Instructions for Use
173 Pages
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ABL9 analyzer Instructions for use
From software version 1.2
Contents 1.
Introduction Intended use... 1 Intended operators... 1 Limitations of use... 1 Operator training requirements... 1 About this document... 1 About hazards...1 General warnings and cautions... 2
2.
Getting to know the analyzer Overview of the analyzer... 3 Front view... 3 Side and back view... 4 Consumables... 4 Position of the inlet handle during a sample analysis... 5
Overview of the menu structure... 5 Menu structure...5
Overview of the system status... 7 To get a quick status overview of the system...7 To see the SC (sensor cassette) status data... 7 Data in the SC STATUS screen...7 To see the SP (solution pack) status data...7 Data in the SP STATUS screen... 8 To see the analyzer status data... 8 Data in the ANALYZER STATUS screen... 8 To see the status of external connections... 9 To see the next scheduled activities... 9
Is the analyzer ready for use?... 9 When is the analyzer ready for use?...9 Symbols on the home screen and their meaning... 10 To see the status of the parameters... 11 Parameter colors and their meaning... 11 Notification messages...12 Elements of a notification message... 12
Common tasks and buttons... 13 To log on... 13 To log off... 13 To enter text in a field... 13 To scan a barcode... 14 To select/deselect a check button...14 The most common buttons...14
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3.
Patient sample analysis Good results come from good samples... 15 What is a good sample?...15 To get a good sample... 16 Sample storage recommendations...17 Anticoagulants... 17
Patient sample analysis... 18 General guidelines for successful analyses...18 To analyze a sample in a syringe...19 To analyze a sample in a capillary tube... 21 To find a patient analysis result...23 Symbols on patient analysis results and their meaning...23 To print a patient analysis result... 24 To enter patient and sample data during analysis... 25 To edit patient and sample data after analysis...25 To see all edits made to patient and sample data after analysis... 25 To see general information about a patient sample... 26 To manually transmit patient results to external communication systems...26 References...26
4.
Replacements and cleaning Replacements... 29 Consumables... 29 When does a consumable need to be replaced?...29 To replace or install a SP (solution pack)... 30 To replace or install a SC (sensor cassette)...33 To replace printer paper...35
Cleaning and disinfection...35 Cleaning – when is it necessary?...35 To clean the outer surfaces of the analyzer...36 To clean and disinfect the touch screen... 36 To clean the solution pack compartment... 37 To clean the sensor cassette area...37 Disinfection – when is it necessary?...37 To disinfect the outer surfaces of the analyzer... 38
5.
Connecting external devices To connect a USB barcode reader...39 To connect an external USB keyboard... 39 To connect the analyzer to a network...39
6.
Quality control management Overview of quality control management... 41
System Checks... 41 Frequency of System Checks... 41 To find System Checks...41
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ABL9 analyzer: Instructions for use
Symbols on System Checks and their meaning... 41 To find a System Check result...42 To print a System Check result... 42 To see general information about a System Check result... 42
Manual QC analysis... 43 Suggested frequency of manual QC analyses... 43 QC solutions for manual QC analyses...43 How to get good manual QC analysis results...43 To analyze a QC solution...44 To find a manual QC result... 45 To print a manual QC result...45 Symbols on manual QC results and their meaning... 46 The statistical range...46 To view QC statistics... 46 To print QC statistics... 46 About QC plots... 47 To view QC plots... 47 To print QC plots...48 To see general information about a QC analysis...48 To manually transmit QC results to external communication systems... 48
Verification Checks (V/C)...49 Frequency of Verification Checks... 49 To find a Verification Check result...49 Symbols on Verification Check results and their meaning...49 To see general information about a Verification Check... 50
7.
Calibration About calibrations... 51 Frequency of calibrations... 51 To start a calibration... 51 To find a calibration result... 51 Symbols on calibration results and their meaning... 52 To print a calibration result...52 To see general information about a calibration result... 52 To manually transmit calibration results to external communication systems... 53
8.
Troubleshooting Troubleshooting – when is it necessary?...55 To troubleshoot a notification message... 55 What is an issue?...55 To find manual QC result with a "?"... 55 To troubleshoot manual QC results outside acceptable control ranges...56 To troubleshoot messages on a calibration result...56 To troubleshoot activities with "?" in the System log... 56
Troubleshooting-related tasks... 57 To start a rinse... 57 To renew the lease of the network connections... 57
Analyzer service... 57 For service...57
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To find the serial number of the analyzer...57 To find the software version of the analyzer...57 About failure reports... 58 To report failed calibrations and QC analyses to your Radiometer representative...58 To create contact information for failure reports... 58 Data in the FAILURE REPORT screen...58 To log information sent to and from the interface board, application software and during data communications...59
9.
Standby About the standby mode...61 To enter the standby mode ...61 To exit the standby mode...61
10.
Shutting down, moving and restarting the analyzer Shutdown... 63 To shut down the analyzer... 63 To move an analyzer... 63 To restart the analyzer... 64 To store the analyzer...64
Screenshots... 64 To take a screenshot... 64 To export a screenshot to a USB flash drive... 65 To delete a screenshot...65
11.
Setup Security settings... 67 To enable access control... 67 To select a default logon procedure... 67 About operator groups...67 To edit an operator group...68 To see the individual members of an operator group... 68 Default operators...68 To add a new operator...68 To edit an operator...69 To delete an operator... 69 To find a list of all operators... 69 To print a list of all the operators... 69 About centralized user management...69 To enable centralized user management...70
Analyzer settings... 70 To display items on the home screen... 70 To enable or disable parameters... 70 To change the measuring unit of a parameter... 70 To change the data columns in the Patient history screen... 71 To change the time and date... 71 About printers... 72 To enable an external printer...72 To name an external printer... 72
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To view enabled printers... 72 To set up the analyzer for automatic printing... 73 To create a header for all printed data... 73 To show a message on the home screen... 73 To adjust the sound volume of the analyzer... 73 To change the screen language... 74
Analysis setup... 74 To select patient and sample data input fields for sample analyses... 74 Patient and sample data input fields... 75 About out-of-range suppression of results... 76 To suppress out-of-range results... 77 To create standard patient types... 77 To edit a patient type... 78 To delete a patient type... 78 To enable Patient lookup... 78 To print a list of all available patient types... 78 To re-arrange sample types...78 About parameter panels...79 To add parameter panels... 79 To delete parameter panels... 79 To retain a parameter panel... 79 To re-arrange parameter panels... 79 About reference ranges... 79 About critical limits... 80 About range of indication... 80 About reportable ranges... 80 About ranges and critical limits... 80 To set up reference ranges and critical limits for measured parameters... 81 To set up reference ranges and critical limits for derived parameters...82 To set up reportable ranges...82 Maximum sample age...82 To enable a maximum sample age for a measured parameter... 83 About operator-defined correlations (offset and slope)... 83 The different correlation types... 83 Limits for slope and offset values... 84 To edit the slope and offset for a parameter... 85 To enable or disable a hemodilution correlation factor for Hct...85 About analysis lockout...86 To activate analysis lockout... 86 To skip the Parameter selection screen during analysis...86 Air detection... 87 To allow analysis when air detection calibration fails... 87 About patient result layout... 87 To create a new patient result layout... 87 To create a patient result layout based on an existing layout...88 To edit a patient result layout... 89 To set a patient result layout as default ...90 To see a print preview of a patient result layout... 91
Manual QC... 91 Why is it necessary to register QC levels?... 91 To see information about the individual QC levels... 91 To select QC type for QC analyses... 91
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To register new Radiometer QC levels... 92 To edit the QC control ranges... 92 About QC temperature settings...93 To enter a default QC temperature... 93 To retain a default QC temperature setting... 93 About QC ranges... 93 About RiliBÄK ranges...93 To enable RiliBÄK ranges...94 To define a validity range for RiliBÄK... 94 To edit RiliBÄK ranges...94
Calibration verification... 95 About calibration verification... 95 Frequency of calibration verification... 95
Data communications... 95 To change the name of the analyzer... 95 To add or change the name of the computer...95 To set up the connection for the external network... 95 To see details about the network connection... 96 To set up connection to the LIVE Connect system... 96 To edit the connection to the LIVE Connect system... 97 To disable the connection to the LIVE Connect system... 97 To set up connection to the AQURE system...97 To edit the connection to the AQURE system...98 To disable the connection to the AQURE system... 98 To set up connection to the HIS/LIS system. ... 98 To edit the connection to the HIS/LIS system... 99 To delete the HIS/LIS connection... 100
Data logs and export of data... 100 About data logs... 100 About what the analyzer does when the data logs are full ... 100 About notification thresholds... 101 To select how the analyzer should react when data logs are full... 101 To set up notification thresholds... 101 To find data...102 To filter patient history records... 103 To find cancelled patient records... 103 To export data to a USB flash drive...103 To remove personally identifiable information from exported logs... 104 To view exported data... 104 To export setup settings...104 To import setup settings...105
Scheduling...105 About scheduling standby events... 105 To schedule a one-time standby event... 105 To schedule recurring standby events... 105 To edit a scheduled standby event... 106 To delete a scheduled standby event ...106 About scheduling manual QC levels... 106 To schedule manual QC levels... 107 To edit the schedule for a manual QC analysis...107 To schedule calibrations... 108
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Sample counter... 108 To find the sample counter... 108 To reset the sample counter... 108 To print the sample counter data...109
12.
Performance characteristics Performance characteristics...111 Overview of performance characteristics... 111 About repeatability and reproducibility... 111 About uncertainty in performance characteristics...112 To convert an uncertainty at a 68 % confidence level... 112
Performance tests... 113 About reference methods... 113 Reference methods used... 113 Testing against a reference method... 114 About performance tests... 115 Test conditions...115 Rounding rules... 115 pH performance test results... 116 pCO2 performance test results... 116 pO2 performance test results... 116 cCa2+ performance test results... 117 cK+ performance test results... 117 cNa+ performance test results... 117 cCl– performance test results...118 Hct performance test results...118 cLac performance test results... 118
Interference tests... 119 About interference tests...119 Interference tests – pH, pCO2 and pO2 ...119 Interference on Hct measurement... 119 Interference test results – cK+, cNa+, cCa2+, cCl–...120 Interference test results – cLac... 120 References... 121
13.
Parameters Parameter symbols ...123 Parameter types... 123 Measured parameters... 123 Input parameters... 124 Derived parameters...124 Derived parameters – acid-base...125 Derived parameters – oxygen... 127 Derived parameters – electrolytes... 129 Default values for derived parameters...130 About standard international units (SI units)...130 Equations used to convert results to other units... 130 References... 131
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14.
Principles of operation About sensors...133 Measuring principles behind the analyses... 133 Fluid transport system... 133 Analysis process... 134
Calibration... 134 About calibrations... 134 About calibration equations... 135 How calibration equations are established and used... 135
Sensitivity and drift...135 Sensitivity ranges... 135 About drift... 136
The potentiometric measuring principle... 136 About the potentiometric measuring principle... 136 Potentiometric measuring system...136
The amperometric measuring principle... 136 About the amperometric measuring principle... 136 Amperometric measuring system... 137
The conductometric measuring principles... 137 About the conductometric measuring principle... 137 Conductometric measuring system... 137
15.
Specifications Ranges of indication and measuring ranges... 139 Product specifications... 139 Environmental specifications...140 EMC – emission and immunity specifications... 141 SP (solution pack) specifications... 141 SC (sensor cassette) specifications... 142
16.
Graphical symbols Explanation of symbols... 143
17.
Ordering information Analyzers – product codes...145 SC (sensor cassettes) – product codes... 145 SP (solution packs) – product codes... 146 Accessories – product codes... 146 Recommended Radiometer samplers – product codes... 146 QC solutions – product codes...149 Power supply cords – product codes... 150
18.
Legal information Patents and trademarks... 151 Patents... 151
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Trademarks... 151
Legal notices... 151 System performance... 151 Third-party software and trademarks... 151 Warranties and disclaimer... 151 Confidentiality... 152 Changes... 152 End-user license agreement with Microsoft... 152
Index
155
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ABL9 analyzer: Instructions for use
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Introduction Intended use
The ABL9 analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, lactate and hematocrit in whole blood. The ABL9 analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in or near a point-of-care setting or in a hospital laboratory environment.
Intended operators The analyzer is intended for use by trained technologists, nurses, physicians and therapists.
Limitations of use The ABL9 analyzer is designed for use with these sample types: • Undiluted human whole blood • Dedicated quality control (QC) solutions If you analyze other sample types, you risk damage to the analyzer and incorrect results on subsequent samples. No tests on animal blood have been done. Animal blood is different from human blood and the composition of the blood can be different within the same species.
Operator training requirements Operators must have received hands-on training in the procedures and functions that are relevant for their field of work and that are described in this Instructions for use. Operators must have been trained in the procedures and functions until they can do them successfully.
About this document The ABL9 analyzer Instructions for use provides instructions for daily use, instructions for the safe and proper operation of the analyzer, and important reference information. Radiometer does not accept warranty claims if operators do not follow these instructions. The analyzer is programmed with default settings that can be customized by the operator. Depending on your settings, not all topics in this document may be relevant for your analyzer.
About hazards A hazard symbol shows which instructions an operator must follow to prevent risk to persons or equipment. For safe and efficient operation of your analyzer, the hazard instructions must be read carefully.
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Chapter 1: Introduction
There are 2 types of hazard. Hazard type
Hazard symbol
Risk
WARNING
Death or injury to persons
CAUTION
Equipment damage
General warnings and cautions WARNING – Risk of infection Contact with potentially infectious blood can cause infection. Gloves are always to be worn during work with the analyzer. WARNING – Risk of infection Contact with potentially infectious blood can cause infection. Used accessories and spare parts are always to be disposed of and handled as biohazardous waste1. WARNING – Risk of incorrect clinical decisions Not to let a clinician examine a patient's results can cause incorrect clinical decisions. Clinicians are always to examine the validity of a patient's results carefully and relate the results to the patient's clinical condition. CAUTION – Risk of interference with monitoring equipment If a patient touches the sensor connector of the analyzer, this could interfere with monitoring equipment that the patient may be connected to. Always place the analyzers a minimum of 1.5 m from patient beds. CAUTION – Risk of equipment damage Blockage of the ventilation grids can cause equipment damage. Always keep the ventilation grids on the back of the analyzer free of blockage. NOTE: Always let trained Radiometer representatives perform repairs. Contact your local Radiometer representative for further information. NOTE: To be EMC compliant, shielded cables are recommended for all port connections. NOTE: To be sure the analyzer is properly grounded, use a 3-prong plug with a compatible 3-prong grounded mains/wall connection. Only this method complies with national electrical codes, local codes and ordinances. NOTE: The AC power supply cord is the primary mains disconnection device of the analyzer. The analyzer should not be positioned in a way that obstructs access to the AC power cord or mains connection.
1
2
Clinical laboratory waste management. CLSI/NCCLS document GP5-A2, Clinical Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA.
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Getting to know the analyzer
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Overview of the analyzer Front view
1
4
2
5 6
3
7 8 9
1
Touch screen
6
Latch on the SC door
2
SC (sensor cassette)
7
SP (solution pack)
3
Inlet handle
8
Latch on the SP door
4
SC door
9
SP door
5
Sensor window
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Chapter 2: Getting to know the analyzer
Side and back view
1 2 8 9 4
10 11
5
12
3
8
6 7
1
Analyzer handle
7
Serial number
2
Printer, if installed (the printer is optional)
8
Ventilation grid
3
USB port
9
Central Processing Unit (CPU) fan exhaust
4
Speaker
10 Ethernet/network cable port
5
Power switch button
11 USB ports
6
Mains power socket
12 HDMI port
Consumables To use the analyzer you must replace consumables when they run out. Consumable
Description
SP (solution pack)
Contains pouches with solutions for calibrations and rinse procedures, and a pouch for collection of waste fluids. The abbreviation of solution pack "SP" is used in the software and on the product.
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Consumable
Chapter 2: Getting to know the analyzer
Description
SC (sensor cassette) Contains the inlet probe and the sensors for parameter analysis. The abbreviation of sensor cassette "SC" is used in the software and on the product.
Paper roll
Paper for the printer if a printer is installed.
Position of the inlet handle during a sample analysis To analyze samples correctly, you must know which position to place the inlet handle in. The inlet handle has 2 different positions. Position of the inlet handle
Used for...
1st position (45o)
•
Syringe samples
•
QC ampoules
•
Capillary tube samples
2nd position (90o – horizontal)
Overview of the menu structure Menu structure To navigate the analyzer menu, this overview of the menu structure is useful. Press these buttons to access the corresponding menus or buttons.
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Chapter 2: Getting to know the analyzer
Overview of the system status To get a quick status overview of the system The status overview screen provides a quick overview of the status of the analyzer and the consumables, the next scheduled activities and the status of external connections. 1.
Press MENU > Overview.
To see the SC (sensor cassette) status data General information, statistics and maintenance dates about the installed SC (sensor cassette) can be found in the SC STATUS screen. 1.
Press MENU > Overview.
2.
Press the
button under the heading SC.
Data in the SC STATUS screen SC = Sensor cassette Data about the installed SC
Description
SC lot
Lot number of the installed SC
SC serial number
Serial number of the installed SC
SC part number
Product code of the installed SC
SC parameter list
Parameters of the installed SC
Number of tests
Number of tests programmed in the installed SC at the time of installation
Number of tests remaining
Number of tests left for the installed SC
SC install date
First date of installation. The date the installed SC was first installed on any analyzer
SC re-install date
Latest date of installation. The date of the most recent installation of the installed SC. NOTE: If the SC has only been installed once, this field will be empty.
SC in-use expiration date
Last date the SC can be used. The date the installed SC expires on the analyzer.
To see the SP (solution pack) status data General information, statistics, information about the calibration solutions in the SP (solution pack) and maintenance dates of the installed SP can be seen in the SP STATUS screen. 1.
Press MENU > Overview.
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2.
Press the
button under the heading SP.
Data in the SP STATUS screen SP = solution pack Data about the installed SP
Description
SP lot
Lot number of the installed SP
SP serial number
Serial number of the installed SP
SP part number
Product code of the installed SP
SP install date
First date of installation. The date the installed SP was first installed on the analyzer
SP re-install date
Latest date of installation. The date of the most recent installation of the installed SP. NOTE: If the SP has only been installed once, this field will be empty.
SP in-use expiration date
Last date the SP can be used. The date the installed SP expires on the analyzer
Standby supported until
The analyzer and the installed SP can only be put in the standby mode until the date shown in this field
CYCLES REMAINING
The number of cycles left of solution 1 (C9001) and solution 2 (C9002)
CALIBRATION VALUES
Names and true values of the calibration solutions in the installed SP. There are three pouches with calibration solution in the installed SP. Two pouches with solution 1 (C9001) and one pouch with solution 2 (C9002). The true values are used when the analyzer calculates calibration results.
To see the analyzer status data Information about the analyzer hardware and software can be seen in the ANALYZER STATUS screen. 1.
Press MENU > Overview.
2.
Press the
button under the heading Analyzer.
Data in the ANALYZER STATUS screen Data about the analyzer Description Analyzer serial number
Serial number of the analyzer. The abbreviation "S/N" is used in the software and on the product.
Analyzer name
8
Defaults to the serial number of the analyzer, but can be customized to be any alphanumeric name
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Chapter 2: Getting to know the analyzer
Data about the analyzer Description Analyzer parameter list
The parameters of the installed SC (sensor cassette)
SC group
The group of SC types supported by this analyzer
HW ID
The unique hardware identification number
Air detection
To see if air detection during analysis is enabled or not
Software version
Build number of the application software
OS image version
Version of the operating system of the analyzer
CPU type
Installed processing and control unit
CFAST card type
Type of CompactFast (CFAST) memory card installed
Serial number
Serial number of the CompactFast card
Firmware version
Build number of the installed firmware
To see the status of external connections The DATA COMMUNICATION STATUS screen provides a status of the connections to external communication systems. 1.
Press MENU > Overview.
2.
Pres the
button under the heading Data communications.
To see the next scheduled activities The SCHEDULED ACTIVITIES STATUS screen provides a list of the activities scheduled. 1.
Press MENU > Overview.
2.
Press the
button under the heading Scheduled activities.
Is the analyzer ready for use? When is the analyzer ready for use? The home screen provides an indication of whether an analyzer is ready for use or not. Check these indicators on the home screen before you analyze samples.
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