 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 specialized cells in the pancreas, plays an important role in regulating the blood level of glucose.
  • Page 640 The glucose and lactate biosensors are complete electrochemical cells that incorporate amperometric technology to measure glucose or lactate concentration in samples. The biosensors consist of four electrodes. contains platinum and glucose oxidase or lactate oxidase in a binder, while the reference electrode is composed of Ag/AgCl.
  • Page 641 The loss of electrons in the oxidation of H 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 to form pyruvic acid and hydrogen peroxide (lactic acid) (pyruvic acid) where LOD is the lactate oxidase.
  • Page 642 Hyperlipemia can result in artificially increased methemoglobin 42, 43 values. High bilirubin concentrations can falsely increase oxyhemoglobin values. Hyperlipemia and administration of fat emulsions can increase total hemoglobin values. Samples frozen with liquid nitrogen can have decreased total hemoglobin levels. Samples from patients receiving blood substitutes yield unreliable results for oxygen content blood due to the different oxygen solubility of the blood substitutes.
  • Page 643 Methemoglobin (MetHb), which is sometimes known as hemoglobin Hi, is hemoglobin whose iron is oxidized to its ferric state (FE(111) and is unable to bind oxygen. High methemoglobin concentrations, a condition called methemoglobinemia, can produce hypoxia and cyanosis. Methemoglobinemia can be the result of hereditary conditions or of exposure to toxic substances such as nitrates, nitrites, aniline dyes and their derivatives and topical anesthetics such as 39,41...
  • Page 644 The CO-oximeter (CO-ox) module detects and indicates concentrations of sulfhemoglobin greater than 1.5%. Hemoglobin derivatives have characteristic absorbance spectra; that is, each derivative absorbs light differently at different wavelengths. Similarly, interfering substances also absorb light at known wavelengths. The spectral absorption method determines concentration using matrix equations. For each substance or fraction, the absorbance at a specific wavelength is equal to the product of the path length, concentration of the fraction or substance, and the molar absorptivity or the extinction coefficient for that substance, as shown in the...
  • Page 645 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 coupled from the sample chamber, by a second pair of lenses, to the polychromator.
  • Page 646 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 solubility in plasma and a factor for converting mmHg to mmol/L. The equation can be further developed to show pH as proportional to the acid-base relationship: –...
  • Page 647 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 pCO of 40 mmHg (5.33 kPa), a total hemoglobin of 15.0g/dL and a temperature of 37.0 C is zero.
  • Page 648 Oxygen saturation can be directly measured or it can be estimated using the relationship described by Kelman – 15N SAT = – 15N + 2400N where N = pO [0.48(pH–7.4) – 0.0013 BE(B)] oxygen saturation. Since oxygen saturation also depends upon the level of carbon monoxide and 2,3 diphosphoglycerate (2,3 DPG) in the blood, the calculated value for oxygen saturation may not be equal to the measured value in patients with abnormal levels of 2,3 DPG or carbon monoxide.
  • Page 649 Oxygen content is determined, using NCCLS recommendations, following relationship: = FO Hb 1.xx ctHb + 0.00314 pO where ctHb is expressed in g/dL. If FO Hb is unavailable, oxygen content is derived from estimated oxygen saturation (O SAT) according to the following equation: CT = O SAT 1.39 If ctHb is not measured or entered,O...
  • Page 650 The oxygen capacity of hemoglobin (BO oxygen that the hemoglobin in a given quantity of blood can carry. This value represents the potential of hemoglobin to bind to oxygen and includes all the oxygen that can be bound to the available hemoglobin. hemoglobin, with hemoglobin oxygen saturation and oxygen content, is a useful parameter for determining the amount of oxygen in the blood that is actually available to the tissues and for determining the effectiveness of oxygen therapy.
  • Page 651 [(pO 51.87074 129.8325 6.82836 –223.7881 –27.953 258.5009 21.84175 –119.2322 Total carbon dioxide (ctCO ), in combination with pH and pCO distinguishing between metabolic and respiratory acid-base disorders. Carbon dioxide exists in several forms in blood plasma, but only two forms, –...
  • Page 652 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, which enables the system to provide temperature corrected results. The following equations, based on NCCLS recommendations, are used: pH correction Gas exchange indices are a quick way to estimate the relationship between...
  • Page 653 The 800 system does not report alveolar oxygen tension, but uses the pO to calculate the alveolar-arterial oxygen tension difference and the arterial-alveolar oxygen tension ratio. The alveolar-arterial oxygen tension difference, pO abbreviated as A–aDO , is useful as an index of gas exchange within the lungs if the ctO measurements are not available.
  • Page 654 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 is corrected according to the following equation. adjusted Ca = Ca measured 10 Calcium value is adjusted only when pH, at 37 , is between 7.2 and 7.7, since no reliable, published, clinical data is available outside that range.
  • Page 655 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 appropriate therapeutic procedures to be initiated. This section describes the parameters associated with a-v studies. The oxygen content of arterial blood (ctO oxygen carried by the arterial blood, including the oxygen bound to hemoglobin and the oxygen dissolved in plasma and in the fluid within the red blood cells.
  • Page 656 The a-v extraction index (ctO ([a-v]/a)) aids in the interpretation of the arterial-venous oxygen content difference and can indicate inadequate oxygen content in arterial blood or inadequate cardiac output to meet oxygen demands of the tissues. The value is most properly determined using arterial blood and mixed venous blood.
  • Page 657 The system determines the physiologic shunt using the following equation: (c)-ctO Qst/Qt(T) = (c)-ctO (c) = [1.39 x ctHb x (1 - FCOHb - FMetHb)] + (0.00314 x A); where ctO /100) x (pAtm - pH2O)] - {pCO A = [(F (v) is for a mixed venous sample;...
  • Page 658 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 below be used to evaluate patient results. 7.350 – 7.450 35.0 – 45.0 mmHg 4.7 –...
  • Page 659 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 maintenance protocol of your laboratory.
  • Page 667 Technical Bulletin from Bayer Business Group Diagnostics. Reagent Water 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 Standards...
  • Page 668 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.
  • Page 669 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.
  • Page 670 Manufactured by: Bayer Diagnostics Bayer Corporation 92807 Puteaux Cedex, France East Walpole, MA 02032-1597 USA Bayer Vital GmbH & Co. KG Bayer Argentina S.A. Geschäftsbereich Diagnostika Division Diagnósticos D-35463 Fernwald, Germany Buenos Aires, Argentina Bayer Hellas AG Bayer Australia Limited BG Diagnostics Diagnostics Business Group 151 25 Athens, Greece...
  • Page 673 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 billing purposes.
  • Page 674 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 diskettes for storage. Use backup to prevent loss of data in case of a hard disk failure.
  • Page 675 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. You can select more than one option from a list of options with check boxes.
  • Page 676 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 a reference when troubleshooting.
  • Page 677 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 during troubleshooting.
  • Page 678 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 and messages, such as message boxes, fields, and option lists.
  • Page 679 Levey-Jennings A visual representation of measured QC values used to chart detect results that fall outside of the established control limits and to observe trends or shifts in control values. Laboratory information system. A computer system that is used for data management in one or more laboratories.
  • Page 680 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 correlation coefficients. option button A diamond symbol that appears next to an option in an option list.
  • Page 681 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 accepts the voltage from the power input, converts it from AC to DC, and directs it through...
  • Page 682 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. reagent fitting The component of the reagent manifold that attaches to the reagent bottles and lets the reagents enter the system.
  • Page 683 required fields Patient data entry fields in which you must enter a value. For example, if the Patient Temp field is a required field, you must enter a patient temperature in the field before you can access the next screen. You define required fields in Setup.
  • Page 684 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 pCO sensor status The area on the screen that indicates the current status indicator of each sensor in the system.
  • Page 685 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 Volume, Auto Move Capillary Sample, and Roll Printer.
  • Page 686 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 screen elements that pertain to the function you are performing.
  • Page 689 ?, 2-31, 2-32, 4-99, 4-116 ?=If Blood, Question Data, 4-7 to 4-9 #, 2-31, 2-32, 4-98, 4-118 –––––– , 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, 4-116, 4-118, E-8, I-36 , 2-30, 2-32, 4-95, 4-98 , 2-30, 2-32, 4-95, 4-98...
  • Page 690 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, 4-114 Bubbles Detected In Sample message, 2-32, 4-6 Busy Icon, meaning of, 1-31 Cal G/L reagent active ingredients, 1-40...
  • Page 691 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 calibration), 4-55, 4-75 overview, 1-17, I-24...
  • Page 692 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 Time Setup screen, 5-31 default passwords menu options, 5-30 operator, 5-28 supervisor, 5-26, 5-27, 5-29, 5-30 defining passwords...
  • Page 693 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 Home key, 1-24, 5-5 household bleach.
  • Page 694 temperature range (warning), 4-112, 4-119 Measurement Module Door Open message, 4-8 Measurement Module Temp Error message, 2-33 Measurement Module Temp Warning message, 2-33 measurement test, 4-55, 4-70 to 4-74 printing stored signals, 4-70 testing a sensor circuit without a sensor, 4-72 measuring hemoglobin, CO-ox module, I-24 menu codes, 1-31 Menu key, 5-4...
  • Page 695 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 samples, 2-14 to 2-29 expired gas samples, 2-20 to 2-29 inserting (illustration), 2-20...
  • Page 696 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 editing file setup information, 5-49 identifying automatically, 1-53 printing QC setup report, 5-56...
  • Page 697 troubleshooting, 4-111 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 components illustration, 1-18 removing obstructions, 4-79...
  • Page 698 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, 3-83 to 3-86 reference sensor, 3-71 to 3-74 reference sensor cassette, 3-74 to 3-76 reference sensor internal reference electrode, 3-77 to 3-80 sample ground/temperature sensor, 3-83 to 3-86...
  • Page 699 temperature/ pAtm test, 4-55, 4-69 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, D-3 examples of printed reports, F-11 total carbon dioxide, I-31...