Operators Manual
699 Pages
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2000 Bayer Corporation. All rights reserved. 115701 Rev C., 4/2000
No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Bayer Corporation. The Rapidlab 800 system is for In Vitro Diagnostics Use. Certain and Ready Sensors are trademarks of Bayer Corporation. APV is a servicemark of Bayer Corporation. Cidex is a trademark of Johnson & Johnson Corporation. IBM and AT are trademarks of International Business Machines Corporation.
The information in this manual was correct at the time of printing. However, Bayer Diagnostics continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice.
This manual is to be used with the Bayer Diagnostics 840, 844, 845, 850, 854, 855, 860, 864, and 865 systems. The manual provides the information and procedures necessary to operate and maintain any of the 800 series systems. The Bayer Diagnostics 800 system document set includes the following: Rapidlab 800 Operator’s Manual Rapidlab 800 Quick Reference Guide Rapidlab 800 Interface Specification Manual These documents are designed to meet the needs of: medical technologists and laboratory technicians who use an 800 system on a daily basis, and who perform routine maintenance and troubleshooting respiratory therapists who use an 800 system to routinely analyze blood gas samples supervisors who customize their 800 system to meet their laboratory requirements Refer to the table below to identify the appropriate document for the task you want to perform.
customize an 800 system to meet the requirements of your laboratory
Rapidlab 800 Operator’s Manual
perform daily operating procedures
Rapidlab 800 Operator’s Manual
review the 800 system components and principles of operation
Rapidlab 800 Operator’s Manual
perform routine maintenance and troubleshooting
Rapidlab 800 Operator’s Manual
review procedures for routine maintenance and troubleshooting
Rapidlab 800 Quick Reference Guide
Use this section to identify the sections in this manual that describe the 800 system and the tasks associated with operating and maintaining the system.
review system features and capabilities and the theory and principles of operation
Section 1, Learning About the System
identify 800 series system components, including the user interface
Section 1, Learning About the System
review sample requirements and reagent information
Section 1, Learning About the System
analyze samples, QC, and calibrators
Section 2, Operating the System
perform system maintenance
Section 3, Maintaining the System
identify the appropriate corrective action to resolve operating problems
Section 4, Troubleshooting the System
customize an 800 series system to meet your laboratory’s requirements
Section 5, System Administration
back up and archive data files
Section 5, System Administration
install a new version of the software
Section 5, System Administration
shut down the system
Section 5, System Administration
review important information about biohazardous conditions
Appendix A, Protecting Yourself from Biohazards
obtain service and technical information and order supplies
Appendix B, Service and Supplies
Appendix C, References
interface external devices, such as a CO-oximeter or a laboratory information system
Appendix D, Connecting to External Devices
review system performance characteristics
Appendix E, Performance Characteristics
Appendix F, Printed Reports
install the system
Appendix H, Installation
review the analytic principles of the sensors and the calculations performed by the system
Appendix I, Operating Principles
review the technical bulletin about water quality
Appendix J, Water Quality Technical Bulletin
record scheduled maintenance procedures and workload statistics
Appendix K, Maintenance Checklist Charts
review key terms describing the 800 system and its operation
Glossary
change the slope and offset values to provide correlation with other analyzers
Appendix G, Correlation Adjustment
The Operator’s Manual uses the following text and symbol conventions throughout the document.
Bold
Bold type indicates a key option that appears on the keypad, or the screen. For example, if the word ‘enter’ appears as , it refers to the key you press to store a value or accept an option.
italic
Italic type refers to a document in the 800 series document set or to a section title within a document. For example, Maintaining the System refers to Section 3 of this manual.
Warning statements provide information about a condition that may cause personal injury.
Caution statements provide information about a condition that may cause product damage or loss of data. Biohazard statements alert you to potentially biohazardous conditions. The note symbol is used with important information that requires your attention.
This symbol indicates that the information or procedure applies to an 840, 844, and an 845 systems.
This symbol indicates that the information or procedure applies to an 850, 854, and an 855 systems.
This symbol indicates that the information or procedure applies to an 860, 864, and an 865 systems.
This is the abbreviation used for systems with a CO-oximeter module attached.
Procedural notes appear after many of the procedures in the Rapidlab 800 Operator’s Manual. They explain conditions that can happen when a procedure is not performed as intended. They also contain brief explanations about how to handle an unexpected situation or how to discontinue a process.
This section describes the symbols that may appear on the exterior of the system. The symbols provide you with the location of certain components and with warnings for proper operation.
ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ ÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁÁ
This symbol warns you of a possible burn hazard for the lamp. Wait at least 5 minutes after the lamp has been off to allow sufficient time for it to cool. This symbol indicates where you insert the sample device (syringe, capillary, or ampule) to perform analysis. This symbol cautions you about the risk of exposure to biohazards.
This symbol cautions you about the risk of exposure to potential electrical hazards. This symbol indicates that the input electricity is alternating current. This symbol alerts you to important information about the fuses.
This symbol identifies that the system is type B equipment, which provides a particular degree of protection against electric shock.
This symbol indicates that the system is class 1 type equipment, which has basic insulation and additional safety grounding precautions. This symbol indicates that the system is approved by UL as meeting U.S. requirements for safety. This symbol indicates that the system meets the requirements of the European Union.
This symbol indicates that the system is approved by CSA as meeting the U.S. and Canadian requirements for safety.
The Rapidlab 800 Operator’s Manual accompanies the 800 series systems- base models 840, 850, 860-and base models with the oximetry module- models 844, 854, 864- and base models with the CO-ox module- models 845, 855, 865. These systems are used for the determination of pO2, pCO2, pH, sodium (Na+), potassium (K+), ionized calcium (Ca++), chloride (Cl–), glucose, lactate, tHb, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
840
pO2, pCO2, pH
850
pO2, pCO2, pH, Na+, K+, Ca++, Cl–
860
pO2, pCO2, glucose, lactate, pH, Na+, K+, Ca++, Cl–
844
pO2, pCO2, pH, tHb, FO2Hb
854
pO2, pCO2, pH, Na+, K+, Ca++, Cl–, tHb, FO2Hb
864
pO2, pCO2, glucose, lactate, pH, Na+, K+, Ca++, Cl–, tHb, FO2Hb
845
pO2, pCO2, pH, tHb, FO2Hb, FHHb, FMetHb, FCOHb
855
pO2, pCO2, pH, Na+, K+, Ca++, Cl–, tHb, FO2Hb, FHHb, FMetHb, FCOHb
865
pO2, pCO2, glucose, lactate, pH, Na+, K+, Ca++, Cl–, tHb, FO2Hb, FHHb, FMetHb, FCOHb
The 800 systems also report results for the following parameters: actual and standard bicarbonate (HCO3–) total carbon dioxide (ctCO2) base excess of blood [BE(B)] and of extracellular fluid [BE(ecf)] estimated oxygen saturation (O2SAT) – for 840, 850 and 860 models estimated oxygen content (O2CT) – for 840, 850 and 860 models temperature corrected pH [pH(T)] temperature corrected pCO2 [pCO2(T)] temperature corrected pO2 [pO2(T)] temperature corrected alveolar-arterial oxygen tension difference [pO2(A–a)(T)] temperature corrected arterial-alveolar oxygen tension ratio [pO2(a/A)(T)] temperature corrected respiratory index [RI(T)]
The 850 and 860 systems report the following parameters: calcium ion concentration adjusted to pH 7.4 [Ca++ (7.4)] anion gap (AnGap) In addition, the 844, 845, 854, 855, 864, and 865 systems report the following parameters: hematocrit hemoglobin oxygen saturation (sO2) oxygen content of hemoglobin [ctO2(Hb)] oxygen capacity of hemoglobin (O2CAP) partial pressure of oxygen at 50% saturation (p50) sulfhemoglobin concentrations greater than 1.5% arterial oxygen content [ctO2(a)] venous oxygen content [ctO2(v)] estimated shunt [Qsp/Qt(est,T)] The 844, 845, 854, 855, 864, and 865 systems report the following parameters for a-v studies: arterial venous oxygen content difference [ctO2(a-v)] a-v extraction index [ctO2([a-v]/a)] oxygen consumption rate (VO2) oxygen delivery (DO2) physiologic shunt [Qsp/Qt(T)]
The 800 system offers advanced features for analyzing samples, managing patient results and QC data, and customizing the system. These features are designed to enhance operator safety, to enhance ease of use, to enhance reliability, and to reduce maintenance.
analyzing samples
fully automated sampler that controls sample delivery with a technique-independent sample entry automated sample entry that minimizes exposure to the sample probe and to biohazardous sample aerosols and spills easy analysis of sample types and devices with small sample size illuminated sample path in the base model measurement module for visibility during analysis easy-to-use, menu-driven software and on-screen prompts online assistance using an integrated Help program optional bar coding capabilities for patient ID and accession numbers
managing patient results and QC data
flags for results that fall outside expected ranges optional laser bar code scanner to streamline data entry QC analysis with range checking, statistical summary reports, and Levey-Jennings charts for up to 12 control materials all measured parameters for one month’s QC data displayed on the screen capacity to store up to 5000 patient sample reports onboard roll printer with paper take-up spool variety of patient report formats on roll printer and optional line printer
customizing the user-definable features
system software that you can customize to meet your laboratory requirements automatic calibration at intervals that you select QC ranges, patient reference ranges, patient sample storage and printing options that you can customize
maintenance and troubleshooting
low maintenance Ready Sensors reduced number of system parts and system complexity waste system designed for biosafety automatic, reagent-path cleaning cycle
expanding system capabilities
advanced on-board data management bidirectional communication with your information systems and Chiron Diagnostics data management systems combined results with an optional CO-ox full-page reports (8.5 x 11 inches) with an optional line printer archive and backup capabilities
The following series of illustrations show the exterior controls and components of the 800 system. The 860, 864, and 865 systems have five reagent bottles, and the 840, 844, 845, 850, 854, and 855 systems have four reagent bottles.
Screen
Keypad Printer
Measurement Module Window Analyze Key Sample Entry
Front Cover
Reagent Bottles
Waste Bottle
Sample Pump
Screen
Keypad Sample Pump
Reagent Pump
Waste Pump Measurement Module Door Latch Measurement Module Analyze Key Sample Entry
Reagent Manifold
Reagent Bottles
Measurement Module Door Latch
Gas Tubing
Waste Bottle
CO-ox Pump
Sample Chamber
Hemolyzer
CO-ox Module
Diskette Eject Button Diskette Drive
Air Filter Cover
Fuse Compartment
Power Input
Contrast Knob
Lamp Cover
Paper Spool
Air Filter Cover
Base Model Interface Bar Code Scanner Port Serial Port 1 Serial Port 2 Serial Port 3
Network Port Parallel Port
Keyboard Port
Contrast Knob
Screen
F-keys
?
F1
F2
F3
F4
F5
Enter
1
2
3
4
5
6
.
7
8
9
0
Printer
Help Home
CIBA-CORNING
Enter Key
Help Key
Arrow Keys Home Key
–
Paper Spool Key Paper Advance Key Numeric Keys
The 800 system components consist of the following functional groups: base model measurement module CO-ox model measurement module fluidic components electronic components
The following illustrations show the measurement module components. Table 1-1 describes these components and their functions.
Preheater
The preheater warms the sample to 37°C.
Sensors
The sensors detect analytes present in the sample and form the actual sample path. The sample leaves the sample path through the measurement module tubing after analysis. Refer to Appendix I, Operating Principles, for more information about each sensor.
Sample Ground/ Temperature Sensor
The sample ground/temperature sensor provides an electrical grounding mechanism for stable sensor readings and also measures the sample temperature.
Measurement Block
The temperature-controlled measurement block contains the sensors and ensures a constant temperature of 37°C during analysis.
Spring-loaded Latch
The spring-loaded latch keeps the sensors aligned in the measurement block. The latch locks open for easy removal of the sensors. The release tab on the latch releases the latch to close it.
Contact Assembly
The contact assembly provides electrical contacts between the sensors and the system.
Measurement Module Door Latch Measurement Module Door Measurement Module Door Latch Release Pin Measurement Block Preheater Contact Assembly pO2 Sensor Spacer
pCO2 Sensor Sample Ground/ Temperature Sensor pH Sensor
Measurement Module Tubing
Release Tab
Reference Sensor
Spring-Loaded Latch
Measurement Block Preheater
Contact Assembly
pO2 Sensor pCO2 Sensor Sample Ground/ Temperature Sensor pH Sensor K+ Sensor
Measurement Module Tubing
Na+ Sensor Cl – Sensor Ca++ Sensor
Release Tab Reference Sensor Spring-loaded Latch
Measurement Block Preheater
pO2 Sensor pCO2 Sensor Sample Ground/ Temperature Sensor
Contact Assembly
Glucose Sensor Lactate Sensor pH Sensor K+ Sensor
Measurement Module Tubing Na+ Sensor Cl – Sensor Ca++ Sensor
Release Tab Reference Sensor
Spring-Loaded Latch
The CO-ox module is connected to the base model, which supplies power to the module. The 844, 854, and 864 systems analyze samples for tHb and FO2Hb; the 845, 855, and 865 systems anlayze samples for tHb, FO2Hb, FHHb, FMetHb, and FCOHb. The measurement components spectrophotometrically measure tHb and its derivatives. Most of the measurement components are enclosed in the CO-ox module. The sample chamber is visible when the CO-ox cover is raised.
The lamp provides the light to illuminate the sample. The optics module includes lenses and filters, fiber optic coupler, and polychromator. The lenses and filters focus the light from the lamp to the fiber optic coupler. The fiber optic coupler transports the light to the sample chamber. The polychromator, which consists of coupling lenses, entrance slit, mirrors, and diode array, disperses the light that passes through the sample chamber into a spectrum and measures the light intensity at several wavelengths.