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Operator’s Guide
Origin: UK
The information in this operator’s guide was correct at the time of printing. However, Siemens continues to
improve products and reserves the right to change specifications, equipment, and maintenance procedures at
any time without notice.
If the system is used in a manner differently than specified by Siemens, the protection provided by the
equipment may be impaired. See warning and hazard statements.
Using This Guide
The Rapidlab® 1200 Systems Operator’s Guide provides information for the
following clinical laboratory professionals who use the Rapidlab1200 system:
• Routine operators
These are medical or laboratory personnel who use the Rapidlab 1200
systems to analyze patient and QC samples, to view and print results, and to
perform routine maintenance.
• System supervisors
These are laboratory supervisors or designated key operators who perform
Setup functions, monitor the use of the Rapidlab 1200 systems, and assist
with troubleshooting and maintenance when necessary.
Organization
The following table describes how this operator’s guide is organized.
If you want to... Then refer to...
learn about system features, Section 1:
learn about the hardware, System Features
learn about user interface components, Hardware Overview,
learn about principles of potentiometry, Software Overview,
Technology.
process samples, monitor status, or manage sample Section 2:
results, Operating the System.
calibrate the system, Section 3:
Calibration.
learn about QC options, Section 4:
analyze QC samples, Quality Control.
perform scheduled maintenance activities, Section 5:
record maintenance activities, Maintenance.
investigate and correct system problems, Section 6: Troubleshooting.
manage data files, Section 7:
Data Management.
modify test definition parameters, Section 8:
modify system parameters, System Configuration.
set up LIS parameters,
learn about biohazard precautions, Appendix A:
learn about laser precautions, Safety.
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Conventions
The Rapidlab® 1200 Operator’s Guide uses the following text and symbol conventions:
Convention Description
BIOHAZARD: Biohazard statements alert you to potentially
biohazardous conditions.
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Convention Description
Italic Italic type refers to the title of a document or a
section title in this operator’s guide. For example,
Operating the System‚ page 2-1 refers to Section 2
of this operator’s guide.
Terminology
The following table explains some of the special terminology used in this
operator’s guide and the specific actions that you need to take when you see the
terminology:
Term Description
Select To select an item, use your finger to select the item on the touchscreen
monitor.
Enter Use the numeric or alphanumeric sections of the touchscreen to enter the
specified information.
Scan Move the hand-held barcode scanner over the specified barcode to enter
the information.
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Contents
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3 Calibration
Understanding Automatic Calibrations . . . . . . . . . . . . . . 3-1
Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . . . . . . . 3-3
Generating Calibration Reports . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Performing Manual Calibrations . . . . . . . . . . . . . . . . . . . . 3-4
Recalling Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
4 Quality Control
Performing QC Sample Analysis. . . . . . . . . . . . . . . . . . . . 4-1
Using the Required QC Analysis Option . . . . . . . . . . . . . . . . . . 4-1
Performing Required QC Sample Analysis. . . . . . . . . . . . . . . . . . . . 4-1
Procedural Notes for Required QC . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Using the AutomaticQC Analysis Option . . . . . . . . . . . . . . . . . . 4-3
Performing AutomaticQC Sample Analysis . . . . . . . . . . . . . . . . . . . 4-3
Manually Performing AutomaticQC Analysis . . . . . . . . . . . . . . . . . . 4-3
Procedural Notes for AutomaticQC Sample Analysis . . . . . . . . . . . . 4-4
Performing STAT Samples during AutomaticQC Analysis . . . . . . . . 4-4
Using the Unscheduled QC Option . . . . . . . . . . . . . . . . . . . . . . 4-4
Performing Unscheduled QC Sample Analysis . . . . . . . . . . . . . . . . 4-4
Accessing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Printing or Sending Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Result Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Recalling QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
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5 Maintenance
Preparing for Maintenance Procedures. . . . . . . . . . . . . . 5-1
Performing Daily Maintenance . . . . . . . . . . . . . . . . . . . . . 5-2
Checking System Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Cleaning and Disinfecting the Exterior Surfaces . . . . . . . . . . . . 5-2
Calibrating the Barometric Sensor . . . . . . . . . . . . . . . . . . . . . . . 5-3
Performing Twice Weekly Maintenance. . . . . . . . . . . . . . 5-3
Analyzing High G/L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Performing Weekly Maintenance . . . . . . . . . . . . . . . . . . . 5-4
Deproteinizing the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Conditioning the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Checking the Level of Fill Solution . . . . . . . . . . . . . . . . . . . . . . . 5-7
Performing Every 60 Days Maintenance . . . . . . . . . . . . . 5-9
Replacing the CO-ox Sample Chamber . . . . . . . . . . . . . . . . . . . 5-9
Checking the Air Filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Performing Quarterly Maintenance . . . . . . . . . . . . . . . . 5-10
Replacing the Pinch Valve Tubing . . . . . . . . . . . . . . . . . . . . . . 5-10
Testing for Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11
Yearly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Replacing the Measurement Module Tubing . . . . . . . . . . . . . . 5-12
Replacing the CO-ox Module Tubing . . . . . . . . . . . . . . . . . . . . 5-13
Replacing the CO-ox Sample Tubing . . . . . . . . . . . . . . . . . . . . . . .5-14
Replacing the CO-ox Waste Tubing . . . . . . . . . . . . . . . . . . . . . . . .5-15
Replacing the CO-ox Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Completing CO-ox Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Replacing the Reagent Manifold. . . . . . . . . . . . . . . . . . . . . . . . 5-17
Completing Reagent Manifold Maintenance . . . . . . . . . . . . . . . . . .5-18
Replacing the AutomaticQC Manifold. . . . . . . . . . . . . . . . . . . . 5-19
Completing AutomaticQC Manifold Maintenance . . . . . . . . . . . . . .5-20
Replacing the Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Cleaning and Disinfecting the Screen. . . . . . . . . . . . . . . . . . . . 5-21
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6 Troubleshooting
Troubleshooting Failed or Missed QC Analysis . . . . . . . 6-1
Troubleshooting the Yellow Parameter Error . . . . . . . . . . . . . . . 6-1
Troubleshooting the Purple Parameter Error . . . . . . . . . . . . . . . 6-3
Troubleshooting the Ampule QC. . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . 6-4
Troubleshooting Checklist for Failed Calibration . . . . . . . . . . . . 6-4
Using the Calibration Report to Identify Problems . . . . . . . . . . . 6-5
Troubleshooting Patient Results . . . . . . . . . . . . . . . . . . . 6-6
Troubleshooting Unavailable Buttons . . . . . . . . . . . . . . . 6-7
Troubleshooting Measurement Module Lights . . . . . . . . 6-8
Troubleshooting Barcode Problems . . . . . . . . . . . . . . . . 6-8
Barcode Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Resetting the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Troubleshooting Internal Printer Problems. . . . . . . . . . 6-11
Troubleshooting Touchscreen Problems . . . . . . . . . . . 6-11
Solving Communication Problems . . . . . . . . . . . . . . . . 6-12
Clearing the Clot from the Reagent Manifold . . . . . . . . . . . . . . 6-13
Clearing the Clot from the Preheater . . . . . . . . . . . . . . . . . . . . 6-17
Clearing the Clot from the Reagent Cartridge . . . . . . . . . . . . . 6-22
Removing Clots Using the Clot-Removal Line . . . . . . . . . . . . . 6-24
Inspecting the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Reinstalling the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Completing the Inspection Procedure. . . . . . . . . . . . . . . . . . . . 6-30
Removing Obstructions from the CO-ox Sample Path 6-31
Using Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Copying Diagnostic Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
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7 File Management
File Names and Formats . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Copying Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Copying Patient, QC, or Calibration Data Files . . . . . . . . . . . . . 7-3
Copying Diagnostic Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Viewing the Sample Totals . . . . . . . . . . . . . . . . . . . . . . . . 7-4
8 System Configuration
Using the Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Setting up QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Setting Up QC Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Entering Customized QC Range Limits . . . . . . . . . . . . . . . . . . . . . . 8-3
Setting Up Required QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Setting up Required QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Editing Required QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Setting up AutomaticQC Schedule . . . . . . . . . . . . . . . . . . . . . . . 8-5
Setting up AutomaticQC Ranges . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Setting up High G/L QC Options . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Setting up Sample Information . . . . . . . . . . . . . . . . . . . . . 8-7
Defining Patient Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Using Default Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Setting up Patient Demographics or Sample Demographics . . . 8-9
Using Patient and Sample Demographics . . . . . . . . . . . . . . . . . . . . 8-9
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Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-9
Addresses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-9
Appendix D: Supplies
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Appendix F: Symbols
Appendix G: Glossary
Index
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1 System Overview and Intended Use
Intended Use
The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare
professionals in the quantitative testing of human whole blood. The systems can
determine the following parameters:
System Parameters
1240 pH, pCO2, pO2
1245 pH, pCO2, pO2, tHb, FO2Hb, FCOHb, FMetHb, FHHb
1260 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate
1265 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb,
FCOHb, FMetHb, FHHb
Features
The Rapidlab 1200 systems have the following features:
• Compact design
• Self-contained reagent and wash cartridges that you can replace easily
• Automatic calibrations of the sensors
• Automatic sample aspiration that eliminates variability in sampling technique
• Automatic sampling for QC at customized intervals using the optional
AutomaticQC® cartridge
• High resolution touchscreen that tilts for viewing information and making
selections quickly and easily
• Built-in removable storage media to copy patient, QC, and calibration data for
storage, or for export to spreadsheet or database programs
• Communication ports for connecting to external data management systems,
such as the Rapidlink® or Rapidcomm® Data Management systems, or an LIS
(laboratory information system)
• Self-contained CO-oximetry sample chamber (Rapidlab 1245 and 1265
systems) that is easy to replace
• Optional external printer availability
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Hardware Overview
The Rapidlab 1200 system consists of 6 modules.
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1 Printer
2 Touchscreen
The thermal roll printer prints reports for samples, calibrations, and diagnostics.
You can also install an external printer. Refer to Setting up Printer and Devices
Options‚ page 8-22.
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AutomaticQC Module
The optional AutomaticQC module allows the system to automatically analyze QC
materials. The system performs analysis of the AutomaticQC levels at pre-programmed
intervals. For information about programming the intervals, refer to Setting up
AutomaticQC Schedule‚ page 8-5.
1 AutomaticQC cartridge
AutomaticQC Cartridge
The AutomaticQC cartridge has bags containing 3 levels of quality control material used
for verification of performance at several points in the clinical range of the Rapidlab 1200.
Level Volume Contents
1 75 mL Buffered bicarbonate solution with Na+, K+, Ca++, Cl-, carbon
dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and
preservative.
2 115 mL Buffered bicarbonate solution with Na+, K+, Ca++, Cl-, carbon
dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and
preservative.
3 155 mL Buffered bicarbonate solution with Na+, K+, Ca++, Cl-, carbon
dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and
preservative.
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The bracket on the AutomaticQC cartridge connects to the support bracket on the
side of the system. When the cartridge lever closes, it punctures the bags of QC
material. The connection to the reagent cartridge allows QC material to flow from
the AutomaticQC cartridge to the reagent cartridge.
Refer to Figure 1-5 for the system interface connections.
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The latch assembly has 4 connections that secure the cartridge to the system. The
connector connects the AutomaticQC manifold and AutomaticQC cartridge. The support
bracket connects to the bracket on the cartridge.
1 Latch assembly
2 Support bracket
3 Connector
The AutomaticQC manifold creates the fluid path for AutomaticQC materials to flow to
the sample entry components in the reagent cartridge.
1 AutomaticQC manifold
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Waste Module
After sample analysis is complete, the waste module collects reagents, samples,
and waste. The waste module consists of the following components:
• waste bottle
• waste bottle housing
• waste bottle latch
• waste detector
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Waste moves from the measurement module through the pressure detector bubbler, and
into the reagent manifold. Waste moves through the reagent manifold and into the waste
bottle.
The waste bottle housing protects the waste bottle. The waste detector detects the presence
of the waste bottle and also detects when the bottle is approaching its capacity. The system
alerts you when the waste bottle is between 70 and 100% full. To reduce exposure to
biohazards when you remove the waste bottle, the system prevents fluidic operations from
starting.
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Reagent Module
The reagent module holds the reagents and creates the fluid path for samples,
calibrators, and wash fluid.
The reagent module consists of the following components:
• reagent cartridge
• cartridge interface frame
• reagent manifold
• reagent door
Reagent Cartridge
The reagent cartridge contains the following 2 calibrators, each in foil bags:
Calibrator Volume Ingredients
Slope 160 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali
halides), organic buffers, catalyst, and surfactant
200 460 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali
halides), organic buffers, glucose, lactate, surfactant, and
preservative
You use these calibrators, as well as the RCx and wash in the wash cartridge, to
calibrate the system. The electrolytes, pH, glucose, lactate, and gases in the
reagents are NIST traceable.
The following table lists the targeted calibration points for each analyte in the
reagents:
Analyte Cal Point Slope Point
pH 6.8 7.4
pCO2 35 mmHg 70 mmHg
pO2 154 mmHg 0 mmHg*
Na+ 116 mmol/L 159 mmol/L
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You introduce samples into the system at the sample port, part of the reagent cartridge.
During sample aspiration, the sample port can hold syringes, capillary tubes, or aspiration
adapters.
1 Sample port
The sample port attaches to the sliding valve. The sliding valve changes positions
dependent on the function:
• Aspirate patient samples and QC samples
• Select and aspirate reagents and AutomaticQC (AQC) material
1 Sliding valve
2 Sample and wash pump tubing
The pumps compress the tubing on the cartridge to generate flow. Adjacent rollers on the
roller cage pinch a segment of the tubing in 2 places. The peristaltic action of the moving
rollers pulls the fluid through the tubing.
The cartridge interface frame attaches the reagent and wash cartridges to the system.
When you load the reagent cartridge into the system and close the door, the frame moves
forward and the pierce pins puncture the bags of calibrators in the cartridge to create a
fluid path.
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The cartridge interface frame also engages the fluid connectors on the cartridge
with the connectors on the reagent manifold to create the fluid path for calibrators,
samples, and waste. The pierce probes engage the pierce pins on the interface
plate and the fittings on the bags of calibrators.
1 Pierce probes
2 Fluid connector for AutomaticQC materials
3 Fluid connectors to the reagent manifold
The fluid connectors on the reagent manifold engage with the fluid connectors on
the reagent and wash cartridges to create the fluid path for reagents, samples, and
waste.
Figure 1-12 Reagent Manifold for the Rapidlab 1245 and 1265
Systems–front view
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The reagent manifold contains the tubing for samples, waste, AQC material, wash, and
calibrators.
Figure 1-13 Reagent Manifold for the Rapidlab 1245 and 1265 Systems–back
view
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Wash Module
The wash module has the following components:
• wash cartridge
• wash door
Wash Cartridge
You load the wash cartridge in the wash door.
1 Wash cartridge
2 Wash door
The wash cartridge contains RCx (a calibrator) and wash reagent (a calibrator and
wash fluid) as described in the following table.
Reagent Volume Ingredients
RCx 60 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali halides),
organic buffers, surfactant, dye, and preservative
Wash 550 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali halides),
surfactant, and preservative
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When you load the wash cartridge into the system, the cartridge interface frame moves
forward and the pierce pins puncture the bags of calibrator and wash fluid. The cartridge
interface engages the fluid connectors on the cartridge with the connector on the reagent
manifold.
1 Fluid connectors
The fluid connectors on the reagent manifold engage with the wash cartridge to create the
fluid path for RCx and wash fluid from the wash cartridge to the sample path.
Figure 1-16 Reagent Manifold for Rapidlab 1240 and 1260–front view
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Measurement Module
The system analyzes the sample in the measurement module.
1 Measurement module
The sample moves through and is analyzed in the sensors, which form the sample
path.
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The sample enters the measurement module at the sample connector and moves through
the preheater, fluid detector 1, and into the sensors for measurement.
1 Preheater
2 Fluid detector 1
3 Sample connector
4 Sensors
The preheater warms the sample to 37°C and the measurement block ensures a constant
temperature of 37°C. The sample connector provides the fluidic path for the sample from
the sample entry components in the reagent cartridge to the measurement module.
The sensors detect analytes present in the sample and form the sample path. The system
moves the sample through the sensors and the fluid detector 2, into the pinch valve tubing,
and through the pressure detector bubbler.
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The contact assembly provides electrical contact between the sensors and the
system. The pressure detector bubbler detects clots in the measurement module.
1 Fluid detector 2
2 Pinch valve tubing
3 Pressure detector bubbler
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The electrolyte sensors, Na+, K+, Ca++, Cl-, pH sensor, and pCO2 sensor work with a
reference sensor and use potentiometry. For more information about potentiometry, refer
to Potentiometry‚ page 1-27.
The biosensors (glucose, lactate) and the pO2 sensor use amperometry. For more
information about amperometry, refer to Amperometry‚ page 1-33.
CO-ox Module
This section applies to the Rapidlab 1245 and 1265 systems.
The Rapidlab 1200 system CO-oximeter measures the concentration of total hemoglobin
and hemoglobin fractions. The CO-ox module contains the following components:
• sample chamber
• sample chamber interface
• polychromator
• pump
1 CO-ox pump
2 CO-ox sample chamber
The system measures as the sample flows through the sample chamber. The optics head
directs light through the sample in the sample chamber. The system collects the light at the
other side of the optics head and then the polychromator measures it.
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The polychromator measures the intensities of light passed through the sample at
a number of different wavelengths and converts the electrical signal to a digital
value for further processing.
The sample chamber has a sliding cell design that opens and closes to allow for
measurement.
The CO-ox sample chamber is stable for up to 60 days after installation on the
system. CO-ox sample chamber use life is independent of the number of samples
analyzed on the system. The system prompts you when you need to replace the
sample chamber.
Software Overview
Rapidlab® User Interface
Screens consist of the banner area and a display area.
• The banner is at the top of all screens and remains visible when you move
from screen to screen.
The banner contains information about system status and has buttons for
accessing the main system screens.
• The display area contains options and information for the task you are
performing.
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The banner displays status messages as reminders for pending tasks. The system always
displays a message for a pending Required QC regardless of other pending tasks.
The system displays a message when maintenance tasks are due and how many are due.
When you perform a maintenance task, the number of tasks on the banner decrements but
the message remains as long as tasks are pending.
Status Symbols
When a cartridge, the CO-ox sample chamber, or the waste bottle approaches its
expiration date or number of tests available, the system displays the appropriate symbol in
the banner:
Supply Symbol % Volume Number of hours
Wash cartridge 10% Less than 24
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The system tracks the number of hours from the install-by-date or expiration date,
which ever date is shorter.
The Analysis symbol accesses the Analysis screen where you analyze samples.
The Recall button accesses stored results. The Status button displays cartridge
status and access to maintenance and diagnostics functions. The Help button
provides information about troubleshooting and maintaining the Rapidlab 1200
system.
Return button.
Displays the previous screen. The system does not save your
selections and entries when you select the Return button.
Video button.
Displays a video demonstration of the steps for a procedure.
Analysis Screen
The Analysis screen is the main screen for the Rapidlab 1200 systems.
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The group of buttons on the left side of the display area define the type of sample to be
analyzed, patient or QC.
The group of buttons in the center of the display area define the parameters to be
measured. Available parameters are determined by the sample device, sample mode
selected, and system configuration.
Before analyzing a sample, you need to select a sample type, sample mode, and
parameters. The Rapidlab 1200 systems provide 4 patient sample type options and 4
analysis mode options. The parameters available depend on the type of system and Setup
options you selected.
When analysis is requested, you must also enter patient information. Refer to Entering
Patient Sample Data‚ page 2-22.
The top 4 buttons on the left of the screen represent the patient sample types: arterial
syringe, capillary, venous, and mixed venous.
The system displays available parameters in the center of the screen. Each parameter can
be in a different state, indicated by its appearance, depending on operator selections,
definitions in Setup, and current parameter condition.
Parameter Description
Parameter is available but does not display as a button and
cannot be selected. Refer to Enabling Parameter Selection at
Analysis‚ page 8-11.
Parameter is not selected and results will not be reported for this
parameter. Refer to Enabling Parameter Selection at Analysis‚
page 8-11.
Parameter is selected for analysis. Refer to Enabling Parameter
Selection at Analysis‚ page 8-11.
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Parameter Description
Parameter is not available for analysis because Required QC was
not performed when scheduled (the button is purple). Refer to
Troubleshooting the Yellow Parameter Error‚ page 6-1.
Custom Panels
If you define custom panels for your system, the system displays the custom
panels in the lower-left corner of the Analysis screen. Each of the panel buttons
displays the parameters that are in that panel. The number buttons, 1 and 2,
represent the 2 sets of panels currently available on the system.
The system displays the buttons only when panels are defined. Refer to Defining
Custom Panels‚ page 8-11.
To simplify patient analysis tasks, the Rapidlab 1200 systems have 4 modes of
operation:
Mode Description
Microsample Use the Microsample mode when you have insufficient sample
for patient analysis in the default sampling mode.
pH Use the pH mode when you analyze samples for a pH result only.
tHb Use the tHb mode when you analyze samples for tHb,
hemoglobin fractions, and oxygenation parameters only (for
Rapidlab 1245 and 1265 systems).
pH, Glu, Lac Use the pH, Glu, Lac mode to test for pH, Glucose, and Lactate
only.
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Recall Screen
Select the Recall button to access stored results. For information about the Recall button
menu options, refer to the following topics:
Button... Refer to...
Patient Recalling Patient Sample Results‚ page 2-30
QC Recalling QC Results‚ page 4-7, including QC Statistics
and Levey-Jennings Graphs
Calibrations Recalling Calibration Results‚ page 3-4
Events Log Viewing System Messages‚ page 6-74
Copy Stored Results Copying Data Files‚ page 7-2
Sample Totals Viewing the Sample Totals‚ page 7-4
Status Screen
The system automatically displays the Status screen if an event occurs that needs your
attention before routine operation can continue. For example, the system displays the
Status screen with a Not Ready message when an error condition prevents sample analysis
or when you need to replace a cartridge because it is empty or expired.
You can also manually display the Status screen by selecting the Status button on the
banner.
The display area of the Status screen displays the current status of each cartridge:
• the cartridge symbol
• percent volume
• time remaining until the cartridges must be replaced
• buttons to access Status area functions
Buttons on the Status screen display area access several system functions:
Button... Refer to...
Replace Replacing Supplies‚ page 2-2
Maintenance Maintenance‚ page 5-1
Diagnostics Using Diagnostics‚ page 6-33
Calibrate Calibration‚ page 3-1
Setup System Configuration‚ page 8-1
System Info Accessing System Information‚ page 2-5
Shutdown Shutting Down the System‚ page 2-6
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1 Sample connector
2 Sample tubing and reagent manifold.
3 Sample port
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1 Preheater
2 Sample chamber
3 Tubing to the reagent manifold
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The molecular recognition mechanism gives a sensor its identity. Each sensor is
designed to selectively measure the activity of a specific substance. Although
many elements in a sample may interact with a sensor, the sensor is highly
selective for 1 substance over others. The common recognition mechanism used
in many Rapidlab 1200 sensors is a membrane designed to be selective for a
specific substance.
The transducer mechanism converts the potential generated by the molecular
recognition mechanism to an electrical signal. In the Rapidlab 1200 systems, this
is accomplished through potentiometry or amperometry. For information about
Potentiometry, continue reading at the next section. For information about
Amperometry, refer to Amperometry‚ page 1-33.
Potentiometry
Potentiometry is the measurement of the voltage or potential generated between
2 electrodes in an electrochemical cell when no external current is applied and the
cell is in a state of equilibrium. The electrochemical cell consists of 2 electrodes (a
measuring or indicator electrode and a reference electrode), an electrolyte solution
(sample solution), and a measuring device such as a voltmeter. The
electrochemical cell is capable of measuring the concentration or activity of a
substance in a solution.
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Each electrode, which acts as a half-cell with a half-cell potential, contains an inner
reference element immersed in an internal electrolyte solution. The measuring electrode is
designed to respond to changes in the concentration of the specific analyte being measured
in the sample solution. The electrode develops a half-cell potential that is directly related
to the concentration or activity of the specific analyte. The reference electrode provides a
steady, unchanging potential to the cell. Both electrodes are connected to the measuring
device. With the current in the cell at zero, the potential developed by the electrochemical
cell is determined by calculating the difference in potential between the measuring
electrode and the reference electrode.
Ecell = Emeas - (Eref + Elj)
where
Ecell = electrochemical cell potential
The liquid junction potential (Elj), a small but significant voltage, develops at the liquid
junction between the reference electrode, which contains a solution of saturated potassium
chloride, and the sample solution. This potential occurs because of the different rates at
which chemical species diffuse across the boundary between 2 liquids. This difference in
rates results in a charge separation that gives rise to the liquid junction potential. Although
the potential formed is small, it must be considered when measuring cell potential.1
System sensors are designed to measure a specific substance in a sample. For the purpose
of measuring a variety of analytes in solution, sensors must have the ability to measure
specific analytes in solution. This ability is known as the recognition mechanism. For
example, an Ion Selective Electrode (ISE) contains a specifically designed membrane that
provides sensor selectivity. Selectivity is the ability of the sensor to interact with a specific
ion in solution. The membrane separates an inner, reference element, which is immersed
in a fixed electrolyte solution, from the sample.
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1 Voltmeter
2 Potassium chloride solution
3 Inner element of the reference electrode
4 Liquid junction potential develops
5 Ion-selective membrane
6 ISE inner reference element
7 A fixed electrolyte solution
where
Ecell = electrochemical cell potential
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In this equation, the reference electrode potential and the potential of ISE inner reference
element are constant; the liquid junction potential can be controlled. Therefore, the
potential remaining is the potential generated at the membrane. The membrane potential
corresponds to the ion activity and is related directly to the concentration of the ion in
solution. The cell potential is expressed quantitatively by the Nernst equation.1
Ecell = K + (2.3 RT/ZF) log ai
where
Ecell = electrochemical cell potential
This equation states that the cell potential is logarithmically related to the activity of the
analyte in the sample.
The potential that the sensor actually measures is the activity of the analyte in solution. In
clinical chemistry, it is typical that the results be expressed in the concentration of total
substance rather that the activity of the substance. For this reason, the measured results
must be expressed in units of concentration.
The activity equals the numerical value of the concentration of the ion (mol/L) times the
activity coefficient. The activity coefficient is a measure of the degree with which the ion
interacts with other ions in solution. The activity coefficient is dimensionless and depends
on the ionic strength of the solution:
I = 1/2 ∑ m * z2
where
I = ionic strength of the solution
m = concentration of the ion (mol/L)
z = the charge number of the ions in solution
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Using an established convention, the activity of ions that are measured by sensors
can be expressed in terms of concentration. This convention contains the
assumption that the normal ionic strength of blood plasma water is 160 mmol/kg.3
Because ionic strength is the primary variable affecting the activity coefficient of
ionic species in solution, controlling the ionic strength of calibrating solutions to
160 mmol/kg sets the activity coefficients of ionic species in the calibrating
solutions equal to those of blood plasma water at sample ionic strengths close to
normal. Both calibrations and the expression of measured quantities may then be
made in units of concentration instead of activity.4
Reference Sensor
The reference sensor for the 1200 systems works with certain measuring sensors
in the measurement module to create an electrochemical cell. The reference
sensor provides a fixed potential, which is independent of analyte activity. The
system compares the fixed potential of the reference sensor to the measured
potential from the following sensors:
Sensor System
pH 1240, 1245, 1260, 1265
Na+ 1260, 1265
K+ 1260, 1265
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The reference sensor contains a silver (Ag) wire, coated with a layer of silver chloride
(AgCl) and an ion permeable polymer, surrounded by a saturated potassium chloride
(KCl) solution. By ensuring that the concentration of Cl- remains unchanged in the
solution, the reference sensor maintains a constant electrical potential. A potassium
chloride (KCl) block is in the reference sensor solution chamber to ensure a saturation
solution of KCl at 37°C.
1 Solution chamber
2 Saturated potassium chloride solution
3 Silver/silver chloride electrode
4 Sample path
A permeable cellulose membrane separates the KCl solution from the sample and provides
the ionic conduction between the KCl solution and the sample. The membrane completes
the conductive path to the sample from the fixed half-cell potential that is required for the
measurement.
The Ag wire conducts the half-cell potential of the reference sensor to the measurement
device where it is compared to the potential of the measuring sensor. The potential
difference measured reflects the concentration of analyte in the sample. Although the
reference sensor provides a constant potential from sample to sample, the potential
difference measured between sensors varies with each sample.
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Amperometry
Amperometry is an electrochemical technique used to determine the amount of a
specific substance in solution by applying a fixed voltage between 2 electrodes in
an electrochemical cell, and then measuring the current generated as a result of a
reaction which produces or consumes electrons (oxidation or reduction,
respectively).
The electrochemical cell contains 2 electrodes: the anode, which is positively
charged and the cathode, which is negatively charged. The measuring electrode,
which is frequently composed of platinum (Pt) or another noble metal, can be
either the anode or the cathode. Each electrode is attached to an external voltage
source.
As the sample comes in contact with the 2 electrodes, a known voltage is applied
between the anode and the cathode. The analyte to be measured is either an
oxidizable or reducible species. If the analyte is an oxidizable species, it will
diffuse to the anode where it is oxidized. If the analyte is a reducible species, it
will diffuse to the cathode, where it is reduced. In either case, the electrochemical
reaction produces a current flow between the anode and cathode that can be
measured by a device, such as a milli/micro ammeter. The current measured is
directly proportional to the concentration of substance (oxidizable or reducible)
present in the sample solution.
pH = − log10 cH +
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Using this formula, a hydrogen ion concentration of 1 x 10-7 mol/L has a pH value of 7.
Because pH is the negative logarithm, its value is inversely proportional to the actual
hydrogen ion concentration in a sample. Therefore, as the hydrogen ion concentration
decreases, the pH value increases. As the hydrogen ion concentration increases, the pH
value decreases.
The normal pH range of human blood is 7.35–7.45.
The Henderson-Hasselbalch equation describes how pH expresses the interaction of acid
and base in blood:
base
pH = pK + log
acid
where K is the dissociation constant, which describes the ability to release hydrogen ions.
Because K, and thus pK, is a constant, this equation can be used to demonstrate that pH is
proportional to the acid-base concentrations in blood:
base
pHα
acid
Therefore, if base increases without a corresponding increase in acid, the pH rises, and if
acid increases without a corresponding increase in base, the pH decreases.
pH is clinically significant as a means of determining acid-base disturbances. Acid-base
disorders can result in several pathologic conditions. Acidosis (low pH) stems from either
respiratory failure (high pCO2) or from metabolic causes (including ketoacidosis, lactic
acidosis, uremia, severe diarrhea, hypoaldosteronism, renal tubular disease, drug effects,
or poisoning from several specific agents). Alkalosis (high pH) stems from
hyperventilation (low pCO2) or from metabolic causes (including excessive vomiting,
gastric drainage, drug effects, hyperadrenocorticism, potassium depletion, or excessive
alkali intake). Extreme abnormalities of pH reflect a potentially life-threatening
pathophysiologic state that must be corrected promptly.6,7
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pH Sensor
1 Buffer solution
2 Silver/silver chloride electrode
3 Sample path
As the sample comes in contact with the membrane of the pH sensor, a membrane
potential develops due to the exchange of hydrogen ions in the membrane. The
silver/silver chloride inner conductor transmits the potential to a voltmeter where
it is compared to the constant potential of the reference sensor. The final measured
potential reflects the hydrogen ion concentration of the sample and is used to
report the pH value of the sample.
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The levels of HCO3–, H2CO3, and dissolved CO2 play a major role in maintaining the pH
in blood. This relationship is best described through the Henderson-Hasselbalch equation:
base
pH = pK + log
acid
Substituting HCO3– as the base and dissolved CO2 and H2CO3 as the acid, the equation
reads as follows:
HCO 3−
pH = pK + log
CO 2 + H 2 CO 3
Taking the equation further, pH is seen as being proportional to the acid-base relationship:
HCO 3−
pHα
H 2 CO3
Although other acids and bases are present in the blood, the H2CO3/HCO3– relationship is
sensitive and dynamic and typically reflects other acid-base changes.
When the measurement of the partial pressure of carbon dioxide (pCO2) in the blood is
combined with the measured pH, the values can be incorporated into the
Henderson-Hasselbalch equation to determine HCO3– and ctCO2. Because the pCO2
value is proportional to the content of dissolved CO2/HCO3– , the value for pCO2 can be
used along with pH not only to calculate HCO3– but also to aid in the differentiation of
acid-base abnormalities.
This analyte reflects the overall respiratory status. Thus high pCO2 indicates respiratory
suppression or failure, whereas low pCO2 indicates hyperventilation (which in turn may
stem from hypoxia, anxiety, fever, cerebral disease, cirrhosis, or excessive mechanical
ventilation). Extreme abnormalities of pCO2 reflect a potentially life-threatening
pathophysiologic state that must be corrected promptly.6,7
Together, pH and pCO2 provide a more definitive diagnostic tool in assessing respiratory
function. An increase in the pCO2 value and a decrease in pH indicates respiratory
acidosis, a condition in which CO2 is retained by the lungs. A decrease in the pCO2 value
and an increase in pH indicates respiratory alkalosis, a condition in which the lungs are
expiring too much CO2 relative to the amount produced.
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pCO2 Sensor
The pCO2 sensor is based upon the electrode described by Severinghaus and
Bradley.8 The pCO2 sensor is a complete electrochemical cell that consists of a
measuring electrode and an internal reference electrode. The measuring electrode,
which is a pH electrode, is surrounded by a chloride bicarbonate solution. A
membrane permeable to gaseous CO2 separates this solution from the sample. The
internal reference electrode, which contains a silver/silver chloride electrode
surrounded by the chloride-bicarbonate solution, provides a fixed potential.
As the sample comes in contact with the membrane, CO2 diffuses into the
chloride-bicarbonate solution, which causes a change in the hydrogen ion activity:
CO2 + H 2 O ↔ HCO3− + H +
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Because it is not possible to measure intra-cellular oxygen tension (pO2), arterial pO2 has
become a standard for clinical evaluation of arterial oxygenation status. Measurement of
pO2(A), which indicates the oxygen tension in arterial blood, reflects the pressure or
driving force for moving oxygen from 1 location to the next due to pressure differential; it
is not a measurement of the O2 content, but it provides a measurement tool to evaluate the
pulmonary gas exchange efficiency from an arterial blood sample.
Complete laboratory evaluation of oxygenation often requires much more than simple
blood gas measurements. Assessment of ventilatory system and acid-base status is
essential to properly interpret clinical significance of arterial oxygenation status. However,
many patients can be evaluated and treated successfully using blood gases alone if clinical
observations and patient history are taken into account.9
This analyte reflects the ability of the lungs to deliver oxygen to the blood. Hypoxia (low
pO2) may occur despite adequate respiration due to parenchymal lung diseases
(pneumonia, asthma, pulmonary edema, and pulmonary fibrosis) due to pulmonary
shunting of blood. Extremely low pO2 is a potentially life-threatening pathophysiologic
state that must be corrected promptly.6,7
The measurement of pO2 is significant in evaluating the degree of hypoxemia (a
deficiency of O2 in arterial blood) present in a patient. The laboratory reference value for
pO2 is usually 95 mmHg (12.7 kPa) for a healthy young adult living near sea level.
However, as with pCO2 and pH, a wider range of values may occur before any therapeutic
action is indicated. Generally a pO2 of 80 mmHg (10.7 kPa) signals therapeutically
significant hypoxemia. Above this value is very little change in oxygen saturation or
oxygen content with changes in oxygen tension, but below this value changes in saturation
can occur rapidly. Exceptions to this limit are newborns, who have an acceptable range of
40 to 70 mmHg (5.3 to 9.3 kPa) and adults over 50 years old, who have a normal
deterioration of lung function that causes a decrease in expected pO2 values of about
1 mmHg (0.13 kPa) per year.10
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pO2 Sensor
The pO2 sensor is based upon the electrode described by Clark.11 It is a complete
electrochemical cell that incorporates amperometric technology. The sensor
consists of a platinum (Pt) cathode, and silver (Ag) anode, an electrolyte solution,
and a gas-permeable membrane.
1 Cathode contact
2 Anode contact
3 Sample path
O2 + 2 H 2O + 4e − → 4OH −
4 Ag → Ag + + 4e −
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Electrolytes
The Rapidlab 1260 and 1265 systems analyze blood samples for Na+, K+, Cl-, and Ca++ in
addition to pH and the blood gases. These systems also report the anion gap and a value
for calcium adjusted to pH of 7.40.
The sensors used for electrolytes are based on ion-selective electrode (ISE) technology.
Each sensor has a membrane that is highly selective for a specific ion.
1 Electrical contact
2 Electrolyte solution
3 Silver/silver chloride electrode
The recognition mechanism in the ISE is the membrane. Each sensor has a membrane
selective for the specific substance that it measures.
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Concentration of Sodium
Sodium (Na+) is the most abundant cation in the extracellular space in the body. Na+ is the
major determinant of extracellular osmotic regulation and plays a central role in
determining body fluid volume. The kidneys are the primary regulator of sodium and
consequently water volume; only minimal amounts of sodium are lost through the skin
and other insensible sites. Two regulatory hormones, aldosterone and the antidiuretic
hormone (ADH), affect kidney function and hence sodium balance. Aldosterone
stimulates the kidneys to reabsorb sodium; ADH stimulates the kidneys to reabsorb water.
Maintaining sodium homeostasis is essential in order to regulate body fluids, maintain
electrical potential in muscle cells, and control cellular membrane permeability.
Abnormal concentrations of Na+ stem from deficit or overload of total body water or of
sodium itself. These abnormal concentrations arise from diverse clinical conditions, such
as congestive heart failure, liver disease (cirrhosis), renal disease, neuropsychiatric
disorders (causing abnormal fluid intake), intravenous fluid therapy, excessive fluid loss
(vomiting, diarrhea, heat stroke), drug therapy (diuretics), diabetes mellitus (causing
osmotic diuresis), and imbalances of hormones (ADH, mineralcorticoid, glucocorticoid)
that regulate sodium and water excretion. An extremely abnormal plasma sodium
concentration may itself directly cause altered mental status, stupor, coma, seizures, brain
swelling, brain dehydration leading to cerebral hemorrhage or, ultimately, death. Thus
extreme abnormalities of sodium reflect a potentially life-threatening pathophysiologic
state that must be corrected promptly.6,12
Sodium Sensor
The sodium sensor is a half-cell that combines with the external reference sensor to form a
complete electrochemical cell. The sensor contains a silver/silver chloride wire
surrounded by an electrolyte solution that has a fixed concentration of sodium and
chloride ions. The membrane, a specially formulated glass capillary that is highly selective
for sodium ions over other clinically encountered cations, separates the electrolyte
solution from the sample.
As the sample comes in contact with the membrane of the sensor, a potential develops due
to the exchange of sodium ions in the membrane. The potential developing across the
membrane is compared to the constant potential of the external reference sensor. The final
measured potential is proportional to the sodium ion concentration in the sample. The
potential developed by the electrochemical cell varies with the ion activity in each sample.
Concentration of Potassium
Potassium (K+) is the major intracellular cation. K+ plays an important role in maintaining
cell membrane potential in neuromuscular tissue. The normal level within cells is
150 mmol/L, while the normal extracellular potassium level is only 4 mmol/L. A depletion
of extracellular potassium causes an increase in the transmembrane electrical potential
gradient, which impedes the impulse formation and propagation involved in muscle
contraction.
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Potassium Sensor
The potassium sensor is a half-cell that combines with the external reference
sensor to form a complete electrochemical cell. The sensor contains a silver/silver
chloride wire surrounded by an electrolyte solution that has a fixed concentration
of potassium ions. The membrane, which consists of the ionophore valinomycin
immobilized in a plasticized PVC (polyvinyl chloride) matrix, separates the
electrolyte solution from the sample. Valinomycin is a neutral ion carrier that is
highly selective for potassium ions over other clinically encountered cations.
As the sample comes in contact with the membrane of the potassium sensor, a
membrane potential is created by the interaction of potassium ions with the
membrane. The potential developing in the potassium sensor is compared to the
constant potential of the external reference sensor. The final measured potential is
directly proportional to the potassium ion concentration in the sample. The
potential developed by the electrochemical cell varies with the ion activity in each
sample.
Concentration of Chloride
Chloride (Cl-) is the major extracellular anion in the body. Cl- plays a large role in
maintaining electrical neutrality and normal osmolality, and it participates in the
regulation of acid-base balance. The kidneys are the main regulator of chloride in
the body. Serum levels of chloride usually correspond to increases and decreases
of sodium. Clinically, the serum chloride level alone is rather meaningless. A
change in chloride level does not reveal much about a patient’s condition; it must
be viewed as part of the overall fluid and electrolyte status.
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Chloride Sensor
The chloride sensor is a half-cell that combines with the external reference sensor to form
a complete electrochemical cell capable of measuring chloride concentration in a sample.
The sensor contains a silver/silver chloride wire surrounded by an electrolyte solution that
has a fixed concentration of chloride ions. The membrane is a derivitized quaternary
ammonium compound that is immobilized in a polymer matrix. It acts as an ion exchanger
with a high selectivity for chloride ions over other ions present in the sample, and
separates the electrolyte solution from the sample.
As the sample comes in contact with the membrane of the chloride sensor, chloride ion
exchange occurs at the membrane and creates a membrane potential. The potential that
develops in the chloride sensor is compared to the constant potential of the external
reference sensor. The final measured potential is directly proportional to the chloride ion
concentration in the sample. The potential developed by the electrochemical cell varies
with the ion activity in the sample.
Ionized calcium (Ca++) is the physiologically active form of calcium, which comprises
approximately 45% of the total calcium in plasma. Ca++ is essential for the contractility of
smooth vascular muscle and plays a vital part in cardiovascular function. Ca++ is also
important in muscle function, nerve function, and bone formation, and it is a cofactor in
many cellular hormone and enzyme reactions.
The action of the parathyroid hormone (PTH) — 1,25 dihydroxyvitamin D (1,25D) — and
calcitonin closely controls the concentration of calcium in extracellular fluid, and
regulates the transport of calcium across the gastrointestinal tract, kidney, and bone.
Calcium is one of the most tightly controlled analytes in the body with fluctuations of less
than 5% occurring about the mean during a 24-hour period.14
Ca++ abnormalities typically stem from parathyroid disease, vitamin D imbalance, renal
disease, pancreatitis, drug effects, abnormalities of magnesium or phosphorus,
malignancy, or sarcoidosis. An extreme abnormality of Ca++ may cause neuromuscular
symptoms, tetany, altered mental status, seizures, heart failure, or arrhythmias. Thus
extreme abnormalities of ionized calcium reflect a potentially life-threatening
pathophysiologic state that must be corrected promptly.6,15
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Calcium Sensor
The calcium sensor is a half-cell that combines with the external reference sensor
to form a complete electrochemical cell capable of measuring calcium levels in a
blood sample. The sensor contains a silver and silver chloride wire surrounded by
an electrolyte solution that has a fixed concentration of calcium ions. A
membrane, consisting of an ionophore imbedded in a polyvinyl chloride
membrane, separates the electrolyte solution from the sample. The ionophore is a
compound that is highly selective for calcium ions over other ions.
When the sample comes in contact with the membrane of the measuring sensor, a
membrane potential develops as calcium ions interact with the membrane. This
membrane potential is compared to the constant potential of the external reference
sensor. The final measured potential is proportional to the calcium ion
concentration in the sample. The potential developed by the electrochemical cell
varies with the ion activity in each sample.
Metabolites
The Rapidlab 1260 and 1265 systems analyze blood samples for glucose and
lactate in addition to pH, blood gases, and electrolytes.
Concentration of Glucose
Glucose is the fundamental molecule in carbohydrate metabolism. Carbohydrates,
which provide a major food supply and energy source for the body, are broken
down into simple sugars such as glucose. Glucose is then absorbed through the
intestine, passes through the liver, and eventually enters the vascular system
where it reaches the cell level to be used as fuel.
A number of factors influence the level of blood glucose. Dietary intake has a
direct effect on glucose concentration. Blood levels of glucose will fluctuate
depending on nutritional condition and the time of day when a sample is taken.
Insulin, a hormone produced by specialized cells in the pancreas, plays an
important role in regulating the blood level of glucose. By promoting
glycogenesis (conversion of glucose to glycogen) and by increasing the
permeability of cells to glucose, insulin can decrease blood glucose levels.
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Determining the blood glucose level is helpful in diagnosing many metabolic diseases.
Glucose is elevated in any of the forms of diabetes mellitus, including Type 1, Type 2,
Gestational, or any of the 50 other specific types. More moderate elevations occur in
pre-diabetic conditions known as impaired glucose levels. Diabetics sometimes suffer
acute, life-threatening metabolic crises, such as diabetic ketoacidosis that is typical in
Type 1 or hyperglycemic hyperosmolar nonketotic state that is typical in Type 2. Low
glucose levels most commonly stem from insulin overdose, but also from a number of
disorders collectively known as hypoglycemic disorders. Examples of the latter include
insulinoma, IGF2-secreting tumor, factitious hypoglycemia, postprandial syndrome,
severe hepatic disorders, endocrine disorders characterized by deficiencies in
gluconeogenic hormones, and some post-surgical gastric states. Extreme abnormalities of
glucose reflect a potentially life-threatening pathophysiologic state that must be corrected
promptly.6,17,18
Concentration of Lactate
Lactate acid is an intermediary product of the anaerobic metabolism of glucose.
Glycolysis is the term commonly used to describe the conversion of glucose to lactic acid.
Under normal circumstances, glycolysis occurs during muscle contraction where the rate
of metabolism outpaces the oxygen supply in the cells. During strenuous exercise, the
level of lactic acid increases significantly and passes to the blood where it is transported to
and metabolized by the liver. In normal aerobic conditions, the lactic acid is readily
oxidized in the cell to pyruvic acid, which is eventually degraded to CO2 and H2O.
The concentration of lactate in the blood is affected by the rate of production, the rate of
metabolism, and the availability of oxygen at the cell level.
Determining the blood lactate level is helpful in assessing the supply of oxygen at the
tissue level. Increased oxygen deprivation causes the normal oxidation of pyruvic acid to
lactate and can cause severe acidosis called lactic acidosis. This condition is characterized
by increased lactate levels and an increased lactate:pyruvic ratio in the blood due to the
lack of cellular oxidative process. Elevations of lactate are a sign of inadequate delivery of
oxygen to the peripheral tissues as occurs in respiratory failure, circulatory failure, and
clinical shock.7
1 Platinized activated carbon electrode technology license from Cambridge Life Sciences plc. under U.S. Patent Nos 4,970,145
and 5,160,418 and foreign counterparts.
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The measuring electrode contains platinum and glucose oxidase or lactate oxidase
in a binder, while the reference electrode is composed of Ag/AgCl. Two other
electrodes are also present. The counter electrode is a Pt (platinum) conductor that
ensures a constant applied potential. Another measuring electrode, without the
enzyme, determines interfering substances in the sample. The potential from
interfering substances is removed from the total differential measurement. A
microporous cover membrane separates the electrodes from the sample.
GOX
C6 H12O6 + H 2O + O2 → C6 H12O7 + H 2O2
( glucose) ( gluconic acid )
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H 2O2 → 2 H + + O2 + 2e −
The loss of electrons in the oxidation of H2O2 creates a current flow that is directly
proportional to the glucose concentration in the sample.
In the lactate sensor, lactic acid from the sample interacts with the lactate oxidase on the
surface of the measuring electrode to form pyruvic acid and hydrogen peroxide:
LOD
C3 H 6O3 + H 2O + O2 → C3 H 4O3 + H 2O2
( lactic acid ) ( pyruvic acid )
H 2O2 → 2 H + + O2 + 2e −
The loss of electrons in the oxidation of H2O2 creates a current flow that is directly
proportional to the lactate concentration in the sample.
The presence of dyshemoglobins (hemoglobins not available for reversible binding with
oxygen), such as carboxyhemoglobin, methemoglobin, and sulfhemoglobin, may also
affect the normal oxygen transport mechanism.21
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Total Hemoglobin
Total hemoglobin (tHb) is the total of all measured hemoglobin fractions.21 Total
hemoglobin determination is important in the assessment of oxygen transport and
in the evaluation of anemia. The total hemoglobin reference range for a normal
adult population is 12.0 to 18.0 g/dL.
Total hemoglobin in the CO-ox module is determined using the following
equation:
tHb = FO2Hb + FHHb + FMetHb + FCOHb
In anemia, hemoglobin is low. Numerous specific types of anemia exist but each
stems from 1 of 3 basic causes: Blood loss, destruction of red blood cells, or
failure to produce new red blood cells. In polycythemia, hemoglobin is high.
Polycythemia may be primary, secondary to hypoxia, secondary to dehydration, or
a complication of over-transfusion. Polycythemia may lead to circulatory
complications as a result of increased blood viscosity. Extreme abnormalities of
hemoglobin reflect a potentially life-threatening pathophysiologic state that must
be corrected promptly.6,24,25
Oxyhemoglobin
Oxyhemoglobin (O2Hb) is the fraction of hemoglobin that is actually delivering
oxygen to body tissues.26 Oxyhemoglobin is reversibly bound to oxygen.21 The
oxyhemoglobin reference range for arterial blood for a normal population is 94.0
to 97.0%.
The percent of oxyhemoglobin is determined using the following equation:
FO2Hb = cO2Hb / ctHb x 100
Deoxyhemoglobin
Deoxyhemoglobin (HHb) refers to the hemoglobin capable of binding oxygen.
Deoxyhemoglobin is sometimes referred to as reduced hemoglobin.21 The
deoxyhemoglobin reference range for arterial blood for a normal population is 0.0
to 5.0%.
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Methemoglobin
This is a fraction of hemoglobin that cannot deliver oxygen to body tissues and is elevated
in certain metabolic diseases.26 Methemoglobin (MetHb), which is sometimes known as
hemoglobin Hi, is hemoglobin whose iron is oxidized to its ferric state [FE(III)] and is
unable to bind oxygen. High methemoglobin concentrations, a condition called
methemoglobinemia, can produce hypoxia and cyanosis. Methemoglobinemia can be the
result of hereditary conditions or of exposure to toxic substances such as nitrates, nitrites,
aniline dyes and their derivatives, and topical anesthetics such as benzocaine.19,27 Infants
and other individuals with significant fetal hemoglobin concentrations show increased
susceptibility to methemoglobinemia because fetal hemoglobin converts to
methemoglobin more readily than adult hemoglobin.21 The methemoglobin reference
range for arterial or venous blood for a normal population is 0.0 to 1.5%.
The percent of methemoglobin is determined using the following equation:
FMetHb = cMetHb / ctHb x 100
Carboxyhemoglobin
Carboxyhemoglobin (COHb) is hemoglobin covalently bound to carbon monoxide.
Hemoglobin has over 200 times greater affinity for carbon monoxide than for oxygen.
Hemoglobin bound to carbon monoxide is unavailable for oxygen transport, and high
levels of carboxyhemoglobin result in hypoxia and cyanosis, which can be fatal.
The carboxyhemoglobin reference range for a normal population is 0.0 to 1.5% . While
the amount of carboxyhemoglobin in the blood of healthy nonsmokers is very small
(between 0.1% and 0.4%), smoking, air pollution, and occupational exposure to carbon
monoxide affect COHb levels.19
The percent of carboxyhemoglobin is determined using the following equation:
FCOHb = cOHb / ctHb x 100
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Sulfhemoglobin
Sulfhemoglobin (SulfHb) is a stable compound of hemoglobin and sulfur. This is
a fraction of hemoglobin that cannot deliver oxygen to body tissues and may be
elevated in some patients taking sulfur-containing drugs or with certain
infections.26 Sulfhemoglobin has an extremely low affinity for oxygen and may
often be accompanied by methemoglobinemia. The presence of sulfhemoglobin
affects oxyhemoglobin values and other quantities if its absorbance spectrum is
not accounted for.19 The sulfhemoglobin reference range for a normal population
is 0.0 to 2.2%.
The CO-oximeter (CO-ox) module detects and indicates concentrations of
sulfhemoglobin greater than 1.5%.
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Before reaching the sample chamber, a portion of the light is diverted to a photodiode
feedback sensor located on the main circuit board. The photodiode sensor provides
electrical feedback to the lamp’s control circuit to control the lamp’s output intensity. The
cable that connects the components of the measurement module is a multi-fiber bundle
containing hundreds of fibers designed to deliver light that is uniformly distributed over
the fiber face.
The sample chamber has a sliding cell design that opens and closes to allow for
measurement. The sample chamber also contains a thermistor to control the temperature
of the sample during measurement and a detector mechanism to sense the position of the
chamber cell.
The polychromater separates the sample into its component wavelengths. The
polychromater measures the intensity of light at the different wavelengths and converts the
electrical signal to a digital value for further processing.
The wavelength calibrator consists of a neon lamp, lenses, and a filter. The neon lamp
emits a stable emission spectrum that is used to test the alignment of the polychromater.
The system makes adjustments to maintain alignment of the polychromator.
Parameters
NOTE: The parameters that your system reports depend on the sensors available on the
system and the parameters selected in Setup.
The Rapidlab 1200 systems provide results for the following parameters:
Parameters Results Description
Blood Gases pCO2 partial pressure of carbon dioxide
pO2 partial pressure of oxygen
K+ potassium
Cl- chloride
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O2 oxygen delivery
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The sections that follow briefly describe the clinical significance of each of these
parameters.
Bicarbonate Ion
The majority of CO2 is transported through the body as the bicarbonate ion (HCO3–),
which is the major buffer substance present in the body. Bicarbonate plays a central role in
maintaining the pH level in blood.
Bicarbonate levels are clinically significant in helping to determine the nonrespiratory,
renal (metabolic) component in acid-base blood disorders.
Two versions of bicarbonate exist:
• Actual bicarbonate (HCO3–act), which is determined directly from the pH and pCO2
values, based on the recommendations from the Clinical and Laboratory Standards
Institute (CLSI) as follows:
HCO3–act = 0.0307 × pCO2 × 10(pH(37)–6.105)
1000
where
NOTE: If ctHb is not available as an entered value or a measured value, the system uses
15 g/dL as a default value.
Base Excess
Base excess is an empirical expression that approximates the amount of acid or base
required to titrate 1 liter of blood to a normal pH of 7.40. Base excess is a clinically useful
way of assessing the metabolic portion of the acid-base balance.9
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The equations for base excess are derived from CLSI recommendations.19
Hematocrit
Hematocrit (Hct) is the ratio of the volume of packed red blood cells to the
volume of human whole blood. Hematocrit, with other parameters such as total
hemoglobin, is useful in the evaluation of anemia.
The estimated hematocrit value is determined using the following equation:
Hct = ctHb × 2.941
where 2.941 is a factor calculated by dividing 100 g/dL by a normal MCHC
(mean corpuscular hemoglobin concentration) of 34%.
Estimated hematocrits should not be used as the sole consideration in the
diagnosis of hematological disorders.
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Δ log pCO2
pCO2 correction = = 0.019
ΔT
Oxygen Content
Oxygen content is the concentration of the total oxygen carried by the blood, including
oxygen bound to hemoglobin as well as oxygen dissolved in plasma and in the fluid within
red cells.
Clinically, dissolved oxygen is unimportant for most situations. However, at very low
levels of hemoglobin or in patients receiving hyperbaric oxygen therapy, dissolved oxygen
may be a very significant contributor to oxygen content and thus to oxygen transport.
Oxygen content is determined, using CLSI recommendations, from the following
relationship:
ctO2 = (FO2Hb ×1.39 × ctHb + 0.00314 × pO2)
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where OBF is the O2 binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup. FO2Hb is in decimal
format.
where OBF is the O2 binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup. FO2Hb + FHHb are in
decimal format.
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p50
Half saturation of hemoglobin by oxygen (p50) indicates the partial pressure of oxygen
when oxygen has saturated 50% of the available hemoglobin. The p50 value indicates the
position of the oxygen-hemoglobin dissociation curve:21
• Low p50 shifts the curve to the left and indicates increased oxygen-hemoglobin
affinity
• High p50 shifts the curve to the right and indicates decreased oxygen-hemoglobin
affinity
The p50 value is useful in indicating the presence of abnormal hemoglobin that affects the
oxygen transport mechanism, and as an indirect measure of the 2,3 DPG concentration.
The p50 can also indicate changes in pH, pCO2, and temperature.19,21
The p50 value is reported for sO2 values between 20% and 90% and is determined using
the following equation:
p50 = 26.6 x (pO2c / pO2s)
where
The system estimates oxygen saturation using the relationship described by Kelman32 and
Thomas33 as follows:
N 4 − 15 N 3 + 2045N 2 + 2000 N
O2 SAT (est ) = *100
N 4 − 15 N 3 + 24000N 2 − 31100N + 2.4 × 106
where
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pO2/FIO2
The pO2/FIO2 ratio is an index of the efficiency of pulmonary oxygen exchange
that relates the arterial pO2 to the fraction of inspired oxygen.34
The system adjusts the calcium value according to the following equation:35
Anion Gap
The anion gap (AnGap) is an approximation of the difference between
unmeasured cations and unmeasured anions in the sample and is useful in
determining the cause of metabolic acidosis.35
An abnormal anion gap indicates electrolyte imbalance or other conditions where
electroneutrality is disrupted, such as diabetes, ingestion of toxins, lactic acidosis,
and dehydration.
The system determines the anion gap as follows:
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The gas exchange indices are provided with the Rapidlab 1200 systems for convenience.
Final judgment of their use is at the discretion of the physician.
All gas exchange indices require an arterial sample and use measured values at patient
temperature.
where pO2(A)(T) is the temperature corrected oxygen tension of alveolar gas and
pO2(a)(T) is the temperature corrected oxygen tension of arterial blood.
where pO2(a)(T) is the temperature corrected oxygen tension of arterial blood and
pO2(A)(T) is the temperature corrected oxygen tension of alveolar gas.
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Respiratory Index
The respiratory index (RI(T)) is the ratio of the alveolar-arterial blood
oxygen-pressure difference to arterial pO2, when both values are corrected
for patient temperature. This index is also a means of assessing the degree of
pulmonary shunting.19
The system determines respiratory index as follows:
RI(T) = pO2(A-a)(T) / pO2(a)(T) × 100
where OBF is the O2 binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup. FO2Hb is in decimal
format.
where OBF is the O2 binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup. FO2Hb is in decimal
format.
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O2 = ctO2(a- ) × Qt × 10
Oxygen Delivery
O2 = ctO2(a) × Qt × 10
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Physiologic Shunt
The physiologic shunt [ sp/ t(T)] is that portion of the cardiac output entering
the left side of the heart that does not perfectly respire with the alveoli. The shunt
calculation represents the best available means of delineating the extent to which
the pulmonary system contributes to hypoxemia.9
The system determines the physiologic shunt using the following equation:
where
ctO2(c) = [OBF x tHb × (1–FCOHb–FMetHb)] + (0.00314 × A)
NOTE: If the FIO2 value is not at least 40, the shunt cannot be calculated.
OBF is the oxygen binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup.
Estimated Shunt
Pulmonary artery blood gases are not always readily available, but a need to
determine changes in the physiologic shunt may still exist. The best alternative
method for reflecting changes in the physiologic shunt is the estimated shunt
[ sp/ t(est,T)] value, which is applicable to most hypoxemic patients with
cardiovascular stability.9
The system determines the estimated shunt using the following equation:
For ctO2(a- ) entered, the system uses the default value of 3.5 mL/dL, or
whatever value is entered as the default value in Setup.
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OBF is the oxygen binding factor. The system uses the default value of 1.39, or whatever
value is entered as the default value in Setup.
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References
1. Kirchhoff JR, Wheeler JF, Lunte CE, Heineman WR. Electrochemistry:
principles and measurements. In: Kaplan LA, Pesce AJ., editors. Clinical
Chemistry: theory, analysis, and correlation. 2nd ed. St. Louis: CV Mosby,
1989:213-227.
2. Siggaard-Andersen O. Electrochemistry. In: Tietz NW, editor. Fundamentals
of clinical chemistry. 3rd ed. Philadelphia: WB Saunders, 1987:87-101.
3. Siggaard-Anderson O, Durst RA, Maas AHJ. Physicochemical quantities and
units in clinical chemistry with special emphasis on activities and activity
coefficients. Pure Appl Chem 1984;56:567-594.
4. Clinical and Laboratory Standards Institute (formerly NCCLS).
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to
the Flame Photometric Reference Method; Approved Standard; CLSI
Document C29-A; (Vol. 15, No. 1); Mar1995.
5. Sørensen, SPL. Enzymstudien. ii, Über die Messung und die Bedeutung der
Wasserstoffionenkonzentration bei enzymatischen Prozessen. Biochem Z
1909;12:131.
6. Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol
1997;108:247-253.
7. Levinsky NG. Acidosis and alkalosis. Ch 46 in Isselbacher KJ et al.
Harrison’s Principles of Internal Medicine, 13th Ed. New York:
McGraw-Hill, 1994:253-262.
8. Severinghaus JW, Bradley AF. Electrodes for blood pO2 and pCO2
determination. J Appl Physiol 1968;13:515-520.
9. Shapiro BA, Harrison RA, Cane RD, Templin R. Clinical application of blood
gases. 4th ed. Chicago: Year Book Medical Publishers, 1989.
10. Moran R, Cormier A. The blood gases: pH, pO2, pCO2. Clin Chem News
1988;14(4/5):10-12.
11. Clark LC Jr. Monitor and control of blood and tissue oxygen tensions. Trans
Am Soc Artif Intern Organs 1956:2:41-56.
12. Levinsky NG. Fluids and electrolytes. Ch 45 in Isselbacher KJ et al.
Harrison’s Principles of Internal Medicine, 13th Ed. New York:
McGraw-Hill, 1994:242-253.
13. Tietz NW. Clinical Guide to Laboratory Tests, 3rd Ed. Philadelphia:
Saunders, 1995:124-127.
14. Mundy GR. Calcium homeostasis - the new horizons. In: Moran RF, editor.
Ionized calcium: its determination and clinical usefulness. Proceedings of an
international symposium. Galveston (TX): The Electrolyte Blood Gas
Division of the American Association for Clinical Chemistry, 1986:1-4.
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2 Operating the System
This section provides procedural information about operating the Rapidlab 1200
system.
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Replacing Supplies
Before you replace supplies, you can view a video of the following procedures:
• Emptying the waste bottle
• Replacing the wash cartridge
• Replacing the reagent cartridge
• Replacing the AutomaticQC cartridge
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CAUTION: Do not move the reagent cartridge valve or the sample port on the
replacement cartridge prior to installation. Moving the valve or the sample port
may invalidate the reagent cartridge.
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Figure 2-1 Back of AQC Cartridge Interface Assembly Showing 2 Arrows Used
to Align Valve
The valve may not be correctly aligned after the cartridge is ejected.
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To check, go to step 2.
2. Verify the valve is correctly aligned as shown in Figure 2-2, with the top of
the valve between the 2 arrows.
If the valve is not correctly aligned, manually move the valve so the top of the
valve is aligned between the two arrows.
3. Select the Status screen.
Enter your password if necessary.
4. Select the AutomaticQC icon
5. Select Replace > Yes.
6. Follow the instructions in the video to reinstall the cartridge.
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CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
CAUTION: To prevent damage to the hard drive and permanent loss of data, use
this procedure to shut down the system.
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Collecting Samples
Collect blood samples under proper medical supervision when selecting a site and
performing the collection procedure. Use sterile technique at all times to avoid
infecting the sample site.
Immediately expel any bubbles that occurred during the sample collection. Cap
the sample device immediately after you collect the sample to avoid room air
contamination. When you collect samples with a capillary tube, fill the capillary
tube completely, cap it securely, and mix the sample thoroughly.
CAUTION: Never use mineral oil or mercury in syringes because these substances
may alter sample values and damage the system.
Collect blood in heparinized syringes that satisfy requirements for blood gas
analysis. Use capillary tubes that contain the appropriate balanced heparin.
NOTE: To prevent hemolysis and maintain sample integrity, use capillary tubes
that do not contain mixing beads.
Using Anticoagulants
For human whole blood samples, use sample devices containing only
calcium-titrated (balanced) heparin or lithium heparin as the anticoagulant.
NOTE: Other anticoagulants, such as EDTA, citrate, oxalate, and fluoride
significantly affect blood pH, sodium, potassium, chloride, ionized calcium
results, and CO-ox results. For more information about substances that interfere
with analyte measurement, refer to Performance Characteristics‚ page E-11.
If you are analyzing samples for ionized calcium, you can use a maximum of 15
units of lithium heparin for each 1.0 mL of sample. If you are not analyzing
samples for ionized calcium, you can use up to 50 units of lithium heparin for
each 1.0 mL of sample.
1 For more information about collecting and handling patient samples, refer to Clinical and Laboratory Standards
Institute. Blood Gas and pH analysis and Related Measurements: Approved Guideline; CLSI Document C46-A;
(Vol. 21, No. 14); 2001.
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You can store a sample collected in a glass syringe in the ice slurry for up to 2 hours
without significant change in values for pH and pCO2, however, this affects the K+
and lactate values. Samples with elevated white blood cell or reticulocyte counts
deteriorate more rapidly, and you should analyze them immediately.
• Before you analyze the sample, roll the syringe or the capillary tube between your
palms and gently invert it several times to mix the sample thoroughly.
Blood cells settle during storage, and if you do not mix the sample well before
analysis, the total hemoglobin results obtained can be falsely decreased or increased.
Mix all samples using a consistent technique.
• If the sample is chilled or has been stored for more than 10 minutes, increase the
mixing time to ensure that the sample is thoroughly mixed.
• Position any labels toward the back of the syringe barrel near the plunger so the label
does not block your ability to insert the syringe into the system or cause it to fall off
after it is inserted.
• Dispose of used sample devices according to your institution’s infection control
policy.
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Analyzing Samples
This section contains information about analyzing the following samples:
• Syringe samples
• Capillary samples
• Microsamples
• pH and pH, Glu, and Lac samples
• tHb samples
1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
NOTE: If you have a priority sample, but a message is displayed indicating
that the system is busy, select Cancel to interrupt the system. If Cancel is not
available, wait until the message is not displayed to analyze the patient
sample.
2. At the Analysis screen, select the patient sample type (arterial, venous, mixed
venous).
The default type is a syringe of arterial blood.
3. Scan the barcode for the patient sample, if required.
4. Insert the syringe into the sample port.
5. Select Analyze.
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If the system determines that insufficient sample is present or bubbles are in the
sample, you are prompted to position the sample like a microsample. For information
about microsample analysis, refer to Analyzing Microsamples‚ page 2-14.
CAUTION: Do not leave the sample device in the sample port after the system
prompts you to remove it. The system performs a wash after each sample analysis.
Leaving the sample device in place while the system performs a wash could
contaminate that wash with blood and adversely affect the next sample or system
operation.
CAUTION: If the wash that is performed after sample analysis does not
completely clean the fluid path, you should perform an additional wash. To
determine if the path is clean, observe if any colored fluid remains in the fluid
path after analysis. To perform a wash at the Analysis screen, select Wash.
The Wash button is grayed out if the system is busy. The Wash button is not
available if the lamp failure or LIS communications error indicators, which
occupy the same space on the screen, are active.
NOTE: Always fill the capillary tube completely. Be sure to use the recommended
volume for the sampling mode and system model. For more information about Fill
Volumes, refer to Recommended Fill Volumes‚ page C-1.
1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
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NOTE: If you have a priority sample, but the system displays a message that
the system is busy, select Cancel to interrupt the system. If Cancel is not
available, wait until the system is not displaying the busy message to analyze
the patient sample.
2. At the Analysis screen, select the button for capillary sample type.
3. Scan the barcode for the patient sample, if required.
4. Hold the capillary tube at the end closest to the sample port and insert the tube
firmly in the sample port.
5. Select Analyze.
NOTE: If the system determines that insufficient sample is present or bubbles
are in the sample, you are prompted to position the sample as you would a
microsample. For information about analyzing microsamples, refer to
Analyzing Microsamples‚ page 2-14.
CAUTION: Do not leave the sample device in the sample port after the system
prompts you to remove it. The system performs a wash after each sample analysis.
Leaving the sample device in place while the system performs a wash could
contaminate that wash with blood and adversely affect the next sample or system
operation.
6. When prompted, remove the sample device and select Continue.
7. If prompted, enter demographic information and select Continue.
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NOTE: You can scan the patient ID and accession number in the appropriate field. For
information about entering patient sample data, refer to Entering Patient Sample
Data‚ page 2-22.
8. View the results.
For information about how results are displayed on the screen and in printed reports,
refer to Viewing Patient Results‚ page 2-27.
9. Select Continue when you finish viewing the results.
CAUTION: If the wash that is performed after sample analysis does not
completely clean the fluid path, you should perform an additional wash. To
determine if the path is clean, observe if any colored fluid remains in the fluid
path after analysis. To perform a wash at the Analysis screen, select Wash.
The Wash button is grayed out if the system is busy. The Wash button is not
available if the lamp failure or LIS communications error indicators, which
occupy the same space on the screen, are active.
Analyzing Microsamples
NOTE: Read this procedure completely before performing microsample analysis for the
first time.
Use this procedure to analyze patient samples when you know that you have insufficient
sample volume for routine analysis. The procedure allows the system to have time to
properly analyze a small volume sample.
The system analyzes the sample in 2 stages. First, the system analyzes pCO2 and pO2, and
then analyzes the remaining parameters. The system also measures pCO2 during the
second stage of the microsample if the pCO2 sensor still contains sample. Using the
following procedure, you position the sample at position 1 in the sample path to begin
analysis of pCO2 and pO2. For Rapidlab 1245 and 1265 systems, the microsample mode
does not analyze hemoglobin parameters.
1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
2. At the Analysis screen, select the button for the patient sample type (arterial, capillary,
venous, mixed venous).
3. Select Microsample.
4. Scan the barcode for the patient sample if required.
5. Insert the sample device into the sample port and select Analyze.
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For an illustration of the sample port, refer to Figure 2-3 Rapidlab 1200
Systems Sample Port.
6. When prompted, remove the sample device and select Continue.
7. To start the sample moving through the sample path, select Advance Sample.
CAUTION: Do not hesitate at any point during this procedure. The sample moves
a short distance through the sample path to position 1. If you do not select an
option for the next stage of the procedure within 30 seconds, the system starts a
wash sequence and the sample becomes unusable.
8. Watch the sample move into the sample path and when the sample reaches
position 1, select Stop Sample.
1 Sample position 1
9. Select Analyze.
Wait while the system analyzes pCO2 and pO2. After the system finishes the
analysis, it moves the sample to the remaining sensors.
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10. Watch the sample move through the sample path and inspect the sample path for
bubbles or gaps.
• Ensure that the trailing edge of the sample remains in contact with the sample/
ground temperature sensor.
• Ensure that the leading edge of the sample fills the reference sensor.
If... Then...
bubbles or gaps are present, select Cancel.
no bubbles or gaps are present, select Analyze.
11. If prompted, enter demographic information and select Continue.
You can scan the patient ID and accession number in the appropriate field. For more
information about entering the data, refer to Entering Patient Sample Data‚ page 2-22.
12. View the results.
For information about how results are displayed on the screen and in printed reports,
refer to Viewing Patient Results‚ page 2-27.
13. When you finish viewing the results, select Continue.
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1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
2. At the Analysis screen, select the button for the patient sample type (arterial,
capillary, venous, mixed venous).
3. Select pH or pH, Glu, Lac.
4. Scan the barcode for the patient sample, if required.
5. Insert the sample device into the sample port and select Analyze.
CAUTION: Do not leave the sample device in the sample port after the system
prompts you to remove it. The system performs a wash after each sample analysis.
Leaving the sample device in place while the system performs a wash could
contaminate that wash with blood and adversely affect the next sample or system
operation.
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CAUTION: If the wash that is performed after sample analysis does not
completely clean the fluid path, you must perform an additional wash. To
determine if the path is clean, observe if any colored fluid remains in the fluid
path after analysis. To perform a wash at the Analysis screen, select Wash.
The Wash button is grayed out if the system is busy. The Wash button is not
available if the lamp failure or LIS communications error indicators, which
occupy the same space on the screen, are active.
1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
2. At the Analysis screen, select the button for the patient sample type (arterial, capillary,
venous, mixed venous).
3. Select tHb.
4. Scan the barcode for the patient sample if required.
5. Insert the sample device into the sample port and select Analyze.
CAUTION: Do not leave the sample device in the sample port after the system
prompts you to remove it. The system performs a wash after each sample analysis.
Leaving the sample device in place while the system performs a wash could
contaminate that wash with blood and adversely affect the next sample or system
operation.
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CAUTION: If the wash that is performed after sample analysis does not
completely clean the fluid path, you must perform an additional wash. To
determine if the path is clean, observe if any colored fluid remains in the fluid
path after analysis. To perform a wash at the Analysis screen, select Wash.
The Wash button is grayed out if the system is busy. The Wash button is not
available if the lamp failure or LIS communications error indicators, which
occupy the same space on the screen, are active.
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Scanning Technique
Use the following technique to ensure that you operate the barcode scanner correctly:
1. Hold the scanner at an angle to the barcode without touching it, not directly over the
barcode.
2. Scan the entire barcode.
Move the scanner to the distance that allows the beam to scan every bar and space.
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NOTE: Select Clear to delete the data in the field or Clear All to delete the data in
all the fields.
NOTE: You can restrict entry of the patient ID so only a barcode scanner can be
used to enter the patient ID. This minimizes errors that can occur if the patient ID
is entered manually. Refer to Selecting the Barcode Only Option for Patient ID
Entry‚ page 8-25.
NOTE: You can deactivate the Patient List button so it is unavailable to select
patients at data entry screens. This eliminates the possibility of accidentally
selecting an incorrect patient from the patient list. To deactivate the patient list
button, at the Status screen select Secured Option > Analysis Options, and
deselect the Patient List button. The Patient List button is on by default.
1. Enter the Patient ID or enter the patient’s demographics.
• If a matching patient ID and patient data is available, the system
automatically displays the name, sex, and date of birth.
To enter the patient ID using the barcode scanner, select Patient ID and
then scan the patient ID barcode. The system enters the name, sex, and
date of birth if available.
• If entering the patient ID did not populate the other fields, select Patient
List to search for a patient ID.
Use Patient List to display the patient ID and name for the last 8 patients
entered. When you select a patient ID from the list and return to the Data
Entry screen, the system displays the patient ID, name, sex, and date of
birth, if available.
2. To manually enter the patient name, select Last Name.
3. Use the alphanumeric buttons to enter the patient name.
4. To enter the accession number using the barcode scanner, select Accession
No.
5. Scan the accession number barcode.
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Editing Demographics
NOTE: You can edit demographics if you turned on this option in Setup. For more
information about selecting this option, refer to Selecting Demographics Editing‚
page 8-39.
Use this procedure to edit patient or sample demographic data, such as the patient
name or temperature, for previously analyzed patient samples.
If you edit the name, sex, or date of birth, the system applies the changes to all
samples saved for the patient. You can also print a patient sample report with the
edited data and send the data to a data management system or an LIS.
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NOTE: If you change a Patient ID (1234) to another patient ID (5678) that already exists,
the system replaces the name, sex, and date of birth for the edited patient ID (1234) with
those of the new patient ID (5678).
NOTE: You cannot edit data after you combine samples for a-v study reports.
1. Select Recall > Patients.
2. Locate the sample you want to edit.
If you want to... Then...
view additional a. Select the up or down arrow buttons to move through
samples, the list.
b. Select the sample you want to edit and select Results.
search for a sample a. Select Search.
by patient ID, b. Select Clear to delete the current patient ID.
c. Enter the patient ID and select Continue.
To return to the complete list of samples, select
Previous.
d. Select the sample you want to edit and select Results.
3. To display the demographic fields, select Edit.
4. Edit the demographic data.
5. Select Continue.
This displays a dialog box asking if you want to save the changes.
6. Select Yes.
7. To print the patient sample report, select Print.
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CAUTION: Only use final results for diagnostic purposes. Never use preliminary
results because using preliminary results can lead to misdiagnosis.
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If your system is set to Auto Print, the report prints automatically. Refer to Defining Send
System Data Option‚ page 8-26.
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Printing Reports
You can print reports using the internal printer and, when installed, an external
printer. You can use the Setup–Printer Options screen to determine which printer
to use, how many copies to print and if the report is printed automatically. Refer to
Selecting Printer Options‚ page 8-22.
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1. Verify that the current coefficients are 1.0 for the slope value and 0.0 for the offset
value:
a. Select Status > Setup > Secured Options.
b. Select the down arrow button and then select Correlation Coefficients.
c. Ensure that the slope value is 1.0 and the offset value is 0.0 for each parameter
that you want to adjust.
NOTE: Analyze the samples in duplicate at each system, if possible. Perform analysis
over several days to include normal analytical variability for both systems.
2. Analyze each sample concurrently at the Rapidlab 1200 system and at the reference
analyzer.
Do not allow more than 3 minutes between analyses of the same sample at each
system.
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3 Calibration
Calibration is the process of testing and adjusting the electronic signal from a
sensor in response to a known concentration. Calibration establishes a relationship
between the electrical signal of a sensor and the concentration of the analyte
measured by the sensor. The relationship between the sensor signal and the
concentration (or the log of the concentration) of a measured analyte is linear.
The system determines a straight line calibration curve by measuring the sensor
signal from 2 different reagents of known concentration. Each measurement
defines 1 point on the calibration curve. The system calculates the calibration
offset (y-intercept) and slope using the measured signal and known concentration
as established on the calibration curve. The system determines the concentration
of an unknown patient sample or QC sample by comparing its generated signal
during measurement to the established calibration curve.
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The system performs the following calibrations after some maintenance procedures:
Calibration
Type Frequency Description
2-Point During accelerated calibration Measures 2 reagents of known
intervals, which occur after you concentration to adjust either the
perform sensor maintenance. offset or the slope drift for the
You can manually initiate this following parameters: pH, pCO2,
calibration. pO2, Na+, Ca++, K+, Cl¯, Glu, and
Lac.
Rapidlab 1245 and 1265 systems:
measures 2 reagents of known
concentration to adjust the offset
and the slope for tHb and CO-ox
fractions.
1-Point Plus Rapidlab 1245 and 1265 systems: Measures 1 reagent of known
after you replace the CO-ox concentration to adjust either the
sample chamber. offset or the slope for the
following parameters: pH, pCO2,
pO2, Na+, Ca++, K+, Cl¯, Glu, and
Lac.
Measures 2 reagents of known
concentration to adjust the offset
and the slope for tHb and CO-ox
fractions.
Accelerated The system starts accelerated The system performs a 2-point
Calibration calibration intervals in 2 instances calibration every 2 hours for the
Intervals after you open and close the first 8 hours of the accelerated
measurement module door: calibration interval.
If you answer the question “Did
you remove or replace any
sensors?” with Yes, or if you
answer with No and the system
detects a drop in pressure in the
sample path. The system only
detects a drop in pressure if you
followed the procedure Replacing
the Sensors‚ page 5-29.
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4 Quality Control
Your laboratory should have procedures for analyzing the number of QC samples
and levels of QC material for each day of testing. Use only RapidQC® Complete
controls or install the AutomaticQC cartridge.
In addition to daily QC monitoring, participation in interlaboratory QC survey
programs lets you compare your system performance with systems in other
laboratories. Participation in interlaboratory QC survey and proficiency testing
programs can identify systematic errors not detected by intralaboratory QC
testing alone.
The Rapidlab 1200 system offers 3 options for quality control analysis. Refer to
Setting Up QC Options‚ page 8-2:
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Accessing QC Results
When the system completes QC analysis, the system displays the Results screen.
For a Required QC analysis and for Unscheduled QC analysis when you scan the
barcode on the ampule, the Results screen immediately under the banner contains
the following information:
• QC type
• Level
• Lot
For AutomaticQC samples, the system displays the level.
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Result Flags
The system displays the following symbols in red on the results screen and in the printed
report:
This symbol... Indicates that...
¦ the result is above the target range.
Ø the result is below the target range.
-----↑ the result is above the reporting range.
-----↓ the result is below the reporting range.
-----? the system has an atypical response when measuring this
parameter.
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Recalling QC Results
Use the Recall screen to view and print results for previously analyzed QC
samples. When you select the Recall button and then select QC, the Recall QC
screen displays the following options:
• QC List
• QC Statistics
• Levey-Jennings Graph
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4-10 Rapidlab 1200 Operator’s Guide: Quality Control
The mean value is defined as the sum of all results divided by the number of results,
according to the following formula:
1 N x + x + L + xN
x= Σ xi = 1 2
N i =1 N
• SD(R), standard deviation with RiliBÄK range checking defined according to the
following formula:
1 n
RMSD= ∑(xi − xt arget )2
n i=1
• SD( x ), standard deviation against the mean is defined according to the following
formula:
1 N
S= Σ ( xi − x ) 2
( N − 1) i =1
• CV, coefficient of variation is defined according to the following formula:
S
CV = ×100%
x
• N, number of samples included for these statistics.
NOTE: For RMSD and RMSD%, a minimum of 15 samples is required. If fewer than
15 samples are analyzed, the field is blank. For Standard Deviation and Coefficient of
Variation, a minimum of 5 samples is required. If fewer than 5 samples are analyzed,
the field is blank.
NOTE: If a sample is out of range it may skew QC Analysis results. To exclude a
sample you suspect is out of range, see Using the QC List Screen‚ page 4-7.
NOTE: Low and high AQC and RQC ranges are adjusted to adhere to the
RiliBÄK 2008 requirements that define deviation from target ranges.
NOTE: CO-ox fractions for FO2Hb, FCOHb, FMetHb, and FHHB are not adjusted.
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Rapidlab 1200 Operator’s Guide: Quality Control 4-11
To print the Recall–QC Statistics data, select the Print button. The printed report
contains the following additional information:
• parameter labels and statistics for all parameters
• measured and target values for each parameter
• the difference between the measured and target values, in percentage
• if a parameter exceeds the RiliBÄK range, text indicates the parameter has
failed
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Restoring Parameters
Use this procedure to turn on parameters that the system turned off for either of the
following reasons:
• The parameter failed Required QC or AutomaticQC analysis, or was not available
when Required QC or AutomaticQC was performed.
• Required QC analysis was not performed when scheduled.
When you restore a parameter, the parameter remains selected and available for analysis
until the next scheduled QC analysis.
1. At the Analysis screen, select a parameter that is turned off.
NOTE: After you select a parameter, it remains selected and you cannot deselect it at
this screen.
2. At the Restore QC screen, select the parameters you want to restore and then select
Continue.
NOTE: For an AutomaticQC analysis, the screen displays parameters and levels that
failed analysis in the Failed QC list.
3. Analyze another QC sample for the failed level to ensure that the parameters are
within the target ranges.
If a restored parameter fails QC analysis, refer to Troubleshooting Failed or Missed QC
Analysis‚ page 6-1.
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5 Maintenance
1 Front cover
2 Latches–measurement module
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5-2 Rapidlab 1200 Operator’s Guide: Maintenance
1. Moisten the cloth with the bleach solution so that the cloth is wet but not dripping.
CAUTION: Do not allow bleach or other cleaners to contact the inside surface of
the sample port. The system could aspirate the cleaners and damage the sensors.
2. Wipe the exterior surfaces of the system using the wet cloth.
3. Allow the exterior surfaces to air dry.
4. Dispose of the bleach solution according to your institution’s protocol.
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5-4 Rapidlab 1200 Operator’s Guide: Maintenance
8. If the Glucose or Lactate results are below the values recommended on the High G/L
package insert, replace the affected biosensor.
Refer to Replacing the Sensors‚ page 5-29.
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5-8 Rapidlab 1200 Operator’s Guide: Maintenance
5. Check the level of fill solution in the K+, Cl¯, Ca++, Na+, and pH sensors:
a. Verify that the K+, Cl¯, and Ca++ sensors are almost full with a small (1 mm)
bubble at the top.
b. Verify that the pH and Na+ sensors are completely full.
c. If the level of fill solution is low, replace the fill solution.
Refer to Performing Measurement Sensor Maintenance‚ page 5-40.
6. Close the measurement module door and close the front cover.
7. Allow the system to warm up for 10 minutes.
8. Select Yes.
9. Select Continue > Return.
10. Select Analyze > Yes.
11. Analyze a minimum of 2 levels of quality control material to verify sensor
performance.
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1. Select Status > Maintenance > Replacing the CO-ox Sample Chamber.
2. To start the procedure, select Continue.
3. Follow the instructions in the video.
4. Allow the system to warm up for 5 minutes.
5. Perform a full calibration.
Refer to Recalling Calibration Results‚ page 3-4.
6. Analyze a minimum of 2 levels of quality control material.
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Rapidlab 1200 Operator’s Guide: Maintenance 5-11
c. Disconnect the tubing from the connector at the pressure sensor bubbler.
5. Connect the new tubing:
a. Connect the new tubing to the spring-loaded latch.
b. Push the new tubing into the pinch valve.
Center the tubing and ensure the tubing does not have any sharp bends.
c. Connect the new tubing to the pressure sensor bubbler.
6. Close the measurement module door.
7. Select No.
8. Reinstall the reagent cartridge and close the reagent cartridge door.
9. Close the front cover.
10. Dispose of the tubing according to your institution’s protocol.
Yearly Maintenance
Yearly maintenance includes the following tasks:
• Replacing the measurement module tubing and pressure sensor bubbler
• Replacing the CO-ox tubing
• Replacing the reagent manifold
• Replacing the AutomaticQC manifold
• Replacing the air filters
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Rapidlab 1200 Operator’s Guide: Maintenance 5-13
b. Connect the new tubing to the pressure sensor bubbler and to the reagent
manifold.
6. Dispose of the tubing according to your institution’s protocol.
7. Close the reagent cartridge door and then close the front cover.
8. If you have a Rapidlab 1245 or 1265 system and are replacing the CO-ox
tubing, continue with step 2 of Replacing the CO-ox Module Tubing‚
page 5-13.
9. Close the measurement module door.
10. Select No.
11. Select Return > Analyze > Yes.
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5-14 Rapidlab 1200 Operator’s Guide: Maintenance
2. Rotate the gray wheel towards you, pull the tubing through the fluid detector, and
remove the tubing from the steel measurement module connector.
3. Push the new tubing through the fluid detector.
4. Connect the tubing to the steel measurement module connector and to the sample
chamber connector.
Use a clamp or tweezers to attach the tubing.
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2. Connect the CO-ox waste tubing to the CO-ox pump tubing and the sample
chamber connector.
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5-16 Rapidlab 1200 Operator’s Guide: Maintenance
1 Roller cage
2 Platen
3 Lower tubing cuff
4 Reagent manifold tubing
2. Disconnect the CO-ox pump tubing from the reagent manifold tubing at the fitting.
3. Do not disconnect the reagent manifold tubing from the reagent manifold.
4. Grasp the lower tubing cuff and pull the tubing away from the platen and the roller
cage.
5. Place the lower tubing cuff of the new tubing under the lower side of the platen, press
the tubing around the outside of the rollers, and turn the roller cage clockwise until the
tubing rests on the rollers.
6. Connect the tubing to the waste tubing and the reagent manifold tubing.
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1 Fitting
2 Reagent manifold tubing (Rapidlab 1245 and 1265 systems)
3 Waste tubing
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d. Squeeze the finger snaps on the reagent manifold and then remove the manifold
by sliding it down and away from the sample connector.
1 Finger snaps
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Rapidlab 1200 Operator’s Guide: Maintenance 5-19
b. Push down on the pins on the manifold and pull the manifold and
connector port away.
7. Install the new AutomaticQC manifold:
a. Insert the bottom clip into the opening on the system.
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b. Align the tube loop that is on the back of the manifold with the groove in the
system.
1 Bottom clip
c. Insert the top clips into the holes and release the clips to lock them in place.
d. Insert the connector port into the indentation in the system wall and replace the
connector port cover.
8. Slide the cartridge connector to the left.
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Cleaning Procedures
This section provides procedures for performing as needed cleaning.
1. Moisten the cloth with the bleach solution so that the cloth is wet but not
dripping.
2. Select Status > Maintenance > Cleaning the Screen.
3. To start the procedure, select Continue.
The cleaning screen is displayed for 20 seconds and allows you to wipe the
screen without activating any buttons.
4. Wipe the screen with the wet cloth.
5. Allow the screen to air dry.
After 20 seconds, the system returns to the Maintenance screen.
6. Dispose of the bleach solution according to your institution’s protocol.
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5-22 Rapidlab 1200 Operator’s Guide: Maintenance
CAUTION: Do not expose the reference sensor to bleach. Replace the reference
sensor with the test/blank reference sensor (TB5) before cleaning.
CAUTION: Do not use alcohol to perform this procedure. Alcohol can damage the
sensors.
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b. Push the spring-loaded latch to the right, grasp the tab on the reference
sensor, and pull the reference sensor up and out.
1 Reference sensor
2 Spring-loaded latch
c. Align the top of the test/blank reference sensor (TB5) with the sensor
contact and snap the sensor into place.
4. If you have a Rapidlab 1260 or 1265 system, replace the Glucose and Lactate
biosensors with the test/blank Glucose Lactate (TB4) sensors.
Refer to step 3.
5. Close the measurement module door and then close the front cover.
6. Aspirate the deproteinizer:
a. Invert the deproteinizer vial several times to mix the deproteinizer
solution.
b. Draw the deproteinizer into a syringe and insert the syringe into the
sample port.
c. Select Continue.
d. When prompted, remove the syringe and select Continue.
The system displays a message prompting you to condition the sensors.
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1 Fitting
2 Reagent manifold tubing
4. Grasp the lower tubing cuff and gently pull it away from the platen.
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5. While holding the lower side of the tubing, turn the roller cage clockwise and gently
pull the tubing away from the platen and the roller cage.
1 Platen
2 Roller cage
3 Lower tubing cuff
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1 Orange lever
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1 Spring-loaded latch
c. Grasp the tab on the sensor and pull the sensor up and out.
d. Discard the sensor according to your institution’s policy.
4. If you are replacing a measurement sensor, refer to Performing Measurement Sensor
Maintenance‚ page 5-40
5. If you are replacing the reference sensor, fill the internal electrode compartment.
Refer to Filling the Reference Sensor Cassette‚ page 5-36.
6. If you are replacing the reference sensor or measurement sensors, install the internal
electrode into the internal electrode compartment and screw the electrode into place.
7. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
b. Wipe any excess fill solution from the exterior of the sensor using a lint-free
tissue.
c. Ensure that the O-ring is in place:
• Reference sensor has an O-ring on both sides of the sensor.
• All other sensors have an O-ring on the left side of the sensor.
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NOTE: D2, D3, and D4 error codes may result when bubbles are detected in the fill
solution. This procedure is designed to minimize the occurence of bubbles in the fill
solution.
NOTE: Bubbles on the surface of the fill solution are acceptable. Only bubbles in the fill
solution result in D2, D3, and D4 error codes.
NOTE: Do not shake the vial containing the fill solution. This can create bubbles in the
fill solution.
1. Remove the sensor.
Refer to Replacing the Sensors‚ page 5-29.
If the sensor is new, go to step 4.
2. Unscrew the internal electrode and place the electrode and sensor assembly on a
lint-free tissue.
3. Empty the fill solution from the sensor.
Dispose of the fill solution according to your institution’s protocol.
4. Attach the needle to the fill solution vial.
a. Twist off the top of the vial that contains the fill solution.
b. Slide the smaller, open-end of the needle cylinder onto the fill solution vial.
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c. Slowly raise the needle as you gently squeeze the fill solution vial, until
the sensor is nearly full.
CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
7. Install the internal reference electrode into the internal electrode compartment
and screw the electrode into place.
8. Inspect the sensor for bubbles.
As the temperature of the sensor rises to 37°C, gas driven from the solution
causes bubbles.
9. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
If bubbles reamain in the sensor, see Step 3 of Verifying Sensor
Performance‚ page 5-31.
b. Wipe any excess fill solution from the exterior of the sensor using a
lint-free tissue.
10. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
11. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.
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1 Reference sensor
2 Spring-loaded latch
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2. Check the sensor for bubbles at the electrode tip and between the electrode
compartment and the KCl reservoir.
1 KCl reservoir
2 Electrode compartment join to the KCl reservoir
3 Electrode tip
4 O-rings
NOTE: The fill solution can become slightly pink as a result of analyzing QC
and AutomaticQC materials. A pink color that becomes very dark over a
12-hour period indicates a pending failure of the reference sensor. Replace the
reference sensor or the reference sensor cassette.
3. Tap the front face of the sensor with your knuckle to remove any bubbles.
4. Remove any salt deposits on the reference sensor using a lint-free swab
moistened with water.
5. Dry the sensor thoroughly.
6. Ensure that the O-rings are in place on both sides of the sensor.
7. Replace any O-ring that is worn or damaged.
8. Clean the O-ring area on the spring-loaded latch using a lint-free swab
moistened with water.
9. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
10. Verify the sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.
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1 Internal electrode
2 Cassette
3 Internal electrode compartment
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b. Fill the internal electrode compartment until the KCl fill solution enters
the KCl reservoir.
CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
4. Install the internal electrode into the internal electrode compartment and
screw the electrode into place using the hex tool.
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CAUTION: Do not overtighten the reservoir cap. Overtightening can deform the
gasket and cause leaks.
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Rapidlab 1200 Operator’s Guide: Maintenance 5-39
1 Internal electrode
2 Cassette
3 Internal electrode compartment
2. If you are replacing the internal reference electrode, dispose of the electrode
according to your institution’s protocol.
3. If you are replacing the internal reference electrode, rinse the electrode
compartment with KCl fill solution:
a. Empty the fill solution from the sensor.
b. Rinse the internal electrode compartment with 3 drops of KCl fill
solution.
c. Empty those drops of fill solution from the sensor.
4. Fill the internal electrode compartment with KCl solution.
Refer to Filling the Reference Sensor Cassette‚ page 5-36.
5. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
6. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.
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CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
5. Install the internal reference electrode into the internal electrode compartment
and screw the electrode into place.
6. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
b. Wipe any excess fill solution from the exterior of the sensor using a
lint-free tissue.
c. Verify that the O-ring is in place on the left side of the sensor.
Replace the O-ring if it is worn or damaged.
7. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
8. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.
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CAUTION: Do not pull the torn paper back through the printer. This can damage
the printing mechanism.
3. Follow the instructions in the video.
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WARNING: Do not touch the lamp until it has been off for at least 5 minutes.
Waiting for at least 5 minutes allows sufficient time for the lamp to cool.
CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
WARNING: To prevent damage to the hard drive and permanent loss of data, use
this procedure to shut down the system.
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1 Electrical connector
2 Lamp base
3 Back cover
CAUTION: Avoid touching the new CO-ox lamp with your fingers. Touching the
glass may cause the lamp to prematurely deteriorate.
8. Install a new lamp:
a. Push the new lamp into the lamp receptacle area.
The lamp has a key that you must line up with the key hole in the side of the
receptacle area.
b. Push the electrical connector onto the electrical fitting.
9. Close the back cover.
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1 Fitting
2 Reagent manifold tubing
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4. Grasp the lower tubing cuff and gently pull it away from the platen.
5. While holding the lower side of the tubing, turn the roller cage clockwise and gently
pull the tubing away from the platen and the roller cage.
1 Platen
2 Roller cage
3 Lower tubing cuff
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WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.
CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
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1 Fuse holder
4. Remove the old fuses and dispose of them according to your institution’s protocol.
5. Install new fuses.
6. Slide the fuse holder into the fuse compartment.
7. Restore power:
a. Reconnect the power cord to the system.
b. Reconnect the power cord to the electrical outlet.
c. Turn the power on.
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WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.
CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
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WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.
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1 Connector
2 Pressure sensor bubbler
3 Water collection area
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1 Connector
2 Waste tubing
3 Water collection area
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You can navigate from week to week by using the right and left pointing arrows at
the top of the right panel. You can navigate within the schedule grid, moving
down the task list or back and forth through the days of the week by using the four
directional arrows at the middle of the right panel. The currently selected cell has
a white background.
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6 Troubleshooting
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Probable
Error Cause Corrective Action
Parameter Perform the following steps until the system is
failed ready for use:
AutomaticQC • Perform up to two 2-point calibrations.
analysis • If the parameter fails the 2-point calibrations,
because the view the events log for D codes and messages.
sensor or the
• Replace the sensor if necessary.
cartridge is not
working • If the parameter passed the 2-point
correctly. calibrations, perform AutomaticQC analysis
for the failed level of control.
• If the parameter fails AutomaticQC analysis,
analyze a QC sample for the failed level using
QC material from an ampule.
• If the parameter fails the ampule QC analysis,
review the events log for D codes and
messages.
• If the parameter passes the ampule QC
analysis, replace the AutomaticQC cartridge.
The target • Verify that the target ranges entered for the
ranges for one control are correct.
or more If you specify target ranges that are narrower
parameters are than those provided with the control,
too narrow. parameters may fail QC analysis.
• Analyze QC for the failed level.
Refer to Performing Unscheduled QC Sample
Analysis‚ page 4-4.
• If the results are within range, restore the
parameter.
Refer to Restoring Parameters‚ page 4-12.
• For AutomaticQC samples, analyze the failed
level.
Refer to Performing Unscheduled QC Sample
Analysis‚ page 4-4.
If the results are within range, the system
restores the parameter.
• If analysis fails again, review the events log for
D codes and messages.
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• Check the solution level in the affected sensor and remove bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH and Na+ sensors
should be completely full without any bubbles.
• Check the sensor contacts and measurement block for salt buildup.
• Check behind the sensors for fluid leaks that can come from the reference
sensor.
• Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed.
• If the pH or Na+ sensor have a D2 or D3, condition the sensors.
• Check for cracks or leaks in the sample tubing, and replace the tubing if
necessary.
• Replace the affected sensor, if necessary.
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This symbol is displayed next to results on the screen and printed reports, and the system
displays the Interfering Substance message in the event log and on printed reports.
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Supplies Description
Plastic syringe Use to clear clots from the reagent manifold.
5cc Luer Lock syringe Use to clear clots from the preheater and reagent cartridge.
Gauze Use to catch excess liquid after insertion of water.
Water Use to fill syringe.
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The parts listed in the table below are optional, as explained in the Clearing the
Clot from the Reagent Manifold procedure below.
Optional Parts
Reagent Manifold Description
06646415 For Rapidlab 1240 and 1260 systems, if needed.
06643971 For Rapidlab 1245 and 1265 systems, if needed.
CAUTION: Do not disconnect the reagent manifold tubing from the port on the
top, left-side of the reagent manifold.
c. Push down the two latches that secure the reagent manifold to the system
(item 5, Figure 6-1).
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d. Carefully pull the reagent manifold out slightly, then straight down, to avoid the
sample connector (item 3, Figure 6-1).
1 Fitting to which the reagent manifold tubing and CO-ox pump tubing are connected
(Rapidlab 1245 and 1265 systems)
2 Reagent manifold tubing that connects the fitting to the port on the top, left-side of the
reagent manifold (Rapidlab 1245 and 1265 systems)
3 Sample connector
4 Waste tubing connected to port on top, right-side of the reagent manifold
5 Two latches that secure the reagent manifold to the system
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1 CO-ox waste exit port (this illustration shows ports only and does not show
the reagent manifold tubing that remains connected to this port when you
perform this procedure)
2 Sample exit port
3 Sensor waste exit port
4 Sensor waste port
5 Sample port
6 CO-ox waste port
CAUTION: Do not disconnect the reagent manifold tubing from the port on the
top, left-side of the reagent manifold.
c. Discard the gauze.
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10. Repeat the procedure on the CO-ox waste port (Rapidlab 1245 and 1265 systems).
a. Fill the plastic syringe with water and place it against the CO-ox waste port
(item 6, Figure 6-2).
b. Press the syringe plunger gently to insert water into the CO-ox waste port, while
holding gauze against the end of the tubing that is connected
to the CO-ox waste exit port (item 2, Figure 6-2), to catch the obstruction and any
excess liquid.
c. Discard the gauze.
11. If there is no obstruction in the reagent manifold, proceed to Clearing the Clot from
the Preheater on page 17.
There is no obstruction if water inserted into a port flushes cleanly through the
corresponding exit port.
If you cleared an obstruction from the reagent manifold, go to step 13 to reinstall the
reagent manifold.
12. If you detect an obstruction in the reagent manifold, but are unable to clear it, you
have 2 options, as described below.
• Perform a clot clearing procedure using a clot-removal line, as described in
Removing Clots Using the Clot-Removal Line‚ page 6-24. Then repeat this
procedure to ensure an obstruction has been removed. If this does not work, go to
step 13 to replace the reagent manifold with a new reagent manifold. See page
page 13 for reagent manifold part numbers.
• Replace the reagent manifold with a new reagent manifold, by following the
procedure in step 13 (for reagent manifold part numbers, see page 13).
There is an obstruction that has not been cleared in the reagent manifold if you insert
water into a port and the water does not flush cleanly through the corresponding exit
port.
13. Reinstall or replace the reagent manifold.
a. Insert the reagent manifold until it latches into place, using the 2 latches
(item 5, Figure 6-1) that secure the manifold to the system.
b. Reinsert the reagent manifold tubing (item 2, Figure 1) into the fitting
(item 1, Figure 6-1) that connects to the CO-ox pump tubing
(Rapidlab 1245 and 1265 systems).
c. Reinsert the waste tubing into the port on the top, right-side of the reagent
manifold (item 4, Figure 6-1).
14. Close the system.
a. Reinstall the reagent and wash cartridges.
b. Close the reagent and wash module doors.
c. Close the front cover of the system.
15. Select the Return button twice to exit Diagnostics mode.
You are prompted to calibrate the system.
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Use this procedure only if the Clearing the Clot from the Reagent Manifold
procedure fails to clear the clot. The Clearing the Clot from the Preheater
procedure continues from step 11 on page 16.
1. Open the measurement module cover, by lifting the 2 latch buttons located at
the bottom left and right of the module. See Figure 6-3.
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b. Remove the pO2 sensor by lifting the sensor lip (item 2, Figure 6-4) up at the
bottom while pressing the top of the sensor (item 3, Figure 6-4) inward.
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c. Insert the clot clearing tool in the place of the pO2 sensor.
d. Press the black lever (item 2, Figure 6-5), located below the black
spring-loaded latch assembly, to reapply pressure to the sensor assembly.
3. Fill the syringe with water.
4. Insert the syringe in clot clearing tool (item 1, Figure 6-6).
a. If using a Luer Lock syringe, thread the syringe into the clot clearing tool
to ensure the syringe is secured firmly to the clot clearing tool.
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CAUTION: If the path is totally obstructed, liquid may be expelled suddenly and
with great force through the port at the back of the sample connector.
5. Press the syringe plunger gently while holding gauze against the port at the back of the
sample connector (item 1, Figure 6-7), to catch the obstruction and any excess liquid.
6. Remove the syringe.
1 Fitting to which the reagent manifold tubing and CO-ox pump tubing are connected
(Rapidlab 1245 and 1265 systems)
2 Reagent manifold tubing that connects the fitting to the port on the top, left-side of the
reagent manifold (Rapidlab 1245 and 1265 systems)
3 Sample connector
4 Waste tubing connected to port on top, right-side of the reagent manifold
5 Two latches that secure the reagent manifold to the system
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-21
b. Reinsert the reagent manifold tubing (item 2, Figure 6-7) into the fitting
(item 1, Figure 6-7) that connects to the CO-ox pump tubing
(Rapidlab 1245 and 1265 systems).
c. Reinsert the waste tubing into the port on the top, right-side of the reagent
manifold (item 4, Figure 6-7).
If an obstruction has been cleared, go to step 9.
If an obstruction has not been cleared, go to Clearing the Clot from
the Reagent Cartridge‚ page 6-22.
9. Reinstall the pO2 sensor.
a. Push the black spring enclosure assembly to the right, until the
mechanism clicks in place.
b. Remove the syringe.
c. Remove the clot clearing tool, by lifting the clot clearing tool lip up at the
bottom while pressing the top of the tool inward.
d. Reinstall the pO2 sensor.
e. Press the black spring enclosure assembly lever to reapply pressure to the
sensor assembly.
10. Close the system.
a. Reinstall the reagent and wash cartridges.
b. Close the reagent and wash module doors.
c. Close the front cover of the system.
11. Select the Return button twice to exit Diagnostics mode.
You are prompted to calibrate the system.
12. Select Yes to calibrate the system.
The clot clearing procedure is complete.
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Use this procedure only if the Clearing the Clot from the Preheater procedure fails to clear
the obstruction. The Clearing the Clot from the Reagent Cartridge procedure continues
from step 8 of the Clearing the Clot from the Preheater procedure, that begins on page 20.
1. Reinstall the reagent and wash cartridges.
2. Close the reagent and wash module doors.
3. Select the Return button.
4. Ensure the Reagent sample port is in position 2 by following these steps:
a. Select Pumps and Valves.
b. Select R Valve > Start > Change.
The character 2 displays on the screen.
5. Fill the syringe with water.
6. Insert the syringe into the clot clearing tool.
a. If using a Luer Lock syringe, thread the syringe into the clot clearing tool to
ensure the syringe is secured firmly to the clot clearing tool.
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e. Press the black spring enclosure assembly lever to reapply pressure to the sensor
assembly.
10. Close the measurement module cover.
11. Close the front cover of the system.
12. Select Stop.
13. Select the Return button twice to exit Diagnostics mode.
You are prompted to calibrate the system.
14. Select Yes to calibrate the system.
15. Replace the reagent sample port by following this procedure:
a. Select Status > Maintenance > Replace Sample Port.
b. Select the Continue.
Follow the instructions in the video to replace the sample port.
16. If the reagent manifold, preheater, and reagent cartridge clot clearing procedures fail
to locate the obstruction, see Removing Clots Using the Clot-Removal Line‚
page 6-24.
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1 Sample connector
2 Fluid connector
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6-26 Rapidlab 1200 Operator’s Guide: Troubleshooting
b. Push a clot-removal line through the preheater from right to left, opposite to the
direction of sample flow, until you see the clot-removal line at the sample
connector.
1 Preheater
2 Sample connector
CAUTION: Do not push the clot-removal line through the gas sensors. To avoid
damaging the gas sensors, do not exert excessive pressure to the gas sensor
membranes.
4. Inspect the pO2 and pCO2 (gas), sample ground/temperature, pH, and the reference
sensors for obstructions:
a. Remove the gas sensors one at a time and inspect each one for obstructions.
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b. If you detect an obstruction, fill a syringe with water, place the syringe
against the sample path and inject water through the sample path.
1 Sensor
2 Syringe
Figure 6-11 Injecting Water into the Gas Sensor Sample Path
CAUTION: Use the clot-removal line carefully to avoid damage to the sample
ground/temperature, pH, and reference sensors.
1 Sensor cartridge
2 Clot-removal line
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6-28 Rapidlab 1200 Operator’s Guide: Troubleshooting
d. If the obstruction is not removed, use a syringe filled with water and inject the
water through the sample path.
5. For Rapidlab 1260 and 1265 systems, inspect the Na+, Ca++, Cl¯, K+, Glu, and Lac
sensors for obstructions:
a. Remove the sensors one at a time and inspect each one for obstructions.
CAUTION: Do not push the clot-removal line through the Ca++, Cl¯, K+, Glu, and
Lac sensors. Pushing the clot-removal line through these sensors could cause
damage to the sensors.
b. Fill a syringe with water, place the syringe against the sample path, and inject
water through the sample path.
c. If the obstruction is not removed from the Na+ sensor, push the clot-removal line
through the sample path to remove obstructions.
6. Remove obstructions from the path through the latch:
a. Grasp the tab on the reference sensor and pull it up and out of the measurement
module.
b. Disconnect the pinch valve tubing from the spring-loaded latch.
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7. Remove obstructions from the sample waste path in the reagent manifold:
a. Disconnect the tubing from the reagent manifold.
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b. Push the clot-removal line through the fluid connector on the reagent manifold
until the clot-removal line appears again.
1 Fluid connector
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6-32 Rapidlab 1200 Operator’s Guide: Troubleshooting
b. Rotate the gray wheel towards you, pull the tubing through the fluid detector, and
remove the tubing from the steel measurement module connector.
c. Push the new tubing through the fluid detector.
d. Connect the tubing to the steel measurement module connector and to the sample
chamber connector.
Use a clamp or tweezers to help you attach the tubing.
3. Remove obstructions from the CO-ox waste tubing:
a. Disconnect the tubing from the steel fluid connector and the connector in the
pump tubing.
b. Push a clot-removal line through the tubing, opposite the direction of sample flow.
c. Reconnect the CO-ox waste tubing.
4. Remove obstructions from the waste path in the reagent manifold:
a. Disconnect the CO-ox pump tubing from the reagent manifold tubing at the
fitting.
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b. Push the clot-removal line through the fluid connector on the reagent
manifold.
Using Diagnostics
NOTE: Operators with level 1 or level 2 security access can access the diagnostic
tests.
NOTE: The system cannot perform routine fluidic activities while the Diagnostics
screen or subscreens are displayed. When you exit from the Diagnostics screen,
the system may perform an extended calibration before you can use the system.
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CAUTION: Do not select any other part of the screen and do not select the button
more than once each time it appears. Touching any other part of the screen or
touching the button more than once causes the screen to become inoperable. If this
occurs, call for technical assistance.
4. Select the button.
The button changes position on the screen.
5. Continue selecting the button again until the system returns to the Diagnostics
screen.
6. To return to the Status screen, select Return.
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Severity of Leak
a indicates a failure to create any pressure, a big leak
b indicates a failure to maintain pressure, a small leak
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CAUTION: Do not remove the wash or reagent cartridges for longer than 6 hours.
If the wash or reagent cartridge is removed from the system for longer than 6
hours, the cartridges are no longer valid.
3. Remove the reagent cartridge:
a. Select Cartridges > Eject R Cartridge.
b. Remove the reagent cartridge from the system and close the door.
c. Select Return.
4. Select Pumps and Valves.
To test the... Select...
sample pump, which is located on the Sample Pump > Start.
right as you face the system, The pump rotates toward you at the first
speed.
wash pump, which is located on the left as Wash Pump > Start.
you face the system, The pump rotates away from you at the
first speed.
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5. Look for obstructions and listen for any unusual noises that may indicate a problem
with the pump.
a. Select Change to advance the pump to the next speed.
b. Continue selecting Change and listening and looking for problems until you have
tested all 4 speeds.
6. Select Stop.
7. If you want to test the other pump, repeat this procedure from step 4.
8. Select Return to return to the Diagnostics screen.
9. Reinstall the reagent cartridge:
a. Select Cartridges > Eject R Cartridge.
b. Install the reagent cartridge and close the door.
10. Select the Return.
11. To return to the Status screen, select Return.
The system performs a prime and a full calibration.
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Use this procedure to test the CO-ox pump. The pump test moves the pump at 4 speeds
numbered 1 through 4. When you select the Change button, the system displays the
number of the current speed on the screen. The test is complete when speed 4 is displayed
on the screen.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Pumps and Valves > CO-ox Pump > Start.
The CO-ox pump rotates at the first speed.
4. Look for obstructions and listen for any unusual noises that may indicate a problem
with the pump.
5. Select Change to advance the pump to the next speed.
6. Continue selecting Change and listening and looking for problems until you have
tested all 4 speeds.
7. Select Stop and wait while the system returns the pump to the correct position.
8. Select Return.
9. To return to the Status screen, select Return.
The system performs a wash.
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CAUTION: Do not remove the wash or reagent cartridges for longer than 6 hours.
If the wash or reagent cartridge is removed from the system for longer than 6
hours, the cartridges are no longer valid.
2. Enter your password, if necessary.
3. Select Cartridges.
To eject the... Select...
wash cartridge, Eject W Cartridge.
reagent cartridge, Eject R Cartridge.
both cartridges, Eject Both Cartridges.
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D Codes
The Rapidlab 1200 diagnostics system assists operators in identifying and
resolving hardware problems. This section describes the Rapidlab 1200 system
diagnostic codes (D codes) and messages, the conditions that cause them, and
possible solutions. D codes identify changes in the system operation that require
corrective action.
Some D codes contain a qualifier after the message. The qualifier indicates a
specific condition related to the D code. For example, D2 indicates excessive drift
for a sensor. D2 Excessive Drift pO2 indicates that the pO2 sensor has excessive
drift. A qualifier that is a number, such as the number 7 in D35 Electronics Error:
7, is important information for the Service Representative.
Work through the corrective actions step by step until the problem is resolved.
When performing recommended corrective actions, refer to procedures described
in this manual and follow the manufacturer’s recommendations. To determine if
your action cleared the D code, view the events log.
For quick access to D code information, select Help.
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D2 Codes
D2 Excessive Drift: pO2 pCO2
Problem Corrective Action
Sensor drift is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • If the sensor was newly installed or if maintenance was
calibration recently performed, allow sufficient time for the sensor to
operations. equilibrate.
• Perform additional calibrations.
• If a D2 for pCO2, with a drift greater than 4.0 mmHg,
occurs twice in a 4-hour period and no drift occurs for pO2,
perform QC analysis.
If the pCO2 result is out of range, replace the sensor.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.
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D3 Codes
D3 Slope Error: pO2 pCO2
Problem Solution
Sensor slope is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • Perform a 2-point calibration.
calibration Refer to Performing Manual Calibrations‚ page 3-4.
operations.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.
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D4 Codes
D4 Offset Error: pO2 pCO2
Problem Corrective Action
Sensor offset is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during a • Perform a 2-point calibration.
1-point or a 2-point Refer to Performing Manual Calibrations‚ page 3-4.
calibration.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.
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D5 Codes
D5 No Endpoint: Ca++
Problem Corrective Action
Sensor does not Correct any reagent problems such as D23 codes before you
reach stable reading attempt to correct this D code.
during predefined • Ensure that the measurement module door was not opened
time limit. during analysis.
The patient sample If door was opened, repeat the sample analysis.
result for the
• Perform a 2-point calibration.
affected sensor is
reported as question Refer to Performing Manual Calibrations‚ page 3-4.
result (-----?). • If a D5 occurs during sample analysis, repeat the sample.
• Deproteinize the sample path and condition the sensors.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Check the solution level in the affected measurement sensor
and look for bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH
and Na+ sensors should be full. If the solution level is low,
refill the sensor.
• If a D5 occurs for more than one sensor, check the solution
level in the reference sensor and look for salt in the vent
hole, and bubbles in the sensor.
• Clean and refill the reference sensor as needed.
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D6 Codes
D6 Excessive Noise: pO2 pCO2
Problem Corrective Action
The sensor signal Correct any reagent problems such as D23 codes before you
has excessive noise. attempt to correct this D code.
The patient sample • Ensure that you did not open or apply pressure to the
result for the measurement module door during analysis.
affected sensor is If you opened or applied pressure to the door during
reported as question analysis, repeat the sample analysis.
result (-----?). • Ensure that you did not apply pressure to the top cover
during analysis.
If you applied pressure to the cover during analysis, repeat
the sample analysis.
• Perform a successful calibration (1-point or 2-point).
• If a D6 for pCO2, with a drift greater than 4.0 mmHg, occurs
twice in a 4-hour period and no drift occurs for pO2,
perform QC analysis.
If the pCO2 result is out of range, replace the sensor.
• If a D6 occurs during sample analysis, repeat the sample.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.
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D8–D22 Codes
D8 pO2 R Cartridge Error
Problem Corrective Action
The pO2 value • Calibrate the Barometric Sensor. Refer to Calibrating the
during a calibration Barometric Sensor‚ page 5-3
is different than the Perform a full calibration. Refer to Performing Manual
assigned value. Calibrations‚ page 3-4.
• If the pO2 sensor is greater than 6 months old, replace the
sensor.
Perform a full calibration. Refer to Performing Manual
Calibrations‚ page 3-4.
• If the problem persists, replace the reagent cartridge.
Perform a full calibration. Refer to Performing Manual
Calibrations‚ page 3-4.
• If the problem persists, call for technical assistance.
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D23 Codes
D23 Reagent Flow Error: 2, 10
Problem Corrective Action
Wash reagent was 1. Perform the highlighted test(s) in Diagnostics > Fluidic
not detected during Functions.
calibration. 2. Perform a leak test.
2 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test
10 FD2 fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed.
For Rapidlab 1245 and 1265 systems, verify that the CO-ox
sample chamber is installed correctly.
3. If the problem persists, replace the wash cartridge.
4. If the problem persists, call for technical assistance.
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D24 Codes
D24 AQC Material Error: 1, 2, 3
Problem Corrective Action
An error was 1. Check that the AutomaticQC connector is completely closed
detected during and that the sensors are aligned correctly.
delivery of AQC 2. Select Diagnostics > Fluidic Functions > Prime AQC
material. Cartridge.
1 level 1 The correct button is highlighted.
2 level 2
3. Check if there is an obstruction in the reagent probe
3 level 3
cartridge.
Refer to Flushing the Tubing for the AutomaticQC Module‚
page 5-57.
4. If the problem persists, replace the AutomaticQC cartridge.
NOTE: If you are not able to replace the cartridge, turn off the
AutomaticQC option in Setup to continue analyzing patient
samples.
5. If the problem persists, call for technical assistance.
D32 Codes
D32 AQC Cartridge Valve Error: 1
Problem Corrective Action
A valve does not 1. Select Diagnostics > Pumps and Valves > AQC Valve.
move to the correct 2. If the problem persists, replace the AutomaticQC cartridge.
position. 3. If the problem persists, call for technical assistance.
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D33 Codes
D33 R Cartridge Valve Error
Problem Corrective Action
The valve in the 1. Select Diagnostics > Pumps and Valves > R Valve.
reagent cartridge 2. Select Diagnostics > Cartridges > Eject Reagent
fails to move to the Cartridge.
correct position. 3. If the problem persists, replace the reagent cartridge.
4. If the problem persists, call for technical assistance.
D34 Codes
D34 Waste Detector Cal Error: 1
Problem Corrective Action
The waste detector 1. Select Diagnostics > Waste Detector.
is out of range 2. Select Status > Shutdown to shut down the system.
during a system 3. Wait 10 seconds, and then turn the system on.
calibration.
4. If the problem persists, call for technical assistance.
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D35 Codes
D35 Electronics Error: 1-3, 7-12
Problem Corrective Action
An error has 1. Select Status > Shutdown.
occurred in the 2. Wait 10 seconds, and then turn the system on.
electronic 3. If the problem persists, call for technical assistance.
components.
D36 Codes
D36 Cartridge Loading Error
Problem Corrective Action
The cartridge 1. Ensure that the cartridge is correctly positioned in the door
loader fails to move and nothing is blocking the cartridge from loading.
to the correct NOTE: Use the Eject Reagent Cartridge or Eject Wash
position during Cartridge test depending on the affected cartridge.
reagent or wash 2. Select Diagnostics > Cartridge > Eject W Cartridge or
cartridge removal Eject R Cartridge.
or installation.
3. If the problem persists, replace the cartridge.
4. If the problem persists, call for technical assistance.
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D37 Codes
D37 Cartridge Eject Error: 1
Problem Corrective Action
The eject 1. Select Diagnostics > Cartridge > Eject W Cartridge and
mechanism fails to Eject R Cartridge.
move to the correct 2. Select Status > Shutdown.
position. 3. Wait 10 seconds, and then turn the system on.
4. If the problem persists, call for technical assistance.
D38–D60 Codes
D38 Temp Error: 1-12
Problem Corrective Action
A component in the Check the Gnd sensor and ensure that it is aligned with the
temperature control contacts.
system failed or the If the problem persists, continue with the following:
ambient The system attempts to re-enable the temperature control every
temperature is 15 minutes and re-evaluates the error condition a maximum of 3
beyond the times. This temperature control process can take up to 3.5 hours.
acceptable • To determine the temperatures in the instrument, select
operating Diagnostics > Temperature/pAtm.
conditions.
• Ensure the ambient temperature is within 15° to 32°C.
• Ensure that the front cover is closed.
Wait while the system attempts to correct the problem.
• If the problem persists, select Status > Shutdown.
Wait 10 seconds, and then turn the system on.
• If the problem persists, call for technical assistance.
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D39 Obstruction
Problem Corrective Action
The system detects Correct any reagent problems such as D23 codes before you
an obstruction attempt to correct this D code.
while moving the • Select Diagnostics > Fluidic Functions > RCx.
sample for analysis. • Correct any new D23 problems if they occur.
• Remove obstructions from reagent manifold, measurement
module, CO-ox sample chamber, and sample tubing where
you suspect obstructions.
Refer to Removing Obstructions from the Sample Path‚
page 6-12 and Removing Obstructions from the CO-ox
Sample Path‚ page 6-31.
• Repeat the RCx test to see if obstructions are cleared.
• Select Diagnostics > Fluidic Functions > Wash Cycle.
• If the problem persists, replace the reagent cartridge.
• If the problem persists, call for technical assistance.
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D70 Codes
D70 Optics Error: 2
Problem Corrective Action
The system fails a 1. Perform a 1-point calibration.
CO-ox optical Refer to Performing Manual Calibrations‚ page 3-4.
clarity test. 2. If the problem persists, replace the CO-ox sample chamber.
3. If the problem persists, call for technical assistance.
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D71–D77 Codes
D71 No Sample Detected at FD3
Problem Corrective Action
Fluid detector 3 • Ensure the sample volume is sufficient for the sample type.
(FD3) does not • Select Diagnostics > Fluidic Functions > RCx.
detect the sample • Look for obstructions or poor flow in the CO-ox sample
during the path.
predefined time • Remove obstructions from the CO-ox sample path:
limit.
If the obstruction is in the CO-ox sample tubing, replace the
CO-ox results are tubing.
not reported. Blood
If the obstruction is in the CO-ox pump tubing or waste
gas, pH, electrolyte,
tubing, remove the obstruction.
and metabolite
• Repeat RCx test to check flow through the sample path.
results are reported.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Perform a full calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
• If the problem persists, call for technical assistance.
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D78 Codes
D78 No Reagent Detected at CO-ox: 1
Problem Corrective Action
Fluid detector 3 • Perform the highlighted test(s) in Diagnostics > Fluidic
(FD3), the CO-ox Functions.
sample chamber, or • If the problem persists, select Diagnostics > Fluidic
both do not detect Functions > RCx and look for obstructions in the CO-ox
wash reagent sample path.
during a Remove obstructions.
calibration. • Repeat the RCx test to check flow through the CO-ox
sample path.
• Perform a leak test.
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For
Rapidlab 1245 and 1265 systems, verify that the CO-ox
sample chamber is installed correctly.
• If no other D codes occur, replace the CO-ox sample
chamber.
• If the problem persists, call for technical assistance.
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Temp Not The temperature of the This message can occur when the
Ready measurement module is beyond system is warming up after being
the acceptable measurement shut down or when the door
range. remains open for too long.
Ensure that you closed the front
cover securely.
Wait until the system removes
the message from the events log
before analyzing samples.
Temp Warning The system detects that the This message can occur when the
temperature of the measurement system is warming up after being
module is beyond the specified shut down or when the door
range for sample analysis. remains open for too long.
Ensure that you closed the front
cover securely.
Wait until the system removes
the message from the events log
before analyzing samples.
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7 File Management
This section contains information about the following file management topics:
• File names and formats
• Copying data files
• Viewing the sample totals
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Row Contents
3 through the end The remaining rows contain the values for each record in the file.
of the file Each record contains results for a single sample analysis. The
records are sorted by date, beginning with the most recently
saved data.
In each calibration file, the data is organized in rows:
Row Contents
1 and 2 The first 2 rows contain column headings. The data includes
columns for 1-point and 2-point calibrations. The system
reserves the last columns for system messages associated with
results.
3 The third row contains units of measure.
4 through the end The remaining rows contain the values for each record in the file.
of the file Each record contains results for 1 calibration. The system sorts
records by date, beginning with the most recently saved data.
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5. Store the diskettes or CD in a safe place, away from heat and strong magnetic
sources such as centrifuges.
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8 System Configuration
Use this section to modify the system configuration options on the Setup menu.
The Setup menu contains the options for customizing the analysis and reporting
characteristics of your Rapidlab 1200 system.
After you customize any of these settings you can select another Setup option or
save the setup data. Refer to Saving and Restoring System Setup Data‚ page 8-41.
To access the Setup screen, perform the following steps:
1. At the user interface, select Status > Setup.
You can select a setup button on the left of the screen to display the setup
options to configure that system function.
2. Select the function type on the left of the screen.
3. Select the function option on the right side of the screen.
4. Enter your password, if necessary.
Refer to Using Basic System Functions‚ page 2-1.
5. Perform the task according to the instructions in this section.
6. Save the Setup data to a diskette or CD each time you change system
configuration.
Refer to Saving and Restoring System Setup Data‚ page 8-41.
setup the printer settings, configure the barcode information, or turn Printer and
on communications to a data management system or LIS, Devices
set security, setup system analysis functions, backup and restore setup Secured
configuration, and install software upgrades, Options
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Setting up QC
When you select QC at the Setup screen, the following options are available:
• QC Options
• Required QC Schedule
• Required QC Ranges
• AutomaticQC Schedule
• AutomaticQC Ranges
• High G/L
Setting Up QC Options
Use the QC Options screen to enable or disable a QC option, enable or disable syringe QC,
require Operator identification, and select a method for QC range checking.
1. At the Setup screen, select QC Options.
2. At the QC options screen, select a performance option:
If you want... Select...
to perform QC sample analysis on an as needed basis, Unscheduled QC.
to require operators to perform QC sample analysis Required QC.
according to a schedule,
the system to perform QC samples as scheduled in QC AutomaticQC.
Setup,
3. If you select AutomaticQC and you want all failed AutomaticQC samples to repeat,
select Repeat.
4. Select the syringe QC button to enable syringe QC samples.
5. At the area labeled Required Field, select Operator ID to display the operator
identification screen when an operator is analyzing QC samples.
6. To make the Operator ID a requirement, select the Required button.
7. Select a QC Range Checking Methodology:
If you want to... Select...
use the manufacturer’s low and high ranges for QC range Low, High.
checking,
to perform RiliBÄK analysis (does not apply to CO-ox RiliBÄK
fractions),
If you want to customize ranges, follow the procedure in the next section, Entering
Customized QC Range Limits‚ page 8-3.
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Setting Up Required QC
Use the Required QC screen to set up a required QC sample schedule. Use the
barcode scanner and RapidQC controls to perform Required QC analysis.
NOTE: Ensure that you enter information for each lot of the controls you
schedule. Refer to Setting up Required QC Ranges‚ page 8-4. You cannot analyze
the scheduled controls until you enter the lot information.
1. At the Setup screen, select QC > Required QC Schedule.
The screen displays the Required QC Schedule with the current schedule for
Required QC analysis, if defined.
NOTE: When you change intervals, the system clears any times and levels
that were previously scheduled.
2. Select Intervals.
The system displays the Intervals screen.
3. Select the number of hours for the interval of the Required QC analysis.
For example, select 8 to have an 8-hour window for performing scheduled
controls.
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4. Select Save.
The Intervals screen closes.
5. Schedule levels for each time and day, as necessary:
a. Use the arrow keys to navigate to a place in the grid indicating the day of the week
and time period for the level or levels.
b. Select one or more buttons for the level or levels to schedule.
A check mark on the button means that you scheduled that level. Select the button
again to remove the check mark.
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6. At the Required QC Ranges screen, select Save to return to the Setup menu.
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* Indicates parameters available only on Rapidlab 1260 and Rapidlab 1265 systems.
† Indicates parameters available only on Rapidlab 1245 and Rapidlab 1265 systems.
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NOTE: Only the first panel in the first set can be selected as a default panel.
7. Select Save > Return > Analysis.
The default panel is selected automatically. Parameters that are not in the
default panel do not display. You can deselect the default panel at the Analysis
screen, then select a different custom panel or select other parameters.
Microsample panels display a µ character at the top-left of the panel.
Setting up Parameters
When you select Parameters at the Setup Window, the following options are
available:
• Parameter On/Off
• Parameter Units
• Demographic Units
• Values
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• If you turn a parameter off, leave Setup, and then turn the parameter on again in Setup,
you may need to calibrate and QC the parameter.
The sensor for that parameter is out of calibration until it passes a successful
calibration. The sensor may also have failed QC if Required QC or AutomaticQC was
scheduled while the parameter was turned off.
• When you select a parameter that uses a sample demographic to report results, the
system automatically turns the demographic on.
For a list of parameters that are dependent on sample demographics and other
parameters for results, refer to Required Parameters and Sample Demographics‚
page 8-17.
Using Hct
• On Rapidlab 1245 and 1265 systems, Hct is a calculated value determined from the
tHb result.
• To report Hct, ensure that tHb is selected at the first Parameters On/Off screen and Hct
is selected at the second screen.
Using tHb
• When tHb is on, the CO-ox fractions are also on.
• If tHb is off, the CO-ox fractions are off.
NOTE: CO-ox fractions may be turned off independently, but if tHb is selected again,
the fractions are turned on.
• When tHb is selected at the Sample Demographic screen, tHb is not available on the
Parameters On/Off screen.
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Na+* mmol/L
K+* mmol/L
Cl¯* mmol/L
FO2Hb† % (decimal)
FCOHb† % (decimal)
FMetHb† % (decimal)
FHHb† % (decimal)
pH(T) (pH units) nmol/L
When selecting alternate units, the parameter name
changes to H+(T).
pCO2(T) mmHg kPa
pO2(T) mmHg kPa
HCO3¯act mmol/L
HCO3¯std mmol/L
BE(B) mmol/L
BE(ecf) mmol/L
ctCO2 mmol/L
sO2† % (decimal)
O2SAT(est) % (decimal)
O2CT mL/dL mL/L, mmol/L
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* Indicates parameters available only on Rapidlab 1260 and Rapidlab 1265 systems.
† Indicates parameters available only on Rapidlab 1245 and Rapidlab 1265 systems.
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Hct‡ tHb
BO2 tHb, (FHHb and FO2Hb) or (FCOHb and FMetHb)
pO2(A-a)(T) pO2(T), FIO2, temperature, pCO2, pAtm
pO2(a/A)(T) pO2(T), FIO2, temperature, pCO2, pAtm
p50 pO2, pH, BE(B), sO2
tHb, ctO2(a), ctO2(a- ), FIO2, temperature, pCO2, pAtm, O2
sp/ t(T)
binding factor‡, (FHHb and FO2Hb) or (FO2Hb, FCOHb, and
FMetHb)
O2 ctO2(a), t
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O2 ctO2(a- ), t
* If ctHb is not available as an entered value and tHb is not available, the system uses 15 g/dL as a
default value.
† The system uses a default value for these parameters.
‡ A calculated value determined from the total hemoglobin value.
Setting up Values
Use this screen to enter the default values for the O2 Binding Factor (OBF) and
ctO2(a- ):
1. At the Setup screen, select Parameters > Values.
The screen shows the current values.
2. Select the demographic you want to change.
3. Enter a value and then select Save.
4. Select Save.
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Selecting a Language
You can select the language for the text on the system screens and messages and the
language used in the videos. English is the default language. You may access other
languages on the drop-down list.
1. At the Setup screen, select System Options > Country Options.
2. Select the language.
3. Select Save.
The Wait screen displays while the system converts the screens to the new language.
If you select the wrong language, you can return to the language selection screen and
select the correct language.
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WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.
CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
Setting up Communications
Use the Communications screen to setup a time for sending system data, and setup
connections to external devices. For systems connected to an LIS, this screen can also be
used to select cSO2
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WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.
CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
3. Connect the interface cable to the system and to the Rapidlink or Rapidcomm
server or workstation:
a. Connect the 9-pin connector on the cable to the serial (RS-232) port
located on the back panel of the Rapidlab 1200 system.
b. Connect the other connector on the cable to a serial port on the Rapidlink
or Rapidcomm server or workstation.
4. Turn the power on.
5. Select the communication settings at the Rapidlab 1200 system:
a. Select Status > Setup.
b. If required, enter your password.
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Entering IP Addresses
Use this procedure to enter network IP addresses.
1. Obtain the following network information from your institution’s network
administrator:
• IP address for the Rapidlab 1200 system
• IP address for the Rapidlink or Rapidcomm server or workstation where
you want to connect the Rapidlab 1200 system
• IP address for the default router port assigned to the network segment on
which the Rapidlab 1200 system is located
• Network mask for the institution’s network
2. Select the communication settings at the Rapidlab 1200 system:
a. At the Setup screen, select Printer and Devices > Communications.
b. Select CompleNet > Configure.
c. Select Save.
d. Select Enter IP Address.
e. Enter the IP addresses for the Rapidlab 1200 system, the default router
port, and the network mask.
Ensure that you enter the IP addresses and the network mask in the correct
fields.
f. Select Save.
3. At the Communications screen, select Save.
4. When prompted that the connection was unsuccessful, select Continue.
5. Connect the network cable to the RJ-45 connector on the back panel of the
Rapidlab 1200 system.
6. Connect the network cable to the site network connection.
7. At the Rapidlink or Rapidcomm workstation, enter the communication
settings.
Refer to the Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.
8. At the Rapidlab 1200 system, select Save.
9. Select Return when finished.
10. To complete any additional setup that may be necessary to operate the
Rapidlab 1200 system with the Rapidlink or Rapidcomm program, refer to the
Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.
02087462 Rev. V
8-30 Rapidlab 1200 Operator’s Guide: System Configuration
Using DHCP
Use this procedure to use dynamic host configuration protocol.
1. Select the communication settings at the Rapidlab 1200 system:
a. At the Setup screen, select Printer and Devices > Communications.
b. Select CompleNet > Configure.
c. If you want to change the name for the Rapidlab 1200 system, select
Rapidlab 1200 and enter the name for the Rapidlab 1200 system.
d. Select Continue.
e. Select Use DHCP > Save.
f. At the Communications screen, select Save.
2. When prompted that the connection was unsuccessful, select Continue.
3. Connect the network cable to the RJ-45 connector on the back panel of the
Rapidlab 1200 system.
4. At the Rapidlink or Rapidcomm workstation, enter the communication settings.
Refer to the Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.
5. At the Rapidlab 1200 system, select Save.
6. Select Return.
7. To complete any additional setup that may be necessary to operate the Rapidlab 1200
system with the Rapidlink or Rapidcomm program, refer to the Rapidlink Supervisor’s
Manual or Rapidcomm User’s Guide.
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-31
WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.
CAUTION: Do not remove power from the system for more than 6 hours if
cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.
f. Select Save.
6. At the Communications screen, select Save.
If an error message displays, refer to Viewing System Messages‚ page 6-74.
7. Select Return.
8. Complete any setup at the LIS that may be required to communicate with the
Rapidlab 1200 system.
02087462 Rev. V
8-32 Rapidlab 1200 Operator’s Guide: System Configuration
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-33
Automatic remote viewing allows the remote user to connect to the local system
any time the local system is operational. Remote viewing is available to remote
users when the local system is restarted.
Manual remote viewing requires the local operator to decide when to allow
remote viewing. Remote viewing is unavailable to remote users when the local
system is restarted.
1. At the Setup screen, select Printer and Devices.
Select the down arrow and then select Remote Viewer.
At the Remote Viewer screen a Services column and a Configure column
display.
2. To enable remote viewing automatically, select Automatic in the Configure
column.
To disable remote viewing, select Manual in the Configure column.
Manual is the default setting.
3. Select Continue.
02087462 Rev. V
8-34 Rapidlab 1200 Operator’s Guide: System Configuration
Enabling Remote Viewing Using the Remote Viewing Buttons in the Banner
1. Enable remote viewing by following the procedure in Enabling Remote Viewing‚
page 8-32.
The message Disconnect Remote User displays when remote viewing is enabled and a
remote user connects to the local system. The message displays in the top-left corner
of the banner and alternates, at 5second intervals, with the current system status text.
When Disconnect Remote User displays, a remote viewer is connected to the system
and can view and control the system.
The Disconnect Remote User button also functions as a touch screen button.
2. To disconnect the remote viewer, select Disconnect Remote User.
The Disconnect Remote User message changes into Enable Remote Viewer message.
When the Enable Remote Viewer message displays, the remote user is disconnected
and cannot view or control the local system.
The Enable Remote Viewer message also functions as a touch screen button.
3. To enable remote viewing, select Enable Remote Viewer.
When selected, the Enable Remote Viewer button ceases to display.
When a remote user connects to the local system after the Enable Remote Viewer
button is selected, the Disconnect Remote Viewer button displays.
As explained in step 2, selecting the Disconnect Remote Viewer button disconnects
the remote user and the Enable Remote Viewer button displays, and can be used to
enable a remote viewer.
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-35
02087462 Rev. V
8-36 Rapidlab 1200 Operator’s Guide: System Configuration
When access is Restricted, the system requires a password for every level of operator for
all functions.
Table 8-1 Restricted Access Setting
Level/Pass Level/Pass Level/Pass Level/Pass
Function 1 2 3 4
analyzing samples Yes/Yes Yes/Yes Yes/Yes Yes/Yes
recalling data Yes/Yes Yes/Yes Yes/Yes Yes/Yes
replacing cartridges Yes/Yes Yes/Yes Yes/Yes No
initiating calibrations Yes/Yes Yes/Yes Yes/Yes No
accessing Setup Yes/Yes Yes/Yes No No
options
accessing Diagnostics Yes/Yes Yes/Yes No No
accessing the Restore Yes/Yes Yes/Yes Yes/Yes No
QC screen
accessing secured Yes/Yes No No No
options
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-37
The Unrestricted access setting allows for more access with fewer password
requirements on every level.
Table 8-3 Unrestricted Access Setting
Level/Pass Level/Pass Level/Pass Level/Pass
Function 1 2 3 4
analyzing samples Yes/No Yes/No Yes/No Yes/No
recalling data Yes/No Yes/No Yes/No Yes/No
replacing cartridges Yes/No Yes/No Yes/No Yes/No
initiating calibrations Yes/No Yes/No Yes/Yes Yes/Yes
accessing Setup Yes/No Yes/No Yes/No Yes/No
options
accessing Diagnostics Yes/Yes Yes/Yes No No
accessing the Restore Yes/Yes Yes/Yes Yes/Yes No
QC screen
accessing secured Yes/Yes No No No
options
02087462 Rev. V
8-38 Rapidlab 1200 Operator’s Guide: System Configuration
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-39
CAUTION: Do not perform analysis during proficiency testing. When this option
is turned on, results for patient samples are not reliable. Turn the option off when
testing is completed.
Use the Display Question Results option with Rapidlab 1245 and 1265 systems to
display the results for tHb and fractions when performing proficiency testing.
To set up Display Question Result, perform the following steps:
1. At the Setup screen, select Secured Options > Analysis Options.
2. Select Display Question Result and then select Save.
3. Select Return.
4. Perform proficiency testing.
5. After proficiency testing, repeat Steps 1 and 2 to turn the Display Question
Results option off.
02087462 Rev. V
8-40 Rapidlab 1200 Operator’s Guide: System Configuration
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-41
Setting up Calibrations
The Calibrations screen allows you to select the interval when you want a 1-point
calibration run and if you want the system to issue a warning for the pending
calibration.
02087462 Rev. V
8-42 Rapidlab 1200 Operator’s Guide: System Configuration
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-43
02087462 Rev. V
8-44 Rapidlab 1200 Operator’s Guide: System Configuration
CAUTION: Do not change the correlation coefficients until you collect the
appropriate data. Changing correlation coefficients affects the reported results for
patient samples. Before changing correlation coefficients, determine the slope and
offset values, as described in Performing a Correlation Study‚ page 2-34.
Use this procedure to enter slope and offset (intercept) values to correlate the patient
sample results from the Rapidlab 1200 system to those obtained using another
measurement system. The following table lists the valid ranges for slope and offset:
Default Slope Default Offset
Parameter Slope Range Offset Range
pH 1.0 0.8–1.2 0.0 +/- 9.9
pCO2, pO2, Na+, K+, Ca++, Cl¯, Glu, 1.0 0.8–1.2 0.0 +/- 99
Lac, tHb
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-45
02087462 Rev. V
8-46 Rapidlab 1200 Operator’s Guide: System Configuration
02087462 Rev. V
Appendix A: Safety Instructions
02087462 Rev. V
A-2 Rapidlab 1200 Operator’s Guide: Safety Instructions
References
1. Centers for Disease Control. 1988. Update: Universal precautions for prevention of
transmission of human immunodeficiency virus, hepatitis B virus and other blood
borne pathogens in healthcare settings. MMWR, 37:377–382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved Guideline -
Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2005).
3. Federal Occupational Safety and Health Administration. Bloodborne Pathogens
Standard. 29 CFR 1910. 1030.
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Safety Instructions A-3
02087462 Rev. V
A-4 Rapidlab 1200 Operator’s Guide: Safety Instructions
02087462 Rev. V
Appendix B: Service, Ordering, and Warranty
Authorized Representative
Siemens Healthcare Diagnostics Ltd.
Sir William Siemens Sq.
Frimley, Camberley, UK GU16 8QD
Warranty Period
The limited warranty period generally commences upon installation of the
original instrument at the customer’s location and extends for a period of
1 year thereafter, unless otherwise specifically agreed to by and between Siemens
(or its authorized distributors) and customer in a writing signed by duly authorized
representatives of both parties (sales representatives are generally not authorized
representatives of Siemens for these purposes).
02087462 Rev. V
B-2 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-3
Replacement of Parts
In performing service, Siemens or its authorized distributors provide appropriate
parts to repair the instrument, or arrange for the exchange of the instrument or
affected parts, at no charge with the exception of certain parts or subassemblies
that are considered Customer Maintenance Items. Customer Maintenance Items
include, but are not limited to, the following items: lamps, electrodes or sensors
(which are covered by a separate warranty), reagents, calibrators, controls, paper,
and pens. Consult the appropriate system operator’s manuals for a complete list of
Customer Maintenance Items for any specific model of instrument.
02087462 Rev. V
B-4 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-5
Copyright Information
The Rapidlab 1200 systems software incorporates a number of third-party
software applications under license to Siemens Healthcare Diagnostics, Inc. or
one of its affiliates. For those applications that request that certain information,
such as software headers, copyright notices, or software headers and copyright
notices, be distributed with the application, see the information listed below,
which is organized by application. The text in these sections is reproduced
verbatim.
02087462 Rev. V
B-6 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty
Baptize V1.0
Baptize
BAPTIZE V1.0
This tool sets the computername to the specified value without the need to reboot the
machine.
Usage:BAPTIZE new_name
After the program finished your computer is visible to others on the network under its new
name. BAPTIZE is tested to work with NetBEUI and TCP/IP.
NOTE:
Depending on the configuration of your computer this program may run for up to 1
minute. Don't get panic! During some amount of this time your computer may not be
visible on the network.
You may freely distribute this tool as long as you include this textfile and don't change
neither this textfile nor the code.
You can reach me at:
e-Mail:bec@advge.magwien.gv.at
CIS: 100112,3051
Jo.Berlakovich
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-7
BDM Download
A Background Debug Mode Driver Package for Motorola's 16- and 32-Bit
Microcontrollers
Scott Howard
February, 1993
The files in this archive are a PRELIMINARY RELEASE of a set of driver
functions, which allow control of the Background Debug Mode interface port of
any Motorola CPU16 or CPU32 microcontroller from the parallel printer port of
an IBM compatible computer. Source code in 'C', as well as object code and
example programs, are all included.
They accompany the forthcoming Motorola applications note of the same name.
You should have this app note in order to use these routines; the app note
documents the use of these functions, and documents the hardware interface
required by these routines.
All routines are Copyright (C) 1992 by Scott Howard, all rights reserved. Any
person or company is entitled to use this software and to make copies for others,
provided no charge is made for doing so. This software is distributed freely and
without warranty of any kind, not even implied warranty of suitability for any
particular use. The user of the software is solely responsible for determining
suitability for a particular purpose.
The user of this software agrees to hold Scott Howard, and Motorola Inc., its
employees, subsidiaries, agents, and distributors, blameless and free from
responsibility for any damages resulting from the use and/or malfunction of this
software, including direct and consequential damages and loss of income.
This is a preliminary release of these routines. You should have received with this
archive a printed preliminary copy of the applications note. If you did not, please
contact me and I will forward a copy.
This is free software, and it was written as a spare-time project. As such, it is
given away freely including source code, but there is no facility for Motorola or
myself to be able to provide support to users. If you need help, I will try to do my
best to support you, but please understand that the amount of time for this work is
limited and may only be available at irregular intervals.
Scott Howard
Motorola Semiconductor Products, Canada
Vancouver, B.C., Canada
POST: SCN088
Internet: Scott_Howard-SCN088@email.mot.com
Fax: +1-604-241-6290
February 1993
02087462 Rev. V
B-8 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-9
Contacts
This section provides the following information:
• the address of the Siemens authorized representative, which is the Siemens
contact within the European community
• addresses for obtaining service and technical information and for ordering
supplies
Authorized Representative
Siemens Healthcare Diagnostics Ltd.
Sir William Siemens Sq.
Frimley, Camberley, UK GU16 8QD
Addresses
For technical assistance contact your local technical support provider. For
customer service or additional information contact your local technical support
distributor. www.siemens.com/diagnostics
Siemens Healthcare
Diagnostics Pty Ltd
885 Mountain Highway
Bayswater Victoria 3153
Australia
02087462 Rev. V
B-10 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty
02087462 Rev. V
Appendix C: System Fluids
02087462 Rev. V
C-2 Rapidlab 1200 Operator’s Guide: System Fluids
02087462 Rev. V
Appendix D: Supplies
02087462 Rev. V
D-2 Rapidlab 1200 Operator’s Guide: Supplies
Item REF
K+ Ready sensor 10376879
02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Supplies D-3
Item REF
Caps (100) 01558100
Caps (200) 08685906
CD, Rapidlab 1200 Interface Specification 06621307
Guide, Rapidlab 1200 Operator’s, English 06621382
Guide, Rapidlab 1200 Operator’s, French 06622214
Guide, Rapidlab 1200 Operator’s, German 06624454
Guide, Rapidlab 1200 Operator’s, Italian 06626058
Guide, Rapidlab 1200 Operator’s, Spanish 06625361
Guide, Rapidlab 1200 Operator’s, Portuguese 06628093
Guide, Rapidlab 1200 Operator’s, Swedish 06629243
Guide, Rapidlab 1200 Operator’s, Japanese 06630926
Guide, Rapidlab 1200 Operator’s, Finnish 02002904
Guide, Rapidlab 1200 Operator’s, Danish 03322392
Guide, Rapidlab 1200 Operator’s, Greek 06856925
Guide, Rapidlab 1200 Operator’s, Polish 06856933
CD, Rapidlab 1200 Operator’s Guide 06631302
02087462 Rev. V
D-4 Rapidlab 1200 Operator’s Guide: Supplies
02087462 Rev. V
Appendix E: System Specifications
The following table lists the specifications for the Rapidlab 1200 systems.
Table E-1 Rapidlab 1200 System Specifications
Property Specification
Ambient operating temperature 15–32°C
Ambient temperature change less than 4°C per hour
Ambient operating relative humidity 5–90%, non-condensing
Ambient shipping temperature -25–45°C
Ambient storage temperature 4–45°C
Power rating 150VA
Voltage requirements 100V/240V (85V to 264V autoranging)
50/60Hz
Ambient operating barometric 523–800 mmHg (69.7–106.7 kPa)
pressure
System dimensions, base model height 61.0 cm (24 inches)*
width 53.5 cm (21 inches)
depth 58.5 cm (23 inches)
weight 29.5 kg (65 lbs)
* Height with screen fully upright
02087462 Rev.V
E-2 Rapidlab 1200 Operator’s Guide: System Specifications
The following table lists the units, reporting ranges, and display resolutions for the
electrolyte parameters measured or calculated by the Rapidlab 1200 systems.
Table E-3 Electrolyte and Metabolite Parameters
Parameter Units Reporting Range Resolution
Na+ mmol/L 70.0–200.0 0.1
The following table lists the units, reporting ranges, and display resolutions for the
oxygenation parameters calculated by the Rapidlab 1200 systems.
Table E-4 Oxygenation Parameters
Parameter Units Reporting Range Resolution
p50 mmHg 15.0–75.0 0.1
kPa 2.00–10.00 0.01
ctO2(a) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
ctO2(v) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
ctO2( ) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
O2SAT(est) % 15.0–100.0 0.1
decimal fraction 0.15–1.000 0.001
pO2/FIO2 mmHg/% 0.25–7.00 0.01
kPa/% 0.033–0.933 0.001
O2CT(est) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.8 0.1
ctO2(a- ) mL/dL 0.0–20.0 0.1
mL/L 0–200 1
mmol/L 0.0–8.9 0.1
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Rapidlab 1200 Operator’s Guide: System Specifications E-3
O2 mL/min 0–3500 1
L/min 0.00–3.50 0.01
mmol/min 0–156.2 0.1
mL/min 0–3500 1
O2
L/min 0.00–3.50 0.01
mmol/min 0–156.2 0.1
The following table lists the units, reporting ranges, and display resolutions for
parameters measured by the Rapidlab 1200 systems CO-ox module.
Table E-5 CO-ox Module Parameters
Parameter Units Reporting Range Resolution
tHb g/dL 2.0–25.0 0.1
g/L 20–250 1
mmol/L 1.2–15.5 0.1
FO2Hb % (blood) 0.0 100.0 0.1
% (QC) 0.0 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
FCOHb % (blood) 0.0−100.0 0.1
% (QC) 0.0 ± 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
FMetHb % (blood) 0.0−100.0 0.1
% (QC) 0.0 ± 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
FHHb % (blood) 0.0−100.0 0.1
% (QC) 0.0 ± 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
sO2 % 15.0–100 0.1
fraction 0.15–1.000 0.001
Hct % 6–74 1
fraction 0.06–0.74 0.01
BO2 (O2CAP) mL/dL 0.0–40.0 0.1
mL/L 0–400 1
mmol/L 0.0–17.9 0.1
02087462 Rev.V
E-4 Rapidlab 1200 Operator’s Guide: System Specifications
The following table lists the units, reporting ranges, and display resolutions for the
metabolic parameters calculated by the Rapidlab 1200 systems.
Table E-7 Metabolic Parameters
Parameter Units Reporting Range Resolution
HCO3-act mmol/L 0.0–99.9 0.1
02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-5
The following table lists the units, reporting ranges, and display resolutions for the
parameters that can be entered into the Rapidlab 1200 systems.
Table E-8 Entered Parameters
Parameter Units Reporting Range Resolution
Temperature °C 10.0–43.9 0.1
°F 50.0–111.0 0.1
FIO2 % 15.0–100.0 0.1
decimal fraction 0.150–1.000 0.001
ctHb g/dL 2.0–25.0 0.1
g/L 20–250 1
mmol/L 1.2–15.5 0.1
Qt L/min 0.00–30.00 0.01
OBF 1.35–1.40 0.01
Flow L/min 0.00–99.99 0.01
Resp Rate b/min 0.0–100.0 0.1
02087462 Rev.V
E-6 Rapidlab 1200 Operator’s Guide: System Specifications
Interference Testing
Interference Testing for Rapidlab 1200 Sensors
Siemens performed interference testing to demonstrate the specificity of the system
sensors.
The results from each of the studies were tabulated and the simple average effect was
determined for each interfering compound. The Effect of Interference column
demonstrates the apparent change in result as a function of introducing the interfering
compound. In several instances multiple tests were performed on an interfering substance
as well as several levels of interfering substance.
The effect of the potential interfering substance on results is summarized in the following
table. The table shows the interference level tested along with the average change in blood
results (test result spiked - control result unspiked) for each of the sensors.
Effect of
Interference Interference
Analyte (units) Interference Level Tested (Test - control)
pH (pH units) Acetaminophen 20 mg/dL 0.000
Sodium Pentothal 300 mg/dL -0.009
Salicylic Acid 20 mg/dL 0.000
pO2 (mm Hg) Isoflurane 3% 0.15
Halothane 3% 0.05
Nitrous Oxide 84% 2.8
pCO2 (mm Hg) Ibuprofen 40 mg/dL 0.35
Sodium Pentothal 300 mg/dL 1.34
Na+ (mmol/L) Acetaminophen 2 mg/dL 0.00
Dobutamine 20 mg/dL 0.37
Dobutamine 10 mg/dL 0.15
Dobutamine 5 mg/dL 0.20
Na+ (mmol/L) Vancomycin 63 µg/dL -0.23
Ofloxacin 6 µg/dL -0.14
Perphenazine 1.25 µg/mL 0.05
Sodium Pentothal 300 mg/dL -0.88
K+ (mmol/L) Sodium Pentothal 300 mg/dL -0.016
02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-7
Effect of
Interference Interference
Analyte (units) Interference Level Tested (Test - control)
Acetylsalicylic 50 mg/dL 0.5
Acid
Acetaminophen 2 mg/dL 0.0
Sodium Pentothal 300 mg/dL -1.0
Ca++ (mmol/L) Acetaminophen 2 mg/dL -0.03
Ibuprofen 40 mg/dL -0.03
Salicylic Acid 20 mg/dL -0.04
Salicylic Acid 30 mg/dL -0.40
Sodium Pentothal 300 mg/dL -0.01
Ca++ (mmol/L) Acetylsalicylic 50 mg/dL 0.04
Acid
Acetylsalicylic 30 mg/dL 0.01
Acid
Acetylsalicylic 15 mg/dL 0.01
Acid
Glucose (mg/dL) Acetaminophen 2 mg/dL -11.8
Heparin 90 units/mL 7.8
Salicylic Acid 30 mg/dL -0.5
Salicylic Acid 20 mg/dL -0.3
Ethanol 350 mg/dL -1.5
Dopamine 10 mg/dL -12.6
Dopamine 5 mg/dL 12.5
Dobutamine 20 mg/dL -9.5
Dobutamine 10 mg/dL -5.5
Dobutamine 5 mg/dL -2.0
Acetylsalicylic 50 mg/dL -1.5
Acid
Sodium Pentothal 300 mg/dL -0.9
pO2 25–85 mm Hg -1.0
Pralidoxime Iodide 16 µg/mL *
02087462 Rev.V
E-8 Rapidlab 1200 Operator’s Guide: System Specifications
Effect of
Interference Interference
Analyte (units) Interference Level Tested (Test - control)
Sodium 70 mg/dL < +/-0.3
Nitroprusside
Thiocyanate 80 mg/dL < +/-0.3
Heparin 20,000 U/dL < +/-0.3
Epinephrine 2 mg/dL < +/-0.3
Norepinephrine 2 mg/dL < +/-0.3
Phenobarbital 15 mg/dL < +/-0.3
Glutamate 16 mg/dL < +/-0.3
Hetastarch 30% < +/-0.3
Acetoacetate 40 mg/dL < +/-0.3
Ascorbate 8 mg/dL < +/-0.3
Dilantin 14 mg/dL < +/-0.3
Bilirubin (Direct) 30 mg/dL < +/-0.3
Bilirubin (Total) 35 mg/dL < +/-0.3
Pralidoxime Iodide 64 µg/mL †
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E-10 Rapidlab 1200 Operator’s Guide: System Specifications
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Rapidlab 1200 Operator’s Guide: System Specifications E-11
NOTE: This interferent is patient- and sample-specific and does not result in
interference to subsequent measurements of other samples on the calcium sensor.
There is no impact to sensor calibration or sensitivity, and other samples that are
run immediately after the Irenat patient sample can be run without impact.
Performance Characteristics
This section contains performance characteristics for each Rapidlab 1200 system
in the series. Each system contains performance data within the following criteria:
• precision on Controls
• recovery and Precision Values–as appropriate to the system
• method Comparison with Human Whole Blood Samples
Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC)
were analyzed on the Rapidlab 1240 system. Manual QC is performed by the
operator while AutomaticQC is performed automatically by the system based on
the QC frequency defined in the system software. The results are presented here.
Precision on manual aqueous quality control materials was estimated using a
minimum of 3 Rapidlab 1240 systems. Controls were measured over a minimum
of 10 days.
Precision on the aqueous quality control materials in the AutomaticQC module
was estimated using a minimum of 3 Rapidlab 1240 systems over a minimum of
10 days. AutomaticQC is automatically scheduled to run (single sample)
independently 3 times per day.
02087462 Rev.V
E-12 Rapidlab 1200 Operator’s Guide: System Specifications
The following tables summarize the results of the Rapidlab 1240 system precision for
manual QC and AutomaticQC.
Table E-9 Rapidlab 1240 Manual QC Precision Results
02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-13
The following tables summarize the results of the Rapidlab 1240 system recovery
and precision testing:
Table E-11 Rapidlab 1240 Recovery and Precision Testing—pH
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E-14 Rapidlab 1200 Operator’s Guide: System Specifications
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Rapidlab 1200 Operator’s Guide: System Specifications E-15
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E-16 Rapidlab 1200 Operator’s Guide: System Specifications
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Rapidlab 1200 Operator’s Guide: System Specifications E-17
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E-18 Rapidlab 1200 Operator’s Guide: System Specifications
Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC) were
analyzed on the Rapidlab 1245 system. Manual QC is performed by the operator while
AutomaticQC is performed automatically by the system based on the QC frequency
defined in the system software. The results are presented here.
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The following tables summarize the results of the Rapidlab 1245 system human
whole blood recovery precision testing.
Table E-18 Rapidlab 1245 Recovery and Precision Testing—pH
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The following tables summarize the results of the Rapidlab 1245 CO-ox module recovery
and precision testing.
Table E-21 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~6 g/dL and Oxyhemoglobin > 75%
Table E-22 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%
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Table E-22 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%
Table E-23 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75%
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Table E-26 Rapidlab 1245 System Human Whole Blood Method Comparison—pO2
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Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC) were
analyzed on the Rapidlab 1260 system. Manual QC is performed by the operator while
AutomaticQC is performed automatically by the system based on the QC frequency
defined in the system software. The results are presented here.
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Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC)
were analyzed on the Rapidlab 1265 system. Manual QC is performed by the
operator while AutomaticQC is performed automatically by the system based on
the QC frequency defined in the system software. The results are presented here.
Precision on manual aqueous quality control materials was estimated using a
minimum of 3 Rapidlab 1265 systems. Controls were measured over a minimum
of 10 days.
Precision on the aqueous quality control materials in the AutomaticQC module
was estimated using a minimum of 3 Rapidlab 1265 systems over a minimum of
10 days. AutomaticQC is automatically scheduled to run (single sample)
independently 3 times per day. The following tables summarize the results of the
Rapidlab 1265 system precision for manual QC and AutomaticQC.
Table E-52 Rapidlab 1265 Manual QC Precision Results
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Table E-64 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Capillary 60 14.14 0.33 0.12
tHb tHb 62 14.17 0.18 0.14
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Table E-64 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Syringe 63 14.06 0.27 0.08
FO2Hb Capillary 62 85.68 -0.55 0.17
FO2Hb tHb 63 86.21 -0.54 0.30
FO2Hb Syringe 63 85.57 -0.30 0.26
FCOHb Capillary 62 5.29 0.05 0.15
FCOHb tHb 63 4.98 0.28 0.22
FCOHb Syringe 63 4.69 0.34 0.21
FMetHb Capillary 62 5.08 -0.05 0.05
FMetHb tHb 63 4.86 -0.23 0.08
FMetHb Syringe 63 5.39 -0.37 0.07
FHHb tHb 63 3.94 -0.05 0.22
FHHb Capillary 62 3.96 0.07 0.11
FHHb Syringe 63 4.35 -0.38 0.24
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation
Table E-65 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Capillary 65 20.11 0.25 0.14
tHb tHb 53 20.11 0.08 0.11
tHb Syringe 62 20.27 0.06 0.10
FO2Hb Capillary 65 85.19 1.04 0.21
FO2Hb tHb 54 86.59 1.43 0.29
FO2Hb Syringe 62 84.89 1.17 0.26
FCOHb Capillary 65 5.13 -0.90 0.14
FCOHb tHb 54 6.29 -0.91 0.32
FCOHb Syringe 62 5.13 -0.89 0.16
FMetHb Capillary 65 5.41 -0.20 0.07
FMetHb tHb 54 6.10 -0.39 0.07
FMetHb Syringe 62 5.45 -0.36 0.06
FHHb tHb 54 1.01 -0.75 0.11
FHHb Capillary 65 4.27 -0.36 0.13
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Table E-65 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
FHHb Syringe 62 4.53 -0.52 0.22
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation
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E-72 Rapidlab 1200 Operator’s Guide: System Specifications
Reference Methods
The following reference or comparative methods were used to generate data for the
Rapidlab 1200 systems.
Analyte Reference Method
pH Internal ISE method used.
pCO2 and pO2 Tonometered whole blood. Refer to CLSI document C46-A.2 Gases
used are traceable to NIST Certified Reference Material SRM 1701.
Na+ and K+ Internal ISE method used.
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Calibrator Traceability
Analyte Traceability
pH Traceable to NIST SRM 186 reference material via the IFCC
reference method.1
pCO2 and pO2 Traceable to tonometered aqueous standards prepared using NIST
traceable temperature and pressure standards and gravimetrically
prepared precision gas standards.
Na+ and K+ Traceable to NIST SRM 919 or 918 reference materials using flame
photometry3 or atomic absorption.
Cl- Traceable to NIST SRM 919 or 918 reference materials using a
coulometric reference method.
Ca++ Traceable to gravimetrically prepared internal standards using NIST
SRM 915 and ISE methods embodied in the Siemens systems.
Glucose Traceable to NIST standard reference materials using the hexokinase/
glucose-6-phosphate dehydrogenase method.4
Lactate Traceable to commercially available standards using a manual
spectrophotometric method.
tHb Traceable to internal standards calibrated against the CLSI
Cyanomethemoglobin Reference Method.5
FO2Hb, Spectral properties traceable to NIST gravimetric standards and
FHHb, verified by assessing tHb versus internal standard calibrated against
FCOHb, the CLSI Cyanomethemoglobin method.
FMetHb
References
1. International Federation of Clinical Chemistry. Reference method (1986) for
pH measurement in blood. IFCC 1987/3.
2. Clinical and Laboratory Standards Institute. Blood Gas and pH Analysis and
Related Measurements; Approved Guideline; CLSI Document C 46-A; (Vol.
21, No. 14); Sept 2001.
3. Clinical and Laboratory Standards Institute. Standardization of Sodium and
Potassium Ion-Selective Electrode Systems to the Flame Photometric
Reference Method; Approved Standard-Second Edition; CLSI Document
C29 A2; (Vol. 20, No. 17); Oct 2000.
4. Clinical and Laboratory Standards Institute. NRSCL Glucose. CLSI
Document RS1-A; Mar 1989.
5. Clinical and Laboratory Standards Institute. Reference and Selected
Procedures for the Quantitative Determination of Hemoglobin in Blood;
Approved Standard - Third Edition. CLSI Document H15-A3, (Vol. 20,
No. 28); Jan 2000.
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E-74 Rapidlab 1200 Operator’s Guide: System Specifications
6. Vreman HJ, Kwong LK, Stevenson DK. Carbon Monoxide in Blood: an Improved
Microliter Blood-Sample Collection System, with Rapid Analysis by Gas
Chromatography, Clin. Chem. 30, 1984:1382-1386.
7. Evelyn KA, and Malloy HT. Microdetermination of Oxihemoglobin, Methemoglobin
and Sulfhemoglobin in a Single Sample of Blood. J Biol. Chem. 1938;126:655-662.
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Appendix F: Symbols
This section describes the symbols that may be on the exterior of the system or on
packaging. The symbols on the system provide you with the location of certain
components and with warnings for proper operation. The symbols on the system
or packaging provide you with other important information.
Symbol Description
indicates where you insert the sample device (syringe,
capillary, or ampule) to perform analysis
indicates the area where you write the date you install the
cartridge on the system, if required
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Symbol Description
indicates that you should not spray this area with cleaning
solutions or other fluids that may damage parts of the system
indicates you should avoid looking directly into the light beam
of the laser to prevent possible exposure to hazardous light
indicates the system contains sufficient for (n) tests (250 tests)
catalog number
serial number
batch code
manufacturer
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Appendix G: Glossary
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Appendix H: Rapidlab 1200 System Maintenance Checklist
Appendix H provides Maintenance Checklist charts for you to record maintenance activities performed on the Rapidlab 1200 series system.
Make photocopies of these charts as necessary and record your maintenance activities according to the maintenance protocol of your institution.
Month/Year:
System ID:
Daily Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check System Status
Clean the Exterior
Surfaces
Weekly Maintenance
Week 1 Week 2 Week 3 Week 4
Deproteinize the
Sample Path
Condition the Sensors
Check the Fill Solution
Levels
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Quarterly Maintenance
3 Months 6 Months 9 Months 12 Months
Replace the Pinch
Valve Tubing
Yearly Maintenance
Replace the Measurement Module Tubing
Replace the CO-ox Module Tubing
Replace the Reagent Manifold
Replace the AutomaticQC Manifold
Replace the Air Filters
As Required Maintenance
Replace the Measurement Module Tubing
Replace the CO-ox Module Tubing
Replace the Reagent Manifold
Replace the AutomaticQC Manifold
Replace the Air Filters
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Rapidlab 1200 Operator’s Guide: Index I-7
system status Y
checking 5-2 yearly maintenance 5-11
T
target ranges
change to default automaticQC ranges 8-6
retaining for automaticQC 8-6
temperature in banner 1-20
tHb
measurement principles 1-49
see CO-ox module 1-49
using 8-14
time
changing 8-20
total carbon dioxide
description 1-55
touch screen
calibrating 6-35
features 1-1
problems 6-11
selecting the language for screens and messages 8-20
turning the touch sound off 8-21
troubleshooting
bar code problems 6-8
communication problems 6-12
failed calibrations 6-4
failed QC 6-1
missed QC 6-1
patient results 6-6
printer problems 6-11
system messages 6-74
touch screen problems 6-11
unavailable buttons 6-7
twice weekly maintenance 5-3
U
unscheduled QC samples 4-4
V
viewing number of samples analyzed 7-4
volume
adjusting for system and video sound 8-21
W
warranty B-1
wash cartridge
replacing 2-2
wash cycle 6-36
wash functionality at Analysis screen 2-12
wash pump test 6-39
wash test 6-36
waste assembly
cleaning 5-27
waste bottle
replacing 2-2
waste components
illustration 1-13
waste detector
calibrating 6-35
weekly maintenance 5-4
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I-8 Rapidlab 1200 Operator’s Guide: Index
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