ABL 80 Operation Manual 1 PDF

ABL80 FLEX Operator's Manual 4. Sample measurement Next – press this button to save the information entered for this field and move to the next field in the list Previous – press this...

ABL80 FLEX Operator's Manual 4. Sample measurement Next – press this button to save the information entered for this field and move to the next field in the list Previous – press this button to save the information entered for this field and move to the previous field in the list View List – press this button to return to the sample information input screen Scan – press this button to activate the internal scanner Barcode Text field information may be entered by scanning a barcode, if desired. To use scanning this feature, highlight the desired field then press the Scan button. Position the barcode in front of the barcode scanner at the front of the analyzer until the scan is completed. Input field list The following table lists the available patient analysis input fields for all analyzer versions. Input Field Characteristics Accession number Up to 12 text characters Patient ID Up to 20 text characters Last name Up to 20 text characters First name Up to 20 text characters Department Up to 20 text characters Department (Patient) Up to 20 text characters Room number Up to 20 text characters 4-17 4. Sample measurement ABL80 FLEX Operator's Manual Input Field Characteristics Gender List choice of male, female and unknown Date of birth Two methods to input the data, either by entering discrete numeric values or as a selection on a calendar date control Patient temperature 12.0-45.0 °C 53.6-113.0 °F Weight 0-500 kg 0-1100 lbs Birth weight 0.00-20.00 kg 0-20000 g 0.0-705.5 oz Gestational age 0-99 weeks Height 0-300 cm 0-3 meters 0-118 inches FO2(I) 0-100% Liter flow Select from values between 0.0-2.0, 3-15, and Flush (maximal flow) sO2(m) 0.0-100.0% Oxygen saturation value measured from another analyzer ctHb(m) 1.0-28.0 g/dL 10-280 g/L 1.0-17.4 mmol/L This field is meant to be used for a total hemoglobin value measured from another analyzer Baro 540-800 mmHg 72.0-106.7 kPa This field is for recording the barometric pressure 4-18 ABL80 FLEX Operator's Manual 4. Sample measurement Input Field Characteristics Sample site List choice of R. radial, L. radial, R. brachial, L. brachial, R. femoral, L. femoral, arterial line, PA catheter, umbilical cord, L. finger, R. finger, L. heel, R. heel, scalp, bypass pump, other NOTE: An alternate list is available in the ABL80 FLEX CO-OX analyzer with OSM software configuration. This alternate list is designed for use in the cardiac catheterization lab. Contact your local Radiometer representative for details. Draw time Two methods to input data, either by entering discrete numeric values or as a selection on a calendar date control Drawn by Up to 20 text characters. The system defaults to the person logged into the analyzer but can be edited Order date Two methods to input data, either by entering discrete numeric values or as a selection on a calendar date control. The system default is the current date Physician Up to 20 text characters Note Up to 100 text characters Input field list The following table lists the additional input fields available only with the ABL80 ABL80 FLEX FLEX CO-OX analyzer. CO-OX Input Field Characteristics pO2(v– ) 0-760 mmHg 0-101.3 kPa sO2(v– ) 0.0-100.0% 0.000-1.000 · 0-xxxx mL/min VO2 0.0-xxx.x mmol/min · 0.0-1000.0 L/min Qt VCO 0.0-1000.0 mL FCOHb(1) 0.0-100.0% 0.000-1.000 FCOHb(2) 0.0-100.0% 0.000-1.000 4-19 4. Sample measurement ABL80 FLEX Operator's Manual Patient report Fetal The ABL80 FLEX CO-OX analyzer can be configured to correct the oximetry hemoglobin sample results for the presence of fetal hemoglobin (HbF). This correction can be correction applied to all samples or only those whose HbF value is greater than 20%. See Chapter 9, Settings (Reports – input fields) for more information. Out of range The ABL80 FLEX CO-OX analyzer can be configured to suppress the reporting of suppression hemoglobin fractions that the system calculates to be less than zero or greater than 100%. See Chapter 9, Settings (Reports – input fields) for more information. Print results All analyzer versions can be configured to automatically print results at the conclusion of every measurement. The number of printouts can be adjusted from 1 to 4 on the sample aspiration screen. Additional printouts can also be initiated manually using the print icon on the results screen. To enable or disable automatic sample result printing, see Chapter 9, Settings (Reports/Printout) for more information. Recall results See Chapter 7, Data logs for instructions on recalling and printing stored results. 4-20 ABL80 FLEX Operator's Manual 4. Sample measurement Edit patient information Introduction The user may edit information in any input field immediately after analysis, while in the results screen. The user may also edit information after completion of sample analysis, through the data logs recall screen. Permission to edit sample information can be limited to specified users only. See Chapter 9, Settings for information on security settings. Edit following To edit patient information immediately after sample analysis, perform the sample analysis following steps: Step Action 1. At the end of a sample analysis the results are automatically displayed. 2. Press the pencil icon. 4-21 4. Sample measurement ABL80 FLEX Operator's Manual 3. The input field entry screen will be displayed. Select the desired input field and perform the necessary edit. See Sample information earlier in this chapter for instructions on how to use this screen. 4. Press OK when all entries are complete. NOTE: The results screen will now include an Edit Log tab to view all edits for this sample. Edit from recall To edit patient information from the Patient Recall screen after a sample result is screen completed, perform the following steps: Step Action 1. Select Menu  Data  Logs  Patient. 2. The recall screen will list general information for each stored patient sample record. 4-22 ABL80 FLEX Operator's Manual 4. Sample measurement 3. Locate the desired sample and highlight it. NOTE: The most recent record is always located at the top of the screen when first accessed. To sort the records by Patient ID or patient name press the desired column header. 4. Press the Patient detail button to view the results of this sample 5. Press the edit button to open the edit screen. All input fields are available for editing. 6. Once all desired edits are performed, press OK to store these changes NOTE: All changes will be recorded in the edit log. 4-23 4. Sample measurement ABL80 FLEX Operator's Manual Patient edit log Introduction All versions of the ABL80 FLEX analyzer record every edit performed on a sample result. Only input field information is available for editing. A record of these edits can be viewed on the Edit Log tab on the results screen and at the bottom of each result printout (see Chapter 9, Settings to enable this feature). Edit Log To view any edits performed on a sample record, perform the following steps: Step Action 1. Select Menu  Data  Logs  Patient. 2. Select the desired patient sample record. 3. Press the Edit Log tab. NOTE: If the patient record has no associated edits, this tab will not appear. 4. A list of every input field edit that has occurred will appear on the screen. The list includes the following information: Edit date/time The user logged into the analyzer The input field that was edited, followed by the original value, an arrow, and the new value NOTE: When patient temperature is edited, only the temperature value is listed in the edit log. All derived parameters affected by the temperature edit will be flagged with the edit symbol (▲). 4-24 ABL80 FLEX Operator's Manual 4. Sample measurement Approval Introduction All ABL80 FLEX analyzer versions provide the ability to approve a sample result prior to uploading those results to an HIS/LIS system. When enabled, this feature provides an Approval button on the patient results screen. See Chapter 9, Settings / Data Communications for instructions on enabling this feature. Status types There are four approval status types. The approval status for each sample is displayed in the upper right corner of the results screen. Pending – the initial status of a sample result Approved – the results are considered acceptable and are sent to the HIS/LIS system Rejected – the results are considered not acceptable and are not sent to the HIS/LIS system. This result is sent to the RADIANCE/AQURE system with an approval status of “rejected”. Rerun – the results are considered questionable and are not sent to the HIS/LIS system. This result is sent to the RADIANCE/AQURE system with an approval status of “rerun”. Approval note The system also allows the entry of a free-text note which can be entered while selecting the approval status. This note, along with the status, is transmitted to the RADIANCE/AQURE system. Editing Once an approval status is selected, the patient record cannot be edited. Screen example When the Approval button is pressed, the user is allowed to select one of the three status types. The analyzer also allows the user to enter a specific approval note which is transmitted to the RADIANCE/AQURE system. 4-25  4. Sample measurement ABL80 FLEX Operator's Manual RADIANCE/ The initial patient result record is automatically uploaded to the AQURE approval RADIANCE/AQURE system with an approval status of pending. The approval status can be determined in the RADIANCE/AQURE system. This status would then be transmitted back to the ABL80 FLEX analyzer and stored and displayed on the analyzer. 4-26 ABL80 FLEX Operator's Manual 4. Sample measurement FlexLink Introduction All ABL80 FLEX analyzer versions can be used with the Radiometer FlexLink system to obtain information about each sample, including parameter panel, patient information and any processing instructions. This information is linked to the unique sampler ID on a safePICO blood gas sampler (or linked to a sample accession number). The analyzer will query the RADIANCE/AQURE system for information on the identified sample. Results are then transmitted back to the RADIANCE/AQURE system. This system ensures the correct results are linked to the correct patient. Enabling To enable the FlexLink feature in the analyzer, please see Chapter 9, Settings / FlexLink FlexLink for further information. A RADIANCE/AQURE connection is required to utilize the FlexLink system. Sample analysis When FlexLink is enabled and Analysis is selected on the main menu, a screen will be displayed for the entry of a sampler ID (or accession number). This number can be scanned or manually entered. Once entered, the ABL80 FLEX analyzer will query the RADIANCE/AQURE system for all available information on this sample. A sample pre-registration screen will then appear displaying patient demographic information. The user must press OK to accept this data and continue with sample analysis. Special The ABL80 FLEX analyzer will alert the user to several different conditions such conditions as: Parameters not supported – If the FlexLink transmission includes a request for measured or derived parameters that are not supported by the analyzer, a warning message will appear. The user has the option of continuing without these parameters if desired. No data found – If the system was unable to locate information on the sampler ID (or accession number) entered, a message will appear. The user has the option of continuing with sample analysis if desired. Derived value requires measured parameter not selected – If the system requests a derived value that requires a measured value for its calculation but that measured value was not requested, the system will automatically report the necessary measured value for this derived value calculation. 4-27 4. Sample measurement ABL80 FLEX Operator's Manual 4-28  5. Calibration Introduction This chapter describes the calibration concept and reporting format for all versions of the ABL80 FLEX analyzer. In this chapter This chapter covers the following topics: General information...............................................................................5-2 Calibration reports.................................................................................5-4 tHb calibration.......................................................................................5-6 Standby mode.........................................................................................5-9 5. Calibration ABL80 FLEX Operator's Manual General information Introduction Sensor calibration is the process of relating sensor electrical outputs to known analyte values. Traditionally, the calibration line slope (sensitivity) of each sensor is derived from the electrical values (end points) obtained by measuring two solutions with different analyte concentrations. With the ABL80 FLEX QC3 automatic quality control system, the calibration process includes the measurement of three solutions with different analyte concentrations. These three measured values are used in different combinations of two points each to establish three two-point calibration lines for each analyte. One calibration line is consistently used to report sample results. All three calibration lines are used together to evaluate system linearity. System Cycle Calibration is performed during a System Cycle. Schedule Calibration is performed every 8 hours, with the ability to increase that frequency up to every 2 or 4 hours, if desired by the user. In the OSM software version of the ABL80 FLEX CO-OX analyzer a System Cycle is performed every 24 hours. A System Cycle is also performed following power-up if the analyzer has been turned off for more than 10 minutes or if turned off without following the appropriate power down process as described in this manual. Blank In the ABL80 FLEX CO-OX analyzer a blank (zero) calibration of the CO- calibration oximeter is performed, using a clear solution, during every System Cycle and sensor cassette installation. A blank calibration is also performed at system power- up. In the OSM software version of the ABL80 FLEX CO-OX analyzer the blank calibration is also performed independently at the 12 hour period between System Cycle events. Drift The system can be configured to display a drift value for any parameter whose drift value falls outside the acceptable drift criteria between System Cycles. See Chapter 9, System Cycle Drift for instructions on enabling this feature. When enabled and at least one parameter drift value is outside the acceptable criteria, a Drift tab will appear on the System Cycle results screen. This information will also be included in the System Cycle download file when this feature is enabled. Inactivation If the calibration fails, the system will not allow the user to perform sample analysis unless the failed parameter is inactivated. The analyzer can be configured to automatically inactivate and re-activate failed parameters. See Chapter 9, Settings for more information on configuring the Active Parameters features. Non-QC3 The ABL80 FLEX analyzer with the FLEX software provides the option to install systems sensor cassette versions that do not support the QC3 system. The calibration process consists of a single two-point calibration only. In these systems, the main menu provides a selection to initiate a manual two-point calibration in place of a manual System Cycle. 5-2 ABL80 FLEX Operator's Manual 5. Calibration When using non-QC3 cassettes, the Schedule controls the frequency of two-point calibrations. The user can set the frequency to every 2, 4 or 8 hours as desired. Two-point calibration records can be reviewed in the 2 Point Cal logs. 5-3 5. Calibration ABL80 FLEX Operator's Manual Calibration reports Description The calibration element of each System Cycle (or two-point calibration in a non- QC3 system) establishes a new calibration line. The calibration sensitivity values are stored in the System Cycle (or 2 Point Cal) database log and can be reviewed under the Calibration tab in the System Cycle Recall (or Two Point Calibration Recall) screen. Calibration The calibration results from each System Cycle can be viewed in the System Cycle records Data logs. This System Cycle is also recorded in the Event log. See Chapter 7, Data logs for more information. Follow the steps below to review calibration records. Step Action 1. Select Menu  Data  Logs  System Cycle. 2. Use the scroll bar if necessary to locate the System Cycle record desired. The most recent record is always located at the top of the screen when first accessed. 3. Highlight the desired record then press the System Cycle detail button to view the results. 4. Press the Calibration tab to view the calibration results. Results that are out of range will be identified with an arrow (up to signify out of range high or down to signify out of range low). In addition, if the linearity evaluation is not successful, the sensitivity value will be replaced by the acronym L/E (linearity error). 5-4 ABL80 FLEX Operator's Manual 5. Calibration 5. Press the General tab to view general information about this calibration event. 6. Press the print button to generate a printout of the results Press the keyboard button to enter a free-text note Status The Status of a calibration result documents the overall pass/fail criteria for this event. If the overall status of the event is successful, then the Status is OK. In addition to sensitivity failures, there are other failures that can occur during this event. When the results of an event are not acceptable, one of the following statements will be displayed in the Status line: List of parameters outside the acceptable sensitivity range Temperature error Air detection system messages Question mark signifying excessive drift since the last System Cycle 2-point The analyzer performs single two-point calibrations during the first few hours calibrations following a new sensor cassette installation to provide more frequent monitoring of the sensitivity values. When the glucose sensor is active and five samples are performed within 15 minutes or 10 samples are performed within one hour, the system will perform a series of additional two-point calibrations. Records of these single calibrations can be viewed by selecting Data  Logs  2 Point Cal. These records also appear in the Event log. 5-5 5. Calibration ABL80 FLEX Operator's Manual tHb calibration Description The suggested calibration frequency of the ABL80 FLEX CO-OX analyzer’s spectrometer is once every three months using the ctHb Calibration Solution S7770. See Chapter 9, Settings for details on setting the tHb calibration schedule. Warning The analyzer can be configured to warn the user (yellow traffic light status) when the tHb calibration is due. See Chapter 9, Settings for details on setting this System Status warning. Preparation Ensure the analyzer is in the Ready mode tHb calibration Follow the steps below to perform a tHb calibration. procedure Step Action 1. Select Menu  Utilities  tHb Calibration. 2. Press the Scan button Scan the ctHb Calibration Solution barcode for the ABL80 FLEX CO-OX analyzer, located on the S7770 package insert. If the scanner is not available, the barcode values may be manually entered using the numeric keypad provided. 3. Once the analyzer scans the barcode, the system will automatically proceed to the next screen. NOTE: If the barcode was manually entered, the user must press OK to proceed. 5-6 ABL80 FLEX Operator's Manual 5. Calibration 4. The system will complete a blank calibration then prompt the user to aspirate the calibration solution. 5. Carefully open an ampoule of S7770 tHb Calibration Solution Raise the sample inlet probe Guide the inlet probe fully into the calibration ampoule solution, ensuring the tip of the inlet probe is fully immersed in the QC solution Press Aspirate. 6. When sample aspiration is complete, the analyzer provides a message and two short beeps. Remove the ampoule Lower the inlet probe 5-7 5. Calibration ABL80 FLEX Operator's Manual 7. The system will proceed to perform the tHb calibration. Once complete, the analyzer will display the calibration results. 8. The result screen displays a value for the cuvette factor (Fcuv). The cuvette factor expresses the ratio of the effective light path of the analyzer cuvette to that of a reference cuvette determined by Radiometer. The Fcuv acceptable range is 0.80 – 1.20. NOTE: If the calibration result is not acceptable, the system will retain the prior Fcuv and inform the user of this calibration failure. 9. Following a successful tHb calibration, the system will automatically initiate a System Cycle. 5-8 ABL80 FLEX Operator's Manual 5. Calibration Standby mode Introduction The ABL80 FLEX CO-OX analyzer with OSM software configuration includes a Standby feature. This feature minimizes the consumption of calibration solutions, optimizing the in-use life of the solution pack. When in the Standby mode, the ABL80 FLEX analyzer postpones all System Cycles and/or two-point calibrations until the Standby mode is exited. In this way, calibration solution is conserved. To take advantage of this feature in the ABL80 FLEX CO-OX analyzer with OSM software, the system should remain in the Standby mode for more than 12 hours. This is important because blank calibrations of the CO-oximeter occur every 12 hours and, though there are no flushes during Standby, flushing does occur upon exiting Standby. Exiting Standby in less than 12 hours using OSM software will result in an increased consumption of calibration solutions. Entering The Standby mode can be entered manually or scheduled using the Standby Standby Schedule screen. See Chapter 9, Settings for more information on setting a schedule. To manually enter Standby, follow the steps below. Step Action 1. From the main menu, press the Enter Standby button. 2. The system will display a text message providing the last day the analyzer can remain in the Standby mode, based on the volume of calibration solution remaining in the installed solution pack. To enter Standby press Yes To cancel, press No Main menu While in Standby, the main menu will display an Exit Standby button. The traffic during Standby light will be yellow and the message displayed in the upper left corner will say Standby. 5-9 5. Calibration ABL80 FLEX Operator's Manual Depending on the method of entering Standby and the status of the consumables installed, several messages will appear below this Exit Standby button providing useful information to the user regarding the length of time the system can support the Standby mode. Consumable While in Standby, the system will monitor the status of the consumables and replacement update messages on the main menu as applicable. These messages are presented with the earliest date at the top of the list. While in Standby, an expired solution pack can be on the analyzer to allow the abbreviated flushes to continue until Standby is exited, at which time a new solution pack must be installed to proceed with sample analysis. The solution pack cannot support the Standby mode, however, if there is an insufficient volume of remaining solution. The system will allow the replacement of a solution pack without exiting the Standby mode. A two-point calibration will be required upon exiting Standby if the solution pack was replaced during this Standby period. The sensor cassette status (tests remaining and expiration status) do not directly affect the Standby mode. A sensor cassette must be in place on the analyzer, however, to support the Standby mode. The status of the sensor cassette is displayed, when applicable, to communicate the readiness of the analyzer to perform sample analysis upon exiting Standby. 5-10 ABL80 FLEX Operator's Manual 5. Calibration Exiting Standby To manually exit the Standby mode, follow the steps below. Step Action 1. From the main menu press the Exit Standby button. 2. The analyzer will ask whether the user is sure they want to exit Standby. To exit Standby press Yes To cancel, press No NOTE: Upon exiting Standby, the system will perform a series of flushes to prepare the system for sample analysis. If overdue, a two- point calibration will also be performed prior to allowing sample analysis. 5-11 5. Calibration ABL80 FLEX Operator's Manual 5-12  6. Quality management Introduction There are two methods of performing quality control to evaluate the performance of the system. One method is automatic and the other is a manual method. The ABL80 FLEX analyzer, using non-QC3 cassettes is limited to the manual QC method only. It is strongly recommended that all analyzers be monitored by at least one of these two methods to ensure the system is functioning within specifications. All ABL80 FLEX analyzers, if configured to support the QC3 feature, perform periodic System Checks to provide further confidence that the analyzer is performing to specification. This chapter provides an overview of the automatic quality control and system check features. It also describes how to perform a manual quality control measurement and review the resulting QC data. In this chapter This chapter covers the following topics: Automatic quality control......................................................................6-2 System Checks.......................................................................................6-6 Analysis Check......................................................................................6-7 Manual quality control...........................................................................6-8 Preparing manual QC solutions.............................................................6-9 Performing a manual QC measurement...............................................6-10 Manual QC results...............................................................................6-15 Out of range manual QC results...........................................................6-16 Manual QC plot....................................................................................6-17 Reviewing manual QC statistics..........................................................6-19 Range+ QUALICHECK QC solution..................................................6-20 RiliBÄK ranges....................................................................................6-22 6. Quality management ABL80 FLEX Operator's Manual Automatic quality control Introduction This section describes the automatic method of the on-board quality control system. With this method, all versions of the ABL80 FLEX analyzer provide automatic quality control analysis for each parameter, measuring at least three levels of quality control material for blood gases, electrolytes and glucose at user- defined intervals. The ABL80 FLEX analyzer also measures two levels of quality control for Hct. The ABL80 FLEX CO-OX analyzer measures three levels of quality control for all oximetry parameters (two levels for the OSM software configuration in the ABL80 FLEX CO-OX analyzer). The automatic quality control system on all ABL80 FLEX analyzers is referred to as QC 3. Schedule These automatic quality control measurements are performed during each System Cycle. The interval of these events can be determined by the user. The default interval is every 8 hours for most analyzer configurations. See Chapter 9, Settings for more information on setting the System Cycle schedule. Control ranges The assigned value and control range for each parameter and level are entered automatically into the analyzer each time a new solution pack is installed. These values can be viewed and printed from the System Information / Solution Pack tab. See Chapter 7, Data logs for more information on the System Information screen. Acceptance The analyzer automatically assesses all automatic QC results and flags any result criteria that is outside the control range. The user can choose, among several options, how the system should react when a result falls outside the control range for a parameter. These options include inactivating the individual parameter involved or disabling patient analysis. To re-enable patient analysis or to re-activate the individual parameter, a subsequent QC analysis must be successful for the subject parameter(s) and level(s). The analyzer can be configured to automatically inactivate and re-activate failed parameters. See Chapter 9, Settings for more information on configuring the Active Parameters features. QC records All automatic quality control results are stored in the analyzer’s database. See QC result records further in this section for an example of a QC record. Also see Chapter 7, Data logs for more information on downloading and printing these records. Description of The table of QC results provided with each System Cycle includes the following results information: Solution ID: the Radiometer ID number of each solution Lot: the unique lot number for each of the solutions Cycles: the number of cycles remaining in each of the solution pouches at the end of the System Cycle Parameter values: the measured QC results for each parameter, each level QC#: a unique sequential number assigned to each QC event 6-2 ABL80 FLEX Operator's Manual 6. Quality management QC result The quality control results from each System Cycle can be viewed in the System records Cycle Data logs. Follow the steps below to review quality control records. Step Action 1. Select Menu  Data  Logs  System Cycle. 2. Use the scroll bar if necessary to locate the System Cycle record desired. NOTE: The most recent record is always located at the top of the screen when first accessed. 3. Highlight the desired record then press the System Cycle detail button to view the results. The Quality Control tab will automatically appear. 4. Press the icon to print a copy of the current record. 5. Press the icon to view a bias trend plot of the QC results. 6. Press the icon to view statistics of the QC results. Automatic QC The QC plot displays results of all automatic quality control measurements for plot each parameter and each solution level. All QC results are displayed in a bias plot. This bias plot charts the difference between the measured value and the assigned value for each parameter and each level (bias = measured – assigned). This plotting method allows for continual analysis and trending of analyte performance while eliminating variations due to solution lot changes. 6-3 6. Quality management ABL80 FLEX Operator's Manual The screen provides the following information and controls: Parameter: This selection box includes right and left arrows to move sequentially through the list of possible parameters. It also provides a dropdown list to directly select one parameter. Solution ID: This selection box includes right and left arrows to move sequentially through the list of possible solutions. It also provides a dropdown list to directly select one solution ID. QC Result: This box contains detailed information regarding the highlighted data point on the graph. This data includes the analysis time, measured value, control range (in brackets), bias value (the actual value plotted), lot number and sensor cassette serial number. Plot area: The plot area provides data over an 11-day period. The upper and lower control limits are represented by the upper and lower lines on the graph. The middle line represents zero bias from the assigned value. The date span is recorded at the bottom of the plot with the most recent date at the far right. – Circular data points on the graph represent measured values that fell within the control range – Single arrows on the graph represent values that fell outside the control range but are within the statistical range – Double arrows on the graph represent values that fell outside both the control range and the statistical range (outlier) – A triangle at the bottom of the graph represents a measurement that did not result in a numeric value, such as I/A (inactive) or N/C (not calculated) Print icon: This button allows the user to print a copy of the plot displayed Group of arrows: This group of arrows moves the cursor to the right or left by one data point, to the first or last point displayed, or adjusts the viewing window to the next or previous set of data points. 6-4 ABL80 FLEX Operator's Manual 6. Quality management Automatic QC The analyzer provides a series of statistical tables to aid the user when reviewing statistics automatic QC results. Each tab on the screen provides information for one of the four solutions analyzed. The tabs are labeled with the solution ID numbers. The following information is provided for the currently installed solution pack: Lot: The solution pouch lot number n: The number of data points included in the statistical calculations Mean: The mean measured value of all data points for this parameter Mean Bias: The mean of the bias values (measured value – assigned value) for all data points for this parameter SD: The standard deviation of all measured data points for this parameter CV%: The coefficient of variation of all measured data points for this parameter Each tab on the screen also provides the following historical information, which includes data for the current and last nine solution packs: n: The number of data points included in the statistical calculations Mean Bias: The mean of the bias values (measured value – assigned value) for all data points for this parameter SD Bias: The standard deviation of the bias values for all data points for this parameter Printout This statistical information may be printed by pressing the print icon at the bottom of the screen. Only the information on the currently displayed tab will be printed. 6-5 6. Quality management ABL80 FLEX Operator's Manual System Checks Description Every 30 minutes the analyzer will perform a System Check to verify the stability and proper function of the analyzer. During System Checks, the analyzer will activate the heater circuitry and air detection system. Measurements will be taken on all sensor cassette sensors and a drift evaluation will be performed. In ABL80 FLEX CO-OX analyzers, proper communication with the CO-oximeter will also be confirmed. User While the analyzer is performing a System Check, the System Check icon notification will be displayed at the top of the main menu to the left of the traffic light. Interrupting a If the Analysis button is pressed during a system check, the analyzer will notify the System Check user that a System Check is in progress and provide the opportunity to interrupt the check. Other activities that may interrupt a System Check include manual QC, manual initiation of a System Cycle, installing a sensor cassette or solution pack and initiating a manual rinse. Corrective The analyzer will automatically perform corrective actions when the results of a action System Check are not acceptable. The first phase of this corrective action is to flush the sensor cassette and repeat the measurements. If repeat measurements are not acceptable, the system will automatically initiate a System Cycle to fully evaluate the measurement system. The event log records these corrective actions by recording the event along with the acronym C/A (corrective action). System Check Each System Check is recorded in the Event log. The status reflects whether the records event was successful. System Check information can be downloaded if desired. See Chapter 7, Data logs for more information. 6-6 ABL80 FLEX Operator's Manual 6. Quality management Analysis Check Description With every blood sample analysis, a System Check with one-point calibration is performed. This specialized System Check is termed an Analysis Check. During analysis, the blood sample is aspirated into the analyzer and sensor measurements are recorded. The sample is then flushed with solution 1 (from the solution pack) and measurements of this solution are recorded. The measurement results from both the sample and the flush (the one-point calibration) are used to determine the final blood sample results. This method ensures compensation for any sensor drift with each sample analysis. 6-7 6. Quality management ABL80 FLEX Operator's Manual Manual quality control Introduction As a second method of quality control, the user has the option to analyze manual quality control samples, if desired. Radiometer provides several types of quality control material for use with the different analyzer versions. QUALICHECK In the ABL80 FLEX analyzer it is recommended to use the Radiometer brand 4+ Control quality control material QUALICHECK4+ for optimal performance and to take Solution full advantage of the analyzer’s design features such as temperature correction and automatic level detection. See Chapter 13, Ordering information for more information. QUALICHECK In the ABL80 FLEX CO-OX analyzer (using both CO-OX and OSM software 5+ Control configurations) it is recommended to use the Radiometer brand quality control Solution material QUALICHECK5+ for optimal performance and to take full advantage of the analyzer’s design features such as temperature correction and automatic level detection. See Chapter 13, Ordering information for more information. Range+ Radiometer provides an additional manual QC type for calibration verification. QUALICHECK Instructions for use differ between the ABL80 FLEX analyzer and the ABL80 Control Solution FLEX CO-OX analyzer. Please see the section titled Range+ QUALICHECK QC solutions further in this chapter for analyzer-specific instructions. Manual Quality Quality control solutions are solutions with predetermined values that cover the control clinically relevant ranges for the measured parameters, the objective being to frequency simulate a patient sample. Manual quality control from Radiometer includes four levels of solutions to cover the entire clinically significant range: low, normal and high. Quality control should be run to comply with special country, state and local regulations. Additional quality control should be run after any troubleshooting or preventive maintenance which might alter performance and whenever the technician has questions about the performance of the analyzer. An example of daily routine with the 4-level quality control system is given below: Shifts per Day Quality Control Routine 3 One level tested at the beginning of each shift. The 4th level is tested in the 8-hour shift with the highest volume of patient samples. 2 Two levels at the beginning of each shift. 1 All levels are tested at the beginning of each shift. 6-8 ABL80 FLEX Operator's Manual 6. Quality management Preparing manual QC solutions Introduction Proper handling and preparation of QC solutions are imperative to successful quality control performance. Thoroughly read and follow the instructions for using QC solutions, which accompany each box of quality control solutions. Handling of Avoid warming the QC ampoule in your hands ampoules before use. Excessive handling can alter the expected results. When handling the ampoules before opening, they should be held between two fingers, as shown. Storage Radiometer quality control material (QUALICHECK4+ and QUALICHECK5+) temperature should be stored between 2 °C and 25 °C (35.6 °F to 77.0 °F), including up to a total of 15 days at 32 °C (89.6 °F). Range+ QUALICHECK ampoules should be stored between 2 °C and 8 °C (35.6 °F to 46.4 °F). If using other brands of QC material, follow the manufacturer’s recommended storage guidelines. Conditioning The quality control ampoule should be conditioned for at least five hours at a prior to use constant temperature between 18 °C and 32 °C (64.4 °F to 89.6 °F) prior to use. Deviation from this temperature can cause value changes resulting in out of range QC results for oxygen, carbon dioxide and pH. Solutions are light and heat sensitive. Temperature The ABL80 FLEX analyzer supports temperature correction of Radiometer QC correction ampoules. See Chapter 9, Settings for detailed instructions. For more information on temperature correction please refer to the Radiometer publication Quality Control Systems Reference Manual. Open ampoule In order to ensure the reliability of the measurement, each QC ampoule must be stability used immediately after opening, for one measurement on one analyzer only. Do not open QC ampoules until the ABL80 FLEX analyzer displays the QC Aspiration screen. NOTES Use only recommended QC solutions in the ABL80 FLEX analyzer. QC solutions must be aqueous based. 6-9 6. Quality management ABL80 FLEX Operator's Manual Performing a manual QC measurement Introduction This topic describes the procedure for performing manual quality control measurements on all ABL80 FLEX analyzer versions. Required QUALICHECK4+ Blood Gas/Electrolyte Control Solutions (recommended for materials the ABL80 FLEX analyzer) QUALICHECK5+ Blood Gas/Electrolyte Control Solutions (recommended for the ABL80 FLEX CO-OX analyzer) Ampoule opener Protective gloves NOTES The reference ampoule temperature at which the package insert control ranges are defined is 25°C. If the quality control solutions are equilibrated (conditioned) at a temperature other than 25°C prior to measurement, entering the exact temperature into the analyzer will ensure reliable blood gas and pH results. To ensure accurate results, it is important that the quality control solutions are conditioned properly before use. This includes verifying that the quality control ampoule analyzed was kept at a known temperature for at least five hours for complete temperature equilibration to occur. Ideally the quality control solution should be stored in the same location as the analyzer. If the quality control solution and analyzer are kept in different locations and at different temperatures, there is a risk that the temperature correction entered into the analyzer will not match the equilibration temperature of the solution when it is introduced into the analyzer. This discrepancy would result in inaccurate and unreliable blood gas and pH results. This possibility exists especially for analyzers that are used in operating rooms or other point-of-care locations with different environmental conditions than other locations in the institution. QUALICHECK+ solutions are light and heat sensitive. Avoid storage in direct sunlight. Do not open QC ampoules until the analyzer displays the QC Aspiration screen. In order to ensure the reliability of the measurement, each QC ampoule must be used immediately after opening, for one measurement on one analyzer only. CAUTION Do not use perfluorocarbon-based quality control solutions. Performing a Follow the steps below to perform a manual QC measurement: QC Step Action measurement 1. Select Menu  Manual QC. 6-10 ABL80 FLEX Operator's Manual 6. Quality management 2. In the ABL80 FLEX analyzer, if Radiometer QUALICHECK4+ control solutions have been set up in the analyzer (see Chapter 9, Settings), two choices are displayed. Select one of the following two control types: BG/Lytes – used to analyze aqueous QC ampoules containing pH, blood gas, electrolyte, and glucose values Hct – used to analyze aqueous QC ampoules for conductivity- based hematocrit measurements 3. In the ABL80 FLEX CO-OX analyzer, if Radiometer QUALICHECK5+ control solutions have been set up in the analyzer (see Chapter 9, Settings), selecting Manual QC will take the user directly to the aspiration screen. 4. In all analyzer versions, if Other control solutions have been set up in the analyzer, the drop-down menu will display all control levels. Select the desired level. 5. The temperature of the QC ampoule may be reviewed and changed in the QC Aspiration screen. The acceptable temperature input range is 15.0 °C to 32.0 °C (60.0-89.6 °F). If the ampoule temperature is equilibrated to a temperature other than 25 °C, enter the actual ampoule temperature. NOTE: Temperature-correction of QC results is not applicable in the OSM software configuration of the ABL80 FLEX CO-OX analyzer. 6. There are several options regarding the entry of the QC ampoule temperature. See Chapter 9, Settings for detailed instructions. These temperature options include: Ask before each analysis – activation of this feature causes a dialog box to appear immediately prior to the QC Aspiration screen. It requires the user to review the temperature value, modify the temperature if desired, and press OK before proceeding with analysis. Retain entry for 30 minutes – activation of this feature causes the system to retain the last entered QC temperature for 30 minutes. Default QC Temperature – the default QC temperature value can be left blank, effectively making entry mandatory. The default temperature can also be set to any numeric value between 15.0 °C and 32.0 °C. 7. To enter a different temperature value, use the numeric keypad next to the temperature field. 8. If one or more QC lots are about to expire, or have expired, the screen will display a warning message. 6-11 6. Quality management ABL80 FLEX Operator's Manual 9. Holding the ampoule between the two fingers as shown, shake it vigorously for at least 15 seconds. 10. Once the analyzer prompts, raise the inlet probe to the first position (45°). 11. Tap the top of the ampoule until all of the solution collects at the bottom. 12. Place the ampoule in the ampoule opener (1) Break off the ampoule neck (2). 13. Guide the inlet probe into the ampoule. Ensure the tip of the inlet probe is fully immersed in the QC solution. 14. Press Aspirate. CAUTION: Place the ABL80 FLEX inlet probe in the QC ampoule and immediately press Aspirate. Use great care to avoid aspiration of air into the sample. 15. When sample aspiration is complete, the analyzer provides a message and two short beeps. Remove the QC ampoule. 6-12 ABL80 FLEX Operator's Manual 6. Quality management 16. Lower the inlet probe. NOTE: The user can cancel the analysis by pressing the Cancel button. The system will display a question box to verify the termination of the QC analysis. 17. When a Radiometer solution ID is selected from the QC Ranges screen (see Chapter 9), the analyzer will automatically recognize the QC level of the measured sample. 18. Final results will appear on the screen in approximately 90 seconds and print the results, if the Auto Print option is enabled (see Chapter 9, Settings for information on enabling the auto-print feature). Level detection If the analyzer cannot determine the level of the sample measured, the system will failure provide the opportunity for the user to select the level or discard the sample. Step Action 1. If at the end of a manual QC sample measurement the QC level cannot be determined automatically, the analyzer will display a message box with two choices: Discard the sample Select a level manually a. Press Discard Sample to discard the results. There will be no record entry in the manual QC log but the measurement will be recorded as an event in the Event log. Press Accept The analyzer will ask whether the user would like to perform another manual QC measurement Press Yes or No as desired 6-13 6. Quality management ABL80 FLEX Operator's Manual b. Press Select Level for access to a selection box to save the results in the manual QC log. Press the selection box down arrow to display the choice of QC levels Press the desired level. This result will be entered into the manual QC log and will also be recorded in the Event file. Press OK 6-14 ABL80 FLEX Operator's Manual 6. Quality management Manual QC results Copy of results Press the print icon to obtain a copy of the results. A copy will be automatically printed if configured in Settings Reports  Printout. QC plot Press the plot icon to view a plot of the QC results. Press the icon to print a copy of the plot. Upload of Press the upload icon to manually upload this record to a host computer. results Review previous Follow the steps below to review previous QC results. QC results Step Action 1. Select Menu  Data  Logs  Manual QC. 2. Use the scroll bar if necessary to locate the QC record desired. NOTE: The most recent record is always located at the top of the screen when first accessed. To sort the records by level, press the column header "Level". 3. Highlight the desired record then press the detail button to view the results 4. Press the print icon to print a copy of the current record. 5. Press the upload icon to manually upload the current record to a host computer. This icon is disabled if automatic data synchronization is activated and/or there is no specified connection type. 6. Press the left and right arrow keys to scroll through other QC records There is a window of information on the QC Results screen displaying the current record number and the total number of results stored in the record log. This can be a useful reference when scrolling through records in the QC Results screen. 6-15 6. Quality management ABL80 FLEX Operator's Manual Out of range manual QC results Introduction An out of range QC result is indicated by marking the result with a () or () to the left of the value. A down arrow indicates the results are below the control range and an up arrow indicates values above the control range. In addition, results on the screen are highlighted in red when they fall out of range. An out of range QC result that falls outside the statistical range is indicated by a red highlight (on the screen only) and a double arrow up or down to indicate above or below the range. For a definition of the statistical range and to set the statistical range, see Chapter 9, Settings. Example The following screen provides an example of a QC result outside the control range (and outside the statistical range). Troubleshooting If the manual QC result is outside of the control range, perform the following: procedure Step Action 1. Ensure that all storage and handling criteria from the manufacturer's package insert have been followed for the quality control solutions. 2. Ensure the correct QC ampoule temperature was entered into the QC Aspiration screen. 3. Initiate a manual System Cycle (or two-point calibration) from the main menu. 4. Re-analyze the failed QC level (using a new ampoule). Repeat a second time if necessary. If the failed QC level remains out of range, replace the sensor cassette If the situation persists after replacing the sensor cassette, replace the solution pack If the situation persists after both consumables have been replaced, contact your local Radiometer representative for assistance 6-16 ABL80 FLEX Operator's Manual 6. Quality management Manual QC plot Introduction All ABL80 FLEX analyzer versions will plot all QC results stored in the current QC file for each parameter and level. The plots are in a Levey-Jennings format. Access to QC There are two areas of the software that provide access to the manual QC plot plot feature: The QC Results screen immediately after QC sample analysis The QC Results screen under Data  Logs  Manual QC Pressing the icon will open the Manual QC Plot screen. Press Close to return to the previous screen. QC plot Parameter: This selection box includes right and left arrows to move description sequentially through the list of possible parameters. It also provides a dropdown list to directly select one parameter. Solution ID: This selection box includes right and left arrows to move sequentially through the list of possible solutions. It also provides a dropdown list to directly select one solution ID. QC Result: This box contains detailed information regarding the highlighted data point on the graph. This data includes the analysis time, measured value and the QC ampoule lot. Plot area: The plot area provides data over an 11-day period. The upper and lower control limits are represented by the upper and lower lines on the graph. The middle line represents zero bias from the assigned value. The date span is recorded at the bottom of the plot with the most recent date at the far right. – Single arrows indicate a value that fell outside the control range but are within the statistical range. – Double arrows indicate a value that fell outside both the control range and the statistical range. 6-17 6. Quality management ABL80 FLEX Operator's Manual – A triangle at the bottom of the graph represents a measurement that did not result in a numeric value, such as I/A, N/E, *** or ###. Group of arrows: This group of arrows moves the cursor to the right or left by one data point, to the first or last point displayed, or adjusts the viewing window to the next or previous set of data points Print the QC Print the currently displayed QC graph by pressing the print icon. It will print plot the prior 31 days worth of QC results, starting with the highlighted value on the screen. 6-18 ABL80 FLEX Operator's Manual 6. Quality management Reviewing manual QC statistics Introduction The analyzer will maintain a current mean, standard deviation (SD) and coefficient of variation (CV%) for each parameter of each manual QC level analyzed. NOTE: A minimum of two QC runs of a level are necessary to report statistics which update with each run of QC. Procedure Step Action 1. Select Data Logs  Manual QC 2. Press the statistics icon. 3. The QC Statistics screen displays a tab for each level of QC. To review a level's statistics, press the Level tab at the top of the screen. The number (n), mean, standard deviation (SD), and percent coefficient of variation (CV%) for each analyte will be available for each level. At least two data points are required before statistical information is reported. Printout of statistics Press the print icon to obtain a printout of the reported statistics. QC plotting Press the plot icon to view a plot of the QC results. Reset The manual QC statistics will automatically be reset when a new lot number is entered for a manual QC level. The lot number is entered in the Settings  Manual QC  Ranges screen. 6-19 6. Quality management ABL80 FLEX Operator's Manual Range+ QUALICHECK QC solution Introduction For all analyzer versions, Range+ QUALICHECK samples should be analyzed in the Manual QC mode. It is important that steps be taken to ensure any statistical data (e.g. mean, SD and CV%) for active manual QC lots (from QUALICHECK4+ and QUALICHECK5+ solutions) are not affected by these additional Range+ QUALICHECK samples. This can be accomplished by modifying the solution ID or QC lot number in the Manual QC Ranges setup screen. See the analyzer- specific instructions below for setting up and using Range+ QUALICHECK material. ABL80 FLEX Follow the steps below to analyzer a Range+ manual QC sample in the ABL80 analyzer FLEX analyzer. Step Action 1. Proceed to the manual QC Ranges setup screen to modify the settings in preparation for the Range + measurement by selecting Menu  Settings  Manual QC  Ranges. 2. Under Solution ID for Level 1, Level 2 and Level 3, select Other from the drop-down list. 3. Press OK. 4. From the main menu select Menu  Manual QC. 5. Select the level of Range+ QUALICHECK solution to be analyzed. 6. Thoroughly mix the Range+ QUALICHECK solution. 7. When prompted by the analyzer, lift the sample inlet flap. 8. Open the ampoule. 9. Guide the inlet probe into the ampoule solution. Ensure the tip of the inlet probe is fully immersed in the QC solution. 10. Press Aspirate. 11. When sample aspiration is complete and the system prompts, remove the QC ampoule. 12. Lower the sample inlet flap. 13. Final results will appear on the screen in approximately 90 seconds and print results if the Auto Print option is enabled. 14. Repeat steps 4 through 13 until all Range+ QUALICHECK samples have been measured. 15. Return to the manual QC Ranges setup screen and return the Solution ID field to its original setting. 6-20 ABL80 FLEX Operator's Manual 6. Quality management ABL80 FLEX Follow the steps below to analyze a Range+ QUALICHECK manual QC sample CO-OX in the ABL80 FLEX CO-OX analyzer. analyzer Step Action 1. Proceed to the manual QC Ranges setup screen to modify the settings in preparation for the Range + measurement by selecting Menu  Settings  Manual QC  Ranges. 2. Ensure the Solution ID fields for all levels are set to the Radiometer solution ID’s (i.e. S7730, S7740, S7750 and S7760). 3. Remove (and leave blank) or modify the current QC solution lot numbers entered in the Ranges setup screen for levels 1, 2 and 3. NOTE: Performing this step ensures that these Range+ QUALICHECK results are not included in the daily QC statistics. 4. Press OK. 5. From the main menu select Menu  Manual QC. 6. Thoroughly mix the Range+ QUALICHECK solution. 7. When prompted by the analyzer, lift the sample inlet flap. 8. Open the ampoule. 9. Guide the inlet probe into the ampoule solution. Ensure the tip of the inlet probe is fully immersed in the QC solution. 10. Press Aspirate. 11. When sample aspiration is complete and the system prompts, remove the QC ampoule. 12. Lower the inlet probe. 13. Final results will appear on the screen in approximately 90 seconds and print results if the Auto Print option is enabled. 14. Repeat steps 5 through 13 until all Range+ QUALICHECK samples have been measured. 15. Return to the manual QC Ranges setup screen and return the lot number fields to their original values. 6-21 6. Quality management ABL80 FLEX Operator's Manual RiliBÄK ranges Introduction An additional set of ranges can be defined in all ABL80 FLEX analyzer versions for use with automatic QC results during a System Cycle as well as manual QC results during manual QC testing. This feature must be enabled by your Radiometer service representative. When this feature is enabled, an additional selection will be present under Settings / Manual QC titled RiliBÄK Ranges. This new screen contains one tab for each measured parameter. A QC control range for each of these parameters can be defined by using the settings on this screen to establish a span. This span will be used in conjunction with the mean (assigned) value from the existing System Cycle or manual QC control range to define a second QC control range. These RiliBÄK ranges can be applied to either or both manual QC and System Cycle automatic QC results. When enabled, the system will automatically compare the manual QC control range (as entered in the Settings / Manual QC / Ranges screen) and the RiliBÄK QC control range. It will then reference the more narrow (tighter) of the two ranges to determine whether QC results are successful or flagged as out of range for that manual QC result. When enabled, the system will also automatically compare the automatic QC control range (from a System Cycle) and the RiliBÄK QC control range. It will then reference the more narrow (tighter) of the two ranges to determine whether QC results are successful or flagged as out of range for that System Cycle automatic QC result. To document which type of range is being applied, the system will display one of three letters with the QC result for each parameter: M – Manufacturer range, either the Manual QC package insert range scanned in the QC Ranges setup screen or the System Cycle automatic QC range as programmed in the solution pack iButton L – Laboratory range, a Manual QC range that was manually entered in the QC Ranges setup screen R – RiliBÄK range, as defined in the setup screen, is being applied to this manual QC or System Cycle QC result Setup screen See Chapter 9, Settings / RiliBÄK ranges for information on setting up RiliBÄK range requirements. 6-22  7. Data logs Introduction Data logs are historical files containing all patient, calibration and quality control measurements as well as a listing of pertinent system events. All data obtained is automatically stored in these logs from which the data can be viewed on the analyzer or downloaded to an external storage device. In this chapter This chapter covers the following topics: General information...............................................................................7-2 Logs........................................................................................................7-4 Upload....................................................................................................7-5 Download...............................................................................................7-8 Data maintenance.................................................................................7-11 System information..............................................................................7-13 7. Data logs ABL80 FLEX Operator's Manual General information Introduction All ABL80 FLEX analyzer versions contain the following data logs: Patient Manual QC System Cycle 2-point cal System Check Events Security Patient, Manual QC, System Cycle and 2 Point Cal logs hold 500 records in each file. The System Check, Event and Security logs hold 1500 records each. In addition, the ABL80 FLEX CO-OX analyzer contains a tHb Calibration log which holds 500 records. In the OSM software version of the ABL80 FLEX CO- OX analyzer, a SC Check log is also included and holds 500 records. Patient log The patient log stores the chronological record of all sample results run in the Analysis mode. Each record contains the measured and derived parameters, reference ranges and critical limits, and all input field information. It also records the temperature corrected values, sample type, sensor cassette lot and serial number, user, sequence number, analyzer name, whether any correlation values were applied, edit information, whether any air detection message occurred or the sample was run following a failed QC measurement, and the status of each record. Manual QC log The manual QC log stores the chronological record of all manual quality control samples and acceptable QC ranges. It also records the user, sequence number, record number, QC lot, QC temperature, sensor cassette lot and serial number, and the status of each record. Both the QC download file and the WDC download file can be created using data from the manual QC log. System Cycle The System Cycle log stores the chronological record of all automatic and manual log System Cycles, including successful installations, re-installations, and failed installations for both sensor cassettes and solution packs. Each record contains the sensor calibration (sensitivities) and quality control results, along with date and time, solution pack serial number and sensor cassette lot and serial number. It also records the user, sequence number, record numbers and status of each record. 2 Point Cal log The 2 Point Cal log stores those single two-point calibrations performed during and just following a sensor cassette initialization. This log also stores all two-point calibrations that occur while using non-QC3 systems. Each record contains the sensor sensitivities, along with date and time, solution pack serial number and sensor cassette lot and serial number. It also records the user, sequence number, record number, and status of each record. System Check The System Check log includes all data from each System Check event. This data log is not available for review on the analyzer but can be downloaded and reviewed in 7-2 ABL80 FLEX Operator's Manual 7. Data logs a spreadsheet format. A record of each System Check is also recorded in the event log with an overall status of that event. Event log The event log stores the chronological record of all events including installations, System Cycles, System Checks, manual QC results, parameter inactivation/re- activation, and out of range patient sample results. It also records the user and status of each record. Security log The security log records every logon and logoff attempt with the analyzer. It records the time, user name, action (logon or logoff) and the status of the activity. The security log is only activated when the system security is configured to require a password. See Chapter 9, Settings to configure password requirements. tHb calibration The ABL80 FLEX CO-OX analyzer has an additional log named the tHb log Calibration log. This log contains all hemoglobin calibration event results. It records the analysis time, cuvette factor and status of each calibration event. SC Check log The ABL80 FLEX CO-OX analyzer with OSM software configuration has an additional log named the SC Check log. This log contains the record of every SC Check performed. It records the solution conductivity values recorded during this check. This check is performed when a new cassette is installed and when exiting Standby to ensure there is no blockage in the cassette fluid pathway. 7-3 7. Data logs ABL80 FLEX Operator's Manual Logs Accessing logs Follow the steps below to view records from the data logs. Step Action 1. Select Menu  Data  Logs. 2. Select the desired log type from the list of choices. 3. Each log will contain columns of data to identify the individual record. 4. Each column can be sorted by pressing the column header. This will cause the list of records to be sorted in A to Z order for the column selected. 5. Highlight the desired record then press the detail button to view the detailed information of that record. Edit patient Follow the steps below to edit a patient record. record Step Action 1. Select Menu  Data  Logs  Patient. 2. Locate the desired record and press the detail button 3. In the results screen, press the edit button. A screen will open listing all input fields. 4. Edit all fields as desired. 5. Press OK to store these changes. NOTE: All changes will be recorded in the patient edit log and can be viewed in the patient results screen, printout, and in the edit log. NOTE: The Patient Results screen will have an additional tab labeled Edit Log when there is at least one edit stored for that particular record. If there are no edits in the system then this tab does not appear. 7-4 ABL80 FLEX Operator's Manual 7. Data logs Upload Introduction Individual records can be manually uploaded from the analyzer to an external network. The available record types are patient, manual QC, System Cycle, 2 Point Cal and WDC. In the ABL80 FLEX CO-OX analyzer the tHb calibration records are also available for upload. To upload data records a communication channel must be established under Settings  Setup  Data Communications. Upload a record Follow the steps below to upload a patient record. Other record types can be uploaded in a similar manner. Step Action 1. Select Menu  Data  Upload  Patient. 2. Locate and highlight the desired records for upload. NOTE: Records already uploaded will be marked with an asterisk in the Uploaded column. 3. Select the desired communication channel at the bottom of the screen. 4. Press Upload. 5. Once the upload process is complete, the system will display a completion message. 7-5 7. Data logs ABL80 FLEX Operator's Manual WDC upload A WDC report can be manually uploaded to the Radiometer QA Portal using this upload feature. Ensure a TCP/IP address is defined in the QA Portal setup screen. See Chapter 9, Settings to enter this address. Follow the steps below to manually upload a WDC report. Step Action 1. Select Menu  Data  Upload  WDC. 2. On the Initiate tab select the desired year and month from the drop- down list of choices. 3. Press OK to begin the upload. A progress bar will communicate the upload progress and notify the user when the upload is complete. 7-6 ABL80 FLEX Operator's Manual 7. Data logs Schedule WDC A WDC report can be scheduled to automatically upload to the Radiometer QA upload Portal using this upload feature. Ensure a TCP/IP address is defined in the QA Portal setup screen. See Chapter 9, Settings to enter this address. Follow the steps below to establish an upload schedule for a WDC report. Step Action 1. Select Menu  Data  Upload  WDC. Select the Schedule tab. 2. Press the Enable check box to enable this feature. 3. Select whether to upload the QC results in one of four time schedules: Each record – the system will upload each QC result at the time of each measurement Daily – the system will upload all QC results, not previously uploaded, once per day at the time specified Weekly – the system will upload all QC results, not previously uploaded, once per week on the day of week and time specified Monthly – the system will upload all QC results, not previously uploaded, once per month on the date and time specified 4. Once all selections have been made, press OK. 7-7 7. Data logs ABL80 FLEX Operator's Manual Download Introduction This topic describes the download procedure and how to view the downloaded files. The analyzer will download the following data to an external storage device: Patient data – patient sample result information, including all edit information Manual QC data – manual QC results for all levels System Cycle data – calibration sensitivity values and QC results from all System Cycles tHb Calibration data (ABL80 FLEX CO-OX analyzer only) – the cuvette factor from each tHb calibration 2 Point Cal data – sensitivity values calculated during the two-point calibrations. In QC3 systems two-point calibrations are performed during and within the two hours following sensor cassette initialization. In non-QC3 systems all calibration records are two-point calibrations. System Check data – measured endpoint data from all System Checks SC Check data (ABL80 FLEX CO-OX analyzer with OSM software configuration only) – the solution conductivity values recorded during a SC Check Event data – all activities considered analyzer events Security data – all logon and