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Rapidlab 1200 Operator’s Guide: Contents

02087462 Rev. V

Viewing Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Performing a Patient Search . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Patient Search Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
Performing a Patient Search. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Recalling Patient Sample Results . . . . . . . . . . . . . . . . . . . . . . 2-30

Interpreting the Patient Recall Screen Symbols . . . . . . . . . . . . . . . 2-30

Printing Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

Procedural Notes for Printing Reports . . . . . . . . . . . . . . . . . . . 2-31

Printing Reports on the Internal Printer . . . . . . . . . . . . . . . . . . . . . 2-31
Printing Reports on the External Printer . . . . . . . . . . . . . . . . . . . . . 2-32

Using Available Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32

Performing a Correlation Study . . . . . . . . . . . . . . . . . . . 2-34
Combining Results for an a-v Study Report . . . . . . . . . 2-35

Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
Setting up the Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

Printing the Arterial-Venous Study Report . . . . . . . . . . . . . . . . . . . 2-37

Calibration

Understanding Automatic Calibrations . . . . . . . . . . . . . . 3-1

Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . . . . . . . 3-3
Generating Calibration Reports . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Performing Manual Calibrations . . . . . . . . . . . . . . . . . . . . 3-4

Recalling Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Quality Control

Performing QC Sample Analysis. . . . . . . . . . . . . . . . . . . . 4-1

Using the Required QC Analysis Option . . . . . . . . . . . . . . . . . . 4-1

Performing Required QC Sample Analysis. . . . . . . . . . . . . . . . . . . . 4-1
Procedural Notes for Required QC. . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Using the AutomaticQC Analysis Option . . . . . . . . . . . . . . . . . . 4-3

Performing AutomaticQC Sample Analysis . . . . . . . . . . . . . . . . . . . 4-3
Manually Performing AutomaticQC Analysis . . . . . . . . . . . . . . . . . . 4-3
Procedural Notes for AutomaticQC Sample Analysis. . . . . . . . . . . . 4-4
Performing STAT Samples during AutomaticQC Analysis . . . . . . . . 4-4

Using the Unscheduled QC Option . . . . . . . . . . . . . . . . . . . . . . 4-4

Performing Unscheduled QC Sample Analysis . . . . . . . . . . . . . . . . 4-4

Accessing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Printing or Sending Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Result Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Recalling QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Summary of Contents for Rapidlab 1200

Page 1: ...Rapidlab 1200 Systems Operator s Guide 02087462 Rev V 2010 01 ...

Page 2: ...cap are trademarks of Siemens Healthcare Diagnostics Windows is a trademark of Microsoft Corporation IBM is a trademark of International Business Machines Corporation Origin UK The information in this operator s guide was correct at the time of printing However Siemens continues to improve products and reserves the right to change specifications equipment and maintenance procedures at any time wit...

Page 3: ...s guide is organized If you want to Then refer to learn about system features learn about the hardware learn about user interface components learn about principles of potentiometry Section 1 System Features Hardware Overview Software Overview Technology process samples monitor status or manage sample results Section 2 Operating the System calibrate the system Section 3 Calibration learn about QC o...

Page 4: ...ous conditions LASER WARNING Laser Warning statements alert you to the risk of exposure to lasers WARNING Warning statements alert you to conditions that may cause personal injury CAUTION Caution statements alert you to conditions that may cause product damage or loss of data On the system this symbol indicates that you should refer to the operator s guide for more information NOTE Note statements...

Page 5: ... 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 Term Description Select To select an item use your finger to select the item on the touchscreen monitor Enter Use the numeric or alphanumeric sections of the touchscreen to enter the specified information Scan Move the hand held barcode scanner...

Page 6: ...iv Rapidlab 1200 Operator s Guide Using This Guide 02087462 Rev V ...

Page 7: ...dule 1 13 Wash Cartridge 1 13 Measurement Module 1 15 CO ox Module 1 18 Software Overview 1 19 Rapidlab User Interface 1 19 Viewing the Banner Information 1 20 Viewing the Display Area 1 21 Rapidlab Main System Screens 1 21 Analysis Screen 1 21 Recall Screen 1 24 Status Screen 1 24 Rapidlab 1200 Systems Sample Path 1 25 System Sample Path 1 25 CO ox Sample Path 1 26 Rapidlab 1200 Systems Technolog...

Page 8: ...ination of Hemoglobin Derivatives 1 51 CO oximeter Measurement Technology 1 51 Parameters 1 52 Bicarbonate Ion 1 54 Base Excess 1 54 Total Carbon Dioxide 1 55 Hematocrit 1 55 Patient Temperature Correction 1 56 Hemoglobin Oxygen Saturation 1 56 Oxygen Content 1 56 Oxygen Content of Hemoglobin 1 57 Oxygen Capacity of Hemoglobin 1 57 p50 1 58 Oxygen Saturation Estimated 1 58 pO2 FIO2 1 59 Calcium Ad...

Page 9: ...p 2 5 Shutting Down the System 2 6 Collecting Patient Samples 2 7 Collecting Samples 2 7 Using Anticoagulants 2 7 Using Different Sample Sources 2 8 Handling and Storing Samples 2 9 Understanding System Limitations 2 10 Analyzing Samples 2 11 Analyzing Syringe Samples 2 11 Analyzing Capillary Samples 2 12 Analyzing Microsamples 2 14 Analyzing pH and pH Glu and Lac Samples 2 17 Analyzing tHb Sample...

Page 10: ...enous Study Report 2 37 3 Calibration Understanding Automatic Calibrations 3 1 Troubleshooting Failed Calibrations 3 3 Generating Calibration Reports 3 3 Performing Manual Calibrations 3 4 Recalling Calibration Results 3 4 4 Quality Control Performing QC Sample Analysis 4 1 Using the Required QC Analysis Option 4 1 Performing Required QC Sample Analysis 4 1 Procedural Notes for Required QC 4 2 Usi...

Page 11: ...5 4 Deproteinizing the Sample Path 5 4 Conditioning the Sensors 5 6 Checking the Level of Fill Solution 5 7 Performing Every 60 Days Maintenance 5 9 Replacing the CO ox Sample Chamber 5 9 Checking the Air Filters 5 9 Performing Quarterly Maintenance 5 10 Replacing the Pinch Valve Tubing 5 10 Testing for Leaks 5 11 Yearly Maintenance 5 11 Replacing the Measurement Module Tubing 5 12 Replacing the C...

Page 12: ...the Internal Reference Electrode 5 39 Performing Measurement Sensor Maintenance 5 40 Replacing System Components 5 42 Replacing the Printer Paper 5 42 Replacing the Sample Port 5 42 Replacing the CO ox Lamp 5 43 Replacing the CO ox Roller Cage 5 45 Removing the Roller Cage 5 45 Cleaning the Roller Cage Shaft 5 46 Installing the New Roller Cage 5 46 Replacing the System Fuses 5 47 Relocating the Sy...

Page 13: ...e Ampule QC 6 3 Troubleshooting Failed Calibrations 6 4 Troubleshooting Checklist for Failed Calibration 6 4 Using the Calibration Report to Identify Problems 6 5 Troubleshooting Patient Results 6 6 Troubleshooting Unavailable Buttons 6 7 Troubleshooting Measurement Module Lights 6 8 Troubleshooting Barcode Problems 6 8 Barcode Quality 6 8 Resetting the Barcode Scanner 6 9 Troubleshooting Internal...

Page 14: ...6 42 Ejecting the Wash or Reagent Cartridge 6 43 Ejecting the AutomaticQC Cartridge 6 43 Using the Sensors Screen 6 44 Using the CO ox Screen 6 45 Performing the Lamp Calibration Test 6 45 Performing the Wavelength Cal Test 6 46 Performing the CO ox Sample Chamber Test 6 46 Performing the Lamp On Off Test 6 47 D Codes 6 47 D2 Codes 6 48 D2 Excessive Drift pO2 pCO2 6 48 D2 Excessive Drift Na K Ca C...

Page 15: ...AQC Material Error 1 2 3 6 63 D32 Codes 6 63 D32 AQC Cartridge Valve Error 1 6 63 D32 AQC Cartridge Valve Error 2 6 64 D33 Codes 6 64 D33 R Cartridge Valve Error 6 64 D34 Codes 6 64 D34 Waste Detector Cal Error 1 6 64 D34 Waste Detector Cal Error 2 3 6 64 D35 Codes 6 65 D35 Electronics Error 1 3 7 12 6 65 D35 Electronics Error 4 6 65 D35 Electronics Error 13 6 65 D36 Codes 6 65 D36 Cartridge Loadi...

Page 16: ...ystem Messages 6 74 7 File Management File Names and Formats 7 1 Copying Data Files 7 2 Copying Patient QC or Calibration Data Files 7 3 Copying Diagnostic Data 7 3 Viewing the Sample Totals 7 4 8 System Configuration Using the Setup Menu 8 1 Setting up QC 8 2 Setting Up QC Options 8 2 Entering Customized QC Range Limits 8 3 Setting Up Required QC 8 3 Setting up Required QC Ranges 8 4 Editing Requ...

Page 17: ...mat 8 20 Setting up the Date and Time 8 20 Setting up the Sound 8 21 Setting up Other Options 8 21 Setting up Printer and Devices Options 8 22 Selecting Printer Options 8 22 Setting up Barcode Options 8 23 Selecting the Barcode Only Option for Patient ID Entry 8 25 Setting up the Barcode Scanner 8 25 Connecting the Barcode Scanner 8 26 Setting up Communications 8 26 Defining Send System Data Optio...

Page 18: ...porting and Exporting Maintenance Activities 8 46 Appendix A Safety Instructions Protecting Yourself from Biohazards A 1 References A 2 Protecting Yourself from Barcode Scanner Lasers A 3 Protecting Yourself from Electrical Hazards A 3 Appendix B Service Ordering and Warranty Authorized Representative B 1 Limited Instrument Warranty and Service Delivery Policy B 1 Warranty Period B 1 Additional Se...

Page 19: ...nterference when Measuring Lactate and Glucose E 11 Performance Characteristics E 11 Rapidlab 1240 System Performance Characteristics E 11 Precision on Controls E 11 Recovery and Precision of Blood Gases in Human Whole Blood E 12 Method Comparison with Human Whole Blood Samples E 17 Rapidlab 1245 System Performance Characteristics E 18 Precision on Controls E 18 Recovery and Precision of Blood Gas...

Page 20: ...le Blood E 66 Method Comparison with Human Whole Blood Samples E 68 Reference Methods E 72 Calibrator Traceability E 73 References E 73 Appendix F Symbols Appendix G Glossary Appendix H Rapidlab 1200 System Maintenance Checklist Daily Maintenance H 1 Twice Weekly Maintenance H 1 Weekly Maintenance H 1 Every 60 Days Maintenance H 2 Quarterly Maintenance H 2 Yearly Maintenance H 2 As Required Mainte...

Page 21: ...QC at customized intervals using the optional AutomaticQC cartridge High resolution touchscreen that tilts for viewing information and making selections quickly and easily Built in removable storage media to copy patient QC and calibration data for storage or for export to spreadsheet or database programs Communication ports for connecting to external data management systems such as the Rapidlink ...

Page 22: ...Intended Use 02087462 Rev V Hardware Overview The Rapidlab 1200 system consists of 6 modules Figure 1 1 Rapidlab 1200 System 1 User interface module 2 AutomaticQC module optional 3 Waste module 4 Reagent module 5 Wash module 6 Measurement and CO ox modules ...

Page 23: ...he touchscreen the printer the CD drive and the optional barcode scanner The adjustable 10 4 inch monitor is easy to clean You select items on the screen to make selections and enter data Figure 1 2 Rapidlab 1200 System User Interface Module The thermal roll printer prints reports for samples calibrations and diagnostics You can also install an external printer Refer to Setting up Printer and Devi...

Page 24: ...tomaticQC cartridge 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 1 AutomaticQC cartridge Level Volume Contents 1 75 mL Buffered bicarbonate solution with Na K Ca Cl carbon dioxide oxygen nitrogen dye glucose lactate surf...

Page 25: ... When the cartridge lever closes it punctures the bags of QC material The connection to the reagent cartridge allows QC material to flow from the AutomaticQC cartridge to the reagent cartridge Refer to Figure 1 5 for the system interface connections Figure 1 4 AutomaticQC Cartridge 1 Connectors to the latch assembly 2 Connector to the reagent cartridge 3 Cartridge lever 4 Bracket ...

Page 26: ...maticQC manifold and AutomaticQC cartridge The support bracket connects to the bracket on the cartridge Figure 1 5 AutomaticQC Cartridge System Interface The AutomaticQC manifold creates the fluid path for AutomaticQC materials to flow to the sample entry components in the reagent cartridge Figure 1 6 AutomaticQC Manifold 1 Latch assembly 2 Support bracket 3 Connector 1 AutomaticQC manifold ...

Page 27: ...le After sample analysis is complete the waste module collects reagents samples and waste The waste module consists of the following components waste bottle waste bottle housing waste bottle latch waste detector Figure 1 7 Waste Module 1 Waste bottle housing 2 Waste bottle latch 3 Waste bottle ...

Page 28: ...ath The waste bottle housing protects the waste bottle The waste detector detects the presence of the waste bottle and also detects when the bottle is approaching its capacity The system alerts you when the waste bottle is between 70 and 100 full To reduce exposure to biohazards when you remove the waste bottle the system prevents fluidic operations from starting 1 Path from the measurement module...

Page 29: ...ystem The electrolytes pH glucose lactate and gases in the reagents are NIST traceable The following table lists the targeted calibration points for each analyte in the reagents Calibrator Volume Ingredients Slope 160 mL gases oxygen carbon dioxide nitrogen salts alkali halides organic buffers catalyst and surfactant 200 460 mL gases oxygen carbon dioxide nitrogen salts alkali halides organic buff...

Page 30: ...es Select and aspirate reagents and AutomaticQC AQC material Figure 1 10 Reagent Cartridge Back View The pumps compress the tubing on the cartridge to generate flow Adjacent rollers on the roller cage pinch a segment of the tubing in 2 places The peristaltic action of the moving rollers pulls the fluid through the tubing The cartridge interface frame attaches the reagent and wash cartridges to the...

Page 31: ...gs of calibrators Figure 1 11 Reagent Cartridge Back View The fluid connectors on the reagent manifold engage with the fluid connectors on the reagent and wash cartridges to create the fluid path for reagents samples and waste Figure 1 12 Reagent Manifold for the Rapidlab 1245 and 1265 Systems front view 1 Pierce probes 2 Fluid connector for AutomaticQC materials 3 Fluid connectors to the reagent ...

Page 32: ...ld contains the tubing for samples waste AQC material wash and calibrators Figure 1 13 Reagent Manifold for the Rapidlab 1245 and 1265 Systems back view 1 Measurement module waste tubing 2 Sample tubing 3 CO ox waste tubing 4 RCx reagent from wash cartridge tubing 5 Wash fluid from wash cartridge tubing ...

Page 33: ... 1 14 Rapidlab 1200 System Wash Module The wash cartridge contains RCx a calibrator and wash reagent a calibrator and wash fluid as described in the following table 1 Wash cartridge 2 Wash door Reagent Volume Ingredients RCx 60 mL gases oxygen carbon dioxide nitrogen salts alkali halides organic buffers surfactant dye and preservative Wash 550 mL gases oxygen carbon dioxide nitrogen salts alkali h...

Page 34: ...e cartridge interface engages the fluid connectors on the cartridge with the connector on the reagent manifold Figure 1 15 Wash Cartridge back view The fluid connectors on the reagent manifold engage with the wash cartridge to create the fluid path for RCx and wash fluid from the wash cartridge to the sample path Figure 1 16 Reagent Manifold for Rapidlab 1240 and 1260 front view 1 Fluid connectors...

Page 35: ...Module The system analyzes the sample in the 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 Figure 1 18 Measurement Module Sample Path 1 Measurement module 1 Measurement module sample path ...

Page 36: ... to 37 C and the measurement block ensures a constant temperature of 37 C The sample connector provides the fluidic path for the sample from the sample entry components in the reagent cartridge to the measurement module The sensors detect analytes present in the sample and form the sample path The system moves the sample through the sensors and the fluid detector 2 into the pinch valve tubing and ...

Page 37: ... clots in the measurement module Figure 1 20 Measurement Module Contact Assembly The measurement module holds up to 11 sensors Figure 1 21 Measurement Module Sensors 1 Fluid detector 2 2 Pinch valve tubing 3 Pressure detector bubbler 1 pO2 Oxygen 7 K Potassium 2 pCO2 Carbon dioxide 8 Ca Calcium 3 Gnd Sample ground temperature 9 Cl Chloride 4 Glu Glucose 10 Na Sodium 5 Lac Lactate 11 Ref Reference ...

Page 38: ...nsor use amperometry For more information about amperometry refer to Amperometry page 1 33 CO ox Module This section applies to the Rapidlab 1245 and 1265 systems The Rapidlab 1200 system CO oximeter measures the concentration of total hemoglobin and hemoglobin fractions The CO ox module contains the following components sample chamber sample chamber interface polychromator pump Figure 1 22 CO ox ...

Page 39: ...ple chamber use life is independent of the number of samples analyzed on the system The system prompts you when you need to replace the sample chamber Software Overview Rapidlab User Interface Screens consist of the banner area and a display area The banner is at the top of all screens and remains visible when you move from screen to screen The banner contains information about system status and h...

Page 40: ... Viewing Status Messages The banner displays status messages as reminders for pending tasks The system always displays a message for a pending Required QC regardless of other pending tasks The system displays a message when maintenance tasks are due and how many are due When you perform a maintenance task the number of tasks on the banner decrements but the message remains as long as tasks are pen...

Page 41: ...e 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 Waste bottle 70 Not limited by time CO ox sample chamber Not limited by volume Less than 72 Button Function Continue button Displays the next screen for the task you are performing The system automatically saves selections and entries t...

Page 42: ...rameter Status The system displays available parameters in the center of the screen Each parameter can be in a different state indicated by its appearance depending on operator selections definitions in Setup and current parameter condition Parameter Description Parameter is available but does not display as a button and cannot be selected Refer to Enabling Parameter Selection at Analysis page 8 1...

Page 43: ...sis Screen To simplify patient analysis tasks the Rapidlab 1200 systems have 4 modes of operation Parameter is not available for analysis because Required QC was not performed when scheduled the button is purple Refer to Troubleshooting the Yellow Parameter Error page 6 1 1 Custom panel buttons 2 Panel set buttons Mode Description Microsample Use the Microsample mode when you have insufficient sam...

Page 44: ... Status screen displays the current status of each cartridge the cartridge symbol percent volume time remaining until the cartridges must be replaced buttons to access Status area functions Buttons on the Status screen display area access several system functions Button Refer to Patient Recalling Patient Sample Results page 2 30 QC Recalling QC Results page 4 7 including QC Statistics and Levey Je...

Page 45: ...ample entry to measurement and then to the waste bottle System Sample Path The system aspirates the sample at the sample port The sample moves through the sample tubing and reagent manifold into the sample connector and into the measurement module Figure 1 26 Rapidlab 1200 Sample Path Sample Port to Measurement Module 1 Sample connector 2 Sample tubing and reagent manifold 3 Sample port ...

Page 46: ... through the CO ox sample tubing to the sample chamber for analysis and exits as waste through the waste tubing The system analyzes the sample in the CO ox sample chamber After analysis the system moves the waste to the reagent manifold passing through the reagent cartridge and on to the waste bottle Figure 1 27 Rapidlab 1200 Sample Path To CO ox Module to Waste 1 Preheater 2 Sample chamber 3 Tubi...

Page 47: ...ic substance The transducer mechanism converts the potential generated by the molecular recognition mechanism to an electrical signal In the Rapidlab 1200 systems this is accomplished through potentiometry or amperometry For information about Potentiometry continue reading at the next section For information about Amperometry refer to Amperometry page 1 33 Potentiometry Potentiometry is the measur...

Page 48: ...trode half cell potential Elj liquid junction potential The liquid junction potential Elj a small but significant voltage develops at the liquid junction between the reference electrode which contains a solution of saturated potassium chloride and the sample solution This potential occurs because of the different rates at which chemical species diffuse across the boundary between 2 liquids This di...

Page 49: ...ectrode Elements The equation for calculating electrochemical cell potential can be expanded to include the inner reference element and the membrane potential of the ISE Ecell Eref elmt Ememb Eref Elj where Ecell electrochemical cell potential Eref elmt potential of the ISE inner reference element Ememb potential of the ISE membrane Eref reference electrode half cell potential Elj liquid junction ...

Page 50: ...ple This equation states that the cell potential is logarithmically related to the activity of the analyte in the sample The potential that the sensor actually measures is the activity of the analyte in solution In clinical chemistry it is typical that the results be expressed in the concentration of total substance rather that the activity of the substance For this reason the measured results mus...

Page 51: ...ity coefficients of ionic species in the calibrating solutions equal to those of blood plasma water at sample ionic strengths close to normal Both calibrations and the expression of measured quantities may then be made in units of concentration instead of activity 4 Reference Sensor The reference sensor for the 1200 systems works with certain measuring sensors in the measurement module to create a...

Page 52: ...llulose membrane separates the KCl solution from the sample and provides the ionic conduction between the KCl solution and the sample The membrane completes the conductive path to the sample from the fixed half cell potential that is required for the measurement The Ag wire conducts the half cell potential of the reference sensor to the measurement device where it is compared to the potential of t...

Page 53: ...uces a current flow between the anode and cathode that can be measured by a device such as a milli micro ammeter The current measured is directly proportional to the concentration of substance oxidizable or reducible present in the sample solution pH and Blood Gases The Rapidlab 1200 systems analyze blood samples for pH pO2 and pCO2 Hydrogen Ion Activity or pH The notation of pH expresses the hydr...

Page 54: ...monstrate that pH is proportional to the acid base concentrations in blood acid base pHα Therefore if base increases without a corresponding increase in acid the pH rises and if acid increases without a corresponding increase in base the pH decreases pH is clinically significant as a means of determining acid base disturbances Acid base disorders can result in several pathologic conditions Acidosi...

Page 55: ...of hydrogen ions in the membrane The silver silver chloride inner conductor transmits the potential to a voltmeter where it is compared to the constant potential of the reference sensor The final measured potential reflects the hydrogen ion concentration of the sample and is used to report the pH value of the sample Carbon Dioxide Tension pCO2 Carbon dioxide CO2 is produced during normal cell meta...

Page 56: ...equation to determine HCO3 and ctCO2 Because the pCO2 value is proportional to the content of dissolved CO2 HCO3 the value for pCO2 can be used along with pH not only to calculate HCO3 but also to aid in the differentiation of acid base abnormalities This analyte reflects the overall respiratory status Thus high pCO2 indicates respiratory suppression or failure whereas low pCO2 indicates hypervent...

Page 57: ...ctrode surrounded by the chloride bicarbonate solution provides a fixed potential Figure 1 31 pCO2 Sensor As the sample comes in contact with the membrane CO2 diffuses into the chloride bicarbonate solution which causes a change in the hydrogen ion activity H HCO O H CO 3 2 2 The internal pH electrode detects the change in hydrogen concentration occurring in the chloride bicarbonate solution and g...

Page 58: ...rly interpret clinical significance of arterial oxygenation status However many patients can be evaluated and treated successfully using blood gases alone if clinical observations and patient history are taken into account 9 This analyte reflects the ability of the lungs to deliver oxygen to the blood Hypoxia low pO2 may occur despite adequate respiration due to parenchymal lung diseases pneumonia...

Page 59: ...called a polarizing voltage is maintained between the anode and the cathode As dissolved oxygen from the sample passes through the membrane into the electrolyte solution it is reduced at the cathode OH e O H O 4 4 2 2 2 The circuit is completed at the anode when the Ag is oxidized e Ag Ag 4 4 The amount of reduced oxygen is directly proportional to the number of electrons gained at the cathode The...

Page 60: ...ap and a value for calcium adjusted to pH of 7 40 The sensors used for electrolytes are based on ion selective electrode ISE technology Each sensor has a membrane that is highly selective for a specific ion Figure 1 33 Electrolyte Sensor The recognition mechanism in the ISE is the membrane Each sensor has a membrane selective for the specific substance that it measures 1 Electrical contact 2 Elect...

Page 61: ...ions selectively interact with the membrane when the sample interfaces with the membrane The negatively charged chloride ions do not interact with the membrane The charge separation causes the membrane potential measured by the electrochemical cell Figure 1 34 Illustrated Electrolyte Sensor 1 Internal electrolyte solution 2 Membrane 3 Electrolyte solution 4 Randomly oriented ions ...

Page 62: ...tself directly cause altered mental status stupor coma seizures brain swelling brain dehydration leading to cerebral hemorrhage or ultimately death Thus extreme abnormalities of sodium reflect a potentially life threatening pathophysiologic state that must be corrected promptly 6 12 Sodium Sensor The sodium sensor is a half cell that combines with the external reference sensor to form a complete e...

Page 63: ...hat combines with the external reference sensor to form a complete electrochemical cell The sensor contains a silver silver chloride wire surrounded by an electrolyte solution that has a fixed concentration of potassium ions The membrane which consists of the ionophore valinomycin immobilized in a plasticized PVC polyvinyl chloride matrix separates the electrolyte solution from the sample Valinomy...

Page 64: ...s compared to the constant potential of the external reference sensor The final measured potential is directly proportional to the chloride ion concentration in the sample The potential developed by the electrochemical cell varies with the ion activity in the sample Concentration of Ionized Calcium Ionized calcium Ca is the physiologically active form of calcium which comprises approximately 45 of...

Page 65: ...ith the membrane This membrane potential is compared to the constant potential of the external reference sensor The final measured potential is proportional to the calcium ion concentration in the sample The potential developed by the electrochemical cell varies with the ion activity in each sample Metabolites The Rapidlab 1260 and 1265 systems analyze blood samples for glucose and lactate in addi...

Page 66: ...umstances glycolysis occurs during muscle contraction where the rate of metabolism outpaces the oxygen supply in the cells During strenuous exercise the level of lactic acid increases significantly and passes to the blood where it is transported to and metabolized by the liver In normal aerobic conditions the lactic acid is readily oxidized in the cell to pyruvic acid which is eventually degraded ...

Page 67: ...he total differential measurement A microporous cover membrane separates the electrodes from the sample Figure 1 35 Glucose and Lactate Biosensor A constant voltage called a polarizing voltage is maintained during analysis In the glucose sensor glucose from the sample interacts with the glucose oxidase on the surface of the measuring electrode to form hydrogen peroxide and gluconic acid 2 2 7 12 6...

Page 68: ...the oxygen transport system The need for hemoglobin determinations led to the development of a number of methods to determine the concentration of total hemoglobin hemoglobin derivatives and dyshemoglobins in human whole blood The presence of dyshemoglobins and toxins changes the oxygen binding capacity of hemoglobin and therefore its ability to transport oxygen 19 Hemoglobin is a tetrameric prote...

Page 69: ...In anemia hemoglobin is low Numerous specific types of anemia exist but each stems from 1 of 3 basic causes Blood loss destruction of red blood cells or failure to produce new red blood cells In polycythemia hemoglobin is high Polycythemia may be primary secondary to hypoxia secondary to dehydration or a complication of over transfusion Polycythemia may lead to circulatory complications as a resul...

Page 70: ...ts and other individuals with significant fetal hemoglobin concentrations show increased susceptibility to methemoglobinemia because fetal hemoglobin converts to methemoglobin more readily than adult hemoglobin 21 The methemoglobin reference range for arterial or venous blood for a normal population is 0 0 to 1 5 The percent of methemoglobin is determined using the following equation FMetHb cMetHb...

Page 71: ...f sulfhemoglobin greater than 1 5 Determination of Hemoglobin Derivatives Hemoglobin derivatives have characteristic absorbance spectra Each derivative absorbs light differently at different wavelengths Similarly interfering substances also absorb light at known wavelengths The spectral absorption method determines concentration using matrix equations For each substance or fraction the absorbance ...

Page 72: ...omater measures the intensity of light at the different wavelengths and converts the electrical signal to a digital value for further processing The wavelength calibrator consists of a neon lamp lenses and a filter The neon lamp emits a stable emission spectrum that is used to test the alignment of the polychromater The system makes adjustments to maintain alignment of the polychromator Parameters...

Page 73: ...respiratory index pO2 A a T alveolar arterial oxygen tension diff pO2 a A T alveolar arterial oxygen tension ratio Qsp Qt T physiologic shunt Qsp Qt T est estimated physiologic shunt a v Study Parameters ctO2 a arterial oxygen content ctO2 v venous oxygen content ctO2 mixed venous oxygen content ctO2 Hb oxygen content of hemoglobin O2 oxygen consumption rate O2 oxygen delivery ctO2 a a a v extract...

Page 74: ...pCO2 10 pH 37 6 105 Standard bicarbonate HCO3 std which is a determination of the plasma HCO3 concentration if the blood is equilibrated to a pCO2 of 40 mmHg9 using the equation described by VanSlyke and Cullin30 where and if sO2 is available it is used in place of O2SAT est NOTE If ctHb is not available as an entered value or a measured value the system uses 15 g dL as a default value Base Excess...

Page 75: ...base excess are derived from CLSI recommendations 19 Total Carbon Dioxide Total carbon dioxide ctCO2 is the sum of the dissolved carbon dioxide and the plasma bicarbonate When evaluated with pH and pCO2 total carbon dioxide is useful in distinguishing between metabolic and respiratory acid base disorders The system determines total carbon dioxide according to the following equation ctCO2 0 0307 pC...

Page 76: ...nd oxygen 19 Hemoglobin oxygen saturation with oxygen content and oxygen capacity is a useful parameter for determining the amount of oxygen in the blood that is actually available to the tissues and for determining the effectiveness of oxygen therapy Hemoglobin oxygen saturation expressed as a percent is determined using the following equation sO2 100 x FO2Hb FO2Hb FHHb Oxygen Content Oxygen cont...

Page 77: ...ness of oxygen therapy The oxygen content of hemoglobin for a sample when pO2 is not available is determined using the following equation ctO2 Hb OBF tHb FO2Hb where OBF is the O2 binding factor The system uses the default value of 1 39 or whatever value is entered as the default value in Setup FO2Hb is in decimal format Oxygen Capacity of Hemoglobin The oxygen capacity of hemoglobin BO2 is the ma...

Page 78: ...es in pH pCO2 and temperature 19 21 The p50 value is reported for sO2 values between 20 and 90 and is determined using the following equation p50 26 6 x pO2c pO2s where pO2c pO2 10 0 48 x 7 4 pH 37 0 0013BE B and pO2s is calculated with an interactive program 31 Oxygen Saturation Estimated Oxygen saturation is a ratio expressed as a percentage of the volume of oxygen carried to the maximum volume ...

Page 79: ...m concentration is dependent upon sample pH The calcium value adjusted to pH of 7 40 Ca 7 4 reflects the true ionized calcium concentration of blood normalized to pH 7 40 The system adjusts the calcium value according to the following equation 35 Ca 7 4 Ca 10 0 178 7 40 pH 37 The calcium value is adjusted only when pH at 37 C is between 7 2 and 7 7 because no reliable published clinical data is av...

Page 80: ...equire an arterial sample and use measured values at patient temperature Alveolar Arterial Oxygen Tension Difference The alveolar arterial oxygen tension difference pO2 A a which is sometimes abbreviated as A aDO2 is useful as an index of gas exchange within the lungs if the ctO2 measurements are not available The following equation36 is used pO2 A a T pO2 A T pO2 a T where pO2 A T is the temperat...

Page 81: ...al blood including the oxygen bound to hemoglobin and the oxygen dissolved in plasma and in the fluid within the red blood cells The system determines the oxygen content of arterial blood based on CLSI recommendations19 as follows ctO2 a OBF tHb FO2Hb 0 00314 pO2 where OBF is the O2 binding factor The system uses the default value of 1 39 or whatever value is entered as the default value in Setup ...

Page 82: ...on Index The a v extraction index ctO2 a a aids in the interpretation of the arterial venous oxygen content difference and can indicate inadequate oxygen content in arterial blood or inadequate cardiac output to meet oxygen demands of the tissues 9 The value is most properly determined using arterial blood and mixed venous blood The system determines the a v extraction index as follows ctO2 a a ct...

Page 83: ...e is not at least 40 the shunt cannot be calculated OBF is the oxygen binding factor The system uses the default value of 1 39 or whatever value is entered as the default value in Setup Estimated Shunt Pulmonary artery blood gases are not always readily available but a need to determine changes in the physiologic shunt may still exist The best alternative method for reflecting changes in the physi...

Page 84: ...idlab 1200 Operator s Guide System Overview and Intended Use 02087462 Rev V 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 ...

Page 85: ...1909 12 131 6 Emancipator K Critical values ASCP practice parameter Am J Clin Pathol 1997 108 247 253 7 Levinsky NG Acidosis and alkalosis Ch 46 in Isselbacher KJ et al Harrison s Principles of Internal Medicine 13th Ed New York McGraw Hill 1994 253 262 8 Severinghaus JW Bradley AF Electrodes for blood pO2 and pCO2 determination J Appl Physiol 1968 13 515 520 9 Shapiro BA Harrison RA Cane RD Templ...

Page 86: ...globin mixtures Anal Biochem 1973 55 245 248 21 Miale JB Laboratory medicine hematology 6th ed St Louis CV Mosby 1982 22 Clinical and Laboratory Standards Institute formerly NCCLS Clinical Laboratory Waste Management Approved Guideline CLSI Document GP5 A Vol 13 No 22 Dec 1993 23 Spurzem JR Bonekat HW Shigeoka JW Factitious methemoglobinemia caused by hyperlipemia Chest 1984 86 7 84 86 24 Bunn HF ...

Page 87: ...1 1375 1376 33 Thomas LJ Algorithms for selected blood acid base and blood gas calculations J Appl Physiol 1972 33 154 158 34 Malley W Clinical blood gases application and noninvasive alternatives Philadelphia WB Saunders 1990 35 Burritt MF Cormier AD Maas AH Moran RF O Connell KM Methodology and clinical applications of ion selective electrodes Proceedings of an international symposium Danvers MA...

Page 88: ...1 68 Rapidlab 1200 Operator s Guide System Overview and Intended Use 02087462 Rev V ...

Page 89: ...ecurity options selected in Setup the system may prompt you to enter your password before performing some tasks If prompted for your password perform the following steps NOTE For systems connected to the Rapidlink or Rapidcomm system your password may expire if you exceed your certification date You cannot access the Rapidlab 1200 system until you renew your password 1 At the interface screen use ...

Page 90: ...to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials 1 Select Status Waste Replace 2 Follow the instructions in the video Replacing the Wash Cartridge The system displays the Wash 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 ...

Page 91: ...ridge The system displays the AutomaticQC cartridge symbol on the banner when 10 or fewer samples remain for any level of QC material or when less than 24 hours remain before the cartridge expires This enables you to replace the AutomaticQC cartridge at a time when the system is not busy If you must replace the cartridge before you can perform any other tasks the system automatically displays a me...

Page 92: ...om which it was removed The cartridge must be reinstalled within 6 hours of removal The cartridge must have at least 1 sample left for all levels of AQC The cartridge must have at least 1 day of use life before expiration The system automatically evaluates the cartridge upon installation If a cartridge fails to meet the AQC cartridge reinstallation criteria a message indicates that the AQC cartrid...

Page 93: ... necessary 4 Select the AutomaticQC icon 5 Select Replace Yes 6 Follow the instructions in the video to reinstall the cartridge Accessing System Information You may need to access system information for assistance or when ordering supplies To access system information select Status System Information Accessing Online Help The system has online Help that provides troubleshooting and maintenance pro...

Page 94: ... the hard drive and permanent loss of data use this procedure to shut down the system 1 Select Status Shutdown Yes 2 When prompted turn the power switch off The power switch is on the back panel of the system 3 To restore power to the system turn the power switch on WARNING Do not operate the system in the presence of flammable anesthetic mixture with air O2 or nitrous oxide The risk of explosion ...

Page 95: ...yringes that satisfy requirements for blood gas analysis Use capillary tubes that contain the appropriate balanced heparin NOTE To prevent hemolysis and maintain sample integrity use capillary tubes that do not contain mixing beads Using Anticoagulants For human whole blood samples use sample devices containing only calcium titrated balanced heparin or lithium heparin as the anticoagulant NOTE Oth...

Page 96: ... labeled to ensure correct interpretation of the results Mixed venous blood Mixed venous pulmonary artery blood may be obtained from a pulmonary artery catheter after carefully clearing the catheter of infusion fluid Take appropriate precautions to prevent mixing of pulmonary capillary blood with the pulmonary artery blood Capillary blood Capillary blood when carefully collected under the proper c...

Page 97: ...ite blood cell count Reticulocyte count Observe the following sample handling and storage steps when you obtain human whole blood samples 2 Analyze the sample as soon as possible to minimize oxygen consumption Blood collected for special studies such as A a O2 gradients or shunt studies should be analyzed within 5 minutes of collection Plastic syringes should not be iced but kept at room temperatu...

Page 98: ... toward the back of the syringe barrel near the plunger so the label does not block your ability to insert the syringe into the system or cause it to fall off after it is inserted Dispose of used sample devices according to your institution s infection control policy Understanding System Limitations The following procedural limitations apply to Rapidlab 1260 and 1265 systems Avoid hemolyzed sample...

Page 99: ...g Yourself from Biohazards for recommended precautions when working with biohazardous materials 1 Observe all rules and guidelines in Collecting Patient Samples page 2 7 NOTE If you have a priority sample but a message is displayed indicating that the system is busy select Cancel to interrupt the system If Cancel is not available wait until the message is not displayed to analyze the patient sampl...

Page 100: ...ecting Yourself from Biohazards for recommended precautions when working with biohazardous materials NOTE Always fill the capillary tube completely Be sure to use the recommended volume for the sampling mode and system model For more information about Fill Volumes refer to Recommended Fill Volumes page C 1 1 Observe all rules and guidelines in Collecting Patient Samples page 2 7 CAUTION Do not lea...

Page 101: ...lab 1200 Systems Sample Port 5 Select Analyze NOTE If the system determines that insufficient sample is present or bubbles are in the sample you are prompted to position the sample as you would a microsample For information about analyzing microsamples refer to Analyzing Microsamples page 2 14 6 When prompted remove the sample device and select Continue 7 If prompted enter demographic information ...

Page 102: ...the following procedure you position the sample at position 1 in the sample path to begin analysis of pCO2 and pO2 For Rapidlab 1245 and 1265 systems the microsample mode does not analyze hemoglobin parameters BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous mate...

Page 103: ...e path and when the sample reaches position 1 select Stop Sample Figure 2 4 Sample Position 1 9 Select Analyze Wait while the system analyzes pCO2 and pO2 After the system finishes the analysis it moves the sample to the remaining sensors CAUTION Do not hesitate at any point during this procedure The sample moves a short distance through the sample path to position 1 If you do not select an option...

Page 104: ...f prompted enter demographic information and select Continue You can scan the patient ID and accession number in the appropriate field For more information about entering the data refer to Entering Patient Sample Data page 2 22 12 View the results For information about how results are displayed on the screen and in printed reports refer to Viewing Patient Results page 2 27 13 When you finish viewi...

Page 105: ... Insert the sample device into the sample port and select Analyze 6 When prompted remove the sample device and select Continue 7 Watch the sample move through the sample path and inspect the sample path for bubbles or gaps 8 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...

Page 106: ...lect tHb 4 Scan the barcode for the patient sample if required 5 Insert the sample device into the sample port and select Analyze 6 When prompted remove the sample device and select Continue CAUTION If the wash that is performed after sample analysis does not completely clean the fluid path you must perform an additional wash To determine if the path is clean observe if any colored fluid remains i...

Page 107: ...ed reports refer to Viewing Patient Results page 2 27 9 Select Continue when you finish viewing the results CAUTION If the wash that is performed after sample analysis does not completely clean the fluid path you must perform an additional wash To determine if the path is clean observe if any colored fluid remains in the fluid path after analysis To perform a wash at the Analysis screen select Was...

Page 108: ...e Analysis screen deselects the other set The Analysis screen only displays a custom button if you select parameters for that panel For example if you only select parameters for 2 of the 3 panels in Set 1 only those 2 panels display when you select Set 1 If you disable a parameter in Setup after selecting a custom panel that contains that parameter the system automatically removes that parameter f...

Page 109: ...sample the tHb parameter is removed from the custom panel while performing that analysis If you select a custom panel that does not contain the pO2 and pCO2 parameters and then select Microsample the system does not perform the gas measurement phase of the microsample measurement The Analysis screen does not display custom panels under some conditions you did not define custom panels in Setup if y...

Page 110: ...es a search of records on the system Scanning Technique Use the following technique to ensure that you operate the barcode scanner correctly 1 Hold the scanner at an angle to the barcode without touching it not directly over the barcode 2 Scan the entire barcode Move the scanner to the distance that allows the beam to scan every bar and space If the patient ID Then the patient ID and is found the ...

Page 111: ...n Analysis Options and deselect the Patient List button The Patient List button is on by default 1 Enter the Patient ID or enter the patient s demographics If a matching patient ID and patient data is available the system automatically displays the name sex and date of birth To enter the patient ID using the barcode scanner select Patient ID and then scan the patient ID barcode The system enters t...

Page 112: ... Secured Options Analysis Options 2 Select Early Demographics Save Early Demographics is off by default When you select Early Demographics the Data Entry screen displays automatically when the following actions are performed You select a patient sample at the Analysis screen and insert a sample You select Microsample mode at the Analysis screen and insert a microsample System Behavior During Norma...

Page 113: ... Save Demographics Option Use the Save Demographics option when you are analyzing samples for the same patient This option allows you to re enter the demographic information from the previous sample when analyzing a sample from the same patient To use this option during patient analysis perform the following steps 1 At the Data Entry screen select Last Patient This automatically re enters the demo...

Page 114: ...the demographic fields select Edit 4 Edit the demographic data 5 Select Continue This displays a dialog box asking if you want to save the changes 6 Select Yes 7 To print the patient sample report select Print If you want to Then view additional samples a Select the up or down arrow buttons to move through the list b Select the sample you want to edit and select Results search for a sample by pati...

Page 115: ...r a required value such as the temperature for a temperature corrected value The Results screen displays the following symbols in red These symbols display with the results on the screen and in the printed report CAUTION Only use final results for diagnostic purposes Never use preliminary results because using preliminary results can lead to misdiagnosis This symbol Indicates that the result is ab...

Page 116: ...y if patient records meet all entered criteria Results for multiple patients are returned if multiple patients meet the entered criteria Start and end dates are always available as patient search criteria If Exact Match is selected and the field associated with Exact Match is blank results are only returned for patients for whom that criterion field is blank To do this Then select View results for...

Page 117: ...n return results such as 123456 or 456123 4 Select Continue At the Patient screen a table displays patient results A blank field indicates no results were returned for that field If a search fails to find a patient the table displays without results Use the arrow keys to access results off screen to the right in the table if needed 5 To review detailed results or print results select Results If re...

Page 118: ... Select Results b Select More Results to view results for other reported parameters c Select Print to print the patient sample report d Select Send to send results to a data management system or an LIS Interpreting the Patient Recall Screen Symbols The following symbols may be displayed on the Patient Recall screen If you want to Then view additional samples a Select the up or down arrow buttons t...

Page 119: ...e system name you created in the Setup Other Options screen Refer to Setting up Other Options page 8 21 You can print most reports on either printer or both printers The only exceptions are the Maintenance Schedule and the Levey Jennings reports You must print these reports on the external printer The system filters error messages so that it only prints messages that affect the reported results Th...

Page 120: ...5 systems Refer to Combining Results for an a v Study Report page 2 35 QC Sample Report Provides a report of QC results performed or recalled Refer to Recalling QC Results page 4 7 QC Report High G L Provides a report of the High G L test Refer to Analyzing High G L page 5 3 AutomaticQC Report Prints a report of an AutomaticQC sample performed or recalled Refer to Using the AutomaticQC Analysis Op...

Page 121: ...ation Only available on Rapidlab 1245 and 1265 systems Refer to Performing the Lamp Calibration Test page 6 45 Wavelength Calibration Report Prints the result of the Wavelength Calibration test Only available on Rapidlab 1245 or 1265 systems Performing the Wavelength Cal Test page 6 46 Sample Chamber Report Prints a Pass Fail value for the result of the Sample Chamber test Only available on Rapidl...

Page 122: ...elect Correlation Coefficients c Ensure that the slope value is 1 0 and the offset value is 0 0 for each parameter that you want to adjust NOTE Analyze the samples in duplicate at each system if possible Perform analysis over several days to include normal analytical variability for both systems 2 Analyze each sample concurrently at the Rapidlab 1200 system and at the reference analyzer Do not all...

Page 123: ...g form y 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 NOTE You must perform the calculations as described above The calculation of a correction equation is the mathematical inverse of the traditional correlation equation Failure to calculate the regr...

Page 124: ...E If you want to edit the demographic data for samples you want to combine you must edit the data before you combine the samples For information about editing demographics refer to Editing Demographics page 2 25 2 Select Patients 3 Locate 1 of the sample results you want to combine 4 Select the sample you want to combine 5 Select Combine The list now shows only samples that can be combined with th...

Page 125: ...he following from the mixed venous sample a v results arterial sample results pO2 tHb and FO2Hb results from the mixed venous sample patient ranges if you selected Ranges at the Setup Printer Options screen Depending on the options selected in Setup the parameters you analyze and the values you enter the report format may be different for your system ...

Page 126: ...2 38 Rapidlab 1200 Operator s Guide Operating the System 02087462 Rev V ...

Page 127: ... Calibration of the Rapidlab 1200 systems occurs automatically at prescribed intervals and requires no operator action NOTE The system can defer a calibration to analyze a sample In this case the message informing you that the system is busy contains a Cancel button that lets you interrupt the calibration However if the maximum time between automatic calibrations has elapsed the system must comple...

Page 128: ... 1265 systems after you replace the CO ox sample chamber Measures 1 reagent of known concentration to adjust either the offset or the slope for the following parameters pH pCO2 pO2 Na Ca K Cl Glu and Lac Measures 2 reagents of known concentration to adjust the offset and the slope for tHb and CO ox fractions Accelerated Calibration Intervals The system starts accelerated calibration intervals in 2...

Page 129: ...s successfully you may need to perform troubleshooting tasks 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 If the system cannot report a value during a calibration the result is blan...

Page 130: ...splays the time remaining until the calibration finishes and a Cancel button so you can interrupt the calibration to analyze a priority sample If a parameter fails the calibration the calibration repeats If a parameter continues to fail calibration refer to Troubleshooting Failed Calibrations page 6 4 Recalling Calibration Results 1 Select Recall Calibrations The screen displays the list of calibr...

Page 131: ...QC Analysis helps ensure that operators analyze controls according to the protocol established in your institution If you have Required QC analysis set to On the system prompts operators to analyze specific levels of controls at intervals that you define You must use RapidQC materials to perform Required QC analysis Performing Required QC Sample Analysis If the system displays the Required QC Due ...

Page 132: ...stem allows you to analyze Unscheduled QC samples in addition to scheduled Required QC analysis but the results of the Unscheduled QC have no affect on parameter status Depending on the options you selected in Setup the system prints a QC sample report If the system is connected to a Rapidlink or Rapidcomm data management system or to an LIS the system automatically sends the QC results to these c...

Page 133: ...tes before the system begins the AutomaticQC Select QC to begin the scheduled QC analysis sooner Manually Performing AutomaticQC Analysis The system allows you to manually initiate analysis of a QC sample from the AutomaticQC cartridge When you initiate analysis of an AutomaticQC sample the results can affect parameter status The system turns on parameters that pass QC analysis and turns off param...

Page 134: ...levels of QC after you finish Using the Unscheduled QC Option Unscheduled QC is the default option for QC analysis Use this option if you do not want to perform scheduled QC analysis using Required QC or AutomaticQC analysis You can still analyze QC material but parameter status is not affected by QC results Parameters are not turned off if they fail or turned on if they pass QC analysis Performin...

Page 135: ...e screen and on the printed reports If the Auto Print option is turned on in Setup the system automatically prints the QC sample report 5 When you finish viewing the results select Continue Accessing QC Results When the system completes QC analysis the system displays the Results screen For a Required QC analysis and for Unscheduled QC analysis when you scan the barcode on the ampule the Results s...

Page 136: ...eport If you select RiliBÄK range checking in Setup the report contains an additional line with the parameter target value and the percentage difference between the measured value and target The report also displays a Failed message if the measured value exceeds the RiliBÄK range Refer to Setting Up QC Options page 8 2 Result Flags The system displays the following symbols in red on the results sc...

Page 137: ...the cartridge serial number as the lot number For Required QC samples the system displays an arrow symbol next to the date 3 Locate the sample results you want to view NOTE You can use the Search to find a specific result or to filter the results according to criteria you select Refer to Using the Recall QC Data Search Screen page 4 8 a Use the up or down arrow buttons to scroll through the screen...

Page 138: ... necessary 3 When you are done selecting the criteria select Continue Select this option To do this Lot enter the lot number of the control you want to view If you do not enter a lot number the system displays all lots that meet the other criteria you define Start Date enter the earliest date for search on a range dates The start date must be earlier than the End Date End Date enter the latest dat...

Page 139: ...ates in the Start and End date boxes using the numeric keypad 4 Select Continue A Wait screen displays during data analysis When data analysis completes the QC Statistics screen displays QC Statistics The Recall QC Statistics screen only displays accepted results Any results that are reported out of the range of the instrument or questionable are excluded from these statistics Viewing the Recall Q...

Page 140: ...mples included for these statistics NOTE For RMSD and RMSD a minimum of 15 samples is required If fewer than 15 samples are analyzed the field is blank For Standard Deviation and Coefficient of Variation a minimum of 5 samples is required If fewer than 5 samples are analyzed the field is blank NOTE If a sample is out of range it may skew QC Analysis results To exclude a sample you suspect is out o...

Page 141: ...ll Levey Jennings Graph screen select the lot number for the QC material Use the up and down scroll arrows to navigate the list The list is in alphanumeric order with the AutomaticQC lots listed first as AQC1 AQC2 and so on 4 Select a month The current month is uppermost of the three buttons The 2 previous months are next in order 5 Select a parameter 6 Select Continue This displays the Recall Lev...

Page 142: ...a point outside the range of 4SD Restoring Parameters Use this procedure to turn on parameters that the system turned off for either of the following reasons The parameter failed Required QC or AutomaticQC analysis or was not available when Required QC or AutomaticQC was performed Required QC analysis was not performed when scheduled When you restore a parameter the parameter remains selected and ...

Page 143: ...ion require you to lift the door on the measurement module 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 Figure 5 1 Rapidlab 1200 System Front Cover Open 1 Front cover 2 Latches measurement module ...

Page 144: ...c Sensor page 5 3 5 Check the printer paper and replace it if necessary Refer to Replacing the Printer Paper page 5 42 Cleaning and Disinfecting the Exterior Surfaces You need the following materials for this task Lint free cloth 10 bleach solution 1 Moisten the cloth with the bleach solution so that the cloth is wet but not dripping 2 Wipe the exterior surfaces of the system using the wet cloth 3...

Page 145: ...is procedure to verify the performance of the Glucose and Lactate biosensors on Rapidlab 1260 or 1265 systems You analyze High G L samples using the Patient mode and no correlation coefficients but the system recalls the results as QC results The system measures Glucose and Lactate parameters for High G L samples Because the system only displays parameters that you turned on in Setup if you turn o...

Page 146: ...mples 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 Monitor your system and sensor performance and adjust the frequency of this procedure as necessary You need the following materials for this task Deproteinizer Syringe Glucose and Lactate test blank sensors TB4 BIOHAZARD Wear person...

Page 147: ...e port c Select Continue d When prompted remove the syringe and select Continue The deproteinizing cycle runs for 10 minutes Any mechanical noise in the area of the sample port is normal and dissipates after the system analyzes a few blood samples 6 At the prompt select Yes to condition the sensors or No to skip this step Refer to Conditioning the Sensors page 5 6 7 If you are not conditioning the...

Page 148: ...t blank sensors a Select the video button and follow the instructions in the video b Select Continue BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials CAUTION Do not expose the glucose and lactate biosensors to bleach conditioner or deproteinizer Replace...

Page 149: ...rmance Checking the Level of Fill Solution Use this procedure to ensure that the sensors contain the correct level of fill solution The pO2 and pCO2 sensors do not require maintenance Slight discoloration of the fill solution in the pO2 and pCO2 sensors is normal The Glucose and Lactate biosensors do not require fill solution BIOHAZARD Wear personal protective equipment Use universal precautions R...

Page 150: ...sensor cassette b If the level of fill solution is low fill the sensor Refer to Performing Reference Sensor Maintenance page 5 34 5 Check the level of fill solution in the K Cl Ca Na and pH sensors a Verify that the K Cl and Ca sensors are almost full with a small 1 mm bubble at the top b Verify that the pH and Na sensors are completely full c If the level of fill solution is low replace the fill ...

Page 151: ...rds for recommended precautions when working with biohazardous materials 1 Select Status Maintenance Replacing the CO ox Sample Chamber 2 To start the procedure select Continue 3 Follow the instructions in the video 4 Allow the system to warm up for 5 minutes 5 Perform a full calibration Refer to Recalling Calibration Results page 3 4 6 Analyze a minimum of 2 levels of quality control material Che...

Page 152: ...rsal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials 1 At the user interface select Status Diagnostics Cartridges 2 Select Eject R Cartridge 3 Lift the door on the measurement module Refer to Preparing for Maintenance Procedures page 5 1 4 Remove the old tubing a Remove the tubing from the connector at the spr...

Page 153: ...module door 7 Select No 8 Reinstall the reagent cartridge and close the reagent cartridge door 9 Close the front cover 10 Dispose of the tubing according to your institution s protocol Testing for Leaks 1 To ensure that the tubing has been properly reinstalled perform the Leak Test Refer to Performing the Leak Test page 6 37 2 Select Return Analyze Yes Yearly Maintenance Yearly maintenance include...

Page 154: ...tus Diagnostics Cartridges 2 Select Eject R Cartridge 3 Lift the door on the measurement module Refer to Preparing for Maintenance Procedures page 5 1 4 Replace the pinch valve tubing Perform steps 4 and 5 of Replacing the Pinch Valve Tubing page 5 10 5 Replace the waste tubing between the pressure sensor bubbler and the reagent manifold a Disconnect the waste tubing from the pressure sensor bubbl...

Page 155: ...eplacing the CO ox Module Tubing page 5 13 9 Close the measurement module door 10 Select No 11 Select Return Analyze Yes Replacing the CO ox Module Tubing You need a CO ox tubing kit for this task BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials 1 Selec...

Page 156: ...mber 2 Rotate the gray wheel towards you pull the tubing through the fluid detector and remove the tubing from the steel measurement module connector 3 Push the new tubing through the fluid detector 4 Connect the tubing to the steel measurement module connector and to the sample chamber connector Use a clamp or tweezers to attach the tubing 1 Sample chamber connector 2 Fluid detector 3 Measurement...

Page 157: ... Waste Tubing 1 Disconnect the CO ox waste tubing from the pump tubing and the sample chamber connector 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 1 CO ox pump tubing 2 CO ox waste tubing 3 Sample chamber ...

Page 158: ...om the platen and the roller cage 5 Place the lower tubing cuff of the new tubing under the lower side of the platen press the tubing around the outside of the rollers and turn the roller cage clockwise until the tubing rests on the rollers 6 Connect the tubing to the waste tubing and the reagent manifold tubing Completing CO ox Maintenance 1 Close the front cover 2 Reinstall the wash cartridge 3 ...

Page 159: ...rtridges 2 Select Eject Both Cartridges remove the cartridges and set them aside 3 Remove the reagent manifold a Lift the front cover Refer to Preparing for Maintenance Procedures page 5 1 b Disconnect the waste tubing from the reagent manifold c For Rapidlab 1245 and 1265 systems disconnect the reagent manifold tubing from the CO ox pump tubing at the fitting Do not disconnect the reagent manifol...

Page 160: ...ew reagent manifold in place NOTE When you are installing the tubing avoid pinching or bending the tubing b Connect the waste tubing c For Rapidlab 1245 and 1265 systems connect the reagent manifold tubing to the CO ox pump tubing at the fitting Completing Reagent Manifold Maintenance 1 Close the front cover 2 Reinstall the reagent and wash cartridges 3 Select Return 4 Verify system performance a ...

Page 161: ...es 4 Select Eject R Cartridge remove the reagent cartridge and set it aside 5 Lift the front cover Refer to Preparing for Maintenance Procedures page 5 1 6 Remove the AutomaticQC manifold a Pull the connector port cover towards you Figure 5 9 Connector Port and Cover b Push down on the pins on the manifold and pull the manifold and connector port away 7 Install the new AutomaticQC manifold a Inser...

Page 162: ...e cartridge connector to the left Completing AutomaticQC Manifold Maintenance 1 Close the front cover 2 Reinstall the reagent cartridge 3 Select Return 4 Verify system performance a Perform a 2 point calibration Refer to Performing Manual Calibrations page 3 4 b Analyze a minimum of 2 levels of quality control material 5 Dispose of the manifold and connector port according to your institution s pr...

Page 163: ...the cloth is wet but not dripping 2 Select Status Maintenance Cleaning the Screen 3 To start the procedure select Continue The cleaning screen is displayed for 20 seconds and allows you to wipe the screen without activating any buttons 4 Wipe the screen with the wet cloth 5 Allow the screen to air dry After 20 seconds the system returns to the Maintenance screen 6 Dispose of the bleach solution ac...

Page 164: ...l protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials CAUTION Do not expose the reference sensor to bleach Replace the reference sensor with the test blank reference sensor TB5 before cleaning CAUTION Do not expose the glucose and lactate biosensors to bleach conditioner or depro...

Page 165: ...1265 system replace the Glucose and Lactate biosensors with the test blank Glucose Lactate TB4 sensors Refer to step 3 5 Close the measurement module door and then close the front cover 6 Aspirate the deproteinizer a Invert the deproteinizer vial several times to mix the deproteinizer solution b Draw the deproteinizer into a syringe and insert the syringe into the sample port c Select Continue d W...

Page 166: ...lank reference sensor and pull the sensor up and out 4 Align the top of the reference sensor with the sensor contact 5 Snap the sensor into place 6 If you have a Rapidlab 1260 or 1265 system replace the test blank sensors with the Glucose and Lactate sensors Completing the Sample Path Maintenance 1 Use the sensor names on the contact assembly to verify that the sensors are installed in the correct...

Page 167: ...ont cover Refer to Preparing for Maintenance Procedures page 5 1 3 Disconnect the reagent manifold tubing from the CO ox pump tubing at the fitting Figure 5 12 CO ox Pump Tubing to Reagent Manifold 4 Grasp the lower tubing cuff and gently pull it away from the platen BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for r...

Page 168: ... rollers and the roller cage shaft using lint free tissues moistened with the bleach solution 2 Clean the interior surface of the roller cage using a lint free swab moistened with the bleach solution 3 Rinse the rollers the cage and the shaft with water 4 Dry the roller cage thoroughly and ensure that the rollers turn freely Reinstalling the Roller Cage 1 Replace the roller cage onto the shaft 2 P...

Page 169: ...tocol Cleaning the Waste Assembly Use this procedure to clean the waste assembly when you are replacing an expired or depleted AutomaticQC cartridge Removing the AutomaticQC cartridge invalidates the cartridge You need the following materials for this task New AutomaticQC cartridge Lint free cloth 10 bleach solution Waste bottle 1 Remove the expired or depleted AutomaticQC cartridge a Select Statu...

Page 170: ... Slide the waste assembly to the right 5 Clean the waste assembly with the 10 bleach solution 6 Replace the waste assembly and push the orange lever down 7 Place the new waste bottle in the waste assembly 8 Install a new AutomaticQC cartridge 9 Select Return 10 Dispose of the bleach solution according to your institution s protocol 1 Orange lever ...

Page 171: ... replacement kit Hex tool Lint free tissue Preparing the Sensors Equilibrate new Glucose and Lactate biosensors at room temperature 18 to 25 C for at least 1 hour before installing Keep the biosensors in their foil packages while they are equilibrating BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended prec...

Page 172: ...ensor refer to Performing Measurement Sensor Maintenance page 5 40 5 If you are replacing the reference sensor fill the internal electrode compartment Refer to Filling the Reference Sensor Cassette page 5 36 6 If you are replacing the reference sensor or measurement sensors install the internal electrode into the internal electrode compartment and screw the electrode into place 7 Clean and inspect...

Page 173: ...ubbles 3 If bubbles are in the sensor remove the bubbles a Select Status Maintenance Performing Sensor Maintenance b To start the procedure select Continue c Remove the sensor d Tap the front face of the sensor with your knuckle to remove bubbles e Reinstall the sensor f Select Yes Continue Return g Select Analyze Yes h Wait 15 to 30 minutes for the sensor to warm up If you replaced Then sample gr...

Page 174: ...hake the vial containing the fill solution This can create bubbles in the fill solution 1 Remove the sensor Refer to Replacing the Sensors page 5 29 If the sensor is new go to step 4 2 Unscrew the internal electrode and place the electrode and sensor assembly on a lint free tissue 3 Empty the fill solution from the sensor Dispose of the fill solution according to your institution s protocol 4 Atta...

Page 175: ...ou gently squeeze the fill solution vial until the sensor is nearly full 7 Install the internal reference electrode into the internal electrode compartment and screw the electrode into place 8 Inspect the sensor for bubbles As the temperature of the sensor rises to 37 C gas driven from the solution causes bubbles 9 Clean and inspect the sensor a Tap the front face of the sensor with your knuckle t...

Page 176: ... sensor Refer to Removing the Sensors page 5 30 Figure 5 16 Measurement Module BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials CAUTION Do not remove or return the sensors to the measurement module without first discharging static buildup Touch the inne...

Page 177: ...e sensor cassette 3 Tap the front face of the sensor with your knuckle to remove any bubbles 4 Remove any salt deposits on the reference sensor using a lint free swab moistened with water 5 Dry the sensor thoroughly 6 Ensure that the O rings are in place on both sides of the sensor 7 Replace any O ring that is worn or damaged 8 Clean the O ring area on the spring loaded latch using a lint free swa...

Page 178: ... 2 Remove the internal reference electrode a Remove the internal reference electrode using the hex tool Figure 5 18 Reference Sensor Cassette BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials CAUTION Do not remove or return the sensors to the measurement...

Page 179: ...nal electrode compartment Figure 5 19 Reference Sensor Cassette and KCl Fill Solution b Fill the internal electrode compartment until the KCl fill solution enters the KCl reservoir 4 Install the internal electrode into the internal electrode compartment and screw the electrode into place using the hex tool 1 KCl fill solution 2 KCl reservoir 3 Internal electrode compartment CAUTION Do not touch th...

Page 180: ...solution to the fill line 6 Hand tighten the reservoir cap 7 Clean and inspect the sensor a Tap the front face of the sensor with your knuckle to remove any bubbles b Wipe any excess fill solution from the exterior of the sensor using a lint free tissue c Ensure that the O rings are in place 8 Install the Reference sensor Refer to Installing the Sensor page 5 31 9 Verify sensor performance Refer t...

Page 181: ...eference electrode rinse the electrode compartment with KCl fill solution a Empty the fill solution from the sensor b Rinse the internal electrode compartment with 3 drops of KCl fill solution c Empty those drops of fill solution from the sensor 4 Fill the internal electrode compartment with KCl solution Refer to Filling the Reference Sensor Cassette page 5 36 5 Reinstall the sensor Refer to Insta...

Page 182: ... sensors to the measurement module without first discharging static buildup Touch the inner surface of the measurement module frame to discharge static buildup 1 Remove the sensor Refer to Replacing the Sensors page 5 29 2 Unscrew the internal electrode and place the electrode and the sensor assembly on a lint free tissue 3 Empty and rinse the sensor a Empty the fill solution from the sensor b Rin...

Page 183: ... fill solution from the exterior of the sensor using a lint free tissue c Verify that the O ring is in place on the left side of the sensor Replace the O ring if it is worn or damaged 7 Reinstall the sensor Refer to Installing the Sensor page 5 31 8 Verify sensor performance Refer to Verifying Sensor Performance page 5 31 For these sensors Add pH Na K Cl and Ca K Cl and Ca sensors almost full but ...

Page 184: ...g the Sample Port Use this procedure to replace the sample port Replace the sample port if you detect a problem or if the system prompts you as a result of obstructions such as fibrin clots You need a sample port for this task BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with ...

Page 185: ...em 4 For ease of access prop the back of the system up by about 3 4 inch 1 9 cm When you prop up the back of the system the back cover can lay flat when you open it WARNING Do not touch the lamp until it has been off for at least 5 minutes Waiting for at least 5 minutes allows sufficient time for the lamp to cool CAUTION Do not remove power from the system for more than 6 hours if cartridges are i...

Page 186: ...steadily with increasing force until it comes free 7 Dispose of the lamp according to your institution s protocol 8 Install a new lamp a Push the new lamp into the lamp receptacle area The lamp has a key that you must line up with the key hole in the side of the receptacle area b Push the electrical connector onto the electrical fitting 9 Close the back cover 1 Electrical connector 2 Lamp base 3 B...

Page 187: ... task Lint free tissue and swabs Roller cage Water Removing the Roller Cage 1 Select Status Maintenance 2 Lift the front cover Refer to Preparing for Maintenance Procedures page 5 1 3 Disconnect the reagent manifold tubing from the CO ox pump tubing at the fitting Figure 5 22 CO ox Module and Reagent Manifold BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix ...

Page 188: ...e straight off its shaft 7 Dispose of the roller cage according to your institution s protocol Cleaning the Roller Cage Shaft Clean the roller cage shaft using lint free tissues moistened with water and then thoroughly dry the shaft Installing the New Roller Cage 1 Place the new roller cage on the shaft 2 Press the roller cage down and turn the cage clockwise until the cage snaps into place 3 Plac...

Page 189: ... Before replacing the fuses verify that power is being supplied to the system The power switch on the back panel is turned on The power cord is firmly connected to the system and to the electrical outlet 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 s...

Page 190: ...Open the fuse holder a Insert a small flat head screwdriver in the tabs on each side of the fuse holder b Pull the fuse holder out from the compartment as far as possible Figure 5 24 Fuse Holder 4 Remove the old fuses and dispose of them according to your institution s protocol 5 Install new fuses 6 Slide the fuse holder into the fuse compartment 7 Restore power a Reconnect the power cord to the s...

Page 191: ...or surfaces of the system Refer to Cleaning and Disinfecting the Exterior Surfaces page 5 2 4 Move the system to its new location 5 To restore power to the system connect the power cord to the electrical outlet 6 Turn the power on WARNING Do not proceed while the power is on To prevent electrical shock or damage to the system remove power from the system as described in this procedure WARNING Do n...

Page 192: ...Removing the Cartridges 1 Select Status Diagnostics Cartridges 2 If an AutomaticQC cartridge is installed remove and dispose of it according to your institution s protocol a Slide the connector on the AutomaticQC cartridge to the right b Select Eject AQC Cartridge 3 Select Eject Both Cartridges remove the reagent and wash cartridges and dispose of them according to your institution s protocol 4 In...

Page 193: ...air described in these procedures Flushing the Tubing for the RCx Reagent 1 Connect a piece of tubing to a syringe 2 Connect the syringe tubing to the connector for the RCx reagent Figure 5 25 Reagent Manifold 3 Flush with a minimum of 3 mL water 4 Flush with a minimum of 12 mL air 5 Collect the water in an absorbent swab or equivalent 1 Water collection area 2 RCx reagent Connector ...

Page 194: ... Connector 1 Connect the syringe tubing to the upper connector for the wash reagent Figure 5 26 Reagent Manifold 2 Flush with a minimum of 3 mL water 3 Flush with a minimum of 12 mL air 4 Collect the water in an absorbent swab or equivalent 1 Water collection area 2 Upper connector ...

Page 195: ...or 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 4 Capture the water in an absorbent swab or equivalent Figure 5 27 Reagent Manifold Lower Connector 1 Water collection area 2 Lower connector ...

Page 196: ...ples 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 4 Collect the water in an absorbent swab or equivalent Figure 5 28 Sample Tubing 1 Water collection area 2 Sample connector ...

Page 197: ... tubing to the pressure sensor bubbler 3 Flush the measurement module tubing with a minimum of 3 mL water 4 Flush the measurement module tubing with a minimum of 12 mL air 5 Collect the water in an absorbent swab or equivalent 6 Reconnect the tubing to the pressure sensor bubbler Figure 5 29 Measurement Module Pressure Sensor Bubbler 1 Pressure sensor bubbler 2 Disconnected tubing 3 Water collecti...

Page 198: ...re sensor bubbler 2 Connect the syringe tubing to the connector on the reagent manifold Figure 5 30 Reagent Manifold Connector 3 Flush the tubing with a minimum of 3 mL of water 4 Flush the tubing with a minimum of 12 mL air 5 Collect the water in an absorbent swab or equivalent 6 Reconnect the tubing to the reagent manifold 1 Connector 2 Pressure sensor bubbler 3 Water collection area ...

Page 199: ...C Module 1 Connect the syringe tubing to the AutomaticQC manifold 2 Flush with a minimum of 3 mL water Figure 5 31 AutomaticQC Tubing 3 Flush with a minimum of 12 mL air 4 Collect the water in an absorbent swab or equivalent 5 Disconnect the syringe tubing 1 Water collection area 2 AutomaticQC manifold ...

Page 200: ...m the CO ox pump tubing 2 Connect the syringe to the waste tubing Figure 5 32 Reagent Manifold Rapidlab 1245 and 1265 Systems 3 Flush the waste tubing with a minimum of 3 mL water 4 Flush the waste tubing with a minimum of 12 mL air 5 Collect the water in an absorbent swab or equivalent 6 Reconnect the reagent manifold tubing from the CO ox pump tubing 1 Connector 2 Waste tubing 3 Water collection...

Page 201: ...bing 3 Flush the tubing with a minimum of 3 mL water 4 Flush the tubing with a minimum of 12 mL air 5 Collect the water in an absorbent swab or equivalent 6 Reinstall the CO ox roller cage 7 Reconnect the CO ox pump tubing and the CO ox sample tubing 8 Remove the CO ox sample chamber and discard it according to your institution s protocol 9 To exit Diagnostics close the cartridge doors 10 Select R...

Page 202: ...of it according to your institution s protocol 2 Clean and disinfect the exterior surfaces Refer to Cleaning and Disinfecting the Exterior Surfaces page 5 2 3 Remove the roll of printer paper and remove any remaining paper from the printer by turning the paper advance knob clockwise Shutting Down and Packing the System 1 Select Status Shutdown Yes 2 After the system displays the Shutdown screen tu...

Page 203: ...t mark it Complete on the schedule Some tasks like Deproteinizing the Sample Path automatically mark the schedule as Complete but you should check for the Complete mark after completing each Maintenance task If you complete the task within the grace period the task is automatically scheduled for its next due date If you complete a task before the grace period the system does not change the schedul...

Page 204: ... only mark tasks Completed on the current date for either of the previous two days When you select any other day in the calendar grid the system disables the Completed button 1 Select Status Maintenance Schedule 2 Select the maintenance task you completed 3 Select Completed Undoing the Completed Marker When you select the Completed button to mark a task as completed it becomes an Undo button If yo...

Page 205: ...ed Frequency To view maintenance task details perform the following steps 1 Select Status Maintenance Schedule 2 Select the maintenance task you want to view 3 Select Details Change System Time for Daylight Saving Time NOTE Setting the date on the system clock back as for daylight saving time eliminates all maintenance completions performed within that hour For instructions on setting system time ...

Page 206: ...5 64 Rapidlab 1200 Operator s Guide Maintenance 02087462 Rev V ...

Page 207: ...ine through it and QC is displayed in the lower left corner The parameter has failed QC because the sensor has drifted since the last automatic calibration Repeat QC Analysis If the parameter fails analysis again check the Results screen perform a successful 2 point calibration Repeat QC analysis If the parameter fails analysis again view the events log for D codes and messages Errors occurred dur...

Page 208: ... QC analysis review the events log for D codes and messages If the parameter passes the ampule QC analysis replace the AutomaticQC cartridge The target ranges for one or more parameters are too narrow Verify that the target ranges entered for the control are correct If you specify target ranges that are narrower than those provided with the control parameters may fail QC analysis Analyze QC for th...

Page 209: ...a constant temperature Do not handle ampules excessively Variation in results may occur due to changes in temperature Do not use expired QC materials Do not analyze QC materials that contain bubbles Use the correct level of QC material that is scheduled for analysis Error Probable Cause Corrective Action The parameter is purple with a line through it and QC is displayed in the lower left corner Re...

Page 210: ...ssive drift check the solution level in the reference sensor and look for salt in the vent hole bubbles in the sensor or leaks Error Probable Cause Corrective Action The parameter has a single line through it The parameter failed calibration For recommendations to resolve failed calibrations refer to Troubleshooting Checklist for Failed Calibration page 6 4 View the events log to determine the eve...

Page 211: ...lace 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 The values in the Meas column represent the actual measured value of the current calibration The values in the Drift column repre...

Page 212: ...ypical response when measuring the parameter Analyze the sample again to verify the result The sensor does not reach a stable reading within the predefined time limit For information about D5 No Endpoint refer to D Codes page 6 47 The sensor signal has excess noise For information about D6 Excessive Noise refer to D Codes page 6 47 Table 6 4 Symbol Probable Cause Corrective Action The sample conta...

Page 213: ...and enter the values for the sample demographics Refer to Editing Demographics page 2 25 Ensure that the parameters and sample demographics are turned on in Setup Refer to Setting up Parameters page 8 13 Problem Probable Cause Corrective Action The QC button on the Analysis screen is not available The lot is expired for the control that is currently scheduled or no lot is entered for the control I...

Page 214: ...g the parameter to fail and follow the appropriate solutions for that event Analyze all the currently scheduled controls for required QC Analyze QC for the failed level Refer to Performing Unscheduled QC Sample Analysis page 4 4 If the results are within range turn the parameter on Refer to Restoring Parameters page 4 12 All parameters are out of calibration because they were turned off in Setup a...

Page 215: ...or information about connecting the barcode scanner refer to Connecting the Barcode Scanner page 8 26 Scanning the patient ID or the accession number the barcode is displayed in the wrong field on the screen The wrong field was selected when you scanned the barcode Select the button for the appropriate field or select the field and then scan the corresponding barcode For example select Patient ID ...

Page 216: ...hat you are scanning the correct barcode for the sample or the control The barcode scanner no longer scans barcodes that it scanned before Faulty scanning technique poor quality of the barcode print or loose cable connection to the port on the Rapidlab 1200 system can cause poor scanner performance The scanner may also need to be reset Use the correct scanning technique Refer to Scanning Technique...

Page 217: ...nsure that the printer is turned on The internal printer is not printing correctly Replace the printer paper Refer to Replacing the Printer Paper page 5 42 Problem Corrective Action The screen is blank Ensure that the screen is adjusted to the correct viewing angle Grasp and squeeze the latch on top of the screen and tilt the screen to the correct viewing angle Ensure that the power is on Ensure t...

Page 218: ...idlink or Rapidcomm system or laboratory information system LIS does not communicate with the Rapidlab 1200 system Ensure that the cable connecting the systems is tightly connected to each system Ensure that the cable is not damaged and that it is the correct cable for connecting the systems Ensure that the Rapidlink or Rapidcomm data management system or the LIS is correctly configured to communi...

Page 219: ...g from the port on the top right side of the reagent manifold item 4 Figure 6 1 b Disconnect the reagent manifold tubing from the fitting that connects the reagent manifold tubing to the CO ox pump tubing item 1 Figure 6 1 This step only applies to Rapidlab 1245 and 1265 systems c Push down the two latches that secure the reagent manifold to the system item 5 Figure 6 1 Optional Parts Reagent Mani...

Page 220: ...le holding gauze against the end of the tubing that is connected to the CO ox waste exit port item 2 Figure 6 2 to catch the obstruction and any excess liquid 1 Fitting to which the reagent manifold tubing and CO ox pump tubing are connected Rapidlab 1245 and 1265 systems 2 Reagent manifold tubing that connects the fitting to the port on the top left side of the reagent manifold Rapidlab 1245 and ...

Page 221: ...hile holding gauze against the end of the tubing that is connected to the CO ox waste exit port item 2 Figure 6 2 to catch the obstruction and any excess liquid c Discard the gauze 1 CO ox waste exit port this illustration shows ports only and does not show the reagent manifold tubing that remains connected to this port when you perform this procedure 2 Sample exit port 3 Sensor waste exit port 4 ...

Page 222: ...ot Removal Line page 6 24 Then repeat this procedure to ensure an obstruction has been removed If this does not work go to step 13 to replace the reagent manifold with a new reagent manifold See page page 13 for reagent manifold part numbers Replace the reagent manifold with a new reagent manifold by following the procedure in step 13 for reagent manifold part numbers see page 13 There is an obstr...

Page 223: ...he measurement module cover by lifting the 2 latch buttons located at the bottom left and right of the module See Figure 6 3 Figure 6 3 Measurement Module Compartment Cover BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for recommended precautions when working with biohazardous materials 1 Measurement module latch butt...

Page 224: ... Figure 6 4 located at the right of the 1200 Reference sensor to the right until the mechanism clicks in place Figure 6 4 Measurement Module Compartment b Remove the pO2 sensor by lifting the sensor lip item 2 Figure 6 4 up at the bottom while pressing the top of the sensor item 3 Figure 6 4 inward 1 spring loaded latch assembly 2 top of the pO2 sensor 3 lip of pO2 sensor ...

Page 225: ... below the black spring loaded latch assembly to reapply pressure to the sensor assembly 3 Fill the syringe with water 4 Insert the syringe in clot clearing tool item 1 Figure 6 6 Figure 6 6 Syringe inserted in Clot Clearing Tool a If using a Luer Lock syringe thread the syringe into the clot clearing tool to ensure the syringe is secured firmly to the clot clearing tool 1 clot clearing tool 2 bla...

Page 226: ...gure 6 7 that secure the manifold to the system CAUTION If the path is totally obstructed liquid may be expelled suddenly and with great force through the port at the back of the sample connector BIOHAZARD Discard the gauze according to the established biohazard disposal practices of your workplace 1 Fitting to which the reagent manifold tubing and CO ox pump tubing are connected Rapidlab 1245 and...

Page 227: ...he pO2 sensor a Push the black spring enclosure assembly to the right until the mechanism clicks in place b Remove the syringe c Remove the clot clearing tool by lifting the clot clearing tool lip up at the bottom while pressing the top of the tool inward d Reinstall the pO2 sensor e Press the black spring enclosure assembly lever to reapply pressure to the sensor assembly 10 Close the system a Re...

Page 228: ...ent and wash module doors 3 Select the Return button 4 Ensure the Reagent sample port is in position 2 by following these steps a Select Pumps and Valves b Select R Valve Start Change The character 2 displays on the screen 5 Fill the syringe with water 6 Insert the syringe into the clot clearing tool a If using a Luer Lock syringe thread the syringe into the clot clearing tool to ensure the syring...

Page 229: ...he syringe and discard the gauze If an obstruction is cleared it is expelled along with any excess liquid through the sample port on the reagent cartridge 9 Reinstall the pO2 sensor a Push the black spring enclosure assembly to the right until the mechanism clicks in place b Remove the syringe c Remove the clot clearing tool by lifting the clot clearing tool lip up at the bottom while pressing the...

Page 230: ... clearing procedures fail to locate the obstruction see Removing Clots Using the Clot Removal Line page 6 24 Removing Clots Using the Clot Removal Line Use the following procedure if the clot clearing procedures in the preceding section fail to remove the obstruction BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix A Protecting Yourself from Biohazards for r...

Page 231: ...removal 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 Figure 6 9 Sample Tubing in the Reagent Manifold 3 Remove obstructions from the preheater a Remove the pO2 and pCO2 gas sensors 1 Sample connector 2 Fluid connector ...

Page 232: ... connector Figure 6 10 Rapidlab 1200 Systems Sample Path 4 Inspect the pO2 and pCO2 gas sample ground temperature pH and the reference sensors for obstructions a Remove the gas sensors one at a time and inspect each one for obstructions 1 Preheater 2 Sample connector CAUTION Do not push the clot removal line through the gas sensors To avoid damaging the gas sensors do not exert excessive pressure ...

Page 233: ...njecting Water into the Gas Sensor Sample Path c For the sample ground temperature sensor pH sensor and reference sensor push the clot removal line through the sample path to remove obstructions Figure 6 12 Clot Removal Line in Sensor Sample Path 1 Sensor 2 Syringe CAUTION Use the clot removal line carefully to avoid damage to the sample ground temperature pH and reference sensors 1 Sensor cartrid...

Page 234: ... inject water through the sample path c If the obstruction is not removed from the Na sensor push the clot removal line through the sample path to remove obstructions 6 Remove obstructions from the path through the latch a Grasp the tab on the reference sensor and pull it up and out of the measurement module b Disconnect the pinch valve tubing from the spring loaded latch CAUTION Do not push the c...

Page 235: ...Rev V c Push a clot removal line through the 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 1 Pinch valve tubing 2 Spring loaded latch ...

Page 236: ...nch valve tubing to the latch and the reagent manifold 3 Press the tab on the spring loaded latch to release the latch 4 Close the measurement module door Completing the Inspection Procedure 1 Reinstall the cartridges and close the reagent and wash doors 2 Perform the RCx reagent flow test a Select Return b Select Fluidic Functions RCx c Look at the sample path for obstructions and flow problems 3...

Page 237: ... materials CAUTION Do not remove or return the sensors to the measurement module without first discharging static buildup Touch the inner surface of the measurement module frame to discharge static buildup 1 Remove the reagent cartridge and the wash cartridge a Select Status Diagnostics Cartridges Eject Both Cartridges b Remove both the cartridges c Leave the doors open 2 If the obstruction is bet...

Page 238: ...ple chamber connector Use a clamp or tweezers to help you attach the tubing 3 Remove obstructions from the CO ox waste tubing a Disconnect the tubing from the steel fluid connector and the connector in the pump tubing Figure 6 16 CO ox Sample Path b Push a clot removal line through the tubing opposite the direction of sample flow c Reconnect the CO ox waste tubing 4 Remove obstructions from the wa...

Page 239: ...or obstructions and flow problems 7 Return to the Status screen to view the events log 8 Verify sensor performance a Perform a 2 point calibration b Analyze a minimum of 2 levels of quality control material Using Diagnostics NOTE Operators with level 1 or level 2 security access can access the diagnostic tests NOTE The system cannot perform routine fluidic activities while the Diagnostics screen o...

Page 240: ... the Select Temperature report Temperature Prints the temperature for various system components and the current pAtm providing the system ID the date and time of the report and temperature information Last Cal report Sensors Last Cal Prints data for each sensor from the last 2 point or full calibration Refer to Using the Sensors Screen page 6 44 Measurement report Sensors Measurement Prints an ind...

Page 241: ... Use this procedure to calibrate the touchscreen when the screen responds inconsistently to selects For example if you must select to the left or the right of an item to select it the touchscreen needs calibration 1 Select Status Diagnostics 2 Enter your password if necessary 3 Select Screen Calibration The screen displays a button NOTE If you do not want to calibrate the touchscreen do not touch ...

Page 242: ...rrent error The system removes the highlighting when you perform the test successfully Use this procedure to test the flow of reagents from the reagent and wash cartridges 1 Select Status Diagnostics 2 Enter your password if necessary 3 Select Fluidic Functions 4 Select the test to perform The system moves the reagent through the sample path 5 Look for obstructions or uneven flow that may indicate...

Page 243: ...rea of the leak The leak test localizes the leak to 1 of 3 areas and 2 levels of severity In some cases a leak test may be unable to run because of causes related to but not originating in the leak test such as D73 D33 and D23 14 events When this occurs the printed leak test report displays a message that says Unable to run If this occurs use the event log to identify and address the issues that c...

Page 244: ...r the leak check the tubing for leaks ensure that you installed the tubing correctly in the pinch valve ensure that the O rings are in place ensure that you closed the spring loaded latch For Rapidlab 1245 and 1265 systems verify that the CO ox sample chamber is installed correctly 5 Select Return 6 To return to the Status screen select Return The system performs a wash Using the Pumps and Valves ...

Page 245: ...recommended precautions when working with biohazardous materials 1 Select Status Diagnostics 2 Enter your password if necessary 3 Remove the reagent cartridge a Select Cartridges Eject R Cartridge b Remove the reagent cartridge from the system and close the door c Select Return 4 Select Pumps and Valves CAUTION Do not remove the wash or reagent cartridges for longer than 6 hours If the wash or rea...

Page 246: ...cedure to test the components that operate the valve located inside the reagent cartridge The test moves the valve to 3 positions When you select the Change button the system displays the number of the current position on the screen The test is complete when the system displays position 3 on the screen 1 Select Status Diagnostics 2 Enter your password if necessary 3 Select Pumps and Valves R Valve...

Page 247: ...n listen for problems If the valve cannot reach the position the Change button is not available 6 Continue selecting Change and listening for problems until you have tested all 5 positions 7 Select Stop and wait while the system moves the valve 8 Select Return 9 To return to the Status screen select Return The system performs a wash Performing the Measurement Module Pinch Valve Test Use this proce...

Page 248: ...ump Start The CO ox pump rotates at the first speed 4 Look for obstructions and listen for any unusual noises that may indicate a problem with the pump 5 Select Change to advance the pump to the next speed 6 Continue selecting Change and listening and looking for problems until you have tested all 4 speeds 7 Select Stop and wait while the system returns the pump to the correct position 8 Select Re...

Page 249: ...een Ejecting the AutomaticQC Cartridge Use this procedure to eject the AutomaticQC AQC cartridge 1 Select Status Diagnostics 2 Enter your password if necessary 3 Open the cartridge connector 4 Select Cartridges Eject AQC Cartridge 5 Dispose of the cartridge During normal operation the AutomaticQC cartridge does not come in contact with biohazardous materials from the system However you should disp...

Page 250: ...bration The report provides the system ID the date and time of the report and sensor data in the order represented in Table 6 6 The Measurement report contains a measurement of readings for all the sensors For information about printing the Last Cal or Measurement report refer to Performing Tests and Printing Diagnostic Reports page 6 34 Table 6 6 Last Cal Report Values Row number Sensor 1 pH 2 pC...

Page 251: ... Lamp Calibration Test This test is only performed on Rapidlab 1245 and 1265 Systems Perform this test whenever you change the CO ox lamp or whenever you remove and reinstall the lamp You can also use this test to perform a lamp calibration The system displays the pass or fail results on a printed report 1 Select Status Diagnostics 2 Enter your password if necessary 3 Select CO ox Lamp Cal 4 Wait ...

Page 252: ...he CO ox sample chamber to move to the open and close positions The systems displays the pass or fail results on a printed report 1 Select Status Diagnostics 2 Enter your password if necessary 3 Select CO ox Start The sample chamber moves to the open position 4 Select Change to move the sample chamber to the closed position 5 Select Stop The system prints the test results Passed or Failed 6 Wait w...

Page 253: ...This section describes the Rapidlab 1200 system diagnostic codes D codes and messages the conditions that cause them and possible solutions D codes identify changes in the system operation that require corrective action Some D codes contain a qualifier after the message The qualifier indicates a specific condition related to the D code For example D2 indicates excessive drift for a sensor D2 Exces...

Page 254: ... to equilibrate Perform additional calibrations If a D2 for pCO2 with a drift greater than 4 0 mmHg occurs twice in a 4 hour period and no drift occurs for pO2 perform QC analysis If the pCO2 result is out of range replace the sensor Deproteinize the sample path Refer to Deproteinizing the Sample Path page 5 4 Check that the sensors are installed in the correct location and are aligned the O rings...

Page 255: ...sensor and look for bubbles The K Ca and Cl sensors should be nearly full The pH and Na sensors should be full If the solution level is low refill the sensor If more than one sensor has drift check the solution level in the reference sensor and look for salt in the vent hole and bubbles in the sensor Clean and refill the reference sensor as needed or replace it Check that the sensors are installed...

Page 256: ...ded latch is closed Check the biosensor contacts and measurement block for salt buildup Check behind the biosensor for fluid leaks that can come from the reference sensor If salt or leaks are present clean the sensors with water dry reinstall and perform a 2 point calibration Refer to Recalling Calibration Results page 3 4 If the biosensor has been installed less than 1 day perform 2 point calibra...

Page 257: ...ode Perform a 2 point calibration Refer to Performing Manual Calibrations page 3 4 Deproteinize the sample path and condition the sensors Refer to Deproteinizing the Sample Path page 5 4 Check the solution level in the affected sensor and look for bubbles The K Ca and Cl sensors should be nearly full The pH and Na sensors should be full If the solution level is low refill the sensor If more than o...

Page 258: ...stalled in the correct location and are aligned the O rings are in place and the spring loaded latch is closed If necessary remove and install the sensors correctly Check the biosensor contacts and measurement block for salt buildup Check behind the biosensor for fluid leaks that can come from the reference sensor If salt or leaks are present clean the sensors with water dry reinstall and perform ...

Page 259: ... 2 point calibration Correct any reagent problems such as D23 codes before you attempt to correct this D code Perform a 2 point calibration Refer to Performing Manual Calibrations page 3 4 Check the solution level in the affected measurement sensor and look for bubbles The K Ca and Cl sensors should be nearly full The pH and Na sensors should be full If the solution level is low refill the sensor ...

Page 260: ...m persists call for technical assistance Problem Corrective Action Sensor does not reach stable reading during predefined time limit The patient sample result for the affected sensor is reported as question result Correct any reagent problems such as D23 codes before you attempt to correct this D code Ensure that the measurement module door was not opened during analysis If door was opened repeat ...

Page 261: ...the sensor If the problem persists call for technical assistance Problem Corrective Action Sensor does not reach stable reading during predefined time limit The patient sample result for the affected sensor is reported as question result Correct any reagent problems such as D23 codes before you attempt to correct this D code Perform a 2 point calibration Refer to Performing Manual Calibrations pag...

Page 262: ...he door during analysis repeat the sample analysis Ensure that you did not apply pressure to the top cover during analysis If you applied pressure to the cover during analysis repeat the sample analysis Perform a successful calibration 1 point or 2 point If a D6 for pCO2 with a drift greater than 4 0 mmHg occurs twice in a 4 hour period and no drift occurs for pO2 perform QC analysis If the pCO2 r...

Page 263: ...hould be full If the solution level is low refill the sensor If a D6 occurs for more than one sensor check the solution level in the reference sensor and look for salt in the vent hole and bubbles in the sensor Clean and refill the reference sensor as needed Check the sensor contacts and measurement block for salt buildup Check behind the sensors for fluid leaks If salt or leaks are present clean ...

Page 264: ...rations page 3 4 If the problem persists replace the reagent cartridge Perform a full calibration Refer to Performing Manual Calibrations page 3 4 If the problem persists call for technical assistance Problem Corrective Action Fluid detector 2 FD2 does not detect the sample during the predefined time limit The sample is discarded and no results are reported Perform a full calibration Refer to Perf...

Page 265: ...solution is unusually low replace the reference sensor cassette 5 If the problem persists call for technical assistance Problem Corrective Action An internal communication problem between the system processors has occurred 1 Shut the system down Select Status Shutdown 2 Wait 10 seconds and then turn the system on 3 If the problem persists call for technical assistance Problem Corrective Action The...

Page 266: ... is installed correctly 3 If the problem persists replace the wash cartridge 4 If the problem persists call for technical assistance Problem Corrective Action 200 Cal reagent was not detected during calibration 3 FD1 11 FD2 1 Perform the highlighted test s in Diagnostics Fluidic Functions 2 Perform a leak test Refer to Performing the Leak Test page 6 37 If the test fails check the tubing for leaks...

Page 267: ...problem persists replace the reagent cartridge Perform the highlighted test s in Diagnostics Fluidic Functions 4 If the problem persists call for technical assistance Problem Corrective Action RCx reagent was not detected during calibration 5 FD1 13 FD2 1 Perform the highlighted test s in Diagnostics Fluidic Functions 2 Perform a leak test Refer to Performing the Leak Test page 6 37 If the test fa...

Page 268: ...agnostics Fluidic Functions 4 If the problem persists replace the wash cartridge Perform the highlighted test s in Diagnostics Fluidic Functions 5 If the problem persists call for technical assistance Problem Corrective Action Wash fluid was not detected during wash after a calibration or sample analysis 7 calibration 8 sample analysis 1 Perform the highlighted test s in Diagnostics Fluidic Functi...

Page 269: ...idic Functions 8 If the problem persists call for technical assistance Problem Corrective Action An error was detected during delivery of AQC material 1 level 1 2 level 2 3 level 3 1 Check that the AutomaticQC connector is completely closed and that the sensors are aligned correctly 2 Select Diagnostics Fluidic Functions Prime AQC Cartridge The correct button is highlighted 3 Check if there is an ...

Page 270: ...eagent cartridge fails to move to the correct position 1 Select Diagnostics Pumps and Valves R Valve 2 Select Diagnostics Cartridges Eject Reagent Cartridge 3 If the problem persists replace the reagent cartridge 4 If the problem persists call for technical assistance Problem Corrective Action The waste detector is out of range during a system calibration 1 Select Diagnostics Waste Detector 2 Sele...

Page 271: ...t Diagnostics Voltage and Temperatures 6 If the problem persists call for technical assistance Problem Corrective Action An error has occurred in the electronic components of the pump motors 1 Select Diagnostics Pumps and Valves Sample Pump 2 Select Status Shutdown 3 Wait 10 seconds and then turn the system on 4 If the problem persists call for technical assistance Problem Corrective Action The ca...

Page 272: ...ridge 3 If the problem persists call for technical assistance Problem Corrective Action A component in the temperature control system failed or the ambient temperature is beyond the acceptable operating conditions Check the Gnd sensor and ensure that it is aligned with the contacts If the problem persists continue with the following The system attempts to re enable the temperature control every 15...

Page 273: ...s Fluidic Functions Wash Cycle If the problem persists replace the reagent cartridge If the problem persists call for technical assistance Problem Corrective Action Wash or RCx reagent failed to flow from a new wash cartridge 1 wash reagent 2 RCx reagent Perform the highlighted test s in Diagnostics Fluidic Functions Remove and reinstall the wash cartridge Refer to Ejecting the Wash or Reagent Car...

Page 274: ...ntinue analyzing patient samples 6 If the problem persists call for technical assistance Problem Corrective Action 200 cal or slope cal reagent failed to flow from a new reagent cartridge 1 200 cal reagent 2 slope cal reagent Perform the highlighted test s in Diagnostics Fluidic Functions Remove and reinstall the reagent cartridge Refer to Ejecting the Wash or Reagent Cartridge page 6 43 Perform a...

Page 275: ... biosensor 1 Check that the biosensor is correctly installed the contacts are aligned and the spring loaded latch is closed 2 If the biosensor has been on the system less than one day perform three 2 point calibrations Refer to Performing Manual Calibrations page 3 4 3 If the problem persists replace the biosensor 4 If the problem persists call for technical assistance ...

Page 276: ...es Ensure that the cable is not damaged and that it is the correct cable for connecting the systems Inspect the cables for wear or crimps Ensure that the Rapidlink or Rapidcomm data management system or the 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 th...

Page 277: ...m persists call for technical assistance Problem Corrective Action Fluid detector 3 FD3 does not detect the sample during the predefined time limit CO ox results are not reported Blood gas pH electrolyte and metabolite results are reported Ensure the sample volume is sufficient for the sample type Select Diagnostics Fluidic Functions RCx Look for obstructions or poor flow in the CO ox sample path ...

Page 278: ...ts call for technical assistance Problem Corrective Action The system detects an error in the CO ox electronics system 1 Select Diagnostics CO ox Lamp Cal 2 Select Status Shutdown 3 Wait 10 seconds and then turn the system on 4 If the problem persists call for technical assistance Problem Corrective Action A component in the temperature control system failed or the ambient temperature is beyond th...

Page 279: ...e CO ox sample chamber is installed correctly If no other D codes occur replace the CO ox sample chamber If the problem persists call for technical assistance Problem Corrective Action Fluid detector 3 FD3 the CO ox sample chamber or both do not detect wash reagent during a wash cycle 2 after calibration 3 after sample Perform the highlighted test s in Diagnostics Fluidic Functions If the problem ...

Page 280: ...ructions Repeat the RCx test to check flow through the sample path Perform a leak test Refer to Performing the Leak Test page 6 37 If the test fails check the tubing for leaks and that the tubing is correctly installed in the pinch valve the O rings are in place and the spring loaded latch is closed For Rapidlab 1245 and 1265 systems verify that the CO ox sample chamber is installed correctly If n...

Page 281: ...ed the calibration to correct the error This message is displayed in the printed report Additional Wash Required 1 Wash reagent fails Optical Clarity Test 2 Operator Error sample device is not removed before sample endpoints A change in transmittance was detected after a CO ox sample analysis The system repeated the wash to attempt to correct the error If the repeated wash fails again the system d...

Page 282: ...s is especially important for samples introduced from capillary tubes 2 If you are analyzing a capillary sample ensure that you insert the smooth end of the capillary tube into the sample port Cal Not Done The system was unable to perform a calibration This occurs if the system is left idle in a state where it cannot perform calibrations such as the following times the waste is full cartridges are...

Page 283: ...mber CO ox Sample Chamber Not Detected The system does not detect the CO ox sample chamber This usually indicates that the sample chamber was removed without using the correct Maintenance procedure If you are replacing the sample chamber install the new sample chamber Refer to Replacing the CO ox Sample Chamber page 5 9 Ensure the tabs on each side are locked in place CO ox Sample Temp Out of Rang...

Page 284: ... the sample again ensuring that the sample has no bubbles before introducing it into the sample port Checking for bubbles is especially important for samples introduced from capillary tubes 3 Check the CO ox sample tubing for cracks or leaks 4 When analyzing a capillary sample ensure that you introduce the smooth end of the capillary tube into the sample port Insufficient Sample The system detects...

Page 285: ...opened without first accessing the Diagnostics or Maintenance screen If this occurred during sample analysis the message is printed with the report 1 Close the measurement module door firmly and ensure both latches are locked in place 2 Respond to the prompt Did you remove or replace any sensors The system starts accelerated calibration intervals in either of 2 instances You select Yes You select ...

Page 286: ...to locate and print results or data that were not printed while the printer was out of paper No Printer Configured You selected the external printer for a printout but you have not configured Microsoft Windows with a default external printer Configure Windows with a default printer No R Cartridge The system does not detect the reagent cartridge The cartridge may not be installed correctly Reinstal...

Page 287: ...r the control Perform QC analysis again QC Lot Not Defined Controls are currently scheduled for Required QC analysis but no lot information is entered for the controls Define a new lot of the controls Refer to Setting up Required QC Ranges page 8 4 and then analyze the scheduled controls QC Material Expired Controls are currently scheduled for Required QC analysis but the lot has expired for the c...

Page 288: ...issed QC when the system becomes available Perform Required QC analysis or restore parameters SulfHb 1 5 The system detects a sulfhemoglobin concentration greater than 1 5 in the sample The message displays on the printed report Temp Not Ready The temperature of the measurement module is beyond the acceptable measurement range This message can occur when the system is warming up after being shut d...

Page 289: ...d wash cartridge was installed or the cartridge was installed after being removed for more than 6 hours The system is unable to use the cartridge Replace the cartridge Refer to Replacing the Wash Cartridge page 2 2 Waste Full The waste bottle is full and can no longer accept waste Replace the waste bottle Refer to Emptying the Waste Bottle page 2 2 Waste is Almost Full The waste bottle is approxim...

Page 290: ...6 84 Rapidlab 1200 Operator s Guide Troubleshooting 02087462 Rev V ...

Page 291: ...ample the system uses the following means of displaying the results pCO2 is displayed as pCO2 the letter H in the column next to a result instead of to indicate that the result is above the patient range the letter L instead of to indicate that the result is below the patient range When a result is above or below the reporting range the system does not display a value The system displays only the ...

Page 292: ...ent samples per day The system maintains 5000 records of patient and QC samples and 2000 records of calibrations on its internal hard disk When the system is at the maximum number of records the system deletes the oldest records to accommodate the new data You need either blank 1 44 MB 3 5 inch diskettes IBM format or a CD RW 3 through the end of the file The remaining rows contain the values for ...

Page 293: ...at provides access to the remote site The system stores data for each day including the current day and the previous 29 days 1 Select Recall Copy Stored Results System Data 2 Select the data or log information to copy If you selected Then Diskette The number of diskettes required is displayed on the screen a When prompted remove the diskette from the drive and insert the next diskette in the seque...

Page 294: ...elect Print to print the sample totals 3 Select Return If you are copying data Then to CD a Select CD b When prompted insert the CD into the drive and select Continue c When prompted remove the CD from the drive and select Continue d Select Return to email a Select Email When the system finishes copying data the system displays the System Data screen b Select Return to diskettes a Select Diskettes...

Page 295: ... 1 5 Perform the task according to the instructions in this section 6 Save the Setup data to a diskette or CD each time you change system configuration Refer to Saving and Restoring System Setup Data page 8 41 Using the Setup Menu The following table lists the Setup options and identifies the buttons on the Setup menu that you select to access each option If you want to Select setup QC ranges sche...

Page 296: ...4 Select the syringe QC button to enable syringe QC samples 5 At the area labeled Required Field select Operator ID to display the operator identification screen when an operator is analyzing QC samples 6 To make the Operator ID a requirement select the Required button 7 Select a QC Range Checking Methodology If you want to customize ranges follow the procedure in the next section Entering Customi...

Page 297: ...Manufacturing Target 6 Repeat steps 4 5 as needed for additional parameters 7 Select Continue Setting Up Required QC Use the Required QC screen to set up a required QC sample schedule Use the barcode scanner and RapidQC controls to perform Required QC analysis NOTE Ensure that you enter information for each lot of the controls you schedule Refer to Setting up Required QC Ranges page 8 4 You cannot...

Page 298: ...r to Setting up AutomaticQC Schedule page 8 5 1 At the Setup screen select QC Required QC Ranges NOTE When you scan a lot for a level it becomes the active lot If you already have an active lot for a level and scan in new lot information for the same level it becomes the trial lot When you scan the barcode the system makes the button corresponding to that level available If a level button is avail...

Page 299: ... select Set Active The Set Active button is only displayed when the lot is a trial lot 8 Use the print button to print the values selected for this level 9 Select Save Setting up AutomaticQC Schedule Use this screen to select the days and times for AutomaticQC analysis and select the controls to analyze at the scheduled times 1 At the Setup screen select QC AutomaticQC Schedule If a schedule is al...

Page 300: ...elds for High G L samples During analysis the system can require the operator to enter selected demographic information for High G L samples NOTE If both Glucose and Lactate are turned off in Setup the Analysis screen does not display the High G L option 1 At the Setup screen select QC High G L 2 Select either or both of the demographics you want entered when performing High G L samples If you wan...

Page 301: ...ges 2 Use the arrows at the left of the screen to select a parameter 3 Use the Low button or High button to enter the low limit and the high limit for each parameter as needed a Select Low b Use the keypad to enter the value in the Low field c Select High d Use the keypad to enter the value in the High field 4 Select Save Using Default Ranges The following table lists the default range for each pa...

Page 302: ... 2 0 25 0 g dL FO2Hb 0 0 200 0 QC ranges FO2Hb 0 0 100 0 patient ranges FCOHb 0 0 200 0 FMetHb 0 0 200 0 FHHb 0 0 200 0 Indicates parameters available only on Rapidlab 1260 and Rapidlab 1265 systems Indicates parameters available only on Rapidlab 1245 and Rapidlab 1265 systems Parameter Default Range Default Units ...

Page 303: ...atient ID field Using Patient and Sample Demographics The following table lists the patient and sample demographics that you can select When you enter a patient ID for an existing patient the system populates the patient data from stored patient information When you modify patient information the system updates this information in all samples that use this patient ID NOTE If you turn off a sample ...

Page 304: ...select 20XX 6 To use alphanumeric characters for the Patient ID field select Keyboard The default option for patient ID is numeric entry only 7 Select Save Defining Sample Demographics 1 At the Setup screen select Sample Sample Demographics 2 Select each demographic button as necessary to turn it on or off Buttons that have a white background and a check mark are turned on 3 Select the Required bu...

Page 305: ...arameter Selection to turn it on or off and then select Save Defining Custom Panels A custom panel contains a set of parameters that you define to meet your testing needs 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 You can set up 6 custom panel...

Page 306: ...elect a normal panel go to 5 NOTE If Microsample is selected parameters not available for microsample analysis such as tHb and nBili do not display 5 Select Save 6 At the Parameter Selection at Analysis screen verify that the panel button contains all the parameters you selected Microsample panels display a µ character at the top left of the panel Repeat steps 2 through 6 for all panels and sets y...

Page 307: ...efault patient sample type or they can select another sample type 1 At the Setup screen select Sample Sample Type 2 Select the sample type button that you want as the default selection 3 Select Save Setting up Parameters When you select Parameters at the Setup Window the following options are available Parameter On Off Parameter Units Demographic Units Values Using the Parameters On Off Screen At ...

Page 308: ...ple Demographics page 8 17 Specific Parameter Guidelines Using Hct On Rapidlab 1245 and 1265 systems Hct is a calculated value determined from the tHb result To report Hct ensure that tHb is selected at the first Parameters On Off screen and Hct is selected at the second screen Using O2SAT and O2CT You can select both O2SAT est and sO2 If parameters that are required to report sO2 are not availabl...

Page 309: ...u want to change 3 Select the units that you want to use for that parameter 4 Select Save 5 Repeat Steps 2 through 4 to select the units for other parameters 6 Select Save NOTE If you change units of measure and then print results for samples saved earlier the data may display differently on the reports To see which parameters have alternate units of measure refer to Default and Alternate Units of...

Page 310: ...lecting alternate units the parameter name changes to H pCO2 mmHg kPa pO2 mmHg kPa Na mmol L K mmol L Ca mmol L mg dL Cl mmol L Glu mg dL mmol L Lac mmol L mg dL tHb g dL g L mmol L FO2Hb decimal FCOHb decimal FMetHb decimal FHHb decimal pH T pH units nmol L When selecting alternate units the parameter name changes to H T pCO2 T mmHg kPa pO2 T mmHg kPa HCO3 act mmol L HCO3 std mmol L BE B mmol L B...

Page 311: ...sp t T est decimal RI T decimal pO2 FIO2 mmHg kPa ctO2 Hb mL dL mL L mmol L ctO2 Hb is reported in place of ctO2 a ctO2 v ctO2 if pO2 is not available ctO2 a mL dL mL L mmol L ctO2 mL dL mL L mmol L ctO2 v mL dL mL L mmol L ctO2 a mL dL mL L mmol L ctO2 a a decimal O2 mL min L min mmol min O2 mL min L min mmol min Indicates parameters available only on Rapidlab 1260 and Rapidlab 1265 systems Indic...

Page 312: ... T pO2 T FIO2 temperature pCO2 pAtm pO2 a A T pO2 T FIO2 temperature pCO2 pAtm p50 pO2 pH BE B sO2 sp t T tHb ctO2 a ctO2 a FIO2 temperature pCO2 pAtm O2 binding factor FHHb and FO2Hb or FO2Hb FCOHb and FMetHb sp t est T tHb ctO2 a ctO2 a entered FIO2 temperature pCO2 pAtm O2 binding factor FHHb and FO2Hb or FO2Hb FCOHb and FMetHb RI T pO2 T pO2 A a T pO2 FIO2 pO2 FIO2 ctO2 Hb tHb FO2Hb O2 binding...

Page 313: ... System Options at the Setup Window the following options are available Country Options Date and Time Sound Other Setting up Country Options The Country Options screen allows you to perform the following tasks Select a language for the system screens and videos Select a date format for your laboratory O2 ctO2 a t If ctHb is not available as an entered value and tHb is not available the system uses...

Page 314: ...em date 1 At the Setup screen select System Options Country Options 2 Select the date format that you want and then select Save Setting up the Date and Time NOTE The system time does not change automatically for Daylight Saving Time If your location is affected by a time change refer to Change System Time for Daylight Saving Time page 5 63 You can change the date and time that displays on the bann...

Page 315: ...n printed reports 1 At the Setup screen select System Options Other Options 2 Enter the telephone number 3 Select System Name and then enter a name for the system 4 Select Save If you want to Then change the date a Select Date b 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 020...

Page 316: ...ent reports to view the available options To set up printer options perform the following steps 1 At the Setup screen select Printer and Devices Printer Options 2 At the Printer Options screen select the report type from the scrollable list The system displays only those options that are available for that report 3 Select the printer that you want to print this report Internal Printer or External ...

Page 317: ...s This screen can also be used to select the barcode only option for Patient ID data entry Refer to Selecting the Barcode Only Option for Patient ID Entry page 8 25 The patient ID can be up to 20 alphanumeric characters in length The accession number and password barcodes can be up to 13 alphanumeric characters in length Within each barcode you can turn any characters off that you do not want the ...

Page 318: ...5 Define the characters for the patient ID accession number or password barcodes a Select the appropriate barcode button b Scan the appropriate barcode The barcode you scan can be up to 20 characters in length The system can accept up to 20 characters for the patient ID but accepts a maximum of 13 characters for the accession number and password If your barcode for these settings is longer than 13...

Page 319: ...lect Printer and Devices Bar Code Setup 2 You can select barcode to turn the barcode scanner on or off 3 Select the barcode symbology that your institution uses for the patient ID accession number and password barcodes For information about setting up the barcode symbology refer to Setting up Barcode Options page 8 23 For information about connecting the barcode scanner refer to Connecting the Bar...

Page 320: ... barcode scanner to the left side of the system 5 Turn the on power switch Setting up Communications Use the Communications screen to setup a time for sending system data and setup connections to external devices For systems connected to an LIS this screen can also be used to select cSO2 Defining Send System Data Option Use this procedure to define the time to automatically send system data to the...

Page 321: ...or if necessary Setting up a Serial RS 232 Connection You need the following materials for this activity Rapidlab 1200 system to Rapidlink or Rapidcomm interface cable Rapidlink Supervisor s Manual or Rapidcomm User s Guide 1 Select Status Shutdown 2 When the Shutdown screen is displayed turn the power off 3 Connect the interface cable to the system and to the Rapidlink or Rapidcomm server or work...

Page 322: ...system with the Rapidlink or Rapidcomm program refer to the Rapidlink Supervisor s Manual or Rapidcomm User s Guide Connecting to a CompleNet Network Connection CompleNet network connection is a proprietary protocol that allows real time communication between a Rapidlab 1200 system and a Rapidlink or Rapidcomm workstation Use this protocol to connect your system to a Rapidlink or Rapidcomm worksta...

Page 323: ...Save d Select Enter IP Address e Enter the IP addresses for the Rapidlab 1200 system the default router port and the network mask Ensure that you enter the IP addresses and the network mask in the correct fields f Select Save 3 At the Communications screen select Save 4 When prompted that the connection was unsuccessful select Continue 5 Connect the network cable to the RJ 45 connector on the back...

Page 324: ...Manual or Rapidcomm User s Guide 5 At the Rapidlab 1200 system select Save 6 Select Return 7 To complete any additional setup that may be necessary to operate the Rapidlab 1200 system with the Rapidlink or Rapidcomm program refer to the Rapidlink Supervisor s Manual or Rapidcomm User s Guide Selecting sO2 as a Measured or Calculated Value for LIS Transmission LIS only You can report sO2 values to ...

Page 325: ...t the other connector on the cable to the LIS 4 Turn the power switch on 5 Select the communication settings at the Rapidlab 1200 system a Select Status Setup b If required enter your password c Select Printer and Devices Communications d Select RS 232 Configure e Select the communication settings that the LIS requires f Select Save 6 At the Communications screen select Save If an error message di...

Page 326: ... local systems can be viewed and controlled remotely using the Rapidcomm software The Rapidcomm software enables the user at an LIS to monitor and troubleshoot the local system remotely Before a remote user can view and control the local system the local system operator must enable the remote viewing feature and allow a remote user to connect to the local system This ensures that no conflict occur...

Page 327: ...mote viewing requires the local operator to decide when to allow remote viewing Remote viewing is unavailable to remote users when the local system is restarted 1 At the Setup screen select Printer and Devices Select the down arrow and then select Remote Viewer At the Remote Viewer screen a Services column and a Configure column display 2 To enable remote viewing automatically select Automatic in ...

Page 328: ...utton also functions as a touch screen button 2 To disconnect the remote viewer select Disconnect Remote User The Disconnect Remote User message changes into Enable Remote Viewer message When the Enable Remote Viewer message displays the remote user is disconnected and cannot view or control the local system The Enable Remote Viewer message also functions as a touch screen button 3 To enable remot...

Page 329: ...ystem Access You can select the security access you want for the system Restricted access Operators must enter a password to use the system Limited access Operators can perform routine tasks such as analyzing samples without entering a password Unrestricted access Operators can perform routine tasks without entering a password and Operators can access the Setup options Use this screen to select th...

Page 330: ...ations Yes Yes Yes Yes Yes Yes No accessing Setup options Yes Yes Yes Yes No No accessing Diagnostics Yes Yes Yes Yes No No accessing the Restore QC screen Yes Yes Yes Yes Yes Yes No accessing secured options Yes Yes No No No Table 8 2 Limited Access Setting Level Pass Level Pass Level Pass Level Pass Function 1 2 3 4 analyzing samples Yes No Yes No Yes No Yes No recalling data Yes No Yes No Yes N...

Page 331: ...to 5000 operators Ensure at least one Level 1 operator is entered in the operator list when you download operators to the system NOTE Instrument screen transition time into and out of instrument Setup may be slow while the analyzer is processing the new list if the operator list downloaded to the system is large or a large preexisting operator list is modified in instrument setup 1 At the Setup sc...

Page 332: ... many consecutive samples for the same patient 1 At the Setup screen select Secured Options Analysis Options 2 Select Save Demographics 3 Select Save If you want to Then add an operator a Select Add b Enter the operator ID c Select Password and enter the password for the operator d To enter an alphanumeric operator ID or password select the label for the entry field to access the keyboard screen e...

Page 333: ...tion Result Use this option to show results that are flagged as question results Calibration verification material sometimes produces results that are displayed as question results When you turn on this option the system shows these results for tHb and the fractions with a question mark instead of displaying no results CAUTION Do not perform analysis during proficiency testing When this option is ...

Page 334: ...he high and low instrument ranges for the selected parameter Enable Analytical Range functionality by following these steps 1 At the Setup screen select Secured Options 2 Select Analysis Options Analytical Ranges Define Analytical Range limits for each parameter by following these steps 1 At the Setup screen select Sample Analytical Ranges At the Analytical Ranges screen a list of parameters displ...

Page 335: ...ssage displays 2 minutes before a scheduled calibration 1 At the Setup screen select Secured Options Calibrations 2 Select Cal Pending to turn the message on or off 3 Select Save Saving and Restoring System Setup Data Saving the data to a diskette or CD allows you to create a record of the Setup options for your system Use this diskette or CD later to restore the setup options If are defining setu...

Page 336: ...ces such as centrifuges Installing New System Software You can install new system software from a CD ROM disks or from a network connection To install software from a network connection your system must be configured for a network and be connected to a device that provides access to the new system software You need the following materials to perform this task Disks containing the Rapidlab 1200 sys...

Page 337: ... until the system reads the data on the CD d Select Continue The system displays the current version number and the new version number of the software e Select Continue to begin the installation f When prompted remove the CD from the drive and select Continue Disks a Select Disk b When prompted insert the first disk into the disk drive and select Continue The system displays the current version nu...

Page 338: ...e Secured Options Maintenance screens Setup Schedule Export Schedule Import Schedule Setting up a Maintenance Schedule At the Maintenance Schedule screen you can perform the following tasks view maintenance task details add up to ten user defined maintenance tasks edit predefined and user defined maintenance tasks delete user defined maintenance tasks enable or disable some predefined and user def...

Page 339: ...ask a Select a task b Select Edit NOTE You cannot decrease the frequency of a predefined task You can only increase it You cannot edit the name of a predefined task c Select Frequency d Select the frequency The system displays screens for selecting a time period or set of times appropriate to your selection e Select Save The Save button is not available until you make all the necessary selections ...

Page 340: ...rt maintenance Data from a disk or CD a Select Import Schedule b Insert a disk or CD in to the drive c Select Disk or CD Schedule information is copied from the disk or CD d When prompted remove the disk or CD from the drive Export maintenance Data to a disk or CD a Select Export Schedule b Insert a disk or CD in to the drive c Select Disk or CD Schedule information is copied to the disk or CD d W...

Page 341: ...is not intended to replace or supplement your laboratory or hospital biohazard control procedures By definition a biohazardous condition is a situation involving infectious agents biological in nature such as the hepatitis B virus the human immunodeficiency virus and the tuberculosis bacterium These infectious agents may be present in human blood and blood products and in other body fluids The fol...

Page 342: ...ny part of the instrument sample path or waste area with 10 v v bleach Do not eat drink smoke or apply cosmetics or contact lenses while in the laboratory Do not mouth pipet any liquid including water Do not place tools or any other items in your mouth Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or washing hands To prevent needlestick injuries needles should not...

Page 343: ...he 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 O2 or nitrous oxide The risk of explosion exists in a potentially explosive environment If you use an adapter ensure the grounding wire is properly conne...

Page 344: ...A 4 Rapidlab 1200 Operator s Guide Safety Instructions 02087462 Rev V ...

Page 345: ... service of the instrument on site or by exchanging the defective instrument or component subject to the limitations and exclusions set forth in Replacement of Parts page B 3 and Warranty and Service Exclusions page B 4 Repairs replacements or exchanges of instruments or components provided during the warranty or any additional service period does not extend the warranty or service period beyond t...

Page 346: ...o the location of the instrument and onsite labor during normal business hours A warranty or service call is initiated by the customer by following the instructions on how to obtain service for the customer s instrument The service call is considered complete when any defects in material or workmanship have been corrected by repair or replacement and the instrument conforms to the applicable speci...

Page 347: ...ncurring any obligation to make such changes available to individual customers or instruments If Siemens notifies customers of a change that improves the performance or reliability of their instrument and requests to retrofit that instrument the customer must agree to allow Siemens or an authorized distributor at Siemens s expense to retrofit components or make design changes which does not advers...

Page 348: ... has not been installed within 90 days of shipment to the customer s facility unless otherwise specified 6 The customer has not performed appropriate customer maintenance procedures as outlined in the system operator s manuals 7 The instrument has been misused or used for a purpose for which it was not intended 8 The instrument has been damaged in transit to the customer or damaged by the customer...

Page 349: ... software applications under license to Siemens Healthcare Diagnostics Inc or one of its affiliates For those applications that request that certain information such as software headers copyright notices or software headers and copyright notices be distributed with the application see the information listed below which is organized by application The text in these sections is reproduced verbatim G...

Page 350: ...am finished your computer is visible to others on the network under its new name BAPTIZE is tested to work with NetBEUI and TCP IP NOTE Depending on the configuration of your computer this program may run for up to 1 minute Don t get panic During some amount of this time your computer may not be visible on the network You may freely distribute this tool as long as you include this textfile and don...

Page 351: ... warranty of any kind not even implied warranty of suitability for any particular use The user of the software is solely responsible for determining suitability for a particular purpose The user of this software agrees to hold Scott Howard and Motorola Inc its employees subsidiaries agents and distributors blameless and free from responsibility for any damages resulting from the use and or malfunc...

Page 352: ...eely subject to the following restrictions 1 Redistributions of source code must retain the above copyright notice definition disclaimer and this list of conditions 2 Redistributions in binary form compiled executables must reproduce the above copyright notice definition disclaimer and this list of conditions in documentation and or other materials provided with the distribution The sole exception...

Page 353: ... service and technical information and for ordering supplies Authorized Representative Siemens Healthcare Diagnostics Ltd Sir William Siemens Sq Frimley Camberley UK GU16 8QD Addresses For technical assistance contact your local technical support provider For customer service or additional information contact your local technical support distributor www siemens com diagnostics Siemens Healthcare D...

Page 354: ...B 10 Rapidlab 1200 Operator s Guide Service Ordering and Warranty 02087462 Rev V ...

Page 355: ...rameters default Microsample pH and pH Glu Lac tHb 100 µL 1240 systems 150 µL 1245 1260 systems 200 µL 1265 systems 3 mL syringe All parameters default Microsample pH and pH Glu Lac tHb 200 µL for all systems in all modes 5 mL syringe All parameters default Microsample pH and pH Glu Lac tHb 500 µL for all systems in all modes Capillary tube All parameters default 90 µL 1240 systems 140 µL 1245 sys...

Page 356: ...t 2 to 8 C Room temperature not to exceed 25 C up to 7 days Wash Cartridge Rapidlab 1245 and 1265 18 days Sample dependent 30 samples per day 12 days of use Room temperature at approximately 25 C Wash Cartridge Rapidlab 1240 and 1260 18 days Sample dependent 30 samples per day 17 days of use Room temperature at approximately 25 C AutomaticQC cartridge 28 days sample dependent at least 1 sample ana...

Page 357: ...915030 Clot removal kit 13078229 Aspiration adapter 30 04889515 Tubing kit common 06645048 Tubing kit CO ox 06645648 CO ox sample chamber 06324604 Air filter 2 03168350 Reagent manifold 1240 1260 06646415 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...

Page 358: ...nce 02563698 High G L 09733092 RapidQC Complete level 1 02017464 RapidQC Complete level 2 07519905 RapidQC Complete level 3 07182730 Lamp assembly CO ox 06650153 Power cord US 03628246 Power cord UK 06139440 Power cord Europe 06048720 Multicap 100 μL 50 05974729 Multicap 100 μL 500 05614986 Multicap 140 μL 50 01198961 Multicap 140 μL 500 06493996 Multicap 175 μL 50 07162853 Multicap 175 μL 500 015...

Page 359: ...54 Guide Rapidlab 1200 Operator s Italian 06626058 Guide Rapidlab 1200 Operator s Spanish 06625361 Guide Rapidlab 1200 Operator s Portuguese 06628093 Guide Rapidlab 1200 Operator s Swedish 06629243 Guide Rapidlab 1200 Operator s Japanese 06630926 Guide Rapidlab 1200 Operator s Finnish 02002904 Guide Rapidlab 1200 Operator s Danish 03322392 Guide Rapidlab 1200 Operator s Greek 06856925 Guide Rapidl...

Page 360: ...D 4 Rapidlab 1200 Operator s Guide Supplies 02087462 Rev V ...

Page 361: ...rating relative humidity 5 90 non condensing Ambient shipping temperature 25 45 C Ambient storage temperature 4 45 C Power rating 150VA Voltage requirements 100V 240V 85V to 264V autoranging 50 60Hz Ambient operating barometric pressure 523 800 mmHg 69 7 106 7 kPa System dimensions base model height 61 0 cm 24 inches width 53 5 cm 21 inches depth 58 5 cm 23 inches weight 29 5 kg 65 lbs Height with...

Page 362: ... L mg dL 0 25 5 00 1 0 20 0 0 01 0 1 Ca 7 4 mmol L mg dL 0 10 5 70 0 4 22 8 0 01 0 1 Cl mmol L 40 160 1 Glucose mg dL mmol L 10 998 0 6 55 4 1 0 1 Lactate mmol L mg dL 0 00 30 00 0 0 270 2 0 01 0 1 AnGap mmol L 5 0 50 0 0 1 Table E 4 Oxygenation Parameters Parameter Units Reporting Range Resolution p50 mmHg kPa 15 0 75 0 2 00 10 00 0 1 0 01 ctO2 a mL dL mL L mmol L 0 40 0 0 400 0 17 9 0 1 1 0 1 ct...

Page 363: ... 0 0 1 g L 20 250 1 mmol L 1 2 15 5 0 1 FO2Hb blood QC 0 0 100 0 0 0 200 0 0 1 0 1 fraction blood fraction QC 0 000 1 000 0 000 2 000 0 001 0 001 FCOHb blood QC 0 0 100 0 0 0 200 0 0 1 0 1 fraction blood fraction QC 0 000 1 000 0 000 2 000 0 001 0 001 FMetHb blood QC 0 0 100 0 0 0 200 0 0 1 0 1 fraction blood fraction QC 0 000 1 000 0 000 2 000 0 001 0 001 FHHb blood QC 0 0 100 0 0 0 200 0 0 1 0 1...

Page 364: ...eter Units Reporting Range Resolution pH T pH 6 000 8 000 0 001 H T nmol L 10 0 1000 0 0 1 pCO2 T mmHg kPa 5 0 250 0 0 67 33 33 0 1 0 01 pO2 T mmHg kPa 0 0 800 0 0 00 106 66 0 1 0 01 pO2 A a T mmHg kPa 0 999 9 0 00 133 31 0 1 0 01 pO2 a A T decimal fraction 0 100 0 00 1 00 1 0 01 RI T decimal fraction 0 2000 0 00 20 00 1 0 01 sp t T decimal fraction 0 100 0 00 1 00 1 0 01 sp t est T decimal fracti...

Page 365: ...ions occur you exceed the expiration dates of cartridges you do not use cartridges according to the manufacturer s recommendations you do not follow standard laboratory practices you do not follow the procedures described in this guide you do not follow the environmental operating conditions and location recommendations Table E 8 Entered Parameters Parameter Units Reporting Range Resolution Temper...

Page 366: ...s summarized in the following table The table shows the interference level tested along with the average change in blood results test result spiked control result unspiked for each of the sensors Analyte units Interference Interference Level Tested Effect of Interference Test control pH pH units Acetaminophen 20 mg dL 0 000 Sodium Pentothal 300 mg dL 0 009 Salicylic Acid 20 mg dL 0 000 pO2 mm Hg I...

Page 367: ...lsalicylic Acid 15 mg dL 0 01 Glucose mg dL Acetaminophen 2 mg dL 11 8 Heparin 90 units mL 7 8 Salicylic Acid 30 mg dL 0 5 Salicylic Acid 20 mg dL 0 3 Ethanol 350 mg dL 1 5 Dopamine 10 mg dL 12 6 Dopamine 5 mg dL 12 5 Dobutamine 20 mg dL 9 5 Dobutamine 10 mg dL 5 5 Dobutamine 5 mg dL 2 0 Acetylsalicylic Acid 50 mg dL 1 5 Sodium Pentothal 300 mg dL 0 9 pO2 25 85 mm Hg 1 0 Pralidoxime Iodide 16 µg m...

Page 368: ... mg dL 0 3 Hydroxybutyrate 200 mg dL 0 3 Urea 500 mg dL 0 3 Guaiacol 5 mg dL 0 3 Pyruvate 9 mg dL 0 3 Theophylline 9 mg dL 0 3 Penicillamine 25 mg dL 0 3 Isoniazid 2 mg dL 0 3 Uric Acid 10 mg dL 0 3 Citrate 1000 mg dL 0 3 Potassium Oxalate 1000 mg dL 0 3 EDTA 800 mg dL 0 3 Sodium Fluoride 1000 mg dL 1 0 Sodium Fluoride Potassium Oxalate 1000 mg dL 1 0 Acetominophen 2 mg dL 0 35 Glucose system perf...

Page 369: ...nt For those effects which were statistically significant a mean effect 0 5 g dL for tHb or 1 0 for the CO ox fractions was considered clinically significant The reported effects for methylene blue at 25 and 40 mg L are the simple mean effect spiked mean control mean For sulfhemoglobin the mean effect was corrected using the difference observed between the spike and control from an additional refe...

Page 370: ... after thyroid surgery Therefore ionized calcium can not be tested to detect hypocalcemia while Irenat is still in the system The following guidelines should be followed if a patient is on Irenat when ionized calcium is measured Measure Ca before administering Irenat Do not measure Ca while the patient is on Irenat Ca may be measured 96 hours after the last dose of Irenat Potential Interferent Lev...

Page 371: ...1240 System Performance Characteristics All performance data presented in this section was generated using the Rapidlab 1240 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 i...

Page 372: ...ults Analyte Level n Mean WRSD WRSD within run standard deviation Total SD Total SD total standard deviation pH 1 162 7 121 0 001 0 001 pH 2 161 7 331 0 001 0 002 pH 3 160 7 534 0 001 0 002 pCO2 1 162 70 8 0 49 0 97 pCO2 2 161 40 3 0 30 0 48 pCO2 3 160 23 0 0 21 0 31 pO2 1 162 147 4 0 71 1 72 pO2 2 161 97 6 0 73 1 21 pO2 3 160 23 8 0 94 1 10 Table E 10 Rapidlab 1240 AutomaticQC Precision Results A...

Page 373: ...Syringe 48 0 005 7 209 7 202 100 09 0 07 3 Syringe 47 0 003 7 353 7 354 99 99 0 05 4 Syringe 48 0 003 7 418 7 41 100 11 0 04 5 Syringe 48 0 004 7 545 7 534 100 15 0 05 6 Syringe 47 0 003 7 621 7 63 99 88 0 04 1 Micro capillary 24 0 01 7 03 7 032 99 97 0 14 2 Micro capillary 24 0 013 7 204 7 202 100 02 0 18 3 Micro capillary 24 0 011 7 359 7 354 100 07 0 15 4 Micro capillary 24 0 012 7 403 7 41 99 ...

Page 374: ...0 003 7 388 7 41 99 7 0 03 5 pH Only Syringe 42 0 004 7 506 7 534 99 62 0 06 6 pH Only Syringe 45 0 004 7 621 7 63 99 88 0 06 WRSD within run standard deviation Table E 12 Rapidlab 1240 Recovery and Precision Testing pCO2 Level Mode n WRSD Observed Expected Recovery WRCV 1 Capillary 24 0 17 7 1 7 1 99 1 2 4 2 Capillary 24 0 42 22 6 21 4 105 6 1 9 3 Capillary 24 0 8 27 1 28 6 94 7 3 4 Capillary 24 ...

Page 375: ...apillary 12 0 42 24 5 28 5 85 9 1 7 4 Micro capillary 12 0 33 33 3 35 7 93 4 1 5 Micro capillary 12 0 85 49 5 49 9 99 1 7 6 Micro capillary 12 1 12 67 6 71 3 94 9 1 7 7 Micro capillary 12 1 23 100 1 99 9 100 2 1 2 8 Micro capillary 12 2 22 134 2 135 6 99 1 7 9 Micro capillary 12 6 69 228 9 228 3 100 2 2 9 1 Micro syringe 24 0 36 6 9 7 2 96 3 5 3 2 Micro syringe 24 0 38 21 4 21 2 100 7 1 8 3 Micro ...

Page 376: ... 198 199 9 99 2 7 Capillary 24 1 53 254 1 249 4 101 9 0 6 8 Capillary 24 4 87 374 8 378 4 99 1 3 9 Capillary 24 10 28 630 649 7 97 1 6 1 Syringe 45 0 36 28 1 28 6 98 1 3 2 Syringe 48 0 42 52 5 50 1 104 9 0 8 3 Syringe 48 0 6 88 2 84 9 103 9 0 7 4 Syringe 48 1 15 103 2 107 3 96 2 1 1 5 Syringe 48 1 13 153 7 148 6 103 4 0 7 6 Syringe 45 2 26 196 2 200 3 98 1 2 7 Syringe 47 3 81 253 9 247 7 102 5 1 5...

Page 377: ... 1 72 199 9 199 5 100 2 0 9 7 Micro capillary 12 2 09 265 249 7 106 1 0 8 8 Micro capillary 12 2 71 371 377 6 98 2 0 7 9 Micro capillary 12 6 27 632 5 649 3 97 4 1 1 Micro syringe 24 0 17 30 4 28 3 107 2 0 6 2 Micro syringe 24 0 33 54 50 1 107 8 0 6 3 Micro syringe 24 0 48 90 2 85 9 105 0 5 4 Micro syringe 24 0 85 104 6 107 4 97 4 0 8 5 Micro syringe 24 5 95 155 4 150 3 103 4 3 8 6 Micro syringe 2...

Page 378: ...ith your Rapidlab 1245 system Precision on Controls Quality control materials including manual QC and automatic AutomaticQC were analyzed on the Rapidlab 1245 system Manual QC is performed by the operator while AutomaticQC is performed automatically by the system based on the QC frequency defined in the system software The results are presented here Table E 14 Rapidlab 1240 Human Whole Blood Metho...

Page 379: ...al QC and AutomaticQC Table E 16 Rapidlab 1245 Manual QC Precision Results Parameter Level n Mean WRSD WRSD within run standard deviation Total SD pH 1 161 7 119 0 001 0 002 pH 2 161 7 328 0 001 0 002 pH 3 160 7 529 0 001 0 003 pCO2 1 161 72 6 0 42 1 14 pCO2 2 162 40 7 0 29 0 56 pCO2 3 160 22 9 0 21 0 36 pO2 1 161 147 3 0 69 1 85 pO2 2 162 97 7 0 85 1 56 pO2 3 160 24 8 0 73 1 07 tHb 1 132 17 8 0 0...

Page 380: ...al SD pH 1 170 7 15 0 002 0 002 pH 2 172 7 352 0 001 0 002 pH 3 168 7 553 0 002 0 003 pCO2 1 169 68 8 1 18 1 38 pCO2 2 172 39 1 0 59 0 95 pCO2 3 167 21 7 0 53 0 55 pO2 1 170 153 2 0 84 0 87 pO2 2 172 102 5 0 76 1 02 pO2 3 168 67 3 1 40 1 54 tHb 1 171 18 0 0 26 0 27 tHb 2 162 14 0 0 08 0 10 tHb 3 170 8 0 0 08 0 08 FO2Hb 1 171 78 3 2 44 2 52 FO2Hb 2 162 92 0 0 36 0 39 FO2Hb 3 170 60 2 0 31 0 31 FCOH...

Page 381: ... 2 Syringe 48 0 005 7 213 7 202 100 15 0 07 3 Syringe 48 0 004 7 347 7 354 99 92 0 05 4 Syringe 48 0 003 7 422 7 410 100 16 0 03 5 Syringe 48 0 002 7 546 7 534 100 15 0 03 6 Syringe 48 0 002 7 626 7 630 99 95 0 03 1 Micro capillary 24 0 011 7 046 7 032 100 20 0 16 2 Micro capillary 24 0 011 7 197 7 202 99 92 0 15 3 Micro capillary 24 0 006 7 366 7 354 100 17 0 08 4 Micro capillary 24 0 009 7 413 7...

Page 382: ... 389 7 410 99 72 0 04 5 pH Only Syringe 48 0 002 7 517 7 534 99 78 0 03 6 pH Only Syringe 48 0 003 7 631 7 630 100 01 0 04 WRSD within run standard deviation Table E 19 Rapidlab 1245 Recovery and Precision Testing pCO2 Level Mode n WRSD Observed Expected Recovery WRCV 1 Capillary 24 0 16 7 5 7 1 104 7 2 1 2 Capillary 24 0 29 22 4 21 4 104 5 1 3 3 Capillary 24 0 56 27 3 28 6 95 4 2 1 4 Capillary 24...

Page 383: ...llary 12 0 58 27 2 28 5 95 3 2 1 4 Micro capillary 12 0 52 36 7 35 7 103 0 1 4 5 Micro capillary 12 1 25 52 3 49 9 104 6 2 4 6 Micro capillary 12 2 41 69 3 71 3 97 2 3 5 7 Micro capillary 12 2 35 102 9 99 9 103 0 2 3 8 Micro capillary 12 3 29 135 8 135 6 100 1 2 4 9 Micro capillary 12 6 71 222 4 228 3 97 4 3 0 1 Micro syringe 24 0 26 7 2 7 2 101 2 3 6 2 Micro syringe 24 0 41 21 1 21 2 99 2 2 0 3 M...

Page 384: ...9 9 99 5 1 2 7 Capillary 24 10 54 259 4 249 4 104 0 4 1 8 Capillary 24 3 90 378 5 378 4 100 0 1 0 9 Capillary 24 4 60 656 6 649 7 101 1 0 7 1 Syringe 48 0 29 27 6 28 6 96 5 1 0 2 Syringe 48 0 39 51 5 50 1 102 9 0 8 3 Syringe 48 0 88 87 1 84 9 102 5 1 0 4 Syringe 48 0 94 104 8 107 3 97 7 0 9 5 Syringe 48 0 97 153 0 148 6 103 0 0 6 6 Syringe 48 2 79 200 1 200 3 99 9 1 4 7 Syringe 45 3 07 258 0 247 6...

Page 385: ...run standard deviation were determined for each blood preparation and sampling mode 5 Micro capillary 12 1 86 150 3 149 8 100 3 1 2 6 Micro capillary 12 2 21 186 7 199 5 93 6 1 2 7 Micro capillary 12 3 70 239 9 249 7 96 1 1 5 8 Micro capillary 12 9 31 332 2 377 6 88 0 2 8 9 Micro capillary 12 10 50 556 7 649 3 85 7 1 9 1 Micro syringe 24 0 33 27 5 28 3 97 0 1 2 2 Micro syringe 24 0 59 51 7 50 1 10...

Page 386: ...7 34 0 80 0 22 FO2Hb Syringe 54 88 15 0 85 0 22 FCOHb Capillary 60 5 17 0 50 0 20 FCOHb tHb 55 4 86 0 63 0 19 FCOHb Syringe 54 5 34 0 70 0 25 FMetHb Capillary 60 4 99 0 22 0 10 FMetHb tHb 55 5 50 0 05 0 11 FMetHb Syringe 54 5 84 0 03 0 10 FHHb tHb 55 2 30 0 02 0 13 FHHb Capillary 60 1 86 0 16 0 19 FHHb Syringe 54 0 67 0 06 0 12 Table E 22 Rapidlab 1245 CO ox Module Recovery and Precision with Tota...

Page 387: ... Capillary 59 20 14 0 05 0 16 tHb tHb 52 20 10 0 07 0 22 tHb Syringe 52 20 23 0 08 0 15 FO2Hb Capillary 61 86 04 0 61 0 27 FO2Hb tHb 53 86 73 1 63 0 35 FO2Hb Syringe 53 87 01 1 41 0 21 FCOHb Capillary 60 5 45 0 04 0 13 FCOHb tHb 58 5 09 0 24 0 22 FCOHb Syringe 53 5 19 0 41 0 14 FMetHb Capillary 60 5 10 0 19 0 09 FMetHb tHb 52 5 80 0 36 0 12 FMetHb Syringe 53 6 23 0 38 0 15 FHHb tHb 54 1 01 0 70 0 ...

Page 388: ...the table below Table E 24 Rapidlab 1245 System Human Whole Blood Method Comparison pH Mode N Slope Intercept RMSE r2 Min Max Capillary 135 1 002 0 013 0 006 0 999 7 0 7 7 Syringe 288 1 008 0 059 0 007 0 999 7 0 7 7 Micro capillary 144 0 988 0 089 0 015 0 994 7 0 7 7 Micro syringe 144 1 003 0 029 0 007 0 999 7 0 7 6 pH Only Capillary 144 1 018 0 123 0 009 0 998 7 0 7 7 pH Only Syringe 288 1 014 0 ...

Page 389: ...6 Table E 29 Rapidlab 1245 System Human Whole Blood Method Comparison FCOHb Mode N Slope Intercept RMSE r2 tHb 188 0 979 0 013 1 119 0 998 Capillary 209 0 996 0 128 0 959 0 999 Syringe 211 0 988 0 174 0 972 0 999 Table E 30 Rapidlab 1245 System Human Whole Blood Method Comparison FMetHb Mode N Slope Intercept RMSE r2 tHb 202 0 990 0 055 1 055 0 999 Capillary 206 1 017 0 077 0 991 0 999 Syringe 210...

Page 390: ... 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 Precision on Controls Quality control materials including manual QC and automatic AutomaticQC were analyzed on the Rapidlab 1260 system Manual QC is performed by the operator while AutomaticQC i...

Page 391: ...ab 1260 system precision for manual QC and AutomaticQC Table E 32 Rapidlab 1260 Manual QC Precision Results Parameter Level n Mean WRSD Total SD Ca 1 154 1 68 0 007 0 011 Ca 2 155 1 31 0 004 0 008 Ca 3 152 0 83 0 006 0 008 Cl 1 152 78 0 42 0 67 Cl 2 153 98 0 34 0 74 Cl 3 150 117 0 44 1 15 Glu 1 156 195 1 33 3 01 Glu 2 157 95 0 92 1 51 Glu 3 154 50 0 54 1 02 K 1 156 3 24 0 005 0 013 K 2 157 5 34 0 ...

Page 392: ...0 0 49 0 50 Cl 2 235 100 0 61 0 63 Cl 3 235 120 0 84 0 85 Glu 1 235 202 1 29 1 61 Glu 2 235 101 0 73 1 38 Glu 3 235 51 0 61 0 94 K 1 235 2 98 0 009 0 009 K 2 235 4 99 0 013 0 013 K 3 235 7 02 0 023 0 025 Lac 1 189 11 7 0 16 0 45 Lac 2 189 1 0 0 03 0 03 Lac 3 189 3 1 0 06 0 11 Na 1 235 114 9 0 31 0 31 Na 2 235 134 6 0 31 0 31 Na 3 235 155 0 0 37 0 38 pCO2 1 235 68 6 0 46 0 56 pCO2 2 235 39 5 0 36 0...

Page 393: ...dard deviation Table E 34 Rapidlab 1260 Recovery and Precision Testing pH Level Mode N WRSD Observed Expected Recovery WRCV 1 Capillary 24 0 003 7 056 7 048 100 11 0 04 2 Capillary 24 0 001 7 228 7 231 99 96 0 02 3 Capillary 24 0 005 7 317 7 311 100 09 0 07 4 Capillary 25 0 001 7 433 7 423 100 14 0 02 5 Capillary 24 0 002 7 539 7 526 100 17 0 02 6 Capillary 24 0 002 7 650 7 637 100 16 0 03 1 Syrin...

Page 394: ...1 pH Only Cap 24 0 004 7 028 7 045 99 75 0 05 2 pH Only Cap 24 0 002 7 218 7 227 99 87 0 03 3 pH Only Cap 24 0 006 7 341 7 329 100 16 0 08 4 pH Only Cap 23 0 002 7 412 7 419 99 90 0 02 5 pH Only Cap 24 0 002 7 515 7 529 99 81 0 02 6 pH Only Cap 24 0 003 7 616 7 608 100 11 0 03 1 pH Only Syr 46 0 005 7 047 7 045 100 02 0 07 2 pH Only Syr 45 0 005 7 233 7 227 100 09 0 07 3 pH Only Syr 47 0 002 7 315...

Page 395: ...pH Glu Lac Syringe 37 0 005 7 068 7 072 99 95 0 07 2 pH Glu Lac Syringe 48 0 004 7 237 7 234 100 03 0 06 3 pH Glu Lac Syringe 37 0 005 7 303 7 309 99 91 0 07 4 pH Glu Lac Syringe 47 0 002 7 438 7 439 99 99 0 02 5 pH Glu Lac Syringe 36 0 002 7 563 7 561 100 02 0 03 6 pH Glu Lac Syringe 48 0 002 7 651 7 650 100 01 0 02 WRSD within run standard deviation Table E 35 Rapidlab 1260 Recovery and Precisio...

Page 396: ...ringe 45 0 60 49 6 49 9 99 4 1 2 6 Syringe 48 0 86 72 7 71 4 101 7 1 2 7 Syringe 48 1 27 95 5 99 3 96 2 1 3 8 Syringe 45 2 16 130 6 135 4 96 5 1 7 9 Syringe 47 5 09 213 4 227 0 94 0 2 4 1 Micro capillary 12 0 25 6 9 7 1 96 9 3 7 2 Micro capillary 12 0 28 21 0 21 3 98 4 1 3 3 Micro capillary 12 0 28 27 9 28 4 98 2 1 0 4 Micro capillary 12 1 03 35 3 35 8 98 7 2 9 5 Micro capillary 12 0 62 48 5 49 8 ...

Page 397: ... 21 0 31 30 4 28 4 106 9 1 0 2 Capillary 21 0 36 49 6 49 9 99 5 0 7 3 Capillary 24 0 66 89 7 84 9 105 6 0 7 4 Capillary 21 0 51 105 2 106 8 98 5 0 5 5 Capillary 24 1 52 150 8 148 6 101 5 1 0 6 Capillary 21 0 60 204 7 198 9 102 9 0 3 7 Capillary 24 1 16 255 4 247 6 103 1 0 5 8 Capillary 21 1 74 379 5 376 5 100 8 0 5 9 Capillary 20 6 79 654 4 648 1 101 0 1 0 1 Syringe 45 0 52 29 8 28 6 104 3 1 8 2 S...

Page 398: ...Micro capillary 12 3 91 380 4 376 6 101 0 1 0 9 Micro capillary 12 8 65 656 9 647 0 101 5 1 3 1 Micro syringe 24 0 26 26 5 28 6 92 8 1 0 2 Micro syringe 24 0 37 46 6 49 5 94 2 0 8 3 Micro syringe 24 0 73 81 3 85 6 95 1 0 9 4 Micro syringe 23 0 88 104 1 106 1 98 1 0 8 5 Micro syringe 24 1 33 147 8 149 7 98 7 0 9 6 Micro syringe 24 3 36 201 4 199 9 100 7 1 7 7 Micro syringe 24 2 75 267 9 249 6 107 4...

Page 399: ... 134 8 134 4 100 3 0 3 4 Syringe 48 0 71 141 2 141 5 99 8 0 5 5 Syringe 48 0 34 148 9 148 6 100 2 0 2 6 Syringe 48 0 78 174 6 179 8 97 1 0 4 1 Micro capillary 12 0 62 110 2 109 9 100 3 0 6 2 Micro capillary 12 0 18 129 5 130 1 99 6 0 1 3 Micro capillary 12 0 60 131 7 132 0 99 8 0 5 4 Micro capillary 12 1 11 143 1 143 8 99 5 0 8 5 Micro capillary 12 0 29 149 6 150 8 99 2 0 2 6 Micro capillary 12 1 ...

Page 400: ...26 4 12 4 12 100 1 0 6 4 Syringe 45 0 052 5 70 5 74 99 2 0 9 5 Syringe 45 0 116 8 18 7 99 102 3 1 4 6 Syringe 45 0 118 11 69 11 31 103 4 1 0 1 Micro capillary 12 0 078 1 45 1 15 126 1 5 3 2 Micro capillary 13 0 027 2 84 2 82 100 8 1 0 3 Micro capillary 12 0 024 3 72 3 77 98 4 0 7 4 Micro capillary 12 0 042 5 57 5 71 97 6 0 7 5 Micro capillary 11 0 073 7 58 8 05 94 1 1 0 6 Micro capillary 12 0 190 ...

Page 401: ...ge 48 0 79 98 99 99 0 0 8 4 Syringe 48 0 80 104 105 99 0 0 8 5 Syringe 48 0 56 110 110 99 3 0 5 6 Syringe 43 1 39 145 146 99 1 1 0 1 Micro capillary 12 0 81 81 80 100 7 1 0 2 Micro capillary 12 0 31 98 98 100 1 0 3 3 Micro capillary 12 0 61 99 100 99 3 0 6 4 Micro capillary 12 1 14 104 105 99 1 1 1 5 Micro capillary 12 0 53 115 116 99 2 0 5 6 Micro capillary 12 3 04 142 141 100 5 2 1 1 Micro syrin...

Page 402: ...9 1 34 1 36 98 5 0 6 4 Syringe 51 0 027 1 87 1 93 97 2 1 4 5 Syringe 45 0 046 2 30 2 36 97 6 2 0 6 Syringe 45 0 099 4 22 4 09 103 1 2 4 1 Micro capillary 12 0 034 0 57 0 56 101 6 5 9 2 Micro capillary 12 0 018 1 24 1 24 100 0 1 4 3 Micro capillary 12 0 005 1 30 1 30 100 0 0 4 4 Micro capillary 12 0 024 1 96 1 98 99 0 1 2 5 Micro capillary 12 0 050 2 39 2 38 100 5 2 1 6 Micro capillary 12 0 055 3 8...

Page 403: ...8 2 87 214 212 101 4 1 3 4 Syringe 48 3 52 338 357 94 6 1 0 5 Syringe 47 5 45 469 467 100 4 1 2 1 Micro capillary 12 1 32 46 44 103 6 2 9 2 Micro capillary 12 0 71 88 88 100 6 0 8 3 Micro capillary 12 1 55 221 219 100 6 0 7 4 Micro capillary 12 4 44 331 343 96 5 1 3 5 Micro capillary 12 7 98 448 452 99 1 1 8 1 Micro syringe 24 0 84 49 48 94 3 1 3 2 Micro syringe 24 2 10 99 98 100 3 1 0 3 Micro syr...

Page 404: ...60 Recovery and Precision Testing Lactate Level Mode N WRSD Observed Expected Recovery WRCV 1 Capillary 21 0 09 1 5 1 5 97 5 6 2 2 Capillary 24 0 06 2 1 2 2 96 8 3 0 3 Capillary 21 0 08 4 7 5 1 91 4 1 7 4 Capillary 24 0 16 9 1 11 0 83 2 1 8 5 Capillary 21 0 17 11 7 14 2 82 4 1 5 1 Syringe 45 0 03 1 1 1 3 89 8 3 0 2 Syringe 48 0 05 2 1 2 2 94 6 2 4 3 Syringe 45 0 15 5 1 5 6 90 5 3 1 4 Syringe 48 0 ...

Page 405: ...3 10 9 85 7 3 8 5 Micro syringe 24 0 15 11 7 13 9 84 1 1 3 1 pH Glu Lac Capillary 24 0 05 0 9 0 9 109 1 5 4 2 pH Glu Lac Capillary 24 0 04 2 8 2 8 99 0 1 6 3 pH Glu Lac Capillary 24 0 12 4 9 5 2 93 8 2 4 4 pH Glu Lac Capillary 24 0 20 11 2 12 3 91 4 1 7 5 pH Glu Lac Capillary 24 0 41 14 9 17 6 84 8 2 7 1 pH Glu Lac Syringe 45 0 02 0 9 0 8 105 0 2 4 2 pH Glu Lac Syringe 44 0 07 2 6 2 7 95 3 2 5 3 p...

Page 406: ...lab 1260 dependent variable versus the Rapidlab 865 independent variable Results are summarized in the table below 4 pH Glu Lac Syringe 46 0 15 11 3 12 6 89 8 1 3 5 pH Glu Lac Syringe 47 0 36 15 6 18 0 86 6 2 3 WRSD within run standard deviation Table E 43 Rapidlab 1260 Human Whole Blood Method Comparison pH Mode N Slope Intercept RMSE r2 Min Max Capillary 145 1 001 0 003 0 009 0 998 7 042 7 684 S...

Page 407: ... 718 10 291 0 997 26 0 723 9 Micro capillary 108 0 987 1 114 6 417 0 999 24 9 684 7 Micro syringe 215 1 013 3 218 7 534 0 999 24 9 714 8 Table E 46 Rapidlab 1260 Human Whole Blood Method Comparison Na Mode N Slope Intercept RMSE r2 Min Max Capillary 144 0 964 5 366 1 596 0 994 107 8 186 1 Syringe 287 0 987 2 153 1 352 0 996 107 6 184 3 Micro capillary 72 0 942 8 008 1 366 0 995 110 5 178 7 Micro s...

Page 408: ...2 14 282 1 626 0 992 86 150 Micro syringe 141 0 915 14 724 1 615 0 992 85 153 Table E 50 Rapidlab 1260 Human Whole Blood Method Comparison Glucose Mode N Slope Intercept RMSE r2 Min Max Capillary 120 0 881 8 096 17 253 0 987 43 528 Syringe 239 0 908 6 686 16 179 0 990 32 521 Micro capillary 60 0 936 3 403 6 436 0 998 43 488 Micro syringe 118 0 964 2 091 4 890 0 999 41 502 pH Glu Lac Capillary 114 ...

Page 409: ...results are presented here Precision on manual aqueous quality control materials was estimated using a minimum of 3 Rapidlab 1265 systems Controls were measured over a minimum of 10 days Precision on the aqueous quality control materials in the AutomaticQC module was estimated using a minimum of 3 Rapidlab 1265 systems over a minimum of 10 days AutomaticQC is automatically scheduled to run single ...

Page 410: ... 33 pCO2 3 148 22 9 0 15 0 30 pH 1 147 7 118 0 001 0 002 pH 2 148 7 327 0 001 0 003 pH 3 148 7 527 0 001 0 003 pO2 1 147 148 2 1 06 1 99 pO2 2 148 97 8 0 81 1 66 pO2 3 148 24 4 1 34 1 86 tHb 1 153 17 4 0 19 0 25 tHb 2 169 13 6 0 14 0 18 tHb 3 164 7 7 0 09 0 12 FO2Hb 1 153 79 0 0 49 0 79 FO2Hb 2 169 94 4 0 70 1 07 FO2Hb 3 164 60 1 0 78 1 07 FCOHb 1 153 2 0 0 60 0 92 FCOHb 2 169 1 3 0 73 0 98 FCOHb ...

Page 411: ...l 2 218 99 0 45 0 49 Cl 3 218 120 0 60 0 68 Glu 1 218 203 1 29 1 47 Glu 2 218 102 0 72 0 96 Glu 3 218 51 0 56 0 67 K 1 218 2 99 0 045 0 045 K 2 218 4 99 0 065 0 071 K 3 218 7 01 0 088 0 097 Lac 1 179 11 8 0 24 0 39 Lac 2 179 1 0 0 03 0 04 Lac 3 179 3 0 0 06 0 09 Na 1 218 114 8 0 30 0 32 Na 2 218 134 6 0 38 0 41 Na 3 218 155 0 0 51 0 56 pCO2 1 215 70 8 0 48 0 77 pCO2 2 215 40 8 0 22 0 37 pCO2 3 215...

Page 412: ...1 22 1 34 pO2 3 218 67 2 1 66 1 95 tHb 1 97 17 1 0 12 0 13 tHb 2 94 13 8 0 20 0 20 tHb 3 95 7 6 0 07 0 08 FO2Hb 1 97 77 3 0 84 0 94 FO2Hb 2 94 91 3 0 77 1 02 FO2Hb 3 95 60 5 0 88 1 07 FCOHb 1 97 6 1 0 78 1 30 FCOHb 2 94 5 9 0 70 1 44 FCOHb 3 95 18 7 0 92 1 46 FMetHb 1 97 17 1 0 32 0 35 FMetHb 2 94 2 8 0 88 0 89 FMetHb 3 95 5 7 0 54 0 55 FHHb 1 97 0 2 0 31 0 41 FHHb 2 94 0 4 0 40 0 64 FHHb 3 9 15 1...

Page 413: ...2 0 002 7 346 7 338 100 10 0 03 4 Micro capillary 12 0 002 7 429 7 420 100 12 0 03 5 Micro capillary 12 0 002 7 530 7 541 99 85 0 03 6 Micro capillary 12 0 002 7 641 7 635 100 07 0 02 1 Micro syringe 24 0 003 7 054 7 048 100 09 0 04 2 Micro syringe 25 0 003 7 197 7 175 100 31 0 04 3 Micro syringe 24 0 004 7 335 7 338 99 95 0 05 4 Micro syringe 24 0 002 7 411 7 420 99 88 0 03 5 Micro syringe 24 0 0...

Page 414: ... 7 419 99 99 0 08 5 pH Only Syringe 45 0 003 7 537 7 529 100 10 0 03 6 pH Only Syringe 36 0 002 7 601 7 608 99 92 0 03 1 pH Glu Lac Capillary 24 0 009 7 068 7 063 100 07 0 12 2 pH Glu Lac Capillary 24 0 005 7 237 7 228 100 11 0 07 3 pH Glu Lac Capillary 21 0 006 7 311 7 320 99 88 0 08 4 pH Glu Lac Capillary 24 0 004 7 433 7 427 100 09 0 05 5 pH Glu Lac Capillary 21 0 005 7 553 7 550 100 03 0 07 6 ...

Page 415: ...4 21 3 105 0 1 4 3 Capillary 21 0 39 28 7 28 4 101 1 1 3 4 Capillary 24 0 29 36 4 35 4 102 9 0 8 5 Capillary 21 0 54 49 8 49 9 99 9 1 1 6 Capillary 21 0 73 72 3 71 1 101 7 1 0 7 Capillary 24 1 49 102 4 99 1 103 4 1 5 8 Capillary 21 0 81 133 4 135 4 98 5 0 6 9 Capillary 24 2 95 227 9 226 4 100 7 1 3 1 Syringe 45 0 19 7 0 7 1 97 9 2 7 2 Syringe 45 0 94 22 6 21 4 105 2 4 2 3 Syringe 44 0 38 28 7 28 6...

Page 416: ... 3 48 133 2 135 1 98 6 2 6 9 Micro capillary 12 3 73 221 7 229 1 96 8 1 7 1 Micro syringe 24 0 21 6 8 7 1 96 8 3 1 2 Micro syringe 24 0 64 21 5 21 4 100 4 3 0 3 Micro syringe 24 0 45 28 3 28 6 99 1 1 6 4 Micro syringe 24 1 11 34 3 35 7 96 2 3 2 5 Micro syringe 24 0 96 47 6 49 5 96 3 2 0 6 Micro syringe 24 1 84 71 1 71 4 99 5 2 6 7 Micro syringe 24 4 35 95 6 99 8 95 7 4 6 8 Micro syringe 24 1 42 13...

Page 417: ...e 42 0 38 29 9 28 6 104 7 1 3 2 Syringe 45 0 77 49 9 49 9 100 1 1 5 3 Syringe 48 0 67 86 4 85 1 101 5 0 8 4 Syringe 45 0 47 104 8 106 9 98 0 0 4 5 Syringe 48 3 58 151 4 148 9 101 7 2 4 6 Syringe 44 1 29 200 2 200 1 100 1 0 6 7 Syringe 48 1 76 259 0 248 2 104 3 0 7 8 Syringe 45 1 35 381 9 378 7 100 8 0 4 9 Syringe 45 10 03 644 1 648 7 99 3 1 6 1 Micro capillary 12 0 40 27 8 28 4 97 6 1 4 2 Micro ca...

Page 418: ...sion Testing Na Level Mode N WRSD Observed Expected Recovery WRCV 1 Capillary 21 0 18 113 6 111 2 102 1 0 2 2 Capillary 21 0 19 129 6 129 4 100 1 0 1 3 Capillary 21 0 42 134 0 134 4 99 7 0 3 4 Capillary 21 0 84 142 1 141 5 100 4 0 6 5 Capillary 21 0 25 147 4 148 6 99 2 0 2 6 Capillary 21 1 06 175 3 179 8 97 5 0 6 1 Syringe 45 0 41 113 5 111 2 102 1 0 4 2 Syringe 45 0 40 129 0 129 4 99 6 0 3 3 Syri...

Page 419: ... 0 6 WRSD within run standard deviation Table E 58 Rapidlab 1265 Recovery and Precision Testing K Level Mode N WRSD Observed Expected Recovery WRCV 1 Capillary 24 0 043 1 10 1 18 92 8 3 9 2 Capillary 21 0 028 2 54 2 63 96 5 1 1 3 Capillary 21 0 046 4 16 4 12 101 0 1 1 4 Capillary 21 0 036 6 04 5 74 105 2 0 6 5 Capillary 24 0 120 7 99 7 99 100 0 1 5 6 Capillary 21 0 115 11 48 11 31 101 5 1 0 1 Syri...

Page 420: ...71 5 71 100 1 1 0 5 Micro syringe 24 0 134 8 22 8 05 102 1 1 6 6 Micro syringe 24 0 280 12 38 11 97 103 4 2 3 WRSD within run standard deviation Table E 59 Rapidlab 1265 Recovery and Precision Testing Cl Level Mode N WRSD Observed Expected Recovery WRCV 1 Capillary 21 0 38 72 73 99 2 0 5 2 Capillary 21 0 38 90 91 99 6 0 5 3 Capillary 21 0 38 97 98 99 3 0 3 4 Capillary 21 0 38 105 106 98 5 0 6 5 Ca...

Page 421: ...99 98 8 0 4 4 Micro syringe 24 0 78 106 106 99 9 0 7 5 Micro syringe 24 0 65 117 116 101 0 0 6 6 Micro syringe 24 1 63 145 144 101 1 1 1 WRSD within run standard deviation Table E 60 Rapidlab 1265 Recovery and Precision Testing Ca Level Mode N WRSD Observed Expected Recovery WRCV 1 Capillary 18 0 009 0 57 0 58 97 0 1 6 2 Capillary 21 0 015 1 26 1 26 100 2 1 2 3 Capillary 18 0 004 1 34 1 36 98 4 0 ...

Page 422: ...0 023 0 51 0 56 91 1 4 5 2 Micro syringe 24 0 012 1 26 1 24 101 4 1 0 3 Micro syringe 24 0 016 1 30 1 30 100 4 1 3 4 Micro syringe 24 0 026 2 00 1 98 101 1 1 3 5 Micro syringe 24 0 044 2 43 2 38 102 2 1 8 6 Micro syringe 24 0 121 4 20 3 98 105 7 2 9 WRSD within run standard deviation Table E 61 Rapidlab 1265 Recovery and Precision Testing Glucose Level Mode N WRSD Observed Expected Recovery WRCV 1...

Page 423: ...capillary 12 4 21 447 452 98 8 0 9 1 Micro syringe 24 1 76 48 48 101 0 3 7 2 Micro syringe 24 2 05 99 98 101 1 2 1 3 Micro syringe 24 1 87 226 222 102 1 0 8 4 Micro syringe 24 18 80 367 374 98 1 5 1 5 Micro syringe 24 8 40 456 452 100 9 1 8 1 pH Glu Lac Capillary 21 0 83 52 44 116 5 1 6 2 pH Glu Lac Capillary 24 1 80 98 93 106 3 1 8 3 pH Glu Lac Capillary 24 2 60 203 205 99 4 1 3 4 pH Glu Lac Capi...

Page 424: ...1 6 102 9 3 5 2 Capillary 21 0 04 2 1 2 2 95 4 2 1 3 Capillary 18 0 10 5 1 5 2 96 3 1 9 4 Capillary 21 0 12 9 6 11 0 87 4 1 2 5 Capillary 18 0 17 12 7 14 4 88 1 1 3 1 Syringe 39 0 04 1 2 1 3 96 2 3 5 2 Syringe 42 0 05 2 3 2 2 101 5 2 1 3 Syringe 38 0 10 5 5 5 6 98 4 1 8 4 Syringe 45 0 15 9 9 10 9 90 8 1 5 5 Syringe 36 0 26 13 4 14 4 92 9 1 9 1 Micro capillary 12 0 05 1 1 1 0 104 4 4 7 2 Micro capi...

Page 425: ...1 0 07 2 8 2 8 98 5 2 6 3 pH Glu Lac Capillary 15 0 06 4 9 5 3 92 9 1 3 4 pH Glu Lac Capillary 21 0 13 10 5 12 1 86 4 1 2 5 pH Glu Lac Capillary 15 0 25 14 2 17 4 81 5 1 7 1 pH Glu Lac Syringe 41 0 03 0 9 0 8 106 5 3 1 2 pH Glu Lac Syringe 45 0 08 2 5 2 7 93 5 3 2 3 pH Glu Lac Syringe 45 0 11 5 5 6 0 91 4 1 9 4 pH Glu Lac Syringe 42 0 33 10 8 12 5 86 9 3 1 5 pH Glu Lac Syringe 45 0 34 14 8 17 9 82...

Page 426: ...b 1265 CO ox module recovery and precision testing Table E 63 Rapidlab 1265 CO ox Module Recovery and Precision with Total Hemoglobin of 6 g dL and Oxyhemoglobin 75 Analyte Mode tHb mode performance is equivalent to sample device used n Mean Reference Mean Bias WRSD WRSD within run standard deviation tHb Capillary 61 6 20 0 29 0 08 tHb tHb 55 6 19 0 29 0 15 tHb Syringe 58 6 16 0 23 0 05 FO2Hb Capi...

Page 427: ...eviation Table E 65 Rapidlab 1265 CO ox Module Recovery and Precision with Total Hemoglobin of 20 g dL and Oxyhemoglobin 75 Analyte Mode n Mean Reference Mean Bias WRSD tHb Capillary 65 20 11 0 25 0 14 tHb tHb 53 20 11 0 08 0 11 tHb Syringe 62 20 27 0 06 0 10 FO2Hb Capillary 65 85 19 1 04 0 21 FO2Hb tHb 54 86 59 1 43 0 29 FO2Hb Syringe 62 84 89 1 17 0 26 FCOHb Capillary 65 5 13 0 90 0 14 FCOHb tHb...

Page 428: ...b Syringe 62 4 53 0 52 0 22 tHb mode performance is equivalent to sample device used WRSD within run standard deviation Table E 66 Rapidlab 1265 Human Whole Blood Method Comparison pH Mode N Slope Intercept RMSE r2 Min Max Capillary 117 0 996 0 036 0 006 0 999 7 052 7 691 Syringe 259 1 005 0 030 0 009 0 998 7 010 7 696 Micro capillary 71 0 986 0 104 0 006 0 999 7 020 7 643 Micro syringe 145 0 991 ...

Page 429: ...107 6 180 2 Syringe 387 1 003 0 417 1 528 0 995 105 4 182 8 Micro capillary 137 1 006 0 603 1 532 0 995 108 1 189 5 Micro syringe 209 1 021 2 613 1 521 0 995 104 2 187 5 Table E 70 Rapidlab 1265 Human Whole Blood Method Comparison K Mode N Slope Intercept RMSE r2 Min Max Capillary 215 0 987 0 082 0 183 0 997 1 35 12 27 Syringe 431 1 021 0 084 0 179 0 997 1 02 12 27 Micro capillary 143 1 007 0 005 ...

Page 430: ... 15 91 25 41 0 987 47 806 Syringe 387 0 899 19 57 31 62 0 981 45 774 Micro capillary 138 0 879 12 881 23 914 0 987 43 693 Micro syringe 214 0 874 16 078 29 439 0 979 43 736 pH Glu Lac Capillary 114 0 922 13 641 9 440 0 997 48 520 pH Glu Lac Syringe 235 0 926 13 831 8 804 0 997 43 530 Table E 74 Rapidlab 1265 Human Whole Blood Method Comparison Lactate Mode N Slope Intercept RMSE r2 Min Max Capilla...

Page 431: ...37 0 996 Table E 77 Rapidlab 1265 Human Whole Blood Method Comparison FCOHb Mode N Slope Intercept RMSE r2 tHb 193 0 978 0 078 1 095 0 999 Capillary 208 0 994 0 130 0 921 0 999 Syringe 205 0 990 0 094 0 997 0 998 Table E 78 Rapidlab 1265 Human Whole Blood Method Comparison FMetHb Mode N Slope Intercept RMSE r2 tHb 208 0 981 0 029 1 019 0 999 Capillary 212 1 025 0 015 0 914 0 999 Syringe 205 0 978 ...

Page 432: ...d Cl Coulometric reference method Ca Internal ISE method used Glucose The hexokinase glucose 6 phosphate dehydrogenase method described in CLSI document RS1 A 4 Lactate Internal method using lactate oxidase assay tHb Cyanmethemoglobin Reference Method per Clinical and Laboratory Standards Institute CLSI approved reference procedure5 using a spectrophotometer FO2Hb Tonometry where whole blood sampl...

Page 433: ...000 Analyte Traceability pH Traceable to NIST SRM 186 reference material via the IFCC reference method 1 pCO2 and pO2 Traceable to tonometered aqueous standards prepared using NIST traceable temperature and pressure standards and gravimetrically prepared precision gas standards Na and K Traceable to NIST SRM 919 or 918 reference materials using flame photometry3 or atomic absorption Cl Traceable t...

Page 434: ... DK Carbon Monoxide in Blood an Improved Microliter Blood Sample Collection System with Rapid Analysis by Gas Chromatography Clin Chem 30 1984 1382 1386 7 Evelyn KA and Malloy HT Microdetermination of Oxihemoglobin Methemoglobin and Sulfhemoglobin in a Single Sample of Blood J Biol Chem 1938 126 655 662 ...

Page 435: ...cal hazards indicates that the input electricity is alternating current indicates important information about the fuses indicates that the main power supply is on indicates that the main power supply is off Class 1 indicates that the system is Class 1 type equipment having basic insulation and additional safety grounding precautions indicates a caution or warning Refer to Section 1 Using This Guid...

Page 436: ...you should avoid looking directly into the light beam of the laser to prevent possible exposure to hazardous light indicates you should consult instructions for use indicates a temperature limitation as in store between 2 8 C indicates the system contains sufficient for n tests 250 tests indicates a use by date catalog number serial number batch code manufacturer Authorized Representative in the E...

Page 437: ...ates to the cathode CO ox Pump test moves the CO ox pump at various speeds Performing the CO ox Pump Test page 6 42 Only on the Rapidlab 1245 and 1265 systems Eject AQC Cartridge ejects the AutomaticQC cartridge Ejecting the AutomaticQC Cartridge page 6 43 Eject R Cartridge ejects the reagent cartridge Ejecting the Wash or Reagent Cartridge page 6 43 Eject W Cartridge ejects the wash cartridge Eje...

Page 438: ...40 Sample Chamber verifies the proper operation of the CO ox sample chamber and prints the results Performing the CO ox Pump Test page 6 42 Only on the Rapidlab 1245 and 1265 systems Sample Pump moves the sample pump at various speeds Performing the Sample Pump and Wash Pump Tests page 6 39 Sensors outputs the raw sensor signals in mV or nA For Field Service use only Temperature test prints the te...

Page 439: ...ord your maintenance activities according to the maintenance protocol of your institution Month Year System ID Daily Maintenance Twice Weekly Maintenance Weekly Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Check System Status Clean the Exterior Surfaces Week 1 Week 2 Week 3 Week 4 Analyze High G L Week 1 Week 2 Week 3 Week 4 Deproteinize the Sampl...

Page 440: ...Sample Chamber Check the Air Filters 3 Months 6 Months 9 Months 12 Months Replace the Pinch Valve Tubing Replace the Measurement Module Tubing Replace the CO ox Module Tubing Replace the Reagent Manifold Replace the AutomaticQC Manifold Replace the Air Filters Replace the Measurement Module Tubing Replace the CO ox Module Tubing Replace the Reagent Manifold Replace the AutomaticQC Manifold Replace...

Page 441: ...tup options 8 3 8 5 automaticQC cartridge capacity 1 4 1 5 contents of levels 1 4 eject cartridge 6 43 automaticQC manifold replacing 5 19 automaticQC ranges retaining 8 6 automaticQC samples 4 3 a v extraction index description 1 62 a v study description 1 61 report 2 37 B bar code problems 6 8 scanning patient ID 2 23 bar code scanner bar code symbologies 8 24 connecting the bar code scanner 8 2...

Page 442: ...ew 6 47 qualifiers 6 47 daily maintenance 5 2 data entry early demographics 2 24 date changing 8 20 changing the century for date of birth 8 10 changing the date format 8 20 date of birth changing the century 8 10 default 8 11 default custom panel 8 11 defining custom panels 8 11 demographics allowing editing of demographics 8 39 demographics needed to determine results 8 17 editing 2 25 entering ...

Page 443: ...ng data 2 34 7 2 copying stored results 7 2 installing software 8 42 viewing number of samples analyzed 7 4 measurement cartridge reagents 1 9 measurement module components 1 16 1 17 measurement module pinch valve test 6 41 measurement module tubing replacing 5 12 measurement sensors checking fill solution 5 8 replacing fill solutions 5 32 5 40 replacing sensor 5 29 measurement technology CO ox mo...

Page 444: ...rements 2 7 defining patient ranges 8 7 handling techniques for whole blood 2 9 sample devices 2 7 2 8 sample volume 2 7 selecting the sample type in setup 8 13 patient search 2 28 patient temperature correction description 1 55 pCO2 measuring 1 35 sensor 1 37 performance 1240 data E 11 1245 data E 18 1260 data E 30 1265 data E 49 limitations E 5 performing sensor and electrode maintenance 5 34 pH...

Page 445: ...artridge 2 4 relocating the system 5 49 remote viewing enabling 8 32 setup 8 32 using buttons in banner 8 34 remote viewing status in banner 1 20 removing obstructions CO ox sample path 6 31 sample path 6 24 replacing air filters 5 20 automaticQC cartridge 2 3 automaticQC manifold 5 19 CO ox lamp 5 43 CO ox module tubing 5 13 CO ox roller cage 5 45 CO ox sample chamber 5 9 measurement module tubin...

Page 446: ... code scanner 8 26 calibration message 8 41 correlation coefficients 8 44 date 8 20 date format 8 20 demographics 8 9 demographics editing 8 39 language 8 20 notify password expiration pending 8 38 operator IDs and passwords 8 37 parameter selection 8 10 patient ranges 8 7 QC automaticQC analysis options 8 3 8 5 rapid sample identification 8 9 sample type 8 13 save and restore system setup data 8 ...

Page 447: ...ng bar code problems 6 8 communication problems 6 12 failed calibrations 6 4 failed QC 6 1 missed QC 6 1 patient results 6 6 printer problems 6 11 system messages 6 74 touch screen problems 6 11 unavailable buttons 6 7 twice weekly maintenance 5 3 U unscheduled QC samples 4 4 V viewing number of samples analyzed 7 4 volume adjusting for system and video sound 8 21 W warranty B 1 wash cartridge rep...

Page 448: ...I 8 Rapidlab 1200 Operator s Guide Index 02087462 Rev V ...

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Siemens Rapidlab 1200, Operator'S Manual, Page: 10 / 448

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