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Siemens Rapidlab 1200 Operator's Manual

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Rapidlab

1200 Systems

Operator's Guide

02087462 Rev. V, 2010–01

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Page 1 ® Rapidlab 1200 Systems Operator’s Guide 02087462 Rev. V, 2010–01...
Page 2 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.
Page 3: Organization
• 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.
Page 4: Conventions
Rapidlab 1200 Operator’s Guide: Using This Guide If you want to... Then refer to... find warranty, legal, and support information, Appendix B: find contact information, Warranty and Support Information. learn about fill volume and stability information about Appendix C: system fluids, System Fluids.
Page 5 Rapidlab 1200 Operator’s Guide: Using This Guide 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.
Page 6 Rapidlab 1200 Operator’s Guide: Using This Guide 02087462 Rev. V...
Page 7: Table Of Contents
Status Screen .........1-24 Rapidlab 1200 Systems Sample Path ....1-25 System Sample Path .
Page 8 Rapidlab 1200 Operator’s Guide: Contents Carbon Dioxide Tension (pCO ) ......1-35 Oxygen Tension (pO ) .
Page 9 Using Basic System Functions ....2-1 Starting up the Rapidlab 1200 System ....2-1 Entering Your Password .
Page 10 Rapidlab 1200 Operator’s Guide: Contents Viewing Patient Results ......2-27 Performing a Patient Search .
Page 11 Rapidlab 1200 Operator’s Guide: Contents Using the QC List Screen ....... . .4-7 Using the Recall QC Data Search Screen .
Page 12 Rapidlab 1200 Operator’s Guide: Contents Cleaning the Sample Path ......5-22 Reinstalling the Reference Sensor and Biosensors ... . 5-24 Completing the Sample Path Maintenance .
Page 13 Rapidlab 1200 Operator’s Guide: Contents Flushing the CO-ox Pump Tubing ......5-59 Removing and Storing the Sensors ..... 5-60 Removing Peripherals and Disinfecting the Exterior Surfaces .
Page 14 Rapidlab 1200 Operator’s Guide: Contents Using the Diagnostics Screen ......6-34 Performing Tests and Printing Diagnostic Reports ... . . 6-34 Performing the Waste Detector Calibration .
Page 15 Rapidlab 1200 Operator’s Guide: Contents xiii D6 Excessive Noise: Glu Lac ......6-57 D8–D22 Codes .
Page 16 Rapidlab 1200 Operator’s Guide: Contents D70 Codes ........6-70 D70 Optics Error: 2 .
Page 17 Rapidlab 1200 Operator’s Guide: Contents Defining Patient Demographics ......8-10 Defining Sample Demographics ......8-10 Setting up Parameter Selection at Analysis .
Page 18 Rapidlab 1200 Operator’s Guide: Contents Setting Up Analysis Options ......8-38 Selecting the Save Demographics Option ....8-38 Selecting Demographics Editing .
Page 19 Recommended Fill Volumes ..... . C-1 Rapidlab 1200 Cartridges ......C-2...
Page 20 Appendix G: Glossary Appendix H: Rapidlab 1200 System Maintenance Checklist Daily Maintenance ....... H-1 Twice Weekly Maintenance .
Page 21: System Overview And Intended Use
This section is an introduction to the Rapidlab 1200 system. 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:...
Page 22: Hardware Overview
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Hardware Overview The Rapidlab 1200 system consists of 6 modules. User interface module AutomaticQC module (optional) Waste module Reagent module Wash module Measurement and CO-ox modules Figure 1-1 Rapidlab 1200 System...
Page 23: User Interface Module
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use User Interface Module You use the user interface to request sample analysis, to view and report results, and to edit demographics. The user interface consists of the touchscreen, the printer, the CD drive, and the optional barcode scanner.
Page 24: Automaticqc Module
• AutomaticQC interface 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 75 mL Buffered bicarbonate solution with Na...
Page 25 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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.
Page 26 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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.
Page 27: Waste Module
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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 •...
Page 28 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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. Path from the measurement module to the reagent manifold...
Page 29: Reagent Module
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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 •...
Page 30 1-10 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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. Sample port Figure 1-9 Reagent Cartridge–Front View...
Page 31 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-11 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.
Page 32 1-12 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use The reagent manifold contains the tubing for samples, waste, AQC material, wash, and calibrators. Measurement module waste tubing Sample tubing CO-ox waste tubing RCx reagent from wash cartridge tubing Wash fluid from wash cartridge tubing Figure 1-13 Reagent Manifold for the Rapidlab 1245 and 1265 Systems–back...
Page 33: Wash Module
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-13 Wash Module The wash module has the following components: • wash cartridge • wash door Wash Cartridge You load the wash cartridge in the wash door. Wash cartridge Wash door Figure 1-14 Rapidlab 1200 System–Wash Module...
Page 34 1-14 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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.
Page 35: Measurement Module
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-15 Measurement Module The system analyzes the sample in the measurement module. Measurement module Figure 1-17 Rapidlab 1200 Measurement Module Location The sample moves through and is analyzed in the sensors, which form the sample path.
Page 36 1-16 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use The sample enters the measurement module at the sample connector and moves through the preheater, fluid detector 1, and into the sensors for measurement. Preheater Fluid detector 1 Sample connector...
Page 37 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-17 The contact assembly provides electrical contact between the sensors and the system. The pressure detector bubbler detects clots in the measurement module. Fluid detector 2 Pinch valve tubing Pressure detector bubbler Figure 1-20 Measurement Module–Contact Assembly...
Page 38: Co-Ox Module
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Sensors provide direct measurement of a specific substance of interest in a sample. For more information about sensors, refer to Rapidlab 1200 Systems Technology‚ page 1-27. The electrolyte sensors, Na , Ca...
Page 39: Software Overview
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-19 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.
Page 40: Viewing The Banner Information
1-20 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Viewing the Banner Information The screen banner area displays the following information: • the current system status (Ready, Not Ready, Calibrating, Analyzing) • the time and type of the next calibration •...
Page 41: Viewing The Display Area
You access the main system screens by selecting the appropriate button on the banner. • Analysis screen • Recall screen • Status screen Analysis Screen The Analysis screen is the main screen for the Rapidlab 1200 systems. 02087462 Rev. V...
Page 42 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.
Page 43 Custom panel buttons Panel set buttons Figure 1-25 Custom Panel Buttons Sampling Modes on the Analysis Screen 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.
Page 44: Recall Screen
1-24 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Recall Screen Select the button to access stored results. For information about the Recall button Recall menu options, refer to the following topics: Button... Refer to... Patient Recalling Patient Sample Results‚ page 2-30 Recalling QC Results‚...
Page 45: Rapidlab 1200 Systems Sample Path
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-25 Rapidlab 1200 Systems Sample Path This section describes the path of a sample through the system from sample entry, to measurement, and then to the waste bottle. System Sample Path The system aspirates the sample at the sample port.
Page 46: Co-Ox Sample Path
1-26 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use CO-ox Sample Path The system splits the sample in the preheater and moves part of the sample through the CO-ox module. The CO-ox sample moves through the CO-ox sample tubing to the sample chamber for analysis and exits as waste through the waste tubing.
Page 47: Rapidlab 1200 Systems Technology
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.
Page 48 1-28 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Each electrode, which acts as a half-cell with a half-cell potential, contains an inner reference element immersed in an internal electrolyte solution. The measuring electrode is designed to respond to changes in the concentration of the specific analyte being measured in the sample solution.
Page 49 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-29 During analysis, a membrane potential develops as a result of the interaction of the analyte (ion) at the membrane. The membrane potential is related to the amount of substance being measured in the sample. The half-cell potential in the sensor consists of the inner reference element potential plus the membrane potential.
Page 50 1-30 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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.
Page 51: Reference Sensor
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-31 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.
Page 52 1-32 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use The reference sensor contains a silver (Ag) wire, coated with a layer of silver chloride (AgCl) and an ion permeable polymer, surrounded by a saturated potassium chloride (KCl) solution. By ensuring that the concentration of Cl remains unchanged in the solution, the reference sensor maintains a constant electrical potential.
Page 53: Amperometry
(oxidizable or reducible) present in the sample solution. pH and Blood Gases The Rapidlab 1200 systems analyze blood samples for pH, pO , and pCO Hydrogen Ion Activity or pH The notation of pH expresses the hydrogen ion activity in a solution as the negative logarithm of the hydrogen ion concentration.
Page 54 1-34 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Using this formula, a hydrogen ion concentration of 1 x 10 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.
Page 55: Carbon Dioxide Tension (Pco 2 )
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-35 pH Sensor The pH sensor, which is based on ISE technology, is a half-cell that forms a complete electrochemical cell when combined with the external reference sensor. It contains a silver/silver chloride wire surrounded by a buffer solution. A glass membrane that is highly sensitive and specific for hydrogen ions separates the sample from the solution.
Page 56 1-36 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use – The levels of HCO , and dissolved CO play a major role in maintaining the pH in blood. This relationship is best described through the Henderson-Hasselbalch equation: base acid –...
Page 57 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-37 Sensor The pCO sensor is based upon the electrode described by Severinghaus and Bradley. The pCO 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.
Page 58: Oxygen Tension (Po 2 )
1-38 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Oxygen Tension (pO Oxygen (O ) is essential for cell and tissue metabolism in the body. The cardiopulmonary system is responsible for transporting oxygen to the cells. Oxygen transport involves 4...
Page 59 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-39 Sensor The pO sensor is based upon the electrode described by Clark. 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.
Page 60: Electrolytes
1-40 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Electrolytes The Rapidlab 1260 and 1265 systems analyze blood samples for Na , Cl , and Ca 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.
Page 61 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-41 The potassium sensor membrane is designed as a charge separator. The positively charged potassium ions selectively interact with the membrane when the sample interfaces with the membrane. The negatively charged chloride ions do not interact with the membrane.
Page 62: Concentration Of Sodium
1-42 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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.
Page 63: Concentration Of Chloride
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-43 Most potassium is excreted by the kidney, which is the major regulator of potassium output in the body. Actually, the kidney is better at conserving sodium and excreting potassium so in cases where potassium intake stops, the kidney requires time to adjust and stop excreting potassium.
Page 64: Concentration Of Ionized Calcium
1-44 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use This assay is used most commonly to distinguish high-anion-gap acidoses (ketoacidosis, lactic acidosis, uremia, poisoning from several specific agents) from hyperchloremic acidoses (loss of alkali as in severe diarrhea, hypoaldosteronism, potassium-sparing diuretics, renal tubular acidosis).
Page 65: Metabolites
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-45 When measuring ionized calcium, pH should also be measured. Because hydrogen ions compete with calcium for calcium binding sites, a change in sample pH can have a direct effect on calcium levels. For example, a change in pH of 0.1 can cause a change in calcium of 0.2 mg/dL, which exceeds the span of the...
Page 66: Concentration Of Lactate
1-46 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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.
Page 67 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-47 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.
Page 68: Hemoglobin And Its Derivatives
1-48 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use → − The loss of electrons in the oxidation of H 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: →...
Page 69: Total Hemoglobin
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-49 22,23 Hyperlipemia can result in artificially increased methemoglobin values. High bilirubin concentrations can falsely increase oxyhemoglobin values. Hyperlipemia and administration of fat emulsions can increase total hemoglobin values. Samples frozen with liquid nitrogen can have decreased total hemoglobin levels.
Page 70: Methemoglobin
1-50 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use The percent of deoxyhemoglobin is determined using the following equation: FHHb = cHHb / ctHb x 100 This is the fraction of hemoglobin that could deliver more oxygen to body tissues if pulmonary oxygenation were improved.
Page 71: Sulfhemoglobin
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-51 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.
Page 72: Parameters
The system makes adjustments to maintain alignment of the polychromator. Parameters The parameters that your system reports depend on the sensors available on the NOTE: system and the parameters selected in Setup. The Rapidlab 1200 systems provide results for the following parameters: Parameters Results Description Blood Gases...
Page 73 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-53 Parameters Results Description ctCO total carbon dioxide Oxygenation SAT(est) oxygen saturation (estimated) CT(est) oxygen content (estimated) hematocrit calculated from tHb † arterial pO to fraction of inspired O ratio glucose...
Page 74: Bicarbonate Ion
1-54 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Parameters Results Description oxygen binding capacity oxygen tension at 50% saturation Indicates parameters available only on Rapidlab 1260 and Rapidlab 1265 systems. † Indicates parameters available only on Rapidlab 1245 and Rapidlab 1265 systems.
Page 75: Total Carbon Dioxide
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-55 Base excess permits the estimation of the number of equivalents of sodium bicarbonate or of ammonium chloride required to correct the blood pH to normal. A negative value for base excess indicates a base deficit.
Page 76: Patient Temperature Correction
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Patient Temperature Correction The Rapidlab 1200 systems measurements and determinations are based on a standard temperature of 37.0°C. During sample analysis, you can enter the actual patient temperature value, which enables the system to provide temperature-corrected results for...
Page 77: Oxygen Content Of Hemoglobin
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-57 If FO Hb is unavailable, oxygen content is derived from estimated oxygen saturation [O SAT(est)] according to the following equation: CT = (1.39 × ctHb × O SAT(est)/100)+ (0.00314 × pO If ctHb is not measured or entered, O CT is not displayed or printed.
Page 78: P50
1-58 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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: •...
Page 79: Po 2 /F I O 2
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-59 Estimated oxygen saturation [O SAT(est)] does not account for variations in 2,3 DPG levels, carbon monoxide levels, or the presence of other dyshemoglobins. Therefore, clinically significant errors can result from...
Page 80: Gas Exchange Indices
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.
Page 81: Respiratory Index
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-61 Respiratory Index The respiratory index (RI(T)) is the ratio of the alveolar-arterial blood oxygen-pressure difference to arterial pO , when both values are corrected for patient temperature. This index is also a means of assessing the degree of pulmonary shunting.
Page 82: Arterial-Venous Oxygen Content Difference
1-62 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use Arterial-Venous Oxygen Content Difference The arterial-venous oxygen content difference (ctO (a- )) refers to the oxygen difference between arterial and venous blood. It is a determination of the amount of oxygen released to the tissues per volume of blood.
Page 83: Physiologic Shunt
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-63 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.
Page 84 1-64 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 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. 02087462 Rev. V...
Page 85: References
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-65 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.
Page 86 1-66 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 15. Toffaletti JG. Calcium, magnesium, and phosphate. Ch 47 in Lewandrowski K. Clinical Chemistry. Laboratory Management & Clinical Correlations. Philadelphia: Lippincott Williams & Wilkins, 2002:710-724. 16. Ladenson JH. Clinical utility of ionized calcium. In: Moran RF, editor. Ionized calcium: its determination and clinical usefulness.
Page 87 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-67 30. VanSlyke DD, Cullin GE. Studies of acidosis 1. The bicarbonate concentration of blood plasma, its significance and its determination as a measure of acidosis. J Biol Chem 1917; 30: 289-346.
Page 88 1-68 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 02087462 Rev. V...
Page 89: Operating The System
Starting up the Rapidlab 1200 System To start up the Rapidlab 1200 system, plug the power cord into an appropriate power receptacle and turn on the power switch. If this is the first time the system is being used, refer to Replacing Supplies‚...
Page 90: Replacing Supplies
Rapidlab 1200 Operator’s Guide: Operating the System 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 Emptying the Waste Bottle The system displays the Waste symbol on the banner when the waste bottle is 70% full.
Page 91: Replacing The Reagent Cartridge
Rapidlab 1200 Operator’s Guide: Operating the System Replacing the Reagent Cartridge The system displays the Reagent Cartridge symbol on the banner when less than 10% of the volume remains or when less than 24 hours remain before the cartridge expires. This enables you to replace the reagent cartridge at a time when the system is not busy.
Page 92: Reinstalling The Automaticqc Cartridge
Rapidlab 1200 Operator’s Guide: Operating the System Reinstalling the AutomaticQC Cartridge If you have a problem the first time you install an AQC cartridge, or you remove an AQC cartridge when in Diagnostics mode, you can reinstall it. You can also reinstall an AQC cartridge after removing it to clean the waste housing.
Page 93: Accessing System Information
Rapidlab 1200 Operator’s Guide: Operating the System To check, go to step 2. Figure 2-2 Valve Aligned so Top of the Valve is Between 2 Arrows 2. Verify the valve is correctly aligned as shown in Figure 2-2, with the top of the valve between the 2 arrows.
Page 94: Shutting Down The System
Rapidlab 1200 Operator’s Guide: Operating the System Shutting Down the System Use this procedure to remove power from the system for 24 hours or less. Do not remove power from the system for more than 6 hours if CAUTION: cartridges are installed. Cartridges installed in the system remain stable for 6 hours without power.
Page 95: Collecting Patient Samples
Rapidlab 1200 Operator’s Guide: Operating the System Collecting Patient Samples This section describes sample requirements, collection procedures, and handling techniques for pH and blood gas. The sample collection and handling guidelines described here are also suitable for CO-ox analysis. Collecting Samples Collect blood samples under proper medical supervision when selecting a site and performing the collection procedure.
Page 96: Using Different Sample Sources
Rapidlab 1200 Operator’s Guide: Operating the System Using Different Sample Sources The Rapidlab 1200 systems can analyze samples obtained from the following sources: Sample Source Description Arterial blood Arterial blood is commonly recommended for use in blood gas studies because it accurately reflects acid-base physiology and oxygenation status.
Page 97: Handling And Storing Samples
Rapidlab 1200 Operator’s Guide: Operating the System Handling and Storing Samples The following condition can cause erroneous results even when samples are collected correctly: • Metabolic activity in the sample that occurs between sampling and completion of analyses • Contamination of the sample by room air •...
Page 98: Understanding System Limitations
2-10 Rapidlab 1200 Operator’s Guide: Operating the System 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 pCO , however, this affects the K and lactate values.
Page 99: Analyzing Samples
Rapidlab 1200 Operator’s Guide: Operating the System 2-11 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 Analyzing Syringe Samples Use this procedure to analyze patient blood samples using a syringe.
Page 100: Analyzing Capillary Samples
2-12 Rapidlab 1200 Operator’s Guide: Operating the System 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.
Page 101 Rapidlab 1200 Operator’s Guide: Operating the System 2-13 If you have a priority sample, but the system displays a message that NOTE: the system is busy, select to interrupt the system. If Cancel is not Cancel available, wait until the system is not displaying the busy message to analyze the patient sample.
Page 102: Analyzing Microsamples
2-14 Rapidlab 1200 Operator’s Guide: Operating the System You can scan the patient ID and accession number in the appropriate field. For NOTE: information about entering patient sample data, refer to Entering Patient Sample Data‚ page 2-22. 8. View the results.
Page 103 Rapidlab 1200 Operator’s Guide: Operating the System 2-15 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 Do not hesitate at any point during this procedure.
Page 104 2-16 Rapidlab 1200 Operator’s Guide: Operating the System 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.
Page 105: Analyzing Ph And Ph, Glu, And Lac Samples
Rapidlab 1200 Operator’s Guide: Operating the System 2-17 Analyzing pH and pH, Glu, and Lac Samples Use this procedure to analyze patient samples for pH results only, or to report pH, Glucose, and Lactate results. Wear personal protective equipment. Use universal precautions.
Page 106: Analyzing Thb Samples
2-18 Rapidlab 1200 Operator’s Guide: Operating the System 10. 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. 11. When you finish viewing the results, select...
Page 107 Rapidlab 1200 Operator’s Guide: Operating the System 2-19 7. 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 108: Using Custom Panels
2-20 Rapidlab 1200 Operator’s Guide: Operating the System Using Custom Panels When you define custom panels in Setup, the Analysis screen displays a set of custom panels in the lower left of the screen. For procedures to define custom panels, refer to Defining Custom Panels‚...
Page 109: Understanding System Behavior With Custom Panels
Rapidlab 1200 Operator’s Guide: Operating the System 2-21 Understanding System Behavior with Custom Panels When you select a custom panel, the system responds as follows: • The system disables any functions that you cannot use with custom panels. • If you select a custom panel that contains the tHb parameter and then select Microsample, the tHb parameter is removed from the custom panel while performing that analysis.
Page 110: Entering Patient Sample Data
2-22 Rapidlab 1200 Operator’s Guide: Operating the System Entering Patient Sample Data The system displays the Data Entry screen during sample analysis. You enter data by scanning the patient sample barcode and by entering patient information at the Data Entry screen.
Page 111: Entering Patient Demographics
Rapidlab 1200 Operator’s Guide: Operating the System 2-23 Entering Patient Demographics When the system displays the Data Entry screen, enter the demographic information as required. When you select the button for a demographic, an alphanumeric keyboard displays. When you select the field for a demographic, a numeric keypad displays.
Page 112: Early Demographics Data Entry
2-24 Rapidlab 1200 Operator’s Guide: Operating the System The system enters only the accession number. 6. To enter data for additional demographics, select the down pointing arrow button. 7. After you finish entering all demographics, select Continue Early Demographics Data Entry Selecting the Early Demographics option enables you to enter demographic data early in the sample analysis process.
Page 113: Using The Save Demographics Option
Rapidlab 1200 Operator’s Guide: Operating the System 2-25 System Behavior During Microsample Analysis • If you finish entering data but aspiration is not complete, the Wait screen displays. When aspiration completes you are prompted to remove the sample. • If you do not finish entering data, and aspiration completes, the system may prompt you to remove the sample.
Page 114 2-26 Rapidlab 1200 Operator’s Guide: Operating the System If you change a Patient ID (1234) to another patient ID (5678) that already exists, NOTE: the system replaces the name, sex, and date of birth for the edited patient ID (1234) with those of the new patient ID (5678).
Page 115: Using Patient Results
Rapidlab 1200 Operator’s Guide: Operating the System 2-27 Using Patient Results This section provides information about viewing and recalling patient results. Viewing Patient Results After you complete the Data Entry screen, the Results screen displays. • The screen displays result values in yellow while analysis is in progress.
Page 116: Performing A Patient Search
2-28 Rapidlab 1200 Operator’s Guide: Operating the System Use buttons on the Results screen to perform functions: To do this... Then select... View results for more parameters, More Results Send the report to a data management system or an LIS,...
Page 117: Performing A Patient Search
Rapidlab 1200 Operator’s Guide: Operating the System 2-29 Performing a Patient Search 1. Select Recall > Patients > Search 2. In the Search criteria fields, enter data matching one or more search criteria. • To enter alphanumeric characters select the criterion button.
Page 118: Recalling Patient Sample Results
2-30 Rapidlab 1200 Operator’s Guide: Operating the System Recalling Patient Sample Results Use the Recall screen to view and print results for previously analyzed patient samples. You can also send the recalled results to a data management system or a laboratory information system (LIS).
Page 119: Printing Reports
Rapidlab 1200 Operator’s Guide: Operating the System 2-31 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 120: Printing Reports On The External Printer
2-32 Rapidlab 1200 Operator’s Guide: Operating the System Printing Reports on the External Printer For reports printed on the external printer, the system formats the report with approximately a 1-inch margin from each edge of the 8-1/2 X 11-inch page or A4 paper.
Page 121 Rapidlab 1200 Operator’s Guide: Operating the System 2-33 Report Name Description Sample Totals Prints a report of the total number of patient and QC samples performed on the system. Refer to Viewing the Sample Totals‚ page 7-4. Last Cal Reports Prints data for each sensor from the last 2-point or full calibration.
Page 122: Performing A Correlation Study
Levey-Jennings Graph Screen‚ page 4-11. Performing a Correlation Study To correlate the results from the Rapidlab 1200 system to a reference analyzer, change the slope and offset (intercept) values for each parameter. Before changing these values, analyze a range of samples at the Rapidlab 1200 system and at the reference analyzer.
Page 123: Combining Results For An A-V Study Report
= mx + b where m is the slope and b is the offset Use the results from the Rapidlab 1200 systems as the independent variable (x). Use the results from the reference analyzer as the dependent variable (y).
Page 124: Before You Begin
2-36 Rapidlab 1200 Operator’s Guide: Operating the System Before You Begin Analyze the arterial and mixed venous syringe samples on a Rapidlab 1245 or 1265 system. Ensure that the samples meet the following requirements: • The difference between analysis times of the 2 samples on the Rapidlab 1245 or 1265 system is less than 60 minutes.
Page 125: Printing The Arterial-Venous Study Report
Rapidlab 1200 Operator’s Guide: Operating the System 2-37 Printing the Arterial-Venous Study Report The printed a-v study report shows the following from the mixed-venous sample: • a-v results • arterial sample results • , tHb, and FO Hb results from the mixed venous sample •...
Page 126 2-38 Rapidlab 1200 Operator’s Guide: Operating the System 02087462 Rev. V...
Page 127: Calibration
Understanding Automatic Calibrations Calibration of the Rapidlab 1200 systems occurs automatically at prescribed intervals and requires no operator action. The system can defer a calibration to analyze a sample. In this case, the...
Page 128 Rapidlab 1200 Operator’s Guide: Calibration 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.
Page 129: Troubleshooting Failed Calibrations
Refer to Troubleshooting Failed Calibrations‚ page 6-4. Generating Calibration Reports The Rapidlab 1200 system offers 2 calibration report formats: full or status. • The full report shows the measurement and drift values, and the D code that explains the result symbols.
Page 130: Performing Manual Calibrations
Rapidlab 1200 Operator’s Guide: Calibration Performing Manual Calibrations Use this procedure to manually start a 1-point, a 2-point, or a full calibration. Only operators with the required security access can start a calibration. For more information about levels of security access, refer to Setting up Operator Security Levels‚ page 8-35.
Page 131: Quality Control
Performing QC Sample Analysis Treat all QC materials as you do patient samples. NOTE: The Rapidlab 1200 system offers 3 options for quality control analysis. Refer to Setting Up QC Options‚ page 8-2: Required QC analysis The system schedules QC analysis and prompts you to analyze the QC samples.
Page 132: Procedural Notes For Required Qc
Rapidlab 1200 Operator’s Guide: Quality Control ® c. Attach a Quick adapter to the ampule. d. Insert the adapter with the attached ampule into the sample port as shown on the screen. e. Select Analyze The system aspirates the sample.
Page 133: Using The Automaticqc Analysis Option
Rapidlab 1200 Operator’s Guide: Quality Control Using the AutomaticQC Analysis Option To use the AutomaticQC analysis feature, you must select the AutomaticQC option in Setup and have an AutomaticQC cartridge on your system. The AutomaticQC cartridge contains all the levels of QC material needed to monitor system performance without operator intervention.
Page 134: Procedural Notes For Automaticqc Sample Analysis
Rapidlab 1200 Operator’s Guide: Quality Control Procedural Notes for AutomaticQC Sample Analysis The system compares the QC results to the ranges for each parameter and identifies results that are out of range. The system turns off parameters that fail QC. Depending on the options defined in Setup, the system repeats the QC analysis if the first attempt fails and the system turns on failed parameters that pass.
Page 135: Accessing Qc Results
Rapidlab 1200 Operator’s Guide: Quality Control 2. Introduce the QC sample: a. Scan the barcode on the QC ampule, if necessary. b. Invert the QC ampule several times and then open the ampule. c. Prepare the sample. If the sample device is...
Page 136: Printing Or Sending Results
Rapidlab 1200 Operator’s Guide: Quality Control Printing or Sending Results At the Results screen, you can send the QC analysis results to your printer or to a data management system or an LIS. • To print a report, select the button.
Page 137: Recalling Qc Results
Rapidlab 1200 Operator’s Guide: Quality Control Recalling QC Results Use the Recall screen to view and print results for previously analyzed QC samples. When you select the button and then select , the Recall QC Recall screen displays the following options: •...
Page 138: Using The Recall Qc Data Search Screen
Rapidlab 1200 Operator’s Guide: Quality Control Using the Recall QC Data Search Screen The Recall QC Data Search screen allows you to search for a specific QC lot, QC sample results performed between a defined date range, or a combination of criteria. The QC Data Search screen acts as a filter to display only those results that meet the criteria you specify on the Search screen.
Page 139: Using The Recall-Qc Statistics Screens
Rapidlab 1200 Operator’s Guide: Quality Control Using the Recall–QC Statistics Screens The Recall–QC Statistics screens allow you to select a particular lot of QC material and then to view all the statistics for that lot. To access the Recall–QC Statistics screens, perform the following steps: 1.
Page 140 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: Σ • SD(R), standard deviation with RiliBÄK range checking defined according to the following formula: ∑...
Page 141: Using The Recall-Levey-Jennings Screens
Rapidlab 1200 Operator’s Guide: Quality Control 4-11 To print the Recall–QC Statistics data, select the button. The printed report Print contains the following additional information: • parameter labels and statistics for all parameters • measured and target values for each parameter •...
Page 142: Restoring Parameters
4-12 Rapidlab 1200 Operator’s Guide: Quality Control • QC material label, RapidQC Complete or AutomaticQC • lot level • lot number • the month and year for the data displayed in the graph The graph contains the following information: •...
Page 143: Maintenance
1. Grasp both sides of the front cover and pull it toward you. 2. Lift the front cover. 3. Push up the latches on the measurement module door. 4. Lift the door. Front cover Latches–measurement module Figure 5-1 Rapidlab 1200 System–Front Cover Open 02087462 Rev. V...
Page 144: Performing Daily Maintenance
Rapidlab 1200 Operator’s Guide: Maintenance Performing Daily Maintenance Daily maintenance includes the following tasks: • Checking system status • Cleaning and disinfecting the exterior surfaces Checking System Status 1. At the system user interface, select Status 2. View the percent volume for the waste bottle, and percent volume and expiration date for each cartridge.
Page 145: Calibrating The Barometric Sensor
Rapidlab 1200 Operator’s Guide: Maintenance Calibrating the Barometric Sensor Use this procedure to calibrate the internal atmospheric pressure sensor to a barometer in your laboratory. Check the barometer calibration every day. 1. At the user interface, select Status > Calibrate 2.
Page 146: Performing Weekly Maintenance
If you are analyzing less than 200 samples per day, deproteinize and condition your Rapidlab 1200 system weekly. If you are analyzing more than 200 samples per day, or if your laboratory often processes certain types of blood, high hematocrit samples or blood with high TPN, you may need to run this procedure more often.
Page 147 Rapidlab 1200 Operator’s Guide: Maintenance 1. Prepare the deproteinizer as directed on the package. 2. Select Status > Maintenance > Deproteinizing the Sample Path 3. Select Continue 4. If you have a Rapidlab 1260 or 1265 system, replace the Glucose and Lactate biosensors with the test/blank sensors: a.
Page 148: Conditioning The Sensors
Rapidlab 1200 Operator’s Guide: Maintenance Conditioning the Sensors Conditioning cleans and conditions the glass membranes of the pH and sodium sensors. You need the following materials for this task: • Conditioner • Syringe • Glucose and Lactate test/blank sensors (TB4) Wear personal protective equipment.
Page 149: Checking The Level Of Fill Solution
Rapidlab 1200 Operator’s Guide: Maintenance 6. Aspirate the conditioner: a. Draw the conditioner solution into a syringe and insert the syringe into the sample port. b. Select Continue c. When prompted, remove the syringe and select Continue The conditioning cycle runs for 10 minutes.
Page 150 Rapidlab 1200 Operator’s Guide: Maintenance 4. Check the level of fill solution in the reference sensor: a. Verify that the reference sensor fill solution is above the fill line. The fill line is on the right side of the KCl reservoir.
Page 151: Performing Every 60 Days Maintenance
Rapidlab 1200 Operator’s Guide: Maintenance Performing Every 60 Days Maintenance The every 60 days maintenance schedule is based on analyzing 30 samples per day, unless otherwise noted. If your laboratory analyzes more than 30 samples per day, perform this maintenance more frequently.
Page 152: Performing Quarterly Maintenance
5-10 Rapidlab 1200 Operator’s Guide: Maintenance Performing Quarterly Maintenance The quarterly maintenance schedule is based on analyzing 30 samples per day, unless otherwise noted. If your laboratory analyzes more than 30 samples per day, perform this maintenance more frequently. Replacing the Pinch Valve Tubing You need a tubing kit for this task.
Page 153: Testing For Leaks
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.
Page 154: Replacing The Measurement Module Tubing
5-12 Rapidlab 1200 Operator’s Guide: Maintenance Replacing the Measurement Module Tubing You need a tubing kit for this task. Wear personal protective equipment. Use universal precautions. BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials.
Page 155: Replacing The Co-Ox Module Tubing
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.
Page 156: Replacing The Co-Ox Sample Tubing
5-14 Rapidlab 1200 Operator’s Guide: Maintenance Replacing the CO-ox Sample Tubing 1. Disconnect the sample tubing from the connector on top of the sample chamber. Sample chamber connector Fluid detector Measurement module connector Figure 5-4 Measurement Module Sample Chamber 2. Rotate the gray wheel towards you, pull the tubing through the fluid detector, and remove the tubing from the steel measurement module connector.
Page 157: Replacing The Co-Ox Waste Tubing
Rapidlab 1200 Operator’s Guide: Maintenance 5-15 Replacing the CO-ox Waste Tubing 1. Disconnect the CO-ox waste tubing from the pump tubing and the sample chamber connector. CO-ox pump tubing CO-ox waste tubing Sample chamber Figure 5-5 CO-ox Module Tubing 2. Connect the CO-ox waste tubing to the CO-ox pump tubing and the sample chamber connector.
Page 158: Replacing The Co-Ox Pump Tubing
5-16 Rapidlab 1200 Operator’s Guide: Maintenance Replacing the CO-ox Pump Tubing 1. Disconnect the CO-ox pump tubing from the CO-ox waste tubing. Roller cage Platen Lower tubing cuff Reagent manifold tubing Figure 5-6 CO-ox Module and Reagent Manifold 2. Disconnect the CO-ox pump tubing from the reagent manifold tubing at the fitting.
Page 159: Replacing The Reagent Manifold
Rapidlab 1200 Operator’s Guide: Maintenance 5-17 Replacing the Reagent Manifold You need a reagent manifold for this task. Wear personal protective equipment. Use universal precautions. BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials.
Page 160: Completing Reagent Manifold Maintenance
5-18 Rapidlab 1200 Operator’s Guide: Maintenance d. Squeeze the finger snaps on the reagent manifold and then remove the manifold by sliding it down and away from the sample connector. Finger snaps Figure 5-8 Reagent Manifold Finger Snaps e. Dispose of the manifold according to your institution’s protocol.
Page 161: Replacing The Automaticqc Manifold
Rapidlab 1200 Operator’s Guide: Maintenance 5-19 Replacing the AutomaticQC Manifold You need an AutomaticQC manifold for this task. 1. Press down on the left side of the AutomaticQC cartridge connector and slide the connector to the right. 2. Select Continue 3.
Page 162: Completing Automaticqc Manifold Maintenance
5-20 Rapidlab 1200 Operator’s Guide: Maintenance b. Align the tube loop that is on the back of the manifold with the groove in the system. Bottom clip Figure 5-10 AutomaticQC Manifold–Back View c. Insert the top clips into the holes and release the clips to lock them in place.
Page 163: Cleaning Procedures
Rapidlab 1200 Operator’s Guide: Maintenance 5-21 Cleaning Procedures This section provides procedures for performing as needed cleaning. Cleaning and Disinfecting the Screen Use a lint-free cloth to clean the screen. Do not use a spray bottle to spray the bleach solution on the screen.
Page 164: Cleaning The Sample Path
5-22 Rapidlab 1200 Operator’s Guide: Maintenance Cleaning the Sample Path Use this procedure to clean the sample path with bleach. You need the following materials for this task: • 10% bleach solution • syringe • lint-free tissue or swabs •...
Page 165 Rapidlab 1200 Operator’s Guide: Maintenance 5-23 b. Push the spring-loaded latch to the right, grasp the tab on the reference sensor, and pull the reference sensor up and out. Reference sensor Spring-loaded latch Figure 5-11 Measurement Module c. Align the top of the test/blank reference sensor (TB5) with the sensor contact and snap the sensor into place.
Page 166: Reinstalling The Reference Sensor And Biosensors
5-24 Rapidlab 1200 Operator’s Guide: Maintenance 7. Perform the cleaning cycle: a. Select b. Draw the 10% bleach solution into a syringe and insert the syringe into the sample port. c. Select Continue d. When prompted, remove the syringe and select Continue Do not replace the test/blank sensors at this time.
Page 167: Cleaning The Co-Ox Roller Cage
Rapidlab 1200 Operator’s Guide: Maintenance 5-25 Cleaning the CO-ox Roller Cage Use this procedure to clean the roller cages of the CO-ox pump. You need the following materials for this task: • Lint-free tissue and swabs • 10% bleach solution •...
Page 168: Cleaning The Roller Cage
5-26 Rapidlab 1200 Operator’s Guide: Maintenance 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. Platen Roller cage Lower tubing cuff Figure 5-13 CO-ox Module 6.
Page 169: Reconnecting The Co-Ox Tubing
Rapidlab 1200 Operator’s Guide: Maintenance 5-27 Reconnecting the CO-ox Tubing 1. Place the lower tubing cuff under the lower side of the platen. Do not stretch the tubing. NOTE: 2. Press the tubing around the outside of the rollers. 3. Place the upper tubing cuff onto the upper side of the platen.
Page 170 5-28 Rapidlab 1200 Operator’s Guide: Maintenance 4. Remove the waste assembly: a. Lift the orange lever up. Orange lever Figure 5-14 Waste Assembly b. Slide the waste assembly to the right. 5. Clean the waste assembly with the 10% bleach solution.
Page 171: Maintaining The Sensors
Rapidlab 1200 Operator’s Guide: Maintenance 5-29 Maintaining the Sensors Performing regular maintenance on the sensors is important to the life of the sensors. This section contains the following information: • Replacing the sensors • Performing reference sensor maintenance • Refilling the sensors...
Page 172: Removing The Sensors
5-30 Rapidlab 1200 Operator’s Guide: Maintenance Removing the Sensors 1. Select Status > Maintenance > Performing Sensor Maintenance 2. To start the procedure, select Continue 3. Remove the sensor: a. Lift the door to the Measurement module. Refer to Preparing for Maintenance Procedures‚ page 5-1.
Page 173: Installing The Sensor
Rapidlab 1200 Operator’s Guide: Maintenance 5-31 Installing the Sensor 1. Align the top of the sensor with the sensor contact. 2. Use the sensor names on the contact assembly to verify that the sensors are installed in the correct order.
Page 174: Filling The Sensor
5-32 Rapidlab 1200 Operator’s Guide: Maintenance 4. If you replaced the pH or Na sensors, condition the sensors. Refer to Conditioning the Sensors‚ page 5-6. 5. Analyze a minimum of 2 levels of quality control material. Filling the Sensor You need the following materials for this task: •...
Page 175 Rapidlab 1200 Operator’s Guide: Maintenance 5-33 c. Remove the cylinder, so the needle remains attached to the vial. 5. Rinse the sensor. a. Insert the needle, attached to the vial, into the sensor. b. Gently squeeze the fill solution vial until the sensor is full of solution.
Page 176: Performing Reference Sensor Maintenance
5-34 Rapidlab 1200 Operator’s Guide: Maintenance Performing Reference Sensor Maintenance The Reference sensor requires regular cleaning to maintain performance. Cleaning and Inspecting the Reference Sensor You need the following materials for this task: • Water • Lint-free swab Wear personal protective equipment. Use universal precautions.
Page 177 Rapidlab 1200 Operator’s Guide: Maintenance 5-35 2. Check the sensor for bubbles at the electrode tip and between the electrode compartment and the KCl reservoir. KCl reservoir Electrode compartment join to the KCl reservoir Electrode tip O-rings Figure 5-17 KCl Reservoir...
Page 178: Filling The Reference Sensor Cassette
5-36 Rapidlab 1200 Operator’s Guide: Maintenance Filling the Reference Sensor Cassette If you do not have a new reference sensor cassette, refill the reference sensor instead. You need the following materials for this task: • Reference electrode refill kit •...
Page 179 Rapidlab 1200 Operator’s Guide: Maintenance 5-37 b. Stand the internal electrode on its cap to drain it. 3. Fill the internal electrode compartment of the new sensor with KCl fill solution: a. Insert the tip of the KCl fill solution container into the internal electrode compartment.
Page 180 5-38 Rapidlab 1200 Operator’s Guide: Maintenance 5. Fill the KCl reservoir with KCl fill solution: a. Remove the reservoir cap using the hex tool and set the cap aside. b. Partially fill the KCl reservoir. c. Tap the front face of the sensor with your knuckle to remove any bubbles.
Page 181: Maintaining The Internal Reference Electrode
Rapidlab 1200 Operator’s Guide: Maintenance 5-39 Maintaining the Internal Reference Electrode 1. Remove the internal reference electrode using the hex tool. Internal electrode Cassette Internal electrode compartment Figure 5-20 Reference Sensor Casette 2. If you are replacing the internal reference electrode, dispose of the electrode according to your institution’s protocol.
Page 182: Performing Measurement Sensor Maintenance
5-40 Rapidlab 1200 Operator’s Guide: Maintenance Performing Measurement Sensor Maintenance You need the following materials for this task: • appropriate sensor fill solution kit • lint-free tissue The following table lists the fill solution to use for each sensor: Sensor Fill Solution , Cl¯, Ca...
Page 183 Rapidlab 1200 Operator’s Guide: Maintenance 5-41 4. Add fill solution: For these sensors... Add... , Cl¯, and Ca sensors almost full but with a small space (1 mm)at the top , Cl¯, and Ca Do not touch the internal electrode wire. The wire is fragile and is CAUTION: easily damaged.
Page 184: Replacing System Components
5-42 Rapidlab 1200 Operator’s Guide: Maintenance Replacing System Components This section contains procedures for replacing system components. Replacing the Printer Paper Replace the printer paper when a red stripe is displayed on the edge of the paper. You need printer paper for this task.
Page 185: Replacing The Co-Ox Lamp
Rapidlab 1200 Operator’s Guide: Maintenance 5-43 Replacing the CO-ox Lamp Do not touch the lamp until it has been off for at least 5 minutes. WARNING: Waiting for at least 5 minutes allows sufficient time for the lamp to cool.
Page 186 5-44 Rapidlab 1200 Operator’s Guide: Maintenance 5. Open the back cover. Electrical connector Lamp base Back cover Figure 5-21 Rapidlab 1200 System–back view 6. Remove the lamp: a. Stand directly behind the system and grasp the base of the lamp.
Page 187: Replacing The Co-Ox Roller Cage
Rapidlab 1200 Operator’s Guide: Maintenance 5-45 10. Start up the system: a. Turn the power switch on. b. At the interface screen, use the numeric buttons to enter your password. c. Select Continue Replacing the CO-ox Roller Cage Use this procedure to replace the roller cage of the CO-ox pump.
Page 188: Cleaning The Roller Cage Shaft
5-46 Rapidlab 1200 Operator’s Guide: Maintenance 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.
Page 189: Replacing The System Fuses
The electrical outlet is working. You need the following materials for this task: • Two fuses of the appropriate rating • Screwdriver The Rapidlab 1200 systems use the following fuses for the voltages shown: Voltage Fuse Rating Fuse Type 100–240V 1.6A Slo Blo 5 x 20 mm Do not proceed while the power is on.
Page 190 5-48 Rapidlab 1200 Operator’s Guide: Maintenance 1. Select Status > Shutdown > Yes The system displays the Shutdown screen and stops all fluidic sequences so that no damage to the cartridges can occur. 2. Turn the power off and disconnect the power cord from the electrical outlet.
Page 191: Relocating The System
Rapidlab 1200 Operator’s Guide: Maintenance 5-49 Relocating the System Use this procedure to move the system for use in another area. Do not proceed while the power is on. To prevent electrical shock or WARNING: damage to the system, remove power from the system as described in this procedure.
Page 192: Shipping Or Storing The System
5-50 Rapidlab 1200 Operator’s Guide: Maintenance Shipping or Storing the System Wear personal protective equipment. Use universal precautions. BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials. Do not proceed while the power is on. To prevent electrical shock or...
Page 193: Cleaning And Drying The Tubing
Rapidlab 1200 Operator’s Guide: Maintenance 5-51 Cleaning and Drying the Tubing Ensure that you follow these instructions using at least the minimum volumes of fluid and air described in these procedures. Flushing the Tubing for the RCx Reagent 1. Connect a piece of tubing to a syringe.
Page 194: Flushing The Upper Connector
5-52 Rapidlab 1200 Operator’s Guide: Maintenance Flushing the Upper Connector 1. Connect the syringe tubing to the upper connector for the wash reagent. Water collection area Upper connector Figure 5-26 Reagent Manifold 2. Flush with a minimum of 3 mL water.
Page 195: Flushing The Lower Connector
Rapidlab 1200 Operator’s Guide: Maintenance 5-53 Flushing the Lower Connector 1. Connect the syringe tubing to the lower connector for the wash reagent. 2. Flush with a minimum of 3 mL water. 3. Flush with a minimum of 12 mL air.
Page 196: Flushing The Tubing For The Samples
5-54 Rapidlab 1200 Operator’s Guide: Maintenance Flushing the Tubing for the Samples 1. Connect the syringe tubing to the connector for samples. 2. Flush the sample tubing with a minimum of 3 mL water. 3. Flush the sample tubing with a minimum of 12 mL air.
Page 197: Flushing The Tubing For The Measurement Module
Rapidlab 1200 Operator’s Guide: Maintenance 5-55 Flushing the Tubing for the Measurement Module 1. Disconnect the tubing from the left side of the pressure sensor bubbler. 2. Connect the syringe tubing to the pressure sensor bubbler. 3. Flush the measurement module tubing with a minimum of 3 mL water.
Page 198: Flushing The Tubing For The Measurement Module Waste
5-56 Rapidlab 1200 Operator’s Guide: Maintenance Flushing the Tubing for the Measurement Module Waste 1. Disconnect the tubing on the reagent manifold coming from the pressure sensor bubbler. 2. Connect the syringe tubing to the connector on the reagent manifold.
Page 199: Flushing The Tubing For The Automaticqc Module
Rapidlab 1200 Operator’s Guide: Maintenance 5-57 Flushing the Tubing for the AutomaticQC Module 1. Connect the syringe tubing to the AutomaticQC manifold. 2. Flush with a minimum of 3 mL water. Water collection area AutomaticQC manifold Figure 5-31 AutomaticQC Tubing 3.
Page 200: Flushing The Reagent Manifold Tubing
5-58 Rapidlab 1200 Operator’s Guide: Maintenance Flushing the Reagent Manifold Tubing This section applies to the Rapidlab 1245 and 1265 systems. 1. Disconnect the reagent manifold tubing from the CO-ox pump tubing. 2. Connect the syringe to the waste tubing.
Page 201: Flushing The Co-Ox Pump Tubing
Rapidlab 1200 Operator’s Guide: Maintenance 5-59 Flushing the CO-ox Pump Tubing This section applies to the Rapidlab 1245 and 1265 systems. 1. Remove the CO-ox roller cage. 2. Disconnect the CO-ox sample tubing from the connector on the measurement module.
Page 202: Removing And Storing The Sensors
5-60 Rapidlab 1200 Operator’s Guide: Maintenance Removing and Storing the Sensors 1. Select Status > Maintenance > Performing Sensor Maintenance 2. To start the procedure, select Continue 3. Remove the sensor: a. Lift the front cover, push up the latches on the measurement module door, and then lift the door.
Page 203: Scheduling Maintenance Activities
Rapidlab 1200 Operator’s Guide: Maintenance 5-61 Scheduling Maintenance Activities The maintenance schedule displays the maintenance tasks that are currently scheduled. The schedule displays a calendar week with the day and date at the top of the schedule and the state of each task in the grid.
Page 204: Maintenance Task Grace Period
5-62 Rapidlab 1200 Operator’s Guide: Maintenance Maintenance Task Grace Period The Grace Period is a defined amount time before or after the scheduled due date. When you perform a maintenance task within this grace period and mark the task as complete, the system automatically sets the next date for the task.
Page 205: Viewing Maintenance Task Details
Rapidlab 1200 Operator’s Guide: Maintenance 5-63 Viewing Maintenance Task Details The following information is available on the Details screen: • Description • Next Due • Last Performed This area is blank if the selected task is “As required.” • Frequency To view maintenance task details, perform the following steps.
Page 206 5-64 Rapidlab 1200 Operator’s Guide: Maintenance 02087462 Rev. V...
Page 207: Troubleshooting
6 Troubleshooting This section contains procedural information for system issues: • troubleshooting system problems • removing obstructions • understanding and resolving D codes • understanding and resolving system messages Troubleshooting Failed or Missed QC Analysis Use this section to help determine causes and corrective actions for failed QC analysis and for QC analysis not performed as scheduled.
Page 208 Rapidlab 1200 Operator’s Guide: Troubleshooting 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.
Page 209: Troubleshooting The Purple Parameter Error
Rapidlab 1200 Operator’s Guide: Troubleshooting Troubleshooting the Purple Parameter Error Probable Error Cause Corrective Action • Analyze all the currently scheduled controls. The parameter Required QC is purple with a analysis was Refer to Performing Required QC Sample Analysis‚ page 4-1.
Page 210: Troubleshooting Failed Calibrations
Rapidlab 1200 Operator’s Guide: Troubleshooting Troubleshooting Failed Calibrations Use this section to help determine causes and corrective actions for failed calibrations. Probable Error Cause Corrective Action The parameter The parameter For recommendations to resolve failed calibrations, has a single failed refer to Troubleshooting Checklist for Failed line through it.
Page 211: Using The Calibration Report To Identify Problems
Replace the affected sensor, if necessary. Using the Calibration Report to Identify Problems The full calibration report shows the measurement and drift values. Rapidlab 1200 systems use a 2-point calibration curve. The two points on the curve are the Cal Point and Slope Point.
Page 212: Troubleshooting Patient Results
Rapidlab 1200 Operator’s Guide: Troubleshooting Troubleshooting Patient Results Use this section to identify the symbols that are displayed with results or instead of results for a parameter. Table 6-2 Symbols -----↑ or -----↓ Probable Cause Corrective Action The result for the parameter is Analyze the sample again, ensuring that the above (-----↑) or below (-----↓)
Page 213: Troubleshooting Unavailable Buttons
Rapidlab 1200 Operator’s Guide: Troubleshooting Table 6-5 Missing Results Probable Cause Corrective Action The Rapidlink or Rapidcomm Contact your system supervisor for assistance if data management system or the you need to analyze samples and obtain results for LIS connected to the this parameter.
Page 214: Troubleshooting Measurement Module Lights
Rapidlab 1200 Operator’s Guide: Troubleshooting Problem Probable Cause Corrective Action All parameters are not View the events log to determine the event available because they causing the parameter to fail, and follow have failed scheduled the appropriate solutions for that event.
Page 215: Resetting The Barcode Scanner
Rapidlab 1200 Operator’s Guide: Troubleshooting Resetting the Barcode Scanner Reset the barcode scanner if the scanner no longer scans barcodes. 1. Scan the barcode shown below. 2. Shut the system down and then restart it. Refer to Shutting Down the System‚ page 2-6.
Page 216 6-10 Rapidlab 1200 Operator’s Guide: Troubleshooting Problem Probable Cause Corrective Action • Use the correct scanning technique. The barcode Faulty scanning scanner works technique, poor Refer to Scanning Technique‚ page 2-22. intermittently, or quality of the data is not barcode print, or •...
Page 217: Troubleshooting Internal Printer Problems
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-11 Troubleshooting Internal Printer Problems Problem Probable Cause Corrective Action • If the printer is out of paper, install a The internal printer The internal printer new roll of paper. does not print at all.
Page 218: Solving Communication Problems
LIS is correctly configured to communicate with the Rapidlab 1200 system. • Ensure that the Rapidlab 1200 system is correctly configured to communicate with the Rapidlink or Rapidcomm system or the LIS and that the connection is turned on.
Page 219: Clearing The Clot From The Reagent Manifold
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-13 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.
Page 220 6-14 Rapidlab 1200 Operator’s Guide: Troubleshooting d. Carefully pull the reagent manifold out slightly, then straight down, to avoid the sample connector (item 3, Figure 6-1). Fitting to which the reagent manifold tubing and CO-ox pump tubing are connected (Rapidlab 1245 and 1265 systems)
Page 221 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-15 8. Discard the gauze. 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) Sample exit port...
Page 222 6-16 Rapidlab 1200 Operator’s Guide: Troubleshooting 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...
Page 223: Clearing The Clot From The Preheater
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-17 16. Select to calibrate the system. The clot clearing procedure is complete. Clearing the Clot from the Preheater Wear personal protective equipment. Use universal precautions. BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials.
Page 224 6-18 Rapidlab 1200 Operator’s Guide: Troubleshooting 2. Replace the pO sensor with the clot clearing tool. a. Push the black spring-loaded latch assembly (item 1, Figure 6-4), located at the right of the 1200 Reference sensor, to the right, until the mechanism clicks in place.
Page 225 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-19 c. Insert the clot clearing tool in the place of the pO sensor. clot clearing tool black lever Figure 6-5 Clot Clearing Tool inserted in pO Sensor Slot 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.
Page 226 6-20 Rapidlab 1200 Operator’s Guide: Troubleshooting b. If using a standard syringe, hold the syringe firmly. If the path is totally obstructed, liquid may be expelled suddenly and CAUTION: with great force through the port at the back of the sample connector.
Page 227 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).
Page 228: Clearing The Clot From The Reagent Cartridge
6-22 Rapidlab 1200 Operator’s Guide: Troubleshooting Clearing the Clot from the Reagent Cartridge Wear personal protective equipment. Use universal precautions. BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials. Use this procedure only if the Clearing the Clot from the Preheater procedure fails to clear the obstruction.
Page 229 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-23 b. If using a standard syringe, hold the syringe firmly. 7. Press the syringe plunger gently into the clot clearing tool, while holding gauze against the sample port of the reagent cartridge, to catch the obstruction and any excess liquid.
Page 230: Removing Clots Using The Clot-Removal Line
6-24 Rapidlab 1200 Operator’s Guide: Troubleshooting 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.
Page 231 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-25 Use gauze to catch waste material cleared by the clot-removal NOTE: line. 2. To remove obstructions from the sample tubing in the reagent manifold, push the clot-removal line through the fluid connector on the reagent manifold.
Page 232 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. Preheater Sample connector Figure 6-10 Rapidlab 1200 Systems Sample Path Do not push the clot-removal line through the gas sensors.
Page 233 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-27 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. Sensor Syringe Figure 6-11 Injecting Water into the Gas Sensor Sample Path...
Page 234 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...
Page 235 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-29 c. Push a clot-removal line through the latch. Pinch valve tubing Spring-loaded latch Figure 6-13 Rapidlab 1200 Systems Sample Path 7. Remove obstructions from the sample waste path in the reagent manifold: a. Disconnect the tubing from the reagent manifold.
Page 236: Reinstalling The Sensors
6-30 Rapidlab 1200 Operator’s Guide: Troubleshooting b. Push the clot-removal line through the fluid connector on the reagent manifold until the clot-removal line appears again. Fluid connector Figure 6-14 Rapidlab 1200 Systems Sample Path Reinstalling the Sensors 1. Dry each sensor, ensure that the O-rings are in place, and then reinstall each sensor.
Page 237: Removing Obstructions From The Co-Ox Sample Path
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-31 Removing Obstructions from the CO-ox Sample Path Use the following procedure to remove obstructions from the CO-ox sample path where you see fluid restrictions and obstructions, or suspect problems based on D code messages.
Page 238 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.
Page 239: Using Diagnostics
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-33 b. Push the clot-removal line through the fluid connector on the reagent manifold. Pump tubing at the fitting. Fluid connector. Figure 6-17 CO-ox Sample Path to Waste c. Re-connect the CO-ox pump tubing. 5. Reinstall the cartridges and close both the reagent and wash doors.
Page 240: Copying Diagnostic Data
6-34 Rapidlab 1200 Operator’s Guide: Troubleshooting Copying Diagnostic Data Refer to Copying Diagnostic Data‚ page 7-3. Using the Diagnostics Screen The Diagnostic screen has options to perform the following functions: • print diagnostic reports • perform the Waste Detector Calibration •...
Page 241: Performing The Waste Detector Calibration
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-35 Performing the Waste Detector Calibration Use this procedure to calibrate the waste detector for the waste bottle. 1. Select Status > Diagnostics 2. Enter your password, if necessary. 3. Select Waste Detector 4. Remove the waste bottle, empty it, and set it aside.
Page 242: Using The Fluidic Functions Screen
6-36 Rapidlab 1200 Operator’s Guide: Troubleshooting Using the Fluidic Functions Screen The Diagnostics > Fluidic Functions screen displays buttons for performing the following actions: • perform Reagent Flow test for Wash, 200 Cal, Slope Cal, RCx, or Wash Cycle •...
Page 243: Priming The Aqc Cartridge
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-37 Priming the AQC Cartridge Use this procedure to test the flow of each level of QC material from the AutomaticQC cartridge. 1. Select Status > Diagnostics 2. Enter your password, if necessary. 3. Select Fluidic Functions >...
Page 244: Using The Pumps And Valves Screen
6-38 Rapidlab 1200 Operator’s Guide: Troubleshooting Use the following steps to perform the leak test. 1. Select Status > Diagnostics 2. Enter your password, if necessary. 3. Select Fluidic Functions > Leak Test 4. Wait while the system performs the test.
Page 245: Performing The Sample Pump And Wash Pump Tests
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-39 Performing the Sample Pump and Wash Pump Tests Use this procedure to test the sample pump or the wash pump located on the system behind the reagent cartridge. The pump test moves the pump at 4 speeds numbered 1 through 4. When you select , the system displays the number of the current speed on the screen.
Page 246: Performing The R Cartridge Valve Test
6-40 Rapidlab 1200 Operator’s Guide: Troubleshooting 5. Look for obstructions and listen for any unusual noises that may indicate a problem with the pump. a. Select to advance the pump to the next speed. Change b. Continue selecting and listening and looking for problems until you have Change tested all 4 speeds.
Page 247: Performing The Aqc Valve Test
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-41 Performing the AQC Valve Test Use this procedure to test the components that operate the valve located inside the AutomaticQC cartridge. The test moves the valve from the home position to each fluid position. During the procedure, select...
Page 248: Performing The Co-Ox Pump Test
6-42 Rapidlab 1200 Operator’s Guide: Troubleshooting Performing the CO-ox Pump Test This test only applies to the Rapidlab 1245 and 1265 systems. NOTE: Use this procedure to test the CO-ox pump. The pump test moves the pump at 4 speeds numbered 1 through 4.
Page 249: Ejecting The Wash Or Reagent Cartridge
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-43 Ejecting the Wash or Reagent Cartridge Use the Eject Cartridges buttons to eject cartridges when you need to access components behind the cartridges. 1. Select Status > Diagnostics Do not remove the wash or reagent cartridges for longer than 6 hours.
Page 250: Using The Sensors Screen
6-44 Rapidlab 1200 Operator’s Guide: Troubleshooting Using the Sensors Screen The Sensors screen has two print buttons: • Last Cal • Measurement The Last Cal report contains data for each sensor from the last 2-point or full calibration. The report provides the system ID, the date and time of the report, and sensor data in the order represented in Table 6-6.
Page 251: Using The Co-Ox Screen
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-45 Using the CO-ox Screen Only Rapidlab 1245 and 1265 systems use the functions on the CO-ox screen. The Diagnostics–CO-ox screen displays buttons for performing the following actions: • testing the lamp calibration • testing wavelength calibration •...
Page 252: Performing The Wavelength Cal Test
6-46 Rapidlab 1200 Operator’s Guide: Troubleshooting Performing the Wavelength Cal Test The Wavelength Cal test verifies the proper operation of the CO-ox neon lamp and prints the results providing the system ID, the date and time of the report, and as represented in Table 6-7.
Page 253: Performing The Lamp On/Off Test
The system automatically turns the lamp off when you exit the Diagnostics screen. 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.
Page 254: D2 Codes
6-48 Rapidlab 1200 Operator’s Guide: Troubleshooting D2 Codes D2 Excessive Drift: pO 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...
Page 255: D2 Excessive Drift: Na + K + Ca ++ Cl
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-49 D2 Excessive Drift: Na Cl¯ 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...
Page 256: D2 Excessive Drift: Glu Lac
6-50 Rapidlab 1200 Operator’s Guide: Troubleshooting D2 Excessive Drift: Glu Lac 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...
Page 257: D3 Codes
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-51 D3 Codes D3 Slope Error: pO 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.
Page 258: D3 Slope Error: Glu Lac
6-52 Rapidlab 1200 Operator’s Guide: Troubleshooting Problem Corrective Action • If the problem persists, replace the sensor. If the reference sensor has the slope error, the K , Ca , Cl¯, pH, and Na sensors will also have slope errors.
Page 259: D4 Codes
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-53 D4 Codes D4 Offset Error: pO 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 •...
Page 260: D4 Offset Error: Glu Lac
6-54 Rapidlab 1200 Operator’s Guide: Troubleshooting D4 Offset Error: Glu Lac 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 • Check that the biosensors are installed in the correct location 2-point calibration.
Page 261: D5 No Endpoint: Glu Lac
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-55 Problem Corrective Action • Check the sensor contacts and measurement block for salt buildup. • Check behind the sensors for fluid leaks. If salt or leaks are present, clean the sensor with water, dry, reinstall, and perform a 2-point calibration.
Page 262: D6 Codes
6-56 Rapidlab 1200 Operator’s Guide: Troubleshooting D6 Codes D6 Excessive Noise: pO 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 •...
Page 263: D6 Excessive Noise: Ph Na K Ca Cl
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-57 D6 Excessive Noise: pH Na Cl¯ Problem Corrective Action The sensor signal Correct any reagent problems such as D23 codes before you has excess noise. attempt to correct this D code. The patient sample •...
Page 264: D8 Po R Cartridge Error
6-58 Rapidlab 1200 Operator’s Guide: Troubleshooting D8–D22 Codes D8 pO R Cartridge Error Problem Corrective Action • Calibrate the Barometric Sensor. Refer to Calibrating the The pO2 value Barometric Sensor‚ page 5-3 during a calibration is different than the Perform a full calibration. Refer to Performing Manual Calibrations‚...
Page 265: D20 Pressure Signal Out Of Range
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-59 D20 Pressure Signal Out of Range Problem Corrective Action The millivolt (mV) Push the spring-loaded latch to the right to relieve excess reading from the pressure and then press the tab on the latch to release the pressure sensor is latch.
Page 266: D23 Codes
6-60 Rapidlab 1200 Operator’s Guide: Troubleshooting D23 Codes D23 Reagent Flow Error: 2, 10 Problem Corrective Action Wash reagent was Perform the highlighted test(s) in Diagnostics > Fluidic not detected during Functions calibration. Perform a leak test. 2 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test...
Page 267: D23 Reagent Flow Error: 4, 12
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-61 D23 Reagent Flow Error: 4, 12 Problem Corrective Action Slope Cal reagent Perform the highlighted test(s) in Diagnostics > Fluidic was not detected Functions during calibration. Perform a leak test. 4 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test...
Page 268: D23 Reagent Flow Error: 6
6-62 Rapidlab 1200 Operator’s Guide: Troubleshooting D23 Reagent Flow Error: 6 Problem Corrective Action The system detects Perform the highlighted test(s) in Diagnostics > Fluidic an air leak in the Functions fluidic path during Perform a leak test. a calibration.
Page 269: D23 Reagent Flow Error: 14
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-63 D23 Reagent Flow Error: 14 Problem Corrective Action The system detects Select and look for Diagnostics > Fluidic Functions > RCx a possible obstructions. obstruction during Remove obstructions from reagent manifold, measurement calibration or module, and sample tubing.
Page 270: D32 Aqc Cartridge Valve Error: 2
6-64 Rapidlab 1200 Operator’s Guide: Troubleshooting D32 AQC Cartridge Valve Error: 2 Problem Corrective Action The AutomaticQC Check that the connector is completely open and then select cartridge fails to to eject the cartridge. Replace eject. Select Diagnostics > Cartridges > Eject AQC Cartridge...
Page 271: D35 Codes
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-65 D35 Codes D35 Electronics Error: 1-3, 7-12 Problem Corrective Action An error has Select Status > Shutdown. occurred in the Wait 10 seconds, and then turn the system on. electronic If the problem persists, call for technical assistance.
Page 272: D37 Codes
6-66 Rapidlab 1200 Operator’s Guide: Troubleshooting D37 Codes D37 Cartridge Eject Error: 1 Problem Corrective Action The eject Select Diagnostics > Cartridge > Eject W Cartridge mechanism fails to Eject R Cartridge move to the correct Select Status > Shutdown position.
Page 273: D39 Obstruction
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-67 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.
Page 274: D41 Aqc Cartridge Prime Error: 1, 2, 3
6-68 Rapidlab 1200 Operator’s Guide: Troubleshooting D41 AQC Cartridge Prime Error: 1, 2, 3 Problem Corrective Action QC material failed Check that the AutomaticQC connector is completely to flow from a new closed. AutomaticQC Prime the AutomaticQC cartridge. cartridge. Refer to Priming the AQC Cartridge‚ page 6-37.
Page 275: D50 Glucose Sensor Error
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-69 D50 Glucose Sensor Error Problem Corrective Action The system detects Check that the biosensor is correctly installed, the contacts an open connection are aligned, and the spring-loaded latch is closed. in the glucose If the biosensor has been on the system less than one day, biosensor.
Page 276: D51 Lactate Sensor Error
Corrective Action • Ensure that the cable is firmly connected to the The system Rapidlab 1200 system and to all external devices. detects a data • Ensure that the cable is not damaged and that it is the correct communication cable for connecting the systems.
Page 277: D70 Optics Error: 9
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-71 D70 Optics Error: 9 Problem Corrective Action The system detects Select Status > Shutdown a failure in the Wait 10 seconds, and then turn the system on. CO-ox optical If the problem persists, call for technical assistance.
Page 278: D73 Co-Ox Chamber Position Error
6-72 Rapidlab 1200 Operator’s Guide: Troubleshooting D73 CO-ox Chamber Position Error Problem Corrective Action The system detects Ensure that the CO-ox sample chamber is properly installed. that the CO-ox Select Diagnostics > CO-ox > Sample Chamber Start sample chamber is If the problem persists, replace the CO-ox sample chamber.
Page 279: D78 Codes
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-73 D78 Codes D78 No Reagent Detected at CO-ox: 1 Problem Corrective Action • Perform the highlighted test(s) in Diagnostics > Fluidic Fluid detector 3 Functions (FD3), the CO-ox • If the problem persists, select Diagnostics >...
Page 280: D78 No Reagent Detected At Co-Ox: 4
6-74 Rapidlab 1200 Operator’s Guide: Troubleshooting D78 No Reagent Detected at CO-ox: 4 Problem Corrective Action • Perform the highlighted test(s) in Diagnostics > Fluidic Fluid detector 3 Functions (FD3), the CO-ox • Remove obstructions. sample chamber, or both do not detect •...
Page 281 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-75 Message Probable Cause Corrective Action AQC Cartridge The system detects that the newly Replace the cartridge. Refer to Not Valid installed AutomaticQC cartridge Replacing the AutomaticQC has exceeded its expiration date, Cartridge‚ page 2-3.
Page 282 6-76 Rapidlab 1200 Operator’s Guide: Troubleshooting Message Probable Cause Corrective Action To avoid bubbles in patient samples, ensure that you use the recommended collection, storage, handling, and mixing techniques. Refer to Collecting Samples‚ page 2-7. For QC samples, ensure that you...
Page 283 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-77 Message Probable Cause Corrective Action CO-ox The system detects that the Ensure that you installed the Chamber Temp temperature of the CO-ox sample CO-ox sample chamber properly. Error chamber is beyond the acceptable Ensure that you tightly close the range.
Page 284 6-78 Rapidlab 1200 Operator’s Guide: Troubleshooting Message Probable Cause Corrective Action Excessive The system detects bubbles in the This occurs if the sample Bubbles in CO-ox sample chamber. contained bubbles, if air leaks are CO-ox Sample present in the CO-ox sample...
Page 285 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-79 Message Probable Cause Corrective Action Ensure that the sample device you use contains sufficient sample. To identify the minimum sample volume for the sample device that you are using, refer to Recommended Fill Volumes‚...
Page 286 6-80 Rapidlab 1200 Operator’s Guide: Troubleshooting Message Probable Cause Corrective Action No AQC The system does not detect the If the AutomaticQC cartridge Cartridge AutomaticQC cartridge after was just installed, the cartridge replacing the cartridge or at may not be installed correctly or power up.
Page 287 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-81 Message Probable Cause Corrective Action No W The system does not detect the Reinstall the cartridge. Cartridge wash cartridge. The cartridge Replace the cartridge. Refer to may not be installed correctly. Replacing the Wash Cartridge‚...
Page 288 6-82 Rapidlab 1200 Operator’s Guide: Troubleshooting Message Probable Cause Corrective Action R Cartridge The system detects that an Replace the cartridge. Refer to Not Valid expired reagent cartridge was Replacing the Reagent installed or the cartridge was Cartridge‚ page 2-3.
Page 289 Rapidlab 1200 Operator’s Guide: Troubleshooting 6-83 Message Probable Cause Corrective Action User Canceled The operator interrupted a No action necessary. Calibration calibration to perform another action, for example to load a STAT test. W Cartridge The wash cartridge has exceeded Replace the cartridge.
Page 290 6-84 Rapidlab 1200 Operator’s Guide: Troubleshooting 02087462 Rev. V...
Page 291: File Management
7 File Management This section contains information about the following file management topics: • File names and formats • Copying data files • Viewing the sample totals File Names and Formats When you copy files to a storage medium, CD or diskette, the file name indicates the type of data the file contains (P for patient, Q for QC, and C for calibration) and the day of the year that the file was created.
Page 292: Copying Data Files
Rapidlab 1200 Operator’s Guide: File Management 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.
Page 293: Copying Patient, Qc, Or Calibration Data Files
Rapidlab 1200 Operator’s Guide: File Management Copying Patient, QC, or Calibration Data Files 1. Select Recall > Copy Stored Results The system displays the date for the last time you copied data to the NOTE: left of the buttons. 2. Select the type of data you want to copy,...
Page 294: Viewing The Sample Totals
Rapidlab 1200 Operator’s Guide: File Management 3. Copy the data: If you are copying data... Then... Select to CD, When prompted, insert the CD into the drive and select Continue When prompted, remove the CD from the drive and select...
Page 295: 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.
Page 296: Setting Up Qc
Rapidlab 1200 Operator’s Guide: System Configuration 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 •...
Page 297: Entering Customized Qc Range Limits
Rapidlab 1200 Operator’s Guide: System Configuration Entering Customized QC Range Limits 1. At the Setup screen, select 2. If performing AQC, select AutomaticQC Ranges If performing RQC, select Required QC Ranges 3. Select the QC range to view. The screen for the QC range you selected displays.
Page 298: Setting Up Required Qc Ranges
Rapidlab 1200 Operator’s Guide: System Configuration 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.
Page 299: Editing Required Qc Ranges
Rapidlab 1200 Operator’s Guide: System Configuration 6. At the Required QC Ranges screen, select to return to the Setup menu. Save Editing Required QC Ranges You can change the range values of each parameter in the selected level. You can also convert a trial lot to an active lot.
Page 300: Setting Up Automaticqc Ranges
Rapidlab 1200 Operator’s Guide: System Configuration Setting up AutomaticQC Ranges Use the AutomaticQC ranges screen to view lot information and target ranges for controls used for AutomaticQC analysis. When you replace the AutomaticQC cartridge, the system replaces the current target ranges with its own target ranges.
Page 301: Setting Up Sample Information
Rapidlab 1200 Operator’s Guide: System Configuration Setting up Sample Information Select the Sample button to display options for the following setup screens: • Patient Ranges • Patient Demographics • Sample Demographics • Parameter Selection • Sample Type Defining Patient Ranges Use this procedure to define the high and low limits of the patient range for each parameter.
Page 302 Rapidlab 1200 Operator’s Guide: System Configuration Parameter Default Range Default Units 10–998 mg/dL 0.00–30.00 mmol/L 2.0–25.0 g/dL † 0.0 ± 200.0 (QC ranges) † 0.0 ± 100.0 (patient ranges) † 0.0 ± 200.0 † FCOHb 0.0 ± 200.0 † FMetHb 0.0 ±...
Page 303: Setting Up Patient Demographics Or Sample Demographics
Rapidlab 1200 Operator’s Guide: System Configuration Setting up Patient Demographics or Sample Demographics At the Patient Demographics or Sample Demographics screen you can select the following options: • Required entries Use this option to set up the demographic fields to use at the Data Entry screen.
Page 304: Defining Patient Demographics
8-10 Rapidlab 1200 Operator’s Guide: System Configuration Defining Patient Demographics 1. At the Setup screen, select Sample > Patient Demographics 2. Select each demographic to turn it on or off. 3. Select the Required button to make the selected demographic required.
Page 305: Enabling Parameter Selection At Analysis
A custom panel allows you to select all the parameters you select for a test with one touch. You can create up to 6 custom panels on the Rapidlab 1200 system. You can also select a default custom panel.
Page 306 8-12 Rapidlab 1200 Operator’s Guide: System Configuration Define a Custom Panel To define a custom panel, perform the following steps. Custom panels can only be defined for patient samples. NOTE: 1. At the Setup screen, select Sample > Parameter Selection Three columns display.
Page 307: Setting Up Sample Types
Rapidlab 1200 Operator’s Guide: System Configuration 8-13 Only the first panel in the first set can be selected as a default panel. NOTE: 7. Select Save > Return > Analysis The default panel is selected automatically. Parameters that are not in the default panel do not display.
Page 308: Specific Parameter Guidelines
8-14 Rapidlab 1200 Operator’s Guide: System Configuration • 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.
Page 309: Setting Parameters On Or Off
Rapidlab 1200 Operator’s Guide: System Configuration 8-15 Setting Parameters On or Off 1. At the Setup screen, select Parameters > Parameter On/Off At the Parameters On/Off screen, selected parameters have a check mark. 2. Select the parameters to turn them on or off.
Page 310: Default And Alternate Units Of Measure
8-16 Rapidlab 1200 Operator’s Guide: System Configuration Default and Alternate Units of Measure This table lists the parameters the system can report and the default and alternate units of measure for each parameter. Parameter Default Units Alternate Units (pH units)
Page 311: Required Parameters And Sample Demographics
Rapidlab 1200 Operator’s Guide: System Configuration 8-17 Parameter Default Units Alternate Units AnGap mmol/L † (decimal) A calculated value determined from the total hemoglobin value. † mL/dL mL/L, mmol/L (A-a)(T) mmHg (a/A)(T) (decimal) mmHg † (decimal) † sp/ t(T) (decimal) †...
Page 312 8-18 Rapidlab 1200 Operator’s Guide: System Configuration Parameter Required Parameters and Sample Demographics , temperature ¯act , pH ¯std , BE(B), sO , or O SAT(est) BE(B) , pH, HCO -act BE(ecf) pH, HCO ¯act ctCO , HCO ¯act Ca++ (7.4)
Page 313: Setting Up Values
Rapidlab 1200 Operator’s Guide: System Configuration 8-19 Parameter Required Parameters and Sample Demographics (a- ), 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.
Page 314: Selecting A Language
8-20 Rapidlab 1200 Operator’s Guide: System Configuration 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.
Page 315: Setting Up The Sound
Rapidlab 1200 Operator’s Guide: System Configuration 8-21 2. Change the date and time. If you want to... Then... Select change the date, Date Enter the date in the format shown on the screen. Enter a leading zero before numbers less than 10. For example, if the date format is mm/dd/yyyy, enter February 4, 2007 as 02042007.
Page 316: Setting Up Printer And Devices Options
8-22 Rapidlab 1200 Operator’s Guide: System Configuration Setting up Printer and Devices Options When you select Printer and Devices at the Setup Window, the following options are available: • Printer Options • Barcode Setup • Communications Selecting Printer Options The Setup–Printer Options screens allow you to perform the following functions: •...
Page 317: Setting Up Barcode Options
Rapidlab 1200 Operator’s Guide: System Configuration 8-23 7. If you select a Calibration Report, select either Status Full Refer to Generating Calibration Reports‚ page 3-3. 8. If you are selecting a Sample or QC report, select to include ranges Ranges on the report.
Page 318 8-24 Rapidlab 1200 Operator’s Guide: System Configuration 3. Select the barcode symbology that your institution uses. • 128, the default • Code 39 • Code 39 with check digit • Codabar • Interleaved 2 of 5 (I/2 of 5) •...
Page 319: Selecting The Barcode Only Option For Patient Id Entry
Rapidlab 1200 Operator’s Guide: System Configuration 8-25 Selecting the Barcode Only Option for Patient ID Entry Restricting patient ID entry to barcode only entry minimizes errors that can occur when the patient ID is entered manually. When the barcode only patient ID data entry option is active, the patient...
Page 320: Connecting The Barcode Scanner
8-26 Rapidlab 1200 Operator’s Guide: System Configuration Connecting the Barcode Scanner You need the a barcode scanner kit, including the barcode scanner, cable, and holder for this activity. Use only the barcode scanner kit provided by the manufacturer. For the part NOTE: number of the barcode scanner kit, refer to Supplies‚...
Page 321: Connecting To A Rapidlink ® Or Rapidcomm ® System
® ® Connecting to a Rapidlink or Rapidcomm System You can connect the Rapidlab 1200 systems to a Rapidlink or Rapidcomm data management system using either of the following methods: • Serial (RS-232) connection • Ethernet network that uses a 10Base-T connection Both methods allow you to connect the Rapidlab 1200 systems to a single Rapidlink or Rapidcomm server, or to a Rapidlink or Rapidcomm workstation.
Page 322: Connecting To A Complenet ® Network Connection
9. At the Rapidlab 1200 system, select Save 10. Select Return 11. 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. ®...
Page 323: Entering Ip Addresses
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.
Page 324: Using Dhcp
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. Selecting sO...
Page 325 2. At the Shutdown screen, turn the power switch off. 3. Connect the interface cable to the Rapidlab 1200 system and to the LIS: a. Connect the 9-pin connector on the cable to the serial (RS-232) port on the back panel of the Rapidlab 1200 system.
Page 326: Setting Up Auto Send Options
8-32 Rapidlab 1200 Operator’s Guide: System Configuration Setting up Auto Send Options You can select the type of results to automatically send to a connected LIS, Rapidlink, or Rapidcomm data management system at the end of analysis. • Patient results •...
Page 327 Rapidlab 1200 Operator’s Guide: System Configuration 8-33 Enabling Remote Viewing Automatically or Manually 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.
Page 328 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.
Page 329: Setting Up Secured Options
Rapidlab 1200 Operator’s Guide: System Configuration 8-35 Setting up Secured Options The secured options screen allows you to determine the level of access to the system and set up the level of access for individual operators. The security access for the system and the level of access assigned to individual operators together determine which functions an operator can access and which functions an operator can access only with a password.
Page 330 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 analyzing samples Yes/Yes Yes/Yes Yes/Yes Yes/Yes...
Page 331: Defining Operator Ids And Passwords
Refer to the tables in Setting up Operator Security Levels‚ page 8-35. If your Rapidlab 1200 system is connected to a data management system, you can turn on the option to notify operators when their password is about to expire. The message is displayed 14 days before the password expires.
Page 332: Setting Up Analysis Options
8-38 Rapidlab 1200 Operator’s Guide: System Configuration 2. Complete the appropriate tasks: If you want to... Then... Select add an operator, Enter the operator ID. Select and enter the password for the Password operator. To enter an alphanumeric operator ID or password, select the label for the entry field to access the keyboard screen.
Page 333: Selecting Demographics Editing
If your system is connected to a Rapidlink or Rapidcomm data management system, or an LIS, the Rapidlab 1200 system also sends the edited sample data to the computer system. 1. At the Setup screen, select Secured Options >...
Page 334: Flagging Microsample Results
8-40 Rapidlab 1200 Operator’s Guide: System Configuration Flagging Microsample Results Some samples start as normal samples but the system analyzes them as microsamples because the system detects insufficient sample material or bubbles in the sample. Selecting Flag Microsamples allows the system to identify samples as microsamples and to flag these results.
Page 335: Setting Up Calibrations
Use this diskette or CD later to restore the setup options. If are defining setup options for more than 1 Rapidlab 1200 system with the same model number, you can use the diskette or CD from the first system to copy the setup options to your other systems using the Restore option.
Page 336: Installing New System Software
You need the following materials to perform this task: • Disks containing the Rapidlab 1200 system software • CD-ROM containing the Rapidlab 1200 system software You can copy patient, QC, and calibration data to a disk or CD. Refer to Copying Data Files‚...
Page 337 Rapidlab 1200 Operator’s Guide: System Configuration 8-43 1. At the Setup screen, select Secured Options > Software Installation 2. Install the software: Select at any time to exit from the installation without NOTE: Return installing the new software. If you are installing from...
Page 338: Setting Up Correlation Coefficients
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:...
Page 339 Rapidlab 1200 Operator’s Guide: System Configuration 8-45 To set up maintenance tasks on your system, perform the following steps: 1. At the Setup screen, select Secured Options 2. Select the down arrow button and then select Maintenance 3. Select Setup Schedule 4.
Page 340: Importing And Exporting Maintenance Activities
8-46 Rapidlab 1200 Operator’s Guide: System Configuration Importing and Exporting Maintenance Activities 1. At the Setup screen, select Secured Options 2. Select the down arrow button and then select Maintenance If you want to... Then... Select Import Schedule Import maintenance Data from a disk or CD Insert a disk or CD in to the drive.
Page 341: Appendix A: Safety Instructions
Appendix A: Safety Instructions This information summarizes the established guidelines for handling biohazards. This summary is based on the guidelines developed by the Centers for Disease Control, the Clinical and Laboratory Standards Institute Document M29-A3, Protection of Laboratory Workers from Occupationally Acquired Infections, and the Occupational Safety and Health Administration’s Bloodborne Pathogens 1–3 Standard.
Page 342: References
Rapidlab 1200 Operator’s Guide: Safety Instructions To prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: • Wear gloves while servicing parts of the instrument that have contact with body fluids such as serum, plasma, urine, or whole blood.
Page 343: Protecting Yourself From Barcode Scanner Lasers
Do not look at the reflection of the beam from a shiny surface. Protecting Yourself from Electrical Hazards When using Rapidlab 1200 system, always observe the following precautions: • Do not operate the system in the presence of flammable anesthetic mixture with air, O , or nitrous oxide.
Page 344 Rapidlab 1200 Operator’s Guide: Safety Instructions 02087462 Rev. V...
Page 345: Appendix B: Service, Ordering, And Warranty
Limited Instrument Warranty and Service Delivery Policy Siemens and its authorized distributors may provide customers who acquire new Siemens instruments with a limited warranty either in a specific agreement or in standard language on their invoices. This limited warranty is designed to protect...
Page 346: Additional Service Period
Service During Normal Hours The customer may obtain service for instruments during normal business hours by contacting the nearest Siemens location or authorized distributor. Refer to the list of Siemens locations in this section. Extent of a Service Call...
Page 347: Replacement Of Parts
Customer Maintenance Items for any specific model of instrument. Design Changes and Retrofitting of Instruments Siemens reserves the right to change the design or construction of specific models of instruments at any time without incurring any obligation to make such changes available to individual customers or instruments.
Page 348: Warranty And Service Exclusions
4. Customer did not purchase the instrument from Siemens or one of its authorized distributors. 5. The instrument has not been installed within 90 days of shipment to the customer’s facility unless otherwise specified.
Page 349: Copyright Information
GNU General Public License v.2 This product includes open source software. Such software is provided by Siemens under the terms of the open source software licenses applicable to such software, and is distributed WITHOUT ANY WARRANTY as set forth in the corresponding licenses.
Page 350: Baptize V1.0
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty Copyright (C) 2004 John Wiggins Copyright (C) 2007 Siemens Healthcare Diagnostics Baptize V1.0 Baptize BAPTIZE V1.0 This tool sets the computername to the specified value without the need to reboot the machine.
Page 351: Bdm Download
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty 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...
Page 352: Zip And Unzip
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty Zip and Unzip This is version 2005-Feb-10 of the Info-ZIP copyright and license. The definitive version of this document should be available at ftp://ftp.info-zip.org/pub/infozip/license.html indefinitely. Copyright (c) 1990-2005 Info-ZIP. All rights reserved.
Page 353: Contacts
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty 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...
Page 354 B-10 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty 02087462 Rev. V...
Page 355: Appendix C: System Fluids
Appendix C: System Fluids Recommended Fill Volumes You can analyze samples with the Rapidlab 1200 systems using the sample collection devices listed in the following table. Always use the recommended minimum fill volumes for the sample devices. This ensures that the systems can aspirate sufficient sample for analysis.
Page 356: Rapidlab 1200 Cartridges
Rapidlab 1200 Operator’s Guide: System Fluids Rapidlab 1200 Cartridges Each of the cartridges has an install-by date on the label. Cartridge Stability Use life Storage temperature ° Reagent 30 days Calibration dependent to 8°C cartridge Room temperature not to exceed 25°C, up to 7 days...
Page 357: Appendix D: Supplies
Reagent manifold (1245, 1265) 06643971 AQC manifold 06647195 Quick adapter (100) 09320618 Barcode scanner kit 10379796 Cable, Rapidlab 1200 to Rapidlink or Rapidcomm 03480125 Fuses (2) 07167332 Reference sensor 06449458 Reference sensor refill (cassette, fill solution, O-rings) 06451843 Reference inner...
Page 358 Rapidlab 1200 Operator’s Guide: Supplies Item 10376879 Ready sensor 01428622 Ready sensor Cl¯ Ready sensor 10376880 Glu sensor 04442537 Lac sensor 01664482 Sample Ground/Temperature sensor 06195871 Test/Blank sensor pO /pCO (TB1) 02195443 05147202 Test/Blank sensor pH/Na (TB2) 00768594 Test/Blank sensor K /Cl¯...
Page 359 Rapidlab 1200 Operator’s Guide: Supplies Item 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...
Page 360 Rapidlab 1200 Operator’s Guide: Supplies 02087462 Rev. V...
Page 361: Appendix E: System Specifications
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...
Page 362 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 mmol/L 70.0–200.0...
Page 363 0–3500 L/min 0.00–3.50 0.01 mmol/min 0–156.2 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 g/dL 2.0–25.0 20–250...
Page 364 0–40.0 mL/L 0–400 mmol/L 0–17.9 The following table lists the units, reporting ranges, and display resolutions for the temperature corrected and respiratory parameters calculated by the Rapidlab 1200 systems. Table E-6 Temperature Corrected and Respiratory Parameters Parameter Units Reporting Range...
Page 365: Understanding System Limitations
Rapidlab 1200 Operator’s Guide: System Specifications 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 °C Temperature 10.0–43.9...
Page 366: Interference Testing
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.
Page 367 Rapidlab 1200 Operator’s Guide: System Specifications Effect of Interference Interference Analyte (units) Interference Level Tested (Test - control) Acetylsalicylic 50 mg/dL Acid Acetaminophen 2 mg/dL Sodium Pentothal 300 mg/dL -1.0 Acetaminophen 2 mg/dL -0.03 (mmol/L) Ibuprofen 40 mg/dL -0.03 Salicylic Acid 20 mg/dL -0.04...
Page 368 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 <...
Page 369: Interference Testing For Rapidlab 1200 Co-Oximetry
Rapidlab 1200 Operator’s Guide: System Specifications Interference Testing for Rapidlab 1200 CO-oximetry Siemens performed interference testing to demonstrate the specificity of the Rapidlab 1200 systems CO-oximetry module. 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.
Page 370: Interference Testing Results For Thb, Fo
E-10 Rapidlab 1200 Operator’s Guide: System Specifications Interference Testing Results for tHb, FO Hb, FCOHb, FMetHb, and FHHb Potential Interferent Level Tested Effect of Interference Lipid 5% Intralipid in serum No effect Bilirubin 40 mg/dL No effect Fetal Hemoglobin 20, 40, 85%...
Page 371: Ethylene Glycol Interference When Measuring Lactate
Falsely decreased glucose results may also be reported. Performance Characteristics This section contains performance characteristics for each Rapidlab 1200 system in the series. Each system contains performance data within the following criteria: •...
Page 372: Recovery And Precision Of Blood Gases In Human Whole Blood
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 † Analyte Level Mean WRSD Total SD 7.121 0.001...
Page 373 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 Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.004 7.042 7.032...
Page 374 E-14 Rapidlab 1200 Operator’s Guide: System Specifications Table E-11 Rapidlab 1240 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV pH Only 0.014 7.031 7.032 99.99 Capillary pH Only 0.007 7.221 7.202 100.27 Capillary pH Only 0.005 7.371 7.354...
Page 375 Rapidlab 1200 Operator’s Guide: System Specifications E-15 Table E-12 Rapidlab 1240 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Syringe 0.39 22.7 21.5 105.7 Syringe 0.59 26.7 28.6 93.3 Syringe 0.81 36.3 35.4 102.5 Syringe 1.08 50.8 50.1...
Page 376 E-16 Rapidlab 1200 Operator’s Guide: System Specifications Table E-12 Rapidlab 1240 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Micro- 1.91 101.7 100.2 101.5 syringe Micro- 2.97 138.3 101.7 syringe Micro- 6.74 241.4 105.4 syringe WRSD = within-run standard deviation Table E-13 Rapidlab 1240 Recovery and Precision Testing—pO...
Page 377: Method Comparison With Human Whole Blood Samples
Rapidlab 1200 Operator’s Guide: System Specifications E-17 Table E-13 Rapidlab 1240 Recovery and Precision Testing—pO Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.66 159.9 149.8 106.7 capillary Micro- 1.72 199.9 199.5 100.2 capillary Micro- 2.09 249.7 106.1 capillary Micro- 2.71...
Page 378: Rapidlab 1245 System Performance Characteristics
All performance data presented in this section was generated using the Rapidlab 1245 system. The system performed calibrations using the default settings recommended by Siemens for optimum performance. All reported values were corrected to 760 mmHg. All data was collected at room temperature (about 23°C). You should determine your own performance characteristics in your laboratory with your Rapidlab 1245 system.
Page 379 Rapidlab 1200 Operator’s Guide: System Specifications E-19 Precision on manual aqueous quality control materials was estimated using a minimum of 3 Rapidlab 1245 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 1245 systems over a minimum of 10 days.
Page 380: Recovery And Precision Of Blood Gases In Human Whole Blood
E-20 Rapidlab 1200 Operator’s Guide: System Specifications † Total SD = total standard deviation Table E-17 Rapidlab 1245 AutomaticQC Precision Results † Parameter Level Mean WRSD Total SD 7.15 0.002 0.002 7.352 0.001 0.002 7.553 0.002 0.003 68.8 1.18 1.38 39.1...
Page 381 Rapidlab 1200 Operator’s Guide: System Specifications E-21 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 Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.004...
Page 382 E-22 Rapidlab 1200 Operator’s Guide: System Specifications Table E-18 Rapidlab 1245 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV pH Only 0.007 7.024 7.032 99.88 0.10 Capillary pH Only 0.004 7.198 7.202 99.94 0.05 Capillary pH Only 0.008...
Page 383 Rapidlab 1200 Operator’s Guide: System Specifications E-23 Table E-19 Rapidlab 1245 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Syringe 0.32 22.3 21.5 104.0 Syringe 0.47 27.4 28.6 95.6 Syringe 1.26 35.5 35.4 100.2 Syringe 1.47 50.9 50.1...
Page 384 E-24 Rapidlab 1200 Operator’s Guide: System Specifications Table E-19 Rapidlab 1245 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Micro- 1.80 98.0 100.2 97.8 syringe Micro- 2.55 127.8 136.0 94.0 syringe Micro- 5.59 224.7 229.0 98.1 syringe...
Page 385: Recovery And Precision Of Hemoglobin Fractions In Human Whole Blood
Rapidlab 1200 Operator’s Guide: System Specifications E-25 Table E-20 Rapidlab 1245 Recovery and Precision Testing—pO Level Mode WRSD Observed Expected Recovery WRCV Micro- 1.86 150.3 149.8 100.3 capillary Micro- 2.21 186.7 199.5 93.6 capillary Micro- 3.70 239.9 249.7 96.1 capillary Micro- 9.31...
Page 386 E-26 Rapidlab 1200 Operator’s Guide: System Specifications 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%...
Page 387 Rapidlab 1200 Operator’s Guide: System Specifications E-27 Table E-22 Rapidlab 1245 CO-ox Module Recovery and Precision with Total Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75% Pooled Mean Mean † Analyte Mode Reference Bias FMetHb Capillary 5.22 -0.02 0.06 FMetHb 5.22...
Page 388: Method Comparison With Human Whole Blood Samples
E-28 Rapidlab 1200 Operator’s Guide: System Specifications Method Comparison with Human Whole Blood Samples For testing syringe and capillary modes, blood was collected in heparinized vacuum tubes. It was tonometered at 37°C or adjusted chemically. Several levels of tHb were prepared by separating the red cells from the plasma and recombining appropriately.
Page 389 Rapidlab 1200 Operator’s Guide: System Specifications E-29 Table E-26 Rapidlab 1245 System Human Whole Blood Method Comparison—pO Mode Slope Intercept RMSE Micro- 0.941 5.553 7.223 0.990 26.2 259.5 syringe Table E-27 Rapidlab 1245 System Human Whole Blood Method Comparison—tHb Mode...
Page 390: Rapidlab 1260 System Performance Characteristics
All performance data presented in this section was generated using the Rapidlab 1260 system. The system performed calibrations using the default settings recommended by Siemens for optimum performance. All reported values were corrected to 760 mmHg. All data was collected at room temperature (about 23°C). You should determine your own performance characteristics in your laboratory with your Rapidlab 1260 system.
Page 391 Rapidlab 1200 Operator’s Guide: System Specifications E-31 Precision on manual aqueous quality control materials was estimated using a minimum of 3 Rapidlab 1260 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 1260 systems over a minimum of 10 days.
Page 392 E-32 Rapidlab 1200 Operator’s Guide: System Specifications Table E-32 Rapidlab 1260 Manual QC Precision Results † Parameter Level Mean WRSD Total SD 148.9 0.79 2.81 97.9 0.89 1.74 23.7 1.22 1.85 WRSD = within-run standard deviation † Total SD = total standard deviation...
Page 393: Recovery And Precision In Human Whole Blood
Rapidlab 1200 Operator’s Guide: System Specifications E-33 Table E-33 Rapidlab 1260 AutomaticQC Precision Results † Analyte Level Mean WRSD Total SD 154.1 0.86 1.34 103.3 1.19 1.27 67.3 1.80 2.14 WRSD = within-run standard deviation † Total SD = total standard deviation...
Page 394 E-34 Rapidlab 1200 Operator’s Guide: System Specifications Table E-34 Rapidlab 1260 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.003 7.532 7.541 99.87 0.05 capillary Micro- 0.002 7.645 7.635 100.13 0.02 capillary Micro- 0.011 7.062 7.048 100.20...
Page 395 Rapidlab 1200 Operator’s Guide: System Specifications E-35 Table E-34 Rapidlab 1260 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV pH, Glu, 0.008 7.064 7.063 100.01 0.12 Capillary pH, Glu, 0.005 7.235 7.228 100.09 0.06 Capillary pH, Glu, 0.004...
Page 396 E-36 Rapidlab 1200 Operator’s Guide: System Specifications Table E-35 Rapidlab 1260 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.50 22.6 21.3 105.9 Capillary 0.34 29.0 28.4 101.9 Capillary 0.45 36.9 35.4 104.2 Capillary 0.83 48.3 49.9...
Page 397 Rapidlab 1200 Operator’s Guide: System Specifications E-37 Table E-35 Rapidlab 1260 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.56 20.7 21.4 96.7 syringe Micro- 0.50 28.2 28.6 98.6 syringe Micro- 1.00 34.7 35.7 97.4 syringe Micro- 1.31...
Page 398 E-38 Rapidlab 1200 Operator’s Guide: System Specifications Table E-36 Rapidlab 1260 Recovery and Precision Testing—pO Level Mode WRSD Observed Expected Recovery WRCV Syringe 13.76 652.3 648.5 100.6 Micro- 0.20 26.2 28.4 92.3 capillary Micro- 0.57 46.6 49.8 93.5 capillary Micro- 0.61...
Page 399 Rapidlab 1200 Operator’s Guide: System Specifications E-39 Table E-37 Rapidlab 1260 Recovery and Precision Testing—Na Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.26 113.8 111.2 102.3 Capillary 0.21 130.6 129.4 100.9 Capillary 0.30 135.0 134.4 100.4 Capillary 0.55 142.8 141.5...
Page 400 E-40 Rapidlab 1200 Operator’s Guide: System Specifications Table E-38 Rapidlab 1260 Recovery and Precision Testing—K Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.096 1.21 1.18 102.2 Capillary 0.046 2.56 2.63 97.3 Capillary 0.034 4.19 4.12 101.7 Capillary 0.107 6.05 5.74...
Page 401 Rapidlab 1200 Operator’s Guide: System Specifications E-41 Table E-39 1260 Recovery and Precision Testing—Cl Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.58 99.2 Capillary 0.29 99.3 Capillary 0.58 98.8 Capillary 0.58 97.8 Capillary 0.50 99.1 Capillary 1.08 98.8 Syringe 0.57...
Page 402 E-42 Rapidlab 1200 Operator’s Guide: System Specifications Table E-40 Rapidlab 1260 Recovery and Precision Testing—Ca Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.015 0.58 0.58 98.5 Capillary 0.015 1.27 1.26 100.6 Capillary 0.006 1.35 1.36 99.5 Capillary 0.017 1.90 1.93...
Page 403 Rapidlab 1200 Operator’s Guide: System Specifications E-43 Table E-41 Rapidlab 1260 Recovery and Precision Testing—Glucose Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.76 50.2 109.1 Capillary 1.29 101.6 Capillary 3.93 102.4 Capillary 6.25 94.3 Capillary 5.75 97.4 Syringe 0.99 109.4...
Page 404 E-44 Rapidlab 1200 Operator’s Guide: System Specifications Table E-41 Rapidlab 1260 Recovery and Precision Testing—Glucose Level Mode WRSD Observed Expected Recovery WRCV pH, Glu, 4.75 97.0 Capillary pH, Glu, 14.82 95.2 Capillary pH, Glu, 1.18 112.8 Syringe pH, Glu, 2.01 107.0...
Page 405 Rapidlab 1200 Operator’s Guide: System Specifications E-45 Table E-42 Rapidlab 1260 Recovery and Precision Testing—Lactate Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.08 85.6 capillary Micro- 0.14 11.8 83.3 capillary Micro- 0.52 13.1 16.2 80.7 capillary Micro- 0.08 101.0...
Page 406: Method Comparison With Human Whole Blood Samples
E-46 Rapidlab 1200 Operator’s Guide: System Specifications Table E-42 Rapidlab 1260 Recovery and Precision Testing—Lactate Level Mode WRSD Observed Expected Recovery WRCV pH, Glu, 0.15 11.3 12.6 89.8 Syringe pH, Glu, 0.36 15.6 18.0 86.6 Syringe WRSD = within-run standard deviation Method Comparison with Human Whole Blood Samples For testing syringe and capillary modes, blood was collected in heparinized vacuum tubes.
Page 407 Rapidlab 1200 Operator’s Guide: System Specifications E-47 Table E-44 Rapidlab 1260 Human Whole Blood Method Comparison—pCO Mode Slope Intercept RMSE Capillary 0.960 2.066 3.430 0.997 226.2 Syringe 0.922 3.229 5.437 0.992 229.0 Micro- 1.056 -2.100 2.851 0.998 238.7 capillary Micro- 1.017...
Page 408 E-48 Rapidlab 1200 Operator’s Guide: System Specifications Table E-48 Rapidlab 1260 Human Whole Blood Method Comparison—Ca Mode Slope Intercept RMSE Capillary 1.085 -0.090 0.097 0.993 0.50 4.81 Syringe 1.101 -0.112 0.087 0.995 0.47 4.89 Micro- 0.987 0.015 0.053 0.998 0.50 4.29...
Page 409: Rapidlab 1265 System Performance Characteristics
All performance data presented in this section was generated using the Rapidlab 1265 system. The system performed calibrations using the default settings recommended by Siemens for optimum performance. All reported values were corrected to 760 mmHg. All data was collected at room temperature (about 23°C).
Page 410 E-50 Rapidlab 1200 Operator’s Guide: System Specifications Table E-52 Rapidlab 1265 Manual QC Precision Results † Parameter Level Mean WRSD Total SD 0.67 1.50 0.71 1.68 3.25 0.005 0.013 5.33 0.012 0.024 7.22 0.013 0.039 11.2 0.11 0.57 0.04 0.04 0.05...
Page 411 Rapidlab 1200 Operator’s Guide: System Specifications E-51 Table E-52 Rapidlab 1265 Manual QC Precision Results † Parameter Level Mean WRSD Total SD FHHb 0.26 0.33 FHHb 0.33 0.37 FHHb 16.4 0.22 0.28 WRSD = within-run standard deviation † Total SD = total standard deviation...
Page 412: Recovery And Precision Of Blood Gases, Electrolytes, And Metabolites In Human Whole Blood
E-52 Rapidlab 1200 Operator’s Guide: System Specifications Table E-53 Rapidlab 1265 AutomaticQC Precision Results † Parameter Level Mean WRSD Total SD 103.4 1.22 1.34 67.2 1.66 1.95 17.1 0.12 0.13 13.8 0.20 0.20 0.07 0.08 77.3 0.84 0.94 91.3 0.77 1.02...
Page 413 Rapidlab 1200 Operator’s Guide: System Specifications E-53 Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.003 7.545 7.526 100.25 0.04 Capillary 0.001 7.657 7.637 100.26 0.02 Syringe 0.013 7.048 7.048 100.01 0.19 Syringe 0.009...
Page 414 E-54 Rapidlab 1200 Operator’s Guide: System Specifications Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV pH Only 0.002 7.407 7.419 99.84 0.03 Capillary pH Only 0.002 7.506 7.529 99.69 0.03 Capillary pH Only 0.004...
Page 415 Rapidlab 1200 Operator’s Guide: System Specifications E-55 Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH Level Mode WRSD Observed Expected Recovery WRCV pH, Glu, 0.006 7.240 7.234 100.07 0.08 Syringe pH, Glu, 0.006 7.304 7.310 99.93 0.08 Syringe pH, Glu, 0.003...
Page 416 E-56 Rapidlab 1200 Operator’s Guide: System Specifications Table E-55 Rapidlab 1265 Recovery and Precision Testing—pCO Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.22 95.2 capillary Micro- 0.28 21.3 21.3 99.7 capillary Micro- 0.24 28.1 28.4 99.0 capillary Micro- 0.18 35.9...
Page 417 Rapidlab 1200 Operator’s Guide: System Specifications E-57 Table E-56 Rapidlab 1265 Recovery and Precision Testing—pO Level Mode WRSD Observed Expected Recovery WRCV Capillary 0.16 29.9 28.4 105.3 Capillary 0.32 49.8 49.9 99.8 Capillary 0.42 85.3 84.9 100.5 Capillary 0.46 105.9 106.9...
Page 418 E-58 Rapidlab 1200 Operator’s Guide: System Specifications Table E-56 Rapidlab 1265 Recovery and Precision Testing—pO Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.41 28.0 28.6 98.0 syringe Micro- 0.22 48.3 49.5 97.5 syringe Micro- 0.97 84.1 85.6 98.3 syringe Micro- 1.53...
Page 419 Rapidlab 1200 Operator’s Guide: System Specifications E-59 Table E-57 Rapidlab 1265 Recovery and Precision Testing—Na Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.11 133.3 132.0 101.0 capillary Micro- 0.60 144.0 143.8 100.1 capillary Micro- 0.40 150.4 150.8 99.7 capillary Micro- 0.83...
Page 420 E-60 Rapidlab 1200 Operator’s Guide: System Specifications Table E-58 Rapidlab 1265 Recovery and Precision Testing—K Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.063 1.27 1.15 110.4 capillary Micro- 0.035 2.77 2.82 98.0 capillary Micro- 0.066 3.85 3.77 101.9 capillary Micro- 0.034...
Page 421 Rapidlab 1200 Operator’s Guide: System Specifications E-61 Table E-59 Rapidlab 1265 Recovery and Precision Testing—Cl Level Mode WRSD Observed Expected Recovery WRCV Syringe 0.38 99.7 Syringe 0.98 100.6 Micro- 0.68 100.1 capillary Micro- 0.43 100.1 capillary Micro- 0.43 98.8 capillary Micro- 0.53...
Page 422 E-62 Rapidlab 1200 Operator’s Guide: System Specifications Table E-60 Rapidlab 1265 Recovery and Precision Testing—Ca Level Mode WRSD Observed Expected Recovery WRCV Syringe 0.012 1.33 1.36 97.7 Syringe 0.022 1.91 1.93 99.0 Syringe 0.043 2.30 2.36 97.8 Syringe 0.062 4.24 4.09...
Page 423 Rapidlab 1200 Operator’s Guide: System Specifications E-63 Table E-61 Rapidlab 1265 Recovery and Precision Testing—Glucose Level Mode WRSD Observed Expected Recovery WRCV Syringe 1.57 105.5 Syringe 2.02 101.2 Syringe 2.24 94.9 Syringe 5.25 101.1 Micro- 2.02 96.8 capillary Micro- 2.47 97.9...
Page 424 E-64 Rapidlab 1200 Operator’s Guide: System Specifications Table E-61 Rapidlab 1265 Recovery and Precision Testing—Glucose Level Mode WRSD Observed Expected Recovery WRCV pH, Glu, 1.13 118.9 Syringe pH, Glu, 2.57 110.0 Syringe pH, Glu, 4.67 99.7 Syringe pH, Glu, 5.21 96.4...
Page 425 Rapidlab 1200 Operator’s Guide: System Specifications E-65 Table E-62 Rapidlab 1265 Recovery and Precision Testing—Lactate Level Mode WRSD Observed Expected Recovery WRCV Micro- 0.06 98.6 syringe Micro- 0.06 90.6 syringe Micro- 0.14 93.0 syringe Micro- 0.23 10.8 89.4 syringe Micro- 0.23...
Page 426: Recovery And Precision Of Hemoglobin Fractions In Human
E-66 Rapidlab 1200 Operator’s Guide: System Specifications Recovery and Precision of Hemoglobin Fractions in Human Whole Blood For testing capillary, tHb, and syringe modes, blood was collected in heparinized vacuum tubes. It was tonometered at 37°C or adjusted chemically. Three target levels of tHb were prepared by separating the red cells from the plasma and recombining appropriately.
Page 427 Rapidlab 1200 Operator’s Guide: System Specifications E-67 Table E-64 Rapidlab 1265 CO-ox Module Recovery and Precision with Total Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75% Mean † Analyte Mode Reference Mean Bias WRSD Syringe 14.06 0.27 0.08 Capillary 85.68 -0.55...
Page 428: Method Comparison With Human Whole Blood Samples
E-68 Rapidlab 1200 Operator’s Guide: System Specifications Table E-65 Rapidlab 1265 CO-ox Module Recovery and Precision with Total Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75% Mean † Analyte Mode Reference Mean Bias WRSD FHHb Syringe 4.53 -0.52 0.22 tHb mode performance is equivalent to sample device used †...
Page 429 Rapidlab 1200 Operator’s Guide: System Specifications E-69 Table E-67 Rapidlab 1265 Human Whole Blood Method Comparison—pCO Mode Slope Intercept RMSE Micro- 1.011 -0.480 3.939 0.996 232.5 capillary Micro- 0.991 -0.772 3.258 0.997 232.3 syringe Table E-68 Rapidlab 1265 Human Whole Blood Method Comparison—pO...
Page 430 E-70 Rapidlab 1200 Operator’s Guide: System Specifications Table E-71 Rapidlab 1265 Human Whole Blood Method Comparison—Ca Mode Slope Intercept RMSE Micro- 1.071 -0.093 0.068 0.997 0.44 4.67 syringe Table E-72 Rapidlab 1265 Human Whole Blood Method Comparison—Cl Mode Slope Intercept...
Page 431 Rapidlab 1200 Operator’s Guide: System Specifications E-71 Table E-74 Rapidlab 1265 Human Whole Blood Method Comparison—Lactate Mode Slope Intercept RMSE pH, Glu, 0.817 0.392 0.494 0.991 16.1 Syringe Table E-75 Rapidlab 1265 Human Whole Blood Method Comparison—tHb Mode Slope Intercept RMSE 0.961...
Page 432: Reference Methods
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 Internal ISE method used. and pO Tonometered whole blood. Refer to CLSI document C46-A.
Page 433: Calibrator Traceability
Traceable to NIST SRM 919 or 918 reference materials using a coulometric reference method. 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.
Page 434 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.
Page 435: Appendix F: Symbols
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.
Page 436 Rapidlab 1200 Operator’s Guide: Symbols Symbol Description indicates that you should not spray this area with cleaning solutions or other fluids that may damage parts of the system indicates in vitro diagnostic medical device indicates you should avoid looking directly into the light beam...
Page 437: Appendix G: Glossary
Appendix G: Glossary amperometry 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).
Page 438 Rapidlab 1200 Operator’s Guide: Glossary Laboratory Information System. Potentiometry Measures 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 Prime AQC Cartridge test moves the individual levels of QC material while you verify proper flow, Priming the AQC Cartridge‚...
Page 439: Appendix H: Rapidlab 1200 System Maintenance Checklist
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.
Page 440: Every 60 Days Maintenance
Rapidlab 1200 Operator’s Guide: Every 60 Days Maintenance 2 Months 4 Months 6 Months 8 Months 10 Months 12 Months Replace the CO-ox Sample Chamber Check the Air Filters Quarterly Maintenance 3 Months 6 Months 9 Months 12 Months Replace the Pinch...
Page 441 Rapidlab 1200 Operator’s Guide: Index Index retaining 8-6 automaticQC samples 4-3 a-v extraction index description 1-62 accessing a-v study setup menu 8-1 description 1-61 air filters report 2-37 checking 5-9 replacing 5-9 5-20 bar code alphanumeric characters problems 6-8 selecting to enter for patient ID field in setup 8-10...
Page 442 Rapidlab 1200 Operator’s Guide: Index analyzing 2-12 daily maintenance 5-2 carboxyhemoglobin (FCOHb) data entry measurement principles 1-50 early demographics 2-24 checking date air filters 5-9 changing 8-20 barometer 5-2 changing the century for date of birth 8-10 fill solution 5-7...
Page 443 Rapidlab 1200 Operator’s Guide: Index installing software 8-42 failed calibrations viewing number of samples analyzed 7-4 troubleshooting checklist 6-4 measurement cartridge failed QC reagents 1-9 troubleshooting checklist 6-3 measurement module fetal hemoglobin 1-50 components 1-16 1-17 file names and formats...
Page 444 Rapidlab 1200 Operator’s Guide: Index description 1-58 description 1-55 oxygen saturation (hemoglobin) description 1-56 measuring 1-35 oxyhemoglobin (FO2Hb) sensor 1-37 measurement principles 1-49 performance 1240 data E-11 1245 data E-18 description 1-58 1260 data E-30 packing the system 5-50 1265 data E-49...
Page 445 Rapidlab 1200 Operator’s Guide: Index performing 4-1 CO-ox sample path 6-31 QC material sample path 6-24 contents of automaticQC cartidge 1-4 replacing QC options 4-1 air filters 5-20 QC results automaticQC cartridge 2-3 recalling 4-7 automaticQC manifold 5-19 search 4-8...
Page 446 Rapidlab 1200 Operator’s Guide: Index sample totals notify password expiration pending 8-38 viewing number of samples analyzed 7-4 operator IDs and passwords 8-37 save demographics parameter selection 8-10 selecting in setup 8-38 patient ranges 8-7 save system setup data 8-41...
Page 447 Rapidlab 1200 Operator’s Guide: Index system status checking 5-2 yearly maintenance 5-11 target ranges change to default automaticQC ranges 8-6 retaining for automaticQC 8-6 temperature in banner 1-20 measurement principles 1-49 see CO-ox module 1-49 using 8-14 time changing 8-20...
Page 448 Rapidlab 1200 Operator’s Guide: Index 02087462 Rev. V...

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