Bayer HealthCareメーカーRapidlab 800の使用説明書/サービス説明書
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2000 Bayer Corporation. All rights reserved. 115701 Rev C., 4/2000.
No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Bayer Corporation. The Rapidlab 800 system is for In V itro Diagnostics Use. Certain and Ready Sensors are trademarks of Bayer Corporation.
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This manual is to be used with the Bayer Diagnostics 840, 844, 845, 850, 854, 855, 860, 864, and 865 systems.
Use this section to identify the sections in this manual that describe the 800 system and the tasks associated with operating and maintaining the system.
obtain service and technical information and order s.
The Operator ’ s Manual uses the following text and symbol conventions throughout the document.
This section describes the symbols that may appear on the exterior of the system. The symbols provide you with the location of certain components and with warnings for proper operation.
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The Rapidlab 800 Operator ’ s Manual accompanies the 800 series systems— base models 840, 850, 860—and base models with the oximetry module— models 844, 854, 864— and base models with the CO-ox module— models 845, 855, 865.
The 850 and 860 systems report the following parameters: calcium ion concentration adjusted to pH 7.
The 800 system offers advanced features for analyzing samples, managing patient results and QC data, and customizing the system.
maintenance and troubleshooting low maintenance Ready Sensors.
The following series of illustrations show the exterior controls and components of the 800 system.
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Power Input Fuse Compartment Diskette.
Contr.
F2 F1 F3 F4 F5 ? – .
The 800 system components consist of the following functional group.
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The hemoglobin content is measured in the sample chamber , which is located between the fiber optics and the polychromator .
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 five fluid detectors in the base model sense the presence, type, and continuity of fluids in the system.
The hemolyzer uses ultrasonic sound vibrations to rupture red blood cell membranes and release hemoglobin molecules.
Preamplifier (Preamp) Amplifies the sig.
The user interface, shown in Figure 1-10, consists of components that you use to direct system activities and obtain operating status information.
Y ou use the system keys to direct system activities and to move through the software.
paper spool winds the paper on the paper spool F-keys .
Y ou use F-keys to access functions that appear on the screen above each key . The F-key labels can vary with each screen. The following keys are some of the more commonly used F-keys.
Screen elements are the components on the screen that enable you to interact with the system software.
Sensor icons appear in the status area of the screen. Each sensor is represented by a box containing the sensor label. The CO-ox module is represented by the tHb icon in the sensor bar .
The Menu mode lets you perform infrequently required functions. Y ou access the Menu mode by pressing Menu. The system displays the Menu screen with the first option in the Main Menu highlighted.
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Use menu codes to quickly select menu options from the Main Menu on the Menu screen. T o use menu codes, you press the numeric key for the menu option instead of using arrow keys and pressing Enter .
Use the Help program to get information about your 800 system. Y ou can access Help when the system is inactive or when the system is performing an operation, such as an analysis, a wash, or a calibration.
This section describes sample requirements, collection procedures, and handling techniques for pH, blood gas, and electrolyte analysis.
The following limitations apply to the 850 and 860 systems: A void hemolyzed samples, because they falsely elevate potassium levels due to intra-erythrocyte potassium levels.
expired gas Expired gas samples may be obtained using a 10 mL syringe.
CAUTION: Do not use clay-capped capillary tubes because the cut edges of a capillary tube can damage the sample port.
T o minimize the errors these conditions can cause, use correct storage and handling techniques. Y ou can minimize errors due to metabolic changes by analyzing samples as soon as possible after collection.
Refer to Emptying the W aste Bottle in Section 3 for detailed instructions for handling the waste bottle and its contents.
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.
Cal G/L 10 mmol/L glucose 2.
The reagents used on the 800 systems have the following intended uses: 7.
This section describes the storage instructions for the reagents used on the 800 systems. CAUTION: Discard any reagent that is frozen.
CAUTION: Discard any reagent that is frozen. Do not thaw and use. The reagent composition is irreversibly altered when the reagent is frozen.
The 800 system requires two gases to calibrate the p CO 2 and p O 2 sensors, Cal Gas and Slope Gas.
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.
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.
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.
The system displays calibration results on the screen and updates them continuously until the parameters reach endpoint.
Y ou can view , print, and transmit stored calibration data using the Recall option. Y ou cannot edit calibration data.
Quality control (QC) procedures are part of an overall quality assurance program.
T o monitor system performance and to chart any trends, Bayer Diagnostics recommends that you analyze controls .
Quality control limits are established by calculating the mean and standard deviation (SD) from multiple measurements of the QC material. 5 T ypical QC limits use ± 2 SD or ± 3 SD where there is approximately a 95.
expected (target) range for each parameter , the .
The system can automatically transmit QC results to an LIS or a data management system when analysis is complete.
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.
Calibration verification is t.
Y ou can also obtain correlation data by parallel testing of patient samples that span the reportable ranges on the new system and on the existing system or method.
The following system sequence diagrams illustrate the flow of liquids and gases through the 800 system.
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean Cal G/L 5 CO H SC 1. The sample door closes and determines the sample type and the probe extends accordingly .
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean Cal G/L 5 CO H SC 3. The sample pump moves the sample to fluid detector 2, pauses for one second, and then moves the sample until the trailing edge is detected at fluid detector 1.
7.3 6.8 Wash Clean Cal G/L Cal Slope Ambient Air 1 5 H SC 1a 2 43 R CO S W ••••••••••••••.
The following steps describe the activities that take place when you initiate a wash sequence by selecting W ash or Cancel.
Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••• ••••••••••••••••• •• ••••••••••••••• • • • ••••• 7.
The following steps describe the activities that take place during a one-point calibration.
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 3. After the wash segment moves through the measurement module, the Cal gas and diverter valves open and Cal gas flows into the inner sample port.
Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••• •• ••••••••••••••••• •• ••••••••••••••• • • • ••••• 7.
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 9. When the measurement completes, the reagent pump starts and moves the remaining foam wash to the inner sample port.
The following steps describe the activities that take place during a two-point calibration.
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 3. After the wash segment moves through the measurement module, the Cal gas and diverter valves open and Cal gas flows into the inner sample port.
Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••••••• •••••••••••••• •• ••••• 7.
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 9. A small amount of foam wash is moved to the measurement module to remove the 7.3 reagent. The reagent pump then moves three 6.
Cal Slope Ambient Air 11 a 2 43 R S W 7.3 6.8 Wash Clean 5 CO H SC 12. The probe extends and the main segment moves until the trailing edge is at fluid detector 1.
Cal Slope Ambient Air 11 a 2 43 R S W •••••••••••••••••••••••• ••.
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The 800 system indicates that it is ready to analyze samp.
If the system detects bubbles when the sample is in the measurement module, the Bubbles Detected in Sample message box appears.
Y ou may have to type a password before you can analyze samples and access certain menus. If your system requires a password, a prompt appears, as shown in Figure 2-1.
The following tables list the mi.
2. Press . The system aspirates the sample. 3. When prompted, remove the sample device. 4. T ype the required information in the Patient Information screen and then press .
The following.
T o ensure the accuracy of the CO-ox measurement, close the CO-ox cover before pressing Analyze.
Do not move the sample backward after it touches the reference sensor . The potassium and chloride values will be affected.
Use this procedure to analyze samples when the sample volume is too small for routine analysis.
3. Select and press .
8. T ype the required information in the Patient Information screen and press when you finish. Refer to Entering Patient Sample Data , page 2-27, if you need more information to complete this screen.
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.
Since pH samples are frequently capillary tubes with insufficient sample volume, the system requires you to move the sample manually to the measurement module.
3. Select and press .
7. When prompted, remove the sample device. 8. T ype the required information in the Patient Information screen and then press . Refer to Entering Patient Sample Data , page 2-27, if you need more information to complete this screen.
The following tabl.
T o ensure the accuracy of the CO-ox measurement, close the CO-ox cover before pressing Analyze. 3. Press . 4. When prompted, remove the aspiration adapter .
Use this procedure to analyze expired gas samples. During this procedure, you inject the gas into the system.
6. When prompted, remove the sample device. 7. T ype the required information in the Patient Information screen and then press . Refer to Entering Patient Sample Data , page 2-27, if you need more information to complete this screen.
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If the patient ID entered at the 800 system and the 270 CO-oximeter do not match, the Patient ID Mismatch message box appears. you want to combine the 270 results with the 800 system results a.
Use this procedure to combine an arterial blood sample with a venous or mixed venous blood samples to create an a-v studies report.
1. Analyze the arterial, and the venous or mixed venous samples you want to use for a-v studies. 2. Select the first patient sample for a-v studies: a. Select . b. Select and press .
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 .
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.
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 .
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.
This section provides an overview of the Patient Sample Results screen and the printed sample report.
# The patient sample contains substances that may interfere with glucose or lactate measurement. ? Optical measurements indicate that the CO-oximeter results should be reviewed.
The following table describes the messages that may appear in patient sample reports on the roll printer: ****** = Not in Calibration The sensor is out of calibration.
COox Cover Open During Meas The cover on the CO-ox module was open while the system was analyzing the sample. COox Sample Chamber T emp Error The CO-ox module sample chamber temperature is ± 0.
Sample T emperature Out of Range The measurement module temperature is not in range at the end of measurement sequence.
Use this procedure to recall patient sample data and results stored in the system.
from the earliest date to a specific date leave the Analysis Date From field blank, and type the specified date in the Analysis Date T o field.
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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.
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.
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.
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7. Perform the required action. Accept accept the results into the QC file and update the statistics. Reject store the results in the appropriate QC file, but the system does not update the statistics.
Ensure that the calibration reagents and quality control materials are not expired or deteriorated. V isible signs of deterioration include color changes or cloudiness of the reagents or quality control materials.
use the keypad or keyboard type the File Number and press . use the optional bar code scanner scan the bar code label on the QC ampule.
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.
3. T ype the search criteria and press after you complete each field. for a selected date type the date in both Analysis Date fields.
5. Select the report that you want to view and press . The QC Data Search Result screen appears.
Use this procedure to edit QC data that you recall. Y ou can edit QC data in the following ways: move a QC report to a different file.
Use this procedure to print or transmit data from the QC Data Search Criteria Log screen or the QC Data Search Result screen.
↓ the result is below the lower limit of the target range. ↑↑ the result is above the upper limit of the action range.
Use this procedure to print statistical summary reports for the current month’ s QC data.
5. Press to return to the Ready screen.
1 2 3 4 5 6 7 8 9 10 11 12 13 1.
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.
Y ou can perform calibrations from either the Analyze mode or the Menu mode.
Y ou can perform calibrations from either the Analyze mode or the Menu mode.
Use this procedure to calibrate the tHb slope for the CO-ox module. Y ou can perform this calibration from either the Analyze mode or the Menu mode.
Press Cancel to interrupt a calibration. The system starts a wash and the W ash screen appears. The system returns to the Ready screen at the end of the wash.
Use this procedure to calibrate the internal atmospheric pressure sensor to a barometer in your laboratory .
Press to interrupt a calibration. If you interrupt an automatic calibration, the system will attempt to start the calibration again in 90 seconds.
Y ou can print calibration data and send the data to an LIS or a data management system. Y ou cannot edit calibration data.
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The following result flags can appear on printed reports: * the measurement did not reach endpoint. ↑ the calibration is above the upper drift limit.
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Use this procedure to view pending maintenance tasks and record completed maintenance tasks in the maintenance log.
Use this procedure to print a Maintenance Schedule Report from the Maintenance Schedule screen.
Use this procedure to view and print the list of completed maintenance tasks for the current or the previous month.
The daily maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted. If your laboratory analyzes more than 30 samples per day , perform daily maintenance more frequently .
NOTE: Do not insert swabs into the sample port or spray anything into the measurement module. 1. Rinse the exterior surfaces with reagent-quality water . NOTE: Bayer Diagnostics recommends using reagent-quality water in accordance with NCCLS guidelines.
Check the amount of paper on the roll. A pink line on the paper indicates that the roll is nearly empty .
2. Compare the displayed atmospheric pressure to your laboratory’ s barometer reading. correct press Done .
The twice weekly maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted.
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 .
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.
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.
9. Press Ye s to perform a two-point calibration. 10. Analyze a minimum of two levels of quality control material to verify sensor performance. Press CANCEL to stop conditioning.
Use this procedure to ensure that the sensors contain fill solution to the levels described in Figure 3-5.
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The monthly maintenance schedule is based on the expiration date of the opened reagents.
NOTE: Do not remove or tighten the cap that contains the reagent septum. Removing or tightening the cap damages the integrity of the reagent septum. 4. Remove the plug from the cap of the new cleaning solution bottle.
3. W rite the date installed in the space provided on the new reagent bottles. NOTE: Do not remove or tighten the cap that contains the reagent s e pt um . Removing or tightening the cap damages the integrity of the reagent septum.
Perform the following procedures every 2 months. The bimonthly maintenance schedule is based on analyzing 30 samples per day , unless otherwise noted.
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.
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1 1. Connect the sample tubing to the sample tubing connector on the measurement module. 12. Press Continue . A wash sequence starts. When the wash sequence sequence finishes, a message box appears prompting you to perform a two-point calibration.
Perform the following procedures every 3 months. The quarterly maintenance described in this section is based on analyzing 30 samples per day .
Sample Chamber Sapphire Window Mounting Pin Cam Bubble T rap 4.
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.
12. Inspect the tubing. a. If the tubing is damaged, or is stretched or loose at the connection, replace the tubing as described in Replacing the CO-ox Sample T ubing on page 3-37.
Materials required: lint-free tiss.
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.
Perform the following procedures every 6 months. The semiannual maintenance described in this section is based on analyzing 30 samples per day .
4. Reinstall the air filter cover: a. Align the two pins, located inside the air filter cover , underneath the holes. b. Push the cover up until it snaps it into place. 5. Press Home to return to the Ready screen.
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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.
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Materials required: CO-ox s.
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.
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 .
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6. Press Continue . A wash sequence starts. When the wash sequence finishes, a message box appears prompting you to perform a two-point calibration. 7. Press No . 8. Calibrate the reagent pump from the Menu screen: a.
Perform the following procedure annually .
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Materials required: 10% solution of household bleach NOTE: Dilute household bleach (5.
NOTE: The waste bottle is disposable and can be autoclaved before you discard it.
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Materials required: 0.022 inch diameter clot-removal line (to fit through a 0.
6. Ensure that the O-ring is in place. Replace the O-ring if it is worn or damaged. CAUTION: Do not remove or return the sensors to the measurement module without first discharging static buildup.
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.
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9. Press Continue . A wash sequence starts. When the wash sequence finishes, a message box appears prompting you to perform a two-point calibration. 10. Press Ye s to perform a two-point calibration.
6. Clean the fitting with a swab moistened with a 10% solution of household bleach. 7. Rinse the fitting with reagent water and dry thoroughly . Ensure that the O-ring is in place on the back of the reagent fitting.
Materials required: 10% solution of household bleach NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent quality water .
NOTE: Ensure that the three O-rings are in place. 7. Reinstall the sample port, matching the tab on the sample port to the notch in the retainer ring. 8.
8. Remove the paper from the printer . 9. Reconnect the power cord to the power supply and allow the system to warm up. 10. Reinstall the printer paper as described in Replacing the Printer Paper , page 3-66.
3. Deproteinize the sample path: a. Prepare the deproteinizer as directed on the package. b. Select 2 Maintenance and press Enter . c. Select 1 Deproteinize and press Enter .
8. Perform a two-point calibration from the Menu screen: Glutaraldehyde may cause excessive drift to the K + and Ca ++ sensors. Repeat calibrations until the system performs a successful calibration.
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.
W ear safety glasses, gloves, and a laboratory coat when handling bleach. 4. Perform the cleaning cycle: a. Press Ye s . b. Insert an aspiration adapter into the sample port and immerse the other end in the 10% bleach solution.
Use this procedure to manually initiate the cleaning sequence.
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.
The 800 system collects workload data and provides month-to-date and year-to-date workload statistics reports.
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W ear safety glasses, gloves, and a laboratory coat when handling the reagents.
9. Perform a two-point calibration. a. Press Calibrate .
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Gently guide the paper against the left edge of the spool when you wind paper on the spool. If the right edge of the paper roll is uneven, the paper can jam.
Materials required: reference electrode .
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Materials required: reference senso.
c. Slowly fill the electrode compartment by gently squeezing the container until the KCl fill solution enters the KCl reservoir .
5. Fill the KCl reservoir in the new sensor: a. Remove the reservoir cap with the hex tool and set it aside as shown in Figure 3-45.
Do not overtighten the reservoir cap. Overtightening can deform the gasket and cause leaks. e. Reinstall the reservoir cap and hand-tighten.
CAUTION: Do not touch the internal electrode wire. The wire is fragile and is easily damaged. 3. Use the hex tool to remove the internal electrode from the cassette you are replacing.
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CAUTION: Do not touch the internal electrode wire. The wire is fragile and is easily damaged. 3. Unscrew the internal electrode and carefully set it aside on a lint-free tissue as shown in Figure 3-57.
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CAUTION: Do not remove or return the sensors to the measurement module without first discharging static buildup. T ouch the inner surface of the module frame to discharge static buildup.
e. Screw the internal electrode into place, ensuring that you do not cross-thread the electrode. f. T ap the front face of the sensor with your knuckle to remove bubbles. g. W ipe any excess fill solution from the exterior of the sensor with a lint-free tissue.
g. Allow the system to warm up. h. Press Exit T est . 1 1. When the temperature is stable, perform a two-point calibration: a. Select 1 Calibration and press Enter .
Do not remove or return the sensors to the measurement module without first discharging static buildup. T ouch the inner surface of the module frame to discharge static buildup.
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12. V erify biosensor performance by completing two successful two-point calibrations. 13. Analyze a minimum of two levels of quality control material to verify sensor performance.
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.
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 .
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Do not turn the needle valve too hard or damage can occur . h. Carefully turn the needle valve adjustment knob counterclockwise until until it stops.
9. Perform a gas two-point calibration from the Menu screen: a.
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.
Use this procedure to replace the roller cage for the reagent, sample, waste, or CO-ox pump.
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Materials required: sample port BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precautions when working with biohazardous materials.
Materials required: sample probe BIOHAZARD: Refer to Appendix A, Pr otecting Y ourself fr om Biohazar ds , for recommended precautions when working with biohazardous materials.
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a. Select 2 Maintenance and press Enter . b. Select 7 Stop System and press Enter . 2. Ensure that the sample probe is fully retracted. 3. Remove the old capillary seal: a.
Materials required: measurement module lamp 1.
8. Pinch the ends of the clamp and pull it away from the bracket. 9. Remove the old lamp from the clamp and discard it. CAUTION: A void touching the lamp with your fingers.
b. Select 7 Stop System and press Enter . 2. Allow the lamp to cool for at least 5 minutes. Ensure that the lamp has been of f for at least 5 minutes to allow sufficient time for it to cool.
b. Select 3 Measurement and press Enter . c. Select 2 COox Optics and press Enter . The COox Optics T est screen appears. 13. Press Start T est . 14. Check the screen for the message, Lamp test passed.
3. Disconnect the power cord from the side panel of the system. 4. Remove the air filter cover . 5. W ith a small, flat-blade screwdriver , gently pry open the fuse compartment door at the top, as shown in Figure 3-72.
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.
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Use this procedure to review and print Status Event Log messages. The Status Event Log stores most diagnostic codes (D codes) and system messages from the last 72 hours of operation.
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.
COox Sample Chamber T emp Error Appears when the CO-ox sample chamber temperature is not in range.
Interfering Substance: Glu Appears when the system detects substances in the sample that may interfere with glucose measurement.
No Sample Device Detected Appears when you press Analyze, the sample door closes, and no device is detected in the sample port.
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This section describes the 800 system diagnostic codes (D codes) and messages, the conditions that cause them, and possible solutions.
Sensor drift is beyond predefined limits during a one-point or a two-point calibration.
Sensor drift is beyond predefined limits during a one-point or a two-point calibration.
Perform the Measurement T est as described on page 4-70. Check the diverter valve to verify that the valve is working by performing the V alves test as described on page 4-62.
Sensor drift is beyond predefined limits during a one-point or a two-point calibration.
The tHb slope is beyond predefined limits during the calibration.
Sensor slope is beyond predefined limits during a two-point calibration.
Sensor slope is beyond predefined limits during a two-point calibration.
Sensor slope is beyond predefined limits during a one- or two-point calibration.
The tHb slope is beyond predefined limits during the calibration.
Sensor offset is beyond predefined limits during a one-point or a two-point calibration.
Sensor offset is beyond predefined limits during a one-point or a two-point calibration.
Sensor offset is beyond predefined limits during a two-point calibration.
Sensor does not reach stable reading within predefined time limit.
Sensor does not reach stable reading during predefined time limit.
Sensor does not reach stable reading during predefined time limit.
Sample door detector cannot determine whether the sample door is open or closed.
Fluid detector 1 (FD1) does not detect the sample during the predefined time limit.
Fluid detector 2 (FD2) does not detect the sample during the predefined time limit.
Fluid detector millivolt (mV) reading is beyond predefined limits.
Fluid detector millivolt (mV) reading is beyond predefined limits. Qualifiers: FD3 FD4 Perform a wash.
Fluid detector millivolt (mV) reading is beyond predefined limits.
An internal communication problem between the system processors has occurred.
The barometer detects atmospheric pressure beyond predefined limits.
Fluid detector 3 (FD3), fluid detector 4 (FD4), or both detectors do not detect reagent.
Fluid detector 1 (FD1), fluid detector 2 (FD2), or both detectors do not detect fluid during a one-point or a two-point calibration.
The wash did not completely clean the sample path due to low volume or poorly segmented flow .
The probe detector cannot determine the position of the sample probe.
The system detects an error in the electronics system.
The system detects an error in the temperature control system.
The system detects an open connection in the glucose biosensor .
The system detects an open connection in the lactate biosensor .
The system detects a transmi.
The system detects an error in the CO-ox optical measurement system.
Fluid detector 5 (FD5) does not detect the sample during the predefined time limit.
The CO-ox sample chamber does not detect the sample during the predefined time limit.
The CO-ox module detects lamp levels that are inadequate for sample analysis. Perform the Lamp On/Off T est as described in CO-ox Optics T est , page 4-75.
The system detects an error in the electronics system.
1 testing occurs at power-up initialization and before each zero and slope calibration.
7 testing occurs at power-up initialization.
The system detects an error in the temperature control system. Every 15 minutes, the system enables the temperature control and reevaluates the error condition.
Fluid detector 5 (FD5), the CO-ox sample chamber , or both do not detect reagent.
Perform the Pump Functions T est as described in Pump Functions T est , page 4-58.
The wash did not completely clean the CO-ox sample path due to low volume or poorly segmented flow .
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This section describes how to use the 800 system diagnostic tests to check the functions of the system components.
Roll Printer T ests the ability of the roll printer to print all characters. Bar Code Scanner T ests the ability of the bar code scanner to read a test pattern.
5. Perform the appropriate action. test another reagent repeat steps 2 through 4. return to the Menu screen press Exit T est .
3. Check the screen for the message, Reagent pump flow rate acceptable, to verify that the flow rate is within the acceptable range. acceptable press Exit T est .
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c. Attach another piece of test tubing to a two-way connector , attach the connector to the outlet tubing for the appropriate pump, and place the test tubing in the graduated cylinder .
c. Attach another piece of test tubing to the waste tubing connector on the CO-ox pump tubing, and place the test tubing in the graduated cylinder . 6. Select the pump and speed to test and press Enter .
1 1. Reinstall the reagent, sample, or waste pump tubing: a.
V ent controls the flow of ambient air into the manifold Clean contro.
5. Perform the appropriate action. test another valve repeat steps 2 through 4. return to the Menu screen press Exit T est .
d. Press Stop T est . Ensure that the bubbles stop flowing from the adapter .
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.
4. T est the fluid detectors with whole blood: a. Select Whole Blood and press Enter . b. Insert a sample device containing a whole blood sample into the sample port.
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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.
4. Perform the appropriate action. T emperature control system on message a. Press Stop T est .
K + 29.
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Lac A 17.602 to 42.398 nA sample ground/temperature 36.840 to 37.373 ° C d.
d. T ake a reading of the actual sensor output signal. e. W ait 100 seconds, and take another reading.
Y ou can use this procedure to test the operation of the CO-ox lamp and to display the integration time for the last CO-ox zero calibration.
b. Select 4 Communications and press Enter . The External Loopback T est screen appears as shown in Figure 4-1 1.
CAUTION: Do not attempt to print without paper in the printer . Damage to the printer can occur . 1. Access the Roll Printer T est from the Menu screen: a. Select 3 T roubleshooting and press Enter .
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Use this procedure to remove obstructions from the sample entry components.
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.
Capillary Seal Drip Tray Sample Door Retainer Ring Sample Port Clot-removal Line Mount O-ring 7.
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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.
T ouch the inner surface of the module frame to discharge static buildup before removing or returning sensors. g. Dry thoroughly and reinstall each sensor , ensuring that the O-rings are in place.
Remove the gas sensors from the measurement module.
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Do not move the obstruction into the hemolyzer , sample chamber, or sample connector .
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.
5. Inspect the sample chamber and bubbletrap for obstructions: near the sample chamber outlet a.
not removed a. Remove the sample chamber . NOTE: Hold the sample chamber by the edges.
Use this procedure to disconnect the CO-ox sample path from the base model.
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.
This section describes information about o.
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Profic.
Use this table if you observe unexpected or out-of-range patient results.
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? is printed next to the CO-oximeter results on reports Optical measurements indicate that the CO-oximeter results should be reviewed.
? i.
Use this table if you observe fluid leaks in or under the 800 system. Sample drips out of sample port 1.
Use this table if you observe problems with fluids flowing too slowly , erratically , or not at all.
Insufficient wash solution is flowing through the sample port 1.
Sample path is obstructed The fluid flow is insuf ficient due to obstructions in the sample path.
During the first 24 hours following installation, the glucose or lactate biosensors measure a large negative slope value during calibration.
Use this table if you observe fluids with cloudiness, color changes, or particulate matter .
Use this table if you observe problems with the supply and delivery of Cal or Slope Gas. Leaking or hissing of gas 1.
Salt deposits appear in measurement module 1. Check the reference sensor for leaks.
Use this table if you observe problems with bar codes or the bar code scanner .
Use this table if you observe electronic problems.
Use this table if you observe problems with the roll printer .
Use this table if you observe problems with the reagent pump, sample pump, or waste pump.
Measurement module temperature error message The measurement module temperature is outside the 37.
Use this table to troubleshoot system messages that appear during analysis mode functions.
Excess.
If Blood, Question Data Optical measurements indicate that the CO-ox results should be reviewed.
If Blood, Question Data is successful is not successful go to step 5.
Insufficient Sample There is not enough sample to fill the measurement block.
Meas Module T emperature Error The measurement module temperature is outside the 37.
No Sample Device Detected No sample device is detected in the sample port after you press Analyze and the sample door closes.
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This section describes the procedures for defining or changing 800 system setup parameters.
control v.
Previous Screen return to the frame or screen from which you entered the present screen. If you press this key after you make changes to the current screen, a message appears prompting you to save your changes.
1. Access the System Information screen from the Menu screen: a. Press 8 Service Setup and press Enter . b. Press 1 System Information and press Enter . The System Information screen appears, as shown in Figure 5-1.
T emperature temperature of the patient tHb total hemoglobin value of the.
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Use this procedure to customize a panel that the system will use to analyze a patient sample. Y ou can define up to 5 customized panels.
Use this procedure to select the panel that the system will use to analyze a patient sample.
855 All Parameters pH/Bl.
1. Access the Select Default Panels screen from the Menu screen: a. Select 6 System Setup and press Enter . b. Select 4 Panels and press Enter . c. Select 1 Default Panel and press Enter .
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If you change parameter units for pH after the system has started to collect data, QC statistics are still computed in the current units.
3.
tHb c tHb O 2 Cap BO 2 AaDO 2 p O 2 (A–a)(T) a/A p O 2 (a/A)(T) 1. Access the Parameter Names screen from the Menu screen: a.
NOTE: The default values for the action range are equal to the measurement range. If you use the default action range values, the system does not flag action range results but instead indicates that the results are out of measurement range.
FO 2 Hb % 94.0 – 97.0 –99.9 – 999.9 FCOHb % 0.
Use this procedure to sele.
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Use this procedure to do the following: Select the report format that the system uses to print the patient sample results.
Y ou can select a report format for the roll printer and, if a line printer is connected, for a line printer .
Use this procedure to turn the roll printer on and off. When you turn the roll printer off, it is of f for all reports.
Use this procedure to turn the paper spool on or off. The paper spool automatically winds the roll printer paper as the reports print.
Use this procedure to select sample analysis and menu functions for password protection.
3. Select the functions that you want to protect and press Enter . Any combination of menu options can be password protected. The password protection default value for all functions is off.
The first operator password has a default value of 12345. T o ensure that there is always at least one active operator password, you can edit the default password, but you cannot delete it.
Operator IDs can contain 1 to 13 alphanumeric characters and can include spaces. Operator passwords can contain 1 to 8 alphanumeric characters, can include spaces, and are case sensitive.
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Use this procedure to change the date and time. T able 5-10 lists the date and time formats that you can use.
2. Change the date and time. Date a. Move the cursor to the Date field.
Use this procedure to change the time when the system performs the automatic cleaning of the reagent manifold.
b. Press 2 Maintenance T asks and press Enter . The Maintenance Setup screen appears, as shown in Figure 5-19.
Use this procedure to define the number of patient samples that can be stored on your hard disk.
Use this procedure to adjust the beeper volume. Y ou can select a high, medium, or low volume.
Use this procedure to control the way the system moves capillary samples to the measurement module.
Use this procedure to select automatic transmission of patient sample results directly to an LIS, HIS, or data management system.
Use this procedure to define the number of significant digits reported for certain primary parameters.
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1. Access the System Options screen from the Menu screen: a. Press 6 System Setup and press Enter . b. Press 5 Systems Options and press Enter . The System Options screen appears, as shown in Figure 5-25.
Use this procedure to define correlation coefficients.
1. Access the Correlation Coef ficients screen from the Menu screen: a. Select 5 Operating Setup and press Enter . b. Select 8 Correlation and press Enter . The Correlation Coefficients screen appears, as shown in Figure 5-26.
Use this procedure to print the setup report. The setup report contains a record of the setup options selected on your 800 system.
This section describes procedures for the following QC options: c.
Use this procedure when you first create a new QC file. The system uses QC files to store results from QC sample analyses.
6. Press Ye s . The QC File Setup screen appears with all data fields empty , as shown in Figure 5-28.
9. Press Done . A message appears prompting you to set up another QC file. save your entries and create another QC file Ye s .
Use this procedure to edit QC setup information in an existing QC.
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8. Press Done when you finish. A message appears prompting you to set up another QC file. save changes and edit another QC file Ye s .
Use this procedure to control the way QC results are assigned to a QC file.
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5. Define another setup function or press Exit Menu to return to the Ready screen.
Use this procedure to print a QC setup report for any QC file. 1. Access the QC File screen from the Menu screen: a.
This section describes procedures for the .
1. Access the Calibration Drift Limits screen from the Menu screen: a. Select 5 Operating Setup and press Enter . b. Select 6 Calibration Setup and press Enter .
CO 2 2.
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c. Select 2 Cal Intervals and press Enter . The Cal Intervals screen appears with the cursor in the Calibration Frequency frame, as shown in Figure 5-37.
Use the fo.
2. Select the appropriate serial port, press Enter , and then press Done . Refer to T able 5-25 to determine which port to select for your device. The Device Selection screen appears, as shown in Figure 5-39.
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5. Press Done when you finish. Y ou are prompted to configure another port. want to configure another device Ye s . The Port Selection screen appears.
Bayer Diagnostics Service Rep.
This section provides the following procedures for managing 800 syste.
Use this procedure to copy the previous month’ s QC files and statistics from the hard disk to a diskette.
If you do not insert a diskette, the No Diskette in Diskette Drive message box appears. If you insert an unformatted diskette, the Cannot W rite to Diskette message box appears.
Use this procedure to view QC data from archive diskettes.
7. Perform one of the following tasks. view the report results select the QC sample you want and press Enter .
If you type invalid data in a field and press Done the system displays either the Invalid Entry or Invalid Range message box. Press OK and type a valid entry in the field.
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If you do not insert a diskette, the No Diskette in Diskette Drive message box appears. If you insert an unformatted diskette, the Cannot W rite to Diskette message box appears.
4. Complete the restore process. a message appears prompting you to insert the next diskette a. Remove the diskette from the diskette drive.
If you want to cancel the restore process, press Cancel .
4. Press Continue to proceed. The following message appears: The system identifies the diskette and displays the Install Id.
6. After the system copies the software files, the Install Identification message box appears.
9. Restart the system: a. W ait at least 10 seconds after disconnecting the power cord. b. Reconnect the power cord into the power source. The system restarts. After a few moments, the system starts initializing.
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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.
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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.
3. Exit standby . automatically Do nothing.
Use this procedure to shut down the system before you perform service and to restart the system when finished.
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This appendix summarizes the established guidelines for handling laboratory biohazards.
Dispose of contaminated materials according to your laboratory’ s biohazard control procedures.
This appendix provides the following service and supply information: .
Bayer OY Suomalaistentie 7 FIN 02270 Espoo, Finland + 35 89 88 78 87 Bayer Medical Ltd. Unosawa T okyu Building 3 F1–19–15, Ebisu Shibuya–Ku T okyo 150–0013, Japan 81.
Bayer Puerto Rico Inc. Diagnostics Division V ictoria Industrial Park Building #1 Carolina, Puerto Rico 787 752–8989 Bayer T aiwan Company Limited Diagnostics Division 8/F No.
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Bayer Diagnostics or its authorized distributors.
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Use T able B-1 and T able B-2 to find the supply or accessary you need to order .
673702000 T est/Blank Sensor K + .
013895701 Reagent Fitting Kit (Sept.
478498000 Reference Sensor Re.
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This appendix lists all references for this manual. 1. National Committee for Clinical Laboratory Standards. Blood Gas Pre–Analytical Considerations: Specimen Collection, Calibration and Controls, Approved Guideline; NCCLS Document C–27A (V ol.
14. Moran R, Cormier A. The blood gases: pH, p O 2 , p CO 2 . Clin Chem News 1988; 14(4/5): 10–12. 15. Severinghaus JW , Bradley AF . Electrodes for blood p O 2 and p CO 2 determination.
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.
48. Shapiro BA, Harrison RA, Cane RD, Kozlowski–T emplin R. Clinical application of blood gases. 4th ed. Chicago: Y ear Book Medical Publishers, 1989: 143.
This section provides information about making the connection between an .
Use this procedure to connect an 800 system to a 270 CO-oximeter .
f. Press ENTER to confirm your selection. g. Select the transmission specifications as shown in T able D-1.
NOTE: Always use serial port 1 for the ticket printer . 3. Connect the 9-pin connector of the interface cable to serial port 1 on the 800 system. Refer to Figure D-1.
T o prevent electrical shock and damage to either system, disconnect the 800 system and the data management system from the AC power source before installing the cable.
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This appendix provides the following information about the 800 series systems:.
T able E-1 lists the specifications for the 800 system.
T able E-2 lists the units, reporting ranges, and display resolutions for the pH and blood gas parameters measured by the 800 system.
Lactate mg/dL mmol/L 0.0 – 270.3 0.
c tO 2 (a-v) mL/dL mL/L mmol/L 0.0 – 20.
% –99.9 – 999.9 0.1 F MetHb fraction –0.
p O 2 (A–a)(T) mmHg kPa 0 – 800.0 0 – 106.
T able E-8 lists the units, reporting ranges, and display resolutions for the parameters that can be entered into the 800 system.
The following reference methods were used for the 800 systems. pH IFCC reference method , * also referenced by NCCLS document C–27A.
Bayer Diagnostics cannot guarantee system performance when any of the following situations occur . Specific terms of warranty , service, and contract agreements may be invalidated if any of these situations occur .
All performance data presented in this section were generated using 840 systems.
Precision on aqueous calibration verification materials was estimated using three 840 systems. At least seven runs per instrument were made over five days.
T able E-1 1 through T able E-13 summarize the results of the 840 system whole blood and expired gas recovery precision testing.
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Capillary 18 0.68 71.7 71.3 100.
4 Syringe 24 0.97 150.5 149.
All performance data presented in this section was generated using 850 systems.
2 71 133.0 0.21 0.86 3 72 154.5 0.36 1.58 K + 1 72 2.42 0.
p O 2 1 44 25.8 1.39 1.97 4 44 237.7 2.99 5.78 Na + 1 44 102.
T able E-16 through T able E-22 summarize the results of the 850 system whole blood, expired gas, and electrolyte recovery and precision testing.
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Capillary 24 1.20 71.7 71.3 100.
4 Syringe 18 2.65 149.6 149.7 99.
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All performance data presented in this section was generated using 860 systems.
Thiocyanate 80 mg/.
T able E-25 lists substances that interfere with the glucose measurement.
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Bilirubin (Dir.
Refer to Sample Collection Devices and Anticoagulants in Section 1 for the specific requirements on sample handling and anticoagulants.
2 241 43.0 0.89 1.41 3 185 23.0 0.64 0.81 p O 2 1 387 61.
2 177 0.
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Capillary 48 0.004 7.507 7.502 100.
Capillary 23 0.44 50.3 49.9 100.
3 Syringe 24 1.19 84.9 85.6 99.
pH/L yte 21 0.42 1 17.8 1 19.
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All performance data presented in this section was generated using the 800 system CO-ox modules.
T able E-41 lists substances that were found not to interfere using the criteria stated in T able E-40.
Fetal Hemoglobin at 80% tHb COHb MetHb HHb –0.
F COHb 1 96 52.64 0.18 0.35 2 96 32.03 0.16 0.30 3 96 9.52 0.
Syringe 66 92.
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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 .
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Roll Printer Report B displays temperature corrected values next to the original values, and it does not display reference ranges. Figure F-2 shows an example of Roll Printer Report B.
Roll Printer Report C is similar to Roll Printer Report B, except that it lists blood gas and CO-oximeter values separately .
Roll Printer Report D provides a four-column layout of parameters. Figure F-4 shows an example of Roll Printer Report D. .
Roll Printer Report E is similar to Report C, except that it includes the pH value with the blood gas values.
This section contains examples of the patient sample reports that you can print on a line printer .
Line Printer Report A is the default line printer report. It includes the CO-oximeter values with the oxygen status values.
Line Printer Report B lists blood gas and CO-oximetry values separately . Figure F-7 shows an example of Line Printer Report B. .
Line Printer Report C is similar to Report B, except that it includes the pH value with the blood gas values.
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.
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The 800 system provides a setup option, Defining Corr elation Coefficients, that you can use to adjust the slope and intercept values to correlate results from an 800 system with results from another analyzer or methodology .
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.
Y our 800 system should be installed by an authorized Bayer Diagnostics representative. Use the following procedure to install your 800 system yourself only if you are located in a region where Bayer Diagnostics Field Service Representatives do not perform installation.
2. Inspect the packing case and report any damage to the shipper . Notify your Bayer Diagnostics representative at installation. 3. Cut the shipping straps and open the packing case.
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Refer to the table below to identify the correct fuses for the voltage you use. 100/120V 4A Slo Blo 5 x 20 mm 220/240V 2A Slo Blo 5 x 20 mm g.
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Second Stage Pressure Gauge Main Tank Pressure Gauge Needle Valve Adjustment Knob Gas Tank i.
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 .
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.
30. V erify that the sensors are installed in the following order: .
e. Pull the paper from under the platen and push it through the slot in the printer cover . f. Push the printer lever down. 35. Close the printer cover: a. Pull up the paper spool. b. Insert the paper into the paper slot on the spool and turn three or four rotations.
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.
48. V erify sensor performance by completing two successful two-point calibrations. The Ready screen appears when the calibration finishes. 49. Analyze QC material and verify acceptable results. 50. Replace the front cover .
ambient operating barometric pressure 400 – 825 mmHg (53.0 – 110.0 kPa) system dimensions height 30.
8. Carefully remove the foam end caps from the module. 9. Remove the plastic bag surrounding the module.
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This procedure refers to right and left as you are looking at the rear of system.
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.
NOTE: Ensure that the waste tubing is positioned through the hole on the CO-ox module fluid detector . 5. Connect the waste tubing to the 800 base model manifold. 6. Connect the sample tubing to the sample connector .
2. Plug the power cord into the AC power receptacle. At startup, the system proceeds through a series of initial tests and then displays Initializing in the banner .
lint-free tissue and swabs aspiration adapter test/blank sodium or pH sensor (TB2) glucose test/blank sensor (TB4) lactate test/bl.
Prolonged exposure to the 10% bleach solution damages the reference sensor membrane. Y ou must replace the reference sensor with a test/blank ref sensor (TB5) while you complete the cleaning procedure.
1. Remove all the reagent bottles from the system and perform a prime sequence. 2.
Drip Tray Sample Door Retainer Ring Mount Sample Port O-ring 4.
NOTE: Do not insert swabs into the sample port or spray anything into the measurement module. 2. Rinse the exterior surfaces with reagent water . 3. Clean spills around any of the roller cages, if required: a.
Compressed gas tanks require cautious handling. T o prevent damage and possible personal injury , refer to Replacing the Gas T anks in Section 3, for more detailed precautions.
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.
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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.
Voltmeter.
System sensors are designed to measure a specific substance in a sample. T o better understand the ability of a sensor to measure specific substances, consider ion-selective electrode (ISE) technology .
E cell = (E ref elmt + E memb ) – (E ref + E lj ) where E cell = electrochemical cell potential E ref .
I = 1/2 ∑ m * z 2 where I = ionic strength of the solution z = the charge number of the ions in solution m = concentration of the ion (mol/L) The activity coefficient generally decreases with increasing ionic strength.
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.
The electrochemical cell contains two electrodes: the anode, which is positively charged and the cathode, which is negatively char ged. The measuring electrode, which is frequently composed of platinum(Pt) or another noble metal, can be either the anode or the cathode.
The notation of pH expresses the hydrogen ion activity in a solution as the negative logarithm of the hydrogen ion concentration.
pH is clinically significant as a means of determining acid-base disturbances. Acid-base disorders can result in several pathologic conditions.
The levels of HCO 3 – , H 2 CO 3 , and dissolved CO 2 play a major role in maintaining the pH in blood.
The p CO 2 sensor is based upon the electrode described by Severinghaus and Bradley . 15 It is a complete electrochemical cell that consists of a measuring electrode and an internal reference electrode.
Since it is not possible to measure intra-cellular oxygen tension ( p O 2 ), arterial p O 2 has become a standard for clinical evaluation of arterial oxygenation status.
Sample Path Cathode Contact Anode Contact A constant voltage, called a polarizing voltage, is maintained between the anode and the cathode.
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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.
Most potassium is excreted by the kidney , which is the major regulator of potassium output in the body .
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.
In critical care situations, especially where large amounts of blood are being transferred, ionized calcium levels should be monitored closely .
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.
The glucose and lactate biosensors are complete electrochemical cells that incorporate amperometric technology to measure glucose or lactate concentration in samples.
The loss of electrons in the oxidation of H 2 O 2 creates a current flow that is directly proportional to the lactate concentration in the sample.
Hyperlipemia can result in artificially increased methemoglobin values. 42, 43 High bilirubin concentrations can falsely increase oxyhemoglobin values. Hyperlipemia and administration of fat emulsions can increase total hemoglobin values.
Methemoglobin (MetHb), which is sometimes known as hemoglobin Hi, is hemoglobin whose iron is oxidized to its ferric state (FE(1 1 1) and is unable to bind oxygen.
The CO-oximeter (CO-ox) module detects and indicates concentrations of sulfhemoglobin greater than 1.
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 .
where pK, which is the dissociation constant describing the ability to release hydrogen ions , equals 6.105 for normal plasma, and 0.0307 is a combination of CO 2 solubility in plasma and a factor for converting mmHg to mmol/L.
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.
Oxygen saturation can be directly measured or it can be estimated using the relationship described by Kelman 24 and Thomas 25 : O 2 SA T = × 100 N 4 – 15N 3 + 2045N 2 + 2000N N 4 – 15N 3 + 2400N 2 – 31,100N + (2.
Oxygen content is determined, using NCCLS recommendations, 26 from the following relationship: c tO 2 = F O 2 Hb × 1.xx × c tHb + 0.00314 × p O 2 where c tHb is expressed in g/dL.
The oxygen capacity of hemoglobin (BO 2 or O 2 CAP ) is the maximum amount of oxygen that the hemoglobin in a given quantity of blood can carry .
sO i 7 i 0 K [( p O 2 S – 27.5) ( p O S 27.5)] i K 51.87074 K 129.8325 K 6.82836 8 K –223.7881 K –27.
All measurements and calculations are based upon a standard temperature of 37.
The 800 system does not report alveolar oxygen tension, but uses the p O 2 (A) value to calculate the alveolar-arterial oxygen tension dif ference and the arterial-alveolar oxygen tension ratio.
Ionized calcium values are dependent upon sample pH. The calcium value adjusted to pH of 7.
When mixed venous blood gases from the pu.
The a-v extraction index ( c tO 2 ([a-v]/a)).
The system determines the physiologic shunt using the following equation: 32 Qst/Qt(T) = c tO 2 (c)- c tO 2 (a) c tO 2 (c)- c tO 2 (v) where c tO 2 (c) = [1.39 x c tHb x (1 - FCOHb - F MetHb)] + (0.
As with all diagnostic tests, each laboratory should establish its own reference ranges for the diagnostic evaluation of patient results.
Appendix J provides Maintenance Checklist charts for you to record maintenance activities performed on the 800 system.
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Reagent W ater Quality Introduction Water quality is an important consider- ation in the laboratory because it can significantly affect the outcome of laboratory procedures and the measure- ment of patient samples.
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.
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.
107060 Rev. C 10/99 Manufactured by: Bayer Corporation East Walpole, MA 02032-1597 USA Bayer Argentina S.A. Division Diagnósticos Buenos Aires, Argentina Bayer Australia Limited Diagnostics Business Group Scoresby, Victoria 3179, Australia Bayer Austria GesmbH GB Diagnostika A-1164 Wien, Austria Bayer Diagnostics 1050 Bruxelles, Belgium Bayer S.
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Accept The F-key that lets you store QC results in a QC file and update the statistics in the QC file.
Auto Send The system setup option that automatically sends patient or QC sample results to a laboratory information system (LIS) or data management system.
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 .
Data Recall The menu option that lets you access stored data, such as patient, quality control, and calibration data, and workload statistics.
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.
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.
Levey-Jennings chart A visual representation of measured QC values used to detect results that fall outside of the established control limits and to observe trends or shifts in control values. LIS Laboratory information system.
Operating Setup The Menu screen option that lets you define QC setup, reference an.
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.
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.
required fields Patient data entry fields in which you must enter a value. For example, if the Patient T emp field is a required field, you must enter a patient temperature in the field before you can access the next screen.
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.
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.
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 .
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?, 2-31, 2-32, 4-99, 4-1 16 ?=If Blood, Question Data, 4-7 to 4-9 #, 2-31, 2-32, 4-98, 4-1 18 –––––– ↑ , 2-30, 2-32, 4-95, 4-98 –––––– .
bicarbonate ion, I-25 biohazards, 2-3 meaning of warning, xviii protecting yourself from, A-1 waste.
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 mes.
managing, 5-67 to 5-82 data management system configuring an 800 system for , 5-62 connecting to an.
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 h.
temperature range (warning), 4-1 12, 4-1 19 Measurement Module Door Open message, 4-8 Measurement M.
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 sam.
QC Data Search Result screen, 2-47 QC file information, 5-45 QC File Information form, screen, 2-43.
troubleshooting, 4-1 1 1 turning on or off, 5-24 roll printer test, 4-56, 4-76 sample chamber cleaning, 3-26 to 3-29 removing (illustration), 3-27 replacing.
reference sensor internal electrode (illustration), 3-78 reservoir cap from reference sensor (il.
temperature/ p Atm test, 4-55, 4-69 tHb See also CO–ox module measurement principles, I-22 tHb measurement values, 5-15 tHb slope analyze mode, 2-57 menu mode, 2-57 tHb .
デバイスBayer HealthCare Rapidlab 800の購入後に（又は購入する前であっても）重要なポイントは、説明書をよく読むことです。その単純な理由はいくつかあります：
Bayer HealthCare Rapidlab 800をまだ購入していないなら、この製品の基本情報を理解する良い機会です。まずは上にある説明書の最初のページをご覧ください。そこにはBayer HealthCare Rapidlab 800の技術情報の概要が記載されているはずです。デバイスがあなたのニーズを満たすかどうかは、ここで確認しましょう。Bayer HealthCare Rapidlab 800の取扱説明書の次のページをよく読むことにより、製品の全機能やその取り扱いに関する情報を知ることができます。Bayer HealthCare Rapidlab 800で得られた情報は、きっとあなたの購入の決断を手助けしてくれることでしょう。
Bayer HealthCare Rapidlab 800を既にお持ちだが、まだ読んでいない場合は、上記の理由によりそれを行うべきです。そうすることにより機能を適切に使用しているか、又はBayer HealthCare Rapidlab 800の不適切な取り扱いによりその寿命を短くする危険を犯していないかどうかを知ることができます。
ですが、ユーザガイドが果たす重要な役割の一つは、Bayer HealthCare Rapidlab 800に関する問題の解決を支援することです。そこにはほとんどの場合、トラブルシューティング、すなわちBayer HealthCare Rapidlab 800デバイスで最もよく起こりうる故障・不良とそれらの対処法についてのアドバイスを見つけることができるはずです。たとえ問題を解決できなかった場合でも、説明書にはカスタマー・サービスセンター又は最寄りのサービスセンターへの問い合わせ先等、次の対処法についての指示があるはずです。
