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.
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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
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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.
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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
Printer
Help
Home
Enter
CIBA-CORNING
2
3
4
5
6
.
7
8
9
0
Enter Key
Help Key
Arrow Keys
Home Key
–
1
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
Glucose Sensor
Lactate Sensor
pH Sensor
K+ Sensor
Contact Assembly
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.
The hemoglobin content is measured in the sample chamber, which is located
between the fiber optics and the polychromator. After passing through the
hemolyzer, the sample moves to the sample chamber where it is warmed to 37°C.
The fluidic components move fluids, gases, and samples through the
800 system. The electronic components direct the fluidic components in response
to the user interface and automatic system activities. The CO-ox module uses the
fluidic components of the base model and additional components.
The sample entry components, shown in the illustration below, include the sample
port and its components, the sample door, the sample probe, and the sample tubing.
You introduce samples into the system through these components.
Sample Tubing
Retainer Ring
Sample Probe
Mount
Sample Probe
Capillary
Seal
Sample Door
Drip Tray
Sample Port
The reagent delivery components include the reagents, the gases, and the solenoid
valves that direct the movement of reagents, ambient air, and gases through the
system. The opening and closing of the 11 solenoid valves allow the fluids and
gases to pass through the system. The solenoid valves are located in the reagent
manifold. The illustration below shows the reagent delivery components for 860,
864, and 865 systems.
Gas Fittings
Reagent Manifold
Reagents
Gas Tubing
The system pumps are the reagent pump, the sample pump, the waste pump, and
the CO-ox pump if the CO-ox module is attached. Each pump consists of a platen,
tubing, a roller cage, and a motor located behind the pump. The tubing is located
between the platens and the rollers on the roller cage. The pressure applied by the
roller cage against the platen creates a peristaltic action to move the fluid in the
tubing.
Platen
Roller Cage
Pump Tubing
Roller Cage
Reagent
Pump
Platen
Roller Cage
Pump Tubing
Tubing Cuff
Sample
Pump
Pump Tubing
Waste Pump
The five fluid detectors in the base model sense the presence, type,
and continuity of fluids in the system. Fluid detectors 1, 1A, and 2 are associated
with the measurement block. These detectors ensure that the sample is positioned
correctly for accurate measurement. Detectors 3 and 4, located in the reagent
manifold, sense the presence of the reagents in the system. The CO-ox module
adds fluid detector 5 to the system. This detector and the CO-ox sample chamber
sense the presence of a sample in the CO-ox module.
The waste components include the waste bottle and latch, the waste outlets, the
waste outlet cover, and the waste detector. The waste components accept waste
reagents and sample pumped from the fluidic components. The waste detector
detects the presence of the waste bottle and also detects when the bottle is full.
Gas Fitting Cover
Waste Outlets
Waste Outlet Cover
Waste Bottle Latch
Waste Detector
Waste Bottle
The sample connector, located in the measurement module of the base model,
connects the sample tubing in the base model with the sample tubing in the CO-ox
module.
The hemolyzer uses ultrasonic sound vibrations to rupture red blood cell
membranes and release hemoglobin molecules. These vibrations also rupture other
cells in the sample, reducing the light scattering from whole cells that can interfere
with hemoglobin analysis in the sample chamber. All CO-ox module samples pass
through the hemolyzer before entering the sample chamber.
The electronic components direct the operation of all system components. The
electronic components communicate with fluidic, measurement, and CO-ox
module components, and with external devices. The electronic components obtain
information from the sensors and perform all calculations required to determine
reported parameters. Table 1-2 describes these components and their functions.
Power Supply
Converts the line voltage from AC to DC and then
provides power to the rest of the system
Real Time
Processor (RTP)
Sends commands to other PC boards to perform system
activities; the RTP controls the fluidic system, acquires
data from the measurement module, calculates parameters,
and communicates with the user-interface processor
User-Interface Processor
(UIP)
Controls user interaction with the screen, the bar code
scanner, the printer, the database, and the external
communication ports
Backplane
Distributes power to each of the attached PC boards; the
backplane connectors route signals to electronic and
electromechanical subsystems
Control Board
Contains all of the drivers to control the fluidic system
valves and pumps, the preheater, and the sample port
Data Acquisition System
Board (DAS)
Performs the analog to digital conversion for a selected
measurement channel; after the conversion, the data is sent
to the RTP PC board for any required calculations
Printer Control
Receives information from the UIP and directs the roll
printer to print reports
Preamplifier (Preamp)
Amplifies the signal from each sensor and sends those
signals to the premux PC board for selection
Premultiplexer (Premux)
Selects the channel to be read and provides programmable
gain; the premux board then sends the signal to the DAS
PC board.
CO-ox Array Board
(CAB)
Produces current proportional to the amount of energy
generated by the optics and provides a coarse alignment of
the diode array with the polychromator
CO-ox Measurement
Board (CMB)
Provides control signals to and collects and limits the
signals from the array board; this board also detects fluid
in the sample chamber and supplies reference values for
the measurement
CO-ox Processor Board
(CPB)
Interfaces to the power supply and the drivers to control
the pump and heater in the CO-ox module; this board
communicates with other boards in the CO-ox module and
base model
The user interface, shown in Figure 1-10, consists of components that you use to
direct system activities and obtain operating status information.
Contrast Knob
Screen
F-keys
?
F1
F2
F3
F4
F5
Printer
Help
Home
Enter
CIBA-CORNING
2
3
4
5
6
.
7
8
9
0
Enter Key
Help Key
Arrow Keys
Home Key
–
1
Paper Spool Key
Paper Advance Key
Numeric Keys
You use the system keys to direct system activities and to move through the
software. The 800 system has the following keys:
Analyze
Analyze
arrows
Help
starts analysis
move the cursor in the direction of the
selected arrow
Enter
?
accepts selected options and moves from
field to field; on the Ready screen it
displays the Reagent Levels screen
accesses the Help screen
Help
Home
numeric
paper
advance
Home
1
accesses the Ready screen; use this key to
return to the Ready screen from any other
screen
types data into text fields
advances the paper on the
roll printer
paper
spool
winds the paper on the paper spool
F-keys
F1
accesses the function that appears in the
F-key labels on the screen above each
key; the labels can vary with each screen
You can use an IBM AT compatible, 101-key, alpha-numeric keyboard to
operate an 800 system. Use the following keys on the keyboard to simulate the
system keys on the 800 system keypad:
Analyze
F8
Roll Printer Paper
Advance
F7
Help
F9
Home
Home
Enter
Enter
F1, F2, F3, F4, F5
F1, F2, F3, F4, F5
Arrow keys
Arrow keys
You use F-keys to access functions that appear on the screen above each key. The
F-key labels can vary with each screen. The following keys are some of the more
commonly used F-keys.
Previous Screen
return to the frame or screen from which you accessed the current
screen.
More Results
display a screen that contains additional results. This key appears
only when another results screen is available.
Send
transmit sample results to a connected LIS, HIS, or data
management system. This key appears on the Results screen only if
Auto Send is off.
Do Not Send
prevent the transmission of sample results to a connected
LIS, HIS, or data management system. This key appears on the
Results screen only if Auto Send is off.
Cancel
stop a current sample analysis or calibration. Cancel also appears in
some message boxes and lets you close the message box without
taking any action.
Change
Parameters
select panels to use for sample analysis.
Change Sample
Type
select a type of sample to use for sample analysis.
Calibrate
select a calibration to initiate.
! #"
Screen elements are the components on the screen that enable you to interact with
the system software.
! '# ## "!" #
$!!# "("# "##$"
#%#( ! "!
##
# !
! ## #" #
## ($ "#
! "#
"# #" ##
! #
!
"! "
(" ##
# # $!!#
"##$" #
""!"
!
! ## #" #
!'# # $# !"" " #
"" '
! ## %"
!# ! ! $!"
($ # !! #
# $##
$## '# # # ")
# "# $## !" !
& ($ "# #
$!"!
#% ! # "!
!
' ## #" "
#" ! """
'# & ($
#( #'#
'
' '# # # $#) #
"# ' !" !
& ($ "# #
Sensor icons appear in the status area of the screen. Each sensor is represented by a
box containing the sensor label. The CO-ox module is represented by the tHb icon
in the sensor bar. The sensor icons indicate the current status of each sensor
installed on the system.
a green box with
black text
turned on and in calibration.
a yellow box with
black text and a slash
across the label
turned on but out of calibration.
not visible
turned off or not installed.
The Analyze mode is the operating mode where you perform the most frequently
required functions. When the system is ready to analyze samples, the Ready screen
appears with the Begin Sample Analysis message box. The F-key labels shown
below appear at the bottom of the Ready screen.
The Menu mode lets you perform infrequently required functions. You access the
Menu mode by pressing Menu. The system displays the Menu screen with the first
option in the Main Menu highlighted.
Use the arrow keys to move up and down a menu to highlight the option you want.
As you highlight an option in the Main Menu, another menu appears to the right.
This menu lets you preview the options available on the next menu. The preview
menu helps you locate the next menu option
you want.
You move to the next menu by pressing the right arrow key or by pressing Enter.
Again use the arrow keys to select the menu option you want. If dots (. . .) appear
after the option, another menu exists for that option. If no dots appear after the
option, the screen associated with the option appears when you press Enter. The
following screen shows three levels of menus on the Menu screen:
The system automatically returns to the Ready screen if you do not press a key for
at least 5 minutes. If you are using a troubleshooting menu option, the period of
time before the system returns to the Ready screen extends to 30 minutes. The
system does not automatically return to the ready screen when you access
maintenance options.
Figure 1-11 shows a map identifying all the menu options available in the Menu
mode. Menu options that are not available appear in lighter text on the screen.
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Use menu codes to quickly select menu options from the Main Menu on the Menu
screen. To use menu codes, you press the numeric key for the menu option instead
of using arrow keys and pressing Enter.
NOTE: For menu codes to work properly, begin only when the cursor is in the
Main Menu.
Menu codes appear in the left margin, opposite procedures that require you to
select menu options. The following example, which describes the steps to stop the
system, shows how menu codes appear in the manual:
1. Stop the system from the Main menu:
a. Select and press .
b. Select and press .
For this example, at the Main Menu you press and then on the numeric keypad
you press to use menu codes.
NOTE: During some procedures, you may need to move to the Main Menu before
you can press the menu code. The menu code for these procedures contains the
phrase to remind you to move to the Main Menu before
pressing the menu code.
The system displays a clock icon to let you know the system is busy executing the
last given command. For example, the clock icon may appear when the system
searches the database to recall patient data from the search criteria screen. Once the
patient records appear on the screen, the clock icon disappears from view.
The system emits three types of beeps:
short beep when you press the wrong key or type too many characters in a field
long beep when the system detects a system error
recurring short beeps when the system requires user action
Use the Help program to get information about your 800 system. You can access
Help when the system is inactive or when the system is performing an operation,
such as an analysis, a wash, or a calibration. When you access help during an
operation, the Help screen appears and the operation continues in the background.
In the Analyze mode, press Help to access Help for the screen you are viewing.
Analyze mode Help presents a general list of topics that are specifically related to
the screen from where you press Help.
In the Menu mode, press Help to display a scroll list of Menu mode topics. Menu
mode Help consists of an index of topics. Each topic describes a menu or menu
selection. The topics do not vary from screen to screen.
The Help screens have two sides. The left side contains a scroll list of topics. You
use the up and down arrow keys to select a topic. When you select a topic and
press Enter, the right side displays information relating to the topic you choose.
You can press Exit Help to leave Help and return to the screen from
which you accessed Help. If you press Help from the Analyze mode
screen when the system is busy, you return to the current screen for
the activity in progress.
This section describes sample requirements, collection procedures, and handling
techniques for pH, blood gas, and electrolyte analysis. For a detailed review of
sample requirements, refer to NCCLS Document C27–A, Blood Gas Preanalytical
Considerations: Specimen Collection, Calibration, and Controls.1
Since blood gases are typically the most sensitive of the parameters measured by
the 800 system, the requirements and procedures described in this section are
based on techniques appropriate to pH and blood gas analysis. The sample
collection and handling guidelines described in this section are also suitable for
electrolyte analysis.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Perform blood sample collection under proper medical supervision when selecting
a site and performing the procedure. Ensure that the appropriate sample handling
documents are in place.
Use sterile technique at all times to avoid infecting the sample site.
The following indicate some of the procedural limitations encountered with blood
gas analysis:
Some auto-venting syringes contain sodium carboxymethylcellulose (CMC), a
substance within the porous venting mechanism. CMC can dissolve into the
sample, causing optical errors during CO-ox measurement. Optical errors may
lower reported tHb and O2Hb levels and elevate reported COHb. The
recommended syringe is Bayer Diagnostics arterial sampling device because it
uses a patented, non-exposed auto-venting design that does not affect the
integrity of the sample.
Interpret results from patients anesthetized with halothane or nitrous oxide
cautiously. Patients anesthetized with these substances may have unreliable pO2
values due to the reduction of halothane or nitrous oxide by the pO2 electrode.2
Avoid using sample collection devices containing EDTA, citrate, oxalate, and
fluoride anticoagulants. These anticoagulants have a significant effect on blood
pH and ionized calcium.
The following limitations apply to the 850 and 860 systems:
Avoid hemolyzed samples, because they falsely elevate potassium levels due to
intra-erythrocyte potassium levels.
Avoid samples with elevated levels of salicylates, salicylate derivatives such as
ibuprofen, and bromide (Br–), because they falsely elevate chloride levels.
Avoid samples contaminated with perchlorate (ClO4–), thiocyanate (SCN–),
iodide (I–), and nitrate (NO3–), because they falsely elevate chloride levels.
Avoid using excessive levels of heparin anticoagulants. Excessive levels of
heparin anticoagulants cause calcium-heparin chelation and falsely decrease
calcium levels.
The following limitations apply only to the 860 system:
Avoid using sample collection devices containing fluoride/oxalate anticoagulants
(the gray top tube). These anticoagulants have a significant effect on glucose and
lactate.
The 800 system can analyze samples obtained from the following sources:
arterial blood
Arterial blood is commonly recommended for use in blood gas
studies because it accurately reflects acid-base physiology and
oxygenation status.
Arterial blood is routinely obtained from the radial, femoral, or
brachial arteries. Other sites can be used following catheterization or
surgical procedures.
venous blood
Venous blood can provide satisfactory pH and pCO2 values;
however, venous pO2 values may not be significant in routine
clinical study without simultaneous study of arterial pO2.
Venous blood is routinely obtained from an antecubital vein using
vacuum tube collection systems. Other sites can be used as necessary.
Venous oxygen saturation values reported must be so 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.
expired gas
Expired gas samples may be obtained using a 10 mL syringe. When
used in conjunction with blood gas samples, expired gas samples
provide an assessment of gas exchange and oxygenation status.
capillary blood
Capillary blood, when carefully collected under the proper
conditions, resembles arterial blood and can be used for blood gas
studies if the sample limitations are understood.1 Only small
quantities of blood are required for capillary blood analysis.
Capillary blood can be obtained from the heel, finger, or earlobe. The
area chosen should be prewarmed or stimulated before the puncture
to promote arterial circulation. The puncture should be deep enough
to ensure that blood flow is free and rapid. Take appropriate
precautions to minimize hemolysis, because potassium levels are
falsely elevated in hemolyzed blood.
When collected correctly, arterial, venous, mixed venous, and capillary blood
samples are also suitable for analyte determinations. For further information, refer
to the Bayer Diagnostics brochure Specimen Collection for Critical Blood
Analyte Testing.
You can use syringes, capillary tubes, and vacuum tubes to collect samples.
CAUTION: Never use mineral oil or mercury in syringes since these substances
may alter sample values and damage the system.
Collect blood in Bayer Diagnostics heparinized syringes or equivalent syringes to
satisfy the requirements for blood gas analysis.
The recommended syringe for analyzing samples is the Bayer Diagnostics arterial
sampling device. This sampling device uses a patented, non-exposed, auto-venting
design that does not affect the integrity of the sample. Some auto-venting syringes
contain sodium carboxymethylcellulose (CMC), a substance within the porous
venting mechanism. CMC can dissolve into the sample, compromising sample
integrity. CMC may lower the reported tHb and O2Hb levels and elevate the
reported COHb levels.
CAUTION: Do not use clay-capped capillary tubes because the cut edges of a
capillary tube can damage the sample port. Use only fire-polished capillary tubes
to prevent damage to the sample port.
NOTE: To prevent hemolysis and maintain sample integrity,
Bayer Diagnostics recommends using capillary tubes that do not contain mixing
fleas.
Collect capillary blood using capillary tubes that contain the appropriate balanced
heparin, such as Bayer Diagnostics Multicap balanced heparin capillary tubes.
Take appropriate precautions to minimize hemolysis, because hemolysis falsely
elevates potassium levels.
When you collect samples with a capillary tube, anticipate some sample loss due to
clotting and capping. Fill the capillary tubes completely and mix the samples
thoroughly.
Collect venous blood using vacuum tubes containing lithium heparin. Fill the tubes
completely and mix the sample by gently inverting the tubes.
CAUTION: Do not use anticoagulants such as EDTA, citrate, oxalate, and fluoride,
since they significantly effect pH, ionized calcium, chloride, and metabolites.
Calcium-titrated (balanced) heparin and lithium heparin are the only acceptable
anticoagulants for pH, blood gas, electrolyte, and metabolite analysis. Clotting and
dilutional effects may be present if the sample collection technique is not
performed correctly.
The following conditions can cause erroneous results even when samples are
collected correctly:
metabolic activity in the sample that occurs between sampling and completion of
analysis
contamination of the sample by room air
incorrect mixing of the sample before analysis
To minimize the errors these conditions can cause, use correct storage and handling
techniques. You can minimize errors due to metabolic changes by analyzing
samples as soon as possible after collection. This is particularly important for pO2,
glucose, and lactate values, because the sample consumes oxygen and glucose, and
lactate is rapidly formed during storage. Lactate is produced by glycolysis and will
increase while the sample is stored. Glycolysis is temperature dependent. Lactate
increases approximately 0.1mM/hour at 4°C and 1.0 mM/hour at 37°C.* The rate
of oxygen consumption depends on several factors:
storage temperature
white blood cell count
reticulocyte count
If you cannot analyze samples within 10 minutes of collection, it may be
appropriate to place the samples in an ice-water slurry, with the portion of the
syringe containing the sample in contact with the ice-water slurry. You can store
samples in an ice-water slurry for up to 2 hours without significant change in
values for pH and pCO2; however this will affect the K+ values. Samples with
elevated white blood cell or reticulocyte counts deteriorate more rapidly, and you
should analyze them immediately.
You can minimize errors due to room-air contamination by preventing air from
getting into the syringe. Immediately after drawing the sample, expel all the air
from the syringe, securely cap the syringe, and thoroughly mix the sample. Never
use corks as capping devices.
You can minimize errors due to incorrect sample mixing before analysis as
follows:
Roll a syringe between your hands and then gently invert the syringe several
times.
Gently invert a vacuum tube until the sample is homogenous.
Thoroughly mix a capillary sample until it is homogenous.
Blood cells settle during storage. If the sample is not well mixed before analysis,
the results obtained can be erroneous.
* Wandrup, Clinical Chemistry, 35/8, 1741, (1989).
Refer to Emptying the Waste Bottle in Section 3 for detailed instructions for
handling the waste bottle and its contents.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
The waste bottle is disposable. You can autoclave the waste bottle before
discarding it, but you cannot use it after autoclaving. After autoclaving, seal the
waste bottle with the disposable cap and then discard the waste bottle.
Discard the waste bottle and its contents according to your laboratory protocol or
hospital infection control procedure and local legal requirements. Refer to
NCCLS Publication GP5–A, Clinical Laboratory Hazardous Waste Guideline, for
detailed guidelines about disposal of hazardous waste.3
This section describes the active ingredients, the intended use, the storage, and the
handling instructions and the preparation instructions for the reagents used on the
800 systems.
Wear safety glasses, gloves, and laboratory coat when handling the
reagents.
All reagents described in this section are for in vitro diagnostic use only.
Bayer Diagnostics cannot guarantee the performance of the system when any of
the following occur:
Reagents other than those recommended are used.
Reagents are used after the expiration date on the label.
Reagents are not used or stored according to Bayer Diagnostics
recommendations.
Standard laboratory practices are not followed.
The procedures in this manual are not followed.
The reagents used on the 800 systems contain the following active ingredients:
7.3/CO-ox Zero
140 mmol/L sodium
4.0 mmol/L potassium
100 mmol/L chloride
1.25 mmol/L calcium
surfactant
buffer
6.838 Buffer
100 mmol/L sodium
8.0 mmol/L potassium
70 mmol/L chloride
2.50 mmol/L calcium
surfactant
buffer
Wash G/L Zero
salts
surfactant
Cal G/L
10 mmol/L glucose
2.0 mmol/L lactate
salts
surfactant
buffer
Cleaning Solution 1
cleaning compound
Cleaning Solution 2
cleaning compound
Conditioner
ammonium bifluoride (NH4HF2)
CO-oximeter Slope
dyes and viscosity adjuster
Deproteinizer
0.1N hydrochloric acid
proteolytic enzyme
Material Safety Data Sheets (MSDS) can be obtained by contacting
Bayer Diagnostics Customer Service.
The reagents used on the 800 systems have the following intended uses:
7.3/CO-ox Zero
7.3 reagent provides the calibration point for the one- and
two-point pH and electrolyte calibrations and the zero
calibration for the CO-ox module. 7.3 reagent is buffered to a
pH of 7.382 at 37°C and is NIST traceable.
6.838 Buffer
6.838 Buffer provides the slope point for the two-point pH and
electrolyte calibrations. 6.838 Buffer is buffered to a pH of
6.838 at 37°C and is NIST traceable.
Wash G/L Zero
Wash G/L Zero cleans the sample path after sample analysis
and during wash sequences. Provides the calibration point for
the two-point metabolite calibration.
Cal G/L
Cal G/L provides the calibration point for the one-point
calibration and the slope point two-point metabolite calibration.
Cleaning Solution 1
Cleaning Solution 1, when alternated with Cleaning Solution 2,
provides thorough cleaning of the reagent path.
Cleaning Solution 2
Cleaning Solution 2, when alternated with Cleaning Solution 1,
provides thorough cleaning of the reagent path.
NOTE: The system automatically cleans the reagent path,
using one of these cleaning solutions, every 24 hours at 02:00
(default time). The cleaning cycle is followed by a two-point
calibration.
Conditioner
Conditioner cleans and conditions the glass membranes of the
pH and sodium sensors. Conditioner should be used regularly
as part of the preventive maintenance for the system.
CO-oximeter Slope
CO-oximeter Slope provides the slope point for the tHb slope
calibration.
Deproteinizer
Deproteinizer removes protein buildup from the sample path.
Deproteinizer should be used regularly as part of the preventive
maintenance for the system.
This section describes the storage instructions for the reagents used on the 800
systems.
CAUTION: Discard any reagent that is frozen. Do not thaw and use. The reagent
composition is irreversibly altered when the reagent is frozen.
NOTE: Do not use any reagents beyond the expiration date. The expiration date
for Bayer Diagnostics reagents indicates the last month of valid use for unopened
reagents.
7.3/CO-ox Zero
Store 7.3/CO-ox Zero upright at 4 to 25°C.
Discard 7.3/CO-ox Zero 30 days after opening.
6.838 Buffer
Store 6.838 Buffer upright at 4 to 25°C.
Discard 6.838 Buffer 60 days after opening.
Wash G/L Zero
Store Wash G/L Zero upright at 4 to 25°C.
Discard Wash G/L Zero 60 days after opening.
Cal G/L
Store Cal G/L upright at 4 to 25°C.
Discard Cal G/L 30 days after opening.
Cleaning Solution 1
Store Cleaning Solution 1 in the dark. The solution is light
sensitive.
Store Cleaning Solution 1 upright at 4 to 25°C.
Discard Cleaning Solution 1 four weeks after opening.
Cleaning Solution 2
Store Cleaning Solution 2 in the dark. The solution is light
sensitive.
Store Cleaning Solution 2 upright at 4 to 25°C.
Discard Cleaning Solution 2 four weeks after opening.
Conditioner
Store Conditioner at 4 to 25°C.
Discard Conditioner 24 hours after opening.
Deproteinizer
Store Deproteinizer at 4 to 25°C. Activated material is stable for
24 hours when stored at 4 to 8°C.
Discard Deproteinizer 24 hours after preparing.
CAUTION: Discard any reagent that is frozen. Do not thaw and use. The reagent
composition is irreversibly altered when the reagent is frozen.
Handle and prepare the reagents used on the 800 systems as follows:
7.3/CO-ox Zero
7.3/CO-ox Zero is ready to use. Invert the bottle several times
to mix thoroughly before use.
6.838 Buffer
6.838 Buffer is ready to use. Invert the bottle several times to
mix thoroughly before use.
Wash G/L Zero
WashG/L Zero is ready to use. Invert the bottle several times to
mix thoroughly before use.
Cal G/L
Cal G/L is ready to use. Invert the bottle several times to mix
thoroughly before use.
Cleaning Solution 1
Cleaning Solution 1 is ready to use. Invert the bottle several
times to mix thoroughly before use.
Cleaning Solution 2
Cleaning Solution 2 is ready to use. Invert the bottle several
times to mix thoroughly before use.
Conditioner
Conditioner is ready to use. Mix thoroughly before use.
CO-oximeter Slope
CO-oximeter slope is ready to use.
Deproteinizer
Prepare Deproteinizer according to the package directions.
Allow the solution to sit at room temperature for 10 to 15
minutes or until the powder dissolves. When the powder
dissolves, invert the vial several times to ensure that the
solution is thoroughly mixed before aspirating it into the
system.
NOTE: Do not tighten or remove the bottle cap on any on-board reagent, or
attempt to mix the contents of one bottle with another. The bottle caps are adjusted
to ensure correct reagent flow.
The 800 system requires two gases to calibrate the pCO2 and pO2 sensors, Cal Gas
and Slope Gas.
Cal Gas provides the calibration point for both pCO2 and pO2 sensors during oneand two-point calibrations. Cal Gas contains 5.00 ±0.03 mol% carbon dioxide and
12.00 ±0.03 mol% oxygen balanced with nitrogen. Cal Gas is NIST traceable.
Slope Gas provides the slope point for pCO2 and pO2 sensors during two-point
calibrations. Slope Gas contains 10.00 ±0.03 mol% carbon dioxide balanced with
nitrogen. Slope Gas is NIST traceable.
Compressed gas tanks can explode if mishandled. To prevent
personal injury or damage to the tank, observe the following precautions when
handling the tanks:
Secure tanks to a wall, a bench, or the floor, or place them in a tank base support
stand.
Use calibration gases only for the calibration of clinical and research
instruments. Do not dispense these gases for drug use.
Do not drop tanks, do not allow tanks to strike each other, and do not subject
tanks to other strong shocks.
Do not drag, roll, or slide tanks. Use a suitable hand truck to move tanks.
Do not tamper with safety devices in regulators or tanks.
Do not puncture the tanks. Tank contents are under pressure.
Do not use or store tanks near heat or open flame.
Do not expose tanks to temperatures above 54°C (130°F) because contents can
vent or explode.
Do not dispose of tanks in a fire or an incinerator. Follow the disposal
instructions printed on the tanks.
Calibration is the process of testing and adjusting the electronic signal from a
sensor in response to a known concentration of a calibration solution or of a gas
standard. Calibration establishes a relationship between the electrical output of a
sensor and the concentration of the analyte measured by the sensor. Electronic drift
and normal sensor aging can cause variations in electronic signals.
The relationship between the sensor signal and the concentration of a measured
analyte (or its logarithm) is linear. A straight line calibration curve can be
determined by measuring the sensor signal from two different reagents of known
concentration. Each measurement defines one point on the calibration curve.
Calibration offset (y-intercept) and slope are calculated using the measured signal
and known concentration as established on the calibration curve. The concentration
of an unknown sample (patient or QC) is determined by comparing its generated
signal during measurement to the established calibration curve. The 800 system
performs calibrations and sample measurements of pH, blood gases, electrolytes,
and metabolites at 37.0 ± 0.15°C, and hemoglobin and its derivatives at
37.0 ± 0.35°C.
The 800 system uses the following calibrations for each measured parameter:
one-point calibration
A one-point calibration adjusts either the offset or the slope drift for a parameter
by measuring one reagent of known concentration.
The metabolite one-point calibration measures the slope drift.
two-point calibration
A two-point calibration adjusts both the offset and the slope drift for a parameter
by measuring two reagents of known concentration.
The following sections describe specific calibration features of the 800 system.
The 800 system automatically performs one- and two-point calibrations. The
system provides two options for determining when automatic calibrations occur.
They are fixed time and flexible time.
Fixed time performs calibrations at regular intervals. You define the intervals in
setup. The system default interval for one-point calibrations is 30 minutes, and the
default for two-point calibrations is 120 minutes.
Flexible time performs calibrations at various intervals. The system uses an
algorithm to determine the number of minutes between calibrations. This algorithm
is based on sensor status and the change in drift values from previous calibrations.
Calibrations are performed at intervals necessary to avoid excessive drift to the
sensor that is experiencing the fastest rate of drift. The default time for the
minimum time between calibrations is 10 minutes. You can define the minimum
time between intervals for one-point calibrations in setup. The minimum time for
two-point calibrations is four times the value entered for one-point calibrations.
Refer to Selecting Calibration Frequency and Automatic Repeat in Section 5 for
more information about defining the time interval for automatic calibrations.
The system indicates that an automatic calibration is pending 5 minutes before the
calibration is scheduled and continues to display the time remaining until the
calibration starts. The sample door closes when a calibration starts. The timing bar
indicates the approximate time to calibration completion. During a calibration, you
cannot access the Menu mode.
You can defer or interrupt calibrations to analyze samples. You can defer automatic
calibrations for up to 30 minutes. After 30 minutes, the system is not in calibration.
The system then starts the required calibration automatically. The system does not
accept samples until the required calibration finishes.
In addition to the regularly scheduled one-and two-point calibrations, the 860
system has a metabolite recal option. The metabolite recal option allows the system
to perform an automatic one-point metabolite calibration to minimize within run
drift during rapid sampling. Metabolite recal is particularly useful in controlling
within run drift for newly installed glucose biosensors. Turning off the metabolite
recal option will increase sample throughput time. With metabolite recal off,
glucose is calibrated only at the regularly scheduled one and two-point
calibrations.
Metabolite recal also decreases within run glucose drift when running many
replicates of QC material. Turning off the recal option does not significantly affect
QC sample results, as most QC samples are limited to 6 replicates in a run.
Individual laboratories should determine if glucose QC recovery is acceptable with
metabolite recal off.
Metabolite recal calibrates the glucose biosensor under two sets of criteria in a
cyclical manner. First, the system uses an algorithm to determine the frequency of
samples. If two consecutive QC samples or a combination of three QC and patient
samples are analyzed at an average rate of 4 minutes or less between samples, the
system begins a metabolite one-point calibration at the completion of the analysis.
If a regularly scheduled one- or two-point calibration is due, the system performs
the scheduled calibration instead.
The system displays a status message indicating that a one-point metabolite
calibration is due at the completion of the sample analysis. The glucose sensor is
inactive until the calibration is successfully completed. You cannot defer this
calibration.
Second, after completing the calibration, the system sets a 5 minute timer. If no
samples are run within this period, the system performs another metabolite recal at
the end of 5 minutes. You can defer this calibration by running samples.
If two consecutive QC samples are run within 4 minutes of each other during the 5
minute timer or when the second calibration is completed, the system begins the
calibration cycle again by returning to the first set of criteria described above.
You can interrupt either calibration, but the glucose sensor is inactive until the
sensor is successfully calibrated.
You can perform calibrations manually from the Analyze mode when the system is
not analyzing samples and from the Menu mode. You perform calibrations from
the Analyze mode by pressing Calibrate. You perform calibrations in the Menu
mode by selecting Calibrations from the Menu screen.
The CO-ox module is calibrated for zero and slope. The zero is performed
automatically during the 7.3 Buffer calibration step of a one- and two-point
calibration. You must introduce the reagent that the system uses to measure the
slope. The default and maximum interval for a tHb slope calibration is 30 days.
The minimum interval between slope calibrations is 1 day.
The atmospheric pressure is important to ensure accurate gas calibration. The 800
system contains an internal barometer. Check the barometer calibration daily.
Measure your laboratory’s current atmospheric pressure using a high-quality
barometer that has been calibrated to, or directly measures, actual atmospheric
pressure. Enter the atmospheric pressure into the 800 system to calibrate its
internal barometer. Refer to Checking the Barometer in Section 3.
The system displays calibration results on the screen and updates them
continuously until the parameters reach endpoint. The system then adjusts the
values to match the theoretically expected results. The screen displays the
measured and the drift values for each calibrated parameter. If a sensor does not
reach endpoint within 90 seconds, the parameter value appears on the screen with
asterisks and the message D5 No Endpoint. The sensor is not in calibration until
the system completes a successful calibration.
Variation in the electronic signal generated by sensors in response to samples and
normal sensor aging can cause calibration drift. You can define acceptable
calibration drift limits for the 800 system. If the detected changes to the offset and
the slope values are larger than defined, the system informs you that drift limits are
exceeded. If the drift for a sensor is greater than defined, that sensor is not in
calibration. Until a successful calibration completes, all subsequent measurements
indicate the not-in-calibration condition on the screen and on the printed reports.
The system automatically repeats a calibration when drift limits are exceeded if the
auto repeat or flexible-time options are defined for the system. The system repeats
up to two calibrations to calibrate a sensor or to zero the CO-ox module. It repeats
the calibration only for the sensor with excessive drift, and prints a calibration
report for each repeat calibration. If connected to an LIS, it sends the calibration
data to the LIS. If a sensor fails two repeat calibrations, the sensor is disabled and
not available to measure samples. The screen and printed results identify the
disabled sensor. When a sensor is not available because of excessive drift, the other
sensors are not affected.
You can specify whether you want to report sample results when calibration drift
limits are exceeded. If you do report results with calibration drift, the system
permanently logs this exception in the status log. Refer to Defining Drift Limits in
Section 5.
You can view, print, and transmit stored calibration data using the Recall option.
You cannot edit calibration data. You can search for the data by calibration type or
calibration date and time.
Quality control (QC) procedures are part of an overall quality assurance program.
Quality control testing evaluates system performance for imprecision and
inaccuracy to ensure that results of patient samples are accurate and reliable.
Imprecision is a measure of random error and variability. Random errors are
sporadic and do not show trends or shifts of values around the mean. Inaccuracy is
a measure of bias or systematic error. Systematic errors show trends or shifts of
values around the mean.
The following are possible causes of systematic errors:
contaminated calibrators
improper calibration
inaccurate barometer calibration
sensor problems or aging of membranes
electronic noise
improper storage and handling of QC materials
U.S. federal regulations state that each laboratory must establish QC procedures to
document and to evaluate system performance that ensure the accuracy and the
reliability of patient results and reports.4 QC procedures must also describe
remedial actions when the measured values for QC materials exceed established
limits. Your institution may also need to fulfill additional country, state, and local
requirements. Analyzing QC materials and evaluating the results using predefined
criteria is part of an overall quality assurance program. A well-designed quality
assurance program also includes written protocols that describe patient preparation
and identification, specimen collection and handling, sample analysis, system
calibration and maintenance schedules, and reporting patient results.
Quality control materials are substances that have known expected values that
cover the clinically significant range for each parameter.
To monitor system performance and to chart any trends, Bayer Diagnostics
recommends that you analyze controls as follows:
pH, pO2, pCO2
one sample of control at least once during each eight–hour
shift using at least two levels of control during each day of
testing.
Na+, K+, Ca++, Cl–,
glucose, lactate
two levels of control at least once every 24 hours.
tHb
two levels of control at least once during each eight–hour
shift.
If your established QC program requires more frequent use of controls, then follow
those procedures. Treat all quality control materials as you do patient samples.
Monitoring the results of QC analyses can alert you to possible system
performance problems and may help you predict sensor failure. More frequent use
of controls may be required to evaluate system performance during troubleshooting
operations.
In addition to daily QC monitoring, participation in interlaboratory QC survey
programs lets you compare your system performance with systems in other
laboratories. Participation in interlaboratory QC survey and proficiency testing
programs can identify systematic errors not detected by intralaboratory QC testing
alone.
Quality control results may differ from one system to another due to sample
handling, system imprecision, and laboratory environment. Therefore, your
institution should establish its own expected results range and action range for each
parameter using data collected from determinations made over at least 20 separate
runs.5 The mean values established by your institution should fall within the ranges
provided by the manufacturer of the QC material for each parameter. To establish
expected result and action ranges for new lots of QC materials, analyze the new
QC materials in parallel with existing materials.
Statistics are used to evaluate QC results and establish the probability of the
accuracy (confidence limits) of a given measurement. These statistics are used to
determine if the system is performing as expected and if patient data should be
accepted or rejected.
Quality control limits are established by calculating the mean and standard
deviation (SD) from multiple measurements of the QC material.5 Typical QC limits
use ± 2 SD or ± 3 SD where there is approximately a 95.5% probability that a
result is within the 2 SD range and approximately a 99.7% probability that a result
is within the 3 SD range when the system is performing as expected. QC results are
compared to the established limits to evaluate system performance. If the results
are within the established limits, the system is considered to be performing
properly and patient results may be accepted. If the results are outside the
established limits, the system may have problems that should be investigated
before reporting patient results. Take corrective action according to procedures
established for your laboratory. Bayer Diagnostics recommends that you do the
following:
Ensure that the calibration reagents and QC materials are not expired or have not
deteriorated. Visible signs of deterioration include color changes or cloudiness of
the reagents or QC materials.
Ensure that you followed the operating procedures recommended in this manual.
Ensure that you handled and sampled the QC materials according to the
procedures recommended by the manufacturer.
Rerun the QC materials.
You can define up to 12 QC files on an 800 system. Each file can store up to 150
QC sample reports. The file maintains the month-to-date and lot-to-date statistics,
which include the mean, standard deviation, and coefficient of variation. After a
QC file reaches 150 reports the system deletes the oldest report in the file to make
room for a new QC report.
Each QC file contains the following information:
file number
the number that identifies the file
QC ID
the code that identifies the QC material assigned to the file
level
the level of the QC material
lot number
the manufacturing lot number of the QC material
expiration date
the last date you can use the QC material
expected (target) mean
for each parameter, the expected average measured value of
the QC samples
expected (target)
range
for each parameter, the measurement limits above and below
the mean where the majority of the QC samples are expected
to fall
action range
for each parameter, the measurement limits above and below
the mean requiring immediate action
sample results
the results for each parameter, the QC sequence number, and
the analysis date and time
cumulative statistics
for each parameter, the mean, standard deviation, coefficient of
variation, and number of samples analyzed
Bayer Diagnostics Service Representatives use File 13 to store data during service
calls. File 14 is the discard file. The system stores QC results in File 14 that you
discard at the end of QC analysis. You can move and change the status of a file in
File 14 using Recall. Refer to Recalling QC Data in Section 2.
The system assigns a sequence number to each QC sample in the order that you
analyze the samples. QC sequence numbers are independent of the QC file
information. Sequence numbers run from 100 through 99999 and then repeat.
If the auto ID option is on, the 800 system automatically identifies the QC sample
results and selects the appropriate QC file to store the results. The system
compares the results for pH and pCO2 to the target ranges defined for each
parameter. If the results for these parameters are within the target ranges, the 800
system selects the QC file in which to store the results and prompts you to confirm
the file assignment. If the results are not within the action range, or if one or both
of the pH or pCO2 sensors are not calibrated or are not available, the system does
not select a QC file. You can then select a QC file for the results. Refer to Selecting
Automatic QC File Assignment in Section 5 to use this option.
If the 800 system is connected to an LIS or a data management system, you can
use Auto Accept to have the system automatically accept QC results and send them
to the LIS or data management system. You can then accept, reject, or discard
results at the LIS or data management system. Refer to Selecting Automatic
Acceptance of QC Results in Section 5 to use this option.
The system can automatically transmit QC results to an LIS or a data management
system when analysis is complete. Refer to Selecting Automatic Transmission of
QC Results in Section 5 to use this option.
You can view, edit, print, and transmit stored QC data using the recall option. You
can search for the data by file number, lot, level, analysis date, and analysis time.
You can view and print the following QC data:
individual QC sample reports
Levey-Jennings charts
statistical summary reports
Refer to Recalling QC Data in Section 2.
You can recall QC data for the previous month before you analyze the first QC
sample of the current month. After you analyze the first QC sample of the current
month, you can view the previous month’s QC data by archiving the previous
month’s QC data and viewing the archived QC data. Refer to Archiving QC Data
and Viewing Archived QC Data in Section 5.
The 800 system provides Levey-Jennings charts, which are visual representations
of QC performance. Levey-Jennings charts allow rapid detection of results that fall
outside the established QC limits. Additionally, Levey-Jennings charts let you
observe trends or shifts in QC values, which may signal system performance
problems, even when the actual values fall within the established limits.
Refer to Viewing and Printing Levey-Jennings Charts in Section 2 to view and
print Levey-Jennings charts for the current month’s QC data.
You can view and print Levey-Jennings charts for the previous month before you
analyze the first QC sample of the current month. After you analyze the first QC
sample of the current month, you can print the previous month’s Levey-Jennings
charts only by archiving the previous month’s QC data and then printing
Levey-Jennings charts of the archived QC data. Refer to Archiving QC Data and
Viewing Archived QC Data in Section 5.
Statistical summary reports present the month-to-date and lot-to-date mean,
standard deviation, coefficient of variation, and number of samples for each QC
file. You can print a statistical summary report for each current QC file using the
recall option. Refer to Recalling QC Data in Section 2.
At 0200 on the first day of the month, the system automatically prints a final
statistical summary report for each QC file. If you change the time of the Auto
Clean, the system prints the final statistical summary reports at that time on the
first day of the month. Review your QC files before the last day of the month to
ensure that the QC files are updated.
After you analyze the first QC sample of the current month, you cannot view or
print the previous month’s QC data on the system. You can archive the previous
month’s QC data and then print the statistical summary reports for the previous
month. Refer to Archiving QC Data and Viewing Archived QC Data in Section 5.
Archiving QC data saves the previous month’s QC file results and statistics on a
diskette. You can use this diskette to retrieve historical QC data, which you can
view or use to print QC reports and statistical summary reports. You cannot edit or
restore data from an archive diskette.
Archiving can be done before or after you analyze the first QC sample of the
current month. When you analyze the first QC sample of the current month, a
message box reminds you to archive the previous month’s QC data.
After you analyze the first QC sample of the current month, you cannot view or
print the previous month’s QC data on the system. However, the previous month’s
QC data is retained on the hard disk until the end of the current month. You can
archive this data one or more times during the current month and then view or print
the archived data. At the end of the current month, the system permanently deletes
the previous month’s QC data.
In addition, you can view, edit, print, or transmit the previous month’s QC data
before you analyze the first QC sample of the current month. Refer to Recalling
QC Data in Section 2.
Calibration verification is the measurement of calibration materials to verify that
the calibration of the system has remained stable throughout the patient reportable
range established for your system.4 While routine QC testing evaluates system
performance in the clinically significant range, calibration verification periodically
checks the upper and lower limits of the reportable range where patient results
occasionally fall.
Use Calibration Verification Material (CVM) to comply with current federal, state,
and local requirements. Your institution should establish its own criteria to evaluate
system performance when verifying calibration.
Verify calibration in the following circumstances:
when you change reagent lot numbers, unless your laboratory can demonstrate
that the patient reportable range and the control values are not adversely affected
when you perform major preventive maintenance or replace critical components
on your system
when controls reflect unusual trends or are consistently outside your laboratory’s
acceptable limits
when a new system is installed
Laboratories introducing new test systems or methods should verify or establish
performance specifications before reporting patient results using the new test
system or method. The APV process that Bayer Diagnostics offers provides you
with data for performance characteristics that you must verify to meet CLIA
requirements. US federal regulations require that each laboratory demonstrates
performance specifications comparable to the manufacturer for the following
characteristics:4
accuracy
precision
reportable range verification and calibration verification
reference range verification
The APV process also provides data for the following performance characteristics
that may not be required to meet CLIA requirements:
control verification
sensitivity
You can also obtain correlation data by parallel testing of patient samples that span
the reportable ranges on the new system and on the existing system or method.
Results from the new system are plotted against the existing system or method.
Typically, linear regression and least squares evaluation are used to compare
results. The slope and intercept of the regression line can be used to match the
results of the new system to an existing system or method. Refer to Appendix G,
Correlation Adjustment.
Refer to the Analyte Performance Verification Interpretive Guide, which is
provided by Bayer Diagnostics during the APV process, for more information
about the APV process.
The following system sequence diagrams illustrate the flow of liquids and gases
through the 800 system. Figure 1-12 identifies the components of the system
sequence diagrams for the base model with a CO-ox module. The legend in
Figure 1-12 describes the conventions used in the diagrams.
Small
Tubing
Reagent
Pump (R)
FD1a
Measurement
Module
Sample
Port
FD2
FD1
CO-ox
Pump (CO)
Sample
Pump (S)
Waste
Pump (W)
Sample
Chamber
Hemolyzer
FD5
Sample
Probe
Sample
Tubing
Waste Bottle
Diverter
Valve
Cal Gas Valve
Cal
Slope
FD4
Slope Gas Valve
Ambient Air
FD3
6.8 Valve
Vent Valve
Clean Valve
7.3 Valve
Wash Valve
Wash Bypass Valve
Foam Wash Valve
7.3
••••••••
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
2
W
S
1. The sample door closes and determines the sample type
and the probe extends accordingly. The waste and sample
pumps start, and the sample moves to fluid detector (FD) 1
and 1A. The CO-ox module pump moves part of the
sample to FD5.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
2
W
S
2. The probe retracts. The sample door opens and the system
prompts you to remove the sample device. When the
sample device is removed, the door closes over the sample
port.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
W
S
2
3. The sample pump moves the sample to fluid detector 2,
pauses for one second, and then moves the sample until
the trailing edge is detected at fluid detector 1. The CO-ox
sample moves through the hemolyzer and the sample
chamber. All parameters are measured.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
2
W
S
5
4. The sample port and reagent manifold are washed while
the measurement is being made. The foam wash and vent
valves open, the reagent pump starts, and foam wash
moves to the outer sample port. The reagent pump stops,
the waste pump starts, and the foam wash is removed from
the sample port. This sequence repeats four times and is
followed by a solid wash segment.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
2
W
S
5
5. When the measurement completes, the sample probe fully
retracts. The reagent pump starts and moves the remaining
foam wash to the outer sample port. The reagent pump
stops, the waste pump starts, and the wash is removed
from the sample port. This cleans the capillary seal and the
measurement module.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
SC H
5
•• •
1 1a
Cal
Slope
••
• • • • • • • • • • • • • • • • • • • •
4
3
W
S
2
••••••••••••••••
•••••••••••••••••
R
• • • • Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
6. After all of the foam wash is removed, the reagent pump
starts, the wash bypass, and vent valves open, and the
remaining solid wash segment moves to the inner sample
port. After the solid wash segment reaches the inner
sample port, the reagent pump stops and the sample pump
empties the wash from the sample port area. The reagent
pump introduces another solid wash segment into the
sample port. When the CO-ox module is attached, wash
segments are split at the sample connector, so the CO-ox
sample path is thoroughly cleaned. This sequence repeats
11 times to create wash segments that thoroughly clean the
measurement module. The waste pump is on.
2
W
S
5
7. After the wash segments pass through the measurement
module, the Cal gas valve opens and the sample pump
starts to move Cal gas into the measurement module. The
CO-ox pump moves the remaining wash segments to the
waste bottle. The waste pump is on to prevent a bubble
from forming at the sample port. The sample door opens
when the sequence completes.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
The following steps describe the activities that take place when you initiate a wash sequence by
selecting Wash or Cancel.
CO
R
SC H
1 1a
W
S
2
5
Cal
Slope
• •
• • • • • • •
4
3
• • • • • Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1. The sample door closes and the probe fully retracts. The
foam wash and vent valves open, the reagent pump starts,
and foam wash moves to the outer sample port. The
reagent pump stops, the waste pump starts and the foam
wash is emptied from the sample port. This sequence
repeats four times and is followed by a solid wash
segment.
1 1a
2
W
S
5
2. The sample probe fully retracts, the reagent pump starts,
the diverter valve opens, and the remaining foam wash
moves to the inner sample port. The reagent pump stops,
the waste pump starts, and the wash is removed from the
sample port. This cleans the inside of the capillary seal
and the measurement module.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash
Clean
CO
5
1 1a
• • • • • • • • • • • • • • • • • • • •
4
3
W
S
2
Cal
Slope
• •
SC H
•• •
• • • • • • • • • • • • • • •
• • • • • • • • • • • • • • • • •
R
• • • • • Ambient Air
7.3
6.8
Wash Clean Cal G/L
CO
R
SC H
1 1a
3. The reagent pump starts, wash bypass, and vent valves
open, and the remaining solid wash segment moves to the
inner sample port. The wash bypass valve is open while
the reagent pump is on to prevent leakage from the foam
wash valve. After the solid wash segment reaches the
inner sample port, the reagent pump stops and the sample
pump moves the wash from the sample port into the
measurement module. The reagent pump introduces
another solid wash segment into the sample port. This
sequence repeats 11 times to create wash segments that
thoroughly clean the measurement module. The waste
pump is on.
2
W
S
5
4. After the wash segments pass through the measurement
module, the Cal gas valve opens, the sample pump starts,
and Cal gas moves to the measurement module. The
CO-ox pump moves the remaining wash segments to the
waste bottle. The waste pump is on to prevent a bubble
from forming at the sample port. The sample door opens
when the sequence completes.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean Cal G/L
The following steps describe the activities that take place during a one-point calibration.
CO
R
SC H
1 1a
W
S
2
5
Cal
Slope
••
• • • • • • • • • • • • • •
4
3
• • • • Ambient Air
7.3
6.8
Wash Clean
CO
S
2
W
•• •
• • ••
• •
•
1 1a
• • • • • • •
•••••••••••
2. The vent valve, wash bypass valve, and diverter valve
open. The sample pump and waste pump start. The wash
segment moves through the measurement module to wet
the sample path and allow humidification of the gas
sensors.
Cal
• • • • • • • • • • • • •
Slope
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
• • • • • Ambient Air
••
5
••••••••••••••••••
SC H
•• •
•••••••••••••••••••••
R
1. The sample door closes and the probe fully retracts. The
reagent pump starts, the wash valve opens, and a wash
segment is introduced into the reagent manifold. The
sample and waste pumps start. The wash valve closes. The
vent valve opens.
7.3
6.8
Wash Clean
CO
R
SC H
1 1a
W
S
2
5
3. After the wash segment moves through the measurement
module, the Cal gas and diverter valves open and Cal gas
flows into the inner sample port. The sample pump
aspirates the Cal gas at a controlled rate through the
measurement module where pO2 and pCO2 are measured.
The CO-ox pumps starts to prevent contamination of the
sample connector by ambient air.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
R
SC H
1 1a
W
S
2
5
Cal
Slope
4
••
• • • • • • • • • • • • • •
3
• • • • • Ambient Air
7.3
6.8
Wash Clean
CO
R
S
2
W
Cal
Slope
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
• • • • • Ambient Air
••
5
1 1a
5. The reagent and waste pumps remain on. The pre-segment
moves through the sample port into the waste and removes
any residual reagent in the manifold.
•••••••••••••••••
SC H
4. After the gases are measured, the 7.3 valve, wash bypass
valve, and diverter valve open. The reagent pump moves a
7.3 reagent pre-segment and main segment from the
reagent manifold toward the inner sample port. The
sample pump is on.
7.3
6.8
Wash Clean
CO
SC H
5
1 1a
•• •
• •
Cal
Slope
• •
• • • • • • • • • • • • • • • • • • • •
4
3
W
S
2
• • • • • • • • • • • • • • •
• • • • • • • • • • • • • • • • •
R
• • • • • Ambient Air
7.3
6.8
Wash Clean
CO
R
SC H
6. The main segment moves toward the sample port. When
the main segment reaches the sample port, the sample
pump starts and moves the segment to the measurement
module until it is detected by fluid detector 1 and 1A. The
CO-ox module pump moves the 7.3 reagent to FD5. The
waste pump starts.
1 1a
W
S
2
7. The probe extends and the main segment moves until the
trailing edge is at fluid detector 1. The pumps stop and the
analytes are measured. The CO-ox zero calibration is
performed.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
R
W
S
2
5
• • • • • • • • • •
4
••
SC H
1 1a
3
• • • •
7.3
6.8
Cal
Slope
8. The sample port and reagent manifold are washed while
the measurement is being made. The probe fully retracts.
The foam wash and vent valves open, allowing the wash
solution to become segmented with air, creating foam
wash. The reagent pump starts and moves foam wash to
the inner sample port. The reagent pump stops, the waste
pump starts, and the foam wash is emptied from the
sample port. This sequence repeats four times and is
followed by a solid wash segment.
Ambient Air
Wash Clean
CO
R
SC H
1 1a
W
S
2
5
9. When the measurement completes, the reagent pump starts
and moves the remaining foam wash to the inner sample
port. The reagent pump stops, the waste pump starts, and
the wash moves from the sample port to the waste. This
cleans the inside of the capillary seal and the measurement
module. The wash valve opens and a solid wash segment
moves toward the sample port during this process.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
5
••••••••••••••••••
SC H
1 1a
•••
W
S
2
••••••••••••••••••••
R
10. After the solid wash segment reaches the inner sample
port, the reagent pump stops, the waste pump remains on,
and the sample pump moves the wash segment from the
sample port into the measurement module. An air segment
follows. The wash valve opens and the reagent pump
introduces another solid wash segment into the sample
port. This sequence repeats 11 times to create wash
segments that thoroughly clean the measurement module.
••
Cal
Slope
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
• • • • • Ambient Air
7.3
6.8
Wash Clean
CO
R
SC H
1 1a
2
W
S
5
11. After the wash segments pass through the measurement
module, the Cal gas valve opens and the sample pump
starts to move Cal gas into the measurement module. The
CO-ox module pump moves the remaining 7.3 reagent to
the waste bottle. The waste pump is on to prevent a bubble
from forming at the sample port. The sample door opens
when the sequence completes.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
The following steps describe the activities that take place during a two-point calibration.
CO
R
SC H
1 1a
W
S
2
5
Cal
Slope
••
• • • • • • • • • • • • •
4
3
• • • • • Ambient Air
7.3
6.8
Wash Clean
CO
1 1a
S
2
W
• ••
• • ••
• •
•
2. The vent valve, wash bypass valve, and diverter valve
open. The sample pump and waste pump start. The wash
segment moves through the measurement module to wet
the sample path and allow humidification of the gas
sensors.
• • • • • • •
•••••••••
• • • • • • • • • • • • • • • • • • •
Cal
• • • • • • • • • • • • •
Slope
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
• • • • • Ambient Air
• •
5
•• •
• • • • • • • • • • • • • • • • • • • •
R
SC H
1. The sample door closes and the probe fully retracts. The
reagent pump starts, the wash valve opens, and a wash
segment is introduced into the reagent manifold. The
sample and waste pumps start. The wash valve closes. The
vent valve opens.
7.3
6.8
Wash Clean
CO
R
SC H
1 1a
W
S
2
3. After the wash segment moves through the measurement
module, the Cal gas and diverter valves open and Cal gas
flows into the inner sample port. The sample pump
aspirates the Cal gas at a controlled rate through the
measurement module where pO2 and pCO2 are measured.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
R
SC H
1 1a
W
S
2
5
4. The Slope gas valve opens and Slope gas flows into the
inner sample port. The sample pump aspirates the Slope
gas at a controlled rate through the measurement module
where pO2 and pCO2 are measured. The CO-ox pumps
starts to prevent contamination of the sample connector by
ambient air.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
R
W
S
2
5
• • • • • • • • • • •
4
Cal
Slope
••
SC H
1 1a
5. After the gases are measured, the 7.3 valve, wash bypass
valve, and diverter valve open. The reagent pump moves a
7.3 reagent pre-segment and main segment from the
reagent manifold toward the inner sample port. The
sample pump is on.
3
• • • • • Ambient Air
7.3
6.8
Wash Clean
CO
R
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
7.3
6.8
Cal
Slope
••
5
W
S
2
••••••••••••••
SC H
1 1a
• • • • • Ambient Air
Wash Clean
CO
W
S
••
••
••
2
•
• • • • • • •
• • • • • • • • • • •
• • • • • • • • • • • • • • • • • • • • • • •
4 3
7.3
6.8
• • • • • Ambient Air
Wash Clean
CO
R
SC H
1 1a
7. The main segment moves toward the sample port. When
the main segment reaches the sample port, the sample
pump starts and moves the segment to the measurement
module until it is detected by fluid detector 1 and 1A.The
CO-ox module pump moves the 7.3 reagent to FD5. The
waste pump starts.
Cal
Slope
•••
5
••••••••••••••••••
SC H
1 1a
•••
••••••••••••••••••••
R
6. The reagent and sample pumps remain on. The
pre-segment moves through the sample port into the waste
and removes any residual reagent in the manifold.
2
W
S
8. The probe extends and the main segment moves until the
trailing edge is at fluid detector 1. The pumps stop and the
analytes are measured. The CO-ox zero calibration is
performed.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
R
1 1a
W
S
2
5
SC H
9. A small amount of foam wash is moved to the
measurement module to remove the 7.3 reagent. The
reagent pump then moves three 6.8 reagent pre-segments
and a main segment to the inner sample port. The
pre-segments are used to remove any residual 7.3 reagent
from the pathways.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
10. The pre-segments move through the sample port into the
waste.
CO
R
5
Cal
Slope
••
••••••••••••••••••••••••
4 3
7.3
6.8
W
S
2
•••••••••••••••••
SC H
1 1a
• • • • • Ambient Air
Wash Clean
CO
1 1a
• • • • • • • • • • •
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
7.3
6.8
W
S
2
•••
5
••••••••••••••••••
SC H
•••
••••••••••••••••••••
R
11. When the main segment reaches the sample port, the
sample pump starts and moves the segment to the
measurement module until it is detected by fluid detector 1
and 1A. The main segment moves toward the sample port.
The waste pump starts.
Cal
Slope
• • • • • Ambient Air
Wash Clean
CO
R
SC H
1 1a
W
S
2
12. The probe extends and the main segment moves until the
trailing edge is at fluid detector 1. The pumps stop and the
analytes are measured.
5
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
R
SC H
1 1a
W
S
2
5
Cal
Slope
• •
• • • • • • • • •
4
3
• • • • • Ambient Air
7.3
6.8
Wash Clean
CO
R
SC H
13. The sample port and reagent manifold are washed while
the measurement is being made. The probe fully retracts.
The foam wash and vent valves open, allowing the wash
solution to become segmented with air, creating foam
wash. The reagent pump starts and moves foam wash to
the inner sample port. The reagent pump stops, the waste
pump starts, and the foam wash is emptied from the
sample port. This sequence repeats four times and is
followed by a solid wash segment.
1 1a
2
W
S
5
14. When the measurement completes, the reagent pump starts
and moves the remaining foam wash to the inner sample
port. The reagent pump stops, the waste pump starts, and
the wash moves from the sample port to the waste. This
cleans the inside of the capillary seal and the measurement
module. The wash valve opens and a solid wash segment
moves toward the sample port during this process.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
CO
SC H
5
1 1a
•• •
W
S
2
••••••••••••••••••
••••••••••••••••••••
R
Cal
Slope
••
• • • • • • • • • • •
• • • • • • • • • • • • • • • • • • • • • • • •
4 3
15. After the solid wash segment reaches the inner sample
port, the reagent pump stops, the waste pump remains on,
and the sample pump moves the wash segment from the
sample port into the measurement module. An air segment
follows. The wash valve opens and the reagent pump
introduces another solid wash segment into the sample
port. This sequence repeats 11 times to create wash
segments that thoroughly clean the measurement module.
7.3
6.8
• • • • • Ambient Air
Wash Clean
CO
R
SC H
1 1a
2
W
S
5
16. After the wash segments pass through the measurement
module, the Cal gas valve opens and the sample pump
starts to move Cal gas into the measurement module. The
waste pump is on to prevent a bubble from forming at the
sample port. The sample door opens when the sequence
completes.
Cal
Slope
4
3
Ambient Air
7.3
6.8
Wash Clean
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The 800 system indicates that it is ready to analyze samples when the following
conditions exist:
Ready screen appears
sample door is open
Analyze key is lit
Do not attempt to analyze samples if the system is not ready.
The system aspirates all samples except expired gas samples. Aspiration reduces
exposure to biohazardous materials and increases precision:
by sampling the correct volume for each analysis
by ensuring precise sample heating before sample analysis
by reducing instrument-to-instrument and operator-to-operator variability
The system automatically identifies the sampling device. If the system cannot
identify the device, a message box appears prompting you to select one of the
following sample devices:
1 mL syringe
>2 mL syringe
capillary
Select the device type and press Enter. Then press Analyze to begin analysis.
If the system detects bubbles when it aspirates a sample, the Bubbles Detected in
Sample message box appears. If the sample is not at point A or beyond, position
the sample manually to continue with analysis.
begin analysis after you move the sample to the measurement
module.
cancel analysis. The system starts a wash and returns to the Ready
screen.
If the system detects bubbles when the sample is in the measurement module, the
Bubbles Detected in Sample message box appears. Look at the sample in the
measurement module to see where the bubble is located because bubbles may
affect the results of all the measured parameters.
continue with analysis. The report prints with the message, Bubbles
Detected in Sample.
stop analysis. The system starts a wash and returns to the Ready
screen.
An LIS can send an order to perform a patient sample or QC sample analysis. If
your system is connected to a laboratory or hospital information system or a data
management system, you may see a message box prompting you to begin a patient
sample assay.
The information system can also send a disable sampling order to the
800 system. A disabled sampling order appears in a message box when
the 800 system is in the Analyze mode.
perform the assay
follow the instructions in the message box.
cancel the order
press .
If your system is connected to a laboratory or hospital information system or a
data management system and Auto Send is on, patient sample and QC sample
results are automatically sent to the external system. If Auto Send is off, you can
perform one of the following tasks when patient or QC analysis is complete:
transmit results.
prevent transmission of results.
You may have to type a password before you can analyze samples and access
certain menus. If your system requires a password, a prompt appears, as shown in
Figure 2-1.
! 1. Type your password in the password field.
2. Press and then press .
If you type the password incorrectly, a message box appears. Press and
type the password again.
If your system requires a password to access selected menu options, the system
prompts you to enter the Menu Options password.
Arterial samples analyzed for blood gas and CO-oximeter values can determine the
estimated shunt [Qsp/Qt (est,T)] value. To do this, turn the parameter on in Setup;
refer to Selecting Parameters for Analysis in Section 5. Then during sample
analysis, enter the FIO2 value. When arterial and mixed venous samples are
combined for a-v studies, the estimated shunt value is replaced with the actual
shunt value [Qsp/Qt (T)].
The following tables list the minimum volumes required by each system to analyze
syringe samples:
840
844, 845
090 µL
140 µL
850
854, 855
110 µL
160 µL
860
864, 865
125 µL
175 µL
The system automatically aspirates the sample. If you want the system to analyze a
different set of parameters for the sample, press Change Parameters to select
another panel. Refer to Selecting Parameter Panels, page 2-29, for more
information.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
1. Prepare the sample and insert the syringe into the sample port, as shown in
Figure 2-2.
Syringe Sample
Sample Port
To ensure the accuracy of the CO-ox measurement, close the
CO-ox cover before pressing Analyze.
2. Press .
The system aspirates the sample.
3. When prompted, remove the sample device.
4. Type the required information in the Patient Information screen and then press
.
You can scan the patient ID and the accession number fields if your
system uses the bar code option feature.
Results appear on the screen and are continuously updated until analysis is
complete. The system then displays the final results and prints the report.
Refer to Entering Patient Sample Data, page 2-27 if you need more
information to complete this screen.
5. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
If the system determines that there is insufficient sample for routine analysis, a
message appears prompting you to position the sample manually. Refer to
Analyzing Microsamples, page 2-11, if you require additional information to move
the sample manually.
To interrupt sample analysis at any time, press Cancel. The system stops analysis
and performs a wash. The Ready screen appears when the wash finishes.
If you do not remove the syringe within 5 minutes of the screen prompt, the system
completes analysis and performs a wash. When you remove the syringe, the Patient
Information screen appears. Complete the screen as required.
The following table lists the minimum volumes required by each system to analyze
capillary tube samples:
840
844, 845
090 µL
140 µL
850
854, 855
110 µL
160 µL
860
864, 865
125 µL
175 µL
NOTE: If an 844, 845, 854, 855, 864, or 865 detects insufficient sample in the
measurement module, the system analyzes the sample as a microsample. If you
want the system to analyze a different set of parameters for the sample, press
Change Parameters to select another panel. Refer to Selecting Parameter Panels,
page 2-29, for more information.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
CAUTION: Insert the fire-polished end of the capillary tube into the sample port to
prevent damage to the capillary seal.
1. Prepare the sample and insert the fire-polished end of the capillary tube into
the sample port, as shown in Figure 2-3.
Capillary Sample
Sample Port
To ensure the accuracy of the CO-ox measurement, close the
CO-ox cover before pressing Analyze.
2. Press .
there is sufficient
sample volume
the system automatically aspirates the sample and moves it
to the measurement module.
the system prompts
you to move the
sample
a. Look to see if the sample has reached point A. If not,
turn the sample pump clockwise to move the leading
edge of the sample to point A, as shown in Figure 2-4.
b. Press .
Sample Pump
Point A
3. When prompted, remove the sample device.
4. Type the required information in the Patient Information screen and then press
.
5. Perform the appropriate task.
the system is moving
the sample
the results appear on the screen and are updated until
analysis is complete. Continue with step 8.
you are moving the
sample
continue with step 6.
Do not move the sample backward after it touches the reference
sensor. The potassium and chloride values will be affected.
6. When prompted, turn the sample pump clockwise until the leading edge of the
sample fills the reference sensor, as shown in Figure 2-5.
Ensure that the trailing edge of the sample remains in contact with the
sample ground/temperature sensor.
Reference Sensor
Sample Pump
Sample Ground/
Temperature Sensor
7. Press .
Results appear on the screen and are continuously updated until analysis is
complete. The system then displays the final results and prints the report.
8. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
If the system analyzes an insufficient sample, the message, Insufficient Sample,
prints on the roll printer report.
The system performs a wash and discards any data for the sample if any of the
following occur:
You press Cancel at any time to interrupt sample analysis.
You do not remove a capillary tube within 5 minutes of the screen prompt.
Use this procedure to analyze samples when the sample volume is too small for
routine analysis. The system determines when a sample volume is too small for
routine syringe or capillary analysis and prompts you to move the sample
manually. The following table lists the minimum volumes required by each system
to analyze a sample:
840, 844, 845
55 µL
850, 854, 855
70 µL
860, 864, 865
95 µL
When you use the Micro Sample option, you move the sample by manually turning
the sample pump. The system analyzes the sample in two stages. First, the system
analyzes pCO2 and pO2, then it analyzes the remaining parameters after you move
the sample into position. Refer to Selecting Parameter Panels, page 2-29, for more
information.
NOTE: The tHb parameters are not measured when you use the Micro Sample
option on an 844, 845, 854, 855, 864, or 865.
If you want the system to analyze a different set of parameters for the sample,
press Change Parameters to select another panel.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
CAUTION: When using capillary tubes, insert the fire-polished end of the
capillary tube into the sample port to prevent damage to the capillary seal.
1. Prepare the sample and insert the device into the sample port.
2. Press .
The Sample Type menu appears, as shown in Figure 2-6.
3. Select and press .
If the sample device is a syringe, the system tries to move the sample
automatically for routine analysis. If the syringe contains sufficient volume,
the system analyzes the sample automatically.
4. Press .
The Position Sample Manually message box appears.
5. Turn the sample pump clockwise to move the leading edge of the sample to
point A, as shown in Figure 2-7.
Sample Pump
Point A
6. Press .
7. When prompted, remove the sample device.
8. Type the required information in the Patient Information screen and press
when you finish.
Refer to Entering Patient Sample Data, page 2-27, if you need more
information to complete this screen.
Do not move the sample backward after it touches the reference
sensor. The potassium and chloride values will be affected.
9. When prompted, turn the sample pump until the leading edge of the sample
fills the reference sensor, as shown in Figure 2-8.
Ensure that the trailing edge of the sample remains in contact with the
sample ground/temperature sensor.
Reference Sensor
Sample Pump
Sample Ground/
Temperature Sensor
10. Press .
Results appear on the screen and are continuously updated until analysis is
complete. The system then displays the final results and prints the report.
11. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
If the system analyzes an insufficient sample, the message, Insufficient Sample,
prints on the roll printer report.
The system performs a wash and discards any data for the sample if any of the
following occur:
You press Cancel at any time to interrupt a sample analysis.
You do not press Sample in Place within 5 minutes of the screen prompt.
You do not remove the capillary tube within 5 minutes of the screen prompt.
Use this procedure to determine the total hemoglobin content and available
hemoglobin derivatives for a sample on an 844, 845, 854, 855, 864, and 865
systems. You can analyze syringe or capillary samples. The minimum sample
volume requirement is 100 µL. If the system detects an insufficient volume, the
analysis cannot be performed.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
1. Press .
2. Select and press .
3. Prepare the sample and insert the device into the sample port.
To ensure the accuracy of the CO-ox measurement, close the
CO-ox cover before pressing Analyze.
4. Press .
5. When prompted, remove the sample device.
6. Type the required information in the Patient Information screen and then press
.
Refer to Entering Patient Sample Data, page 2-27, if you need more
information to complete this screen.
The system displays only the final results and prints the report.
7. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
To interrupt sample analysis at any time, press Cancel. The system stops analysis
and performs a wash. The Ready screen appears when the wash finishes.
If you do not remove the sample device within 5 minutes of the screen prompt, the
system completes analysis and performs a wash. When you remove the sample
device, the Patient Information screen appears. Complete the screen as required.
"# " Since pH samples are frequently capillary tubes with insufficient sample volume,
the system requires you to move the sample manually to the measurement module.
If the sample device is a syringe that contains sufficient volume for analysis, the
system positions the sample automatically. The following table lists the minimum
sample volumes required by each system to determine pH:
&$%! !
" ! !
840, 844, 845
35 µL
850, 854, 855
70 µL
860, 864, 865
95 µL
NOTE: When you select pH only, the system measures everything except pCO2
and pO2. On systems with the CO-ox module, the system measures everything
except pCO2, pO2, and tHb parameters.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
CAUTION: Insert the fire-polished end of the capillary tube into the sample port to
prevent damage to the capillary seal.
1. Prepare the sample and insert the device in the sample port. Figure 2-9 shows
a capillary sample in the sample port.
!&$ " Capillary Sample
Sample Port
2. Press .
The Sample Type menu appears, as shown in Figure 2-10.
3. Select and press .
4. Press .
Ensure that the trailing edge of the sample remains in contact with the
sample ground/temperature sensor.
5. Turn the sample pump clockwise until the leading edge of the sample fills the
reference sensor, as shown in Figure 2-11.
Reference Sensor
Sample Pump
Sample Ground/
Temperature Sensor
6. Press .
7. When prompted, remove the sample device.
8. Type the required information in the Patient Information screen and then press
.
Refer to Entering Patient Sample Data, page 2-27, if you need more
information to complete this screen.
Results appear on the screen and are continuously updated until analysis is
complete. The system then displays the final results and prints the report.
9. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
If the system analyzes an insufficient sample, the message, Insufficient Sample,
prints on the roll printer report.
The system performs a wash and discards any data for the sample if any of the
following occur:
You press Cancel at any time to interrupt a sample analysis.
You do not press Sample in Place within 5 minutes of the screen prompt.
You do not remove the capillary tube within 5 minutes of the screen prompt.
The following table lists the minimum volumes required by each system to analyze
vacuum tube samples:
#!" 840
844, 845
090 µL
140 µL
850
854, 855
110 µL
160 µL
860
864, 865
125 µL
175 µL
If you want the system to analyze a different set of parameters for the sample,
press Change Parameters to select another panel. Refer to Selecting Parameter
Panels, page 2-29, for more information.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
1. Prepare the sample and insert an aspiration adapter into the sample port.
2. Insert the adapter into the vacuum tube, as shown in Figure 2-12.
#! Aspiration Adapter
Sample Port
Vacuum Tube
To ensure the accuracy of the CO-ox measurement, close the
CO-ox cover before pressing Analyze.
3. Press .
4. When prompted, remove the aspiration adapter.
5. Type the required information in the Patient Information screen and then press
.
Refer to Entering Patient Sample Data, page 2-27, if you need more
information to complete this form.
Results appear on the screen and are continuously updated until analysis is
complete. The system then displays the final results and prints the report.
6. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
If the system determines that there is insufficient sample for routine analysis, the
system prompts you to position the sample manually. Refer to Analyzing
Microsamples, page 2-11, if you require additional information to move the sample
manually.
To interrupt sample analysis at any time, press Cancel. The system stops analysis
and performs a wash. The Ready screen appears when the wash finishes.
Use this procedure to analyze expired gas samples. During this procedure, you
inject the gas into the system. The minimum sample volume requirement is 10 mL.
BIOHAZARD: Refer to Appendix A , Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
1. Prepare the sample and insert the syringe in the sample port, as shown in
Figure 2-13.
! Expired Gas Sample
Sample Port
2. Press .
The Sample Type menu appears, as shown in Figure 2-14.
! 3. Select and press .
4. Press .
Wait for the sample pump to start.
5. When the pump starts, slowly inject gas until the sample pump stops. Inject at
least 10 mL of gas.
6. When prompted, remove the sample device.
7. Type the required information in the Patient Information screen and then press
.
Refer to Entering Patient Sample Data, page 2-27, if you need more
information to complete this screen.
Results appear on the screen and are continuously updated until analysis is
complete. The system then displays the final results and prints the report.
8. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system continues to display the Results screen after the
wash finishes, press to return to the Ready screen.
To interrupt sample analysis at any time, press Cancel. The system stops analysis
and performs a wash. The Ready screen appears when the wash finishes.
The Sample Source field on the Patient Information screen contains the words,
Expired Gas. You cannot change this field.
Use this procedure to analyze a patient sample at an 840, 850, or 860 system and
combine the results with results from a sample analyzed at a 270 CO-oximeter that
is connected to one of these systems. Refer to Appendix D, Connecting to External
Devices, for information about connecting the 270 CO-oximeter to an 800 base
model.
To combine results, you must simultaneously analyze the sample at the 800 system
and the 270 CO-oximeter. The 800 system assigns a sequence number to each
sample and reports sample results by this number. The 800 system stores the 270
results and prints a report showing the blood gas, CO-oximeter, and combined
results. The 800 also stores any pass-through results from the 270. You can recall
these results from the 800 system. Refer to Appendix F, Printed Reports, to see an
example of a combined report.
If you want the system to analyze a different set of parameters for the sample,
press Change Parameters to select another panel. Refer to Selecting Parameter
Panels, page 2-29, for more information.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
1. Prepare the sample and introduce the sample at the 270 CO-oximeter.
2. Insert the device into the sample port at the 840, 850, or 860 system.
3. Press .
4. When prompted, remove the sample device.
5. When prompted, remove the sample device.
If your laboratory requires you to enter an ID number at each
system, be sure that you enter the same ID number at each system. The patient
ID you enter at your 800 system and the sample ID you enter at your 270
CO-oximeter must match to combine results.
6. Return to the 800 system and type the required information in the Patient
Information screen. Press when you finish.
Refer to Entering Patient Sample Data, page 2-27, if you need more
information to complete this screen.
7. If required by your laboratory, type the sample ID at your 270 CO-oximeter.
When the CO-oximeter data is available, the 800 system displays the final
results and prints the report.
8. Press to return to the Ready screen. If you do not press Home, the
system automatically returns to the Ready screen after 45 seconds.
If the patient ID entered at the 800 system and the 270 CO-oximeter do not match,
the Patient ID Mismatch message box appears.
you want to combine
the 270 results with
the 800 system results
a. Press . The Patient Information screen
appears.
you do not want to
combine the 270
results with the 800
system results
press .
b. Type the patient ID and press .
If the 800 system completes analysis before the 270 CO-oximeter completes
analysis, the Waiting for CO-oximetry Results message box appears.
you want to combine
results
press . The 800 system creates a combined
report when the results are ready.
you do not want to
combine results
press . Separate reports will be generated at the 270
CO-oximeter and at the 800 system.
Use this procedure to combine an arterial blood sample with a venous or mixed
venous blood samples to create an a-v studies report.
To complete a-v studies successfully, ensure that the samples meet the following
requirements:
The difference between analysis times of the two samples at the 800 system must
be less than 60 minutes.
Each sample can have the same draw date and draw time, no draw date or draw
time, or only one sample with a draw date and draw time.
Each sample must have the same patient ID.
Samples must be analyzed on the 800 for blood gas and CO-oximeter values.
You cannot combine results using a sample that was already combined with
another sample. For example, you cannot combine one arterial sample with two
different venous samples.
Samples analyzed for a-v studies can produce the following results:
ctO2(a-v)
ctO2([a-v]/a)
VO2
DO2
Qsp/Qt(T)
The system determines a-v study results using the following rules:
VO2 and DO2 results are determined only if the cardiac output value (Qt) is
entered during the a-v studies procedure. The Qt value cannot be entered after
the a-v study results are complete.
Qsp/Qt(T) value is determined only when arterial and mixed venous are selected
for a-v studies. Any estimated shunt value that appeared on the arterial report is
removed after the a-v study results are complete.
The ctO2(a) value is added to the venous results, and the ctO2(v) value is added
to the arterial results.
NOTE: When analyzing patient samples that will be used for a-v studies, be sure
to select arterial as the sample source for one sample and either venous or mixed
venous as the sample source for the other sample.
1. Analyze the arterial, and the venous or mixed venous samples you want to use
for a-v studies.
2. Select the first patient sample for a-v studies:
a. Select .
b. Select and press .
c. Select and press .
The Patient Data Search Criteria screen appears.
3. Enter the patient ID for the sample and press .
The Patient Data Search Log screen appears.
4. Select the patient sample for a-v studies and press .
The Reporting Options message box appears.
5. Select ! and press .
The First a-v Sample Selected message box appears.
6. Press .
only one sample is found
the Patient Data Search Result screen
appears.
Press . The Reporting
Options message box appears.1
more than one sample is found
the Patient Data Search Log screen appears.
a. Select the next sample for a-v studies
and press .
b. Press . The
Reporting Options message box appears.
7. Select ! and press .
The Confirm Samples for a-v Studies message box appears.
Record and use the sequence numbers to access the sample results
from the Patient Data Search Log.
8. Enter the Qt value if you want VO2 and DO2 results.
9. Press to create the a-v study results.
The Patient Data Search Log screen appears.
10. Select the sample used for a-v studies and press .
The Patient Data Search Result screen appears.
11. Press to view the a-v study results.
The a-v results are not automatically sent to the LIS. Select Reporting Options on
the patient results screen, and then select Send Results to transmit the results to an
LIS.
If the Invalid Selection message box appears, review the sample requirements to
ensure that the samples selected meet the requirements. Then select the samples
again.
Use this procedure to enter data in the Patient Information screen. The Patient
Information screen appears on the screen during sample analysis after you remove
the sample device. Figure 2-15 shows the default Patient Information screen.
NOTE: The Patient Information screen may appear differently on your system.
Certain fields may not appear because they were turned off. Depending on the
number of data entry fields defined for your system, you may have only one
patient information screen. The Sample Source field has the default value of
arterial.
NOTE: Any field that has a symbol is a required field and must be completed.
1. Type the patient ID and press . You can enter patient sample data using
the keypad, an optional keyboard, or a bar code scanner.
When scanning a bar code label, the correct field must be highlighted.
If a field other than the Patient ID or Accession Number is highlighted as you
scan a label, the field remains blank and no data is entered. Refer to the 800
Series Bar Coding Features technical bulletin for detailed information about
using the bar code option.
2. Enter data in the remaining fields until all required fields are completed. Press
the arrow keys to move to other fields.
3. Press .
The second Patient Information screen appears.
4. Enter data in all required fields.
5. Press .
The Patient Information screen closes.
If you want to make changes to the Patient Information screen during analysis,
press . The Patient Information screen reappears. Make your
changes to the fields and press .
If you do not complete all required fields before you press Done, a message box
appears prompting you to complete the required data entry fields. Press to return
to the Patient Information screen. The incomplete field is highlighted.
If you do not complete data entry within 5 minutes, the system stores the sample
result, and enters a message containing a sequence number, the date, and the time
of analysis in the status log. The system returns to the Ready screen. You can
search for the sample results by sequence number and analysis time, and then enter
the patient data for the sample. Refer to Recalling Patient Sample Data, page 2-35.
You can enter a patient’s year of birth in a 2-digit or 4-digit format. However, the
system stores, prints, and transmits the birth year in a 4-digit format.
If you enter the birth year in a 2-digit format (xx), the system assumes the birth
year to be 19xx.
In the year 2000 and beyond, you must enter birth years in the 4-digit format to
ensure an accurate birthdate and patient age. The system verifies that the 4-digit
year entered is the current or a prior year. The valid range for years entered as 4
digits is 1880 to 2050.
Use this procedure when you want to measure specific parameters for a single
patient sample. After the sample is analyzed, the system restores the default panel
for your system. Different panels are available for each system.
1. Press .
The Parameter Panels menu appears, as shown in Figure 2-16.
$# "
" !
2. Select a parameter.
" ! one of the panels displayed
select the parameter panel and press . Custom
panels are listed as Panels 1–5 and are defined during
system setup by the system administrator or authorized
personnel.
specific parameters to
analyze
a. Press . The Select Parameters
screen appears.
b. Select the parameters you want and press to
return to the Ready screen.
3. Insert the sample device into the sample port.
4. Press .
After the next sample is analyzed, the default panel is restored.
If you select Previous Screen, the system returns to the Ready screen and restores
the default panel.
This section provides an overview of the Patient Sample Results screen and the
printed sample report. Figure 2-17 shows the results screen. Your screen may
appear differently depending on your system and how parameters were defined in
setup.
#" !
The following table describes the symbols seen in patient sample reports:
!
******
The sensor is out of calibration.
------↑
The result is above the measurement range. On the screen, the result, dashes,
and arrow appear in red.
------↓
The result is below the measurement range. On the screen, the result, dashes,
and arrow appear in red.
*
The patient sample did not reach endpoint.
↑
The patient sample result is above the reference range. On the screen, the
result and arrow appear in red.
↓
The patient sample result is below the reference range. On the screen, the
result and arrow appear in red.
↑↑
The patient sample result is above the action range. On the screen, the result
and arrow appear in red.
↓↓
The patient sample result is below the action range. On the screen, the result
and arrow appear in red.
#
The patient sample contains substances that may interfere with glucose or
lactate measurement.
?
Optical measurements indicate that the CO-oximeter results should be
reviewed. See Troubleshooting Patient Results in Section 4.
Figure 2-18 shows an example of a printed report. Your printed report may appear
differently depending on your system and how parameters were defined in setup.
PATIENT SAMPLE REPORT
SYSTEM 865-1001
Patient Sample Data
Sequence no 00099
Accession no 00231
Source Arterial
JUL 12 1992
13:02
Analysis Date JUL 12 1992
Analysis Time 11:42
Draw Date JUL 12 1992
Draw Time 11:38
Operator ID 12345678901
Patient ID 12345678901
Pt Name John Jones
Birthdate 05 30 22
Age 70
Sex M
Physician ID 12345
Physician Dr. Smith
Location ICU
850
860
..........................................
.............................................................................
.........................................................................................
SYRINGE SAMPLE
ACID/BASE 37°C
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . pH
7.415
pCO2
79.8
pO2
58.0
HCO3-act
21.0
HCO3-std
22.0
ctCO2
26.0
BE(B)
1.0
BE(ecf)
1.0
840
CORRECTED 38.5°
pH
7.407
pCO2
81.6
60.1
pO2
Patient Sample Data
Sample Type
Units
mmHg
mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
Reference Range
(7.350 - 7.450)
( 35.0 - 45.0)
( 80.0 - 100.0)
mmHg
mmHg
Temperature
Corrected Values
OXYGEN STATUS 37°C
.......
ELECTROLYTES
Na+
K+
Ca++
Ca++(7.4)
Cl. . . . . . . . . . . . . . . . . . . . AnGap
METABOLITES
Glucose
Lactate
.................................
ENTERED
Temp
ctHb
FIO2
Flow
Resp Rate
p50
135.5
4.18
1.31
1.00
100
18.6
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
75.2
1.25
mg/dL
mmol/L
38.5
13.8
30.0
2.00
15.00
25.0
°C
mmol/L
%
L/min
b/min
mmHg
or = exceeds reference range
or
= exceeds action range
(135.0 - 145.0)
( 3.50 - 5.30)
( 1.12 - 1.30)
( 98.0 - 106.0)
( 66.8 ( 0.50 -
93.2)
2.60)
Entered Values
Report Symbols
The following table describes the messages that may appear in patient sample
reports on the roll printer:
****** = Not in
Calibration
The sensor is out of calibration.
------↑ or ------↓ = Out of
Range: ____
The result is above or below the measurement range.
* = D5 No Endpoint: __
The sensor did not reach a stable reading within the
predefined time limit.
* = exception or D–code
noted (in Patient Data Log)
The sample has an exception or D code. Appears in
Patient Data Log.
↑ or ↓ = exceeds reference
range
The result is above or below the reference range.
↑↑ or ↓↓ = exceeds action
range
The result is above or below the action range.
? = If blood, question data
Optical measurements indicate that the CO-oximeter
results should be reviewed. See Troubleshooting Patient
Results in Section 4.
SulfHb > 1.5%
The system detects a sulfhemoglobin concentration
greater than 1.5% in a CO-ox sample.
# = Interfering Substance:
Glu
The system detects the presence of substances in the
sample that may interfere with glucose measurement.
NOTE: Repeated, unexpected occurrence of this
message may indicate sensor failure. See Troubleshooting
Patient Results in Section 4.
# = Interfering Substance:
Lac
The system detects the presence of substances in the
sample that may interfere with lactate measurement.
NOTE: Repeated, unexpected occurrence of this
message may indicate sensor failure. See Troubleshooting
Patient Results in Section 4.
D38 Temperature Error
The system detects an error in the temperature control
system of the base model.
Bubbles Detected In
Sample
The system detects a non-continuous fluid in the sample
path of the base model.
COox Cover Open During
Meas
The cover on the CO-ox module was open while the
system was analyzing the sample.
COox Sample Chamber
Temp Error
The CO-ox module sample chamber temperature is ±
0.35°C of range and cannot accept sample analysis
requests.
COox Sample Temp Out
of Range
The CO-ox module sample chamber temperature is not in
range at the end of a measurement sequence.
Edited Report
The Patient Information screen was edited after initial
completion.
Excessive Bubbles in COox
Sample
The CO-ox module detects a non-continuous fluid in the
sample path.
D2 Excessive Drift: __
The sensor drift is beyond predefined limits during a
one-point or a two-point calibration.
Data Entry Incomplete
__ Not Sent
Appears when required data entry fields were not
completed and Auto Send is turned on.
Insufficient COox Sample
Appears when there is not enough sample to fill the
CO-ox module sample chamber and the analysis cannot
be performed.
Insufficient Sample
Appears when there is not enough sample to fill the
measurement module and you manually positioned the
sample for measurement.
Interfering Substance
Detected
Substances that interfere with analysis are present in the
sample. Only appears when 270 CO-ox is attached.
Interfering Substance: tHb
The CO-ox module detects the presence of substances in
the sample that may interfere with the measurement.
Measurement Module
Temp Error
The measurement module temperature is not in range and
the system cannot accept sample analysis requests.
Measurement Module
Temp Warning
The measurement module temperature is ± 0.15°C of
range and can accept sample analysis requests.
__ Not Sent
Appears when you press Do Not Send at the end of
analysis.
Sample Temperature
Out of Range
The measurement module temperature is not in range at
the end of measurement sequence.
__ Sent
Appears when you press Send at the end of analysis.
Use this procedure to recall patient sample data and results stored in the system.
When the system locates patient sample data, you can edit data, print reports, and
transmit the data to an LIS or a data management system.
1. Access the Patient Data Search Criteria screen from the Menu screen:
a. Select and press .
b. Select and press .
The Patient Data Search Criteria screen appears, as shown in Figure 2-19.
#" !
The Analysis Date fields contain the current day’s date. If you do not
complete any other fields, the system recalls all patient samples for this day.
Use this screen to enter the criteria that you want the system to use to search
for patient sample data. The system locates only the samples that meet all the
criteria you specify. For example, if you enter a patient ID, the system searches
for all samples with that patient ID. If you enter a patient ID and an analysis
date, the system searches only for samples with that patient ID and analysis
date. If you do not complete any of the criteria fields, the system recalls all the
samples stored in the system.
2. Type the search criteria and press after you complete each field.
for a selected date
type the date in both Analysis Date fields.
from the earliest date
to the present date
leave the Analysis Date and Analysis Time fields blank.
from the earliest date
to a specific date
leave the Analysis Date From field blank, and type the
specified date in the Analysis Date To field.
from a specific date
to the present date
type the start date in the Analysis Date From field, and type
nothing in the Analysis Date To field.
for a specific range
of dates
type the start date in the Analysis Date From field, and type
the end date in the Analysis Date To field.
by shift or any other
specific time period
type the start time in the Analysis Time From field, and
type the end time in the Analysis Time To field.
by sequence and
accession number
type the sequence number in the first Sample Sequence
Number field.
3. Press .
more than one
sample is found
the Patient Data Search Log screen appears, as shown in
Figure 2-20. The log contains the reports that the system
located for the search criteria specified. The most recent
report appears first.
Use the log to select reports you want to view, edit, print, or
transmit. You can also print the log.
one sample is found
the Patient Data Search Result screen appears, as shown in
Figure 2-21.
4. Select the report that you want to view and press .
The Patient Data Search Result screen appears.
!$# ! ! " 5. Edit, print, or transmit the appropriate patient reports.
6. Press Done when you finish.
more than one sample
is found
the Done Options message box appears.
Select Next Record and press to view the next report
that appears on the log.
Select Previous Record and press to view the
previous report that appears on the log.
Select Search Criteria Screen and press to view the
Patient Data Search Criteria screen.
Press to close this message box and return to the
Search Results screen.
one sample is found
the Patient Data Search Criteria screen appears as shown
in Figure 2-19.
Refer to the following procedures to edit patient data, print the report or the
log, or transmit the report.
!
If you press Home while in the Patient Data Search Criteria screen, all data is
cleared from the fields and the Ready screen appears.
If you want to recall patient samples for which no fields in the Patient Information
screen were completed, use the sequence number or the date and time of analysis
for the search criteria. View the Patient Data Search Log to locate the sequence
number and date and time of analysis.
If the selected sample has a D code or status message associated with it, the View
Diagnostics F-key appears. Press View Diagnostics to view the Diagnostics
message box. Scroll through the D codes and messages. Press Cancel when you
finish.
If no patient sample results are recalled, the system prompts you to ensure the
accuracy of the search criteria or to enter new search criteria.
Use this procedure to edit patient information that you recall. You can edit patient
information in the following ways:
Change the sample temperature or the hemoglobin value and recalculate the
results.
Change the text in fields on the Patient Information screen. You cannot edit
fields that are entered by the system, such as Analysis Date and Time and
Sequence Number.
1. Use the procedure described in Recalling Patient Sample Data, page 2-35, to
locate the sample you want to edit.
2. Press .
The Patient Information screen appears.
enter a new temperature
and recalculate results
a. Move to the temperature field.
b. Press .
c. Type the new temperature.
d. Press enter a new hemoglobin
value and recalculate
results
a. Move to the tHb field.
b. Press .
c. Type the new value.
d. Press 3. Press .
The system displays the Results screen, which now contains the changes you
made.
4. Press to return to the Ready screen.
If you change the patient ID to match another existing patient ID, the Duplicate
Patient ID message box appears.
Continue
accept the patient ID and return to the Patient Information screen.
Cancel
return to the Patient Information screen without accepting the patient ID.
Use this procedure to print or transmit data from the Patient Data Search Log
screen or the Patient Data Search Result screen.
1. Locate the sample you want as described in Recalling Patient Sample Data,
page 2-35.
2. Press .
The Reporting Options message box appears.
print a sample
report
a. Select Print Report and press .
transmit sample
results to an LIS
or HIS
b. Press . Refer to Figure 2-18 for an example of a
patient sample report.
a. Select Send Results and press .
b. Press .
3. Press to return to the Ready screen.
If the selected sample has a D code or status message associated with it, the View
Diagnostics F-key appears. Press View Diagnostics to view the Diagnostics
message box. Scroll through the D codes and messages. Press Cancel when you
finish.
The 800 systems accept QC samples from a syringe or from an aspiration adapter.
When you perform routine QC analysis, all parameters available on your system
are analyzed. You can specify a panel of parameters to analyze for each sample.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
1. Press .
The Sample Type menu appears as shown in Figure 2-22.
"! 2. Select and press .
If you are using Bayer Diagnostics controls, you can scan the bar code
on the ampule now.
analyze all parameters for
this sample
continue with step 3.
specify a panel of
parameters to analyze
a. Select . The Parameter Panel
appears.
b. Select the parameter panel and press .
c. Continue with step 3.
3. Prepare the sample and insert the device into the sample port. Figure 2-23
shows how to introduce a QC sample using an aspiration adapter.
Aspiration Adapter
Sample Port
QC Sample
To ensure the accuracy of the CO-ox measurement, close the
CO-ox cover before pressing Analyze.
4. Press .
5. When prompted, remove the sample device.
The QC File Information screen appears.
you already
scanned the
ampule
the QC File Information screen is complete. Continue with
step 7.
Auto ID is on
the system completes the data entry form automatically at the
end of analysis. The data entry form remains on the screen
until you press Done.
Press to assign the results to the file. The system then
displays the final results and prints the report. Continue with
step 8.
you did not scan
the ampule and
Auto ID is off
the QC File Information screen remains displayed until you
complete all required fields and press Done. Continue with
step 6.
6. Type the file number or scan the bar code from the ampule, and press .
When you enter the file number, the system scans the QC database for that file
number. If a match is found, the system completes the remaining fields except
the Operator ID field.
Refer to Entering QC Sample Data, page 2-43, if you need more information
to complete the QC File Information screen.
7. Perform the required action.
Accept
accept the results into the QC file and update the statistics.
Reject
store the results in the appropriate QC file, but the system does not
update the statistics.
Discard
discard the results.
The system stores the results in QC File 14. The system does not
update the statistics.
8. The system performs a wash at the end of analysis and then returns to the
Ready screen. If the system displays the Results screen after the wash finishes,
press to return to the Ready screen.
To interrupt sample analysis at any time, press Cancel. The system stops analysis
and performs a wash. The Ready screen appears when the wash finishes.
If you press Done before you enter the QC file number in the QC File Information
screen, the Unidentified QC File message box appears. Press OK to return to the
File ID field and enter the file number.
If you press Done in the QC File Information screen and a field contains incorrect
data, the QC Data Mismatch message box appears. Press OK to enter the correct
data.
If you scan a bar code other than the QC ampule bar code, the Bar Code Not
Recognized message box appears. Press OK. The QC File Information screen
appears. Scan the correct QC ampule bar code.
If you scan a bar code for a QC sample that you have not defined in setup, the QC
File Not Defined message box appears. Press OK. You must define the QC file for
the QC material before you can analyze and store the results.
If you do not press Analyze within 30 seconds while in the Sample Type menu, the
system returns to the Ready screen with the default sample type selected.
If you do not complete the QC File Information screen within 5 minutes, the
system stores the results in QC File 14, sends a message to the status log, and
returns to the Ready screen. You can search for the results in File 14 by sequence
number and analysis time. Refer to Recalling QC Data, page 2-45.
If the results fall outside of the established control limits, take corrective action
according to procedures established for your laboratory. Bayer Diagnostics
recommends that you do the following:
Ensure that the calibration reagents and quality control materials are not expired
or deteriorated.
Visible signs of deterioration include color changes or cloudiness of the reagents
or quality control materials.
Ensure that you followed the operating procedures recommended in this manual.
Ensure that you handled and sampled the quality control materials according to
the procedures recommended by the manufacturer.
If required, analyze the quality control materials again.
Use this procedure to enter QC sample data in the QC File Information screen. You
can complete the QC File Information screen using the optional bar code scanner,
the keypad or a keyboard, or you can have the system do it automatically.
1. Complete the QC data fields as shown in Figure 2-24.
! use the keypad or
keyboard
type the File Number and press .
use the optional
bar code scanner
scan the bar code label on the QC ampule.
turn Auto ID on
NOTE: To ensure accurate sample identification, scan QC
ampule bar codes only after selecting Quality Control (QC)
from the Sample Type screen or when the QC File Information
form is displayed.
system automatically determines which file and completes the
QC File Information screen.
NOTE: If the pH or pCO2 sensor or tHb is disabled or not in
calibration, Auto ID does not work.
do not complete
the screen
system stores results in QC File 14 and a message that contains
the sequence number and date and time of analysis is placed in
the status log. Refer to Editing QC Data, page 2-48, to move
the results to the correct file.
2. Type the Operator ID and press .
If you want to change text in the QC File Information screen after you press
Done, press . The QC File Information screen reappears. Make
your changes and press .
If you do not identify a QC file and you press Done, a message box appears
prompting you to identify the QC file. Press OK to return to the QC File
Information screen and complete the File Number field.
If you do not identify the QC file and press Done within 5 minutes, the QC sample
results are stored in the Discarded Data File. The system returns to the Ready
screen. Refer to Recalling QC Data, page 2-45, for instructions to recall, edit, and
print QC sample data after results are stored.
If you scan a bar code label that is not a QC ampule bar code, a message box
appears prompting you to scan a QC ampule bar code. Press OK to return to the
QC File Information screen and scan the correct QC ampule bar code label.
Use this procedure to recall the current month’s QC sample data and statistics.
When the system locates the QC sample data, you can edit the data, print reports,
and transmit the data to an LIS or data management system.
You can recall QC data for the previous month by archiving the previous month’s
QC data and then viewing the data. Refer to Archiving QC Data and Viewing
Archived QC Data in Section 5.
1. Access the Recall QC Data screen from the Menu screen:
2. Select and press .
a. Select and press .
The QC Data Search Criteria screen appears, as shown in Figure 2-25.
$# " " ! " "
The Analysis Date fields contain the current day’s date. If you do not
complete any other fields, the system recalls all QC samples for this day.
Use this screen to enter the criteria used to search the system for QC sample
data. The system uses all entered parameters when searching for patient data.
Samples meeting all criteria are recalled. For example, if you enter a QC file
number, the system searches for all samples stored in that QC file. If you enter
a file number and an analysis date, the system searches only for samples stored
in that QC file and analyzed on that date. If you do not complete any of the
criteria fields, the system recalls all the QC samples stored in the system.
3. Type the search criteria and press after you complete each field.
" ! for a selected date
type the date in both Analysis Date fields.
from earliest date to
the present date
leave the Analysis Date and Analysis Time fields blank.
from the earliest date
to a specific date
leave the Analysis Date From field blank, and type the
specified date in the Analysis Date To field.
from a specific date
to the present date
type the start date in the Analysis Date From field, and
type nothing in the Analysis Date To field.
for a specific range of
dates
type the start date in the Analysis Date From field, and
type the end date in the Analysis Date To field.
by shift or any other
specific time period
type the start time in the Analysis Time From field and the
end time in the Analysis Time To field.
4. Press .
more than one sample
is found
the QC Data Search Log screen appears as shown in
Figure 2-26.
one sample is found
the QC Data Search Result screen appears as shown in
Figure 2-27.
$# 5. Select the report that you want to view and press .
The QC Data Search Result screen appears.
!#" ! 6. Use this screen to edit, print, or transmit QC reports; to view and print
Levey-Jennings Charts; and to print statistical summary reports. When a
CO-ox module is attached, you press to display the CO-ox
parameters.
7. Press .
more than one
sample is found
the Done Options message box appears:
Select Next Record and press to view the next
report that appears on the log.
Select Previous Record and press to view the
previous report that appears on the log.
Select Search Criteria Screen and press to view the
QC Data Search Criteria screen.
Press to close this message box.
one sample is
found
the QC Data Search Criteria screen appears as shown in
Figure 2-25.
8. Press to return to the Ready screen.
!
If no QC sample results are recalled, the No QC Data message box appears. Press
OK to return to the QC Data Search Criteria screen.
If the selected sample has a D code or status message associated with it, the View
Diagnostics F-key appears. Press View Diagnostics to view the Diagnostics
message box. Scroll through the D codes and messages. Press Cancel when you
finish.
Use this procedure to edit QC data that you recall. You can edit QC data in the
following ways:
move a QC report to a different file.
change the Accept, Reject, or Discard status.
1. Use the procedure described in Recalling QC Data, page 2-45, to locate the
QC sample you want to edit.
2. Press .
The QC File Information screen appears.
edit data in text fields
a. Move to the field you want to edit.
b. Type the changes and press .
edit the status of a
QC sample
a. Move the cursor to the Status field.
b. Press until the status you want appears.
3. Press .
The system displays the QC Data Search Result screen, which now contains
the changes you made.
4. Press to return to the Ready screen.
If you change the file, level, or lot number on a QC report, the report moves to the
new file number. For example, if you change file number 2 to number 3, the file
moves to file 3 when you press Done. The statistics for each file are updated.
If you change the status of a QC sample, the file statistics are adjusted. For
example, if you originally discarded the results of a QC sample and you change the
status to Accept, the system stores the edited results and updates the
Levey-Jennings chart and the file statistics.
Use this procedure to print or transmit data from the QC Data Search Criteria Log
screen or the QC Data Search Result screen.
1. Locate the sample you want as described in Recalling QC Data, page 2-45.
2. Press .
print a QC sample report
a. Select Print QC Sample Report and
press .
b. Press . Refer to Figure 2-28 for an example of
a QC sample report.
a. Select Send Results and press .
transmit a QC sample
report to an LIS or data
management system
b. Press .
! QC SAMPLE
SYSTEM 850-1001
Sequence No 00099
Operator ID 12345
Analysis Date Apr 12 1994
Analysis Time 11:42
APR 12 1994 13:02
QC ID 123
Level 1
Lot 12345
Expiration Dec 31 1995
QC File Information
.................................
...........
..............
850
..............
860
....................
..........................
Results
Units
Target Range
pH
7.613
(7.594 - 7.634)
pCO2
21.0
mmHg
(19.8 - 23.8)
pO2
148.8
mmHg
(142.9 - 162.9)
.......
Na+
155.9
mmol/L
(150.6 - 160.6)
K+
7.0
mmol/L
(6.72 - 7.72)
Ca++
0.65
mg/dL
(0.55 - 0.75)
. . . . . . . . . . . . . . . . . . . . Cl100
mmol/L
(95 - 105)
Glucose
41
mg/dL
(30 - 50)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Lactate
. . . . . . . . . . . . . . . . . . . 12.15
. . . . . . . . . . . . . . . .mmol/L
. . . . . . . . . . . . . .(9.82
. . . . . . . .. . .13.82)
.....................
ctHb
14.4
g/dL
(13.5 - 15.5)
FO2Hb
1.3
%
(0.7 - 1.7)
FCOHb
96.0
%
(93.5 - 97.5)
FMetHb
0.5
%
(0.2 - 0.6)
. . FHHb
. . . . . . . . . . . . . . . . . . . . . . .2.2
. . . . . . . . . . . . .%. . . . . . . . . . . . . . . . . .(2.1
. . . . . . .-. . .3.1)
..................
840
These results
CO-ox appear when an
845, 855, or 865
is interfaced.
Accepted into QC File 1
File Status
3. Press to return to the Ready screen.
The following result flags can appear on printed reports:
*
the measurement did not reach endpoint.
↑
the result is above the upper limit of the target range.
↓
the result is below the lower limit of the target range.
↑↑
the result is above the upper limit of the action range.
↓↓
the result is below the lower limit of the action range.
- - -↑
the result is above the upper limit of the measurement range.
- - -↓
the result is below the lower limit of the measurement range.
The following table describes the messages that may appear in QC sample reports
on the roll printer:
****** = Not in Calibration
Sensor is out of calibration.
* = D5 No Endpoint: __
QC sample analysis did not reach endpoint.
↑ or ↓ = exceeds target range
QC sample result is above or below the target range.
↑↑ or ↓↓ = exceeds action
range
QC sample result is above or below the action range.
ACCEPTED INTO QC FILE
__
Indicates the QC result status (accepted) and the file
number in which the results are stored.
Bubbles Detected In Sample
System detects a non-continuous fluid in the
measurement module sample path.
D2 Excessive Drift: __
Sensor drift is beyond predefined limits during a
one-point or a two-point calibration.
D38 Temperature Error
System detects an error in the temperature control
system.
DISCARDED INTO QC
FILE __
Indicates the QC result status (discarded) and the file
number in which the results are stored.
REJECTED INTO QC
FILE __
Indicates the QC result status (rejected) and the file
number in which the results are stored.
Use this procedure to print statistical summary reports for the current month’s QC
data. The statistical summary report includes QC samples analyzed to date.
You can print statistical summary reports for the previous month by archiving the
previous month’s QC data and then printing statistical summary reports for the
archived data. Refer to Archiving QC Data and Viewing Archived QC Data in
Section 5.
1. Locate the QC file, as described in Recalling QC Data, page 2-45.
2. Press .
3. Select Print Statistical Summary and press .
4. Press .
The statistical summary report prints as shown in Figure 2-29.
If a QC file has fewer than five data points, the standard deviation and the
coefficient of variation do not print.
QC STATISTICAL SUMMARY
System 850-1001
APR 12 1994
11:42
File: 1
QC ID 1234
Level 1
Lot number 93419
Expiration date Jul 12 1995
QC File Information
Standard Deviation
Month-to-Date Statistics Apr 1 1994 To Apr 12 1994
Mean
SD
CV
n
Number of Samples
pH
7.12
0.015
0.2
45
840 pCO2
80.4
3.1
3.9
48
49
0.6
1.2
46
pO2
.......
850
tHb
13.7
0.2
1.4
50
Na
143.0
1.2
0.8
47
860
Coefficient of Variation
+
K
10.94
0.25
2.3
46
. . . . . . . . . . . . . . . . . . . . Ca++
1.63
0.7
1.1
47
Cl79
0.2
2.2
48
Glucose
38
0.4
1.2
46
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Lactate
. . . . . . . . . . . . . .11.82
. . . . . . . . . . . . . . . 0.5
. . . . . . . . . . . . . . . .4.2
. . . . . . . . . . . . . . .46
.....................
tHb
15
0.1
0.2
44
These results
0.3
0.1
44.3
44
FO2Hb
FCOHb
98.0
0.1
0.3
44
CO-ox appear when an
FMeTHb
0.1
0.1
92.1
44
845, 855, or 865
FHHb
1.5
0.2
11.4
44
..............
...........
..............
....................
............................
.................................
....................................................................................
Lot-to-Date Statistics Apr 1 1994 To Apr 12 1994
Mean
SD
CV
n
pH
7.15
0.004
0.1
460
71.2
1.1
1.6
465
pCO2
65.8
1.4
2.2
472
pO2
tHb
11.4
0.20
1.8
479
Na
142.0
0.4
1.0
462
K+
9.8
0.2
0.9
470
++
Ca
1.61
0.6
1.2
461
Cl77
0.4
1.0
460
Glucose
39
0.5
1.3
459
ctHb
15.1
0.1
0.3
451
0.3
0.1
44.4
451
FO2Hb
FCOHb
98.1
0.2
0.2
451
FMetHb
0.1
0.1
91.1
451
FHHb
1.5
0.2
11.5
451
is interfaced.
5. Press to return to the Ready screen.
Use this procedure to view and print Levey-Jennings charts of the current month’s
QC data.
You can print Levey-Jennings charts for the previous month by archiving the
previous month’s QC data and then printing Levey-Jennings charts of the archived
data. Refer to Archiving QC Data and Viewing Archived QC Data in Section 5.
1. Access the Recall QC Data screen from the Menu screen:
a. Select and press .
b. Select and press .
The QC Data Search Criteria screen appears.
2. Type only the file number and press .
The QC Data Search Criteria Log screen appears.
3. Select .
NOTE: You can view the previous month’s Levey-Jennings charts before you
analyze the first QC sample of the current month. After you analyze the first QC
sample of the current month, Levey-Jennings charts contain data only for the
current month.
4. Select either Levey-Jennings Current Month or Levey-Jennings Previous
Month.
5. Press .
6. The Levey-Jennings Parameter Selection screen appears.
7. Select the parameter you want to display on the chart and press .
8. Press .
The Levey-Jennings Chart appears, as shown in Figure 2-30.
Lot 331302
88.3
78.3
System 850-1001
QC ID 473841
LEVEL 1
Expiration Date DEC 12 1995
pCO2
Month
APR
QUALITY CONTROL LEVEY-JENNINGS CHART
April 10 1994
16:25
Y-axis shows
measured values
68.3
58.3
48.3
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
Rejected Values
X-axis shows days
of the month
Accepted Values
Upper Target Limit
(+2SD)
Target Value
(mean)
±3SD
Lower Target Limit
(-2SD)
The Levey-Jennings chart for the previous month displays only the
data points for QC samples remaining in the file. The Levey-Jennings chart for
the current month displays only the data points for QC samples analyzed to
date.
9. Perform one of the following tasks.
print a Levey-Jennings report
press . The Levey-Jennings report prints.
view a Levey-Jennings report
for another parameter
press . Select a different
parameter and press .
return to the QC Data Search
Criteria screen or the QC Data
Search Log
press .
10. Press to return to the Ready screen.
If the QC Data Search Log contains samples from more than one file and you
choose to view a Levey-Jennings chart, the chart that appears is for the file number
of the sample that you selected on the log.
The following symbols appear on Levey-Jennings charts:
The results are accepted.
The sample is rejected.
x
The result is beyond the 4 standard deviations range.
"! " %& You can perform calibrations from either the Analyze mode or the Menu mode. All
calibrations available on the 840, 850, and 860 are also available on systems with
the CO-ox module—the 844, 845, 854, 855, 864, and 865.
1. Press .
The Calibration Type menu appears, as shown in Figure 2-31.
# (' " % # # ! ! " "
$(" "
!! " " " "
" "
2. Select a calibration type and press .
The tHb Slope Calibration requires you to enter a value and to
introduce the slope reagent. Refer to Performing tHb Slope Calibrations, page
2-57, for instructions.
3. Press .
4. Press to return to the Ready screen.
# "!
If the Auto Repeat function is on or Flexible Time calibration intervals are selected
and a parameter shows excessive drift, the system prints a report and repeats the
appropriate calibration for the parameter. Refer to Selecting Calibration Frequency
and Automatic Repeat in Section 5 for more information about these functions.
If a sensor does not reach endpoint within 90 seconds, the parameter value appears
on the screen with an asterisk and the message D5 No Endpoint also appears. The
sensor is considered not in calibration until the system completes a successful
calibration.
The metabolite one-point calibration is available only from the Analyze mode.
You can perform calibrations from either the Analyze mode or the Menu mode. All
calibrations available on the 840, 850, and 860 are also available on systems with
the CO-ox module—the 844, 845, 854, 855, 864, and 865.
1. From the Menu screen, select and press .
The Calibration menu appears, as shown in Figure 2-32.
2. Select a calibration type and press .
The tHb Slope Calibration requires you to enter a value and to
introduce the slope reagent. Refer to Performing tHb Slope Calibrations on
page 2-57 for instructions.
3. Press to return to the Ready screen. If you do not press Home, the
system automatically returns to the Ready screen after 45 seconds.
If the Auto Repeat function is turned on or Flexible Time calibration intervals are
selected and a parameter shows excessive drift, the system prints a report and
repeats the appropriate calibration for the parameter. Refer to Selecting Calibration
Frequency and Automatic Repeat in Section 5 for more information about these
functions.
If a sensor does not reach endpoint within 90 seconds, the parameter value appears
on the screen with an asterisk and the message D5 No Endpoint also appears. The
sensor is considered not in calibration until the system completes a successful
calibration.
The metabolite one-point calibration is available only from the Analyze mode.
Use this procedure to calibrate the tHb slope for the CO-ox module. You can
perform this calibration from either the Analyze mode or
the Menu mode.
1. Initiate the tHb slope calibration procedure.
Analyze mode
a. Press .
b. Select Menu mode
a. Select and press .
b. Select and press .
The tHb Slope Calibration screen appears, as shown in Figure 2-33.
2. Enter the slope value for the slope reagent and press .
The last-entered value is displayed. To remove this value, press the
F-key and enter the new value.
3. Press .
4. Insert the sample device into the sample port.
5. Press .
6. When prompted, remove the sample device.
The system performs a wash at the end of the calibration and then returns to
the Ready screen.
Press Cancel to interrupt a calibration.
The system starts a wash and the Wash screen appears. The system returns to the
Ready screen at the end of the wash.
The maximum time between tHb slope calibrations is 90 days. One day before a
tHb slope calibration is scheduled, a status message appears on the screen
indicating that a calibration is due.
Use this procedure to calibrate the internal atmospheric pressure sensor to a
barometer in your laboratory.
1. Access the Barometer Calibration screen from the Menu screen:
a. Select and press .
b. Select and press .
2. Type the correct atmospheric pressure and press .
The acceptable range for atmospheric pressure is 400 – 825 mm Hg
(53.0 – 110.0 k Pa).
3. Press to save the new atmospheric pressure and return to the Ready
screen.
Press to interrupt a calibration.
If you interrupt an automatic calibration, the system will attempt to start the
calibration again in 90 seconds. You can delay calibrations for up to 30 minutes
beyond the scheduled time. After 30 minutes, the system starts the required
calibration. You cannot analyze samples until the required calibration completes.
You cannot defer a one-point calibration that is initiated following rapid sampling.
You can interrupt or defer the one-point calibration that occurs when the 5 minute
timer expires.
The maximum times between automatic one-point and two-point calibrations are
60 minutes and 240 minutes, respectively. Five minutes before an automatic
calibration is scheduled, a status message appears on the screen indicating that a
calibration is pending.
You can print calibration data and send the data to an LIS or a data management
system. You cannot edit calibration data.
1. Access the Recall Calibration Data screen from the Menu screen:
a. Select and press .
b. Select and press .
2. Select a calibration type and press .
3. Type the search criteria and press .
The Calibration Date fields contain the current day’s date. If you do
not complete any other fields, the system recalls all one-point calibrations for
this day.
for a selected date
type the date in both Calibration Date fields.
from the earliest date to a
specific date
leave the Calibration Date From field blank and type
the specific date in the Calibration Date To field.
from a specific date to the
present date
type the start date in the Calibration Date From field
and leave the Calibration Date To field blank.
by shift or any other
specific time period
type the start time in the Calibration Time From field
and type the end time in the Calibration Time To
field.
4. Press .
more than one calibration
is found
the Calibration Data Search Log screen appears as
shown in Figure 2-34. Continue with step 5.
one calibration is found
the Calibration Data Search Result screen appears, as
shown in Figure 2-35. Continue with step 6.
"&% ! ! ! $ ! !
! ! !
The system uses two sequence numbers for two-point calibrations.
Only one number appears in the log.
5. Perform the appropriate task at the Calibration Data Search Log.
$" #! ! view the data for a
calibration
select the report you want and press . The
Calibration Data Search Result screen appears, as shown
in Figure 2-35.
print a calibration report
a. Select the report you want.
b. Press .
c. Press The calibration report prints, as shown in
Figure 2-36.
transmit the results to an
LIS or a data management
system
a. Select the report you want.
b. Press .
c. Select Send Results and press .
d. Press .
"&% ! ! "! !
! ! !$
" "
! !
! !
! ! !
! ! ! ! !
6. Perform the appropriate task at the Calibration Data Search Result screen.
$" #! ! print the calibration report
a. Press .
b. Press . The calibration report prints, as
shown in Figure 2-36.
transmit the results to an LIS
or a data management
system
a. Press .
b. Select Send Results and press .
c. Press .
2-POINT CALIBBRATION REPORT
SYSTEM 860-1001
Sequence no 433
Calibration Date
Calibration Time
850
860
...........
......................
............................
.................................
840
.......
....................
.................................
850
860
...........
..........................
..............................
.................................
840
.......
....................
.................................
APR 12 1994 13:02
APR 12 1994
11:42
CAL POINT
pH
pCO2
pO2
Na+
K+
Ca++
ClGlucose
Lactate
pAtm
New
7.382
35.4
85.0
140.0
4.00
1.25
100
0
0.00
Meas
7.381
34.9
85.0
140.9
4.00
1.26
99
0
0.02
755
Drift
-0.001
-0.5
0.0
0.9
0.00
0.01
-1
0
0
Meas
6.839
71.3
-0.1
100.3
8.04
2.52
70
180
0.02
Drift
0.001
0.5
-0.1
0.3
0.04
0.02
0.00
0
0
Units
mmHg
mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
mmol/L
mmHg
SLOPE POINT
pH
pCO2
pO2
Na+
K+
Ca++
ClGlucose
Lactate
New
6.838
70.8
0.0
100.0
8.00
2.50
70
180
0.00
Atmospheric pressure
appears on all systems
Units
mmHg
mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
mmol/L
7. Press when you finish.
more than one report is
found
the Done Options message box appears:
Select Next Record and press to view the next
report that appears on the log.
Select Previous Record and press to view the
previous report that appears on the log.
Select Search Criteria Screen and press to view the
Calibration Data Search Criteria screen.
Press to close this message box. The Search
Results screen appears.
one sample is found
the Calibration Data Search Criteria screen appears.
If the selected sample has a D code or status message associated with it, the View
Diagnostics F-key appears. Press View Diagnostics to view the Diagnostics
message box.
The following result flags can appear on printed reports:
*
the measurement did not reach endpoint.
↑
the calibration is above the upper drift limit.
↓
the calibration is below the lower drift limit.
- - -↑
the result is above the upper limit of the measurement range.
- - -↓
the result is below the lower limit of the measurement range.
The following table describes the messages that may appear in calibration reports
on the roll printer:
↑ or ↓ = D2
Excessive Drift: __
Sensor drift is beyond predefined limits during a one-point or a
two-point calibration.
* = D5 No Endpoint:
__
Calibration did not reach endpoint.
D3 Slope Error: __
Sensor slope is beyond predefined limits during a two-point
calibration.
D4 Offset Error: __
Sensor offset is beyond predefined limits during a one-point or
a two-point calibration.
D22 Barometric
Pressure Error
(for gas cals)
Signal from the barometer detects atmospheric pressure beyond
predefined limits.
D50 Glucose Sensor
Error
System detects an open connection in the glucose sensor.
D51 Lactate Sensor
Error
System detects an open connection in the lactate sensor.
..
" " %!"
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5
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5
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5
%" '&*$ /%" -+)"/"-
5
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&
*(34&*$ &$% 5
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&
",-+/"&*&4&*$ /%" ),(" /%
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5
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5
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'!)%)# /$! 6*3 (+'! $(!-
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'!)%)# /$! !(*'45!-
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6
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6
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6
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6
-%(%)# /$! 4./!(
6
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6
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6
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6
"&+"&"& +! .*+%
($"& +! )"&+) ()
/
"$$"& +! )& &*')
/
($"& +! )& &*')
/
($"& +! )& &*') **++
/
($"& +! &+)&$ )& $+)'
/
"$$"& +! *,)%&+ &*')*
/
($"& +! *,)%&+ ') %($ )',&%()+,) &*')*
/
($"& +! $,'* & ++ "'*&*')*
/
"&*+$$"& &*')
/
($"& +! * &#*
/
($"& +! * ,"&
/
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($"& +! %($ ')+
/
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/
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/
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/
($"& +! /'- %(
/
($"& +! .*+% ,**
/
..
Use this procedure to view pending maintenance tasks and record completed
maintenance tasks in the maintenance log.
Menu Code
2
4
1. Access the Maintenance Schedule screen from the Menu screen:
a. Press 2 Maintenance and press Enter.
b. Press 4 View Schedule and press Enter.
The Maintenance Schedule screen appears as shown in Figure 3-1.
Tasks due for the current date appear at the top of the scroll list.
"! 2. Use the arrow keys to highlight the task you want to record as completed.
3. Press Task Done.
The Maintenance Task Done dialog box appears.
4. Enter your operator ID and press OK.
The Maintenance Schedule screen reappears with the updated task list.
5. Select another task to record or press Done to return to the Menu screen.
Record maintenance tasks on the day you complete them. If you perform a task on
Monday but record it on Tuesday, the system will list the task as being completed
on Tuesday, not Monday.
Use this procedure to print a Maintenance Schedule Report from the
Maintenance Schedule screen. The report lists all the maintenance tasks for the
system model. The tasks are sorted by frequency. Tasks due for the current date
appear at the top of the report. The Due field displays the date on which the task is
due next. The Date/Time Done field displays the date and time the maintenance
task was last recorded as complete. If a task was not performed, the Date/Time
field is blank.
Menu Code
2
4
1. Access the Maintenance Schedule screen from the Menu screen:
a. Press 2 Maintenance
b. Press 4 View Schedule.
2. Press Print.
3. Press Done to return to the Menu screen.
Use this procedure to view and print the list of completed maintenance tasks for
the current or the previous month.
Menu Code
4
3
1. Access the Maintenance Log screen from the Menu screen:
a. Press 4 Data Recall and press Enter.
b. Press 3 Maintenance Log and press Enter.
The Maintenance Log screen appears as shown in Figure 3-2.
2. Use the arrow keys to scroll through the task list.
3. Press Previous Month to view tasks completed in the previous month.
4. Press Done to return to the Menu screen.
The system only keeps two months of data online. At Autoclean time on the first
day of each month, the data is rotated and the oldest data is erased.
The daily maintenance schedule is based on analyzing 30 samples per day, unless
otherwise noted. If your laboratory analyzes more than 30 samples per day,
perform daily maintenance more frequently.
Materials required:
10% solution of household bleach
NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent
quality water.
reagent-quality water44
lint-free tissues or swabs
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Wipe with a 10% solution of household bleach all exterior surfaces, including:
the sample entry components and the drip tray
the waste area
NOTE: Do not insert swabs into the sample port or spray anything into the
measurement module.
1. Rinse the exterior surfaces with reagent-quality water.
NOTE: Bayer Diagnostics recommends using reagent-quality water in accordance
with NCCLS guidelines. Refer to the Water Quality Technical Bulletin included at
the back of this manual.
2. Clean spills around the roller cages:
a. Remove the roller cage as described in Replacing a Roller Cage, page
3-96.
b. Clean the roller cage and the roller cage shaft with a 10% solution of
household bleach.
c. Rinse with reagent-quality water and dry thoroughly.
d. Reinstall the roller cage.
Wear safety glasses, gloves and a laboratory coat when handling the
reagents.
Check the reagent levels and expiration dates for the 7.382 Buffer, 6.838 Buffer,
Wash G/L Zero, Cleaning Solution, and Cal G/L reagents. On the Ready screen,
press Enter to display the Reagent Levels screen as shown in Figure 3-3.
View the reagent levels. Replace the bottles if they are empty, nearly empty, or are
at the expiration date as described in Replacing the Reagent Bottles, page 3-65.
Check the amount of paper on the roll. A pink line on the paper indicates that the
roll is nearly empty. Replace the paper if the roll is empty or nearly empty as
described in Replacing the Printer Paper, page 3-66.
Check the fluid volume in the waste bottle. Empty the waste bottle if it is at or near
the waste full line as described in Emptying the Waste Bottle, page 3-45.
Menu Code
3
2
1. Access the Temperature screen from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 2 Temp/pAtm and press Enter.
2. Press Start Test.
3. Press Stop Test.
4. Check the screen to verify that the sample temperature is 37 ±0.15°C for the
base model and 37 ±0.35°C for the CO-ox module.
NOTE: The 37°C temperature point is NIST traceable.
5. Press Exit Test.
Use this procedure to check the atmospheric pressure detected by the 800 system.
Menu Code
1
8
1. Access the Barometer Calibration screen from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 8 Barometer and press Enter.
2. Compare the displayed atmospheric pressure to your laboratory’s barometer
reading.
correct
press Done.
incorrect
a. Type the correct atmospheric pressure and press
Enter.
b. Press Done to save the new atmospheric
pressure and return to the Ready screen.
c. Perform a gas two-point calibration.
The twice weekly maintenance schedule is based on analyzing 30 samples per day,
unless otherwise noted. If your laboratory analyzes more than 30 samples per day,
perform twice weekly maintenance more frequently.
Use this procedure to verify the performance of the glucose and lactate biosensors.
Materials required:
High G/L ampule
aspiration adapter
1. Perform a successful two-point calibration.
2. Prepare the High G/L ampule and insert an aspiration adapter into the sample
port and into the ampule.
3. Press Analyze
4. When prompted, remove the sample.
5. Type the required information in the Patient Information screen and press
Done.
6. Review the results.
If the glucose or lactate results are below the values recommended on the High
G/L package insert, replace the affected biosensor as described in Replacing
the Glucose and Lactate Biosensors, page 3-86.
The weekly maintenance schedule is based on analyzing 30 samples per day,
unless otherwise noted. If your laboratory analyzes more than 30 samples per day,
perform weekly maintenance more frequently.
Use this procedure to clean the sample path with deproteinizer once a week or
every 210 samples. Deproteinizing removes protein buildup from the sample path.
NOTE: If your system has a CO-ox module, follow the procedure described for
the appropriate base model. For example, information identified for an 860 also
applies to an 865.
Materials required:
deproteinizer
aspiration adapter
glucose and lactate test/blank sensors (TB4)
1. Prepare the deproteinizer as directed on the package.
Menu Code
2
1
2. Access the Deproteinize screen from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 1 Deproteinize and press Enter.
CAUTION: Do not expose the glucose and lactate biosensors to deproteinizer.
CAUTION: Do not remove or return the sensors to the measurement module
Replace the biosensors with the test/blank sensors (TB4) before deproteinizing.
Reinstall the biosensors within 2 hours.
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
3. Take the appropriate action.
840 or 850
go to step 4.
860
a. Remove the glucose and lactate biosensors.
b. Install the test/blank sensors.
c. Go to step 4.
4. Invert the deproteinizer vial several times to mix.
5. Insert an aspiration adapter into the sample port and insert the other end into
the deproteinizer vial, or decant the deproteinizer into a syringe and insert the
syringe into the sample port.
6. Press Analyze.
7. When prompted, remove the adapter or syringe.
8. Wait 5 minutes for the deproteinizing cycle to finish.
9. Take the appropriate action.
CAUTION: Do not remove or return the sensors to the measurement module
NOTE: As you reinstall the biosensors, ensure that the biosensors are in the
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
correct location. Visually verify that you align the contacts on the biosensors with
the contacts in the measurement module. You can slide the remaining sensors to
the right to create more space.
you want to condition
the sensors
press Yes. The Conditioning screen appears. Go to step 2 of
Conditioning the Sensors, page 3-14.
you do not want to
condition the sensors
a. Press No.
A wash starts. When the wash finishes, a message box
appears prompting you to perform a two-point calibration.
b. On the 860 remove the test/blank sensors and reinstall the
biosensors.
c. Press Yes.
Press Cancel to stop deproteinizing. The system performs a wash and then
displays the Calibrate System message box.
Use this procedure to condition the sensors once a week or after 210 samples.
Conditioning cleans and conditions the glass membranes of the pH and sodium
sensors.
Materials required:
conditioner
syringe
glucose and lactate test/blank sensors (TB4)
NOTE: If your system has a CO-ox module, follow the procedure described for
the appropriate base model. For example, information identified for an 860 also
applies to an 865.
Menu Code
2
2
1. Access the Condition screen from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 2 Condition and press Enter.
CAUTION: Do not expose the glucose and lactate biosensors to the conditioner.
CAUTION: Do not remove or return the sensors to the measurement module
Replace the biosensors with the test/blank sensors (TB4) before conditioning.
Reinstall the biosensors within 2 hours.
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Take the appropriate action.
840 or 850
go to step 3.
860
a. Remove the glucose and lactate biosensors.
b. Install the test/blank sensors.
c. Go to step 3.
3. Draw the conditioner solution into a syringe.
4. Insert the syringe into the sample port.
5. Press Analyze.
6. When prompted, remove the syringe.
7. Wait 10 minutes for the conditioning cycle to finish.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
NOTE: As you reinstall the biosensors, ensure that the biosensors are in the
correct location. Visually verify that you align the contacts on the biosensors with
the contacts in the measurement module. You can slide the remaining sensors to
the right to create more space.
8. Remove the glucose and lactate test/blank sensors and reinstall the glucose and
lactate biosensors as described in Replacing the Glucose and Lactate
Biosensors, page 3-86.
9. Press Yes to perform a two-point calibration.
10. Analyze a minimum of two levels of quality control material to verify sensor
performance.
"
!
Press CANCEL to stop conditioning. The system performs a wash and then
displays the Calibrate System message box.
! "
The main tank pressure must be higher than 300 psi. The second stage pressure
must be 3 to 5 psi.
1. Check the main tank and second-stage pressure for each gas tank by looking at
pressure gauges on the gas tank regulator as shown in Figure 3-4.
"&$%! "!
"
"
& !
" "
#
" !! 2. If the main tank pressure is below 300 psi, verify that the gas tank is open.
3. If the main tank is open and the pressure is still below 300 psi, replace the tank
as described in Replacing the Gas Tanks, page 3-90.
Use this procedure to ensure that the sensors contain fill solution to the levels
described in Figure 3-5.
pH, K+, Cl–, and Ca++
nearly full and with a bubble at the top
Na+
to the top
Reference
to the fill line
NOTE: The pO2 and pCO2 sensors do not require you to maintain them, even
though they have fill solution. Slight discoloration of the fill solution in the pO2
and pCO2 sensors is normal.
NOTE: The glucose and lactate biosensors do not require fill solution.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Open the measurement module door as shown in Figure 3-6:
a. Push up the latches on the measurement module door.
b. Lift the door.
3. Verify that the reference sensor fill solution is not below the fill line. Refer to
Filling the Reference Sensor, page 3-69.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
4. If necessary, fill the sensor as described in Filling the Reference Sensor,
page 3-69.
5. Verify that the pH, K+, Cl–, and Ca++ sensors are almost full with only a
bubble at the top and that the Na+ sensor is completely full.
If any sensor is not properly filled, replace the fill solution as described in
Filling the Measurement Sensors, page 3-80.
6. Close the measurement module door.
7. Press Continue and allow the system to warm up.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
you want to perform a
two-point calibration
press Yes.
you do not want to perform a
two-point calibration
a. Press No.
b. Press Home to return to the Ready screen.
" The monthly maintenance schedule is based on the expiration date of the opened
reagents.
! Effective cleaning is accomplished by alternating Cleaning Solution 1 (C1) and
Cleaning Solution 2 (C2) each month.
C1 is on your system
replace it with C2.
C2 is on your system
replace it with C1.
Wear safety glasses, gloves, and a laboratory coat when handling the
reagents.
1. At the Ready screen, press Enter.
The Reagent Levels screen appears.
2. Remove the cleaning solution bottle from the reagent manifold as shown in
Figure 3-7.
%#$ 3. Write the date installed in the space provided on the new cleaning solution
bottle.
NOTE: Do not remove or tighten the cap that contains the reagent septum.
Removing or tightening the cap damages the integrity of the reagent septum.
4. Remove the plug from the cap of the new cleaning solution bottle.
5. Insert the cleaning solution bottle into position on the reagent manifold.
6. Push the bottle to ensure that it fits tightly on the reagent fitting.
7. Press Reset Levels.
The Reset Levels screen appears.
8. Select C1/C2 and press Done.
&# Use this procedure to discard and replace the 7.3/CO-ox Zero and Cal G/L reagents
if they are opened and installed on the system for 30 days.
Materials required:
7.3/CO-ox Zero (7.382 Buffer)
Cal G/L
Wear safety glasses, gloves, and a laboratory coat when handling the
reagents.
1. At the Ready Screen, press Enter.
The Reagent Levels screen appears.
2. Remove the reagent bottles from the reagent manifold as shown in Figure 3-8
for an 860 system.
!&$%" &# !
3. Write the date installed in the space provided on the new reagent bottles.
NOTE: Do not remove or tighten the cap that contains the reagent septum.
Removing or tightening the cap damages the integrity of the reagent septum.
4. Remove the plugs from the caps of the new reagent bottles.
5. Insert the new reagent bottles into position on the reagent manifold.
6. Push the bottles to ensure that they fit tightly on the reagent fitting.
7. Press Reset Levels.
The Reset Levels screen appears.
8. Select the reagent(s) that you replaced and press Done.
A prime sequence starts followed by a wash sequence. When the wash
sequence finishes, the Ready screen appears.
9. Perform a two-point calibration.
a. Press Calibrate.
b. Select Two-point and press Enter.
c. Press Start Calibration.
Perform a two-point calibration after changing the reagents to ensure that the
reagents are acceptable and the system is functioning properly. You can analyze
quality control materials with the new reagents and compare the results with the
previous QC results after the system is recalibrated.
1. Remove the capillary seal as described in Replacing the Capillary Seal, page
3-100.
2. Inspect the seal for damage such as abrasion and cuts. Replace the capillary
seal if the seal is damaged.
3. Reinstall the capillary seal.
" Perform the following procedures every 2 months. The bimonthly maintenance
schedule is based on analyzing 30 samples per day, unless otherwise noted. If your
laboratory analyzes more than 30 samples per day, perform bimonthly maintenance
more frequently.
Use this procedure to discard and replace the 6.838 Buffer and Wash G/L Zero
reagents if they are opened and installed on the system for 60 days.
Materials required:
6.838 Buffer
Wash G/L Zero
Wear safety glasses, gloves, and a laboratory coat when handling the
reagents.
1. At the Ready screen, press Enter.
The Reagent Levels screen appears.
2. Remove the reagent bottles from the reagent manifold as shown in Figure 3-9
for an 860 system.
%#$! 3. Write the date installed in the space provided on the new reagent bottles.
NOTE: Do not remove or tighten the cap that contains the reagent septum.
Removing or tightening the cap damages the integrity of the reagent septum.
4. Remove the plugs from the caps of the new reagent bottles.
5. Insert the new reagent bottles into position on the reagent manifold.
6. Push the bottles to ensure that they fit tightly on the reagent fittings.
7. Press Reset Levels.
The Reset Levels screen appears.
8. Select the reagent(s) that you replaced and press Done.
A prime sequence starts followed by a wash sequence. When the wash
sequence finishes, the Ready screen appears.
9. Perform a two-point calibration.
a. Press Calibrate.
b. Select Two-point and press Enter.
c. Press Start Calibration.
Perform a two-point calibration after changing the reagents to ensure that the
reagents are acceptable and the system is functioning properly. You can analyze
quality control materials with the new reagents and compare the results with the
previous QC results after the system is recalibrated.
Materials required:
sample tubing
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Disconnect the sample tubing from the connector on the measurement module.
3. Disconnect the sample tubing from the probe mount.
4. Rotate the sample tubing toward you as shown in Figure 3-10.
! 5. Disconnect the tubing from the sample probe as shown in Figure 3-11.
! 6. Discard the tubing according to your laboratory’s biohazard protocol.
7. Orient the new sample tubing as shown in the diagram on the system.
8. Connect the new sample tubing to the sample probe.
9. Place the sample tubing in the bracket on the probe mount.
10. Rotate the sample probe toward the system.
11. Connect the sample tubing to the sample tubing connector on the measurement
module.
12. Press Continue.
A wash sequence starts. When the wash sequence sequence finishes, a
message box appears prompting you to perform a two-point calibration.
13. Press Yes to perform a two-point calibration.
Perform the following procedures every 3 months. The quarterly maintenance
described in this section is based on analyzing 30 samples per day. If your
laboratory analyzes more than 30 samples per day, perform this maintenance more
frequently.
Materials required:
lint-free tissue or lint-free swabs
lens paper
reagent quality water
dilute cleaning solution (do not use bleach, alcohol, or abrasive powder)
sample chamber gasket and support
0.16-inch diameter clot-removal line
bubble trap seal, if necessary
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Disconnect the tubing and the bubble trap from the sample chamber.
3. Remove the sample chamber as shown in Figure 3-12:
a. Turn the tab on the cam to the left to loosen the sample chamber.
b. Grasp the sample chamber by the edges and pull it off of the mounting
pins.
c. Remove metal plate installed behind the sample chamber.
"! Sample Chamber
Mounting
Pin
Bubble Trap
Sapphire
Window
Cam
4. Remove the gasket and support:
a. Slide your finger under the flat metal support of the gasket.
b. Lift the gasket and support from the sample chamber.
"! Mounting Pin
Holes
Outlet
Inlet
Gasket
Gasket Support
CAUTION: Do not touch the optical zone (front or back area enclosed by the
gasket) of the sample chamber with your fingers.
"!
Optical Zone Areas
Sample Side
Port Side
5. Push a 0.016-inch diameter clot-removal line into the metal tubing of the inlet
and outlet ports of the sample chamber.
6. Flush the inlet and outlet ports to remove any clots or debris:
a. Fill a syringe with reagent-quality water.
b. Attach a capillary adapter or a piece of 0.016-inch diameter sample tubing
to the syringe.
c. Attach the tubing or capillary adapter to the port and flush the water
through the port.
7. Clean the glass sapphire window with a lint-free tissue or swab soaked with
cleaning solution. Wash the window with reagent-quality water.
8. Blot the exterior of the window dry with lint-free tissue.
9. Install a new gasket on the sample chamber:
a. Soak the gasket and the grooved area of the sample chamber with reagent
quality water to facilitate the installation.
b. Wipe both sides with a lint-free tissue soaked in cleaning solution.
c. Wipe both sides with a lint-free tissue soaked in reagent-quality water.
d. Blot both sides dry with lint-free tissue.
10. Clean the metal plate:
a. Wipe both sides of the plate with a lint-free tissue soaked in cleaning
solution.
b. Wipe both sides with a lint-free tissue soaked in reagent-quality water.
c. Blot both sides dry with lint-free tissue.
11. Clean the bubble trap:
a. Visually inspect the bubble trap seal on the outlet port of the bubble trap.
Replace the seal if it is torn or frayed.
b. Push a 0.016-inch diameter clot-removal line into the metal tubing of the
outlet port of the bubble trap.
c. Flush the bubble trap by injecting reagent-quality water into the metal port
using a syringe and a separate piece of tubing or capillary adapter as shown
in Figure 3-15.
Tubing
Outlet Port
Seal
Syringe
Inlet Port
Bubble Trap
d. Wipe the exterior of the bubble trap with a lint-free tissue soaked in reagent
quality water.
e. Blot the exterior dry with lint-free tissue.
12. Inspect the tubing.
a. If the tubing is damaged, or is stretched or loose at the connection, replace
the tubing as described in Replacing the CO-ox Sample Tubing on page
3-37.
b. If there is an obstruction in the tubing, remove the sample tubing.
c. Push a 0.016-inch diameter clot-removal line through the sample tubing
from back to front, opposite the direction of sample flow.
d. Reinstall the sample tubing.
CAUTION: Ensure that the area between the metal plate and the sapphire window
is free of dust or debris.
13. Reinstall the metal plate into the sapphire window by aligning onto the
mounting pins.
14. Reinstall the sample chamber:
a. Connect the bubble trap to the sample chamber inlet port.
b. Align the mounting pin holes on the sample chamber with the mounting
pins.
c. Turn the tab on the cams to the right until the cams tighten against the
sample chamber.
d. Reconnect the tubing to the sample chamber outlet port.
e. Reconnect the tubing to the bubble trap inlet port.
15. Press Continue.
A wash sequence starts. When the wash sequence sequence finishes, a
message box appears prompting you to perform a two-point calibration.
16. Press No.
17. Perform a pH/lytes one-point calibration.
18. Perform a tHb slope calibration.
#$
Materials required:
lint-free tissue or lint-free swabs
reagent-quality water
dilute cleaning solution (do not use bleach, alcohol, or abrasive powder)
hemolyzer gasket
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Disassemble the hemolyzer as shown in Figure 3-16:
!'%&
#$
" !
" " ! "
#$
a. Remove the anvil cap on the hemolyzer by turning it one quarter-turn
counterclockwise.
b. Disconnect the sample tubing from the anvil.
c. Pull the anvil and anvil spring away from the mounting pin on the
hemolyzer.
d. Lay the anvil on its side.
e. Remove the gasket and discard it according to your laboratory biohazard
protocol.
3. Clean the hemolyzer and the anvil:
a. Clean the hemolyzer with a lint-free tissue soaked in mild cleaning
solution.
b. Wipe the surface with a lint-free tissue soaked in reagent-quality water.
c. Dry the surface thoroughly.
d. Repeat steps a through c for the anvil.
4. Reassemble the hemolyzer:
a. Insert a new gasket in the groove of the anvil.
b. Place the anvil on the mounting pin. Make sure the anvil is seated on the
pin and does not rotate. The anvil spring does rotate.
c. Reconnect the sample tubing to the anvil.
d. Reinstall the anvil cap to secure the anvil. Listen for a click, which
indicates that the anvil is in place.
The anvil sits loosely on the hemolyzer. As you turn the anvil cap, the
anvil is secured against the hemolyzer.
5. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
6. Press No.
Menu Code
(from the Main Menu)
1
1
7. Perform a one-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 1 One-point and press Enter.
Perform the following procedures every 6 months. The semiannual maintenance
described in this section is based on analyzing 30 samples per day. If your
laboratory analyzes more than 30 samples per day, perform this maintenance more
frequently.
Materials required:
air filter
1. Push the air filter cover down until it snaps out and then pull the cover away
from the system as shown in Figure 3-17.
2. Remove the old air filter and discard it.
3. Press the new air filter into place.
4. Reinstall the air filter cover:
a. Align the two pins, located inside the air filter cover, underneath the holes.
b. Push the cover up until it snaps it into place.
5. Press Home to return to the Ready screen.
Materials required:
CO-ox air filter
1. Push the air filter cover up until it snaps out and then pull the cover away from
the system as shown in Figure 3-18.
2. Remove the old air filter and discard it.
3. Press the new air filter into place.
4. Reinstall the air filter cover:
a. Align the tabs on the cover with the slots in the module.
b. Push the cover up until it snaps it into place.
5. Press Home to return to the Ready screen.
Materials required:
measurement module tubing
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
NOTE: If your system has a CO-ox module, follow the procedure described for
the appropriate base model. For example, information identified for an 860 also
applies to an 865.
1. Cut a piece of measurement module tubing to the appropriate length as shown
in Figure 3-19.
$"# !
840
15.2 cm (6 inches)
850
12 cm (4.75 inches)
860
11.43 cm (4.5 inches)
Menu Code
2
7
2. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
3. Push up the latches on the measurement module door and lift the door.
4. Take the appropriate action.
! 840
step 5.
850 or 860
step 6.
5. Replace the measurement module tubing:
a. Remove the tubing from the connector at the spring-loaded latch in the
measurement block as shown in Figure 3-20.
# '%& " !# " # # !# " # #
# $
" " "
' "
!" "
b. Remove the tubing from the spacer.
c. Disconnect the tubing from the connector at position 3 on the reagent
manifold.
d. Push the new tubing through the spacer.
e. Connect the left end of the tubing to the spring-loaded latch.
f. Connect the right end of the tubing to the connector at position 3.
g. Press the tubing into the tubing groove.
h. Continue with step 7.
6. Replace the measurement module tubing:
a. Remove the tubing from the connector at the spring-loaded latch in the
measurement block as shown Figure 3-21.
b. Disconnect the tubing from the connector at position 3 on the reagent
manifold.
c. Connect the left end of the new tubing to the spring-loaded latch.
d. Connect the right end of the tubing to the connector at position 3.
e. Press the tubing into the tubing groove.
#!" # 7. Close the measurement module door.
8. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
9. Press Yes to perform a two-point calibration.
Materials required:
CO-ox sample tubing
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Replace the CO-ox sample tubing as shown in Figure 3-22:
CO-ox Pump
Reagent Pump
Waste Tubing
FD5
Outlet
Sample
Connector
Inlet
Sample Chamber
Hemolyzer
Bubble Trap
a. Remove the anvil cap from the hemolyzer.
b. Disconnect both pieces of tubing from the anvil.
c. Remove the tubing guide on FD5 and gently pull the tubing through FD5
toward the sample connector.
d. Disconnect the CO-ox sample tubing from the sample connector.
e. Connect the flared end of the replacement tubing to the sample connector.
f. Press the tubing guide on FD5 into place.
g. Thread the replacement tubing through FD5.
h. Connect the replacement tubing to the anvil.
i. Disconnect both pieces of sample tubing from the sample chamber.
j. Connect one end of the replacement tubing to the inlet on the sample
chamber and the other end to the anvil.
k. Reinstall the anvil cap on the hemolyzer. Listen for a click, which indicates
that the anvil is in place.
l. Disconnect the sample tubing from the CO-ox pump.
m. Connect one end of the replacement tubing to the outlet on the sample
chamber and the other end to the CO-ox pump.
3. Replace the waste tubing:
a. Disconnect the waste tubing from the CO-ox pump.
b. Disconnect the waste tubing from the inlet on the reagent manifold on the
base model.
c. Gently pull the waste tubing through the hole in the FD5 housing.
d. Thread the replacement tubing through the hole in the FD5 housing.
e. Connect the replacement tubing to the inlet on the reagent manifold.
f. Connect the other end of the replacement tubing to the CO-ox pump.
4. Press Continue
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
5. Press No.
Menu Code
(from the Main Menu)
1
1
6. Perform a one-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 1 One-point and press Enter.
Perform the following procedures every 12 months. These procedures are based on
analyzing 30 samples per day. If your laboratory analyzes more than 30 samples
per day, perform this maintenance more frequently.
Use this procedure to replace the tubing on the sample pump, the waste pump, the
reagent pump, and the CO-ox module pump. The sample pump, waste pump, and
CO-ox module pump tubing assemblies each contain one piece of tubing. The
reagent pump tubing assembly contains two pieces of tubing.
NOTE: When you replace pump tubing, replace the tubing for all the pumps.
Replacing the tubing on only one or two pumps can affect pump calibration and
cause incorrect flow rates.
Materials required:
sample pump tubing assembly
waste pump tubing assembly
reagent pump tubing assembly
CO-ox pump tubing assembly
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Replace the sample pump and waste pump tubing as shown in Figure 3-23.
The CO-ox pump has one piece of tubing, which is replaced using the
procedure for the sample pump tubing.
$"# a. Perform the appropriate step.
! sample pump tubing
tubing from both connectors at position 4 on the
reagent manifold.
waste pump tubing
tubing from both connectors at position 5 on the
reagent manifold.
CO-ox pump tubing
sample and waste tubing with two-way
connectors from the CO-ox pump as shown in
Figure 3-24.
3. Replace the reagent pump tubing as shown in Figure 3-23:
a. Select the replacement tubing that has the tubing collar.
b. Grasp the left tubing cuff and pull it away from the platen.
c. While holding the tubing, turn the roller cage clockwise and gently pull the
tubing away from the platen and the roller cage.
d. Discard the tubing according to your laboratory protocol.
e. Hold the new tubing assembly with the tubing in front.
"! " f. Place the left tubing cuff under the left side of the platen.
Do not stretch the tubing.
g. Place the tubing around the outside of the rollers.
h. Hold the right tubing cuff below the right side of the platen and turn the
roller cage clockwise to gently work the new tubing between the platen and
roller cage.
i. Place the right tubing cuff under the right side of the platen.
4. Connect the pump tubing.
sample pump tubing
connect tubing to both connectors at position 4 on the
reagent manifold.
waste pump tubing
connect tubing to both connectors at position 5 on the
reagent manifold.
CO-ox pump tubing
connect sample and waste tubing connectors on CO-ox
pump tubing.
a. Disconnect the tubing from the reagent manifold.
b. Grasp the left tubing cuff and pull it away from the platen.
c. While holding the tubing, turn the roller cage clockwise and gently pull the
tubing away from the platen and the roller cage.
d. Discard the tubing according to your laboratory protocol.
e. Hold the new tubing assembly with the large tubing in front.
f. Place the left tubing cuff in the groove under the left side of the platen.
Do not stretch the tubing.
g. Place the tubing around the outside of the rollers.
h. Hold the right tubing cuff below the right side of the platen and turn the
roller cage clockwise to gently work both pieces of the new tubing between
the platen and roller cage.
i. Place the right tubing cuff under the right side of the platen.
5. Connect the tubing to the reagent manifold:
a. Connect the left end of the large tubing to the connector at left position 1.
b. Connect the right end of the large tubing to the connector at right
position 1.
c. Connect the left end of the small tubing to the connector at left position 2.
d. Connect the right end of the small tubing to the connector at right position 2.
6. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
7. Press No.
Menu Code
(from the Main Menu)
3
1
2
Menu Code
(from the Main Menu)
1
2
8. Calibrate the reagent pump from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 2 Pump Flow Rate and press Enter.
d. Press Calibrate Pump.
e. Press Exit Test when the Pump calibration complete message appears.
9. Perform a two-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
Perform the following procedure annually. This schedule is based on analyzing 30
samples per day. If your laboratory analyzes more than 30 samples per day,
perform this maintenance more frequently.
Materials required:
reagent manifold vent filter
1. Remove the old reagent manifold vent filter from the reagent manifold vent
inlet and discard it.
2. Insert the new filter into the reagent manifold vent inlet as shown in
Figure 3-26.
Reagent Manifold
Vent Filter
3. Press Home to return to the Ready screen.
..
& # Materials required:
10% solution of household bleach
NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with
reagent-quality water.
reagent water
lint-free tissue or swabs
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Wear safety glasses, gloves, and a laboratory coat when performing
this procedure.
1. Press and hold down the waste bottle latch while removing the waste bottle
from the compartment, as shown in Figure 3-27.
&$%! !
" 2. Cover the waste bottle with the attached cap to avoid spills when transporting
the bottle.
NOTE: The waste bottle is disposable and can be autoclaved before you discard it.
The waste bottle is not reusable after autoclaving. Cover the waste bottle with the
cap provided and discard the bottle according to your laboratory protocol or
infection control policy.
3. Discard the waste bottle contents according to your laboratory biohazard
protocol.
4. Clean the waste outlets:
a. Wipe the waste outlet cover with a lint-free tissue dampened with a 10%
solution of household bleach.
b. Rinse with reagent water.
5. If required, remove the waste outlet cover and clean the waste outlets as shown
in Figure 3-28:
a. Grasp the waste outlet cover and pull it off.
b. Wipe the outlets with a lint-free tissue dampened with a 10% solution of
household bleach.
c. Clean the waste outlet cover with the bleach solution.
d. Rinse the waste outlets and the waste outlet cover with reagent water.
6. Reinstall the waste outlet cover:
a. Press the alignment pins on the bottom of the waste outlet cover into the
system holes.
b. Align the alignment pins on the top of the waste outlet cover with the
system holes, and then align the waste outlets with the holes in the cover.
c. Press the cover firmly into place, leaving no gaps
7. Reinstall the waste bottle, ensuring that the latch slides back in place.
8. Ensure that the waste outlet cover fits tightly into the waste bottle opening.
Use this procedure to clean the reference sensor and to remove bubbles at the
electrode tip and in the passage between the electrode compartment and the KCl
reservoir.
Materials required:
reagent water
lint-free swab
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Push up the latches on the measurement module door and lift the door.
3. Push the spring-loaded latch to the right as shown in Figure 3-29.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
4. Grasp the tab on the reference sensor and pull the sensor up and out of the
measurement module.
#!" #
5. Check the sensor for bubbles at the electrode tip and between the electrode
compartment and the KCl reservoir as shown in Figure 3-30.
# '%& " ! #!
! $ " " ""
' ! $
#!
' #!
6. Tap the front face of the sensor with your knuckle to release any bubbles.
7. Clean any salt deposits on the reference sensor with a lint-free swab moistened
with deionized water and dry it thoroughly.
8. Ensure that the O-rings are in place on both sides of the sensor.
9. Clean the O-ring area on the spring-loaded latch with a lint-free swab
moistened with reagent water.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
10. Reinstall the sensor:
a. Gently align the top of the reference sensor with the sensor contact.
b. Snap the sensor down into place.
c. Press the tab on the spring-loaded latch to release the latch.
11. Close the measurement module door.
12. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
13. Allow the system to warm for up at least 15 minutes.
14. When the temperature is stable, press Yes to perform a two-point calibration.
# "!
After the sensor temperature equilibrates, remove the sensor and inspect for
bubbles. As the temperature of the sensor rises to 37°C, gas is driven from the
solution, causing bubbles. Remove any bubbles present.
# !$ !#$! "!
Materials required:
0.022 inch diameter clot-removal line (to fit through a 0.030 inch ID pathway)
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Push up the latches on the measurement module door and lift the door.
3. Push the spring-loaded latch to the right as shown in Figure 3-31.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
4. Grasp the tab on the sample ground/temperature sensor and pull the sensor up
and out of the measurement module.
$!(&'% # !$ !#$! "! ! !" # # # " !$
""! $ # $ $# #
"$!# $
$" # " !(
# # # !#
5. Push a clot removal line through the sensor to clear away any obstructions as
shown in Figure 3-32.
$!(&'
# !$ !#$! "!
(!
# % 6. Ensure that the O-ring is in place. Replace the O-ring if it is worn or damaged.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
NOTE: If the sensor does not insert easily into the measurement module, slide the
remaining sensors to the right to create more space.
7. Reinstall the sensor:
a. Gently align the top of the sensor with the sensor contact.
b. Snap the body of the sensor down into place.
c. Press the tab on the spring-loaded latch to release the latch.
8. Close the measurement module door.
9. Press Continue .
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
10. Press No.
11. Allow the system to warm up for at least 15 minutes.
Menu Code
(from the Main Menu)
3
2
Menu Code
(from the Main Menu)
1
2
12. Check the sample path temperature from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 2 Temp/pAtm and press Enter.
c. Press Start Test.
d. Press Stop Test.
e. Check the screen for the sample path temperature.
f. If the temperature control system is off, press Reset Control.
g. Press Exit Test.
13. Perform a two-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
Use this procedure to clean the roller cages for the reagent, sample, or waste
pumps.
Materials required:
10% solution of household bleach
NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with
reagent-quality water.
reagent water
lint-free tissue and swabs
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Disconnect the pump tubing from the reagent manifold.
NOTE: Do not stretch the tubing.
3. While holding the left side of the tubing, turn the roller cage clockwise and
gently pull the tubing away from the platen and the roller cage.
4. Set the tubing assembly aside.
5. Grasp the roller cage and gently pull it straight off its shaft as shown in
Figure 3-33.
Wear safety glasses, gloves, and a laboratory coat when handling
bleach.
6. Clean the roller cage:
a. Clean the rollers with a lint-free tissue moistened with a 10% solution of
household bleach.
b. Clean the interior surface of the roller cage with a lint-free swab moistened
with the bleach solution.
c. Clean the roller cage shaft with a lint-free tissue moistened with the bleach
solution.
d. Rinse the rollers, the cage, and the shaft with reagent water.
e. Dry the roller cage thoroughly.
f. Ensure that the rollers turn freely.
7. Reinstall the roller cage:
a. Replace the roller cage on the shaft.
b. Turn the roller cage on the shaft until it stops.
c. Press the roller cage down until the cage snaps into place.
8. Connect the tubing as described in Replacing the Pump Tubing, page 3-39.
9. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
10. Press Yes to perform a two-point calibration.
Materials required:
10% solution of household bleach
NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent
quality water.
reagent water
lint-free swabs
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Remove the required reagent bottle as shown in Figure 3-34.
3. Grasp the reagent fitting and turn it counterclockwise one-quarter turn.
4. Pull the fitting straight out.
#!"
# 5. Replace the fitting if it is deformed, and then continue with step 8.
bleach.
Wear safety glasses, gloves, and a laboratory coat when handling
6. Clean the fitting with a swab moistened with a 10% solution of household
bleach.
7. Rinse the fitting with reagent water and dry thoroughly.
Ensure that the O-ring is in place on the back of the reagent fitting.
8. Reinstall the fitting into the appropriate position on the reagent manifold, and
turn clockwise one-quarter turn.
Ensure that the fitting fits tightly into the reagent manifold.
9. Reinstall the reagent bottle.
Push the bottle to ensure that it fits tightly on the reagent fitting.
10. Repeat steps 2 through 9 to remove and clean other reagent fittings as
required.
11. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
12. Press No.
Menu Code
3
13. Perform a prime sequence:
a. Select 3 Prime and press Enter.
b. Select the appropriate reagents to prime and press Enter.
c. Press Done.
d. Press Home or Menu when the Prime menu appears.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
14. Take the appropriate action.
you want to perform a two-point
calibration
press Yes.
you do not want to perform a
two-point calibration
a. Press No.
b. Press Home to return to the Ready screen.
Materials required:
10% solution of household bleach
NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with reagent
quality water.
reagent water
lint-free swabs
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code
2
7
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Pull off the sample door as shown in Figure 3-35.
3. Grasp the tab on the retainer ring and firmly pull the tab toward you to rotate
the ring.
4. Grasp the sample port and attached drip tray and pull it off the mount as
shown in Figure 3-35.
Wear safety glasses, gloves, and a laboratory coat when handling
bleach.
5. Clean any deposits on the sample port, the drip tray, and the mount with a
lint-free swab moistened with a 10% solution of household bleach.
6. Rinse the sample port and drip tray and the mount with reagent water.
NOTE: Ensure that the three O-rings are in place.
7. Reinstall the sample port, matching the tab on the sample port to the notch in
the retainer ring.
8. Push the tab on the retainer ring away from you until it locks in place.
9. Reinstall the sample door, ensuring that it snaps in place.
10. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
11. Press Yes to perform a two-point calibration.
Materials required:
alcohol
standard copier paper
Wear gloves to protect your hands from the alcohol.
1. Remove the paper roll from the roll printer:
a. Pull the paper spool up and remove the paper from the spool.
b. Lift the printer lever and remove the paper from the printer.
c. Remove the paper roll and set it aside.
2. Cut a piece of standard copier paper in half lengthwise to make a strip of paper
10.8 cm (4.25 inches) wide.
3. Moisten the center of the paper along its width with the alcohol. Leave the two
ends of the paper dry.
Menu Code
7
4. Shut down the system from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 3 Shutdown and press Enter.
c. Press Yes.
3
You must wait at least 1 minute before you disconnect the power
cord, and then wait at least 10 seconds before you reconnect the power cord. If
you do not adhere to the time intervals, you can damage the system.
5. Wait at least 1 minute, and then disconnect the power cord from the power
supply.
6. Insert the paper into the printer, and push the paper through the printer until
the moistened part of the paper is past the print head.
7. Pull the paper back and forth several times past the printer head.
8. Remove the paper from the printer.
9. Reconnect the power cord to the power supply and allow the system to warm
up.
10. Reinstall the printer paper as described in Replacing the Printer Paper, page
3-66.
11. Verify the printing quality as described in Roll Printer Test in Section 4.
Materials required:
glutaraldehyde
aspiration adapter
lint-free tissue or swabs
test/blank reference sensor (TB5)
test/blank glucose sensor (TB4)
test/blank lactate sensor (TB4)
Bayer Diagnostics recommends using Cidex, a 2% activated glutaraldehyde
solution, to discourage microbial growth in the sample path.
CAUTION: Do not use alcohol to perform this procedure. Alcohol can damage the
sensors.
When handling glutaraldehyde, follow appropriate chemical safety
guidelines, which include wearing safety glasses, gloves, and laboratory coat.
1. Prepare the glutaraldehyde solution according to the manufacturer’s
instructions.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Take the appropriate action.
840 or 850
go to step 3.
860
a. Remove the glucose and lactate biosensors.
b. Install the test/blank sensors.
c. Go to step 3.
Menu Code
2
3. Deproteinize the sample path:
a. Prepare the deproteinizer as directed on the package.
b. Select 2 Maintenance and press Enter.
c. Select 1 Deproteinize and press Enter.
d. Invert the deproteinizer vial several times to mix.
e. Insert an aspiration adapter into the sample port and insert the other end
into the deproteinizer.
f. Press Analyze.
g. When prompted, remove the adapter.
h. Wait for the deproteinizing cycle to finish.
A message box appears prompting you to condition the sensors.
1
4. Perform the cleaning cycle:
a. Press Yes.
b. Insert an aspiration adapter into the sample port and immerse the other end
in the glutaraldehyde solution.
c. Press Analyze.
d. When prompted, remove the adapter.
e. Wait 5 minutes for the cleaning cycle to finish.
Press Cancel if you want to stop cleaning.
The cleaning cycle finishes. The system performs an extended wash sequence.
The Calibrate System message box appears at the end of the wash sequence.
5. Press No.
Menu Code
6. Initiate a wash sequence from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 8 Wash and press Enter.
(from the Main Menu)
2
8
As you install the biosensors, ensure that the biosensors are in the
correct location. Visually verify that you align the contacts on the biosensors
with the contacts in the measurement module.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
7. When the wash sequence finishes, remove the test/blank glucose and lactate
sensors and reinstall the biosensors as described in Replacing the Glucose and
Lactate Biosensors page 3-86.
Menu Code
8. Perform a two-point calibration from the Menu screen:
(from the Main Menu)
1
2
Glutaraldehyde may cause excessive drift to the K+ and Ca++ sensors.
Repeat calibrations until the system performs a successful calibration.
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
9. Analyze a minimum of two levels of quality control material to verify sensor
performance.
10. Empty and clean the waste bottle, waste outlets, and waste outlet cover as
described in Emptying the Waste Bottle, page 3-45.
Materials required:
10% solution of household bleach
NOTE: Dilute household bleach (5.25% sodium hypochlorite) 1:10 with
reagent-quality water.
aspiration adapter
lint-free tissue or swabs
test/blank reference sensor (TB5)
test/blank glucose sensor (TB4)
test/blank lactate sensor (TB4)
NOTE: If your system has a CO-ox module, follow the procedure described for
the appropriate base model. For example, information identified for an 860 also
applies to an 865.
CAUTION: Do not remove or return the sensors to the measurement module
CAUTION: Do not expose the glucose and lactate biosensors to deproteinizer or
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
bleach. Replace the biosensors with test/blank sensors (TB4) before cleaning the
sample path. Reinstall the biosensors within 2 hours.
1. Take the appropriate action.
840 or 850
go to step 2.
860
a. Remove the glucose and lactate biosensors.
b. Install the test/blank glucose and lactate sensors
(TB4).
c. Go to step 2.
Do not expose the reference sensor to bleach. Replace the
reference sensor with the test/blank reference sensor (TB5). Do not substitute a
new reference sensor.
2. Replace the reference sensor with a test/blank reference sensor:
a. Remove the reference sensor from the measurement module and set it
aside.
b. Install a test/blank reference sensor (TB5) in the measurement module.
Menu Code
2
1
3. Deproteinize the sample path:
a. Prepare the deproteinizer as directed on the package.
b. Select 2 Maintenance and press Enter.
c. Select 1 Deproteinize and press Enter.
d. Invert the deproteinizer vial several times to mix.
e. Insert an aspiration adapter into the sample port and insert the other end
into the deproteinizer.
f. Press Analyze.
g. Remove the adapter when prompted.
h. Wait 5 minutes for the deproteinizing cycle to finish.
A message box appears prompting you to condition the sensors.
Wear safety glasses, gloves, and a laboratory coat when handling bleach.
4. Perform the cleaning cycle:
a. Press Yes.
b. Insert an aspiration adapter into the sample port and immerse the other end
in the 10% bleach solution.
c. Press Analyze.
d. When prompted, remove the adapter.
e. Wait 5 minutes for the cleaning cycle to finish.
Press Cancel if you want to stop cleaning.
When the cycle finishes, the system performs an extended wash sequence. The
Calibrate System message box appears at the end of the wash sequence.
5. Press No.
Menu Code
(from the Main Menu)
2
8
6. Initiate a wash sequence from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 8 Wash and press Enter.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
NOTE: As you install the sensors, ensure that the sensors are in the correct
location. Visually verify that you align the contacts on the sensors with the contacts
in the measurement module.
7. When the wash sequence finishes, remove the test/blank glucose and lactate
sensors (TB4) and reinstall the glucose and lactate biosensors as described in
Replacing the Glucose and Lactate Biosensors, page 3-86.
8. Remove the test/blank reference sensor (TB5) and reinstall the reference
sensor as described in Replacing the Reference Sensor, page 3-71.
9. Empty and clean the waste bottle, waste outlets, and waste outlet cover as
described in Emptying the Waste Bottle, page 3-45.
Menu Code
(from the Main Menu)
1
2
10. Perform a two-point calibration:
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
11. Analyze a minimum of two levels of quality control material to verify sensor
performance.
Use this procedure to manually initiate the cleaning sequence. The system
automatically initiates the cleaning sequence every 24 hours at 02:00.
Menu Code
2
6
1. Access Auto Clean from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 6 Auto Clean and press Enter.
To interrupt the Auto Clean sequence at any time, press Cancel.
The Auto Clean sequence takes 10 minutes. A message box appears prompting
you to perform a two-point calibration.
2. Press Yes to perform a two-point calibration.
Menu Code
2
8
1. Access wash from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 8 Wash and press Enter.
2. Press Home to return to the Ready screen.
Menu Code
2
3
1. Access the Prime screen from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 3 Prime and press Enter.
2. Select the appropriate reagent to prime and press Enter.
3. Press Done.
4. Press Home or Menu when the Prime menu appears.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
5. Take the appropriate action.
you want to perform a
two-point calibration
press Yes.
you do not want to initiate a
two-point calibration
press No.
press Home to return to the Ready screen.
Use this procedure to stop the system when you perform maintenance activities
such as replacing components. Stopping the system discontinues all fluidic
activities such as calibrations and sample analyses.
Menu Code
2
7
CAUTION: Because no fluids reach the sensors while the system is stopped,
stopping the system for a prolonged period of time may affect the performance of
the sensors.
1. Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Perform the required maintenance task.
3. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
4. Take the appropriate action.
you want to perform a
two-point calibration
press Yes.
you do not want to initiate a
two-point calibration
a. Press No.
b. Press Home to return to the Ready screen.
If calibrations were scheduled while the system was stopped, the system performs
the calibrations when you exit the stopped mode.
The 800 system collects workload data and provides month-to-date and
year-to-date workload statistics reports. The workload statistics report includes the
total cycle count of all patient samples, calibrations, and QC samples performed by
the system. The yearly statistics are reset every January 1 after the system performs
the first sample analysis or calibration. The system automatically prints a workload
statistics report.
Menu Code
4
6
1. Access the Workload Stats screen from the Menu screen:
a. Select 4 Data Recall and press Enter.
b. Select 6 Workload Stats and press Enter.
2. Press Print Statistics to print a workload statistics report.
The workload statistics report is shown in Figure 3-36.
WORKLOAD STATISTICS REPORT
System 850-1001
Total cycle cnt: 025356
Apr 12 1994
11:42
Month-to-Date Statistics Apr 1 1994 to Apr 12 1994
Month-to-Date
Workload Statistics
Patient Samples:
QC Samples:
1 Point Cal:
2 Point Cal:
000573
000102
000861
000145
Year-to-Date Statistics Jan 1 1994 to Apr 12 1994
Year-to-Date
Workload Statistics
Patient Samples:
QC Samples:
1 Point Cal:
2 Point Cal:
009150
001675
006680
002196
3. Press Done to return to the Menu screen.
4. Press Home to return to the Ready screen.
Total cycle count is the
number of patient
samples,QC samples,
calibrations, and
operator-initiated washes.
..
Wear safety glasses, gloves, and a laboratory coat when handling the
reagents.
1. At the Ready screen, press Enter.
The Reagent Levels screen appears.
2. Remove the reagent bottle from the reagent manifold, as shown in Figure 3-37.
3. Write the date installed in the space provided on the new bottle.
NOTE: Do not remove or tighten the cap that contains the reagent septum.
Removing the cap damages the integrity of the reagent septum.
4. Remove the plug from the cap of the new reagent bottle.
5. Insert the new reagent bottle into position on the reagent manifold.
6. Push the bottle to ensure that it fits firmly on the reagent fitting.
7. Press Reset Levels.
The Reset Levels screen appears.
8. Select the reagent(s) that you replaced and press Done.
A prime sequence starts followed by a wash sequence. When the wash
sequence finishes, the Ready screen appears.
9. Perform a two-point calibration.
a. Press Calibrate.
b. Select Two-point and press Enter.
c. Press Start Calibration.
Perform two-point calibrations after changing the calibration reagents to ensure
that the reagents are acceptable and the system is functioning properly. You can
analyze quality control materials with the new reagents and compare the results
with the previous QC results after the system is recalibrated.
CAUTION: Do not attempt to print without paper installed or with a double
thickness of paper in the printer. Use the paper advance key to feed the paper
through the printer.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Pull up the paper spool.
3. Firmly grasp the old roll of paper and pull it off the spool.
NOTE: Grasp the roll of paper tightly to slide the paper completely off the spool.
4. Reinstall the paper spool.
5. Lift the printer cover.
6. Push up the printer lever.
7. Install a roll of printer paper:
a. Unroll a small amount of paper from the new roll and cut or fold a clean
straight edge, if necessary.
b. Place the paper roll in the cavity with the paper unrolling from the bottom
as shown in Figure 3-38.
c. Push the paper under the platen until it comes out the front side.
d. Pull the paper from under the platen and push it through the slot in the
printer cover.
e. Push down the printer lever.
Pull up the paper firmly as you close the cover to ensure that the
paper does not jam under the cover.
f. Close the printer cover.
g. Press the paper advance key to ensure the paper moves smoothly and to
remove the no paper message.
8. Install the printer paper on the paper spool:
a. Pull up the paper spool as shown in Figure 3-39.
Gently guide the paper against the left edge of the spool when you
wind paper on the spool. If the right edge of the paper roll is uneven, the paper
can jam.
b. Insert the paper into the paper slot on the spool and turn the spool three or
four rotations away from you.
You can fold the end of the paper 1.3 cm (0.5 inch) and place it into the
slot. Press the paper advance key if there is not enough paper.
c. Lower the paper spool until it snaps into place.
9. Press Continue.
A wash sequence starts. When the wash finishes, a message box appears
prompting you to perform a two-point calibration.
10. Press No.
Press the paper advance key to remove the No Paper in Printer message from the
status area.
Materials required:
reference electrode refill
hex tool
lint-free tissue
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the reference sensor as shown in Figure 3-40:
a. Push up the latches on the measurement module door and lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the reference sensor and pull the sensor up and out of the
measurement module.
"! "
3. Remove the reservoir cap from the reference sensor with the hex tool and set
the cap aside as shown in Figure 3-41.
$"# ! 4. Add KCl fill solution to the KCl reservoir to the fill line, as shown in
Figure 3-42.
$"# CAUTION: Do not overtighten the reservoir cap. Overtightening can deform the
gasket and cause leaks.
5. Reinstall the reservoir cap and hand-tighten.
6. Continue with Reinstalling a Sensor, page 3-89.
Materials required:
reference sensor replacement kit
hex tool
lint-free tissue
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the reference sensor as shown in Figure 3-43:
a. Push up the latches on the measurement module door and lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the reference sensor and pull the sensor up and out of the
measurement module.
d. Discard the reference sensor according to your laboratory protocol.
"! " 3. Fill the electrode compartment in the new reference sensor:
a. Remove the reference sensor cassette (KCl reservoir) from its box.
b. Insert the tip of the KCl fill solution container into the electrode
compartment as shown in Figure 3-44.
c. Slowly fill the electrode compartment by gently squeezing the container
until the KCl fill solution enters the KCl reservoir.
"! Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
4. Install the internal electrode in the sensor:
a. Use the hex tool to remove the internal electrode from its container.
b. Insert the internal electrode into the electrode compartment.
c. Screw it into place with the hex tool, ensuring that you do not cross-thread
the electrode.
d. Tap the front face of the sensor with your knuckle to release any bubbles.
5. Fill the KCl reservoir in the new sensor:
a. Remove the reservoir cap with the hex tool and set it aside as shown in
Figure 3-45.
%#$ ! " b. Partially fill the KCl reservoir as shown in Figure 3-46.
%#$ c. Tap the front face of the sensor with your knuckle to release any bubbles.
d. Gradually fill the KCl reservoir with KCl fill solution to the fill line.
Do not overtighten the reservoir cap. Overtightening can deform
the gasket and cause leaks.
e. Reinstall the reservoir cap and hand-tighten.
6. Continue with Reinstalling a Sensor, page 3-89.
Materials required:
reference electrode refill kit
hex tool
lint-free tissue
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the reference sensor as shown in Figure 3-47:
a. Push up the latches on the measurement module door and lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the reference sensor and pull the sensor up and out of the
measurement module.
$"#! $ CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
3. Use the hex tool to remove the internal electrode from the cassette you are
replacing.
4. Discard the cassette according to your laboratory protocol.
5. Stand the internal electrode on its cap in a safe place.
6. Remove the new reference sensor cassette from its box.
7. Fill the electrode compartment in the new cassette:
a. Insert the tip of the KCl fill solution container into the electrode
compartment as shown in Figure 3-48.
b. Slowly fill the electrode compartment by gently squeezing the container until
the KCl fill solution enters the KCl reservoir.
#!"
CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
8. Use the hex tool to screw the internal electrode into the electrode
compartment, ensuring that you do not cross-thread the electrode.
9. Fill the KCl reservoir in the new sensor:
a. Remove the reservoir cap with the hex tool as shown in Figure 3-49.
&$%! ! " # ! b. Partially fill the KCl reservoir as shown in Figure 3-50.
&$%
!
c. Tap the front face of the sensor with your knuckle to release any bubbles.
d. Gradually fill the KCl reservoir with KCl fill solution up to the fill line.
Do not overtighten the reservoir cap. Overtightening can deform
the gasket and cause leaks.
e. Reinstall the reservoir cap and hand tighten.
10. Continue with Reinstalling a Sensor, page 3-89.
Materials required:
reference electrode internal replacement kit
hex tool
lint-free tissue
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the reference sensor as shown in Figure 3-51:
a. Push up the latches on the measurement module door and lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the reference sensor and pull the sensor up and out of the
measurement module.
$"#! $ 3. Use the hex tool to remove the internal electrode from the reference sensor as
shown in Figure 3-52.
4. Discard the internal electrode according to your laboratory protocol.
5. Empty the KCl fill solution from the cassette.
6. Add 3 drops of KCl fill solution to the electrode compartment and then drain
the compartment.
7. Fill the electrode compartment in the new cassette as shown in Figure 3-53:
a. Insert the tip of the KCl fill solution container into the electrode
compartment in the cassette.
b. Partially fill the electrode compartment by gently squeezing the KCl fill
solution container.
c. Tap the front face of the sensor with your knuckle to release any bubbles.
d. Continue filling until the KCl fill solution enters the KCl reservoir.
!'%&
"
CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
8. Use the hex tool to remove the new internal electrode from its container.
9. Insert the internal electrode into the compartment and screw it into place with
the hex tool, ensuring that you do not cross-thread the electrode.
10. Fill the KCl reservoir in the sensor:
a. Remove the reservoir cap with the hex tool and set it aside as shown in
Figure 3-54.
!'%&" " # $ " b. Partially fill the KCl reservoir by gently squeezing the KCl fill solution
container as shown in Figure 3-55.
#!"
c. Tap the front face of the sensor with your knuckle to release any bubbles.
d. Gradually fill the KCl reservoir with KCl fill solution to the fill line.
Do not overtighten the reservoir cap. Overtightening can damage
the gasket and cause leaks.
e. Reinstall the reservoir cap and hand-tighten.
11. Continue with Reinstalling a Sensor, page 3-89.
Use this procedure to fill any measurement sensors that do not have sufficient fill
solution. Refer to Table 3-1 to determine the appropriate fill solution to use.
Materials required:
appropriate fill solution
lint-free tissue
NOTE: If your system has a CO-ox module, follow the procedure described for
the appropriate base model. For example, information identified for an 860 also
applies to an 865.
NOTE: The pO2 and pCO2 sensors do not require fill solution.
NOTE: The glucose and lactate biosensors do not require fill solution.
&$% ! ! # pH
pH
840, 850, 860
Na+
Na+, K+, Cl–, Ca++
850, 860
K+
Na+, K+, Cl–, Ca++
850, 860
Cl–
Na+, K+, Cl–, Ca++
850, 860
Ca++
Na+, K+, Cl–, Ca++
850, 860
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the sensor as shown in Figure 3-56:
a. Push up the latches on the measurement module door and lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the sensor and pull the sensor up and out of the
measurement module.
!&$%" ! ! ! ! !
!
! & CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
3. Unscrew the internal electrode and carefully set it aside on a lint-free tissue as
shown in Figure 3-57.
! !
!
4. Empty the fill solution remaining in the sensor.
NOTE: Refer to Table 3-1 to determine the appropriate fill solution to use.
5. Rinse the electrode compartment with 3 drops of the appropriate sensor fill
solution and then empty the fill solution from the sensor.
6. Slowly add the appropriate fill solution as shown in Figure 3-58:
Fill the pH, K+, Cl–, and Ca++ sensors almost full, leaving a bubble at the
top.
Fill the Na+ sensor to the top.
! 7. Insert the internal electrode into the electrode compartment and screw it into
place, ensuring that you do not cross-thread the electrode.
8. Continue with Reinstalling a Sensor, page 3-89.
If you need to replace the reference sensor, refer to Replacing the Reference
Sensor, page 3-71.
If you need to replace the glucose or lactate biosensors, refer to Replacing the
Glucose and Lactate Biosensors, page 3-86.
Materials required:
appropriate sensor
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
NOTE: If your system has a CO-ox module, follow the procedure described for
the appropriate base model. For example, information identified for an 860 also
applies to an 865.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the sensor as shown in Figure 3-59:
a. Push up the latches on the measurement module door and lift the door.
!&$%" ! ! ! ! !
!
! & b. Push the spring-loaded latch to the right.
c. Grasp the tab on the sensor and pull the sensor up and out of the
measurement module.
d. Discard the sensor.
3. Perform the appropriate action.
#! the chloride sensor
go to step 4.
other measurement sensors or the
sample ground/temperature sensor
go to step 5.
4. Fill the chloride sensor with the Na+, K+, Cl–, Ca++ fill solution:
a. Remove the new sensor from the box.
Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
b. Unscrew the internal electrode and set it aside on a lint-free tissue.
c. Rinse the electrode compartment with 3 drops of fill solution and then empty
it.
d. Fill the sensor almost full, leaving a bubble at the top.
e. Screw the internal electrode into place, ensuring that you do not
cross-thread the electrode.
f. Tap the front face of the sensor with your knuckle to remove bubbles.
g. Wipe any excess fill solution from the exterior of the sensor with a lint-free
tissue.
5. Ensure that the O-ring is in place on each sensor.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
NOTE: If the sensor does not easily insert into the measurement module, slide the
remaining sensors to the right to create more space.
6. Install the sensor:
a. Align the top of the sensor with the sensor contact.
b. Snap the body of the sensor down into place.
c. Press the tab on the spring-loaded latch down to release the latch.
d. Verify that the sensors are installed from left to right in the following order
in the measurement module:
pO2 pCO2 GRD
850
pO2 pCO2 GRD pH
K+
860
pO2 pCO2 GRD Glu
Lac
pH
Ref
Ca++
Cl–
pH K+
Na+
Ca++
Ref
Cl–
Na+
Ref
7. Close the measurement module door.
8. Press Continue and allow the system to warm up for at least 15 minutes.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
9. Press No.
Menu Code
(from the Main Menu)
3
2
10. If you replaced the sample ground/temperature sensor, check the sample path
temperature from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 2 Temp/pAtm and press Enter.
c. Press Start Test.
d. Press Stop Test.
e. Check the screen for the sample temperature reading.
f. If you see the message, Temperature control system off, press Reset
Control.
g. Allow the system to warm up.
h. Press Exit Test.
Menu Code
(from the Main Menu)
1
2
11. When the temperature is stable, perform a two-point calibration:
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
The Ready screen appears when the calibration finishes.
12. Analyze a minimum of two levels of quality control materials to verify sensor
performance.
After the sensor temperature equilibrates, remove the sensor and inspect for
bubbles. As the temperature of the sensor rises to 37°C, gas is driven from the
solution, causing bubbles. Remove any bubbles present.
Materials required:
glucose biosensor
lactate biosensor
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
NOTE: Equilibrate the glucose and lactate biosensors at room temperature (18 to
25°C) for at least 1 hour before use. Keep the biosensors in their foil packages
while they are equilibrating.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
2. Remove the biosensors as shown in Figure 3-60:
! ! a. Push up the latches on the measurement module door and lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the biosensor and pull the biosensor up and out of the
measurement module.
d. Discard the biosensor.
3. Remove the new biosensor from the foil package.
4. Ensure that the O-ring is in place on the biosensor.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
NOTE: As you install the biosensors, ensure that the biosensors are in the correct
location. Visually verify that you align the contacts on the biosensors with the
contacts in the measurement module. Slide the remaining sensors to the right to
create more space, if needed.
5. Install the biosensor:
a. Align the contacts on the biosensor with the contacts in the measurement
module.
b. Snap the body of the biosensor down into place. The contacts must be flush
with the biosensor.
c. Press the tab on the spring-loaded latch down to release the latch.
d. Verify that the biosensors are installed from left to right in the following
order in the measurement module:
pO2 pCO2 GRD Glu
Lac
pH K+
Ca++
Cl–
Na+
Ref
6. Close the measurement module door.
7. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
8. Press Yes to perform a two-point calibration.
Menu Code
(from the Main Menu)
1
2
9. Perform two additional two-point calibrations to start hydrating the biosensor
as soon as possible:
a. Move to the Main Menu.
b. Select 1 Calibration and press Enter.
c. Select 2 Two-point and press Enter.
10. Allow the biosensors to warm up for at least 30 minutes.
11. Verify that the system temperature is within the acceptable range.
12. Verify biosensor performance by completing two successful two-point
calibrations.
13. Analyze a minimum of two levels of quality control material to verify sensor
performance.
Use this procedure to reinstall the reference sensor after completing any of the
following procedures:
Filling the Reference Sensor, page 3-69.
Replacing the Reference Sensor, page 3-71.
Replacing the Reference Sensor Cassette, page 3-74.
Replacing the Internal Reference Electrode, page 3-77.
Filling the Measurement Sensors, page 3-80.
1. Tap the front face of the sensor with your knuckle to release any bubbles.
2. Wipe any excess fill solution from the exterior of the sensor with a lint-free
tissue. On the reference sensor ensure that the vent hole in the reservoir cap is
free of KCl crystals.
3. Replace any O-ring that is worn or damaged.
4. Verify that the O-rings are in place.
NOTE: The reference sensor has an O-ring on both sides. The measurement
sensors have one O-ring, only on the left side.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
5. Reinstall the sensor:
a. Align the top of the sensor with the sensor contact.
b. Snap the sensor into place.
c. Press the tab on the spring-loaded latch to release the latch.
6. Close the measurement module door.
7. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
8. Allow the system to warm up for at least 15 minutes.
9. Press Yes to perform a two-point calibration.
10. Analyze a minimum of two levels of quality control material to verify sensor
performance.
After the sensor temperature equilibrates, remove the sensor and inspect for
bubbles. Remove any bubbles that are present.
Use this procedure to replace a gas tank or cylinder when the main tank pressure
falls below 300 psi.
Handle compressed gas tanks with caution. To prevent damage and
possible personal injury, comply with the following precautions:
Never drop tanks, allow them to strike each other, or subject them to other strong
shocks.
Secure tanks to a wall or bench, on the floor, or place them in a tank base
support stand.
Avoid dragging, rolling, or sliding tanks, even for short distances. Use a suitable
hand truck to move tanks.
Never tamper with safety devices in regulators or tanks.
Use these gases for the calibration of clinical and research instrumentation only.
Do not dispense these gases for any therapeutic use.
Do not puncture. Contents are under pressure.
Do not use or store near heat or open flame.
Do not expose tanks to temperatures above 54C (130F) because contents may
vent or explode.
Never throw tanks into a fire or incinerator. Follow the disposal instructions on
the tanks.
Do not refill tanks. Federal law prohibits the refilling of these tanks.
Materials required:
Cal Gas or Slope Gas tank
valve wrench
soapy water
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Disconnect the gas line from the system.
3. Remove and dispose of the empty gas tank, as shown in Figure 3-62:
a. Using a valve wrench, close the gas tank by turning the valve stem fully
clockwise.
Do not remove the yoke screw before releasing the gas from the
regulator. Gas under pressure can cause bodily injury and property damage.
b. Disconnect the gas regulator from the gas tank by unscrewing the yoke
screw. You may hear a short spurt of gas. Remove the regulator.
c. Visually inspect the gas line for cracks and leaks.
d. Remove the gas tank to a well-ventilated, open area.
e. Inspect the gas outlet and ensure that it is free of dirt or other foreign
matter.
Do not come in contact with the gas stream. Gas under pressure
can cause bodily injury and property damage.
f. To avoid injury or damage, position the valve outlet so that it is facing
away from your face, body, and loose objects.
Do not turn the valve stem more than is necessary to hear gas
exiting the valve stem. Gas under pressure can cause bodily injury and
property damage.
g. Using a wrench, release the contents of the gas tank by slowly turning the
valve stem counterclockwise until you hear gas exiting the valve stem.
h. When the gas tank is completely vented and no more gas is heard exiting
the valve, open the valve stem completely to ensure all of the contents is
vented.
i. Label the container Empty and dispose of the tank according to your
laboratory protocol.
&#,*+$ ' $$) &%!#
$ &%!# ""
!
#(
$ '
&$% % !
!
!( $
' &%%
' %
!( !$
4. Install the new gas tank:
a. Check the gas tank label to verify that you are installing the correct gas:
Bayer Diagnostics Cal Gas contains 5% CO2 and 12% O2
Bayer Diagnostics Slope Gas contains 10% CO2 and 0% O2
b. Place the gas tank into its final position and secure the tank.
c. Remove the protective shrink seal from the valve assembly of the gas tank.
d. Verify that the gas tank seal is in good condition and in place on the
regulator, as shown in Figure 3-62.
e. Attach the gas regulator to the gas tank by aligning the regulator nipple
with the valve outlet and ensure that the dowel pins on the regulator-yoke
screw line up properly with the holes in the tank valve, as shown in
Figure 3-62.
f. Tighten the yoke screw firmly.
The typical main tank pressure is 2200 psi. The typical regulator
valve pressure is 3 to 5 psi.
g. Slowly open the gas tank by turning the valve stem counterclockwise with
the wrench until the pressure gauge on the regulator indicates pressure and
then turn it one more turn.
Do not turn the needle valve too hard or damage can occur.
h. Carefully turn the needle valve adjustment knob counterclockwise until
until it stops.
i. Listen carefully for any gas leaks.
j. Check the gas line for good gas flow.
k. Visually check for leaks by applying soapy water around all connections, as
shown in Figure 3-63, and watching for bubbles.
5. If the 800 system will not be used for an extended period of time, close the gas
tank by turning the valve stem clockwise.
6. Connect the gas line to the appropriate 800 system port.
7. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
Menu Code
(from the Main Menu)
3
1
4
8. Check the gas flow rate from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 4 Valves and press Enter.
d. Select the gas type that you replaced and press Enter.
e. Insert an aspiration adapter into the sample port and immerse the open end
of the adapter into a small container of reagent water.
f. Press Start Test.
g. Verify that a steady stream of bubbles flows into the water.
h. Press Stop Test.
i. Verify that the bubbles stop flowing into the water.
j. Remove the adapter.
k. Press Exit Test.
Menu Code
(from the Main Menu)
1
4
9. Perform a gas two-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 4 Gas Two-point and press Enter.
Perform two-point calibrations after changing the calibration reagents, including
the gas standards, to ensure that the reagents are acceptable and the system is
functioning properly. Additionally, you can analyze quality control materials with
the new reagents and compare the results with the previous QC results after the
system is recalibrated.
If you do not install Bayer Diagnostics Cal Gas or Slope Gas tanks, ensure that you
define the calibration gas values for the gases used during calibration, as described
in Defining Calibration Gas Values in Section 5.
Materials required:
gas tubing
valve wrench
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Using a valve wrench, close the gas tank by turning the valve stem clockwise.
3. Disconnect the tubing from the gas fitting on the reagent manifold as shown in
Figure 3-64.
4. Disconnect the tubing from the gas regulator and discard the tubing.
5. Connect one end of the new tubing to the fitting on the regulator.
6. Connect the other end of the tubing to the fitting on the reagent manifold.
NOTE: The average main tank pressure is 2200 psi. The average secondary valve
pressure is 3 to 5 psi.
7. Slowly open the gas tank by turning the valve stem counterclockwise with the
wrench.
Turn the valve stem approximately 3/4 turn until the regulator pressure gauge
indicator stops rising.
8. Open the valve stem one more turn.
9. Listen carefully for any gas leaks.
10. Check for leaks using soapy water and watching for bubbles.
11. Verify that the regulator outlet gauge indicates 3 to 5 psi.
12. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
13. Press No.
Menu Code
(from the Main Menu)
1
3
4
Menu Code
(from the Main Menu)
1
4
14. Check the gas flow rate from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 4 Valves and press Enter.
d. Select the gas type that you replaced and press Enter.
e. Insert an aspiration adapter into the sample port and immerse the open end
of the adapter into a small container of reagent water.
f. Press Start Test.
g. Verify that a steady stream of bubbles flows into the water.
h. Press Stop Test.
i. Verify that the bubbles stop flowing into the water.
j. Remove the adapter.
k. Press Exit Test.
15. Perform a two-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 4 Gas Two-point and press Enter.
Use this procedure to replace the roller cage for the reagent, sample, waste, or
CO-ox pump.
Materials required:
reagent water
lint-free tissue
roller cage
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Disconnect the pump tubing from the reagent manifold.
NOTE: Do not stretch the tubing.
3. While holding the left side of the tubing, turn the roller cage clockwise and
gently pull the tubing away from the platen and the roller cage.
4. Set the tubing assembly aside.
5. Grasp the roller cage and gently pull it straight off its shaft as shown in
Figure 3-65.
6. Clean the roller cage shaft with a lint-free tissue moistened with reagent water
and dry thoroughly.
7. Place the new roller cage on the shaft.
8. Turn the roller cage on the shaft until the roller cage stops.
9. Press the roller cage down until the cage snaps into place.
10. Reinstall the tubing as described in Replacing the Pump Tubing, page 3-39.
11. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
12. Press Yes to perform a two-point calibration.
Materials required:
sample port
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Pull off the sample door as shown in Figure 3-66.
3. Grasp the tab on the retainer ring and firmly pull the tab toward you to rotate
the ring.
4. Grasp the sample port and attached drip tray and pull it off the mount as
shown in Figure 3-66.
NOTE: Ensure that the three O-rings are in place.
5. Install the new sample port on the mount.
6. Push the tab on the retainer ring away from you until it locks into place.
7. Reinstall the sample door, ensuring that it snaps in place.
8. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
9. Press Yes to perform a two-point calibration.
Materials required:
sample probe
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Remove the old probe:
a. Disconnect the sample tubing from the connector on the measurement
module.
b. Disconnect the sample tubing from the bracket on the probe mount.
c. Rotate the sample tubing toward you by pulling it up until it is
perpendicular to the bench top as shown in Figure 3-67.
d. Disconnect the sample tubing from the sample probe.
e. Pull the probe tab to the left into the slot, and pull the probe out of the
sample port, as shown in Figure 3-68.
3. Install the new probe:
Insert the probe slowly to avoid bending the shaft.
a. Push the sample probe into the opening in the sample port and place the
probe tab in the slot.
b. Connect the sample tubing to the new sample probe.
c. Rotate the sample probe and tubing down toward the system.
d. Place the sample tubing in the bracket on the probe mount.
e. Connect the sample tubing to the sample tubing connector on the
measurement module.
4. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
5. Press Yes to perform a two-point calibration.
Materials required:
capillary seal
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Ensure that the sample probe is fully retracted.
3. Remove the old capillary seal:
a. Grasp the top of the capillary seal and pull it toward the right and out of the
sample port, as shown in Figure 3-69.
b. Discard the capillary seal according to your laboratory protocol.
4. Install the new capillary seal:
a. Hold the seal at the top, angle it toward the right, and push it into the
opening in the sample port.
b. Insert a capillary tube into the port to ensure that the capillary seal fits
securely in place.
5. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
6. Press Yes to perform a two-point calibration.
Materials required:
measurement module lamp
Menu Code 1.
7
3
Shut down the system from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 3 Shutdown and press Enter.
c. Press Yes.
CAUTION: You must wait at least 1 minute before you disconnect the power cord,
and then wait at least 10 seconds before you reconnect the power cord. If you do
not adhere to the time intervals, you can damage the system.
2. Wait until prompted, and then disconnect the power cord from the power
source.
3. Disconnect the power cord from the side panel of the system.
4. Turn the system around so that the rear panel faces you.
5. Push the lamp cover up and remove the cover.
Ensure that the lamp has been off for at least 5 minutes to allow
sufficient time for it to cool.
6. Allow the lamp to cool for at least 5 minutes.
7. Remove the connector from the system as shown in Figure 3-70.
8. Pinch the ends of the clamp and pull it away from the bracket.
9. Remove the old lamp from the clamp and discard it.
CAUTION: Avoid touching the lamp with your fingers.
10. Place a new lamp in the clamp with the front of the lamp facing the system.
11. Pinch the ends of the clamp together and reinstall it in the bracket.
12. Reinstall the connector in the system.
13. Reinstall the lamp cover by inserting the tabs on the cover into the system and
snapping the cover back into place.
14. Reconnect the power cord to the power source and allow the system to warm
up for at least 15 minutes.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
15. Press No.
Menu Code 16. Verify the system component temperatures from the Menu screen:
3
2
a. Select 3 Troubleshooting and press Enter.
Select 2 Temp/pAtm and press Enter.
Press Start Test.
Verify that the system components warm up.
Press Stop Test.
If the temperature control system is off, press Reset Control and allow the
system to warm up.
g. Press Exit Test.
b.
c.
d.
e.
f.
Menu Code
(from the Main Menu)
1
2
17. When the temperature is stable, perform a two-point calibration from the
Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
Burn Hazard. Do not touch or look at the lamp when the lamp is
illuminated. Injury to the skin or the eye can occur when the lamp is operated
outside the lamp housing.
Materials required:
CO-ox lamp
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Allow the lamp to cool for at least 5 minutes.
Ensure that the lamp has been off for at least 5 minutes to allow
sufficient time for it to cool.
3. Remove the lamp cover from the CO-ox module.
4. Remove the lamp connector, as shown in Figure 3-71.
5. Remove the old lamp from the lamp housing and discard it.
6. Place a new lamp in the housing aligning the lamp with the guide pin.
7. Pinch the ends of the clamp together and replace it in the bracket.
8. Install the lamp connector.
9. Reinstall the lamp cover.
10. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
11. Press No.
Menu Code
3
3
2
12. Calibrate the new lamp:
a. Select 3 Troubleshooting and press Enter.
b. Select 3 Measurement and press Enter.
c. Select 2 COox Optics and press Enter.
The COox Optics Test screen appears.
13. Press Start Test.
14. Check the screen for the message, Lamp test passed.
15. Press Exit Test.
16. Press Exit Menu
Menu Code
(from the Main Menu)
1
1
17. Perform a one-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 1 One-point and press Enter.
Materials required:
2 fuses of the appropriate rating
small, flat-blade screwdriver
Refer to Table 3-2 to identify the correct fuses for the voltage you use.
100/120V
4A Slo Blo
5 x 20 mm
220/240V
2A Slo Blo
5 x 20 mm
To prevent electrical shock or damage to the system, remove power
from your system before performing this procedure.
Menu Code 1.
7
3
Shut down the system from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 3 Shutdown and press Enter.
c. Press Yes.
CAUTION: You must wait at least 1 minute before you disconnect the power cord,
and then wait at least 10 seconds before you reconnect the power cord. If you do
not adhere to the time intervals, you can damage the system.
2. Wait until prompted and then disconnect the power cord from the power
source.
3. Disconnect the power cord from the side panel of the system.
4. Remove the air filter cover.
5. With a small, flat-blade screwdriver, gently pry open the fuse compartment
door at the top, as shown in Figure 3-72.
6. Remove the fuse holders from the compartment.
$"# ! 7. Remove the old fuses and install new fuses with the correct rating.
Refer to Table 3-2 to identify the correct fuse.
8. Slide the fuse holders into the fuse compartment with the arrows pointing to
your right.
9. Close the fuse compartment.
10. Ensure that the voltage selection bobbin is in place and the correct setting is
visible through the window.
11. Reinstall the air filter cover.
12. Reconnect the power cord to the power source and allow the system to warm
up for at least 15 minutes.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
13. Press No.
Menu Code 14. Verify the system component temperatures from the Menu screen:
3
2
a. Select 3 Troubleshooting and press Enter.
Select 2 Temp/pAtm and press Enter.
Press Start Test.
Verify that the system components warm up.
Press Stop Test.
If the temperature control system is off, press Reset Control and allow the
system to warm up.
g. Press Exit Test.
b.
c.
d.
e.
f.
Menu Code
(from the Main Menu)
1
2
15. Perform a two-point calibration from the Menu screen:
a. Select 1 Calibration, and press Enter.
b. Select 2 Two-point, and press Enter.
..
2
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&.% !-!-)+ ++)+
&.% !-!-)+ ++)+
+)!,,%(# ++)+
+)'!-+% +!,,.+! ++)+
#- (%")& ) .&%"%!+
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(,.""%%!(- ,$ &)0
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!'*!+-.+! ++)+
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
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,
Use this procedure to review and print Status Event Log messages. The Status
Event Log stores most diagnostic codes (D codes) and system messages from the
last 72 hours of operation. The D codes and system messages listed in the Status
Event Log can help you determine what recent events may have contributed to an
existing system problem.
Menu Code 1.
4
5
Access the Status Event Log from the Menu screen:
a. Select 4 Data Recall and press Enter.
b. Select 5 Status Event Log and press Enter.
The Message Date fields contain the current day’s date. Press Done to
recall all messages for this day.
2. Type the search criteria and press Enter after you complete each field.
3. Press Done.
4. Press Print to print a list of the entries that met the search criteria.
Figure 4-1 shows a printed Status Event Log.
System messages provide information about the operating status of the system and
can appear in the status area of the screen, in the Status Event Log, or on printed
reports. Table 4-1 describes each system message.
1-pt Cal Pending
in __ Min
Appears 5 minutes before a one-point calibration is due and
counts down until the calibration starts.
1-pt Metabolite Cal
Due
Appears during an analysis to indicate the system will perform a
metabolite calibration at the completion of the analysis.
1-pt Metabolite Cal
Due in __ Min
Appears 5 minutes before a one-point metabolite calibration is
due and counts down until the calibration starts.
2-pt Cal Pending
in __ Min
Appears 5 minutes before a two-point calibration is due and
counts down until the calibration starts.
Additional
Messages
Appears in the status area to indicate that there are more
messages, which can be viewed in the status log.
Auto Clean
Pending in __ Min
Appears 5 minutes before an Auto Clean sequence is due and
counts down until the sequence starts.
Bubbles Detected
In Sample
Appears when the system detects a non-continuous fluid in the
measurement module sample path. See Troubleshooting System
Messages, page 4-114.
Calibration
Overdue: __
Appears when the system must perform a calibration on the
sensor(s) indicated.
COox Cover Open
During Meas
Appears when the cover of the CO-ox module is open during a
sample or slope measurement. Question the results.
COox Cover Open
During Zero
Appears when the CO-ox module cover is open during the CO-ox
module zero measurement sequence of a one- or two-point
calibration. Repeat the calibration with the CO-ox cover closed.
COox Cover is
Open
Appears when the cover of the CO-ox module is open when you
begin the sample measurement. You must close the cover before
pressing Analyze to ensure an accurate CO-ox analysis.
COox Sample
Chamber Temp
Error
Appears when the CO-ox sample chamber temperature is not in
range. The system cannot accept tHb sample measurement
requests. See Troubleshooting System Messages, page 4-114.
COox Sample
Temp Out of Range
Appears when the CO-ox sample chamber temperature is not in
range at the end of measurement sequence. See Troubleshooting
System Messages, page 4-114.
Correlation
Adjustment
Appears when the correlation coefficient is changed.
Data Entry
Incomplete
Appears when required data entry fields were not completed.
Device Connected
to Port __
Appears after you configure an 800 system for an external device
and the connection is established.
Excessive Bubbles
in COox Sample
Appears when the system detects a non-continuous fluid (sample
or QC material) in the sample chamber and cannot complete the
analysis. See Troubleshooting System Messages, page 4-115.
Excessive Bubbles
in COox Zero
Appears when the system detects a non-continuous fluid (7.3
buffer) in the sample chamber and cannot perform the zero. See
Troubleshooting System Messages, page 4-115.
NOTE: The CO-ox module is zeroed during the loading of the
7.3 buffer during a one- or two-point calibration.
Excessive Bubbles
in tHb Slope
Appears when the system detects a non-continuous fluid (slope
material) in the sample chamber and cannot slope the CO-ox
module. See Troubleshooting System Messages, page 4-115.
Excessive Scatter in
COox Meas
Appears when the lipid level detected in the CO-ox sample
exceeds the expected physiological maximum. Also appears if
the hemolyzer is disconnected. See Troubleshooting System
Messages, page 4-115.
File (file number)
Outdated QC
Notifies you that a specific QC file is outdated.
If Blood,
Question Data
Optical measurements indicate that the CO-oximeter results
should be reviewed. A question mark (?) is printed next to the
CO-oximeter results on reports. See Troubleshooting System
Messages, page 4-116.
Interfering
Substance: Glu
Appears when the system detects substances in the sample that
may interfere with glucose measurement. See Troubleshooting
System Messages, page 4-118.
NOTE: Repeated, unexpected occurrence of this message may
indicate sensor failure. See Troubleshooting Patient Results, page
4-98.
Interfering
Substance: Lac
Appears when the system detects substances in the sample that
may interfere with lactate measurement. See Troubleshooting
System Messages, page 4-118.
NOTE: Repeated, unexpected occurrence of this message may
indicate sensor failure. See Troubleshooting Patient Results, page
4-98.
Interfering
Substance: tHb
Appears when the CO-ox module detects the presence of
substances in the sample that may interfere with CO-ox
measurement and will try to correct the measurement to account
for the substance. See Troubleshooting System Messages, page
4-118.
Insufficient COox
Sample
Appears when there is not enough sample to fill the CO-ox
sample chamber, so the measurement cannot be completed. See
Troubleshooting System Messages, page 4-117.
Insufficient Sample
Appears when there is not enough sample to fill the measurement
block and you manually position the sample for measurement.
See Troubleshooting System Messages, page 4-118.
Maintenance Due
Today
Appears when a scheduled, non-daily maintenance task is due to
be performed.
Meas Module Door
Open
Appears when the measurement module door is open.
Meas Module
Temperature Error
Appears when the measurement module temperature is out of
range and the system cannot accept sample analysis requests. See
Troubleshooting System Messages, page 4-119.
Meas Module
Temperature
Warning
Appears when the temperature of the measurement module is
outside of the 37 ± 0.15°C range but can accept sample analysis
requests. See Troubleshooting System Messages, page 4-119.
No Paper In Printer
Appears when the system detects that there is no paper in the roll
printer.
No Sample Device
Detected
Appears when you press Analyze, the sample door closes, and no
device is detected in the sample port. See Troubleshooting System
Messages, page 4-120.
No Waste Bottle
Detected
Appears when the waste bottle is not installed.
__ Not Sent
Appears when you press Do Not Send at the end of analysis.
Out of Range
Appears when results for a parameter are out of the measurement
range.
Probe Detected
Obstruction
Appears when the probe hits an obstruction such as the plunger
because there is insufficient sample.
Report Results with
Cal Drift
Appears when results are reported for a sensor that exhibits
calibration drift.
Sample
Temperature
Out of Range
Appears when the measurement block temperature is not in range
at the end of measurement sequence. See Troubleshooting System
Messages, page 4-120.
__ Sent
Appears when you press Send at the end of analysis or if results
are sent automatically.
SulfHb > 1.5%
Appears when the CO-ox module detects a concentration of
SulfHb greater than 1.5%.
tHb Slope
Calibration Due
Appears when you need to perform a tHb Slope calibration for
the CO-ox module.
Unexpected Device
Detected
Appears if the system detects an unexpected device, such as
when a sample device is inserted as the door attempts to close to
perform an automatic sequence.
Waste Full
Appears when the waste bottle can no longer accept waste.
Waste Is Almost
Full
Appears when the waste bottle is near capacity and can accept
waste from three more samples.
..
This section describes the 800 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 also 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. The qualifier identifies the sensor that has
excessive drift. The D code, D2 Excessive Drift pO2, indicates that the pO2 sensor
has excessive drift. A qualifier that is a number, such as the number 6 in D35
Electronics Error (6), is important information for the Service Representative.
The system displays D codes in the status area. When the system displays a D
code, the View Status F-key appears on the screen. The Not Ready screen appears
if the D code prevents the system from being ready. Press View Status to display
the View Status screen.
The View Status screen lists D codes and messages on the left side. The right side
of the screen displays possible solutions associated with the D code that is
highlighted on the left side.
Press Troubleshooting to access the list of system diagnostic tests. Use these tests
to troubleshoot D code problems as required.
The section that follows identifies each D code and message, describes the
problems that cause the D code, and provides a list of solutions arranged in the
appropriate sequence for the problem.
Perform the procedures in sequence until you resolve the problem. If you cannot
resolve the problem, contact your Bayer Diagnostics Service Representative.
Sensor drift is beyond predefined limits during a one-point or a two-point calibration.
Qualifiers:
pO2 pCO2
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct this D code.
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.
Ensure that the gas tank pressures are greater than 300 psi. Ensure that the Cal
Gas and Slope Gas tanks are connected to the correct gas fittings. Ensure that
all connections are tight. If the pressure is too low, replace the affected gas
tanks as described in Replacing the Gas Tanks in Section 3.
Deproteinize the sample path as described in Deproteinizing the Sample Path in
Section 3.
Check for cracks or leaks in the sample tubing. If necessary, replace the sample
tubing as described in Replacing the Sample Tubing in Section 3.
Check for leaks or crimps in the gas tubing. If necessary, replace the gas tubing
as described in Replacing the Gas Tubing in Section 3.
Check the gas flow rate and valve operation for Cal Gas and Slope Gas as
described on page 4-64. Perform the Valves Test as described on page 4-62.
Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed. Remove and install
the sensors correctly if necessary, as described in Removing and Checking the
Sensors on page 4-65.
Perform the Measurement test for the affected sensor as described in
Measurement Test, page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor drift is beyond predefined limits during a one-point or a two-point calibration.
Qualifiers:
pH
K+ Ca++
Cl– Na+
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct this D code.
If more than one sensor has excessive drift, check the reference sensor for KCl
leaks as described in Cleaning the Reference Sensor and Removing Bubbles in
Section 3.
Check the expiration dates and the levels of the reagents. Ensure that the
reagent bottles are installed properly and in the correct location. If reagents
have expired, are low, or are incorrectly installed, replace the affected reagents,
prime the system, and perform a two-point calibration.
Deproteinize and condition as described in Deproteinizing the Sample Path and
Conditioning the Sensors in Section 3.
Check the solution level in the affected measurement sensor and look for
bubbles. If the solution level is low, refill the sensor as described in Filling the
Measurement Sensors in Section 3.
Check the solution level in the reference sensor and look for salt in the vent
hole, bubbles in the sensor, or leaks. If the solution level is low or salt, bubbles,
or leaks are present, clean and refill the reference sensor as described in
Cleaning the Reference Sensor and Removing Bubbles and Filling the Reference
Sensor in Section 3.
Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described in
Removing and Checking the Sensors on page 4-65.
Check the sensor contacts and measurement block for salt buildup. Check
behind the sensors for fluid leaks that can come from the reference sensor. If
salt or leaks are present, clean the sensor with reagent water, dry, and perform a
two-point calibration after reinstalling the sensor.
Perform the Measurement Test as described on page 4-70.
Check the diverter valve to verify that the valve is working by performing the
Valves test as described on page 4-62.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor drift is beyond predefined limits during a one-point or a two-point calibration.
Qualifiers:
Glu
Lac
If D codes also exist for reagent problems such as D23, D24, D29, or
D50, correct these problems first, then correct this D code.
Check the expiration dates and the levels of the reagents. Ensure that the
reagent bottles are installed properly and in the correct location. If reagents
have expired, are low, or are incorrectly installed, replace the affected reagents,
and perform a two-point calibration.
Check that the biosensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described in
Removing and Checking the Sensors on page 4-65.
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 reagent water, dry, and perform
a two-point calibration after reinstalling the biosensors.
Perform the Measurement Test for the affected biosensor as described in
Measurement Test, page 4-70.
Check the diverter valve to verify that the valve is working. Perform the Valve
Test as described on page 4-62.
If the glucose or lactate biosensors have been on the system less than 1 day, the
sensors may require additional time to hydrate the membranes.
Replace the glucose or lactate biosensor as described in Replacing the Glucose
and Lactate Biosensors in Section 3.
The tHb slope is beyond predefined limits during the calibration.
Qualifiers:
tHb
Ensure the target value entered for the tHb slope is correct for the slope reagent
used. If required, re-enter the value and repeat the tHb slope calibration.
Deproteinize the sample path as described in Deproteinizing the Sample Path in
Section 3. Repeat the tHb slope calibration.
Check that the sample chamber is tightly in place. Refer to Cleaning the Sample
Chamber, in Section 3. The tab on the cams should be vertical. Repeat the tHb
slope calibration.
Check that the gasket in the sample chamber is seated correctly.
If the D code reappears, contact your Service Representative.
Sensor slope is beyond predefined limits during a two-point calibration.
Qualifiers:
pO2 pCO2
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct this D code.
Perform a gas two-point calibration.
Ensure that the gas tank pressures are greater than 300 psi. Ensure that the Cal
Gas and Slope Gas tanks are connected to the correct gas fittings. Ensure that
all connections are tight. If necessary, replace the affected gas tanks, as
described in Replacing the Gas Tanks in Section 3.
Check for cracks or leaks in the sample tubing. If necessary, replace the sample
tubing, as described in Replacing the Sample Tubing in Section 3.
Check for leaks or crimps in the gas tubing. If necessary, replace the gas tubing,
as described in Replacing the Gas Tubing in Section 3.
Check the gas flow rate and valve operation for Cal Gas and Slope Gas as
described on page 4-64. Perform the Valves Test as described on page 4-62.
Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed. Remove and install
the sensors correctly if necessary, as described in Removing and Checking the
Sensors on page 4-65.
Perform the Measurement Test for the affected sensor as described in
Measurement Test, page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor slope is beyond predefined limits during a two-point calibration.
Qualifiers:
pH
K+
Ca++
Cl–
Na+
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct this D code.
Perform a two-point calibration.
Check the expiration dates and the levels of the reagents. Ensure that the
reagent bottles are installed properly and in the correct location. If reagents
have expired, are low, or are incorrectly installed, replace the affected reagents,
prime the system, and perform a two-calibration.
Deproteinize the sample path and condition the sensors as described in
Deproteinizing the Sample Path and Conditioning the Sensors in Section 3.
Check the solution level in the affected measurement sensor and look for
bubbles. The pH, K+, Ca++, and Cl– sensors should be nearly full. The Na+
sensor should be full. If the solution level is low, refill the sensor as described in
Filling the Measurement Sensors in Section 3.
Check the sensor contacts and measurement block for salt buildup. Check
behind the sensor for fluid leaks that can come from the reference sensor. If salt
or leaks are present, clean the sensor with reagent water, dry, and perform a
two-point calibration after reinstalling the sensor.
Perform the Measurement Test for the affected sensor as described on
page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor slope is beyond predefined limits during a one- or two-point calibration.
Qualifiers:
Glu
Lac
If D codes also exist for reagent problems such as D23, D24, D29, or
D50, correct these problems first, then correct this D code.
Perform a two-point calibration.
Check the expiration dates and the levels of the reagents. Ensure that the bottles
are installed properly and in the correct location. If reagents have expired, are
low, or are incorrectly installed, replace the affected reagents, and perform a
two-point calibration.
Check that the biosensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described in
Removing and Checking the Sensors on page 4-65.
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 reagent water, dry, and perform
a two-point calibration after reinstalling the biosensors.
Perform the Measurement Test for the affected biosensor as described on page
4-70.
If the glucose or lactate biosensors have been on the system less than one day,
then perform three two-point calibrations.
Replace the glucose or lactate biosensors as described in Replacing the Glucose
and Lactate Biosensors in Section 3.
If the D code reappears, contact your Service Representative.
The tHb slope is beyond predefined limits during the calibration.
Qualifiers:
tHb
Ensure the target value entered for the tHb slope is correct for the reagent used.
If required, re-enter the value and repeat the calibration.
Ensure the slope reagent is appropriate for the instrument.
Check that the sample chamber is tightly in place. The tab on the cams should
be vertical. Repeat the tHb slope calibration.
Check that the gasket in the sample chamber is seated correctly. Refer to
Cleaning the Sample Chamber, in Section 3. Replace the gasket, if necessary.
If the D code reappears, contact your Service Representative.
Sensor offset is beyond predefined limits during a one-point or a two-point calibration.
Qualifiers:
pO2
pCO2
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct the D4.
Perform a gas two-point calibration.
Check for cracks or leaks in the sample tubing. If necessary, replace the sample
tubing as described in Replacing the Sample Tubing in Section 3.
Ensure that the gas tank pressures are greater than 300 psi. Ensure that the Cal
Gas and Slope Gas tanks are connected to the correct gas fittings. Ensure that
all connections are tight. If necessary, replace the affected gas tanks as
described in Replacing the Gas Tanks in Section 3.
Check for leaks or crimps in the gas tubing. If necessary, replace the gas tubing
as described in Replacing the Gas Tubing in Section 3.
Check the gas flow rate and valve operation for Cal Gas and Slope Gas as
described on page 4-64. Perform the Valves Test as described on page 4-62.
Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described in
Removing and Checking the Sensors on page 4-65.
Perform the Measurement Test for the affected sensor as described in
Measurement Test, page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor offset is beyond predefined limits during a one-point or a two-point calibration.
Qualifiers:
pH
K+
Ca++
Cl–
Na+
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct the D4.
Perform a two-point calibration.
Check the expiration dates and the levels of the reagents. Ensure that the
reagent bottles are installed properly and in the correct location. If reagents
have expired, are low, or are incorrectly installed, replace the affected reagents,
and perform a two-point calibration.
Check the solution level in the affected measurement sensor and look for
bubbles. The pH, K+, Ca++, and Cl– sensors should be nearly full. The Na+
sensor should be full. If the solution level is low, refill the sensor as described in
Filling the Measurement Sensors in Section 3.
850 860
If K+ or Ca++ have a D4 Offset Error, replace the fill solution even if
the fluid levels are sufficient.
If more than two sensors have the D4 Offset Error, check the solution level in
the reference sensor and look for salt in the vent hole, bubbles in the sensor, or
leaks. If the solution level is low or salt, bubbles, or leaks are present, clean and
refill the reference sensor as described in Cleaning the Reference Sensor and
Removing Bubbles and Filling the Reference Sensor in Section 3.
Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described in
Removing and Checking the Sensors on page 4-65.
Perform the Measurement Test for the affected sensor as described in
Measurement Test, page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor offset is beyond predefined limits during a two-point calibration.
Qualifiers:
Glu
Lac
If D codes also exist for reagent problems such as D23, D24, D29, or
D50, correct these problems first, then correct the D4.
Check that the biosensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described in
Removing and Checking the Sensors on page 4-65.
Check the expiration dates and the levels of the reagents. Ensure that the
reagent bottles are installed properly and in the correct location. If reagents
have expired, are low, or are incorrectly installed, replace the affected reagents,
and perform a two-point calibration.
If the glucose or lactate biosensors have been on the system less than one day,
then perform three two-point calibrations.
Replace the biosensor as described in Replacing the Glucose and Lactate
Biosensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor does not reach stable reading within predefined time limit.
Qualifiers:
pO2
pCO2
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct the D5.
If a D5 for pCO2 occurs twice in a 4-hour period, perform QC analysis. If the
pCO2 result is out of range, replace the sensor.
Ensure measurement module door was not opened during measurement. If door
was opened, repeat the sample analysis.
Perform a gas two-point calibration.
Deproteinize the sample path as described in Deproteinizing the Sample Path in
Section 3.
Perform the Measurement Test for the affected sensor as described in
Measurement Test, page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/ Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor does not reach stable reading during predefined time limit.
Qualifiers:
pH
K+
Ca++
Cl–
Na+
If D codes also exist for reagent problems such as D23, D24, or D29,
correct these problems first, then correct the D5.
Perform a two-point calibration.
Deproteinize the sample path and condition the sensors as described in
Deproteinizing the Sample Path and Conditioning the Sensors in Section 3.
Check the solution level in the affected measurement sensor and look for
bubbles. The pH, K+, Ca++, and Cl– sensors should be nearly full. The Na+
sensor should be full. If the solution level is low, refill the sensor as described in
Filling the Measurement Sensors in Section 3.
Check the solution level in the reference sensor and look for salt in the vent
hole, bubbles in the sensor, or leaks. If the solution level is low or salt, bubbles,
or leaks are present, clean and refill the reference sensor as described in
Cleaning the Reference Sensor and Removing Bubbles and Filling the Reference
Sensor in Section 3.
Check the sensor contacts and measurement block for salt buildup. Check
behind the sensors for fluid leaks, which can come from the reference sensor. If
salt or leaks are present, clean the sensor with reagent water, dry, and perform a
two-point calibration after reinstalling the sensor.
Perform the Measurement Test for the affected sensor as described in
Measurement Test, page 4-70.
Replace the affected sensor as described in Replacing the Measurement or
Sample Ground/Temperature Sensors in Section 3.
If the D code reappears, contact your Service Representative.
Sensor does not reach stable reading during predefined time limit.
Qualifiers:
Glu
Lac
If D codes also exist for reagent problems such as D23, D24, D29, or
D50, correct these problems first, then correct the D5.
Perform a metabolite two-point calibration.
Perform the Measurement Test for the affected biosensor as described in
Measurement Test, page 4-70.
If the glucose or lactate biosensors have been on the system less than one day,
then perform three two-point calibrations.
Replace the biosensor as described in Replacing the Glucose and Lactate
Biosensors in Section 3.
If the D code reappears, contact your Service Representative.
Sample door detector cannot determine whether the sample door is open or closed.
Check that your hand does not prevent the door from closing.
Check that the door is installed correctly.
Perform the Sample Entry Test as described on page 4-67.
If the D code reappears, contact your Service Representative.
Fluid detector 1 (FD1) does not detect the sample during the predefined time limit.
Check the sample entry components for obstructions and the sample path for
blood clots. If obstructions are found press Stop as prompted in the message
box. Remove them as described in Removing Obstructions from the Sample
Entry Components page 4-79.
Perform a two-point calibration and analyze QC materials to verify
sensor performance after removing a clot.
If there is no obstruction, perform a wash. Observe the fluid as it moves through
the system for sufficient wash flow, wash segments, and no leaks at sample
port.
Check for cracks or leaks in the sample tubing. If necessary, replace the sample
tubing as described in Replacing the Sample Tubing in Section 3.
Check the measurement module for leaks. Check that the sensors are installed
in the correct order and are aligned, the O-rings are in place, and the
spring-loaded latch is closed as described in Removing and Checking the
Sensors on page 4-65.
Check the sample pump tubing for leaks, flattened areas, or other signs of wear.
If necessary, replace the tubing as described in Replacing the Pump Tubing in
Section 3.
Perform the Fluid Detector Test as described in Fluid Detector Test, page 4-66.
Perform the Pump Functions Test as described in Pump Functions Test,
page 4-58.
If the D code reappears, contact your Service Representative.
Fluid detector 2 (FD2) does not detect the sample during the predefined time limit.
Check the sample position in the measurement module.
not positioned in the
measurement module
1. Perform a wash.
2. Repeat the analysis and observe whether the
sample moves past the measurement module
without stopping.
3. If the sample moves past the measurement module
without stopping, perform the Fluid Detector Test,
page 4-66.
4. If the sample does not enter the measurement
module, continue with the solutions to remove
obstructions.
present in the
measurement module
1. Perform a wash and observe the sample path for
obstructions.
2. If you see obstructions, continue with the solutions
to remove obstructions.
Check the measurement module for obstructions and remove them as described
in Removing Obstructions from the Measurement Module, page 4-82.
Check the sample entry components for obstructions and remove them as
described in Removing Obstructions from the Sample Entry Components,
page 4-79.
Ensure that O-rings are in place on the sensors and that the sensors are aligned
correctly as described in Removing and Checking the Sensors on page 4-65.
Perform the Fluid Detector Test as described in Fluid Detector Test, page 4-66.
Perform the Pump Functions Test as described in Pump Functions Test,
page 4-58.
If the D code reappears, contact your Service Representative.
Fluid detector millivolt (mV) reading is beyond predefined limits.
Qualifiers:
FD1
FD1A
FD2
Check the sample path in the measurement module for obstructions or leaks.
Ensure that O-rings are in place on the sensors and that the sensors are aligned
correctly as described in Removing and Checking the Sensors on page 4-65.
If you see obstructions, remove them as described in Removing Obstructions
from the Measurement Module, page 4-82.
Perform the Fluid Detector Test as described in Fluid Detector Test, page 4-66.
Deproteinize the sample path as described in Deproteinizing the Sample Path in
Section 3, and repeat the Fluid Detector Test.
If the D code reappears, contact your Service Representative.
Fluid detector millivolt (mV) reading is beyond predefined limits.
Qualifiers:
FD3
FD4
Perform a wash. Observe the fluid as it moves through the system for sufficient
wash flow, wash segments, and no leaks at the sample port.
Perform the Fluid Detector Test as described on page 4-66.
If the D code reappears, contact your Service Representative.
Fluid detector millivolt (mV) reading is beyond predefined limits.
Qualifier:
FD5
Check the CO-ox sample path for obstructions. If you see any obstructions,
remove them as described in Removing Obstructions from the CO-ox Sample
Path, page 4-87.
Check the sample tubing that goes through FD5 for cracks, leaks, and
discoloration. If you see cracks or leaks, replace the tubing as described in
Replacing the CO-ox Sample Tubing in Section 3.
Perform the Fluid Detector Test as described in Fluid Detector Test, page 4-66.
Deproteinize the sample path as described in Deproteinizing the Sample Path in
Section 3 and repeat the Fluid Detector Test.
If the D code reappears, contact your Service Representative.
An internal communication problem between the system processors has occurred.
Qualifiers:
1
3
1
Shut the system down and restart as described in Shutting Down and
Restarting the System in Section 5.
3
Disconnect the CO-ox sample path as described in Disconnecting the
CO-ox Sample Path, page 4-92. You can continue to analyze samples
on the base model.
Check that the communications cable connecting the CO-ox module
to the base model is installed correctly.
Shut the system down and restart as described in Shutting Down and
Restarting the System in Section 5.
If the D code reappears, contact your Service Representative.
The barometer detects atmospheric pressure beyond predefined limits.
Check that the system barometer is functioning properly:
Menu Code
3
2
1. From the Menu screen, select 3 Troubleshooting and press Enter.
2. Select 2 Temp/pAtm and press Enter.
3. Press Start Test.
4. Check the screen to verify whether the atmospheric pressure (pAtm) is
within the range of 400 to 825 mm Hg (53 to 110 kPa) and that the reading
is stable.
5. Compare the atmospheric pressure displayed to the barometer in your
laboratory to verify its accuracy.
6. Press .
7. Press Exit Test.
If the reading is stable but does not match the barometer in your laboratory,
calibrate the barometer:
Menu Code
1
8
8. From the Menu screen, select 1 Calibration and press Enter.
9. Select 8 Barometer and press Enter.
10. Type the correct atmospheric pressure and press Enter.
11. Press Done.
12. Perform a two-point calibration.
If the D code reappears, contact your Service Representative.
Fluid detector 3 (FD3), fluid detector 4 (FD4), or both detectors do not detect reagent.
Qualifiers:
7.3
6.8
Wash
C1/C2
Cal G/L
For the 7.382 Buffer, 6.838 Buffer, Wash G/L Zero and Cal G/L reagents, check
the expiration dates and the levels. Ensure that the reagent bottles are installed
properly and in the correct location. If reagents have expired, are low, or are
incorrectly installed, replace the affected reagents as described in Section 3.
Menu Code
3
1
1
disappears
perform a two-point calibration.
appears
perform the Fluidics Functions Test as described on page 4-56
for the appropriate reagent.
For the C1/C2 reagent, check the expiration date and level. Ensure that the
reagent bottle is installed properly and in the correct location. If the C1/C2 has
expired, is low, or is incorrectly installed, replace it. Prime the system.
Perform the Fluidics Functions Test as described in Fluidics Functions Test,
page 4-56. If the D23 disappears, perform an Auto Clean as described in
Performing the Automatic Clean Sequence in Section 3.
Check the reagent fittings for obstructions and clean the fittings as described in
Cleaning the Reagent Fittings in Section 3.
Perform the Pump Flow Rate Test as described on page 4-57.
Perform the Valves Test as described on page 4-62 to verify that the 6.8, 7.3,
Glu/Lac, Clean, and Vent valves are working.
Perform the Fluid Detector Test as described on page 4-66.
If the D code reappears, contact your Service Representative.
Fluid detector 1 (FD1), fluid detector 2 (FD2), or both detectors do not detect fluid during a one-point
or a two-point calibration.
Qualifiers:
7.3
6.8
Wash
Cal G/L
If a D23 code also exists, correct that problem first, then correct
the D24.
Check for cracks or leaks in the sample tubing.
Replace the sample tubing, if necessary, as described in Replacing the Sample
Tubing in Section 3. Perform the Fluidics Functions Test as described in
Fluidics Functions Test, page 4-56.
Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed as described as
described in Removing and Checking the Sensors on page 4-65.
Check the expiration dates and the levels of the reagents. Ensure that the
reagent bottles are installed properly and in the correct location. If reagents
have expired, are low, or are incorrectly installed, replace the affected reagents,
prime the system, and perform the Fluidics Functions Test as described on
page 4-56.
Deproteinize the sample path as described in Deproteinizing the Sample Path in
Section 3.
Perform the Fluid Detector Test as described in Fluid Detector Test, page 4-66.
Perform the Fluidics Functions Test as described in Fluidics Functions Test,
page 4-56. If the D24 code disappears, perform a two-point calibration.
If the D code reappears, contact your Service Representative.
The wash did not completely clean the sample path due to low volume or poorly segmented flow.
If a D23 or D24 code also exists, correct these problems first, then
correct the D29.
Perform a wash.
Ensure that the bottle is installed properly. Check the level of Wash/Zero
reagent. If the level is low, replace the reagent as described in Replacing the
Reagent Bottles in Section 3.
Check for cracks or leaks in the sample tubing. If you find cracks or leaks,
replace the sample tubing, as described in Replacing the Sample Tubing in
Section 3.
Check the sample entry components for obstructions and remove them as
described in Removing Obstructions from the Sample Entry Components,
page 4-79.
Check the measurement module for leaks. Check that the sensors are installed
in the correct order and are aligned, the O-rings are in place, and the
spring-loaded latch is closed as described as described in Removing and
Checking the Sensors on page 4-65.
If you see obstructions, remove them as described in Removing Obstructions
from the Measurement Module, page 4-82.
Perform the Valves Test as described on page 4-62 to verify that the wash,
diverter, vent, and wash bypass valves are functioning.
Perform the Pump Functions Test as described on page 4-58.
Check the pump tubing for leaks, flattened areas, or other signs of wear. If
necessary, replace the tubing as described in Replacing the Pump Tubing in
Section 3.
If the D code reappears, contact your Service Representative.
The probe detector cannot determine the position of the sample probe.
Check to see if the probe is bent. If the probe is bent replace it as described in
Replacing the Sample Probe in Section 3.
Check the sample port, the probe mount, and the capillary seal for obstructions,
and ensure that the capillary seal is installed correctly. If obstructions are
present:
1. Remove obstructions and reposition the capillary seal as described in
Removing Obstructions from the Sample Entry Components, page 4-79.
2. Clean the sample probe with a lint-free tissue moistened with a 10%
solution of household bleach, and rinse with reagent water.
Undiluted household bleach is 5.25% sodium hypochlorite.
Perform the Sample Entry Test as described on page 4-67.
Remove the sample probe and repeat the Sample Entry Test.
If the screen indicates that the probe is working properly, install a new sample
probe as described in Replacing the Sample Probe in Section 3.
If the D code reappears, contact your Service Representative.
The system detects an error in the electronics system.
Qualifiers:
1 2
4
5
6
7
8
9
10 11 12 13
1, 2, 4, 5, 8,
9, 11
perform the Measurement Test as described on page 4-70.
6 or 7
shut down and restart the system as described in Shutting Down and
Restarting the System in Section 5.
10
check the temperature control as described in Temperature/pAtm Test,
page 4-69.
12
perform the Valves Test as described on page 4-62.
13
perform the Pump Functions Test as described on page 4-58.
If the measurement test does not remove the D35, shut the system
down and restart it as described in Shutting Down and Restarting the
System in Section 5.
If the D code reappears, contact your Service Representative.
The system detects an error in the temperature control system.
Qualifiers:1
2
3
4 5
6 7
8
9
10 11
Every 15 minutes, the system enables the temperature control and reevaluates the error condition. If
the problem that caused the condition has been corrected, the system clears the D38 condition
automatically. If the problem has not been corrected, it displays the D38 condition code again.
Check that the measurement module door is closed tightly.
Check that the sample ground/temperature sensor is installed correctly. If the
sensor is not correctly installed, remove and install it as described in Cleaning
the Sample Ground/Temperature Sensor in Section 3.
Check that the location of the system meets the specifications for ambient
operating temperatures as described in Appendix H, Installation.
Check the air filter to ensure that the air vent is not obstructed. If the air filter is
obstructed or dirty, replace the air filter as described in Replacing the Air Filter
in Section 3.
Check that the fan is operating.
Perform the Temperature/pAtm Test as described in Temperature/pAtm Test,
page 4-69.
If the D code reappears, contact your Service Representative.
The system detects an open connection in the glucose biosensor.
Check that the biosensor is installed correctly with the contacts aligned, and the
spring-loaded latch is closed as described in Removing and Checking the
Sensors on page 4-65.
Check the levels of the reagents. Ensure that the reagent bottles are installed
properly and in the correct location. If reagents are low or are incorrectly
installed, replace the affected reagents, and perform a two-point calibration.
If the biosensor has been on the system less than one day, then perform three
two-point calibrations.
Replace the biosensor as described in Replacing the Glucose and Lactate
Biosensors in Section 3.
If the D code reappears, contact your Service Representative.
The system detects an open connection in the lactate biosensor.
Check that the biosensor is installed correctly with the contacts aligned, and the
spring-loaded latch is closed as described in Removing and Checking the
Sensors on page 4-65.
Check the levels of the reagents. Ensure that the reagent bottles are installed
properly and in the correct location. If reagents are low or are incorrectly
installed, replace the affected reagents, and perform a two-point calibration.
If the biosensor has been on the system less than one day, then perform three
two-point calibrations.
Replace the biosensor as described in Replacing the Glucose and Lactate
Biosensors in Section 3.
If the D code reappears, contact your Service Representative.
The system detects a transmission error in port 1, 2, 3, or the bar code scanner port, which is caused by
a faulty cable connection or by the failure of the communications electronics.
Qualifiers: 1
2
3
4
5
Ensure that the cable is firmly connected to the 800 system and to the external
device.
Inspect the cable for wear or crimps.
Perform the procedure to configure the 800 system for the port with the
transmission error. Refer to Configuring for External Devices in Section 5.
Perform the External Loopback Test for the port where the error occurred as
described in External Loopback Test, page 4-75.
If the External Loopback Test fails and the cable is firmly connected to the port,
replace the interface cable.
Perform the External Loopback Test again to ensure that the system sends and
receives the transmissions. If the D code appeared when the system was
transmitting results to the external device connected to the port, you can recall
the results and transmit them again. You can also recall and transmit results
obtained while the port was not operating. Refer to Recalling Patient Sample
Data, Recalling QC Data, or Recalling Calibration Data in Section 2.
If the D code reappears, contact your Service Representative.
The system detects an error in the CO-ox optical measurement system.
Qualifiers: 2
3
4
7
9
2
Perform a pH/Lytes one-point calibration.
Replace the 7.3 Buffer/CO-ox zero reagent.
Check that the area around the sample chamber is free from lint or dust.
Prime and perform a pH/Lytes one-point calibration.
Clean the sample chamber as described in Cleaning the Sample
Chamber. It is not necessary to remove or replace the sample chamber
gasket.
3
Perform a pH/Lytes one-point calibration.
Perform CO-ox Optics test.
Clean the sample chamber as described in Cleaning the Sample
Chamber. It is not necessary to remove or replace the sample chamber
gasket.
4
Ensure the CO-ox cover is closed.
Perform a pH/Lytes one-point calibration.
7
Ensure the CO-ox cover is closed.
9
Contact your Service Representative.
If the D code reappears, contact your Service Representative.
Fluid detector 5 (FD5) does not detect the sample during the predefined time limit.
Ensure the sample volume is sufficient for the sample type.
Check the sample entry components for obstructions and the sample path for
blood clots. Remove them as described in Removing Obstructions from the
Sample Entry Components, page 4-79.
Check the CO-ox sample tubing for cracks or leaks. Replace the tubing, if
necessary, as described in Replacing the CO-ox Sample Tubing, in Section 3.
If you move the tubing or unfasten the FD5 tube locking mechanism you must
perform a manual wash to recalibrate the fluid detector.
Deproteinize the sample path as described in Deproteinizing the Sensors, in
Section 3.
Perform a two-point calibration and analyze QC materials, as necessary, to
verify CO-ox performance.
Perform the Fluidics Functions Test as described in Fluidics Functions Test,
page 4-56.
If the D code reappears, contact your service representative.
The CO-ox sample chamber does not detect the sample during the predefined time limit.
Ensure the sample volume is sufficient for the sample type.
Ensure the sample is red.
Check the CO-ox sample path for leaks or cracks. If you find cracks or leaks,
replace the tubing as described in Replacing the CO-ox Sample Tubing in
Section 3.
Check the CO-ox sample path for obstructions. If you see any obstructions,
remove obstructions as described in Removing Obstructions from the CO-ox
Sample Path, page 4-87.
If the D code reappears, contact your Service Representative.
The CO-ox module detects lamp levels that are inadequate for sample analysis.
Perform the Lamp On/Off Test as described in CO-ox Optics Test, page 4-75.
Remove the lamp cover from the CO-ox module and visually verify that the
lamp is on. If the lamp is not on, replace it as described in Replacing the CO-ox
Lamp in Section 3.
Visually verify that light is passing through the CO-ox sample chamber.
If the D code reappears, contact your Service Representative.
The system detects an error in the electronics system.
Qualifiers:
1 2
3
4
5
6
7
8
9
10 11 12
1, 2, 3, 5, 8, 11
perform the CO-ox Lamp On/Off test, and then perform a
one-point calibration.
Shut the system down and restart:
Menu Code
7
1. From the Menu screen, select 7 System Utilities and
press Enter.
3
2. Select 3 Shutdown and press Enter.
3. Press Yes.
4. Wait at least 1 minute and then disconnect the power cord
from the power source.
5. Wait at least 10 seconds and then connect the power cord
to the power source.
4, 7, 9, 12
shut the system down and restart.
6
check the temperature control as described in
Temperature/pAtm Test, page 4-69.
Shut the system down and restart.
10
perform the Pump Functions Test as described in Pump
Functions Test, page 4-58.
If the D code reappears, contact your Service Representative.
1
testing occurs at power-up initialization and before each zero
and slope calibration. The 12V is checked before and after
every sample measurement. A GO pulse is sent to the CMB.
PWRGOOD is polled to determine if the power supplies are
within range. .
2
testing occurs at power-up initialization and before each zero
and slope calibration. A GO pulse is sent to the CMB. A
counter verifies if the CMB generates 256 interrupts on
ADCRDY. Integration time and CMB DAC value is checked.
3
testing occurs at power-up initialization and before each zero
and slope calibration. Ground input to the ADC on the CMB
is selected. A GO pulse is issued sent to the CMB and the
resulting 256 values are averaged. An error is reported if the
average value is outside the range 7F00H to 80FFH.
4
testing occurs only at power-up initialization. The DAC value
016FH is loaded. A dark measurement is initiated, the DAC is
loaded with 05D0H, and another dark measurement is taken.
The difference in ADC counts between the two measurements
is to be 32,768 200 counts.
5
testing occurs at power-up initialization and before each zero
and slope calibration. Ground is selected as the ADC input. A
GO pulse is issued. The resulting 256 values are collected and
the SD computed. An error is reported if SD is greater than
3.30 ADC counts.
6
testing occurs at power-up initialization and any time a heater
control error is detected. This tests the integral non-linearity
of the DAC. The DAC is alternately set to zero, mid-, and full
scale. The output is read at each level. The value at each level
must be within 100 mV after subtracting the offset of the
GPADC (Refer to qualifier 11.):
Program 0 value into the DAC and read 0 100 mV.
Program 2047 into the DAC and read 2500 100 mV.
Program 4095 into the DAC and read 5000 100 mV.
7
testing occurs at power-up initialization. Communications
between the microstepper controller and the CPB are
monitored for the response time to a command from the
microstepper controller. The test steps are:
Reset the microstepper controller.
Enable microstepper controller.
Wait 100 µS for a response from the controller. If no
response, the controller is not operating correctly.
8
testing is performed on a clean, sample chamber filled with
bubble-free 7.3 Buffer/CO-ox Zero solution. During
subsequent zeros the integration time is checked and
readjusted (zero occurs during any 1-point calibration, except
metabolite). If necessary, the lamp voltage or intensity is
adjusted. Full calibration occurs during system initialization at
start up. Testing also occurs during every sample, slope, or
zero measurement.
9
testing occurs at power-up initialization by reading +12V and
–12V with the general purpose ADC. The 12V values are
scaled to 3.0V before going into the ADC. The ADC
reading is to be +3.0V 3% and –3.0V 3%, respectively.
10
testing occurs at start up and during the CO-ox pump MIT
(Pump MIT selects CO-ox). This test checks for current flow
through the windings. A failure indicates that the motor driver
electronics are malfunctioning or that the motor is
disconnected. A MTR_CLR signal is initiated prior to reading
the MTR_STATUS bit, which clears the latch from prior
motor function. A TTL 1 on the MTR_STATUS identifies
current flow through the motor windings.
11
testing occurs each time the general purpose ADC is
calibrated. The GPADC is calibrated at power-up
initialization, and each zero and slope calibration. Setting the
GPADC to signal return and averaging several A/D readings
determines Offset. Offset is checked to be within the range 0
100 mV. Setting the channel to the DAC reference signal
and averaging several A/D readings determines Gain. Gain is
computed as 5000 mV /(gain – offset reading). The value of
Gain is 1.00 0.01.
12
testing occurs at start up. This test checks the status of the
24V power supply by measuring the 24V supply with the
general purpose ADC. The 24V feed to the ADC is scaled
down to 3.0V. The ADC reading is to be 3.0V 10%.
The system detects an error in the temperature control system.
Every 15 minutes, the system enables the temperature control and reevaluates the error condition. If
the problem that caused the condition has been corrected, the system automatically clears the D77
condition. If the problem has not been corrected, the system displays the D77 condition code again.
Check that the ambient temperature of the laboratory is between 15 and 32°C.
Perform the Temperature/pAtm Test as described on page 4-69.
Shut down and restart the system from the Menu screen as described in Shutting
Down and Restarting the System in Section 5.
If the D code reappears, contact your Service Representative.
Fluid detector 5 (FD5), the CO-ox sample chamber, or both do not detect reagent.
Qualifiers:
7.3
Wash
Check the expiration dates and levels of the 7.3/COox Zero and the Wash/Glu
Zero. Ensure that the reagent bottles are installed properly and in the correct
location. If reagents have expired, are low, or are incorrectly installed, replace
the affected reagent. Perform a one-point calibration if the D78 disappears.
Ensure that the CO-ox sample path is connected to the base model. If the
sample connector needs to be inverted, refer to Disconnecting the CO-ox
Sample Path, page 4-92 for instructions.
Check the CO-ox sample path for obstructions. If you see any obstructions,
remove obstructions as described in Removing Obstructions from the CO-ox
Sample Path, page 4-87.
Check the CO-ox sample tubing for leaks or cracks. If you find cracks or leaks,
replace the tubing as described in Replacing the CO-ox Sample Tubing in
Section 3.
Check the gasket in the hemolyzer for cracks and that the gasket is seated
correctly. If necessary, replace or reinstall the gasket as described in Cleaning
the Hemolyzer in Section 3.
Check the CO-ox sample chamber for obstructions and that the gasket is seated
correctly. If necessary, remove obstructions or reinstall the gasket as described
in Cleaning the CO-ox Sample Chamber in Section 3.
Perform a one-point calibration.
Perform the Fluidics Functions Test for the appropriate reagent as described in
Fluidics Functions Test, page 4-56.
Check the CO-ox pump tubing for leaks, flattened areas, or other signs of wear.
Replace the tubing, if necessary, as described in Replacing the CO-ox Pump
Tubing in Section 3.
Perform the Pump Functions Test as described in Pump Functions Test,
page 4-58.
If the D code reappears, contact your Service Representative.
The wash did not completely clean the CO-ox sample path due to low volume or poorly
segmented flow.
If a D78 also exists, correct that problem first, then correct the D79.
Perform a wash.
Ensure that the Wash/Glu zero reagent bottle is installed properly. Check the
level of reagent. If the level is low, replace the reagent as described in
Replacing the Reagent Bottles in Section 3.
Check the CO-ox sample tubing for leaks or cracks. If necessary, replace the
tubing as described in Replacing the CO-ox Sample Tubing in Section 3.
Check that the gaskets in the CO-ox sample chamber and hemolyzer are seated
correctly. If necessary, reinstall either gasket as described in Cleaning the
CO-ox Sample Chamber or Cleaning the Hemolyzer in Section 3.
Perform the valves diagnostic test to verify that the wash, diverter, vent, and
wash bypass valves are functioning as described in Valves Test, page 4-62.
Perform the Pump Functions Test as described in Pump Functions Test,
page 4-58.
Check the CO-ox pump tubing for leaks, flattened areas, or other signs of wear.
Replace the tubing, if necessary, as described in Replacing the CO-ox Pump
Tubing in Section 3.
If the D code reappears, contact your Service Representative.
..
This section describes how to use the 800 system diagnostic tests to check the
functions of the system components. Access the tests from the Troubleshooting
menu or by pressing Troubleshooting at the View Status screen. Table 4-2
describes the function of each test.
Fluidics Functions
Tests the ability of the reagent components to deliver the
reagents to the fluid detectors in the reagent manifold and the
measurement module.
Pump Flow Rate
Tests the ability of the reagent pump to pump a specified amount
of fluid in a specified period of time.
Pump Functions
Tests the ability of all pumps to turn on and off and lets you
manually test the flow rates for these pumps.
Valves
Tests the solenoid valve electronics and the ability of the valves
to open and close. The valves tested are 6.8, 7.3, foam, wash,
vent, clean, bypass, cal gas, slope gas, glu/lac, and diverter.
Gas Flow Rates
Tests the ability of the Cal Gas and Slope Gas valves to control
the flow of gases.
Fluid Detector
Tests the ability of the fluid detectors to detect the presence of
fluids and to detect whether the fluids are clear or opaque.
Sample Entry
Tests the ability of the system to identify the position of the
sample door and of the sample probe and to detect the type of
sample device. This test can also calibrate the sample door.
Temperature/pAtm
Displays the temperature readings for the measurement module,
the sample, the measurement module window, and the preheater.
The test also displays the atmospheric pressure.
Measurement
Tests the measurement electronics by displaying sensor voltage
and current output.
COox Optics
Tests the operation of the lamp on the CO-ox module and
provides the integration time of the last one-point calibration.
External Loopback
Tests the communication between the user-interface processor,
the serial ports, and the external cable connected to each port.
Roll Printer
Tests the ability of the roll printer to print all characters.
Bar Code Scanner
Tests the ability of the bar code scanner to read a test pattern.
Use this procedure to test the ability of the reagent components to deliver reagents
to the fluid detectors in the reagent manifold and the measurement module.
1. Access the Fluidics Functions Test screen from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 1 Fluidics Functions and press Enter.
The Fluidics Functions Test screen appears as shown in Figure 4-2 for an 860
system.
2. Select the reagent you want to test and press Enter.
3. Press Start Test.
4. Check the screen for the message, Fluidics functions acceptable, to verify that
the system delivers the reagent to the fluid detectors.
5. Perform the appropriate action.
! test another reagent
repeat steps 2 through 4.
return to the Menu
screen
press Exit Test.
6. Press Exit Menu.
Use this procedure to test the flow rate of the reagent pump and to calibrate the
reagent pump, if necessary.
1. Access the Pump Flow Rate Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 2 Pump Flow Rate and press Enter.
The Pump Flow Rate Test screen appears as shown in Figure 4-3.
#" 2. Press Start Test.
3. Check the screen for the message, Reagent pump flow rate acceptable, to
verify that the flow rate is within the acceptable range.
acceptable
press Exit Test.
unacceptable
a. Press Calibrate Pump.
b. Check the screen for the message, Pump calibration
complete.
c. Press Exit Test.
4. Press Exit Menu.
Use this procedure to test the ability of the reagent, sample, and waste pumps to
turn on and off and to manually test the flow rates for the reagent, sample, waste,
and CO-ox pumps. The flow rate is the amount of fluid the pumps can pump in a
specified time.
Materials required for the manual pump flow rate test:
stopwatch
10 mL graduated cylinder
small container of reagent water
2 small two-way connectors
2 pieces of test tubing, each approximately 30 cm (10 inches) long with
approximately 0.15 cm (0.060 inches) inner diameter
1. Access the Pump Functions Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 3 Pump Functions and press Enter.
The Pump Functions Test screen appears as shown in Figure 4-4.
2. Test the pump electronics:
a. Select the pump and speed to test and press Enter.
b. Press Start Test.
The pump turns on.
When you select the reagent pump, the waste pump also turns on.
c. Check the screen for the message, Pump current acceptable, to verify that
the pump electronics are functioning correctly.
d. Press Stop Test.
3. Perform the appropriate action.
measure the flow rate of the
reagent, sample, or waste
pump
continue with step 4.
return to the Menu screen
continue with step 11.
4. Install the test tubing on the reagent, sample, or waste pump as shown in
Figure 4-5:
The reagent pump turns counterclockwise and the sample and waste
pumps turn clockwise.
a. Disconnect the pump tubing from the connectors for the pump.
b. Attach one piece of test tubing to a two-way connector, attach the
connector to the inlet tubing for the appropriate pump, and place the test
tubing in a beaker of reagent water.
c. Attach another piece of test tubing to a two-way connector, attach the
connector to the outlet tubing for the appropriate pump, and place the test
tubing in the graduated cylinder.
test the reagent pump
a. to the pump inlet tubing connected to right position 1
b. and to the outlet tubing connected to left position 1.
test the sample pump
a. to the pump inlet tubing connected to left position 4
b. and to the outlet tubing connected to right position 4.
test the waste pump
a. to the pump inlet tubing connected to left position 5
b. and to the outlet tubing connected to right position 5.
! Sample or
Waste Pump
Two-Way
Connector
Tubing
Reagent
Water
Two-Way
Connector
Tubing
5. Install the test tubing on the CO-ox pump:
The CO-ox pump turns clockwise.
a. Disconnect the sample and waste tubing from the pump tubing.
b. Attach one piece of test tubing to sample tubing connector on the CO-ox
pump tubing, and place the test tubing in a beaker of reagent water.
c. Attach another piece of test tubing to the waste tubing connector on the
CO-ox pump tubing, and place the test tubing in the graduated cylinder.
6. Select the pump and speed to test and press Enter.
7. Prime the tubing:
a. Press Start Test.
b. Allow reagent water to flow through all the tubing.
c. Press Stop Test.
d. Empty the graduated cylinder.
8. Test the pump flow rate for 1 minute:
a. Place the outlet tubing in the graduated cylinder.
b. Press Start Test and simultaneously start timing with a stopwatch.
c. Collect fluid for exactly 1 minute.
d. Press Stop Test.
e. Compare the volume of collected fluid to the expected ranges.
reagent
1.51 – 1.85 mL/min
5.94 – 7.26 mL/min
sample
1.51 – 1.85 mL/min
5.94 – 7.26 mL/min
waste
1.51 – 1.85 mL/min
7.02 – 8.58 mL/min
CO-ox
0.27 – 0.33 mL/min
5.94 – 7.26 mL/min
9. If the measured volume is not acceptable, the pump tubing may be worn or
damaged, the roller cage or shaft may be dirty, or the pump speed may require
calibration.
10. Perform the appropriate action.
measure the flow rate of the same
pump at a different speed
a. Empty the graduated cylinder.
b. Select the pump and speed to test and press
Enter.
c. Repeat steps 7 and 8.
measure the flow rate of a
different pump or return to the
Menu screen
continue with step 11.
11. Reinstall the reagent, sample, or waste pump tubing:
a. Disconnect the test tubing and the two-way connectors from the pump
tubing.
b. Reinstall the pump tubing:
reagent pump tubing to the connectors at position 1
sample pump tubing to the connectors at position 4
waste pump tubing to the connectors at position 5
12. Reinstall the CO-ox tubing:
a. Disconnect the test tubing from the pump tubing.
b. Reconnect the sample tubing to the sample tubing connector on the pump.
c. Reconnect the waste tubing to the waste tubing connector on the pump.
13. Perform the appropriate action.
measure the flow rate
of a different pump
repeat steps 4 through 9.
return to the Menu
screen
a. Press Exit Test.
The Menu screen appears.
b. Press Exit Menu.
When you use the left arrow key to exit the Troubleshooting menu and enter the
Main menu, the system performs a wash.
Use this procedure to test the solenoid valve electronics and to test the ability of
the valves to open and close. You can test the following valves:
6.8
controls the flow of 6.838 Buffer
7.3
controls the flow of 7.3/CO-ox Zero Buffer
Foam
controls the flow of Wash G/L Zero Reagent during the foam wash
sequence
Wash
controls the flow of Wash G/L Zero Reagent
Vent
controls the flow of ambient air into the manifold
Clean
controls the flow of Cleaning Solution
G/L
controls the flow of Cal G/L Reagent
Bypass
diverts the Wash G/L Zero Reagent in the reagent manifold when the
foam wash valve is off, preventing a pressure buildup
Diverter
directs the flow of reagent into either the calibration passage or the
wash passage of the sample port
If you want to test the Cal Gas or Slope Gas valves, refer to Checking the Gas
Flow, page 4-64.
1. Access the Valves Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 4 Valves and press Enter.
The Valve Test screen appears as shown in Figure 4-6.
2. Select the valve you want to test and press Enter.
3. Press Start Test.
Listen for a distinctive click, which indicates the opening of the valve, and
check the screen for the message, Valve energized, to verify that the valve is
operating correctly.
4. Press Stop Test.
Listen for a distinctive click, which indicates the closing of the valve.
5. Perform the appropriate action.
test another valve
repeat steps 2 through 4.
return to the Menu screen
press Exit Test.
6. Press Exit Menu.
When you use the left arrow key to exit the Troubleshooting menu and enter the
Main menu, the system performs a wash.
Use this procedure to test the flow of Cal Gas and Slope Gas. Refer to Figure 4-7
as you perform this procedure.
"! Aspiration Adapter
Sample Port
Water
Steady Stream of
Bubbles
1. Fill a small container with reagent water.
2. Access the Valves Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 4 Valves and press Enter.
3. Check the flow of Cal Gas:
a. Select Cal Gas and press Enter.
b. Push down the sample door halfway open, insert an aspiration adapter into
the sample port, and immerse the other end in the water.
c. Press Start Test.
Ensure that a steady stream of bubbles flows from the aspiration adapter.
d. Press Stop Test.
Ensure that the bubbles stop flowing from the adapter.
4. Check the flow of Slope Gas:
a. Select Slope Gas and press Enter.
b. If required, push down the sample door halfway open, insert an aspiration
adapter into the sample port, and immerse the other end in the water.
c. Press Start Test.
Ensure that a steady stream of bubbles flows from the aspiration adapter.
d. Press Stop Test.
Ensure that the bubbles stop flowing from the adapter.
5. Remove the aspiration adapter and manually close the sample door.
6. Press Exit Test.
7. Press Exit Menu.
When you use the left arrow key to exit the Troubleshooting menu and enter the
Main menu, the system performs a wash.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
CAUTION: Touch the inner surface of the module frame to discharge static
buildup before removing or returning sensors.
2. Remove the sensors.
3. Check that the O-rings are in place.
4. Install the sensors in their correct positions by aligning the top of the sensor
with the sensor contact and snapping the body of the sensor into place.
5. Close the measurement module door.
6. Press Continue and allow the system to warm up.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
7. Press Yes to perform a two-point calibration.
Use this procedure to test the ability of the fluid detectors to detect the presence of
fluids and to detect whether the fluids are clear or opaque. You can also test fluid
detectors 1, 1A, and 2 with whole blood by inserting a sample device containing
whole blood into the sample port.
1. Access the Fluid Detector Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 5 Fluid Detector and press Enter.
The Fluid Detector Test screen appears as shown in Figure 4-8.
2. Test the fluid detectors with clear fluid and air:
a. Select Baseline/Clear and press Enter.
b. Press Start Test.
c. Check the screen for the message FD1, FD1A, FD2, FD3, FD4, FD5
acceptable to verify correct fluid detector function.
d. Press Exit Test.
3. Perform the appropriate action.
the fluid detector failed the Baseline test
continue with step 6.
you want to test whole blood
continue with step 4.
you want to return to the Menu screen
continue with step 6.
4. Test the fluid detectors with whole blood:
a. Select Whole Blood and press Enter.
b. Insert a sample device containing a whole blood sample into the sample
port.
c. Press Start Test.
d. Remove the sample device when prompted.
e. Check the screen for the message, FD1, FD1A, FD2, FD5 acceptable, to
verify correct fluid detector function.
The system automatically performs a full wash sequence.
5. Repeat step 4 if you want to test the fluid detectors with another type of fluid.
6. Press Exit Test.
7. Press Exit Menu.
Use this procedure to test the ability of the system to:
move the sample door and the sample probe
identify the position of the sample door and the sample probe
detect the type of sample device
detect an obstruction
calibrate the sample door to various types of sample devices
1. Access the Sample Entry Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 6 Sample Entry and press Enter.
The Sample Entry Test screen appears as shown in Figure 4-9.
2. Test the positions of the sample door and the sample probe:
a. Select Automatic and press Enter.
b. Press Start Test.
c. Check the screen for the message, Sample entry module acceptable, to
verify that the sample door and sample probe function correctly.
d. Press Exit Test.
3. Test the ability of the system to recognize the sample device:
a. Select Manual and press Enter.
b. Insert a sample device, with the plunger pulled back, into the sample port
when prompted.
c. Press Start Test.
d. Remove the sample device when prompted.
e. Check the screen to verify that the system correctly identifies the size and
the type of the sample device.
f. Press Exit Test.
4. Test the ability of the sample probe to detect obstructions:
a. Select Manual and press Enter.
b. Push in completely the plunger of a syringe and insert the syringe into the
sample port when prompted.
c. Press Start Test.
d. Remove the syringe when prompted.
e. Check the screen to verify that the sample probe detects an obstruction and
identifies the size of the sample device.
5. If the system does not correctly recognize the sample device, calibrate the
sample door:
a. Press Calibrate Door.
b. Insert the door calibration gauge. Use a Bayer Diagnostics 1 mL
syringe size.
c. Press Start Test.
d. Remove the sample device when prompted.
e. Check the screen to verify that the sample door is calibrated.
6. Press Exit Test twice.
Use this procedure to test the temperature and barometer controls when the system
generates a D38 or D22 code. If this test is successful, the D38 or D22 code is
cleared from the status area. This test also displays the temperature readings for the
measurement module, the sample path, the measurement module window, the
preheater, and the barometric pressure.
NOTE: The 37°C temperature set point is NIST traceable.
Menu Code 1.
3
2
Access the Temperature/pAtm Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 2 Temp/pAtm and press Enter.
2. Press Start Test.
3. Perform the appropriate action.
D38 code
a. Check the screen for the message, Temperature control
system on.
b. Press Stop Test.
c. If the temperature control system is off, press Reset
Control.
d. Continue with step 4.
D22 code
a. Press Stop Test.
b. Look at the status area to see if the D22 code has
disappeared.
c. Continue with step 5.
4. Perform the appropriate action.
" Temperature control system on
message
a. Press Stop Test.
b. Look at the status area to see if the D38
code has disappeared.
c. Allow the system to reach operating
temperature.
Temperature control system off
message
the system cannot reset the temperature control
system.
5. Press Exit Test.
Use this procedure to test the measurement electronics. You can:
print stored signals from the last successful two-point calibration
test the sensor circuit without a sensor and with a test/blank sensor
1. Access the Measurement Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 3 Measurement and press Enter.
c. Select 1 Measurement and press Enter.
2. Press Print Last Cal Mv.
3. Compare the results on the report to the expected values in the following
tables.
! ! pH
194.0 to 406.0 mV
20 to 90
pCO2
–216.0 to +106.0 mV
25 to 90
pO2
–0.129 to +2.071 nA
5 to 90
Na+
29.0 to 131.0 mV
15 to 90
K+
29.0 to 126.0 mV
15 to 90
Cl–
29.0 to 126.0 mV
15 to 90
Ca++
29.0 to 126.0 mV
20 to 90
Glu I
–5.35 to +16.45 nA
Glu A
–5.35 to +16.45 nA
Lac I
–5.35 to +16.45 nA
Lac A
–5.35 to +16.45 nA
45
45
pH
217.1 to 443.3 mV
20 to 90
42.5 to 68.5 mV/Dec
pCO2
–203.2 to +126.6 mV
25 to 90
42.5 to 68.5 mV/Dec
pO2
–0.300 to +0.360 nA
5 to 90
0.002 to 0.020
nA/mmHg
Na+
35.2 to 141.0 mV
15 to 90
42.5 to 68.5 mV/Dec
K+
41.8 to 146.6 mV
15 to 90
42.5 to 68.5 mV/Dec
Ca++
34.7 to 137.1 mV
20 to 90
19.0 to 36.8 mV/Dec
Cl–
18.4 to 121.3 mV
15 to 90
–30.0 to –68.5 mV/Dec
Glu I
–5.35 to 16.45 nA
Glu A
1.85 to 88.45 nA
12 to 90
0.040 to 0.400
nA/mg/dL
Lac I
–5.35 to 16.45 nA
Lac A
–3.35 to 42.45 nA
12 to 90
1.00 to 13.00
nA/mmol/L
4. Press Exit Test.
TB1, pO2/pCO2 Test/Blank Sensor
TB2, pH/Na+ Test/Blank Sensor
TB3, K+/Ca++/Cl– Test/Blank Sensor
TB4, Glucose/Lactate Test/Blank Sensor
Menu Code 1.
3
3
Access the Measurement Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 3 Measurement and press Enter.
CAUTION: Touch the inner surface of the module frame to discharge static
buildup before removing or returning sensors.
2. Remove the appropriate sensors:
a. Open the measurement module door.
b. If you are testing a pH or ISE sensor circuit, remove the reference sensor.
c. Remove the measurement sensor.
d. Close the measurement module door.
3. Perform the Measurement Test without a sensor:
a. Press Start Test.
b. Take a reading of the actual sensor output signal.
c. Compare the result to the expected value.
Two values are reported for the glucose and lactate biosensors.
pCO2
–6.000 to +6.000 mV
pO2
20.607 to 16.191 nA
pH, Na+, K+, Ca++, or Cl–
–6.000 to +6.000 mV
Glu I
–5.348 to +5.348 nA
Glu A
25.252 to 54.748 nA
Lac I
–5.348 to +5.348 nA
Lac A
17.602 to 42.398 nA
sample ground/temperature
36.840 to 37.373°C
d. Press Stop Test.
e. Perform the appropriate action.
is within the expected
value
continue with step 4.
is not within the expected
value
the sensor circuit fails the test. Continue with step 6.
The measurement test, which requires approximately 8 minutes to
complete, can effectively evaluate measurement system failures.
4. Install a test/blank sensor:
a. Open the measurement module door.
b. Perform the appropriate action.
pO2 or pCO2 sensor circuit
TB1 test/blank sensor.
pH or Na+ sensor circuit
TB2 test/blank sensor.
K+, Ca++, or Cl– sensor
circuit
TB3 test/blank sensor.
Glu biosensor circuit
TB4 test/blank sensor.
Lac biosensor circuit
TB4 test/blank sensor.
c. Close the measurement module door.
5. Perform the Measurement Test:
a. Press Start Test.
b. Check the screen for a value of –250 to +250 mV for pCO2 and –450 to
+450 mV for pH and ISE. If required, remove and reinstall the test/blank
sensor until the value is within this range.
c. For all sensor circuits except pO2, wait at least 4 minutes after closing the
door.
d. Take a reading of the actual sensor output signal.
e. Wait 100 seconds, and take another reading.
value = (reading 1 – reading 2) / 100 seconds
f. Calculate the resulting value and then compare the resulting value to the
expected value:
pCO2
–0.800 to +0.800 mV/s
pO2
–0.300 to +0.300 nA
pH, Na+, K+, Ca++, or Cl–
–0.545 to +0.545 mV/s
Glu I, Glu A
–5.348 to +5.348 nA
Lac I, Lac A
–5.348 to +5.348 nA
g. Press Stop Test.
CAUTION: Touch the inner surface of the module frame to discharge static
buildup before removing or returning sensors.
6. Reinstall the sensors:
a. Open the measurement module door.
b. Remove the test/blank sensor.
c. Reinstall the measurement sensor.
If you want to test another sensor, repeat steps 4b through 6c.
d. Reinstall the reference sensor if you removed it.
e. Close the measurement module door.
CAUTION: Before you press Exit Test, replace all sensors to prevent fluid from
spilling into the measurement module.
7. Press Exit Test.
Perform a two-point calibration to ensure optimum performance.
If you encounter any difficulties when performing or interpreting the
results of this test, contact your Service Representative for assistance.
" You can use this procedure to test the operation of the CO-ox lamp and to display
the integration time for the last CO-ox zero calibration.
1. Access the CO-ox Optics Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 3 Measurement and press Enter.
c. Select 2 COox Optics and press Enter.
The CO-ox Optics Test screen appears as shown in Figure 4-10.
"! " 2. Press Start Test.
3. Check the screen for the message, Lamp test passed.
The system requires a one-point calibration to zero the CO-ox module
when the lamp test is complete. The message, Calibration Overdue: COox
Zero, is displayed when the test is run.
The integration time for the zero calibration should be between 8,000 and
80,000 µsec.
4. Press Exit Test.
Use this procedure to test the communication between the user-interface processor,
the serial ports, and the external cable connected to each port. The loopback
connector and the cable matching connector are required for this test.
Menu Code 1.
3
4
Access the External Loopback Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 4 Communications and press Enter.
The External Loopback Test screen appears as shown in Figure 4-11.
"! 2. Select the appropriate port and press Enter.
Attach the loopback connector to the cable matching connector, if
your cable requires one.
3. Attach the loopback connector as follows.
the 800 system
a. Remove the cable from the port on the 800 system.
b. Attach the loopback connector to the port.
the cable between the
800 system and the
external device
a. Remove the cable from the port on the external device.
b. Attach the loopback connector to the end of the cable.
4. Press Start Test.
5. Check the screen for the message, Port_acceptable, to verify that the port
passes the test.
6. Remove the loopback connector and reconnect the external device to that port.
7. Press Exit Test.
Use this procedure to test the ability of the roll printer to print all characters in the
character set. Failure of the roll printer to print the entire character set indicates a
problem with the printer assembly, the printer interface, or the printer assembly
cables.
CAUTION: Do not attempt to print without paper in the printer. Damage to the
printer can occur.
Menu Code 1.
3
5
Access the Roll Printer Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 5 Roll Printer and press Enter.
2. Press Start Test.
3. Check the printed test pattern to verify that the roll printer prints all characters
clearly across the page.
4. If the test results are unacceptable, refer to Cleaning the Roll Printer in
Section 3, and then repeat the roll printer test.
5. Press Exit Test.
Use this procedure to test the ability of the bar code scanner to read a test pattern.
Menu Code 1.
3
6
Access the Bar Code Scanner Test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 6 Barcode Scanner and press Enter.
2. Scan the bar code scanner test pattern in Figure 4-12 with the bar
code scanner.
1234567890
3. Check the screen to verify that the characters are readable and that they
correspond to the bar code in the test pattern.
If the screen shows no characters, refer to Troubleshooting Bar Codes, page
4-109.
If you successfully scan the bar code label in Figure 4-12 but you cannot
successfully scan the bar code labels that your laboratory uses, use better
quality bar code labels.
4. Press Exit Test.
..
Use this procedure to remove obstructions from the sample entry components.
Perform the steps in sequence until you locate and remove the obstructions.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
2. Remove obstructions from the sample entry area:
a. Place a gauze pad in front of the sample port.
b. Turn the sample pump counterclockwise until the obstruction is ejected
onto the gauze pad.
3. Remove obstructions from the sample tubing:
a. Inspect the sample tubing for obstructions.
b. Remove the sample tubing.
c. Push a 0.558 mm (0.022-inch) diameter clot-removal line through the
sample tubing from back to front, opposite the direction of sample flow, as
shown in Figure 4-13.
d. Reinstall the sample tubing.
! Sample Tubing
Clot-removal
Line
4. Remove obstructions from the sample probe using the clot-removal line from
the probe clot removal kit:
a. Disconnect the sample tubing from the sample probe.
b. Push a 0.016-inch diameter clot-removal line through the sample probe
until the line comes out of the sample port.
5. Remove obstructions from the capillary seal, as shown in Figure 4-14:
a. Grasp the top of the capillary seal and pull it out of the sample port.
b. Inspect the capillary seal for obstructions.
c. Inspect the opening in the sample port for obstructions.
d. Push a 0.558 mm (0.022-inch) diameter clot-removal line through the
capillary seal, against the direction of sample flow.
e. Install a new capillary seal if you cannot remove the obstruction or the seal
is excessively worn or damaged.
Clot-removal
Line
Capillary Seal
Sample Port
6. Remove obstructions from the sample port, as shown in Figure 4-15:
a. Pull the sample door off.
b. Grasp the tab on the retainer ring and rotate the ring toward you.
c. Grasp the sample port and drip tray and pull it to the right to remove it.
The sample port and the drip tray are one piece.
d. Push a 0.558 mm (0.022-inch) diameter clot-removal line through the
sample port from left to right, opposite the direction of sample flow.
Mount
O-ring
Drip Tray
Retainer Ring
Capillary Seal
Sample Port
Sample Door
Clot-removal Line
7. Inspect the mount for obstructions and clean if necessary.
8. After removing any obstructions, reinstall the sample port:
Ensure that the three O-rings are in place on the mount.
a. Reinstall the sample port onto the mount, matching the tab on the sample
port to the notch in the retainer ring.
b. Grasp the tab on the retainer ring and turn the retainer ring away from you
to lock it in place.
c. Replace the sample door, and ensure that it snaps into place.
9. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
10. Press Yes to perform a two-point calibration.
11. Analyze QC material as necessary to verify sensor performance.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Open the measurement module door:
a. Push up the door latches located on the lower corners of the module door
and lift up the door.
b. Push the spring-loaded latch to the right.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
3. Inspect the pO2 and pCO2 (gas) sensors for obstructions:
To avoid damage to the sensors, do not attempt to push the
clot-removal line through the gas sensors.
a. Remove the sensors and inspect the sample path for obstructions.
b. Place a piece of tubing, or use a capillary adapter, on the tip of a syringe.
Do not exert excessive pressure on the gas sensor membrane.
c. Place the syringe against the sensor sample path and inject air through the
sensor as shown in Figure 4-16.
! Sensor
Capillary Adapter
O-ring
Syringe
Use wash reagent that has not expired and has not been open longer
than 60 days. Do not install the wash reagent bottle that you use for this
procedure on the system.
d. If the obstruction is not removed, fill the syringe with fresh wash reagent
and inject the wash reagent into the sensor sample path.
e. Dry thoroughly and reinstall the gas sensors, ensuring that the O-rings are
in place.
To avoid damage to the sensors, use the clot-removal line
carefully. Be particularly careful with the pH sensor.
4. Inspect the reference sensor, the sample ground/temperature sensor, pH sensor,
and the Na+ sensor for obstructions:
a. Remove the sensors one at a time and inspect the sample path for
obstructions.
b. Cut a piece of tubing, or use a capillary adapter, and place the tubing on the
tip of the syringe.
c. Push a 0.558 mm (0.022-inch) diameter clot-removal line through the
sensor to remove obstructions, as shown in Figure 4-17.
$!'
& % "#!$#" ! ! ! !$ !#$! "! Lift the sensor up
and out of the
measurement module.
Clot-removal
Line
Push the spring-loaded
latch to the right.
d. If the obstruction is not removed, cut a piece of tubing, or use a capillary
adapter, and place the tubing on the tip of the syringe.
e. Place the syringe against the sensor sample path and inject air through the
sensor to remove obstructions.
f. If the obstruction is not removed, fill the syringe with fresh wash reagent
and inject the wash reagent into the sensor sample path.
Touch the inner surface of the module frame to discharge static
buildup before removing or returning sensors.
g. Dry thoroughly and reinstall each sensor, ensuring that the O-rings are in
place.
To avoid damage to Ca++, Cl–, K+, Glu, and Lac sensors, do not
attempt to push the clot-removal line through these sensors.
5. Inspect the Ca++, Cl–, K+, Glu, and Lac sensors for obstructions:
a. Remove the sensors one at and inspect each one for obstructions.
Do not exert excessive air pressure on the glucose or lactate
sensor membrane.
b. Place the syringe against the sensor sample path and inject air through the
sensor to remove obstructions.
c. If the obstruction is not removed, fill the syringe with fresh wash reagent
and inject the wash reagent into the sensor sample path to remove
obstructions.
As you install the biosensors, ensure that the biosensors are in the
correct location. Visually verify that you align the contacts on the biosensors
with the contacts in the measurement module.
d. Dry thoroughly and reinstall each sensor, ensuring that the O-rings are in
place.
6. Remove obstructions from the preheater:
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
a. Remove the gas sensors.
b. Disconnect the sample tubing from the preheater.
c. Push a clot-removal line through the preheater from right to left, opposite
to the direction of sample flow, as shown in Figure 4-18.
Remove the gas sensors
from the measurement
module.
Preheater
Connector for Sample
Tubing
Clot-removal
Line
Push the spring-loaded
latch to the right.
d. Connect the sample tubing to the preheater.
e. Reinstall the gas sensors, ensuring that the O-rings are in place.
7. Remove obstructions from the path through the latch, as shown in Figure 4-19:
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
a. Grasp the tab on the reference sensor and pull it up and out of the
measurement module.
b. Remove the tubing from the spring-loaded latch.
c. Push a clot-removal line through the latch.
! !
Grasp the tab on the
reference sensor and
pull it up and out of the
measurement module.
Clot-removal
Line
Push the spring-loaded
latch to the right.
d. Connect the measurement module tubing to the latch.
e. Reinstall the reference sensor, ensuring that O-rings are in place.
8. Press the release tab to close the spring-loaded latch.
9. Ensure that the sensors are aligned correctly.
10. Close the measurement module door.
11. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
12. Allow the system to warm up at least 15 minutes.
13. Press Yes to perform a two-point calibration.
14. Analyze a minimum of two levels of QC material to verify sensor
performance.
#! BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
NOTE: Do not use a needle on the syringe that you use to introduce reagent water
or air into the CO-ox sample tubing. Using a needle may damage the CO-ox
sample tubing.
Menu Code 1.
2
7
Stop the system from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 7 Stop System and press Enter.
2. Inspect the CO-ox sample tubing and waste tubing for obstructions, as shown
in Figure 4-20.
#" #! CO-ox Pump
Reagent Pump
Waste Tubing
FD5
Outlet
Inlet
Sample Chamber
Hemolyzer
Bubble Trap
Sample
Connector
Do not move the obstruction into the hemolyzer, sample chamber, or
sample connector.
in the CO-ox sample
tubing that connects the
hemolyzer and bubble trap
or the sample chamber and
CO-ox pump
a. Remove the piece of sample tubing that contains
the obstruction.
in the CO-ox sample
tubing that connects the
sample connector and the
hemolyzer
a. Disconnect the end of the CO-ox sample tubing
that is closest to the obstruction.
b. Push a clot-removal line, less than 0.020 mm
diameter, through the tubing to remove the clot.
c. Reinstall the sample tubing.
b. If you disconnected the sample tubing from the
sample connector, disconnect the waste tubing
from the inlet on the reagent manifold and
manually turn the CO-ox pump counterclockwise
to remove the obstruction.
NOTE: If air does not remove the obstruction, place
the waste tubing into a beaker of reagent water, and
manually turn the CO-ox pump counterclockwise to
remove the obstruction.
c. If you disconnected the sample tubing from the
hemolyzer, disconnect the sample pump tubing on
the base model from the right connector 4. Attach
a piece of tubing to a two-way connector and
attach the connector to the pump tubing. Manually
turn the sample pump counterclockwise to remove
the obstruction.
NOTE: If air does not remove the obstruction, place
the sample tubing into a beaker of reagent water and
manually turn the sample pump counterclockwise to
remove the obstruction.
d. If the obstruction is not removed, replace the
sample tubing.
3. Inspect the sample connector for obstructions:
a. Disconnect the tubing from the sample connector.
b. Remove the sample connector.
c. Push a clot-removal line through the sample connector to remove
obstructions.
If the obstruction is in the preheater, see Removing Obstructions from
the Measurement Module for instructions.
d. Reinstall the sample connector.
e. Reconnect the tubing.
4. Inspect the hemolyzer for obstructions:
a. Remove the anvil cap on the hemolyzer by turning it a quarter turn
counterclockwise.
b. Disconnect the sample tubing from the anvil.
c. Pull the anvil and anvil spring away from the mounting pin on the
hemolyzer.
d. Push a clot-removal line through the tubing connectors on the anvil.
e. Clean the exterior surface.
f. Reassemble the hemolyzer.
5. Inspect the sample chamber and bubbletrap for obstructions:
near the sample chamber
outlet
a. Disconnect the CO-ox sample tubing from the
sample connector.
b. Manually turn the CO-ox pump clockwise.
c. Move the obstruction just into the sample tubing
that connects the sample chamber to the CO-ox
pump.
NOTE: If air does not remove the obstruction from
the sample chamber, place the sample tubing from the
sample connector into a beaker of reagent water. Turn
the CO-ox pump clockwise to remove the
obstruction.
d. Disconnect the sample tubing from the sample
chamber outlet.
e. Disconnect the CO-ox waste tubing from the inlet
on the reagent manifold.
f. Manually turn the CO-ox pump counterclockwise
to remove the obstruction from the sample tubing.
NOTE: If air does not remove the obstruction from
the sample tubing, place the CO-ox waste tubing in
water. Turn the CO-ox pump counterclockwise to
remove the obstruction.
g. Reconnect all tubing.
near the sample chamber
inlet
a. Disconnect the waste tubing from the inlet on the
reagent manifold.
b. Disconnect the sample tubing from the bubble trap
and the sample chamber inlet.
c. Manually turn the CO-ox pump counterclockwise
to remove the obstruction.
NOTE: If air does not remove the obstruction from
the sample tubing, place the waste tubing into a
beaker of reagent water. Turn the CO-ox pump
counterclockwise to remove the obstruction.
d. Reconnect all tubing.
not removed
a. Remove the sample chamber.
NOTE: Hold the sample chamber by the edges.
b. Disconnect the bubble trap from the sample
chamber.
c. Push a clot-removal line through the two sample
chamber ports.
d. Clean the glass sapphire window.
e. Reconnect the bubble trap to the sample chamber.
f. Reinstall the sample chamber.
g. Perform a one-point calibration.
h. Perform a tHb slope calibration.
in the bubble trap
a. Disconnect the tubing from the bubble trap.
b. Disconnect the bubble trap from the sample
chamber.
c. Push a 0.016-inch diameter clot-removal line into
the metal tubing of the outlet port of the bubble
trap.
NOTE: If the clot-removal line does not remove the
obstruction, flush the bubble trap by injecting reagent
quality water into the metal port using a syringe and a
separate piece of tubing or capillary adapter.
d. Reconnect the bubble trap to the sample chamber.
e. Reconnect the tubing to the bubble trap.
6. Press Continue.
A wash sequence starts. When the wash sequence finishes, a message box
appears prompting you to perform a two-point calibration.
7. Press No.
8. Perform a one-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 1 One-point and press Enter.
Use this procedure to disconnect the CO-ox sample path from the base model. You
can continue to measure the remaining parameters.
BIOHAZARD: Refer to Appendix A, Protecting Yourself from Biohazards, for
recommended precautions when working with biohazardous materials.
Menu Code 1.
6
3
Turn the CO-ox parameters off:
a. Select 6 System Setup and press Enter.
b. Select 3 Parameters and press Enter.
c. Move to the CO-oximetry frame.
d. Select the tHb parameter and press Enter.
This turns all CO-ox parameters off.
e. Press Next Screen to access the second screen of parameters.
f. Press Next Screen to access the third screen of parameters.
g. Press Done when you finish.
2. Disconnect the CO-ox and base model sample tubing from the sample
connector.
3. Remove the screw from the sample connector.
4. Invert the sample connector so that the “Y” is on the bottom as shown in
Figure 4-21.
Preheater
Sample Connector
Inverted
Connector
5. Align the sample connector with the guide pin and slide the “Y” prongs into
the slot at the bottom of the face plate.
The straight path is on top when the CO-ox sample path is disconnected.
6. Reinstall the screw.
7. Reconnect the base model sample tubing.
8. Press OK.
To reconnect the CO-ox sample path, turn the CO-ox parameters on, invert the
sample connector. The instructions in the procedure for disconnecting the sample
path describe how to invert the sample connector. When the connector is inverted
and the “Y” is on top, reconnect the CO-ox and base model sample tubing. Press
OK.
This section describes information about observed problems that are not usually
associated with diagnostic codes (D codes), that appear as system messages
requiring operator intervention, or that are not cleared by a diagnostic test.
Use the appropriate subsections to troubleshoot the following:
results
reagents
sensors and CO-ox
bar codes
electronics
roll printer
probe
pumps
thermal control
system messages
If the problem remains after you perform the suggested solutions, contact your
Service Representative.
Use this section to troubleshoot observed problems in the following:
quality control results
patient results
Use this table if you observe quality control results that are outside the expected
range or proficiency test results that are not as expected.
↑ or
↓ or
The result is above (up arrows) or below (down arrows)
the limits of the system’s measurement range, as described
in Appendix E, Performance Characteristics.
Out of Range message
1. Verify the manufacturer’s control values and ascertain
whether a value outside the system’s measurement
range is likely.
2. Check for sample movement during measurement.
3. Check the fluid in the sample path for bubbles.
4. Perform a wash.
5. Retest the control if appropriate.
6. Check pH, ISE, and reference sensor fill levels.
7. Perform a successful two-point calibration.
8. Verify that the control is prepared, handled, and stored
correctly.
9. Test a new set of controls.
10. Verify that the sample pump is operating correctly and
test the sample pump flow rate as described in Pump
Functions Test, page 4-58.
↑ or ↓
↑↑ or ↓↓
The result is above (up arrow) or below (down arrow) the
established control range.
1. Verify that the control is prepared, handled, mixed,
and sampled correctly.
2. Review the control manufacturer’s storage
instructions. Avoid storing controls near heated or
cooled areas, such as the system, a heating vent, or an
air conditioner vent.
3. Verify that the controls are not outdated or
deteriorated. Use controls only within their expiration
date.
4. Verify that the reagents are not outdated.
5. Perform a successful two-point calibration.
6. Check for sample movement during measurement.
7. Check the fluid in the sample path for bubbles.
8. Perform a wash.
9. Retest the control.
10. Ensure that sensors are filled with the appropriate
solutions and are free of bubbles.
11. Verify that the sample pump is operating correctly and
test the sample pump flow rate as described in Pump
Functions Test, page 4-58.
Proficiency test
results are not
as expected
System requires cleaning or maintenance, or reagents or
controls are outdated, deteriorated, or incorrectly handled.
1. Perform all required maintenance and cleaning.
2. Ensure that reagents, controls, and unknown samples
are prepared, handled, and stored correctly.
3. Check all quality control results.
4. Check any unusual occurrences such as error flags or
irreproducible results.
5. Check reagent and instrument reporting categories for
transcription or setup errors.
6. Verify that the controls are not outdated or
deteriorated. Use controls only within their expiration
date.
7. Verify that the reagents are not outdated.
8. Perform a successful two-point calibration.
9. Check for sample movement during measurement.
10. Check the fluid in the sample path for bubbles.
11. Perform a wash.
12. Ensure that sensors are filled with the appropriate
solutions and are free of bubbles.
13. Verify that the sample pump is operating correctly and
test the sample pump flow rate as described in Pump
Functions Test, page 4-58.
Use this table if you observe unexpected or out-of-range patient results.
The patient sample result is
not as expected
The result is inconsistent with the patient’s diagnosis,
current treatment, or past history including previous
measurements on that patient, or is inconsistent with other
values on the same specimen.
1. Ensure that you use the correct sample collection
techniques and anticoagulant, as described in Sample
Collection Devices and Anticoagulants in Section 1.
2. Ensure that you use the recommended storage,
handling, and mixing techniques.
3. Retest the sample. Ensure that the sample, especially
those from capillary tubes, has no air bubbles.
4. Check for sample movement during measurement.
5. Ensure that reagents are installed in the correct
positions on the manifold.
6. Perform a wash.
7. Perform a successful two-point calibration.
8. Retest the sample and verify the results.
* is printed next to the
result on reports
A measurement sensor does not reach the endpoint within
90 seconds (glucose within 60 seconds).
1. Retest the sample.
2. Verify that cleaning and maintenance procedures have
been performed. If not, deproteinize and condition the
sensors.
3. Ensure that you use the correct sample collection
techniques and anticoagulant, as described in Sample
Collection Devices and Anticoagulants in Section 1.
4. Check for sample movement during measurement.
5. Check the fluid in the sample path for bubbles.
6. Ensure that you use the recommended storage,
handling, and mixing techniques.
7. Check for salt deposits and leaks around the sensors.
Clean and refill sensors, if required.
8. If the problem recurs repeatedly, replace the sensor.
↑
↓
The result is above (up arrows) or below (down arrows)
the limits of the system’s measurement range, as described
in Appendix E, Performance Characteristics.
or
or
Out of Range message
1. Check the source and result, and ascertain whether a
value outside the range is likely.
2. Check for sample movement during measurement.
3. Check the fluid in the sample path for bubbles.
4. Perform a wash.
5. Ensure that you use the correct sample collection
techniques and anticoagulant, as described in Sample
Collection Devices and Anticoagulants in Section 1.
6. Ensure that you use the recommended storage,
handling, and mixing techniques.
7. Retest the sample.
↑ or ↓
↑↑ or ↓↓
The result is above (up arrow) or below (down arrow) the
established range.
1. Check the sample source and result, and ascertain
whether a value outside the range is likely.
2. Check for sample movement during measurement.
3. Check the fluid in the sample path for bubbles.
4. Perform a wash.
5. Ensure that you use the correct sample collection
techniques and anticoagulant, as described in Sample
Collection Devices and Anticoagulants in Section 1.
6. Ensure that you use the recommended storage,
handling, and mixing techniques.
7. Retest the sample.
# is printed next to the
glucose or lactate result on
reports
The system detects substances in the sample that may
interfere with glucose or lactate measurement.
1. Check the sample source and determine whether the
presence of an interfering substance is likely. See
Appendix E, Performance Characteristics, for a list of
interfering substances.
2. If the message appears on multiple patient samples
that do not contain interfering substances, replace the
appropriate biosensor, as described in Replacing the
Glucose and Lactate Biosensors in Section 3.
? is printed next
to the CO-oximeter results
on reports
Optical measurements indicate that the CO-oximeter
results should be reviewed.
Results may still be clinically valid. When reporting
CO-oximeter results, consider the patient’s history and
clinical condition to determine acceptability of results.
To troubleshoot an If Blood, Question Data message,
determine whether the problem is with the sample type,
the patient sample, or the system.
NOTE: When analyzed as a patient sample, aqueous
materials with dyes cause the If Blood, Question Data
message to appear.
1. Ensure that you analyzed a patient sample, not a QC
or calibration sample. Ensure that the patient sample
is free of clots and unidentified interfering substances.
2. If the problem is not with the sample type, analyze the
sample again.
3. If the message reappears, perform a pH/lytes
one-point calibration to zero the CO-oximeter.
is successful
go to step 5.
is not successful
repeat the pH/lytes
one-point calibration
two more times.
? is printed next
to the CO-oximeter results
on reports
4. Review the last calibration.
is successful
go to step 5.
is not successful
a. Clean the sample chamber.
Refer to Cleaning the
Sample Chamber in
Section 3.
b. Check that the hemolyzer
is correctly assembled and
that the gasket is in place.
c. Perform a pH/lytes
one-point calibration and
then perform a tHb slope
calibration.
d. Analyze the sample again.
e. If the message reappears,
go to step 6.
5. Obtain and analyze a new sample from the patient.
6. If the message reappears, the problem may be with the
patient. Analyze a sample from a different patient.
7. If the message reappears, contact your
Service Representative.
This section contains information to troubleshoot observed problems with the
following:
fluid leaks
insufficient fluid flow
cloudiness or particulate matter
gas leaks
Use this table if you observe fluid leaks in or under the 800 system.
Sample drips out of
sample port
1. Ensure that you do not inject the sample into the
sample port.
2. Ensure that the syringe is fully seated in the sample
port before you press Analyze.
3. Ensure that all parts of the sample port, including the
capillary seal, retainer ring, and O-rings are installed
correctly and are not deteriorated.
4. Check the sample pump tubing for worn areas or
leaks at fittings. Replace worn or leaking tubing as
described in Replacing the Pump Tubing in Section 3.
5. Test the sample pump flow rate as described in Pump
Functions Test, page 4-58.
Fluid is leaking from the
left side of the sample port
1. Ensure that the sample probe is installed correctly.
Fluid is leaking in the
measurement module
1. Verify that all sensor O-rings are aligned with the
sample path and that they are not deteriorated. Verify
that the sensors are installed correctly.
2. Check that the O-rings are installed on the sample port
and are not deteriorated.
NOTE: The reference sensor has two O-rings.
2. Check that sample tubing and measurement module
tubing are installed correctly.
Reagent is leaking from
the reagent module, bottle,
or fitting
1. Ensure that bottles are installed correctly and fit
securely on the reagent fittings.
2. Check the O-rings on the back of the reagent fittings.
3. Install a new bottle of Bayer Diagnostics reagent.
4. Check the valve function as described in Valves Test,
page 4-62.
Fluid is leaking from the
tubing
1. Check the tubing connections.
2. Replace the tubing if it is deteriorated.
Use this table if you observe problems with fluids flowing too slowly, erratically,
or not at all.
Insufficient wash solution is
flowing to clean the sample
path
1. Check the level of wash reagent and install a new
bottle of Bayer Diagnostics wash reagent if
required.
2. Ensure that the bottle of wash reagent is seated
correctly on the reagent manifold.
3. Check the reagent fitting for obstructions.
4. Install a new bottle of Bayer Diagnostics wash
reagent.
5. Inspect the sample path in the measurement module
for obstructions and leaks.
6. Verify that all sensor O-rings and sensors are
correctly aligned with the sample path and that the
O-rings are not deteriorated.
NOTE: The reference sensor has two O-rings.
7. Inspect all tubing and fittings for leaks.
8. Check the waste outlets for obstructions.
9. Verify that the wash, foam, and diverter valves are
operating correctly as described in Valves Test, page
4-62.
10. Test the reagent pump flow rate as described in
Pump Functions Test, page 4-58, and verify that the
pump is operating correctly.
11. Clean the roller cage and shaft and replace the
pump tubing if required.
Insufficient wash solution is
flowing through the sample
port
1. Check the level of wash reagent and install a new
bottle of Bayer Diagnostics wash reagent if
required.
2. Ensure that the bottle of wash reagent is seated
correctly on the reagent manifold.
3. Check the wash reagent fitting for obstructions.
4. Check the sample port for obstructions or leaks and
ensure that it is installed correctly.
5. Inspect the capillary seal and O-rings for proper
installation and for deterioration. Reinstall or
replace them if required.
6. Check the sample tubing for obstructions or leaks.
7. Check the sample pump tubing for worn areas or
leaks at the fittings.
8. Test the reagent pump flow rate as described in
Pump Functions Test, page 4-58, and verify that the
pump is operating correctly.
9. Clean the roller cage and shaft and replace the
pump tubing if required.
No waste is flowing out of
the waste outlets into the
waste bottle
1. Check for obstructions in the sample entry
components as described in Removing Obstructions
from the Sample Entry Components, page 4-79.
2. Check for obstructions in the measurement module
as described in Removing Obstructions from the
Measurement Module, page 4-82.
3. Check for obstructions in the CO-ox module as
described in Removing Obstructions from the
CO-ox Sample Path, page 4-87.
4. Check for obstructions in the measurement tubing
and waste outlets.
5. Ensure that the sample port, retainer ring, and
O-rings are installed correctly and not leaking.
6. Inspect the sample pump and waste pump tubing
for obstructions and leaks, and inspect the roller
cages and shafts.
7. Test the sample pump and waste pump flow rates as
described in Pump Functions Test, page 4-58, and
verify that the pumps are operating correctly.
Sample path is obstructed
The fluid flow is insufficient due to obstructions in the
sample path.
1. Check for obstructions in the sample entry
components as described in Removing Obstructions
from the Sample Entry Components, page 4-79.
2. Check for obstructions in the measurement module
as described in Removing Obstructions from the
Measurement Module, page 4-82.
3. Check for obstructions in the measurement module
tubing and waste outlets.
4. Check for obstructions in the CO-ox module as
described in Removing Obstructions from the
CO-ox Sample Path, page 4-87.
5. Inspect all connections and fittings for obstructions
and leaks.
6. Verify that all sensor O-rings and sensors are
correctly aligned with the sample path and that the
O-rings are not deteriorated.
NOTE: The reference sensor has two O-rings.
7. Test the sample pump flow rate as described in
Pump Functions Test, page 4-58, and verify that the
pump is operating correctly.
Air bubbles in fluid in
sample path
1. Check your sampling technique as described in
Sample Collection Devices and Anticoagulants in
Section 1.
2. Verify that all sensor O-rings and sensors are
correctly aligned with the sample path and that the
O-rings are not deteriorated.
NOTE: The reference sensor has two O-rings.
3. Check the sample probe and the sample tubing for
damage or incorrect installation.
4. Test the reagent and sample pump flow rates as
described in Pump Functions Test, page 4-58, and
verify that the pumps are operating correctly.
During the first 24 hours
following installation, the
glucose or lactate biosensors
measure a large negative
slope value during
calibration. The biosensors
measure an equal, but
positive slope valve during
the next calibration.
The shift in slope value is due to bubbles trapped in the
glucose or lactate biosensor.
Erratic sample flow
Analyze several blood samples sequentially.
NOTE: The problem may clear itself if no blood
samples are analyzed for 12 – 24 hours.
The fluid flow is insufficient due to clots in the sample
or to obstructions in the sample path.
1. Check your sampling technique as described in
Sample Collection Devices and Anticoagulants in
Section 1.
2. Check for obstructions in the sample entry
components as described in Removing Obstructions
from the Sample Entry Components, page 4-79.
3. Check for obstructions in the measurement module
as described in Removing Obstructions from the
Measurement Module, page 4-82.
4. Check for obstructions in the CO-ox module as
described in Removing Obstructions from the
CO-ox Sample Path, page 4-87.
5. Verify that all sensor O-rings and sensors are
correctly aligned with the sample path and that the
O-rings are not deteriorated.
NOTE: The reference sensor has two O-rings.
6. Verify that the hemolyzer gasket on the CO-ox
module is seated correctly.
7. Verify that the sample chamber gasket on the
CO-ox module is seated correctly.
8. Test the sample pump flow rate as described in
Pump Functions Test, page 4-58, and verify that the
pump is operating correctly.
Use this table if you observe fluids with cloudiness, color changes, or particulate
matter.
A reagent is cloudy or
has particulate matter
The reagent may be outdated or deteriorated.
1. Remove the reagent, and then prime the lines to purge all
reagent from the system.
2. Install a new bottle of Bayer Diagnostics reagent.
3. Prime the system with the reagent.
4. Check the fill solution level in the sensors, and empty and
refill if required.
5. Initiate the Auto Clean sequence.
6. Perform two successful two-point calibrations.
7. Run controls and verify the results.
The sample path is
cloudy or has
particulate matter
The sample path may require cleaning or routine maintenance.
1. Deproteinize the sample path and condition the sensors as
described in Section 3.
2. Inspect reagents and replace any reagents that are outdated
or deteriorated.
3. Prime the system with the reagent.
4. Perform a successful two-point calibration.
Use this table if you observe problems with the supply and delivery of Cal or
Slope Gas.
Leaking or hissing of
gas
1. Locate the source of the leak by listening closely for
hissing around the regulators and gas tubing. Apply soapy
water around the regulator or the gas fittings on the reagent
manifold and look for bubbles.
NOTE: Do not apply any fluids to the area behind the reagent
manifold.
2. Ensure that the connections are tight.
3. If you find a leak in the tubing, replace the tubing as
described in Replacing the Gas Tubing in Section 3.
4. Check the regulators for leaks and replace if required.
5. Ensure the seal is in place between the gas tank and
regulator.
6. If the leak is between the gas tank and regulator, tighten
the yoke screw or replace the plastic seal.
7. Test the gas flow rate as described in Checking the Gas
Flow, page 4-64.
Use this table if you observe problems with any of the sensors. Also refer to
Removing Obstructions from the Measurement Module, page 4-82.
More than one sensor
shows excessive drift
1. If the pH or ISE sensors show drift, check the reference
sensor for salt deposits and leaks.
2. If the gas sensors show drift, check the gas supplies.
Sensors with drift
also show reagent
problems
1. Correct the reagent problems in this order: D23, D24, and
D29.
2. Correct the drift problem (D2, D3, D4, or D5).
Salt deposits appear
in measurement
module
1. Check the reference sensor for leaks. Tighten cap if
required and clean any deposits with a swab moistened in
reagent water.
2. Clean deposits in measurement module and on all sensors
with swabs moistened in reagent water.
3. Verify that all sensor O-rings and sensors are correctly
aligned with the sample path and that the O-rings are not
deteriorated.
NOTE: The reference sensor has two O-rings.
Fluid in sensor too
low
Refill the sensor. Refer to the appropriate procedure in
Section 3.
More than two
sensors have a D4
Offset Error
1. If the pH or ISE sensors show offset errors, check the
reference sensor for the correct solution level, salt in the
vent hole, bubbles in the sensor, or leaks.
2. If the gas sensors show offset errors, check the gas
supplies.
3. For a K+ or Ca++ sensor, replace the fill solution even if it
is sufficient.
Sensor fails the
measurement test
An open circuit sensor contact or an electronic failure has
occurred, or a fluid leaked into the preamplifier assembly.
1. Ensure that the sensor is installed correctly.
2. Wipe the contact on the sensor with a clean lint-free tissue.
3. Replace the sensor.
Use this table if you observe problems with bar codes or the bar code scanner.
The bar code scanner
works intermittently
Faulty scanning technique, poor bar code print quality, or loose
cable connection to the port on the 800 system.
1. Check the bar code scanner, cable, and cable connections.
2. Check system setup to ensure that the bar code scanner is
enabled.
3. Ensure that you are scanning the correct bar code symbol
for the sample or control.
4. Test the bar code scanner as described in Bar Code
Scanner Test, page 4-77.
The system does not
emit a beep and data
does not appear on
screen when you scan
with the bar code
scanner
Incorrect symbology selected in system setup; incorrect or
defaced bar code labels; or faulty bar code scanner, cable, or
port, incorrect field in focus.
1. Check system setup to ensure that the bar code scanner is
enabled.
2. Ensure that you are scanning the correct bar code symbol
for the sample or control.
3. Check the bar code scanner, cable, and cable connections.
4. Ensure that the labels were created with the correct
symbology.
5. Ensure you have the correct field highlighted.
6. Ensure that the system has power.
7. Test the bar code scanner as described in Bar Code
Scanner Test, page 4-77.
Refer to the 800 Series Bar Coding Features technical bulletin for detailed
information about the set up for the bar code features.
Use this table if you observe electronic problems.
The system does not
respond to input from
the keypad
1. If your system has a keyboard, check the keyboard to see if
it is working, and ensure that Num Lock is turned off.
2. Disconnect the power cord from the power source.
3. Wait at least 10 seconds, and then connect the power cord
to the power source.
An external device,
LIS, or HIS does not
respond to the system
1. Ensure the port is enabled as described in Configuring for
External Devices in Section 5 and Appendix D, Interfacing
to External Devices.
2. Check the cable connections at both ends.
3. Check the cable for crimps or deterioration.
4. Connect the external device, LIS, or HIS to another port as
described in Configuring for External Devices in Section 5
and Interfacing to External Devices in Appendix D.
5. Perform the external loopback test as described in External
Loopback Test, page 4-75.
6. Check the operation of the external device, LIS, or HIS.
No system power or
screen is blank
1. Ensure the screen is adjusted to the correct viewing angle
and brightness.
2. Ensure the power cord of the 800 system is connected to
the electrical outlet.
3. Ensure the electrical outlet has power.
4. Check the system fuse.
Use this table if you observe problems with the roll printer.
Printer is not printing
at all
1. Ensure the thermal paper is feeding correctly and that it is
not reversed. Refer to Replacing the Printer Paper in
Section 3.
2. Check for a paper jam and clear it.
3. Remove paper dust if it has accumulated in the printer.
4. Ensure the system has power.
5. Check the operating setup to ensure that the roll printer
report option is on.
Printer is not printing
correctly
1. Test the roll printer as described in Roll Printer Test,
page 4-76.
2. Clean the roll printer as described in Cleaning the Roll
Printer in Section 3.
3. Repeat the Roll Printer Test.
4. Replace the roll of printer paper as described in Replacing
the Printer Paper in Section 3 using Bayer Diagnostics
paper.
Use this table if you observe problems with the sample probe. Refer to Removing
Obstructions from the Sample Entry Components, page 4-79.
Sample probe is not
working correctly
1. Ensure the sample probe is installed correctly and that it is
clean.
2. Ensure the capillary seal is installed correctly.
3. Check the probe, sample port, probe mount, and capillary
seal for obstructions.
4. Test the sample entry components as described in Sample
Entry Test, page 4-67.
5. If the probe is damaged, replace the probe.
Use this table if you observe problems with the reagent pump, sample pump, or
waste pump.
Pump is not operating
correctly
1. Inspect the pump tubing and replace if required.
2. Clean the roller cage and shaft as described in Cleaning the
Roller Cages in Section 3.
3. Test the pump electronics and flow rate for the appropriate
pump as described in Pump Functions Test, page 4-58.
Use this table if you observe problems with temperature control.
Measurement module
temperature warning
message
The measurement module is outside the 37.00 ± 0.15°C range.
The system can accept sample analysis.
1. Ensure that the measurement module door is closed.
2. Perform the Temperature/pAtm Test, as described in
Section 4, to check the sample temperature.
3. Wait at least 15 minutes for the system to warm up.
4. Verify that the location of the system meets the
specifications for ambient operating temperatures, as
described in Appendix H, Installation.
5. Check the air filter to ensure that the air vent is not
obstructed and that the filter is clean. See Replacing the Air
Filter in Section 3.
6. Verify that the fan is operating.
Measurement module
temperature error
message
The measurement module temperature is outside the
37.0 ± 0.5°C range. The system cannot accept sample analysis
requests.
1. Ensure the measurement module door is closed.
2. Wait at least 15 minutes for the system to warm up.
3. Perform the Temperature/pAtm Test, as described in
Section 4.
4. If the temperature control is off, press Reset Control.
5. Verify that the sample ground/temperature sensor is
installed correctly.
6. Verify that the location of the system meets the
specifications for ambient operating temperatures, as
described in Appendix H, Installation.
7. Check the air filter to ensure that the air vent is not
obstructed and that the filter is clean. See Replacing the Air
Filter in Section 3.
8. Verify that the fan is operating.
CO-ox sample
chamber temperature
error message
The CO-ox sample chamber is outside the 37.00 ± 0.35°C
range. The system cannot accept tHb sample measurement
requests.
1. Perform the Temperature/pAtm Test, as described in
Section 4.
2. If the temperature control is off, press Reset Control.
3. Wait at least 15 minutes for the system to warm up.
Use this table to troubleshoot system messages that appear during analysis mode
functions. The system messages are listed in the status area of the Analysis Mode
home screen.
Bubbles Detected in
Sample
The system detects a non-continuous fluid in the measurement
module sample path. The system asks whether you want to
continue.
1. If the sample is not at point A or beyond, you can position
the sample manually to continue with analysis. Press
Sample in Place.
2. Ensure that you use proper sampling technique, as
described in Analyzing . . . Samples in Section 2.
NOTE: The reference sensor has two O-rings.
3. Verify that the sensor O-rings are not deteriorated and that
all sensors and sensor O-rings are aligned correctly with
the sample path.
4. Check the sample probe and the sample tubing for damage
or incorrect installation.
5. Verify that the reagent and sample pumps are operating
correctly and test the reagent and sample pump flow rates,
as described in Pump Functions Test in Section 4.
COox Sample
Chamber Temp Error
The CO-ox sample chamber is outside the 37.00 ± 0.35°C
range. The system cannot accept tHb sample measurement
requests.
1. Perform the Temperature/pAtm Test, as described in
Section 4.
2. If the temperature control is off, press Reset Control.
3. Wait at least 15 minutes for the system to warm up.
COox Sample Temp
Out of Range
The CO-ox sample chamber temperature is not in range at the
end of the measurement sample.
1. Perform the Temperature/pAtm Test, as described in
Section 4.
2. If the temperature control is off, press Reset Control.
3. Wait at least 15 minutes for the system to warm up.
Excessive Bubbles in
COox Sample
The system detects a non-continuous fluid in the CO-ox sample
path.
Excessive Bubbles in
COox tHb Slope
1. Ensure that you use proper sampling technique, as
described in Analyzing . . . Samples in Section 2. Analyze
the sample again or perform a pH/lytes one-point
calibration.
Excessive Bubbles in
Zero
2. Check the CO-ox sample tubing for leaks, cracks, crimps,
or loose connections, particularly at the inlet and outlet to
the sample chamber. See Replacing the CO-ox Sample
Tubing in Section 3.
3. Check the bubble trap for large bubbles. Clean or replace
the bubble trap.
4. Check for obstructions in the CO-ox sample path. See
Removing Obstructions from the CO-ox Sample Path in
Section 4.
5. Check for clots in the hemolyzer. See Cleaning the
Hemolyzer in Section 3.
6. Clean the sample chamber, as described in Cleaning the
Sample Chamber in Section 3.
Excessive Scatter in
COox Meas
Excessive scatter may be due to excessive lipids, unlysed cells
or particles, or an abnormally high tHb level in the CO-ox
sample. This message also appears if the hemolyzer is
disconnected.
1. Check that the hemolyzer is assembled properly.
2. Clean the hemolyzer, as described in Cleaning the
Hemolyzer in Section 3.
3. Check the sample source. Do not use syringes with
carboxymethylcellulose. See Sample Collection Devices
and Anticoagulants in Section 1.
4. Analyze a QC sample, which should not cause an
excessive scatter message.
5. Clean the bubble and sample chamber, as described in
Cleaning the Sample Chamber in Section 3.
If Blood, Question
Data
Optical measurements indicate that the CO-ox results should be
reviewed. A question mark (?) is printed next to the CO-ox
results on reports.
Results may still be clinically valid. When reporting CO-ox
results, consider the patient’s history and clinical condition to
determine acceptability of results.
To troubleshoot an If Blood, Question Data message,
determine whether the problem is with the sample type, the
patient sample, or the system.
NOTE: When analyzed as a patient sample, aqueous materials
with dyes cause the If Blood, Question Data message to appear.
1. Ensure that you analyzed a patient sample, not a QC or
calibration sample. Ensure that the patient sample is free of
clots and unidentified interfering substances.
2. If the problem is not with the sample type, analyze the
sample again.
3. If the message reappears, perform a pH/lytes one-point
calibration to zero the CO-oximeter
is successful
go to step 5.
is not successful
repeat the pH/lytes one-point
calibration two two more
times.
If Blood,
Question Data
4. Review the last calibration.
is successful
go to step 5.
is not successful
a. Clean the sample chamber.
Refer to Cleaning the
Sample Chamber in
Section 3.
b. Check that the hemolyzer
is correctly assembled and
that the gasket is in place.
c. Perform a pH/lytes
one-point calibration and
then perform a tHb slope
calibration.
d. Analyze the sample again.
e. If the message reappears,
go to step 6.
5. Obtain and analyze a new sample from the patient.
6. If the message reappears, the problem may be the result of
the patient’s clinical condition. Analyze a sample from a
different patient.
7. If the message reappears, contact your Service
Representative.
Insufficient COox
Sample
The CO-ox sample chamber does not detect the sample during
the predefined time limit. The CO-ox measurement cannot be
completed.
1. Ensure that the sample volume is sufficient for the
sampling device used and the tests requested.
2. Ensure that the sample is red, i.e., a blood sample or a
colored aqueous solution.
3. Check the CO-ox sample path for leaks, cracks, or loose
connections. See Replacing the CO-ox Sample Tubing in
Section 3.
4. Check the CO-ox sample path for obstructions. Remove
obstructions, as described in Removing Obstructions from
the CO-ox Sample Path in Section 4.
5. Verify that the CO-ox pump is operating correctly and test
the flow rate of the CO-ox pump, as described in the Pump
Functions Test in Section 4.
Insufficient Sample
There is not enough sample to fill the measurement block. You
can manually position the sample for measurement. See
Analyzing Microsamples, Steps 5-11, in Section 2.
1. Ensure that the sample volume is sufficient for the
sampling device used and the tests requested.
2. Check sample entry components for leaks or obstructions.
See Removing Obstructions from Sample Entry
Components in Section 4.
3. Replace the sample tubing.
4. Verify that the sample pump is operating correctly and test
the flow rate of sample pump, as described in the Pump
Functions Test in Section 4.
Interfering
Substance: Glu
Interfering
Substance: Lac
The system detects substances in the sample that may interfere
with glucose or lactate measurement. # is printed next to the
glucose or lactate result on reports.
1. Check the sample source and determine whether the
presence of an interfering substance is likely. See
Appendix E, Performance Characteristics, for a list of
interfering substances.
2. If the message appears on multiple patient samples that do
not contain interfering substances, replace the appropriate
biosensor, as described in Replacing the Glucose and
Lactate Biosensors in Section 3.
Interfering
Substance: tHb
The CO-ox module detects substances in the sample that may
interfere with CO-ox measurement. The system tries to correct
the measurement to account for the substance.
1. Check the sample source and determine whether the
presence of an interfering substance is likely. See
Appendix E, Performance Characteristics, for a list of
interfering substances.
2. If the message appears on multiple patient samples that do
not contain interfering substances, clean the bubble trap
and sample chamber, as described in Cleaning the Sample
Chamber in Section 3.
Meas Module
Temperature Error
The measurement module temperature is outside the
37.0 ± 0.5°C range. The system cannot accept sample analysis
requests.
1. Ensure that the measurement module door is closed.
2. Wait at least 15 minutes for the system to warm up.
3. Perform the Temperature/pAtm Test, as described in
Section 4.
4. If the temperature control is off, press Reset Control.
5. Verify that the sample ground/temperature sensor is
installed correctly.
6. Verify that the location of the system meets the
specifications for ambient operating temperatures, as
described in Appendix H, Installation.
7. Check the air filter to ensure that the air vent is not
obstructed and that the filter is clean. See Replacing the Air
Filter in Section 3.
8. Verify that the fan is operating.
Meas Module
Temperature Warning
The measurement module temperature is outside the
37.00 ± 0.15°C range. The system can accept sample analysis
requests.
1. Ensure that the measurement module door is closed.
2. Perform the Temperature/pAtm Test, as described in
Section 4, to check the sample temperature.
3. Wait at least 15 minutes for the system to warm up.
4. Verify that the location of the system meets the
specifications for ambient operating temperatures, as
described in Appendix H, Installation.
5. Check the air filter to ensure that the air vent is not
obstructed and that the filter is clean. See Replacing the Air
Filter in Section 3.
6. Verify that the fan is operating.
No Sample Device
Detected
No sample device is detected in the sample port after you press
Analyze and the sample door closes.
1. Ensure that you use proper sampling technique, as
described in Analyzing . . . Samples in Section 2.
2. Perform the Sample Entry Test, as described in Section 4.
3. Analyze the sample again.
4. If the message appears repeatedly with capillary samples,
replace the capillary seal.
Sample Temperature
Out of Range
The measurement module block temperature is not in range at
the end of the measurement sequence.
1. Verify that the sample ground/temperature sensor is
installed correctly.
2. Perform the Temperature/pAtm Test, as described in
Section 4, to check the temperature of the preheater.
3. Remove any obstructions in the preheater, as described in
Removing Obstructions from the Measurement Module in
Section 4.
..
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This section describes the procedures for defining or changing 800 system setup
parameters. Table 5-1 describes many of the tasks that you can do in setup and lists
the setup menu option you select to perform each task.
create and edit QC files
Operating Setup and QC Setup
define the number of patient samples
stored on the system
System Setup and System Options
select Auto ID and Auto Accept for
QC samples
Operating Setup and QC Setup
define reference and action ranges
Operating Setup and Patient Data
define the Patient Information screen
Operating Setup and Patient Data
select fields to appear on the screen
and in the printed reports
Operating Setup and Report Formats
select units of measure for parameter
results
Operating Setup and Units/Defaults
select names for parameters
Operating Setup and Parameter Names
define drift limits
Operating Setup and Calibration Setup
select the calibration frequency
Operating Setup and Calibration Setup
define the calibration gas values
Operating Setup and Calibration Setup
select printing options
Operating Setup and Printing Options
define correlation coefficients
Operating Setup and Correlation
change the date and time
System Setup and Date and Time
select the parameters to be analyzed
System Setup and Parameters
select the panel the system uses to
analyze samples
System Setup and Panels
control various system functions such
as beeper volume, auto move
capillaries, auto send results, and
reporting resolution
System Setup and Systems Options
select maintenance functions such as
record, view, or schedule maintenance
tasks
System Setup and Systems Options
configure the 800 systems for a 270, a
printer, a bar code scanner, an LIS, or
a data management system
System Setup and Communications
define passwords to protect operations
and menu access
System Setup and Security Setup
select the language used on the screen
and in the printed reports
Service and System Information
view system serial number, ID, install
date, software version, and phone
number for technical assistance
Service and System Information
You use the following keys while performing setup:
Menu
access the Menu screen.
Clear Entry
delete either a single character or the entire contents of the current
field. Press the key once to delete a single character. Press the key
twice in rapid succession to delete the contents of the field.
Done
accept any selections or entries made in a screen and display the next
or previous screen in the sequence.
Next Screen
display another screen that contains additional text fields and options
for the setup function you are performing. This key appears only
when another screen of information is available.
Previous
Screen
return to the frame or screen from which you entered the present
screen. If you press this key after you make changes to the current
screen, a message appears prompting you to save your changes. Press
Yes to save changes. Press No if you do not want to save your
changes. If you made no changes, the prompt does not appear.
Reset Default
Values
reset the values for a system parameter to the values entered by
Bayer Diagnostics during manufacture. When you press this key, a
message appears prompting you to reset the Bayer Diagnostics
values. Press Yes to reset the values.
Exit Menu
return the system to the Ready screen.
Cancel
discontinue the setup procedure.
Enter
accept data you type in fields and selections you make on screens.
Enter also lets you move forward through fields. Enter is located on
the keypad.
Home
return you to the Ready screen. If you made changes to a screen, a
message appears prompting you to save your changes. Press Yes to
save changes. Press No if you do not want to save your changes. If
you made no changes, the prompt does not appear. Home is located
on the keypad.
Use this procedure to view system information:
service contact telephone number
service contact
system ID
serial number
CO-ox module serial number
software version
date software installed
total cycle count (number of patient samples, QC samples, calibrations, and
operator initiated washes)
sample and calibration count (total of all patient samples and calibrations)
#
1. Access the System Information screen from the Menu screen:
a. Press 8 Service Setup and press Enter.
b. Press 1 System Information and press Enter.
The System Information screen appears, as shown in Figure 5-1.
# (& %!" " " % #" ! "
# ""
!! !!
"! " (""
$!!
2. Press Menu when you finish viewing the screen.
3. Define another setup function or press Exit Menu to return to the Ready screen.
" "" " Use this procedure to select the fields you want to use in the Patient Information
screen. The Patient Information screen can contain 16 fields. The default for each
field is On, which means that all fields appear on the Patient Information screen.
You can choose to have a field not appear on the form by turning the field off.
Certain fields can be made required fields. Required fields are fields that must be
completed to continue with analysis. You can make a field required by selecting the
check box next to the field. The default for required fields is Off, which means that
none of the fields are required. Table 5-2 describes the Patient Information fields.
(&'"" " !
! "
Patient ID
number used to identify the patient
Accession #
number used to identify the sample
Location
location of the patient
Temperature
temperature of the patient
tHb
total hemoglobin value of the patient
Source
origin of the patient sample
Draw Date
date sample was drawn
Draw Time
time sample was drawn
FI O 2
fraction of inspired air
Ventilator Flow
flow rate setting on the patient’s ventilator
Respiratory Rate
respiration rate per minute of the patient
p50
partial pressure of oxygen at which hemoglobin is 50% saturated
Sex
gender of the patient
Birthdate
date patient was born
Physician ID
number used to identify the physician
Operator ID
number used to identify the 800 system operator
1. Access the Data Entry Format screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 2 Patient Data and press Enter.
c. Select 2 Data Entry Format and press Enter.
The Data Entry Format screen appears, as shown in Figure 5-2.
"'& ! !% ! ! $ ! ! ! !!
! 2. Define another setup function or press Exit Menu to return to the Ready screen.
3. Select the fields you want to change:
%" #! ! make a field
appear or not
appear
a. Move to the On/Off check box for the field you want.
make a field a
required field
a. Move to the Required check box for the field you want.
b. Press Enter to turn the field on or off. A dark box indicates
the field is on. The default value is On. If you turn a field
off, it does not appear on the Patient Information screen.
b. Press Enter The check box becomes dark, which indicates
the field is required. A required field has a symbol
before it on the Patient Information screen.
4. Press Done.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
"
!
If you turn all fields off, the Patient Information screen does not appear on the
screen during analysis. The system stores results by sequence number.
#!" !
Use this procedure to customize a panel that the system will use to analyze a patient
sample. You can define up to 5 customized panels.
The system measures only the parameters listed in the panel. You can choose to
have a parameter not appear on the panel by turning the parameter off.
NOTE: If you select a parameter to be off, the system does not measure or
calculate results during analysis, and the parameter name does not appear on the
Results screen or in the printed report. However, a parameter that is turned off is
evaluated during quality control testing.
#
1. Access the Select Custom Panels screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 4 Panels and press Enter.
c. Select 2 Custom Panel and press Enter.
The Select Custom Panels screen appears, as shown in Figure 5-3.
# '& " #!" ! %!"
" " %#
$" !! " 2. Select one of panels to configure and press Done.
The Custom Panel screen appears. All parameters are selected.
3. Move to the frame that contains the appropriate parameter. Press Enter to turn
the parameter on or off.
4. Take the appropriate action.
%# !! want to to save the custom
panel
Done to return to the Ready screen.
do not want to save the
custom panel
Restore Defaults to clear the screen. Press Done to
return to the Ready screen.
Use this procedure to select the panel that the system will use to analyze a patient
sample. You can select default panels from a predefined list or from any defined
custom panels. The system measures only the parameters listed in the panel. The
system default is All Parameters. Different predefined panels are available on each
800 system, as shown in Table 5-3.
If you want to individually select parameters as the default set of parameters for
analysis, refer to Selecting Parameters for Analysis, page 5-12.
NOTE: Default panels are used in patient sample analysis only. All parameters are
evaluated during quality control analysis.
840
All Parameters
pH, pO2, pCO2
844
All Parameters
pH/Blood gas
CO-ox
pH, pO2, pCO2, tHb, FO2Hb
845
All Parameters
pH/Blood gas
CO-ox
pH, pO2, pCO2
tHb, FO2Hb
pH, pO2, pCO2, tHb, FO2Hb, FCOHb, FMetHb,
FHHb
pH, pO2, pCO2
tHb, FO2Hb, FCOHb, FMetHb, FHHb
850
854
All Parameters
pH, pO2, pCO2, Na+, K+, Ca++, Cl–
pH/Blood Gas
pH, pO2, pCO2
pH/lytes
pH, Na+, K+, Ca++, Cl–
Blood gas/lytes
pO2, pCO2, Na+, K+, Ca++, Cl–
pH/Ca++
pH, Ca++
All Parameters
pH, pO2, pCO2, Na+, K+, Cl–, Ca++, tHb, FO2Hb
pH, pO2, pCO2
pH/Blood gas
tHb, FO2Hb
CO-ox
pH, Na+, K+, Ca++, Cl–
pH/lytes
pO2, pCO2, Na+, K+, Ca++, Cl–
Blood gas/lytes
pH, Ca++
pH/Ca++
855
All Parameters
pH, pO2, pCO2, Na+, K+, Cl–, Ca++, tHb, FO2Hb,
FCOHb, FMetHb, FHHb
pH/Blood gas
pH, pO2, pCO2
CO-ox
tHb, FO2Hb, FCOHb, FMetHb, FHHb
pH/lytes
pH, Na+, K+, Cl–, Ca++
Blood gas/lytes
pO2, pCO2, Na+, K+, Cl–, Ca++
pH/Ca++
pH, Ca++
All Parameters
pH, pO2, pCO2, Na+, K+, Ca++, Cl–, glucose,
lactate
pH/Blood Gas
pH, pO2, pCO2
pH/Blood Gas/lytes
pH, pO2, pCO2, Na+, K+, Ca++, Cl–
pH/lytes/metabolites
pH, Na+, K+, Ca++, Cl–, glucose, lactate
pH/Ca++
pH, Ca++
All Parameters
pH, pO2, pCO2, Na+, K+, Ca++, Cl–, glucose,
lactate, tHb, FO2Hb
pH/Blood gas
pH, pO2, pCO2
CO-ox
tHb, FO2Hb
pH/lytes/metabolites
pH, Na+, K+, Ca++, Cl–, glucose, lactate
pH/Ca++
pH, Ca++
pH/Blood gas/lytes/
metabolites
pH, pO2, pCO2, Na+, K+, Ca++, Cl–, glucose,
lactate
All Parameters
pH, pO2, pCO2, Na+, K+, Cl–, Ca++, glucose,
lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb
860
864
865
pH, pO2, pCO2
pH/Blood gas
tHb, FO2Hb, FCOHb, FMetHb, FHHb
CO-ox
pH, Na+, K+, Cl–, Ca++, glucose, lactate
pH/lytes/metabolites
pH, Ca++
pH/Ca++
pH, pO2, pCO2, Na+, K+, Cl–, Ca++, glucose,
lactate
pH/Blood gas/lytes/
metabolites
"
1. Access the Select Default Panels screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 4 Panels and press Enter.
c. Select 1 Default Panel and press Enter.
The Select Default Panel screen appears, as shown in Figure 5-4.
"&% ! "! $ !
! ! $"
#! !
2. Select the appropriate panel and press Enter.
Custom panels are listed as Panels 1–5. Custom panels are defined during
system setup by the system administrator or authorized personnel. Refer to
Defining Custom Panels on page 5-9.
3. Press Done when you finish.
! ! $ Use this procedure to select the default set of parameters you want the system to
analyze. If you select a parameter to be off, the system does not measure or
calculate results during analysis, and the parameter name does not appear on the
Results screen or the printed report. The default value for all parameters is on,
except for O2SAT, O2CT, and [Qsp/Qt (est,T)].
NOTE: Any calculated parameters that rely on another parameter value, which has
been selected to be off, are not calculated. However, the parameter name appears on
the Results screen, but no value is reported and the parameter name and value do
not appear on the printed report.
"
1. Access the Parameters screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 3 Parameters and press Enter.
The Parameters screen appears, as shown in Figure 5-5.
!(& % %! # $ "#
2. Select the parameters.
a. Move to the frame that contains the appropriate parameter.
b. Select the parameter that you want and press Enter.
c. Repeat steps a and b for each parameter you want to change.
d. Press Next Screen to access the second screen of parameters.
e. Repeat steps a and b for each parameter you want to change.
f. Press Next Screen again to access the final screen of parameters.
g. Repeat steps a and b for each parameter you want to change.
3. Press Done.
4. You can define another setup function or press Exit Menu to return to the
Ready screen.
!
When you select a measured parameter to be on, you activate a sensor. Perform a
two-point calibration before you analyze a sample.
Use this procedure to select the measurement units that the system displays for each
parameter. Table 5-4 lists the default and optional measurement units that you can
select for the base models and for the base models with a CO-ox module.
(&' ! ! % pCO2, pO2
mmHg
kPa
840, 850, 860
O2CT, BO2
mL/dL
mL/L, mmol/L
840, 850, 860
! % ctHb
g/dL
g/L, mmol/L
840, 850, 860
pH
pH
H+ nmol/L
840, 850, 860
O2SAT, FIO2, sO2,
Hct, Hb Fractions
%
decimal fraction
840, 850, 860
Ca++
mmol/L
mg/dL
850, 860
Glucose
mg/dL
mmol/L
860
Lactate
mmol/L
mg/dL
860
!
1. Access the Units and Values screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 4 Units/Values and press Enter.
The Units and Values screen appears, as shown in Figure 5-6.
!'& ! $ "#
2. Select the measurement units:
a. Move to the frame that contains the measurement unit you want to change.
b. Select the unit you want and press Enter.
c. Repeat steps a and b for each measurement unit you want to change.
d. Press Next Screen to view additional parameters.
e. Repeat steps a and b for each measurement unit you want to change.
3. Press Done.
4. You can define another setup function or press Exit Menu to return to the
Ready screen.
If you change parameter units for pH after the system has started to collect data,
QC statistics are still computed in the current units.
Use this procedure to define the values for ctHb and p50 that the system uses when
no value is entered or measured, and to define the value for the O2 binding factor
and ctO2(a-v), which are constants supplied by the system. The system uses these
values for certain calculations. Table 5-5 lists the default values and valid ranges
for ctHb, O2 binding factor, p50, and ctO2(a-v).
ctHb
2.0 – 25.0
15.0
g/dL
p50
20 – 250
g/L
1.2 – 15.5
mmol/L
0.0 – 100.0
26.5
0.00 – 13.32
mmHg
kPa
O2 Binding
1.35 – 1.39
1.39
ctO2(a-v)
0.0 – 20.0
3.5
mL/dL
0 – 200
mL/L
0.0 – 9.0
mmol/L
1. Access the Units and Values screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 4 Units/Values and press Enter.
The first Units and Values screen appears.
2. Press Next Screen.
The second Units and Values screen appears as shown in Figure 5-7.
"%# ! " 3. Change the appropriate parameter values:
a. Move to the field you want to change.
b. Type in the new value and press Enter.
c. Repeat steps a and b for each parameter value you want to change.
4. Press Done when you finish.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
"
!
If you press Done before completing all the fields, the Incomplete Data Entry
message box appears. Press OK and complete the required fields.
If you type an invalid value in a field and press Done, the Invalid Entry message
box appears. Press OK and type a valid entry in the field.
! ! Use this procedure to select the parameter name (nomenclature) that the system
uses to display results on the screen and in reports. Table 5-6 lists the parameter
names available for parameters that have more than one acceptable chemical name.
Option 2 is the default.
%#$! !
! ! BEvt
BE(B)
BEvv
BE(ecf)
tCO2
ctCO2
tHb
ctHb
O2Cap
BO2
AaDO 2
pO2(A–a)(T)
a/A
pO2(a/A)(T)
1. Access the Parameter Names screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 5 Parameter Names and press Enter.
The Parameter Names screen appears, as shown in Figure 5-8.
2. Select Option 1 or Option 2 and press Enter.
3. Press Done when you finish.
4. You can define another setup function or press Exit Menu to return to the
Ready screen.
Use this procedure to define the reference and action ranges for each parameter.
The system uses reference ranges to determine if a result is outside of the expected
range. The system uses action ranges to determine if a result requires immediate
action. Each laboratory should establish its own reference and action ranges for the
evaluation of patient results. Table 5-7 lists the default values for reference and
action ranges for the base models and for the base models with a CO-ox module.
NOTE: The default values for the action range are equal to the measurement range.
If you use the default action range values, the system does not flag action range
results but instead indicates that the results are out of measurement range. Change
the action range values to have the system flag action range results.
%#$ pH
7.350 – 7.450*
"
6.000 – 8.000
840, 850, 860
pCO2
mmHg
35.0 – 45.0*
5.0 – 250.0
840, 850, 860
pO2
mmHg
75.0 – 100.0
0.0 – 800.0
840, 850, 860
Na+
mmol/L
135.0 – 148.0
70.0 – 200.0
850, 860
K+
mmol/L
3.50 – 5.30*
0.50 – 20.00
850, 860
1.13 – 1.32
0.25 – 5.00
850, 860
Ca++
Cl–
mmol/L
98 – 106*
40 – 160
850, 860
Glucose
mg/dL
66 – 93
10 – 999
860
Lactate
mmol/L
0.5 –2.0*
0.0 – 30.0
860
* Tietz NW ed. Fundamentals of Clinical Chemistry. 3rd ed. Philadelphia: WB Saunders, 1987; 864-891.
Weisberg HF. Acid-Base pathophysiology in the neonate and infant. Annals of Clinical and Laboratory
Science 1982; 12(4)249.
Lentner C ed. Geigy scientific tables. Vol 3, 8th ed. Basle: Ciba-Geigy Ltd., 1984; 82-83.
Toffaletti et al., Clinical Chemistry, 38/12; 2430-2434, 1992
Sabata V, Stubbe P, Wolf H. Energy metabolism in the premature fetus. Biology Neonate. 1971; 19:299.
Table 5-8 lists additional default values available on systems with a CO-ox module.
%#$
%! tHb
g/dL
12.0 – 18.0*
2.0 – 27.0
ctO2
mL/dL
15.0 – 23.0
0.0 – 40.0
BO2
mL/dL
16.0 – 24.0
0.0 – 40.0
sO2
%
92.0 – 98.5
–99.9 – 999.9
FO2Hb
%
94.0 – 97.0
–99.9 – 999.9
FCOHb
%
0.5 – 1.5
–99.9 – 999.9
FMetHb
%
0.0 – 1.5
–99.9 – 999.9
FHHb
%
0.0 – 5.0
–99.9 – 999.9
* Tietz NW ed. Fundamentals of clinical chemistry. 3rd ed. Philadelphia: WB Saunders, 1987; 864-891.
Weisberg HF. Acid-Base pathophysiology in the neonate and infant. Annals of Clinical and Laboratory
Science 1982; 12(4)249.
1. Access the Reference and Action Ranges screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 2 Patient Data and press Enter.
c. Select 1 Ref/Action Ranges and press Enter.
The Reference and Action Ranges screen appears, as shown in Figure 5-9.
2. Move to the field that you want to change.
3. Type the new value and press Enter.
4. Repeat steps 2 and 3 for any other values that you want to change.
5. Press Done.
6. You can define another setup function or press Exit Menu to return to the
Ready screen.
If you press Done before completing all required fields, the Incomplete Data Entry
message box appears. Press OK and complete the required fields.
If you type an invalid value in a field and press Done, the Invalid Range message
box appears. Press OK and type a valid entry in the field.
Use this procedure to select automatic printing, number of copies, and printer type
for the following reports:
patient sample reports
QC reports
calibration reports
You select options separately for each type of report. Table 5-9 lists the available
report printing options.
Roll Printer
Lets you turn the roll printer on or off. When you turn the roll printer
off, it is off for all report types. The default is On.
Paper Spool
Lets you turn the printer paper spool on or off. The default is On.
Copies
Lets you select the number of copies the system prints automatically at
the end of analysis. The default is 1. Entry values are 1 – 3.
NOTE: This option is available only when the roll printer is selected.
Auto Print
Lets you control whether the system prints a report automatically at the
end of analysis. The default setting is On.
Printer
Lets you select the printer (roll, line, and ticket) the system uses to print
reports. The default is roll printer.
You can select more than one printer, but you cannot select line printer
for calibration reports, or ticket printer for QC reports.
1. Access the Printing Options screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 7 Printing Options and press Enter.
The Printing Options screen appears with the cursor in the Report frame, as
shown in Figure 5-10.
2. Select the type of report required.
3. Press Done.
The second Printing Options screen appears.
4. Select the printing options you want from this screen. Press Enter after your
selections. Refer to Table 5-9 for the list of options.
5. Press Done.
A message appears prompting you to set up another report.
want to select options for
another report
Yes. The Printing Options screen reappears. Repeat
steps 2 thru 5 to select options for another report.
do not want to select options
for another report
No. The Menu screen appears.
want to remain at the current
screen
Cancel. The cursor returns to the last field you
completed.
6. You can define another setup function or press Exit Menu to return to the
Ready screen.
Use this procedure to do the following:
Select the report format that the system uses to print the patient sample results.
Select the report formats for roll and line printers.
Print a copy of each report format.
Create four lines of information to appear at the top of each report. You need an
alphanumeric keyboard to type the information.
The 800 systems provide a variety of printed report formats. Refer to Appendix F,
Printed Reports, for an example of each report format.
1. Access the Printer Report Format screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 3 Report Formats and press Enter.
The Printer Report Format screen appears, as shown in Figure 5-11.
"! 2. Select the format you require and press Enter.
You can select a report format for the roll printer and, if a line printer
is connected, for a line printer.
3. You can print a copy of a report to view the format and create lines of
information to appear in the header of the report:
print a report
a. Select the report type you want.
b. Press Print Report Format. A copy of the report format
prints on the printer you selected.
create information
lines for a report
a. Press Enter Header. The Enter Header Information box
appears.
b. Type the text (up to 25 characters) for each line and press
Enter.
c. Press Save when you finish.
4. Press Done when you finish.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
Use this procedure to turn the roll printer on and off. When you turn the roll printer
off, it is off for all reports. You cannot turn the roll printer on for a specific report
type.
The default value for the roll printer is On.
1. Access the Printing Options screen from the Menu screen:
a. Press 5 Operating Setup and press Enter.
b. Press 7 Printing Options and press Enter.
The Printing Options screen appears, as shown in Figure 5-12.
$# ! 2. Move to the Roll Printer frame.
3. Select On or Off and press Enter.
4. Press Done.
The next Printing Options screen appears.
5. Press Done again.
6. You are prompted to set up another report.
" want to set up another report
press Yes. The first Printing Options screen
appears.
do not want to set up another
report
press No. The Menu screen appears.
want to return to the second
Printing Options screen
press Cancel. The second Printing Options
screen appears.
Use this procedure to turn the paper spool on or off. The paper spool automatically
winds the roll printer paper as the reports print. The default value is On.
1. Access the Printing Options screen from the Menu screen:
a. Press 5 Operating Setup and press Enter.
b. Press 7 Printing Options and press Enter.
The Printing Options screen appears, as shown in Figure 5-13.
#" 2. Move to the Paper Spool frame.
3. Select On or Off and press Enter.
4. Press Done.
The next Printing Options screen appears.
5. Press Done again.
6. You are prompted to set up another report.
! want to set up another report
press Yes. The first Printing Options screen
appears.
do not want to set up another
report
press No. The Menu screen appears.
want to return to the second
Printing Options screen
press Cancel. The second Printing Options
screen appears.
Use this procedure to select sample analysis and menu functions for password
protection. When you password protect sample analysis or menu functions,
operators must enter a password to access the protected function.
Select the Sample Analysis option to password protect the system from
unauthorized use. Operators must then enter a valid operator password to analyze
samples and to perform any other system function. You can define passwords for
up to 500 operators. Refer to Defining Operator Passwords, page 5-27, to define
passwords for authorized operators.
Select the menu options you want password protected to prevent unauthorized
changes by operators. Operators must then enter the valid menu options password
to access the protected menus. For example, you can password protect the
Operating Setup menu. Operators must then enter the menu options password to
access the Operating Setup menu. They can still access other menu functions
without a password. Refer to Defining the Menu Options or Supervisor Password,
page 5-29, to define the menu options password.
1. Access the Password Protection screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 7 Security Setup and press Enter.
c. Select 4 Password Protection and press Enter.
You must enter the supervisor password to access the Password
Protection screen. The default supervisor password is 12345. If you already
defined the supervisor password, you must enter that password.
A message appears prompting you to enter the supervisor password.
2. Type the supervisor password in the Password field and press OK.
As you type the password, the password does not appear on the screen.
The Password Protection screen appears, as shown in Figure 5-14.
3. Select the functions that you want to protect and press Enter.
Any combination of menu options can be password protected.
The password protection default value for all functions is off.
4. Press Done.
5. Define the appropriate passwords.
Sample Analysis for
password protection
define the operator passwords, as described in Defining
Operator Passwords, page 5-27.
any menu options for
password protection
define the menu options password, as described
Defining the Menu Options or Supervisor Password,
page 5-29.
Use this procedure to define new operator passwords and to edit or delete existing
passwords. You can assign passwords for up to 500 operators.
When an operator enters a password to access system functions, the system
automatically enters the operator’s ID in the Patient and QC Data Entry forms and,
when recording maintenance tasks, the Maintenance Task Done dialog box. The
operator ID also prints on the patient sample, QC sample, and maintenance log
reports.
If you want to protect access to sample analysis, select Sample Analysis for
password protection. Refer to Selecting Password Protection, page 5-26, if you
have not already selected Sample Analysis for password protection.
1. Access the Operator Passwords screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 7 Security Setup and press Enter.
c. Select 3 Operator Passwords and press Enter.
You must enter the Supervisor Password to access the Operator
Passwords screen. The default supervisor password is 12345. If you already
defined the supervisor password, you must enter that password.
A message appears prompting you to enter the supervisor password.
2. Type the supervisor password in the Password field and press OK.
As you type the password, the password does not appear on the screen.
The Operator Passwords screen appears, as shown in Figure Figure 5-15.
The first operator password has a default value of 12345. To ensure
that there is always at least one active operator password, you can edit the
default password, but you cannot delete it.
If you want to define only one operator password for all operators to
use, enter the password you want and leave the Operator ID field blank. The
operator ID in the Patient and QC Data Entry forms and the Maintenance Task
Done dialog box will be blank. The operator ID on the patient sample, QC
sample, and maintenance log reports will also be blank.
3. Take the appropriate action.
define a new operator
password
a. Type the ID in the Operator ID field and press
Enter.
b. Type the password in the Operator Password field
and press Enter.
edit a password or ID
retype the ID in the Operator ID field or the password
in the Operator Password field and press Enter
delete a password or ID
press Clear Entry to delete text in the Operator ID or
Operator Password field.
Bayer Diagnostics recommends that you keep a record of operator IDs and
passwords to help you track and manage assigned operator passwords.
Operator Password Screens are numbered 1 to 50 and operator fields are
numbered 1 to 10 on each screen to help you list the passwords.
4. Press Done.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
Operator IDs can contain 1 to 13 alphanumeric characters and can include spaces.
Operator passwords can contain 1 to 8 alphanumeric characters, can include
spaces, and are case sensitive.
If you enter an operator ID without an operator password, the system does not
accept the entry.
When you have entered 10 operator passwords, press Next Screen to continue
entering passwords. At Screen 50, Next Screen takes you to Screen 1. At Screen 1,
Previous Screen takes you to Screen 50.
Use this procedure to define or edit the supervisor password or the password
required to access menu functions.
The supervisor password must be used to access screens in Security Options and
can be used to access sample analysis.
Define a menu options password only if you want to password protect access to
menu functions. Refer to Selecting Password Protection, page 5-26, to select menu
options for password protection.
1. Access the Set Passwords screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 7 Security Setup and press Enter.
c. Select 1 Set Passwords and press Enter.
You must enter the supervisor password to access the Set Passwords
screen. The default supervisor password is 12345. If you already defined the
supervisor password, you must enter that password.
A message appears prompting you to enter the supervisor password.
2. Type the supervisor password in the Password field and press OK.
As you type the password, the password does not appear on the screen.
The Set Passwords screen appears, as shown in Figure 5-16.
You must enter values into both the Supervisor Password and the
Menu Password fields. If you do not use or uniquely define one or the other
password, you can enter the default password. The default for both passwords
is 12345.
3. Enter the supervisor or menu options password you want to use:
a. Type the password in the Supervisor Password field and press Enter.
b. Type the same password in the Supervisor Password Check field and press
Enter.
You can use the same password for the supervisor and menu passwords or
create a different password for each.
c. Type the password in the Menu Password field and press Enter.
d. Type the same password in the Menu Password Check field and press
Enter.
4. Press Done.
If the Password Check you typed does not match the Password, the system
prompts you to try again. Press OK and retype the Password Check.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
If you press Done before you assign passwords, a message appears prompting you
to enter a password. Press OK.
You can enter up to 8 alphanumeric characters including the dash in the password
field.
! ! Use this procedure to change the date and time. Table 5-10 lists the date and time
formats that you can use.
'%&! !
!
!
#
Date
MM/DD/YY
06/24/94
NOTE: The date that appears on reports and on
the screen uses three letters for the month, for
example, Jun 24 1994.
DD/MM/YY
24/06/94
NOTE: The date that appears on reports and on
the screen uses three letters for the month, for
example, 24 Jun 1994.
YY/MM/DD
94/06/24
NOTE: The date that appears on reports and on
the screen is completely numeric, for example,
1994.06.24.
Time
HH:MM (24-hour clock)
18:23 (6:23 p.m.)
"
1. Access the Date and Time Setup screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 1 Date and Time and press Enter.
The Date and Time Setup screen appears, as shown in Figure 5-17.
"'% ! !" !$ !
! !#! 2. Change the date and time.
Date
a. Move the cursor to the Date field.
b. Type the month, date, and year in the selected format. Press
Enter after you complete the field. The cursor moves to the
Time field.
Time
a. Move the cursor to the Time field.
b. Type the hour and minutes in the format, HH:MM. You can
enter 0 – 23 hours and 0 – 59 minutes.
c. Press Enter after you complete the field.
Date Format
a. Move the cursor to the required format.
b. Press Enter The date is reformatted, if necessary.
3. Press Done when you finish.
If you changed the date or format, the Updating Database message box
appears.
4. Define another setup function or press Exit Menu to return to the Ready
screen.
If you press Done before completing all required fields, the Incomplete Data Entry
message box appears. Press OK and complete the required fields.
If you type an invalid value in a field and press Done, the Invalid Entry message
box appears. Press OK and type a valid entry in the field.
To type a single number in a date or time field, you must precede the number with
a zero. For example, to enter June as the date, you must enter 06 in the month field.
Use this procedure to select the language that the system uses to present
information on the screen and in printed reports.
1. Access the Service Setup screen from the Menu screen:
a. Select 8 Service Setup and press Enter.
b. Select 3 Language Selection and press Enter.
2. Select the appropriate language and press Enter.
3. Press Done.
4. You can define another setup function or press Exit Menu to return to the
Ready screen.
Use this procedure to change the time when the system performs the automatic
cleaning of the reagent manifold. Auto Clean occurs once every 24 hours. The
default time is 0200.
On the first day of the month, the system also prints out final statistical summary
reports of the previous month’s QC data at the time of the Auto Clean.
1. Access the System Options screen from the Menu screen:
a. Press 6 System Setup and press Enter.
b. Press 5 Systems Options and press Enter.
The System Options screen appears, as shown in Figure 5-18.
$# " ! 2. Move to the Auto Clean Time field.
3. Type the hour and minutes in the format, HH:MM. You can enter 0 – 23 hours
and 0 – 59 minutes.
4. Press Done when you finish.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
Use this procedure to:
define the start date for scheduling maintenance on your system
increase or decrease the frequency of the maintenance tasks
1. Access the Maintenance Setup screen from the Menu screen:
a. Press 6 System Setup and press Enter.
b. Press 2 Maintenance Tasks and press Enter.
The Maintenance Setup screen appears, as shown in Figure 5-19.
2. Enter the start date for recording the maintenance tasks.
Tasks become due on midnight of the scheduled date. For example, weekly
tasks are due every 7 days after the start date, monthly tasks are due every
fourth week after the start date.
3. Take the appropriate action.
keep the existing
maintenance schedule
go to step 10.
change the frequency of a
maintenance task
go to step 4.
4. Select Edit Frequency.
5. Use the arrow keys to select a task.
6. Select Select Frequency.
7. Use the arrow keys to select a frequency for the task.
8. Select OK to change the frequency or select Cancel to return to the
Maintenance Schedule screen.
9. Repeat steps 5 through 8 to change the frequency of another task or go to step
10.
10. Press Done to return to the Main menu screen.
! $ !! ! Use this procedure to define the number of patient samples that can be stored on
your hard disk. You have the option of maximizing your patient sample database
and storing up to 5,000 samples on your hard disk or minimizing the database by
reducing the number of stored samples.
"
1. Access the System Options screen from the Menu screen.
a. Select 6 System Setup and press Enter.
b. Select 5 System Options and press Enter.
The System Options screen appears, as shown in Figure 5-20.
"&% # ! ! ! ! !!
! 2. Highlight the Patient Sample Limit field.
3. Type a number from 100 to 5000.
The default is 1500. Set the limit slightly higher than the usual number of
samples stored on the system before your scheduled backup. The system
overwrites the oldest records on the system once the number reaches the
specified limit.
For example, if your laboratory averages 250 samples per week, and has a
weekly backup schedule, you could set the patient sample limit to 350. This
reduces the database yet ensures that no data is overwritten before the
scheduled backup.
4. Press Done when you finish.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
" ! ! "
Use this procedure to adjust the beeper volume. You can select a high, medium, or
low volume. The default value is high.
"
1. Access the System Options screen from the Menu screen:
a. Press 6 System Setup and press Enter.
b. Press 5 Systems Options and press Enter.
The System Options screen appears, as shown in Figure 5-21.
"&% $ ! ! # ! ! " ! #"
2. Move to the Beeper Volume frame.
3. Select a volume level and press Enter.
4. Press Done when you finish.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
#! !& %#
Use this procedure to control the way the system moves capillary samples to the
measurement module. You can choose to move the samples manually or to have
the system move them automatically.
)'($# % !& #"
#
"! #
Yes
The system moves capillary samples automatically to the measurement
module. The default value is Yes.
No
The operator moves capillary samples to the measurement module by
turning the sample pump.
$
1. Access the System Options screen from the Menu screen:
a. Press 6 System Setup and press Enter.
b. Press 5 Systems Options and press Enter.
The System Options screen appears, as shown in Figure 5-22.
$!)' &"# #" ! ! % # # $# %
!& ! "# " ! 2. Move to the Auto Move Capillary frame.
3. Select Yes or No and press Enter.
4. Press Done.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
%$ $ "### #%$#
Use this procedure to select automatic transmission of patient sample results
directly to an LIS, HIS, or data management system. You can use this option only
if your 800 system is connected to an LIS or data management system. Refer to
Selecting Automatic Transmission of QC Results, page 5-55, for the procedure to
define auto send for QC results.
*()
%$ $$ ! !$ #
!$ #"!$ On
The system automatically sends patient sample results to an LIS or data
management system. The default setting is On.
Off
Results are not automatically transmitted. The operator must press to
transmit results or press to prevent transmission of results.
% 1. Access the Systems Options screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 5 Systems Options and press Enter.
The System Options screen appears, as shown in Figure 5-23.
%"*( '#$ !$ # " " & $ $ %$ " #$
$$
2. Move to the Auto Send frame.
3. Select Patient and press Enter.
A dark box indicates the option is on.
4. Press Done.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
Use this procedure to define the number of significant digits reported for certain
primary parameters. Table 5-13 lists the parameters that have high and low
resolution options. The default value is high.
#!" Low
pH
0.01
H+
nmol/L
1
pCO2
mmHg
1
kPa
0.1
mmHg
1
kPa
0.1
pO2
High
pH
0.001
H+
nmol/L
0.1
pCO2
mmHg
0.1
kPa
0.01
mmHg
0.1
kPa
0.01
pO2
1. Access the System Options screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 5 System Options and press Enter.
The System Options screen appears with the cursor in the Reporting
Resolution frame, as shown in Figure 5-24.
&#,* )$% "%! $ # !# !' %! % "!#% $!&%! # $% !# !(
2. Select High or Low and press Enter.
3. Press Done.
4. Define another setup function or press Exit Menu to return to the Ready
screen.
#!&#
!%$
The option that you select for the Reporting Resolution is saved with each patient
and QC sample. If you recall the sample data later and have changed the
resolution, the system prints the report using the resolution selected when the
sample was saved.
"!#% $&%$ (% #%! #%
Use this procedure to define the way the system processes patient sample results
when a sensor is out of calibration. When the system detects a sensor that has
excessive calibration drift, it cannot analyze samples until the drift is corrected. By
selecting Yes for Report Results with Cal Drift, you have the option to let the
system analyze a sample when a sensor is out of calibration.
,*+"!#% $&%$ (% #% "%! $
"%!
$#"%!
Yes
The system analyzes the sample and logs the event in the status log. The
printed report contains the message, not in calibration.
No
A D2 code appears and the affected sensor is turned off. Analysis continues
but no results are generated for the affected sensor. The default value is No.
#
1. Access the System Options screen from the Menu screen:
a. Press 6 System Setup and press Enter.
b. Press 5 Systems Options and press Enter.
The System Options screen appears, as shown in Figure 5-25.
# (' &!" "! $ " " " %"
" !" ! 2. Move to the Report with Cal Drift frame.
3. Select Yes or No and press Enter.
4. Press Done.
&#
!" Yes
A password message appears prompting you to enter the menu
password and an operator ID.
a. Type the menu password and operator ID and press Enter.
b. Press OK. The Menu screen appears.
No
The Menu screen appears.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
Use this procedure to define correlation coefficients. Correlation coefficients allow
you to adjust the patient results from an 800 system to match the patient results
from another system. You can specify correlation coefficients for slope and offset
(y-intercept). Refer to Appendix G, Correlation Adjustment, for the procedure to
determine correlation coefficients. Table 5-15 describes the slope and offset
correlation values.
! Slope
1.0
Slope of the line for the method you want the 800 system
to match.
Offset
0.0
Difference between the 800 system value and the method
you want to match.
Table 5-16 lists the correlation coefficient ranges for the listed base models and
base models with CO-ox module.
! pH
0.8 – 1.2
±9.9
840, 850, 860
pCO2
0.8 – 1.2
±99
840, 850, 860
pO2
0.8 – 1.2
±99
840, 850, 860
Na+
0.8 – 1.2
±99
850, 860
K+
0.8 – 1.2
±99
850, 860
Ca++
0.8 – 1.2
±99
850, 860
Cl–
0.8 – 1.2
±99
850, 860
Glucose
0.8 – 1.2
±99
860
Lactate
0.5 – 1.2
±99
860
tHb
0.8 – 1.2
±99
base model with CO-ox module
1. Access the Correlation Coefficients screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 8 Correlation and press Enter.
The Correlation Coefficients screen appears, as shown in Figure 5-26.
2. Type the slope and offset values you want for each parameter.
3. Press Done when you finish.
4. Define another setup function or press Exit Menu to return to the Ready
screen.
If you press Done before completing all the fields, the Incomplete Data Entry
message appears. Press OK and complete the required fields.
If you type an invalid value in a field and press Done, the Invalid Entry message
box appears. Press OK and type a valid entry in the field.
pH values on this screen are always expressed in pH units and not in nmols/L.
Use this procedure to print the setup report. The setup report contains a record of
the setup options selected on your 800 system. Bayer Diagnostics recommends that
you print the setup report when you change a setup parameter or value. The report
is a record of your setup definitions which can be used later when you want to
make another change.
1. Access the Print Setup Report screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 9 Print Setup Report and press Enter.
The report takes 1 to 2 minutes to print.
2. When the report finishes printing, press Exit Menu to return to the Ready
screen.
This section describes procedures for the following QC options:
creating new QC setup files
editing QC files
turning QC Auto Identity on and off
turning Auto Accept QC on and off
turning QC Auto Send on or off
printing a QC setup report
Each QC file can store the following information:
file identification information
results for the last 150 QC samples
cumulative statistics, such as the mean, standard deviation, and coefficient of
variation
total number of samples
When you create a new QC setup file, you enter the information shown in
Table 5-17.
! QC ID
number that identifies the QC material
level
number that describes the level of QC material
lot number
number that identifies the lot of QC material
expiration date
date after which you cannot use the QC material
Bayer Diagnostics Service Representatives use File 13 to store data during service
calls.
" $ !
Use this procedure when you first create a new QC file. The system uses QC files
to store results from QC sample analyses. You can use this QC information to
create reports summarizing QC results.
NOTE: If you have an existing QC file and want to change to a new lot of QC
material, refer to Editing QC File Setup, page 5-49.
#
1. Access the QC Files screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 1 QC Setup and press Enter.
c. Select 1 QC Files and press Enter.
2. Select the file number you want to create and press Enter.
You cannot select File 13 as a QC file.
3. Press Done.
The QC File Setup screen appears as shown in Figure 5-27.
# '& "# ! !%! " # "" %# !"
4. Complete the QC data form:
%# #! the keypad
type the QC ID, level, lot number, and expiration date. Press
Enter after you complete each field.
the optional bar
code scanner
scan the QC Catalog and QC Lot/Expiration bar codes from
QC Expected Values.
5. Press Done when you finish.
A message appears prompting you to delete the current QC file setup data.
6. Press Yes.
The QC File Setup screen appears with all data fields empty, as shown in
Figure 5-28.
"&% !" !$ !
! !#! 7. Complete the form.
$" " the keypad
type the low and high target limits for each parameter. Press
Enter after you complete each field.
the optional bar
code scanner
scan the target range bar code for each parameter from QC
Expected Values. If you scan the wrong bar code, a message
appears prompting you to scan the correct parameter bar code.
Press OK and continue.
When you complete both fields for a parameter, the system automatically
calculates the target value and the action range.
8. If a second screen of parameters exists, press Next Screen and enter values on
that screen.
9. Press Done.
A message appears prompting you to set up another QC file.
save your entries and
create another QC file
Yes. The QC File screen appears. Continue with step 2.
save your entries and you
do not want to create
another file
No. The Menu screen appears. Define another setup
function or press Exit Menu to return to the Ready
screen.
return to the QC File
Setup (ranges) screen
Cancel. The cursor returns to the last field you
completed.
If you press Done before you complete both the low and high fields for a
parameter, a message appears telling you the empty field is an invalid range.
Press OK. Complete the field. If any other incomplete fields exist, the cursor
moves to those fields.
If you press Menu before you press Done, a message appears prompting you
to save your entries.
save your entries
Yes. The Menu screen appears.
delete your entries
No. The Menu screen appears.
return to the screen
Cancel. The cursor returns to the last field you
completed.
Use this procedure to edit QC setup information in an existing QC file under one
of the following circumstances:
When you change QC lots, you want to replace the old QC file information with
the new lot information.
You want to change the high and low range values for a parameter.
If you are creating a QC file for the first time, refer to Creating New QC Files,
page 5-46.
NOTE: During this procedure, if you are changing QC lots, you must delete the
existing QC data stored in the file. If you want to save a copy of the data, archive
the file to a diskette before performing this procedure. Refer to Archiving QC
Data, page 5-68, for more information.
When you change QC lots, replace the information shown in Table 5-18 with the
data from the new QC material.
"! QC ID
number that identifies the QC material
level
number that describes the level of QC material
lot number
number that identifies the lot
expiration date
date after which you cannot use the QC material
1. Access the QC File screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 1 QC Setup and press Enter.
c. Select 1 QC Files and press Enter.
2. Select the file number that you want to edit and press Enter.
You cannot select File 13 as a QC file.
3. Press Done.
The QC File Setup screen appears as shown in Figure 5-29.
#" !
! 4. Perform one of the following options.
! change to a new
QC lot
type the new QC file information in the fields or, if you use
the optional bar code scanner, scan the new QC file
information. Continue with step 5.
edit the ranges for
this QC file
continue with step 5.
edit fields on this
screen
move to the field requiring a change and type the new data.
Press Enter after you complete each field. Continue with
step 5.
5. Press Done.
A message appears prompting you to delete the current QC file setup data.
You must delete the current QC file data when you change lots.
Otherwise, the QC file will contain data from the old and the new lots.
! changing to a new
QC lot
press Yes. The system prints a copy of the current QC file
setup data, deletes this data, and prints a copy of the QC
statistical summary report.
The QC File Setup (ranges) screen appears with all data fields
empty, as shown in Figure 5-30. Continue with step 6.
editing the existing
QC file ranges
press No. The QC File Setup (ranges) screen appears. The
fields contain the data for the file you selected. Continue with
step 6.
!%$ ! # " 6. Perform one of the following options.
#! changing to a new QC
lot
type the high and low target limits for each parameter.
Press Enter after you complete each field.
NOTE: If you use the optional bar code scanner to enter
QC information, scan the QC Parameter bar codes.
editing a portion of the
existing QC file ranges
move to the field requiring change, press Clear Entry
and type the new data. Press Enter after you complete
each field.
editing all of the
existing QC file ranges
press the Erase All key to delete the target ranges for all
fields. A dialog box appears on the screen asking you to
confirm that you want to delete the target ranges in all
fields. Press OK to clear all fields. Press Cancel to keep
the target ranges.
7. If a second screen of parameters exists, press Next Screen.
8. Press Done when you finish.
A message appears prompting you to set up another QC file.
save changes and edit
another QC file
Yes. The QC File screen reappears. Continue with step 2.
save the entries and you
do not want to edit
another file
No. The Menu screen appears. You can define another
setup function or press Exit Menu to return to the Ready
screen.
return to the QC File
Setup (ranges) screen
Cancel. The cursor returns to the last field you
completed.
If you press Menu before you press Done in the QC File Setup screen, a
message appears prompting you to save your changes.
save the changes
Yes. The Menu screen appears.
delete the changes
No. The Menu screen appears. No changes are saved.
return to the
screen
Cancel. The cursor returns to the last field you completed.
If you scan an incorrect bar code, the Unexpected Bar code message box
appears. Press OK and then scan the correct bar code.
If you press Done before completing all text fields in a row, the Incomplete
Data Entry message appears. Press OK and complete the required fields.
$ %$ $ ##$
Use this procedure to control the way QC results are assigned to a QC file.
Table 5-19 describes the options for assigning QC results.
)'(%$ $& !$ #
!$ #"!$ On
The system automatically determines the appropriate QC file
to assign QC sample results, by comparing the QC sample
results for pH and pCO2 to the ranges entered in setup for
these parameters.
NOTE: If the pH, pCO2, or tHb sensor is disabled or not in
calibration, Auto ID does not work.
Off
The operator assigns the QC sample results to the appropriate
file. The default value is Off.
% 1. Access the Global QC Settings screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 1 QC Setup and press Enter.
c. Select 2 Global QC Settings and press Enter.
The Global QC Settings screen appears with the cursor in the Auto ID frame,
as shown in Figure 5-31.
%")' $$# "
$ " " $ %$ !"## $"
2. Select On or Off and press Enter.
3. Press Done.
4. Define another setup function or press Exit Menu to return to the Ready
screen.
# $## # "$#"
Use this function if you are connected to an LIS or data management system and
you want the 800 system to automatically accept QC results. When you use Auto
Accept with Auto Send, the 800 system accepts all QC samples and sends them to
the connected LIS or data management system. You can review the QC results at
the LIS or data management system and, if required, change the status to reject or
discard.
NOTE: Auto Send must be turned on to have results automatically sent to an LIS
or data management system.
(&'$# # #"
#
"! #
On
The system automatically accepts QC results and, when Auto Send is on,
sends the results to an LIS or data management system.
Off
The operator accepts, rejects, or discards QC results at the end of analysis.
The default setting is Off.
$
1. Access the Global QC Settings screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 1 QC Setup and press Enter.
c. Select 2 Global QC Settings and press Enter.
The Global QC Settings screen appears, as shown in Figure 5-32.
$!(& ##" !
% # # $#
# ! "# ! 2. Move to the Auto Accept QC frame.
3. Select On or Off and press Enter.
4. Press Done.
5. Define another setup function or press Exit Menu to return to the Ready
screen.
$ %$ $ "### #%$#
Use this procedure to control transmission of QC results directly to an LIS or data
management system. This option is available only if your 800 system is connected
to an LIS or data management system. Refer to Defining Automatic Transmission
of Results, page 5-38, for the procedure to define patient sample auto send.
*()
%$ #%$# !$ #
!$ #"!$ On
The system automatically transmits QC results to an LIS or data management
system. The default setting is On.
Off
Results are not automatically transmitted. The operator must press Send to
transmit results or press Do Not Send to prevent transmission.
% 1. Access the Systems Options screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 5 Systems Options and press Enter.
The Systems Options screen appears, as shown in Figure 5-33.
%"*( '#$# !$ # " " & $ $ %$ "
#$ 2. Move to the Auto Send frame.
3. Select QC and press Enter. A dark box indicates the option is on.
4. Press Done.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
Use this procedure to print a QC setup report for any QC file.
1. Access the QC File screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 1 QC Setup and press Enter.
c. Select 1 QC Files and press Enter.
2. Select the file number that you want to print.
3. Press Print QC Setup.
The QC Setup report prints. Figure 5-34 shows an example of a QC Setup
Report.
QC SETUP REPORT
SYSTEM 850-1001
GLOBAL QC SETUP
Auto ID is:
Auto accept QC:
APR 12 1994
11:42
On
Off
QC FILE SETUP
File 1
QC ID:
Level:
Lot number:
Expiration date:
473842
2
41561
Dec 30
95
.............
.........................
..............................
.................................
MEAN
TARGET RANGE
ACTION RANGE
7.419 ( 7.399 - 7.439)( 7.389 - 7.449)
43.4 ( 38.4 - 48.4)( 35.9 - 50.9)
103.1 ( 96.1 - 110.1)( 92.6 - 113.6)
.......
850
135.0 ( 130.0 - 140.0)( 127.5 - 142.5)
4.81 ( 4.31 - 5.31)( 4.06 - 5.56)
1.16 ( 1.06 - 1.26)( 1.01 - 1.31)
860
102 (
97 107)( 94.5 - 109.5)
....................
Glucose
102.5 ( 97.5 - 107.5)( 87.5 - 117.5)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Lactate
. . . . . . . . . . . . . . . . .0.92
. . . . . . .(. . . .0.71
. . . . . . .. . . . 1.11)(
. . . . . . . . . . . .0.61
. . . . . . .-. . . .1.21)
...................
ctHb
14.5 ( 13.5 - 15.5)( 13.0 - 16.0)
1.2 (
0.7 1.7)(
0.4 2.0)
FO2Hb
FCOHb
95.5 ( 93.5 - 97.5)( 92.5 - 98.5)
CO-ox
FMetHb
0.4 (
0.2 0.6)(
0.1 0.7)
FHHb
2.6 (
2.1 3.1)(
1.8 3.4)
840
..............
..............
pH
pCO2
pO2
Na+
K+
Ca++
Cl-
....................................................................................
These results
appear when an
845, 855, or 865
is interfaced.
4. Press Menu.
5. You can define another setup function or press Exit Menu to return to the
Ready screen.
This section describes procedures for the following calibration options:
changing drift limits
changing calibration gas values
selecting calibration frequency and Auto Repeat
Use this procedure to enter the drift limits allowed during calibrations. Drift is the
difference between the value expected from a known calibrant and the actual value
measured during the calibration. Some drift is acceptable. This procedure lets you
define the acceptable drift limits for your laboratory.
If drift exceeds the acceptable limits, the results are flagged on the screen and on
the report and are reported in the status log. The drift limits defined in Table 5-22
are for cal points only. The drift limits for slope points are fixed and cannot be
changed. Table 5-22 lists the valid range and default value for each parameter for
the listed base models and base models with CO-ox module.
"! 0.000 – 0.050
±0.015
840, 850, 860
pCO2
3.5 – 9.0%
±5.6%
840, 850, 860
pO2
2.0 – 7.0%
±4.1%
840, 850, 860
Na+
0.00 – 10.00
±2.5
850, 860
K+
0.00 – 1.00
±0.15
850, 860
Ca++
0.00 – 1.00
±0.05
850, 860
Cl–
0.0 – 10.0
±3.0
850, 860
Glucose
3.5 – 12.5
±9.0
860
Lactate
0.05 – 0.40
±0.10
860
0.0 – 0.4
±0.2
base model with a CO-ox module
pH
tHb
#
1. Access the Calibration Drift Limits screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 6 Calibration Setup and press Enter.
c. Select 1 Drift Limits and press Enter.
The Calibration Drift Limits screen appears, as shown in Figure 5-35.
# '& " " "! !! " % "
" "$" 2. Move to the field that you want to change.
The number you enter establishes a range above and below the
expected value. For example, if you enter 2 as the drift limit, the range is plus
or minus 2 from the expected value.
3. Type the new drift limit and press Enter.
4. Repeat steps 2 and 3 for each parameter for which you want to enter or change
the drift limit.
5. Press Done when you finish.
6. You can define another setup function or press Exit Menu to return to the
Ready screen.
# "!
If you type an invalid value in a field and press Done, the Invalid Entry message
box appears. Press OK and type a valid entry in the field.
" ! #!
Use this procedure to define the calibration gas values for the gases used during
calibration. Table 5-23 lists slope and cal ranges for CO2 and pO2.
)'(!# " $"
"
$#
$#
CO2
2.00 – 7.90%
5.00%
(Cal CO2 + 2.9) –
99.9%
10.00%
O2
5.00 – 98.00%
12.00%
0.00% (fixed)
0.00%
$
1. Access the Calibration Gas Values screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 6 Calibration Setup and press Enter.
c. Select 3 Gas Values and press Enter.
The Calibration Gas Values screen appears, as shown in Figure 5-36.
$!)' !# " $" !
$ # " !"" ! #!& #
# #%# 2. Move the cursor to the field that you want to change.
3. Type the new gas value and press Enter.
4. Repeat steps 2 and 3 for each gas value you want to change.
5. Press Done.
6. Define another setup function or press Exit Menu to return to the Ready
screen.
! Use this procedure to select the frequency at which automatic calibrations occur
and to direct the system to repeat calibrations automatically whenever the drift is
out of limits. There are two calibration frequency options: fixed time and flexible
time. Table 5-24 describes the Calibration Frequency and Auto Repeat options.
$"# ! Fixed Time
Lets you schedule one- and two-point calibrations to occur at regular
intervals. You enter the time intervals in the One-point Interval and
Two-point Interval fields. With Fixed Time, you can also control the
Auto Repeat function.
One-point intervals range from 05 to 60 minutes; default is 30 minutes.
Two-point intervals range from 120 to 240 minutes; default is 120
minutes.
The tHb slope interval ranges from 1 to 30 days; default is 30 days.
Flexible Time
The system determines the rate of drift and schedules the time of the
next calibration to avoid excessive drift in subsequent calibrations.
Flexible Time schedules the one-and two-point calibrations and lets
you define a minimum time interval for one-point calibrations.
Auto Repeat is always turned on when you select flexible time.
Auto Repeat
This option is available when you select Fixed Time frequency. You
can choose to have the system automatically repeat the calibration or a
portion of a calibration when the drift is out of limits. The default
value is On.
In Flexible Time, all calibrations automatically repeat when the drift is
out of limits.
NOTE: The tHb slope does not automatically repeat when the drift is
out of limits.
Metabolite
Recal
This option allows you to turn off the metabolite recal. Turning off
metabolite recal allows faster throughput of samples. When you turn
off metabolite recal, the system calibrates glucose only at the regularly
scheduled one- and two-point calibrations.
1. Access the Cal Intervals screen from the Menu screen:
a. Select 5 Operating Setup and press Enter.
b. Select 6 Calibration Setup and press Enter.
c. Select 2 Cal Intervals and press Enter.
The Cal Intervals screen appears with the cursor in the Calibration Frequency
frame, as shown in Figure 5-37.
&% ! $ "
$
! " $ # $ & ! " $
# 2. Select the options you want.
$ " Calibration Frequency
Select Fixed Time or Flexible Time and press Enter.
NOTE: If you select Flexible Time the interval and
Auto Repeat options are not available.
One-point, Two-point, or
tHb Slope Interval
a. Move to the appropriate field.
Auto Repeat
a. Move to the Auto Repeat frame.
b. Type the amount of time you want between
calibrations and press Enter.
b. Select On and press Enter to automatically repeat
calibrations.
Select Off and press Enter to stop repeat automatic
calibrations.
Metabolite Recal
a. Move to the Metabolite Recal frame.
b. Select On and press Enter to perform one-point
metabolite calibrations automatically.
Select Off and press Enter to stop automatic
one-point metabolite calibrations.
3. Press Done when you finish.
4. You can define another setup function or press Exit Menu to return to the
Ready screen.
! $ "
Use the following procedures to configure the 800 system for any of the following
external devices:
270 CO-oximeter
800 series compatible ticket printer
Bayer Diagnostics data management systems
bar code scanner
line printer
laboratory or hospital information system
Table 5-25 lists the ports you can use with each device.
(&' "
Serial port 1
the ticket printer.
Serial port 2 and 3
the 270 CO-oximeter and an LIS or data management system.
Parallel port
other printer types, such as a line printer.
Barcode
the bar code scanner.
!
1. Access the Port Selection screen from the Menu screen:
a. Select 6 System Setup and press Enter.
b. Select 6 Communications and press Enter.
The Port Selection screen appears, as shown in Figure 5-38.
!(& %!
# !
2. Select the appropriate serial port, press Enter, and then press Done.
Refer to Table 5-25 to determine which port to select for your device.
The Device Selection screen appears, as shown in Figure 5-39. If the port
already has a device assigned, that device is selected. If required, press
Previous Screen and select another port.
You can only select a device that has the diamond symbol before it. If
a device cannot be connected to the selected port the diamond symbol is
absent.
3. Select the required device, and then press Enter.
select Bar Code
press The Bar Code Options screen appears. Select
the appropriate symbology. Select if
Code 128 is the only symbology you require. Then press Symbology 128 is always enabled when you install the bar code
scanner. You cannot select or deselect it from the menu. You may
select one more symbology in addition to code 128. Refer to the
800 Series Bar Coding Features technical bulletin for detailed
information on barcode setup. Press Done when you finish.
select LIS/HIS
press Next Screen. The Device Selection screen appears
containing the communication parameters, as shown in
Figure 5-40. Continue to Step 4.
select any other
device
press Done. You are prompted to configure another port. If you
press No the Menu screen appears. If you press Yes, the Port
Selection screen appears.
!&$ " ! " #!
4. Select the parameters according to the communication requirements for the
device you are connecting. Table 5-26 describes each of the communication
parameters.
&$%
! protocol
the set of conventions that governs the format and timing of the
information transferred between the 800 system and the LIS, HIS, or
data management system
baud rate
speed at which data is sent or received when devices are
communicating through a serial channel
parity
method used to detect errors during transmission by setting an extra
binary digit on the basis of the number of 1 bits in a one-byte data
item
stop bits
a binary digit that signals that the transmission of a byte of data is
complete; used for synchronization
data bits
the number of binary digits that define a unit of information
5. Press Done when you finish.
You are prompted to configure another port.
want to configure
another device
Yes. The Port Selection screen appears.
do not want to
configure another
device
No. The Menu screen appears. You can define another setup
function or press Exit Menu to return to the Ready screen.
want to return to the
last field edited
Cancel.
When the system establishes the connection to an external device, the Device
Connected to Port __ message appears in the status area. If the system is
unable to establish the connection, the D60 Port Error message appears.
Refer to the 800 Series Bar Coding Features technical bulletin for detailed
information about bar code setup procedures.
Bayer Diagnostics Service Representatives use the Service Setup menus to enter
various types of system and service information, such as the system model number,
the serial number, and the service contact. You can view the system information,
but you cannot change any of the information. Refer to Viewing System
Information on page 5-5 for the procedure to view the system information.
This section provides the following procedures for managing 800 system data files
using the disk utilities:
back up and restore data files
archive QC data
view and print archived QC data
install system software
copy patient data files to a diskette in a CSV file format
NOTE: When you backup or archive, use DOS-formatted, 3.5-inch diskettes.
Table 5-27 describes the tasks you can perform using the disk utilities functions.
Backup
copy system files from the hard disk to diskettes that you can use
to restore files or to copy troubleshooting trace log information
for service representatives if required.
Archive
remove QC data from the hard disk and store it on diskettes.
View Archive
view QC data and print QC reports from archived diskettes.
Restore
copy data from backup diskettes to the hard disk.
Install
install or update operating software on the system.
Copy Files
copy patient data files from the hard disk to a diskette in a CSV
file format
You can access disk utilities screens from the Menu screen.
Use this procedure to copy the previous month’s QC files and statistics from the
hard disk to a diskette. The system copies all QC files at the same time.
You can archive the previous month’s QC data one or more times during the
current month. At the end of the current month, the system permanently deletes the
previous month’s QC data.
Use the archive diskette to view and print QC file reports, Levey-Jennings charts,
and statistical summary reports of archived QC data. Refer to Viewing Archived
QC Data, page 5-70, for more information on viewing and printing archived data.
You cannot edit or restore data from an archive diskette.
1. Access the Archive QC screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 2 Disk Utilities and press Enter.
c. Select 2 Archive and press Enter.
If you archive before you analyze the first QC sample of the current
month, you can print statistical summary reports of the previous month’s QC
data before you archive.
2. Perform one of the following options.
print a QC statistical
summary report before
archiving
Print. The system prints the QC Statistical
archive QC data without
printing a report
Archive. The Begin Archiving message appears,
prompting you to insert a diskette.
stop the archiving process
Cancel. The system returns to the Archive QC
screen. Press Cancel again.
Summary. When printing is complete, the Begin
Archiving message appears, prompting you to insert
a diskette.
3. Insert a DOS-formatted diskette in the diskette drive and press Continue.
The Writing to the diskette message appears during the archive. When
archiving is complete, a message box appears containing archive diskette
information.
4. Remove the diskette and label it with the date and time of archive.
5. Press OK.
6. Press Home to return to the Ready screen.
If you do not insert a diskette, the No Diskette in Diskette Drive message box
appears. If you insert an unformatted diskette, the Cannot Write to Diskette
message box appears.
you want to continue
to archive
insert a formatted diskette and press Continue.
you do not want to
continue to archive
press Cancel. The Cancel Archive screen appears. Press Yes.
The Menu screen appears.
If you insert a diskette that already contains data, a message box appears indicating
that the system will overwrite the data currently on the diskette.
you want to overwrite
the data
Continue. The system starts archiving the data.
you do not want to
overwrite the data
Cancel. The Begin Archiving message appears. Press Cancel
again.
If you press Cancel at the Begin Archiving message, you are prompted to cancel
archiving.
you want to continue
to archive
No.
you do not want to
continue to archive
Yes. A message appears prompting you to remove the
diskette.
Use this procedure to view QC data from archive diskettes. You can also print the
following QC reports from archive diskettes:
Levey-Jennings Chart
QC Sample Report
QC Statistical Summary
NOTE: You cannot edit or restore archived QC data.
1. Access the View Archived QC Data screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 2 Disk Utilities and press Enter.
c. Select 3 View Archive and press Enter.
The View Archived QC Data screen appears, with the Begin Viewing Archive
message box.
2. Insert the archived diskette in the diskette drive and press Continue.
The system reads the diskette. When the system is ready, a message appears
containing archive diskette information.
3. Press Continue
4. Remove the diskette when the system prompts you. The Archived QC Search
Criteria screen appears.
5. Type the search criteria and press Enter after you complete each field. Refer to
Recalling QC Data in Section 2, for information about entering the search
criteria.
6. Press Done when you finish entering your search parameters.
more than one QC
sample is found
the Archived QC Search Log appears. The log contains the
reports that the system located for the search criteria you
entered. Continue with step 7.
one QC sample is
found
the Archived QC Search Result screen appears. Continue
with step 8.
7. Perform one of the following tasks.
view the report results
select the QC sample you want and press Enter.
print a Levey-Jennings,
QC sample, or statistical
summary report
press Reporting Options. Continue with step 9.
8. Press Reporting Options to print a Levey-Jennings, QC sample, or statistical
summary report.
9. Select the report you want to print.
Levey-Jennings Chart
a. Select Levey-Jennings Current Month or Previous
Month.
b. Press OK. The list of parameters appears.
c. Select the parameter you want and press Done. The
Levey-Jennings chart appears.
QC Sample Report
a. Select Print QC Sample Report and press Enter.
b. Press OK.
QC Statistical Summary
a. Select Print Statistical Summary and press Enter.
b. Press OK.
10. When you finish viewing archived QC data, press Done.
more than one sample is
found
the Done Options message box appears.
Select Next Record and press OK to view the next
report that appears on the log.
Select Previous Record and press OK to view the
previous report that appears on the log.
Select Search Criteria Screen and press OK to view
the Archived QC Search Criteria screen.
Press Cancel to close this message box and return to
the Search Results screen.
one sample is found
the Archived QC Search Criteria screen appears.
11. Press Home to return to the Ready screen.
If you type invalid data in a field and press Done the system displays either the
Invalid Entry or Invalid Range message box. Press OK and type a valid entry in the
field.
If there is no QC data found for the search criteria you entered, the No QC Data
message box appears. Press OK and ensure that the search criteria you entered is
accurate.
Use this procedure to copy system data files from the hard disk to diskettes. You
can also use this procedure to copy trace log information for service
representatives to use in troubleshooting software problems.
Backup protects the system files on your hard disk by making copies of the files on
a diskette that you can restore to the hard disk. The stored data from the disk
includes:
patient sample data
quality control data
calibration, diagnostic, and maintenance data
setup data
workload statistics and cycle counts
Establish a backup schedule that meets your laboratory’s data requirements. The
frequency with which you backup data files should correspond to the amount of
data you want to restore in case of a data loss. For example, if you want to be able
to restore all your patient sample data from the previous day, then backup patient
data every day. Bayer Diagnostics recommends that you backup patient data every
day.
NOTE: Bayer Diagnostics recommends that you backup system data files each
time you change system setup options and QC files.
You can restore backed up data to the hard disk using the procedure in Restoring
System Data, in this section.
1. Access the Backup screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 2 Disk Utilities and press Enter.
c. Select 1 Backup and press Enter.
The Backup screen appears, as shown in Figure 5-41.
$# ! 2. Perform one of the following tasks.
" ! back up the system
data
select All Stored Data.
copy the trace log
select Trace Log
3. Press Done. The Backing Up message box appears prompting you to insert a
diskette.
4. Insert an IBM-formatted diskette in the diskette drive and press Continue.
The Writing to diskette message box appears while the system performs the
backup.
5. Complete the backing up process.
a message appears
prompting you to
insert a new diskette
a. Remove the diskette from the diskette drive.
the Backup Finished
screen appears
a. Remove the diskette from the diskette drive.
b. Label the diskette with the date and time
c. Insert another formatted diskette and press Continue.
b. Label the diskette with the date and time
c. Press OK. The Menu screen appears.
6. Press Home to return to the Ready screen.
If you do not insert a diskette, the No Diskette in Diskette Drive message box
appears. If you insert an unformatted diskette, the Cannot Write to Diskette
message box appears.
you want to continue with
the backup
insert a formatted diskette and press Continue.
you do not want to continue
with the backup
press Cancel. The Cancel Backup screen appears.
If you insert a diskette that already contains data, a message box appears indicating
that the system will overwrite the data currently on the diskette.
you want to overwrite the
data
Continue. The system starts backing up the data.
you do not want to
overwrite the data
Cancel. The Backing Up message box appears. Insert a
formatted diskette and press Continue.
Use this procedure to copy data from your backup diskettes to the system hard
disk.
CAUTION: When you restore data from a backup diskette, the restore process
replaces any files created since the last back up.
1. Access the Restore screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 2 Disk Utilities and press Enter.
c. Select 4 Restore and press Enter.
The Restore screen appears with the Insert Backup Diskette message box.
2. Insert the backup diskette in the diskette drive and press Continue.
The system reads the diskette. When the system is ready, a message box
appears containing backup diskette information. The message also indicates
that the restore process will overwrite the data currently on the hard disk.
3. Press Continue.
The Restoring screen appears with the Reading from Diskette message box.
4. Complete the restore process.
a message appears
prompting you to
insert the next diskette
a. Remove the diskette from the diskette drive.
the Restore Finished
screen appears
Continue with step 5.
b. Insert another backup diskette and press Continue.
5. Press OK and the remove the diskette.
The system performs an automatic shutdown.
The Shutdown screen appears.
6. Press Yes to shut down the system.
You must wait for at least 1 minute before you disconnect the
power cord and then wait at least 10 seconds before you reconnect the power
cord. If you do not adhere to the time intervals, you can damage the system.
A message appears on the screen and on the roll printer, directing you to wait
before you disconnect the power.
7. Wait at least 1 minute.
8. Disconnect the power cord from the power supply.
9. Restart the system:
a. Wait at least 10 seconds after disconnecting the power cord.
b. Reconnect the power cord to the power source.
After a few moments, the system starts initializing. When initializing is
complete, a screen for Analyze Mode appears.
Ensure that you restore data to the system hard disk only from the backup
diskettes that are labeled for that system.
If you insert a diskette that is not a backup diskette, the Invalid Diskette Data
type message appears.
you want to continue
insert the correct diskette and press Continue.
you do not want to
continue
Press Cancel The Cancel Restore message appears.
If you want to cancel the restore process, press Cancel. When prompted, press Yes
and remove the diskette from the diskette drive.
Format Disk
Previous
Screen
Done
Menu
Use this procedure to install or update operating software on your 800 system. You
update system files using program diskettes that contain new system software.
CAUTION: To protect against data loss, always back up files before installing new
software. Refer to the procedure, Backing Up System Data, page 5-72.
1. Access the Install Software screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 2 Disk Utilities and press Enter.
c. Select 5 Install and press Enter.
The Install Software screen appears with a message prompting you to back up
the system before installing software.
2. Press Continue if you have backed up the system.
A message appears prompting you to insert the program diskette.
Installing
Software
timing bar
Previous
Screen
3. Insert program diskette one.
Menu
Done
4. Press Continue to proceed.
The following message appears:
The system identifies the diskette and displays the Install Identification
message box:
Do not remove the diskette.
5. Press Continue to proceed using the diskette the system just read.
The system copies the software files from the diskette to the hard disk:
6. After the system copies the software files, the Install Identification message
box appears.
you have more program
diskettes to install
the Insert Next Diskette message appears on the
Install Identification message box instruction line.
NOTE: Do not press Continue until you have inserted
the diskette.
a. Remove the diskette from the diskette drive.
b. Insert the next program diskette.
c. Repeat steps 4 and 5.
the Last Diskette message
appears on the Install
Identification message
box instruction line
a. Press OK.
A message appears prompting you to remove the
diskette.
b. Remove the diskette from the diskette drive.
The Processing Software Installation message
appears. The system emits a beep every few
seconds until the installation is complete.
If the Last Diskette message does not appear after the system reads
the last program diskette, it is likely that at least one of the program diskettes
was not installed. Cancel the installation and start the procedure again.
When the system finishes the software installation, the Install Software
Finished screen appears prompting you to shut down the system.
7. Press OK to shut down the system.
The system initiates an automatic shut down.
A message appears on the screen and on the roll printer, directing you to wait
before you disconnect the power.
Do not unplug the system until the following message appears on
the screen:
...synching disks... done
This is an operating system message, indicating that the system has
successfully completed the shutdown procedures. Unplugging the system
before this message appears can damage the system.
8. When you see the operating system message, disconnect the power cord from
the power supply.
Wait at least 10 seconds before you reconnect the power cord. If
you do not adhere to the time intervals, you can damage the system.
9. Restart the system:
a. Wait at least 10 seconds after disconnecting the power cord.
b. Reconnect the power cord into the power source.
The system restarts. After a few moments, the system starts initializing. When
initializing is complete, a screen for Analyze Mode appears.
The software version number appears on the System Information screen with
the date and time of installation.
If you insert a diskette that has already been processed, a message box appears
prompting you to insert a different diskette.
If the system encounters a diskette containing an invalid data type or a diskette that
it cannot read, a message appears prompting you to remove the diskette and insert
another one.
If you want to cancel the software installation, press Cancel. When prompted,
press Yes and remove the diskette from the diskette drive. If you cancel the
installation, the previous version of the software remains installed.
CAUTION: Occasionally the system may shut down if you cancel the installation.
If this happens, follow the instructions given in the Caution statement in step 7 and
then continue through step 9.
When the screen for the Analyze Mode appears, you can start the installation
procedure again.
Use this procedure to copy patient data files from the hard disk on your 800 system
to a diskette. The system copies the data to the diskette in a CSV file format. You
can then import this data into PC applications, such as spreadsheets and databases,
that accept comma-delimited lists of ASCII-text information. You can use these
applications for data analysis or management. Refer to File Format, page 5-81, for
more information about how the data is stored in the copied files.
1. Access the Copy Files screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 2 Disk Utilities and press Enter.
c. Select 6 Copy Files and press Enter.
The Copy Files screen appears.
2. Select Patient Data and press Done.
The Patient Data Search Criteria screen appears, as shown in Figure 5-42.
!%$ ! ! #! " #
#! " #
# ! # Use this screen to define the criteria for the patient data files you want to copy.
The system locates only the files that meet the criteria you specify. For
example, if you want to copy patient data files from a specific period, type in
the start date in the Analysis Date From field and the end date in the Analysis
Date To field. You can also copy files with consecutive sample sequence
numbers.
The system can copy up to 1500 patient samples on a single diskette.
If your search criteria produce too many samples to fit on a single diskette, the
system prompts you to reenter the search criteria to select fewer samples.
3. Type the search criteria and press after you complete each field. Press
Done when you finish.
The Copying Files screen appears, with the Begin Copying Files dialog box.
4. Insert a clean, formatted diskette in the diskette drive and press Continue.
The Writing to diskette message box appears while the system copies the files.
5. When the Copy Files Finished screen appears, remove the diskette and label it.
!
If you do not insert a diskette, the No Diskette in Diskette Drive message box
appears. If you insert an unformatted or faulty diskette or a diskette that
already contains files, the Cannot Write to Diskette message box appears.
you want to copy files
insert a clean, formatted diskette and press Continue.
you do not want to copy
files
press Cancel. The Copying Files screen appears,
with the Cancel Copy Files dialog box.
The Copy Files option allows you to copy patient data files stored on your system
to a diskette in a format that can be imported into PC applications, such as
spreadsheets and databases. You can then use these applications for data
management and analysis.
The copied data files are in a CSV format, which uses a comma-delimited record
structure. The files contain ASCII characters without character formatting. For
example, pCO2 appears as pCO2.
The numbers in the sample status and parameter status columns represent
messages, such as out-of-range messages, in the original patient sample report.
Refer to the Sample Status and Parameter Status tables that appear in the patient
data file for an explanation of the status number.
When imported into a PC spreadsheet, the data in each file is organized in rows:
1
The first row contains headings that define the contents of
the column. These headings list patient demographics or
parameter names as found on an 800 system. The copied file
includes all headings, even if there are no patient results in
the columns.
2
The second row contains the status heading and the units of
measure for each parameter. A status number appears for
every parameter with a reported result. Sample status
numbers are reported in a separate column.
3 through the end of
the file
The remaining rows contain the status numbers,
demographic information, and reported values for each
patient sample. Each row contains results for a single
sample analysis. Columns that are not relevant to the system
model or whose values are unavailable are left blank.
The following tables list the status numbers and the associated messages that are
reported for sample and parameter status. Although the original patient result may
contain more than one message, the copied report lists only one status number. The
status numbers are listed in the table in the hierarchical order in which they are
reported.
Blank
No exceptions
1
Blood gas and CO-ox sample temp out of range
2
Blood gas sample temp out of range
3
CO-ox sample temp out of range
4
Bubbles detected in blood gas and CO-ox sample
5
Bubbles detected in blood gas sample
6
Bubbles detected in CO-ox sample
Blank
No exceptions
1
Entered value
2
Sensor has a drift D2 error
3
Interference detected
4
If blood, question data
5
>1.5% SulfHb detected
6
Above reference range
7
Above action range
8
Below reference range
9
Below action range
This section describes procedures to place the 800 system in standby and to shut
down the system.
Standby is an inactive state that disables the automatic calibration functions to
reduce reagent consumption. During Standby, the system continues to perform
purge sequences to maintain the integrity of the sensors, and it performs the Auto
Clean sequence.
Shutdown discontinues all operations in an orderly fashion. Always perform a
shutdown procedure before you disconnect the power cord to perform maintenance
or troubleshooting procedures.
Place the system in standby when sample analysis is not required for a prolonged
period of time. Using standby reduces reagent consumption by turning off
automatic calibrations. While in standby, the system performs the scheduled auto
clean and purges the sensors on a regular basis.
1. Access the Set Standby screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 1 Standby and press Enter.
2. Place the system in standby.
schedule a date and time to
exit standby
Type the date and time.
a. Type the month, date, and year in the selected
format and press Enter.
b. Type the hour and minutes in the format
HH:MM. Enter 0 – 23 hours and 0 – 59
minutes.
c. Press Done to enter standby.
place the system in standby
indefinitely
Press Done.
The Standby screen appears. If you do not type the date and time to exit
standby, the Date and Time fields do not appear.
The system remains in standby until the scheduled date and time or until you
exit standby manually.
3. Exit standby.
automatically
Do nothing. The system automatically exits
standby at the scheduled date and time.
manually
Press Exit Standby or Home.
After the system exits standby, it performs the required calibrations and returns
to the Ready screen.
If you turn off the power while the system is in standby, the system returns to
standby when you turn on the power.
If the system is scheduled to perform an automatic calibration while in standby, the
calibration starts when the system exits standby. If multiple calibrations are
pending, the system performs a two-point calibration.
Use this procedure to shut down the system before you perform service and to
restart the system when finished.
1. Access the Shutdown screen from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 3 Shutdown and press Enter.
2. Press Yes.
A message appears on the screen and on the roll printer, prompting you to wait
before you disconnect the power.
Do not unplug the system until the following message appears on
the screen:
...synching disks... done
This operating system message indicates that the system has successfully
completed the shutdown procedures. Unplugging the system before this
message appears can damage the system.
3. When you see this message, disconnect the power cord from the power supply.
Adhere to the time interval or damage can occur to the system.
4. Wait at least 10 seconds after disconnecting the power cord, then reconnect the
power cord into the power source.
After a few moments, the system starts initializing. When initializing is
complete, a screen for Analyze Mode appears.
In the event of a power failure or a power surge and the system shut down,
perform a two-point calibration when the system completes initializing.
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This appendix summarizes the established guidelines for handling laboratory
biohazards. The summary is based on the guidelines developed by the National
Institutes of Health (NIH) and the Centers for Disease Control and Prevention
(CDC) and Guideline M–29A from the National Committee for Clinical
Laboratory Standards (NCCLS): Protection of Laboratory Workers from
Instrument Biohazards and Infectious Disease Transmitted by Blood and Tissue,
Approved Guideline.7,8
Use this summary for general information only. It 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
that are biological in nature, such as the hepatitis B virus (HBV), the human
immunodeficiency virus (HIV), or the tubercle bacillus. These infectious agents
may be present in human blood and blood products or in other body fluids.
The major sources of contamination when handling potentially infectious agents
are as follows:
needlesticks
hand-to-mouth contact
hand-to-eye contact
direct contact with superficial cuts, open wounds, and other skin conditions that
may permit absorption into subcutaneous skin layers
splashes or aerosol contact with skin and eyes
To prevent accidental contamination in a clinical laboratory, strictly adhere to the
following procedures:
Wear gloves when touching the screen, which can be contaminated by contact
with body fluids from gloves or splattering.
Wear gloves while servicing parts of the instrument that have contact with body
fluid such as serum, plasma, urine, or whole blood.
Wash your hands before going from a contaminated area to a noncontaminated
area, or when you remove or change gloves.
Perform procedures carefully to minimize aerosol formation.
Wear facial protection when splatter or aerosol formation are possible.
Wear protective clothing such as lab coats or aprons when working with possible
biohazard contaminants.
Keep your hands away from your face.
Cover all superficial cuts and wounds before starting any work.
Dispose of contaminated materials according to your laboratory’s biohazard
control procedures.
Keep your work area disinfected.
Disinfect tools and other items that have been near any part of the instrument
sample path or waste area with 15% v/v bleach.
Do not eat, drink, smoke, or apply cosmetics 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 be recapped, purposely bent,
cut, broken, removed from disposable syringes, or otherwise manipulated by hand.
This appendix provides the following service and supply information:
addresses and communication numbers for obtaining service and technical
information and for ordering supplies and accessories
system warranty and service delivery policy information
a list of the system supplies that you are most likely to order
For technical assistance contact your local authorized representative.
For customer service or additional information contact your local authorized
distributor.
Bayer Argentina S.A.
División Diagnósticos
Ricardo Gutiérrez 3652
B1605EHD Munro – Buenos Aires
Argentina
54 11 4 762 7000
Bayer S.A.
Produtos Diagnósticos
Rua Domingos Jorge 1100
04779–900 – São Paulo – SP
Brazil
55 11 5694 5574
Bayer Australia Limited
Diagnostics Business Group
2 Keith Campbell Court
Scoresby
Victoria 3179 Australia
1 800 034 477
Bayer Inc.
Bayer Diagnostics
Healthcare Division
77 Belfield Road
Toronto, OntarioCanada M9W 1G6
416 248–0771
Bayer Austria GesmbH
Geschäftsbereich Diagnostika
Lerchenfelder Gürtel 9–11
A–1164 Wien,
Austria
43 – 1– 71146 – 2411
Bayer S.A.
División Diagnóstica
A.A. 80387
Av. de las Américas No 57–52
Santafé de Bogotá, D.C. – Colombia
(571) 4234199–4234352
Bayer s.a.–n.v.
Division Diagnostics
Avenue Louise 143 Louizalaan
1050 Bruxelles–Brussel,
Belgium 32 2 535 66 81
Bayer A/S
Nørgaardsvej 32
DK–2800 Lyngby,
Denmark
+ 45 45 23 50 00
Bayer OY
Suomalaistentie 7
FIN 02270 Espoo,
Finland
+ 35 89 88 78 87
Bayer Medical Ltd.
Unosawa Tokyu Building 3
F1–19–15, Ebisu
Shibuya–Ku
Tokyo 150–0013, Japan 81.3.3440.4881
Bayer Diagnostics
Tour Horizon
52, quai de Dion Bouton
92807 Puteaux Cedex, France
01 49 06 56 00
Bayer Diagnostics Korea Limited
4/F Kyemyung Building
48–7 Myungil–Dong
Kangdong–Ku
Seoul, Korea 134–07082–2–428–5980
Bayer Vital GmbH & Co. KG
Geschäftsbereich Diagnostics
Siemensstraße
3D–35463 Fernwald,
Germany
0049–(0)641–4003–0
Bayer de México, S.A. de C.V.
Division Diagnósticos
Ave. Colonia del Valle No. 615
Col. del Valle
Delegación Benito Juárez
México, D.F. C.P. 03100 525 7283301
Bayer Hellas S.A.
Akakion 54A
Marousi
Athens 151 25, Greece
01 –68 83 648
Bayer B.V.
Division Diagnostics
Energieweg 1
3641 RT Mijdrecht, The Netherlands
+31 (0)297 280 666
Bayer Diagnostics Limited
20/F Gee Chang Hong Centre
65 Wong Chuk Hang Road
Hong Kong
852–28147337
Bayer As
Brennaveien 18
N–1483 Skytta,
Norway
+ 47 67 06 86 00
Bayer Diagnostics India Limited
589, Sayajipura
Ajwa Road, Baroda – 390019
Gujarat, India
91 265 46 2720
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02–326 Warszawa,
Polska
+48(0)225723500
Bayer S.p.A.
Divisione Diagnostici
Via Grosio 10/4
20151 Milano, Italia
+39/023978.1
Bayer Portugal S.A.
Divisao PH / DS
Rua da Quinta do Pinheiro, 5
2795–653 Carnaxide, Portugal
351.21.416.50.22
Bayer Puerto Rico Inc.
Diagnostics Division
Victoria Industrial Park
Building #1
Carolina, Puerto Rico
787 752–8989
Bayer Taiwan Company Limited
Diagnostics Division
8/F No. 109 Sec. 2
Keelung Road
Taipei, Taiwan R.O.C.
886–2–23777520
Bayer (Pty) Ltd.
Healthcare Division
27 Wrench Road
Isando 1600,
South Africa
27 11 921–5048
Bayer plc
Diagnostics Division
Bayer House, Strawberry Hill
Newbury, RG14 1JA
United Kingdom
+44 (0)1635 563000
Química Farmacéutica Bayer, S.A.
División Diagnósticos
Calabria, 268
08029 Barcelona, España
+ 34 93 495.65.00
Bayer Corporation
Diagnostics Division
511 Benedict Avenue
Tarrytown, NY 10591–5097 USA
914 631–8000
Bayer AB
Drakegatan 1
S–402 24 Göteborg,
Sweden
+ 46 31 83 98 00
Bayer Corporation
Diagnostics Division
333 Coney Street
East Walpole, MA 02032–1597 USA
508 668–5000
Bayer (Schweiz) AG
Geschäftsbereich Diagnostika
Grubenstrasse 6
8045 Zuerich, Switzerland
0041/1/465 81 11
Bayer Diagnostics and its authorized distributors provide customers who acquire
new Bayer Diagnostics systems with a one-year comprehensive, but limited,
warranty. This limited warranty is designed to protect customers from the cost
associated with repairing systems that exhibit malfunctions due to defects in
materials and/or workmanship during the warranty period.
The warranty period commences upon installation at the customer’s location and
extends for a period of one year thereafter. The customer, with some exceptions,
may purchase additional service coverage beyond the one year warranty period as
part of the original system acquisition for second or subsequent years beyond the
original installation date. The customer’s original Purchase Invoice or appropriate
Agreement Addendum must indicate the term in months for additional service
coverage.
The customer may obtain warranty service for systems during normal business
hours by contacting the Bayer Diagnostics location or authorized distributor. Refer
to the list of Bayer Diagnostics locations in this section.
During the warranty period, Bayer Diagnostics or an authorized distributor will
repair the system during normal business hours, at their expense, subject to the
exclusions listed below. Bayer Diagnostics or an authorized distributor will initiate
a warranty field service call when notified. The call will be considered complete
when the system is again operating to its published specifications and the
customer, or the customer’s representative, has agreed by signing the appropriate
Field Service Report. When service is complete, the customer will receive a copy
of the Field Service Report detailing all work performed by the Bayer Diagnostics
representative.
# " ! !
Customers, with some exceptions, may also request warranty service to be
delivered outside of normal business hours, including evenings, weekend days, or
nationally observed holidays by contacting the Bayer Diagnostics location or
authorized distributor. Warranty service performed at these times is subject to a
surcharge unless the customer has purchased a service product option that provides
warranty service outside normal hours.
In performing warranty service under this agreement, Bayer Diagnostics or its
authorized distributors will provide appropriate parts to repair the system at no
charge with the exception of certain parts or subassemblies that are considered
Customer Maintenance Items. Customer Maintenance Items include, but are not
limited to, the following items: lamps, electrodes or sensors (which are covered by
a separate warranty), Bayer Diagnostics reagents and calibrators, controls, paper,
and pens. Consult the appropriate operator’s manual for a complete list of
maintenance items for any specific model of system.
# During the warranty period, Bayer Diagnostics reserves the right to change the
design or construction of specific models of systems without incurring any
obligation to make such changes available to an individual system. If
Bayer Diagnostics notifies customers of a change that improves the performance
or reliability of their system, and requests to retrofit that system, customers must
agree to allow Bayer Diagnostics or an authorized distributor, at Bayer Diagnostics
expense, to retrofit components or make design changes, which will not adversely
affect the system’s performance characteristics.
# Customers will designate a key operator who will be available to
Bayer Diagnostics representatives to describe system malfunctions by telephone
and/or to perform simple adjustments and corrections as requested. If a key
operator is not designated or is unavailable when the customer requests service, the
delivery of warranty service may be delayed.
! #
When service is required at a customer location, the customer must provide the
Bayer Diagnostics representative with adequate facilities that comply with the
regulations of the Secretary of Labor under the Occupational Safety and Health
Act (OSHA) of 1970, as amended.
Bayer Diagnostics or its authorized distributors will provide warranty service to
customers during the warranty period, which includes appropriate parts, travel to
the location of the system, and on-site labor during normal business hours. In
addition, Bayer Diagnostics or its authorized distributors will provide warranty
service during the warranty period only, and system repairs, labor, or replacement
parts, as provided during the original warranty period, will not extend the original
warranty period.
This warranty will not apply if any of the following occurs:
1. Repairs or modifications have been made to the system by other than an
authorized Bayer Diagnostics representative.
2. The system has been operated using other than Bayer Diagnostics brand
accessories, or consumable supplies and/or reagents not having the same
grade, quality, and composition as defined by Bayer Diagnostics.
3. The system has not been installed within 90 days of shipment to the
customer’s facility unless otherwise specified.
4. The customer has not performed appropriate customer maintenance
procedures, as outlined in the system operator’s manual.
5. The system has been misused or used for a purpose for which it was not
intended.
6. The system has been damaged in transit to the customer or damaged by the
customer while moving or relocating it without supervision by a
Bayer Diagnostics representative.
7. Damage was caused by floods, earthquakes, tornados, hurricanes or other
natural or man-made disasters.
8. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil
commotion.
9. Damage was caused by electrical surges or voltages exceeding the tolerances
outlined in the system operator’s manual.
10. Damage was caused by water from any source external to the system.
11. The customer has purchased an alternative agreement whose terms of warranty
supersede this agreement.
Bayer Diagnostics or its authorized distributors will invoice customers, at current
standard labor and parts rates, for systems repaired to correct damage or
malfunctions due to any of the reasons listed above.
Bayer Diagnostics warrants to all customers that service will be performed in a
professional manner consistent with the industry. If the system is not performing
according to its specifications, Bayer Diagnostics will, at its option, repair or
replace the system. This is the customer’s sole and exclusive remedy for breach of
warranty.
Other than as stated above, there are no other warranties, express or implied,
accompanying either the leasing of the equipment or its sale to the customer at the
expiration or termination of this agreement. In addition, the warranties of
merchantability and fitness for a particular purpose are disclaimed. In addition,
Bayer Diagnostics shall not be liable for any damages caused by delay in providing
repair service from any cause. Bayer Diagnostics liability for breach of this
warranty shall be limited to the repair or replacement of defective equipment and
shall not include any incidental, contingent, or consequential damages.
Use Table B-1 and Table B-2 to find the supply or accessary you need to order.
115701
Manual, Rapidlab 800 Operator’s
115713
Manual, Rapidlab 800 Quick Reference Guide, English
115716
Manual, Rapidlab 800 Quick Reference Guide, Spanish
115719
Manual, Rapidlab 800 Quick Reference Guide, French
115722
Manual, Rapidlab 800 Quick Reference Guide, Italian
115710
Manual, Rapidlab 800 Interface Specification
106363
Brochure, Specimen Collection for Critical Blood Analyte Testing
673709000
Printer Paper
473385000
Buffer 7.382 (7.3/CO-ox Zero Buffer)
473386000
Buffer 6.838
473387000
Wash G/L Zero Reagent
570096
Cal G/L Reagent
473389000
Cleaning Solution 1 and Cleaning Solution 2 (C1/C2)
478701000
Conditioner Kit (5 pack)
473643000
Deproteinizer Kit (5 pack)
105610
Deproteinizer Kit (10 pack)
476282000
Test/Blank Sensor pO2/pCO2 (TB1)
476281000
Test/Blank Sensor pH/Na+ (TB2)
673701000
Test/Blank Sensor Glucose and Lactate (TB4)
673702000
Test/Blank Sensor K+/Ca++/Cl– (TB3)
673396000
Test/Blank Sensor Ref (TB5)
477832000
Ticket Printer
478736000
Fuse Kit
477570000
Clot Removal Kit
673703000
Aspiration Adapter Kit
858040001
Power Cord, US
858071001
Power Cord, International
111399
Kit Bar Code Scanner LS4004
110889
Bar Code Scanner (LS4004)
110890
Cable, Bar Code Scanner (LS4004)
858086001
Cable, Bar Code Scanner (LS2020)
673715000
Air (Dust) Filter
673712000
Capillary Seal
013896701
Sample Door Kit (Luer)
673357000
Drip Tray Kit
673714000
Sample Probe
673704000
Sample Tubing
673705000
Pump Tubing Kit
014448701
Measurement Module Tubing Kit
014738001
Sample Connector (Sample Tee Adapter)
104794
Reagent Manifold Vent Filter Kit (2 filters per kit)
013895701
Reagent Fitting Kit (Septum Probe)
673708000
Lamp Bulb (incandescent)
014073002
9-pin Cable-Matching Connector
013899001
Loopback Connector
013902701
O-ring Kit
013903701
Blank 3.5-inch Diskette, Preformatted
673356000
Waste Bottle Kit
476267000
pH Ready Sensor
476247000
pCO2 Ready Sensor
476246000
pO2 Ready Sensor
476270000
Potassium Ready Sensor
476266000
Sodium Ready Sensor
476268000
Calcium Ready Sensor
476279000
Chloride Ready Sensor
476378000
Glucose Ready Sensor
476379000
Lactate Ready Sensor
476273000
Reference Sensor
471854000
Arterial Blood Sampler (3 mL, 17 USP units lithium heparin per mL)
473395000
850 to 860 Upgrade Kit
473396000
840 to 860 Upgrade Kit
473397000
840 to 850 Upgrade Kit
478509000
Reference Sensor Internal (internal electrode, fill solution)
478498000
Reference Sensor Refill (cassette, fill solution, O-rings)
013174001
Retainer, Sample Port
013186001
Sample Port
013199001
Front Cover
477833000
Analysis Report Ticket
477434000
Cal Calibration Gas (5% CO2, 12% O2)
477438000
Slope Calibration Gas (10% CO2)
823736001
Gas Tank Seal
478740000
Sample Ground/Temperature Sensor
013662001
Waste Nozzle (waste outlet cover)
014117701
Cable, 800 to 270 Interface
014118001
9-pin to 25-pin Cable Adapter
014374001
Alphanumeric Keyboard
"! " 473120000
CO-oximeter Slope (10 pack)
570017
CO-ox Air Filter
570051
CO-ox Pump Tubing
014801001
CO-ox Pump Tubing Connector
570019
CO-ox Sample Tubing Kit
570050
CO-ox Lamp
570018
CO-ox O-ring/Gasket Kit (for hemolyzer and sample chamber)
673700000
Clot Removal Kit (tubing diameter <0.022mm)
570049
Sample Chamber
106371
Bubble Trap Kit
015552701
CO-ox Spares Kit
570018
CO-ox O-ring/Gasket Kit
570052
Anvil Kit
014607002
Anvil Cap
014734002
Cam 1
014735002
Cam 2
823851001
Wave Spring (fits behind assembled Cam 1 and 2)
This appendix lists all references for this manual.
1.
National Committee for Clinical Laboratory Standards. Blood Gas Pre–Analytical
Considerations: Specimen Collection, Calibration and Controls, Approved Guideline;
NCCLS Document C–27A (Vol. 13, No. 6); April 1993.
2.
Douglas IHS, McKenzie PJ, Leadingham I, Smith G. Effect of halothane h. on pO2
electrode. Lancet 1978; (Dec. 23 and 30).
3.
National Committee for Clinical Laboratory Standards. Clinical Laboratory Waste
Management; Approved Guideline; NCCLS Document GP5–A; (Vol. 13, No. 22);
Dec 1993.
4.
U.S. Dept. of Health and Human Services. Health Care Financing Administration
Public Health Service. 42 CFR Part 405, Subpart K, et al, Federal Register: Clinical
Improvement Amendments of 1988; Final Rule. Washington, D.C.: GPO, 1992.
5.
National Committee for Clinical Laboratory Standards. Statistical Quality Control for
Quantitative Measurements: Principles and Definitions, Approved Guideline – Second
Edition; NCCLS Document C24–A; (Vol. 19, No. 5); Feb 1999.
6.
Selby, Samuel M., editor. CRC standard mathematical tables. Cleveland (OH): The
Chemical Rubber Co., 1971.
7.
National Committee for Clinical Laboratory Standards. Protection of Laboratory
Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood,
Body Fluids and Tissue; Approved Guideline; NCCLS Document M29–A;
(Vol 17, No. 20); Dec 1997.
8.
National Committee for Clinical Laboratory Standards. Protection of Laboratory
Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood,
Body Fluids and Tissue; Approved Guideline; NCCLS Document M29–A;
(Vol 17, No. 20); Dec 1997.
9.
Kirchhoff JR, Wheeler JF, Lunte CE, Heineman WR. Electrochemistry: principles and
measurements. In: Kaplan LA, Pesce AJ., editors. Clinical Chemistry: theory, analysis,
and correlation. 2nd ed. St. Louis: CV Mosby, 1989. 213–227.
10. Siggaard-Andersen O. Electrochemistry. In: Tietz NW, editor. Fundamentals of
clinical chemistry. 3rd ed. Philadelphia: WB Saunders, 1987. 87–101.
11. Siggaard-Anderson O, Durst RA, Maas AHJ. Physicochemical quantities and units in
clinical chemistry with special emphasis on activities and activity coefficients. Pure
Appl Chem 1984; 56: 567–594.
12. National Committee for Clinical Laboratory Standards. Standardization of Sodium and
Potassium Ion–Selective Electrode Systems to the Flame Photometric Reference
Method; Approved Standard; NCCLS Document C29–A; (Vol. 15, No. 1);
Mar 1995.
13. Sorensen, SPL. Enzymstudien. ii, uber die messung and die bedeutung der
wasserstoffionenkonzentration bei enzymatischen prozessen. Biochem Z 1909;
12:131.
14. Moran R, Cormier A. The blood gases: pH, pO2, pCO2. Clin Chem News 1988;
14(4/5): 10–12.
15. Severinghaus JW, Bradley AF. Electrodes for blood pO2 and pCO2 determination.
J Appl Physiol 1968; 13:515–520.
16. Shapiro BA, Harrison RA, Cane RD, Templin R. Clinical application of blood gases.
4th ed. Chicago: Year Book Medical Publishers, 1989. 270–272.
17. Clark LC Jr. Monitor and control of blood and tissue oxygen tensions. Trans Am Soc
Artif Intern Organs 1956; 2:41–56.
18. Pagana KD, Pagana TJ. Diagnostic testing and nursing implications. 3rd ed. St. Louis:
CV Mosby, 1990. 448–449.
19. Mundy GR. Calcium homeostasis – the new horizons. In: Moran RF, editor. Ionized
calcium: its determination and clinical usefulness. Proceedings of an international
symposium. Galveston (TX): The Electrolyte Blood Gas Division of the American
Association for Clinical Chemistry, 1986: 1–4.
20. Ladenson JH. Clinical utility of ionized calcium. In: Moran RF, editor. Ionized
calcium: its determination and clinical usefulness. Proceedings of an international
symposium. Galveston (TX): The Electrolyte Blood Gas Division of the American
Association for Clinical Chemistry, 1986: 5–11.
21. Ravel R. Clinical Laboratory Medicine. 3rd ed. Chicago: Year Book Medical
Publishers, 1978; 273–281.
22. National Committee for Clinical Laboratory Standards. Definitions of Quantities and
Conventions Related to Blood pH and Gas Analysis; Approved Standard; NCCLS
Document C12–A; (Vol. 14, No. 11); Sept 1994.
23. VanSlyke DD, Cullen GE. Studies of acidosis 1. The bicarbonate concentration of
blood plasma, its significance and its determination as a measure of acidosis. J Biol
Chem 1917; 30:289–346.
24. Kelman GR. Digital computer subroutine for the conversion of oxygen tension into
saturation. J Appl Physiol 1966; 21:1375–1376.
25. Thomas LJ. Algorithms for selected blood acid-base and blood gas calculations.
J Appl Physiol 1972; 33:154–158.
26. National Committee for Clinical Laboratory Standards. Fractional Oxyhemoglobin,
Oxygen Content and Saturation, and Related Quantities in Blood: Terminology,
Measurement, and Reporting; Approved Guideline; NCCLS Document C25–A;
(Vol. 17, No. 3); Jan 1997.
27. Miale JB. Laboratory medicine hematology. 6th edition. St. Louis: CV Mosby;
1982. 608.
28. Martin L. Abbreviating the alveolar gas equation: an argument for simplicity. Respir
Care 1985; 30(11):964–967.
29. Aberman A, Cavanilles JM, Trotter J, Erbeck D, Weil MH,Shubin H. J Appl Physiol
1935; 4: 570–571.
30. Peris LV, Boix JH, Salom JV, Valentin V, et al. Clinical use of the arterial/alveolar
oxygen tension ratio. Crit Care Med 1983; 11(11):888–891.
31. Burritt MF, Cormier AD, Maas AHJ, Moran RF, O’Connell KM. Methodology and
clinical applications of ion-selective electrodes. Proceedings of an international
symposium. Danvers (MA): The Electrolyte/Blood Gas Division of the American
Association of Clinical Chemistry, 1987.
32. Aberman A, Cavanille JM, Trotter J, Erbeck D, Weil MH, Shubin H. An equation for
the oxygen hemoglobin dissociation curve. J Appl Physiol 1973; 35(4):570–571.
33. National Committee for Clinical Laboratory Standards. Definitions of Quantities and
Conventions Related to Blood pH and Gas Analysis; Approved Standard; NCCLS
Document C12–A; (Vol. 14, No. 11); Sept 1994.
34. Moran RF, Fallon KD. Oxygen saturation, content, and the dyshemoglobins: part I.
Clin Chem News, 16:1, 11, 1990.
35. VanAssendelft OW. Spectrophotometry of hemoglobin derivatives. The Netherlands:
Thomas, 1970:47–65.
36. VanAssendelft OW, Zijlstra WG. Extinction coefficients for use in equations for the
spectrophotometric analysis of hemoglobin mixtures. Anal Biochem 1975;69:43–48.
37. Benesch RE, Benesch R, Yung S. Equations for the spectrophotometric analysis of
hemoglobin mixtures. Anal Biochem 1973; 55:245–248.
38. Miale JB. Laboratory medicine hematology. 6th ed. St. Louis: CV Mosby,
1982:388–392.
39. National Committee for Clinical Laboratory Standards. Fractional Oxyhemoglobin,
Oxygen Content and Saturation, and Related Quantities in Blood: Terminology,
Measurement, and Reporting; Approved Guideline; NCCLS Document C25–A;
(Vol. 17, No. 3); Jan 1997.
40. Miale JB. Laboratory medicine hematology. 6th ed. St. Louis: CV Mosby,
1982:456–464.
41. Cooper HA, Hoagland JC. Fetal hemoglobin. Mayo Clin Proc 1972; 47(6):402–414.
42. National Committee for Clinical Laboratory Standards. Clinical Laboratory Waste
Management; Approved Guideline; NCCLS Document GP5–A; (Vol. 13, No. 22);
Dec 1993.
43. Spurzem JR, Bonekat Hw, Shigeoka JW. Factitious methemoglobinemia caused by
hyperlipemia. Chest 1984; 86(7): 84–86.
44. Young DS, Pestaner LC, Gibberman V. Effects of drugs on clinical laboratory tests.
Clin Chem 1975; 21(5): 315D–329D.
45. National Committee for Clinical Laboratory Standards. Preparation and testing of
reagent water in the clinical laboratory; Approved Guideline; NCCLS Document
C3–A3; (Vol. 17, No. 18); Oct 1997.
46. National Committee for Clinical Laboratory Standards. Fractional Oxyhemoglobin,
Oxygen Content and Saturation, and Related Quantities in Blood: Terminology,
Measurement, and Reporting; Approved Guideline; NCCLS Document C25–A;
(Vol. 17, No. 3); Jan 1997.
47. Malley W. Clinical blood gases: application and noninvasive alternatives.
Philadelphia: WB Saunders, 1990; 95.
48. Shapiro BA, Harrison RA, Cane RD, Kozlowski–Templin R. Clinical application of
blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989: 143.
49. Shapiro BA, Harrison RA, Cane RD, Kozlowski–Templin R. Clinical application of
blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989: 140.
50. Malley W. Clinical blood gases: application and noninvasive alternatives.
Philadelphia: WB Saunders, 1990; 97–98.
51. Shapiro BA, Harrison RA, Cane RD, Kozlowski–Templin R. Clinical application of
blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989: 144.
52. Shapiro BA, Harrison RA, Cane RD, Kozlowski–Templin R. Clinical application of
blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989: 159.
This section provides information about making the connection between an 800
series system and the following external devices:
270 CO-oximeter
800 series compatible ticket printer
bar code scanner
Bayer Diagnostics data management system
line printer
laboratory information system (LIS)
hospital information system (HIS)
Figure D-1 identifies the various ports available on the 800 system.
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
Use this procedure to connect an 800 system to a 270 CO-oximeter.
Materials Required:
800 to 270 interface cable (part number 014117701)
To prevent electrical shock and damage to either system, disconnect
the 800 system and 270 CO-oximeter from the AC power source before installing
the cable. Refer to Shutting Down and Restarting the System in Section 5 for the
procedure to disconnect the 800 system.
1. Disconnect the 800 system from the AC power source.
2. Disconnect the 270 CO-oximeter from the AC power source.
3. Connect the 9-pin connecter of the interface cable to serial port 2 or 3 on the
800 system. Refer to Figure D-1.
4. Connect the 25-pin connector to port 1, 2, or 3 on the 270.
5. Tighten the hold down screws on the connectors.
6. Restore power to the 800 system and to the 270.
7. Refer to Configuring for External Devices in Section 5 to configure the 800
system for the 270.
8. Refer to Configuring a 270 CO-oximeter in Section 6 of the
270 CO-oximeter Operator’s Manual to configure the 270 for the 800 system.
9. Define the setup at the 270 CO-oximeter:
a. At the Main Menu, press the right arrow key two times, and press SETUP.
b. Press the right arrow key two times, and press INTERFACES.
c. Press PORT NO.
The port numbers 1, 2 and 3 correspond to the port labels on the 270 rear
panel.
d. Enter the number of the serial port to which the interface cable is
connected, and press ENTER.
e. Press the right arrow key twice, and select LIS3.
f. Press ENTER to confirm your selection.
g. Select the transmission specifications as shown in Table D-1.
baud rate
9600
parity
even
stop bit
1
data bits
8
modem control
no
h. Press ENTER to confirm the selections.
The display shows the port number and the device connected to the port.
i. Press CONTINUE to return to the Select INTERFACES setup option
prompt. The printer prints the port number and the device type connected to
the port.
10. Refer to Defining the Auto Send Option in Section 6 of the
270 CO-oximeter Operator’s Manual to specify whether the 270 automatically
sends results as soon as they are available or whether the operator can select
the results to transmit.
Use this procedure to connect an 800 system to the 800 series compatible ticket
printer.
Materials Required:
ticket printer (part number 477832)
800 system to ticket printer interface cable (part number 014116701)
To prevent electrical shock and damage to either system, disconnect
the 800 system and the printer from the AC power source before installing the
cable. Refer to Shutting Down and Restarting the System in Section 5 for the
procedure to disconnect the 800 system.
1. Disconnect the 800 system from the AC power source.
2. Disconnect the printer from the AC power source.
NOTE: Always use serial port 1 for the ticket printer.
3. Connect the 9-pin connector of the interface cable to serial port 1 on the 800
system. Refer to Figure D-1.
4. Connect the 25-pin connector to the printer.
5. Tighten the hold down screws on the connectors.
6. Restore power to the 800 system and to the printer.
7. Refer to Configuring for External Devices in Section 5 to configure the 800
system for the printer and to Selecting Printing Options in Section 5 to select
the ticket printer as the printer used to print reports.
Use this procedure to connect an 800 system to the 800 bar code scanner.
Materials Required:
bar code scanner
800 system to bar code scanner cable
To prevent electrical shock and damage to either system, disconnect
the 800 system from the AC power source before installing the bar code scanner.
Refer to Shutting Down and Restarting the System in Section 5 for the procedure to
disconnect the 800 system.
1. Disconnect the 800 system from the AC power source.
2. Connect the 9-pin connector of the bar code scanner to the bar code scanner
port on the 800 system. Refer to Figure D-1.
3. Tighten the hold down screws on the connectors.
4. Restore power to the 800 system.
5. Refer to Configuring for External Devices in Section 5 to configure the 800
system for the bar code scanner.
Use this procedure to connect the 800 system to a Bayer Diagnostics data
management system.
Materials Required:
data management to 800 system to interface cable (supplied with the data
management system)
To prevent electrical shock and damage to either system, disconnect
the 800 system and the data management system from the AC power source before
installing the cable. Refer to Shutting Down and Restarting the System in Section 5
for the procedure to disconnect the 800 system.
1. Disconnect the 800 system from the AC power source.
2. Disconnect the computer for the data management system from the AC power
source.
3. Connect the interface cable to serial port 2 or 3 on the 800 system and to the
Bayer Diagnostics data management system. Refer to Figure D-1.
4. Tighten the hold down screws on the connectors.
5. Restore power to the 800 system and the computer for the data management
system.
6. Refer to Configuring for External Devices in Section 5 to configure the 800
system for the data management system.
Use this procedure to connect an 800 system to a line printer.
Materials Required:
printer to 800 system interface cable for a parallel port (supplied with printer)
To prevent electrical shock and damage to either instrument,
disconnect the 800 system and the printer from the AC power source before
installing the cable. Refer to Shutting Down and Restarting the System in Section 5
for the procedure to disconnect the 800 system.
1. Disconnect the 800 system from the AC power source.
2. Disconnect the printer from the AC power source.
3. Connect the interface cable to the line printer and to the parallel port on the
800 system. Refer to Figure D-1.
4. Restore power to the 800 system and to the line printer.
5. Refer to Configuring for External Devices in Section 5 to configure the 800
system for the line printer.
Use this procedure to connect an 800 system to a laboratory information system
(LIS) or hospital information system (HIS).
Materials Required:
LIS or HIS to 800 system interface cable and 9-pin, cable-matching connector
(supplied with the LIS or HIS)
if you are converting from a 200 series system, 9-pin to 25-pin cable adapter
(part number 014118001)
To prevent electrical shock and damage to either system, disconnect
the 800 system and Data Management system from the AC power source before
installing the cable. Refer to Shutting Down and Restarting the System in Section 5
for the procedure to disconnect the 800 system.
1. Contact your LIS or HIS system manager to determine the appropriate
interface cable.
2. Disconnect the 800 system from the AC power source.
3. Connect the interface cable to serial port 2 or 3 on the 800 system and to the
LIS or HIS. Refer to Figure D-1.
4. Tighten the hold down screws on the connectors.
5. Restore power to the 800 system.
6. Refer to Configuring for External Devices in Section 5 to configure the 800
system for the LIS or HIS.
7. Refer to the 800 Series Interface Specification Manual to configure the LIS or
HIS for the 800 system.
This appendix provides the following information about the 800 series systems:
system specifications
limitations
reference methods
840 system performance characteristics
850 system performance characteristics
860 system performance characteristics
CO-ox module performance characteristics
Table E-1 lists the specifications for the 800 system.
ambient operating
temperature
15 – 32°C
ambient operating
relative humidity
5 – 85%, non-condensing
power rating
400VA
voltage requirements
100V/120V (85V to 132V)
50/60Hz
220V/240V (170V to 264V)
50/60Hz
ambient operating
barometric pressure
400 – 825 mmHg (53.0 – 110.0 kPa)
system dimensions,
base model
height 50.8 cm (20 inches)
width 55.9 cm (22 inches)
depth 48.3 cm (19 inches)
weight 29.5 kg (65 lbs)
system dimensions,
CO-ox module
height 30.3 cm (11.94 inches)
when installed 47.8 cm (18.81 inches)
width 17.35 cm (6.83 inches)
when installed 70.3 cm (27.66 inches)
depth 50.3 cm (19.81 inches)
weight 7.9 kg (17.5 lbs)
when installed 36.5 kg (82 lbs)
Table E-2 lists the units, reporting ranges, and display resolutions for the pH and
blood gas parameters measured by the 800 system.
$"# pH
pH
H+
nmol/L
pCO2
mmHg
0.001
0.01
10.0 – 1000.0
0.1
1
5.0 – 250.0
0.1
1
0.67 – 33.33
0.01
0.1
0 – 800
0.1
1
kPa
0.0 – 106.67
0.01
0.1
mmHg
400 – 825
1
1
kPa
53.3 – 110.0
0.1
0.1
kPa
pO2
pAtm
mmHg
6.000 – 8.000
Table E-3 lists the units, reporting ranges, and display resolutions for the electrolyte
parameters measured or calculated by the 850 and 860 systems.
$"#! Na+
mmol/L
70.0 – 200.0
0.1
K+
mmol/L
0.50 – 9.99
0.01
mmol/L
10.0 – 20.0
0.1
mmol/L
0.25 – 5.00
0.01
mg/dL
1.0 – 20.0
0.1
Ca++
Ca++(7.4)
mmol/L
0.10 – 5.70
0.01
mg/dL
0.4 – 22.8
0.1
Cl–
mmol/L
40 – 160
1
Glucose
mg/dL
10 – 999
1
mmol/L
0.6 – 55.4
0.1
Lactate
AnGap
mg/dL
0.0 – 270.3
0.1
mmol/L
0.00 – 30.00
0.01
mmol/L
–5.0 – 50.0
0.1
Table E-4 lists the units, reporting ranges, and display resolutions for the
oxygenation parameters calculated by the 800 system or calculated from a sample
analyzed on the 800 system and a connected CO-oximeter.
p50
mmHg
15.0 – 75.0
0.1
kPa
2.00 –10.00
0.01
ctO2
0 – 40.0
0.1
mL/L
0 – 400
1
0 – 17.8
0.1
mL/dL
0 – 40.0
0.1
mL/L
0 – 400
1
0 – 17.8
0.1
mL/dL
0 – 40.0
0.1
mL/L
0 – 400
1
0 – 17.8
0.1
%
0.0 – 100.0
0.1
decimal
fraction
0.0 – 1.000
0.001
mmol/L
ctO2(v)
mmol/L
O2SAT(est)
O2CT(est)
mL/dL
mmol/L
ctO2(a)
mL/dL
0 – 40.0
0.1
mL/L
0 – 400
1
0 – 17.8
0.1
mmol/L
ctO2(a-v)
mL/dL
0.0 – 20.0
mL/L
0 – 200
mmol/L
ctO2([a-v]/a))
VO2
0.0 – 9.0
%
0 – 100
decimal
fraction
0.00 – 1.00
mL/min
0 – 3500
L/min
DO2
0.00 – 3.50
0.1
1
0.1
1
0.01
1
0.01
mmol/mi
n
0 – 156.2
0.1
mL/min
0 – 3500
1
L/min
0.00 – 3.50
mmol/mi
n
0 – 156.2
0.01
0.1
Table E-5 lists the units, reporting ranges, and display resolutions for parameters
measured by the 800 system CO-ox module.
tHb
g/dL
2.0 – 27.0
0.1
g/L
20 – 270
1
mmol/L
1.2 – 16.8
0.1
FO2Hb
sO2
FCOHb
fraction
–0.999– 9.999
0.001
%
–99.9 – 999.9
0.1
fraction
–0.999– 9.999
0.001
%
–99.9 – 999.9
0.1
fraction
–0.999– 9.999
0.001
FMetHb
FHHb
BO2 (O2CAP)
p50
ctO2(Hb)
%
–99.9 – 999.9
0.1
fraction
–0.999– 9.999
0.001
%
–99.9 – 999.9
0.1
fraction
–0.999– 9.999
0.001
%
–99.9 – 999.9
0.1
mL/dL
0.0 – 40.0
mL/L
0 – 400
0.1
1
mmol/L
0.0 – 17.8
0.1
mmHg
15.0 – 75.0
0.1
kPa
2.00 – 10.00
0.01
mL/dL
0 – 40.0
0.1
mL/L
0 – 400
1
mmol/L
0 – 17.8
0.1
Table E-6 lists the units, reporting ranges, and display resolutions for the
temperature corrected and respiratory parameters calculated by the 800 system.
pH(T)
pH
H+(T)
nmol/L
10.0 – 316.3
0.1
pCO2(T)
mmHg
5.0 – 250.0
0.1
0.67 – 33.33
0.01
mmHg
0 – 800
0.1
kPa
0 – 106.67
0.01
kPa
pO2(T)
6.000 – 8.000
0.001
pO2(A–a)(T)
mmHg
0 – 800.0
0.1
kPa
0 – 106.67
0.01
%
0 – 100
1
pO2(a/A)(T)
decimal
fraction
RI(T)
0.00 – 1.00
%
0 – 2000
decimal
fraction
Qsp/Qt(T)
0.00 – 20.00
%
0 – 100
decimal
fraction
Qsp/Qt(est, T)
0.00 – 1.00
%
0 – 100
decimal
fraction
0.00 – 1.00
0.01
1
0.01
1
0.01
1
0.01
Table E-7 lists the units, reporting ranges, and display resolutions for the metabolic
parameters calculated by the 800 system.
HCO3–act
mmol/L
0 – 99.9
0.1
HCO3–std
mmol/L
0 – 99.9
0.1
ctCO2
mmol/L
0 – 99.9
0.1
BE(B)
mmol/L
±29.9
0.1
BE(ecf)
mmol/L
±29.9
0.1
Table E-8 lists the units, reporting ranges, and display resolutions for the
parameters that can be entered into the 800 system.
Temperature
C
10.0 – 43.9
0.1
F
50.0 – 111.0*
0.1
%
15.0 – 100.0
0.1
FI O 2
decimal
fraction
ctHb
0.150 – 1.000
0.001
g/dL
2.0 – 27.0
0.1
g/L
20 – 270
1
mmol/L
1.3 – 16.8
0.1
1.35 – 1.40
0.01
OBF
Flow
L/min
0.00 – 99.99
0.01
Resp Rate
b/min
0.0 – 100.0
0.1
p50
mmHg
15.0 – 75.0
0.1
kPa
2.00 – 10.00
0.01
L/min
0.00 – 30.0
0.01
Qt
* The 800 system converts Fahrenheit values to centigrade values.
The following reference methods were used for the 800 systems.
pH
IFCC reference method,* also referenced by NCCLS document C–27A.1
pCO2 and
pO2
Tonometered whole blood as described in NCCLS document C21–A.
Gases used are traceable to NIST Certified Reference Material SRM
series 1701.
Na+ and
K+
Method described in NCCLS document C2912, which serves as the basis
for the NIST Certified Reference Material SRM 956 using flame
photometry.
Cl–
Coulometric reference method. This method, which is embodied in the
Bayer Diagnostics 925, is also used to assign values to NIST Certified
Reference Material SRM 956.
Ca++
Internal method used.
Glucose
The hexokinase/glucose-6-phosphate dehydrogenase method described
in NCCLS document RS1–A.
Lactate
LD Manual Assay
tHb
Cyanmethemoglobin Reference Method per National Committee for
Clinical Laboratory Standards (NCCLS), approved reference procedure
using Cary 4 Spectrophotometer.
FO2Hb
Tonometry, where whole blood samples are tonometered with
95% O2, 5% CO2.
FHHb
Tonometry, where whole blood samples are tonometered with
95% N2, and 5% CO2.
FCOHb
Gas Chromatography for COHb ≤ 15% and Ishizawa# method using a
Cary 4 Spectrophotometer for COHb ≤ 15%
FMetHb
Modified Evelyn–Malloy37 method utilizing a Cary 4 Spectrophotometer.
* International Federation of Clinical Chemistry. Reference method (1986) for pH measurement in blood.
IFCC 1987/3.
National Committee for Clinical Laboratory Standards. Performance characteristics for devices measuring
PO2 and PCO2 in blood samples; Approved Standard; NCCLS Document C21–A; (Vol 12, No. 3);
March 1992.
National Committee for Clinical Laboratory Standards. Glucose; Approved Summary of Methods and
Materials; NRSCL Document RS1–A; 1998.
Vreman, H.J., Kwong, L.K., and Stevenson, D.K., Carbon Monoxide in Blood: an Improved Microliter
Blood-Sample Collection System, with Rapid Analysis by Gas Chromatography, Clin. Chem.30, (1382 1386) 1984.
National Committee for Clinical Laboratory Standards. Reference and Selected Procedures for the
Quantitative Determination of Hemoglobin in Blood – Second Edition; Approved Standard;
NCCLS Document H15–A; (Vol 14, No. 6); May 1994.
# Ishizawa F. A Study on the Spectrophotometric Determination of Carboxyhemoglobin in Blood —
Isobestic Point Method. Jpn J Legal Med 1981, 35(3), 191–200.
Bayer Diagnostics cannot guarantee system performance when any of the following
situations occur. Specific terms of warranty, service, and contract agreements may
be invalidated if any of these situations occur.
Reagents other than those recommended are used.
Expiration dates of reagents have been exceeded.
Reagents are not used according to Bayer Diagnostics recommendations.
Standard laboratory practices are not followed.
The procedures described in this manual are not followed.
Environmental operating conditions and location recommendations are not
followed.
" All performance data presented in this section were generated using
840 systems. The system used default correlation factors, and performed
calibrations using the default settings recommended by Bayer Diagnostics for
optimum performance. All reported values were corrected to 760 mmHg. The
operating environment during the collection of this data was normal room
temperature (about 23C).
You should determine your own performance characteristics in your laboratory
with your 840 system.
Quality control (QC) materials and calibration verification materials (CVM) were
analyzed on the 840 systems. The results are presented here.
Precision on aqueous quality control materials was estimated using three 840
systems. At least seven runs per instrument were made over five days. Two
replicates of each control level were analyzed in each run.
Table E-9 summarizes the results of the 840 system precision on QC materials.
%#$ 7.165
0.001
0.002
48
7.426
0.001
0.002
3
46
7.623
0.001
0.002
1
48
71.7
0.50
1.27
2
48
44.1
0.12
0.63
3
46
22.4
0.12
0.56
1
48
57.6
1.20
1.67
2
48
100.7
0.75
1.77
3
46
149.1
1.11
2.31
!
pH6.5
1
48
2
pCO2
pO2
* WRSD = within-run standard deviation
TotSD = total standard deviation
Precision on aqueous calibration verification materials was estimated using three
840 systems. At least seven runs per instrument were made over five days. Two
replicates of each control level were analyzed in each run.
Table E-10 summarizes the results of the 840 system precision for CVM levels 1
and 4.
*() ! !#"!
"
6.804
0.001
0.002
50
7.804
0.001
0.002
1
50
103.9
0.67
1.73
4
50
12.8
0.21
0.52
1
50
24.3
0.72
1.81
4
50
249.9
2.06
5.11
"
$
pH
1
50
4
pCO2
pO2
* WRSD = within-run standard deviation
TotSD = total standard deviation
$ ' ! %" & !!
For testing syringe, capillary, microsyringe, and microcapillary modes, blood was
collected in heparinized vacuum tubes. It was tonometered at 37.0C to each of
three levels to prepare samples for pH analysis and five levels to prepare samples
for pCO2 and pO2 analysis. Multiple runs were made using these samples on three
840 systems. The experimental protocol called for three replicates of each level in
each run.
For testing the expired gas mode, 10 mL of tonometry gas were drawn into a
12 mL syringe and aspirated into the 840 system for analysis. Multiple runs were
made using five levels of expired gas on four 840 instruments. The experimental
protocol called for three replicates of each level in each run.
Table E-11 through Table E-13 summarize the results of the 840 system whole
blood and expired gas recovery precision testing.
%#$ " &
!
"
1
Syringe
15
0.002
7.251
7.251
100.0
Capillary
12
0.003
7.255
7.258
100.0
Microcapillary
17
0.006
7.261
7.256
100.1
Microsyringe
18
0.003
7.248
7.238
100.1
pH Only
15
0.004
7.235
7.235
100.0
Syringe
12
0.003
7.427
7.420
100.1
Capillary
14
0.003
7.429
7.423
100.1
Microcapillary
12
0.004
7.380
7.374
100.1
Microsyringe
15
0.002
7.400
7.397
100.0
pH Only
12
0.007
7.411
7.410
100.0
Syringe
15
0.002
7.663
7.654
100.1
Capillary
12
0.002
7.656
7.650
100.1
Microcapillary
18
0.007
7.664
7.664
100.0
Microsyringe
18
0.003
7.651
7.645
100.1
pH Only
15
0.004
7.636
7.635
100.0
2
3
* WRSD = within-run standard deviation
&$% !# '
!
!
" 1
Syringe
24
0.08
14.0
14.3
98.0
Capillary
18
0.32
13.6
14.3
95.1
Microcapillary
24
0.34
14.0
14.3
97.6
Microsyringe
24
0.13
14.3
14.3
99.9
Expired Gas
24
0.10
14.5
14.3
101.4
Syringe
24
0.14
21.6
21.4
100.8
Capillary
18
0.17
21.4
21.4
100.0
Microcapillary
24
0.45
21.4
21.4
100.2
Microsyringe
24
0.15
21.6
21.4
101.2
Expired Gas
24
0.14
21.6
21.4
100.7
Syringe
24
0.22
35.8
35.7
100.4
Capillary
18
0.53
35.3
35.7
98.8
Microcapillary
23
0.77
36.2
35.7
101.3
Microsyringe
24
0.30
35.7
35.7
99.9
Expired Gas
24
0.25
35.5
35.7
99.4
Syringe
24
0.28
50.1
49.9
100.3
Capillary
18
0.40
51.3
49.9
102.8
Microcapillary
24
1.28
51.5
49.9
103.2
Microsyringe
24
0.21
50.3
49.9
100.8
Expired Gas
24
0.37
49.4
49.9
99.0
Syringe
24
0.26
71.5
71.3
100.3
2
3
4
5
!#
!
!
" !#
Capillary
18
0.68
71.7
71.3
100.6
Microcapillary
24
2.24
71.0
71.3
99.5
Microsyringe
24
0.33
71.4
71.3
100.1
Expired Gas
24
0.17
71.1
71.3
99.7
* WRSD = within-run standard deviation
&$% !# '
!
1
Syringe
24
Capillary
2
3
!
" !#
0.21
28.2
28.5
99.1
18
0.40
28.3
28.5
99.3
Microcapillary
24
1.15
29.0
28.5
101.7
Microsyringe
24
0.17
28.6
28.5
100.3
Expired Gas
24
0.15
28.2
28.5
98.8
Syringe
24
0.19
50.0
49.9
100.3
Capillary
18
0.23
50.5
49.9
101.2
Microcapillary
24
0.71
49.0
49.9
98.3
Microsyringe
24
0.15
49.7
49.9
99.6
Expired Gas
24
0.14
49.7
49.9
99.7
Syringe
24
0.66
86.6
85.6
101.2
Capillary
18
0.36
84.8
85.6
99.1
Microcapillary
23
1.11
86.2
85.6
100.7
Microsyringe
24
1.08
85.8
85.6
100.3
Expired Gas
24
0.15
85.5
85.6
99.9
4
Syringe
24
Capillary
5
0.97
150.5
149.7
100.5
18
0.86
150.2
149.7
100.3
Microcapillary
24
2.00
151.8
149.7
101.4
Microsyringe
24
0.80
150.6
149.7
100.6
Expired Gas
24
0.25
150.4
149.7
100.5
Syringe
24
1.20
377.9
377.9
100.0
Capillary
18
2.40
379.0
377.9
100.3
Microcapillary
24
4.08
380.7
377.9
100.7
Microsyringe
24
3.22
378.9
377.9
100.3
Expired Gas
24
0.66
378.7
377.9
100.2
* WRSD = within-run standard deviation
# All performance data presented in this section was generated using 850 systems.
The system used default correlation factors, and performed calibrations using the
default settings recommended by Bayer Diagnostics for optimum performance. All
reported values were corrected to 760 mmHg. The operating environment during
the collection of this data was normal room temperature (about 23C).
You should determine your own performance characteristics in your laboratory
with your 850 system.
Quality control materials and calibration verification materials were analyzed on
the 850 systems. The results are presented here.
Precision on aqueous quality control materials was estimated using four 850
systems. At least seven runs per instrument were made over ten days. Two
replicates of each control level were analyzed in each run.
Table E-14 summarizes the results of the 850 system precision on QC materials.
&$% ! 7.169
0.002
0.002
71
7.428
0.001
0.003
3
72
7.623
0.001
0.002
1
72
71.5
0.43
1.01
2
71
44.1
0.21
0.58
3
72
22.6
0.13
0.38
1
72
58.3
2.64
3.25
2
71
98.2
1.93
3.32
3
72
142.2
1.90
2.92
1
72
113.1
0.20
0.81
"
pH
1
72
2
pCO2
pO2
Na+
K+
Cl–
Ca++
133.0
0.21
0.86
72
154.5
0.36
1.58
1
72
2.42
0.007
0.023
2
71
4.96
0.017
0.036
3
72
7.71
0.022
0.087
1
72
79.2
0.35
0.57
2
71
101.7
0.27
0.53
3
72
121.6
0.29
0.92
1
72
1.54
0.006
0.012
2
71
1.12
0.005
0.011
3
72
0.62
0.004
0.009
2
71
3
* WRSD = within-run standard deviation
TotSD = total standard deviation
Precision on aqueous calibration verification materials was estimated using four
850 systems. As many as seven runs per instrument were made over seven days.
Two replicates of each control level were analyzed in each run.
Table E-15 summarizes the results of the 850 system precision for CVM levels 1
and 4.
"! 6.806
0.001
0.004
44
7.805
0.002
0.004
1
44
103.5
0.93
1.49
4
44
13.4
0.13
0.28
pH
1
44
4
pCO2
25.8
1.39
1.97
44
237.7
2.99
5.78
1
44
102.4
0.34
1.31
4
44
167.2
0.48
1.43
1
44
2.04
0.059
0.073
4
44
16.87
0.170
0.235
1
44
132.1
0.95
1.22
4
44
75.9
0.47
0.52
1
44
2.82
0.035
0.056
4
44
0.55
0.009
0.017
pO2
1
44
4
Na+
K+
Cl–
Ca++
* WRSD = within-run standard deviation
TotSD = total standard deviation
For testing syringe, capillary, microsyringe, and microcapillary modes, blood was
collected in heparinized vacuum tubes. It was tonometered at 37.0C to each of
three levels to prepare samples for pH analysis, and five levels to prepare samples
for pCO2 and pO2 analysis. Blood was spiked/diluted to each of three levels to
prepare samples for sodium, potassium, calcium, and chloride analysis. Multiple
runs were made using these samples on four 850 systems. The experimental
protocol called for three replicates of each level in each run.
For testing the expired gas mode, 10 mL of tonometry gas were drawn into a
12 mL syringe and aspirated into the 850 system for analysis. Multiple runs were
made using five levels of expired gas on four 850 instruments. The experimental
protocol called for three replicates of each level in each run.
Table E-16 through Table E-22 summarize the results of the 850 system whole
blood, expired gas, and electrolyte recovery and precision testing.
&$% !# '
!
!
" 1
Syringe
24
0.002
7.194
7.193
100.0
Capillary
24
0.003
7.194
7.194
100.0
Microcapillary
24
0.003
7.170
7.175
99.9
Microsyringe
24
0.002
7.229
7.225
100.1
pH/Lytes
18
0.003
7.220
7.218
100.0
Syringe
24
0.001
7.399
7.405
99.9
Capillary
24
0.002
7.397
7.393
100.1
Microcapillary
24
0.003
7.402
7.396
100.1
Microsyringe
24
0.002
7.383
7.397
99.8
pH/Lytes
18
0.004
7.357
7.356
100.0
Syringe
24
0.004
7.493
7.493
100.0
Capillary
24
0.003
7.502
7.505
100.0
Microcapillary
24
0.006
7.449
7.459
99.9
Microsyringe
24
0.003
7.557
7.560
100.0
pH/Lytes
18
0.005
7.673
7.676
100.0
2
3
!#
* WRSD = within-run standard deviation
'%& "$ !(
"
"
#!
1
Syringe
24
0.28
14.0
14.3
97.9
Capillary
24
0.08
14.7
14.3
102.5
Microcapillary
24
0.20
14.5
14.3
101.7
Microsyringe
24
0.14
14.1
14.3
98.7
Expired Gas
24
0.14
14.5
14.3
101.6
Syringe
21
0.12
21.3
21.4
99.7
Capillary
24
0.12
21.5
21.4
100.5
Microcapillary
18
0.59
20.7
21.4
96.9
Microsyringe
18
0.42
21.3
21.4
99.4
Expired Gas
18
0.77
21.0
21.4
98.3
Syringe
18
0.43
35.1
35.7
98.2
Capillary
24
0.25
36.4
35.7
102.0
Microcapillary
18
0.50
34.5
35.7
96.6
Microsyringe
18
0.34
35.9
35.7
100.7
Expired Gas
18
0.30
34.9
35.7
97.8
Syringe
24
0.72
50.5
49.9
101.3
Capillary
24
0.29
48.4
49.9
97.1
Microcapillary
24
0.47
51.1
49.9
102.4
Microsyringe
24
0.21
49.9
49.9
100.0
Expired Gas
24
0.26
49.9
49.9
100.1
Syringe
21
1.13
71.7
71.3
100.5
2
3
4
5
"$
!
"
Capillary
24
1.20
71.7
71.3
100.6
Microcapillary
18
1.36
71.1
71.3
99.7
Microsyringe
18
0.55
70.5
71.3
98.9
Expired Gas
18
0.49
71.0
71.3
99.6
* WRSD = within-run standard deviation
%#$ " &
1
Syringe
21
Capillary
2
3
!
"
0.16
28.2
28.5
98.9
21
0.18
28.9
28.5
101.4
Microcapillary
18
0.35
29.0
28.5
101.8
Microsyringe
18
0.25
28.5
28.5
100.2
Expired Gas
18
0.16
27.9
28.5
98.0
Syringe
24
0.22
50.5
49.9
101.2
Capillary
18
0.34
49.2
49.9
98.6
Microcapillary
24
0.41
49.4
49.9
99.0
Microsyringe
24
0.13
49.8
49.9
99.8
Expired Gas
24
0.10
49.4
49.9
99.1
Syringe
18
0.34
85.3
85.6
99.6
Capillary
22
0.33
85.5
85.6
99.9
Microcapillary
18
0.99
84.5
85.6
98.7
Microsyringe
18
0.70
85.6
85.6
100.0
Expired Gas
18
0.20
84.7
85.6
98.9
4
Syringe
18
Capillary
5
2.65
149.6
149.7
99.9
22
0.83
150.0
149.7
100.2
Microcapillary
18
0.98
150.0
149.7
100.2
Microsyringe
18
0.62
149.4
149.7
99.8
Expired Gas
18
0.31
149.5
149.7
99.8
Syringe
21
1.40
377.4
377.9
99.9
Capillary
21
2.41
377.5
377.9
99.9
Microcapillary
18
5.50
378.9
377.9
100.3
Microsyringe
17
5.51
377.5
377.9
99.9
Expired Gas
17
1.55
379.2
377.9
100.3
* WRSD = within-run standard deviation
'%& "$ !( "
"
#!
1
Syringe
24
0.25
115.6
115.5
100.1
Capillary
24
0.29
115.6
115.5
100.1
Microcapillary
24
0.47
115.1
115.1
100.0
Microsyringe
24
0.42
115.4
115.3
100.1
pH/Lytes
24
0.43
121.0
120.9
100.1
Syringe
24
0.49
150.9
151.0
99.9
Capillary
24
0.46
150.9
151.2
99.8
Microcapillary
24
0.80
151.2
151.1
100.0
Microsyringe
24
0.49
151.0
151.3
99.8
pH/Lytes
24
0.75
151.3
151.6
99.7
Syringe
24
0.39
174.2
174.2
100.0
Capillary
24
0.39
174.3
174.1
100.1
Microcapillary
24
1.81
173.9
173.9
100.0
Microsyringe
24
0.45
174.1
173.9
100.1
pH/Lytes
24
1.33
170.4
170.2
100.2
2
3
"$
* WRSD = within-run standard deviation
&$% !# '
!
1
Syringe
24
Capillary
2
3
!
" !#
0.071
1.89
1.90
99.3
24
0.050
1.89
1.88
100.6
Microcapillary
24
0.092
1.88
1.83
102.3
Microsyringe
24
0.043
1.79
1.83
97.7
pH/Lytes
24
0.029
1.95
1.95
99.8
Syringe
24
0.020
3.49
3.51
99.5
Capillary
24
0.034
4.14
4.14
100.0
Microcapillary
24
0.037
3.81
3.78
100.7
Microsyringe
24
0.016
3.81
3.82
99.7
pH/Lytes
24
0.013
3.74
3.74
100.2
Syringe
24
0.109
7.21
7.23
99.8
Capillary
24
0.126
7.43
7.38
100.7
Microcapillary
24
0.139
7.21
7.27
99.2
Microsyringe
24
0.079
7.33
7.28
100.7
pH/Lytes
24
0.131
6.44
6.45
100.0
* WRSD = within-run standard deviation
'%& "$ !( "
1
Syringe
21
Capillary
2
3
"
#!
"$
0.007
0.78
0.76
102.5
24
0.011
0.79
0.77
102.1
Microcapillary
24
0.025
0.80
0.75
106.4
Microsyringe
21
0.014
0.72
0.74
97.6
pH/Lytes
18
0.016
0.78
0.76
103.2
Syringe
21
0.012
1.87
1.84
102.0
Capillary
24
0.017
1.85
1.82
101.8
Microcapillary
24
0.010
1.65
1.65
99.7
Microsyringe
21
0.008
1.66
1.58
104.8
pH/Lytes
18
0.023
1.64
1.57
104.5
Syringe
21
0.028
2.48
2.46
101.2
Capillary
24
0.035
2.56
2.56
100.2
Microcapillary
24
0.077
2.21
2.26
97.6
Microsyringe
21
0.026
2.20
2.14
102.8
pH/Lytes
18
0.042
2.13
2.12
100.6
* WRSD = within-run standard deviation
&$% !# ' !
1
Syringe
24
0.4
88
88
99.6
Capillary
24
0.6
88
89
99.7
Microcapillary
24
0.8
88
89
99.5
Microsyringe
24
0.6
89
89
99.8
pH/Lytes
24
0.6
91
90
100.2
Syringe
24
0.7
117
116
100.5
Capillary
24
0.3
117
116
100.5
Microcapillary
24
1.1
117
116
100.8
Microsyringe
24
0.6
116
116
100.4
pH/Lytes
24
1.4
118
119
99.6
Syringe
24
0.5
140
141
99.9
Capillary
24
0.5
141
141
99.8
Microcapillary
24
2.7
141
142
99.7
Microsyringe
24
0.7
141
141
99.8
pH/Lytes
24
2.1
140
140
100.2
2
3
!
" !#
* WRSD = within-run standard deviation
# All performance data presented in this section was generated using 860 systems.
The system used default correlation factors, and performed calibrations using the
default settings recommended by Bayer Diagnostics for optimum performance. All
reported values were corrected to 760 mmHg. The operating environment during
the collection of this data was normal room temperature (about 23C).
You should determine your own performance characteristics in your laboratory
with your 860 system.
! ! To test for interferences, serum was spiked with a potentially interfering substance
up to the test concentration shown in the following two tables. The interference was
calculated by comparing the spiked sample to an unspiked sample immediately
preceding it. To evaluate the interference from fluoride/oxalate, the blood was
drawn in grey-top tubes and compared to the glucose recovery in heparinized
blood.
Table E-23 lists substances that were found not to interfere with the glucose
measurement. At the concentrations listed, these compounds produced less than
6 mg/dL (0.3 mmol/L) error in the recovered glucose concentration.
&$%! " ! Chlorpromazine
5 mg/dL
Dopamine
0.5 mg/dL*
Ethanol
350 mg/dL
Salicylate
50 mg/dL
Sodium Nitroprusside
70 mg/dL
Citrate
1000 U/dL
Heparin
20,000 U/dL
Acetoacetate
40 mg/dL
Ascorbate
6 mg/dL
Thiocyanate
80 mg/dL
Bilirubin (Direct)
30 mg/dL
Bilirubin (Total)
34 mg/dL
Creatinine
30 mg/dL
Hydroxybutyrate
200 mg/dL
Lactate
100 mg/dL
Urea
500 mg/dL
Uric Acid
10 mg/dL
* Interference by dopamine and structurally related drugs is dependent on glucose concentration. However,
even at high glucose concentrations, therapeutic levels of dopamine do not interfere with the glucose
measurement.
The following anticoagulants were found not to interfere with glucose recovery at
the indicated concentrations but they cannot be used on the 860 system due to
potential interferences on other sensors or analytes.
Citrate
1000 mg/dL
Potassium Oxalate
1000 mg/dL
Refer to Sample Collection Devices and Anticoagulants in Section 1 for the specific
requirements on sample handling and anticoagulants.
Table E-25 lists substances that interfere with the glucose measurement.
"! Sodium Fluoride
1000 mg/dL each
25 mg/dL (1.4 mmol/L)
Acetominophen
2 mg/dL
7 mg/dL (0.4 mmol/L)
Sodium Fluoride/
Potassium Oxalate
1000 mg/dL each
25 mg/dL (1.4 mmol/L)
* Increased reported glucose values by the amount shown.
To test for interferences, serum was spiked with a potentially interfering substance
up to the test concentration shown in the following tables. The interference was
calculated by comparing the spiked sample to an unspiked sample immediately
preceding it. To evaluate the interference from fluoride/oxalate, the blood was
drawn in grey-top tubes and compared to the lactate recovery in heparinized blood.
The following table lists substances that were found not to interfere with the lactate
measurement. At the concentrations listed, these compounds produced less than
0.3 mmol/L (2.7 mg/dL) error in the recovered lactate concentration.
! Chlorpromazine
17 mg/dL
Dopamine
1 mg/dL
Ethanol
350 mg/dL
Salicylate
50 mg/dL
Sodium Nitroprusside
70 mg/dL
Thiocyanate
80 mg/dL
Heparin
20,000 U/dL
Epinephrine
2 mg/dL
Norepinephrine
2 mg/dL
Phenobarbital
15 mg/dL
Glutamate
16 mg/dL
Hetastarch
30%
Acetoacetate
40 mg/dL
Ascorbate
8 mg/dL
Dilantin
14 mg/dL
Bilirubin (Direct)
30 mg/dL
Bilirubin (Total)
35 mg/dL
Creatinine
30 mg/dL
Glucose
1000 mg/dL
Hydroxybutyrate
200 mg/dL
Urea
500 mg/dL
Guaiacol
5 mg/dL
Pyruvate
9 mg/dL
Theophylline
9 mg/dL
Penicillamine
25 mg/dL
Isoniazid
2 mg/dL
Uric Acid
10 mg/dL
The following anticoagulants were found not to interfere with lactate recovery at
the indicated concentrations but they cannot be used on the 860 system due to
potential interferences on other sensors or analytes.
Citrate
1000 mg/dL
Potassium Oxalate
1000 mg/dL
EDTA
800 mg/dL
Refer to Sample Collection Devices and Anticoagulants in Section 1 for the specific
requirements on sample handling and anticoagulants.
)'($"#" #!! &# # ## "$!#
$"#
#!# "#
% #!!
Sodium Fluoride
1000 mg/dL
1 mmol/L (9 mg/dL)
Sodium Fluoride/
Potassium Oxalate
1000 mg/dL
1 mmol/L (9 mg/dL)
Acetominophen
2 mg/dL
0.35 mmol/L (3.2 mg/dL)
!" #! "
Quality control materials and calibration verification materials were analyzed on
the 860 systems. The results are presented here.
Precision on aqueous quality control materials was estimated using fifteen 860
systems. Seventeen runs per instrument were made over a twenty-two day period.
Two replicates of each control level were analyzed in each run.
For glucose, precision on aqueous calibration verification materials was estimated
using fifteen 860 systems. Data from seven to sixteen runs per instrument were
available. The data were collected over a two-month period. Two replicates of each
control level were analyzed in each run.
For lactate, precision on aqueous calibration verification materials was estimated
using fifteen 860 systems. Six runs per instrument were made over an eight day
period. Two replicates of each control level were analyzed in each run.
Table E-29 summarizes the results of the 860 system precision on QC materials.
)'( !" "$#"
#
7.157
0.002
0.004
316
7.423
0.001
0.004
3
235
7.617
0.003
0.006
1
293
72.5
1.12
1.87
!#!
%
pH6.5
1
387
2
pCO2
pO2
Na+
K+
Cl–
Ca++
Glu
Lactate
43.0
0.89
1.41
185
23.0
0.64
0.81
1
387
61.7
1.79
2.17
2
316
103.5
1.46
2.66
3
236
152.3
1.89
4.51
1
387
112.7
0.25
0.62
2
316
135.1
0.21
0.50
3
236
151.3
0.40
0.77
1
387
2.68
0.014
0.020
2
316
5.04
0.014
0.022
3
236
7.34
0.033
0.050
1
387
119.5
0.57
1.14
2
316
100.0
0.34
0.74
3
236
77.6
0.41
0.57
1
386
1.47
0.006
0.011
2
316
1.12
0.004
0.007
3
236
0.59
0.004
0.008
1
387
37.73
0.795
1.157
2
316
103.5
1.585
2.165
3
236
212.6
2.743
4.570
1
183
11.27
0.404
0.433
2
241
3
2
177
3
170
0.99
0.011
0.049
0.52
0.008
0.033
* WRSD = within-run standard deviation
TotSD = total standard deviation
Performance determined with metabolite recal on. Refer to Glucose Biosensor Calibration, in Section 1
for information on performance with recal off.
Table E-30 summarizes the results of the 860 system precision for CVM levels 1
and 4.
"! 6.782
0.002
0.004
551
7.830
0.007
0.009
1
575
107.6
1.48
3.11
4
548
13.0
0.37
0.74
1
563
26.0
1.63
2.02
4
539
249.0
6.05
8.36
1
592
89.6
0.65
1.25
4
560
166.1
0.75
1.32
1
592
1.44
0.036
0.052
4
563
15.34
0.177
0.315
1
586
134.2
0.95
2.48
4
560
73.0
0.85
1.17
1
592
2.75
0.038
0.065
4
560
0.51
0.012
0.017
pH
1
565
4
pCO2
pO2
Na+
K+
Cl–
Ca++
* WRSD = within-run standard deviation
TotSD = total standard deviation
$!' !" %# & !
""
For testing syringe, capillary, microsyringe, and microcapillary modes, blood was
collected in heparinized vacuum tubes. It was tonometered at 37.0C to each of
three levels to prepare samples for pH analysis, and five levels to prepare samples
for pCO2 and pO2 analysis. Blood was spiked/diluted to each of three levels to
prepare samples for sodium, potassium, calcium, chloride glucose and lactate
analysis. Multiple runs were made using these samples on four 860 systems, except
for lactate. For lactate, multiple runs were made on six 860 systems. The
experimental protocol called for three replicates of each level in each run.
For testing the expired gas mode, 10 mL of tonometry gas were drawn into a
12 mL syringe and aspirated into the 860 system for analysis. Multiple runs were
made using five levels of expired gas on four 860 systems. The protocol called for
three replicates of each level in each run.
Table E-31 through Table E-44 summarize the results of the 860 system whole
blood, expired gas, and electrolyte recovery and precision testing.
*() $!' !" "#+ $
7.21
Syringe
48
Capillary
7.37
7.52
"!$
& #
$!'
0.002
7.213
7.214
100.0
48
0.004
7.202
7.202
100.0
Microcapillary
48
0.003
7.205
7.205
100.0
Microsyringe
48
0.002
7.204
7.205
100.0
pH/Lyte
48
0.003
7.207
7.208
100.0
Syringe
48
0.002
7.373
7.369
100.1
Capillary
44
0.002
7.376
7.375
100.0
Microcapillary
48
0.006
7.376
7.376
100.0
Microsyringe
48
0.002
7.371
7.370
100.0
pH/Lyte
48
0.002
7.361
7.363
100.0
Syringe
48
0.003
7.544
7.546
100.0
!
!
" !#
Capillary
48
0.004
7.507
7.502
100.1
Microcapillary
36
0.005
7.529
7.526
100.0
Microsyringe
48
0.004
7.503
7.500
100.0
pH/Lyte
36
0.003
7.507
7.507
100.0
&$% !# '
!
1
Syringe
24
Capillary
2
3
4
!
" !#
0.20
14.5
14.3
101.5
24
0.15
14.4
14.3
100.4
Microcapillary
24
0.19
14.3
14.3
100.0
Microsyringe
24
0.10
14.2
14.3
99.5
Expired Gas
18
0.09
14.7
14.3
102.9
Syringe
24
0.12
21.8
21.4
101.7
Capillary
24
0.19
21.6
21.4
100.9
Microcapillary
24
0.33
21.6
21.4
101.2
Microsyringe
24
0.28
22.1
21.4
103.1
Expired Gas
24
0.16
21.5
21.4
100.3
Syringe
24
0.41
35.0
35.7
98.0
Capillary
24
0.44
35.2
35.7
98.5
Microcapillary
24
0.25
35.6
35.7
99.7
Microsyringe
24
0.31
35.2
35.7
98.7
Expired Gas
24
0.11
35.2
35.7
98.6
Syringe
24
0.52
50.0
49.9
100.2
5
!
"
Capillary
23
0.44
50.3
49.9
100.8
Microcapillary
24
0.71
49.9
49.9
100.0
Microsyringe
24
0.54
49.8
49.9
99.7
Expired Gas
18
0.62
49.4
49.9
99.1
Syringe
24
0.52
71.3
71.3
100.1
Capillary
24
0.82
71.2
71.3
99.8
Microcapillary
24
1.07
71.0
71.3
99.5
Microsyringe
24
1.46
71.0
71.3
99.5
Expired Gas
24
0.24
70.5
71.3
98.8
* WRSD = within-run standard deviation
%#$ " &
1
Syringe
24
Capillary
2
!
"
0.21
28.5
28.5
99.9
24
0.25
28.5
28.5
100.1
Microcapillary
24
0.44
28.6
28.5
100.4
Microsyringe
24
0.33
28.7
28.5
100.7
Expired Gas
24
0.12
28.0
28.5
98.1
Syringe
24
0.35
50.2
49.9
100.6
Capillary
23
0.23
49.9
49.9
100.1
Microcapillary
24
0.38
50.0
49.9
100.2
Microsyringe
24
0.49
49.7
49.9
99.6
Expired Gas
24
0.56
49.8
49.9
99.7
"
3
Syringe
24
Capillary
4
5
"
#!
"$
1.19
84.9
85.6
99.2
24
0.61
85.4
85.6
99.7
Microcapillary
24
0.80
84.8
85.6
99.0
Microsyringe
24
1.08
85.2
85.6
99.5
Expired Gas
24
0.09
85.4
85.6
99.8
Syringe
24
1.34
150.0
149.7
100.2
Capillary
24
0.87
150.0
149.7
100.2
Microcapillary
24
2.04
150.1
149.7
100.2
Microsyringe
24
0.95
150.6
149.7
100.6
Expired Gas
24
0.19
150.0
149.7
100.2
Syringe
24
1.52
378.8
377.9
100.2
Capillary
24
1.55
378.7
377.9
100.2
Microcapillary
24
4.69
378.9
377.9
100.3
Microsyringe
24
2.35
379.6
377.9
100.5
Expired Gas
24
0.39
377.5
377.9
99.9
* WRSD = within-run standard deviation
'%& "$ !( "
"
#!
"$
119.4
Syringe
24
0.30
119.8
120.2
99.7
Capillary
24
1.33
120.0
119.8
100.2
Microcapillary
36
0.76
116.3
117.7
98.8
Microsyringe
24
0.47
119.4
120.3
99.2
148.7
171.5
pH/Lyte
21
0.42
117.8
119.1
98.9
Syringe
24
0.63
149.2
149.9
99.5
Capillary
24
0.44
149.0
149.7
99.5
Microcapillary
36
0.98
147.1
147.4
99.9
Microsyringe
33
0.58
148.3
148.4
99.9
pH/Lyte
24
0.57
148.4
148.6
99.9
Syringe
24
0.38
172.1
171.6
100.3
Capillary
24
1.25
171.6
171.2
100.2
Microcapillary
36
2.44
171.7
171.2
100.3
Microsyringe
24
0.97
172.3
172.0
100.2
pH/Lyte
21
1.08
171.9
171.4
100.3
* WRSD = within-run standard deviation
'%& "$ !( "
1
Syringe
24
Capillary
2
3
"
#!
"$
0.043
1.37
1.39
97.2
24
0.095
1.34
1.38
96.2
Microcapillary
24
0.145
1.67
1.73
96.4
Microsyringe
24
0.032
1.53
1.62
92.8
pH/Lyte
24
0.060
1.66
1.66
100.4
Syringe
48
0.028
3.75
3.73
100.6
Capillary
48
0.027
3.72
3.69
100.7
Microcapillary
48
0.027
3.63
3.66
99.3
Microsyringe
48
0.038
3.78
3.78
100.2
pH/Lyte
48
0.022
3.54
3.51
100.9
Syringe
24
0.142
8.47
8.57
98.9
Capillary
24
0.106
8.51
8.42
101.1
Microcapillary
24
0.164
8.43
8.48
99.3
Microsyringe
24
0.223
8.37
8.36
100.1
pH/Lyte
24
0.193
8.45
8.51
99.3
* WRSD = within-run standard deviation
&$% !# ' !
0.69
Syringe
48
Capillary
1.66
2.38
!
" !#
0.008
0.70
0.69
102.3
48
0.016
0.72
0.70
102.3
Microcapillary
48
0.017
0.71
0.69
102.6
Microsyringe
48
0.009
0.71
0.69
103.2
pH/Lyte
48
0.013
0.71
0.68
104.3
Syringe
48
0.014
1.67
1.65
100.8
Capillary
44
0.011
1.66
1.65
100.5
Microcapillary
48
0.026
1.67
1.65
100.9
Microsyringe
48
0.014
1.67
1.67
100.4
pH/Lyte
48
0.022
1.66
1.66
100.1
Syringe
48
0.036
2.42
2.39
101.2
Capillary
48
0.061
2.37
2.37
100.0
Microcapillary
48
0.049
2.38
2.40
99.2
Microsyringe
48
0.039
2.35
2.36
99.7
pH/Lyte
48
0.034
2.39
2.40
99.9
* WRSD = within-run standard deviation
'%& "$ !( "
86
Syringe
24
0.4
86
87
99.7
Capillary
24
1.1
87
86
100.4
Microcapillary
36
1.3
84
85
99.1
Microsyringe
24
1.0
86
86
100.2
pH/Lyte
24
0.6
86
87
99.2
Syringe
24
0.6
116
117
98.9
Capillary
24
1.0
118
118
100.3
Microcapillary
36
1.0
117
116
100.2
Microsyringe
36
1.2
116
117
99.4
pH/Lyte
24
0.6
117
117
99.5
Syringe
24
1.2
141
142
99.8
Capillary
24
1.7
142
142
100.1
Microcapillary
36
2.9
141
141
99.6
Microsyringe
24
1.4
141
142
99.5
pH/Lyte
24
1.7
142
142
100.2
117
142
"
#!
"$
* WRSD = within-run standard deviation
&$% !# ' !
45
Syringe
39
0.9
47
46
102.8
Capillary
30
1.4
46
43
107.9
Microcapillary
30
1.8
44
43
101.2
Microsyringe
36
1.2
45
45
100.6
pH/Lyte
21
1.6
47
47
100.7
Syringe
33
2.1
85
84
100.6
Capillary
33
1.4
85
83
102.5
Microcapillary
36
2.5
79
79
99.8
Microsyringe
45
1.9
84
82
102.3
pH/Lyte
24
1.1
81
80
101.1
Syringe
33
3.5
205
205
100.4
Capillary
33
2.9
206
203
101.5
Microcapillary
36
3.9
206
205
100.8
Microsyringe
45
3.8
205
203
101.2
pH/Lyte
23
3.1
206
205
100.6
81
207
!
"
!#
* Performance determined with metabolite recal on. Refer to Glucose Biosensor Calibration in Section 1
for information on performance with recal off.
WRSD = within-run standard deviation
&$% !# ' !
!
" !#
1.75
Syringe
36
0.030
1.69
1.61
105.2
Capillary
36
0.062
1.83
1.79
102.3
Microcapillary
36
0.089
1.65
1.73
95.4
Microsyringe
36
0.028
1.75
1.70
103.3
pH/Lyte
35
0.075
2.11
1.90
110.7
Syringe
36
0.046
2.83
2.89
98.1
Capillary
36
0.074
2.67
2.80
95.4
Microcapillary
36
0.145
2.69
2.73
98.6
Microsyringe
35
0.057
2.70
2.84
95.1
pH/Lyte
36
0.066
2.73
2.79
98.0
Syringe
18
0.019
3.80
3.64
104.3
Capillary
36
0.112
4.19
3.90
107.3
Microcapillary
36
0.189
3.93
3.92
100.3
Microsyringe
36
0.046
4.10
3.95
103.8
pH/Lyte
36
0.107
4.44
4.22
105.2
2.81
3.94
* WRSD = within-run standard deviation
'# " ! !
All performance data presented in this section was generated using the 800 system
CO-ox modules. The system performed recommended tHb slope procedures, and
calibrations using the default settings recommended by Bayer Diagnostics for
optimum performance. The operating environment during collection of this data
was normal room temperature (about 23°C).
You should determine your own performance characteristics in your laboratory
with your 800 system.
'# " ! " !
To test for interferences, blood was spiked with an interfering substance up to the
test concentration shown in the following two tables. The interference was
calculated by comparing the average difference between the spiked and unspiked
samples.
Any substance that absorbs light in the same regions as whole blood could
potentially cause an interference.
'%&! ! "! $!
!
tHb
<0.5 g/dL
O2Hb
<1.0%
COHb
<1.0%
MetHb
<1.0%
HHb
<1.0%
Table E-41 lists substances that were found not to interfere using the criteria stated
in Table E-40.
! Indocyanine Green
5 mg/L
Lipid
equivalent to 3% intralipid
Bilirubin
20 mg/dL
Fetal Hemoglobin
at 21%
Table E-42 lists substances that showed interference using the criteria stated in
Table E-40.
! Evans Blue at 5 mg/L
O2Hb
–2.1%
MetHb
+1.4%
O2Hb
–3.3%
HHb
+2.7%
O2Hb
–1.8%
MetHb
–1.3%
Methylene Blue at 25 mg/L
Cyanmethemoglobin
at 10 %
HHb
Sulfhemoglobin at 10%
Fetal Hemoglobin at 40%
+2.3%
O2Hb
+3.3%
MetHb
–3.3%
COHb
+1.5%
HHb
–1.3%
#!"
" ! %" $ " Fetal Hemoglobin at 80%
tHb
–0.9 g/dL
COHb
+3.1%
MetHb
–1.1%
HHb
–2.6%
Carboxymethylcellulose
tHB
–2.0 g/dL
COHb
+10.0%
O2Hb
–10.0%
HHb
+6.5%
! " !
Quality control materials were analyzed on the 800 series CO-ox module. The
results are presented here.
Precision on aqueous quality control materials was estimated using four 800
systems. One run per instrument was made over a eight day period. Three replicates
of each control level were analyzed in each run.
Table E-43 summarizes the results of the 800 CO-ox module precision on QC
materials.
)'( )& # ! !#"!
"
9.36
0.05
0.25
96
13.98
0.07
0.37
3
96
21.60
0.08
0.54
1
96
5.79
0.11
0.28
2
96
13.56
0.18
0.30
3
96
22.01
0.22
0.30
"
$
tHb
1
96
2
FO2Hb
%(
52.64
0.18
0.35
96
32.03
0.16
0.30
3
96
9.52
0.35
0.39
1
96
5.05
0.13
0.23
2
96
4.70
0.14
0.24
3
96
4.07
0.19
0.30
1
96
36.52
0.30
0.44
2
96
49.71
0.25
0.36
3
96
64.40
0.30
0.41
&#(&
*"
$
FCOHb
1
96
2
FMetHb
FHHb
$
* WRSD = within-run standard deviation
TotSD = total standard deviation
%*&- $ &!'!%$ +!( %" "%%
For testing syringe and capillary modes, blood was collected in heparinized vacuum
tubes. It was tonometered at 37°C and/or adjusted chemically. Three levels of tHb
were prepared by separating the red cells from the plasma and recombining
appropriately. For each run, three replicates of each level were run on four 800
systems.
Table E-44 through Table E-46 summarize the results of the 800 CO-ox module
recovery and precision testing.
"0./ 0%, %)" %*&- $ &!'!%$ +!( %(" #%"%!$ %
$ ,- #%"%!$ $"-(
%
$
$
&$
tHb
Capillary
72
6.64
–0.19
0.30
Syringe
66
6.53
–0.27
0.11
Capillary
72
91.96
1.16
0.45
FO2Hb
$ !&$
&%# &$
%#.)
FCOHb
FMetHb
FHHb
&
%
%
'%
% "'%
'&$ '%
Syringe
66
92.18
0.90
0.39
Capillary
72
4.23
–0.43
0.33
Syringe
66
4.24
–0.45
0.12
Capillary
72
3.81
–0.95
0.68
Syringe
66
3.58
–0.67
0.39
Capillary
72
0.00
0.23
0.08
Syringe
66
0.00
0.22
0.05
* WRSD = within-run standard deviation
#1/0 1&- &*# &+'. % '"("&% ,")! &)# $& #&"% &
% -.!$& #&"% %#.)
&
%
%
'%
tHb
Capillary
68
15.18
–0.36
0.35
Syringe
66
15.00
–0.31
0.11
Capillary
68
92.31
–0.09
0.25
Syringe
66
92.27
–0.23
0.29
Capillary
68
4.52
0.24
0.45
Syringe
66
4.02
0.19
0.19
Capillary
68
3.17
–0.44
0.25
Syringe
66
3.71
–0.76
0.20
Capillary
68
0.00
0.29
0.08
Syringe
66
0.00
0.34
0.08
FO2Hb
FCOHb
FMetHb
FHHb
% "'%
'&$ '%
* WRSD = within-run standard deviation
#1
/0 1&- &*# &+'. % '"("&% ,")! &)# $& #&"% &
% -.!$& #&"% %#.)
&
%
%
'%
tHb
Capillary
72
21.04
0.21
0.21
Syringe
68
20.72
0.19
0.22
Capillary
72
90.03
–0.73
0.24
Syringe
68
92.31
–1.21
0.64
Capillary
72
6.56
0.53
0.16
Syringe
68
4.48
0.95
0.72
Capillary
72
3.41
–0.08
0.21
Syringe
68
3.21
–0.01
0.20
Capillary
72
0.00
0.27
0.11
Syringe
68
0.00
0.28
0.16
FO2Hb
FCOHb
FMetHb
FHHb
% "'%
'&$ '%
* WRSD = within-run standard deviation
This appendix contains examples of the patient sample reports that you can print
on the roll printer, the line printer, and the 800 series compatible ticket printer.
The examples display all parameters, patient sample data fields, temperature
corrected values, entered values, and CO-oximeter values for the 800 series
systems. Some of the reports display reference ranges. The report you print will
look different if the system you are using measures different parameters or if all
data entry fields are not filled in.
This section contains examples of the patient sample reports that you can print on
the 800 system roll printer. The examples include all possible parameters, patient
sample data fields, temperature corrected values, entered values, and CO-oximeter
values for the 800 system. The examples include the following reports:
Roll Printer Report A
Roll Printer Report B
Roll Printer Report C
Roll Printer Report D
Roll Printer Report E
Refer to Defining the Printer Report Format in Section 5 for information about
how to select the roll printer report you want to print.
Roll Printer Report A is the default patient sample report. It displays reference
ranges and it lists temperature corrected values separately. Figure F-1 shows an
example of Roll Printer Report A.
Patient Data
840
APR 12 1994
13:02
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxxx
Pt name xxxxxxxxxxx
Patient ID xxxxxxxxxxx
Birthdate xxx xx xxxx
Age xxx
Sex x
Physician ID xxxxxxxxxxxx
Physician ID xxxxxxxxxxxx
Location xxx
Syringe Sample
ACID/BASE 37°C
pH
xx.xxx
pCO2
xxx.xx
p02
xxx.xx
xxx.xx
HCO3-act
HCO3-std
xxx.xx
ctCO2
xxx.xx
BE(B)
xxx.xx
BE(ecf)
xxx.xx
CORRECTED 38.5°C
pH
xx.xxx
pCO2
xxx.xx
pO2
xxx.xx
Sample Data
Sample Type
Units
mmHg
mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
Reference
(x.xxxx (xxx.xx (xx.xxx -
Range
x.xxxx)
xxx.xx)
xxxx.x)
nmol/L
mmHg
mmHg
Temperature
Corrected Values
............
............
. . . .OXYGEN
. . . . . . . . . .STATUS
. . . . . . . . . 37°C
.............................................................
.......
OXYGEN STATUS
pO2 (A-a) (T)
pO2 (a/A) (T)
RI (T)
ELECTROLYTES
Na+
K+
Ca++
Ca++(7.4)
ClAnGap
....................
METABOLITES
Glucose
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lactate
ENTERED
Temp
ctHb
FIO2
Flow
Resp Rate
p50
38.5°C
xxx.xx
xxx.xx
xxx.xx
mmHg
%
%
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
(xxx.xx - xxxx.x)
(xxx.xx - xxxx.x)
(xxx.xx - xxxx.x)
xxxxxx
xx.xx
mg/dL
mmol/L
(xxxxxx - xxxxxx)
( xx.xx - xx.xx )
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
°C
mmol/L
%
L/min
B/min
mmHg
....................
................
ctHb
xxx.xx
mmol/L (xx.xxx - xxxx.x)
Hct
xxx.xx
%
......
ctO2(a)
xxx.xx
mL/dL
(xxx.xx - xxxx.x)
BO
xxx.xx
mL/dL
(xxx.xx
xxxx.x)
......2
..............................................................................
xxx.xx
mmHg
pO2
. . . .p50
. . . . . . . . . . . . . . . . . . . xxxx.x
. . . . . . . . . . . . . . . .mmHg
............................................
sO2
xxx.xx
%
(xxx.xx - xxxx.x)
FO2Hb
xxx.xx
%
(xxx.xx - xxxx.x)
FCOHb
xxx.xx
%
(xxx.xx - xxxx.x)
......
FMetHb
xxx.xx
%
(xxx.xx - xxxx.x)
FHHb
xxx.xx
%
(xxx.xx
xxxx.x)
...................................................................................
...............
850
...............................................................................................
860
....................................................................................................................
................................................................................................................................
.................................
PATIENT SAMPLE REPORT
SYSTEM xxx-xxxx
SYSTEM xxx-xxxx
Sequence no xxxxx
Acc no xxxxx
Source xxxxxxxx
These results
CO-ox appear when an
845, 855, or 865
is interfaced.
Temperature
Corrected Values
(xxx.xx - xxxx.x)
Entered Values
Roll Printer Report B displays temperature corrected values next to the original
values, and it does not display reference ranges. Figure F-2 shows an example of
Roll Printer Report B.
Patient Data
860
.......................
.......
Patient ID xxxxxxxxxxx
Birthdate xxx xx xxxx
Age xxx
Sex x
Physician ID xxxxxxxxxxxx
Location xxx
SYRINGE SAMPLE
ACID/BASE 37°C
pH
xx.xxx
xxx.xx
pCO2
xxx.xx
pO2
HCO3-act
xxx.xx
HCO3-std
xxx.xx
ctCO2
xxx.xx
BE(B)
xxx.xx
BE(ecf)
xxx.xx
Corrected 38.5°C
xxx.xx
xxx.xx mmHg
xxx.xx mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
Sample Data
Sample Type
Temperature
Corrected Values
. . . .OXYGEN
. . . . . . . . . .STATUS
. . . . . . . . . .37°C
. . . . . . . . . . . . . . .Corrected
. . . . . . . . . . . . . .38.5°C
...............................
...........
............
..................
ctHb
xxx.xx
g/dL
......
Hct
xxx.xx
%
ctO2(a)
xxx.xx
mL/dL
These results
xxx.xx
mL/dL
BO
. . . . . . .2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pO2
xxx.xx
xxx.xx mmHg
appear when an
p50
xxxx.x
mmHg
845, 855, or 865
....................................................................................
sO2
xxx.xx
%
is interfaced.
FO2Hb
xxx.xx
%
......
FCOHb
xxx.xx
%
FMetHb
xxx.xx
%
. . . .FHHb
. . . . . . . . . . . . . . . . . . . .xxx.xx
. . . . . . . . . . . . . . . . . . . . . . . . . .%
..................................
pO2 (A-a) (T)
xxx.xx mmHg
pO2 (a/A) (T)
xxx.xx %
Temperature
RI (T)
xxx.xx %
CO-ox
.............
850
840
APR 12 1994
13:02
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxxx
.............
.........................................................................................
..................................................................................................
.................................
PATIENT SAMPLE REPORT
System xxx-xxxx
System xxx-xxxx
Sequence no xxxxx
Acc no xxxxx
Source xxxxx
Corrected Values
ELECTROLYTES
Na+
K+
Ca++
Ca++(7.4)
ClAnGap
....................
.................................
xxx.xx
xxx.xx
xx.xxx
xx.xxx
xxxxxx
xxx.xx
METABOLITES
Glucose
Lactate
xxxxxx
xxx.xx
ENTERED
Temp
ctHb
FIO2
Flow
Resp Rate
p50
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
mmol/L
°C
mmol/L
%
L/min
b/min
mmHg
Entered Values
Roll Printer Report C is similar to Roll Printer Report B, except that it lists blood
gas and CO-oximeter values separately. Figure F-3 shows an example of Roll
Printer Report C.
Patient Data
860
.........................
.......
APR 12 1994
13:02
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxx
Patient ID xxxxxxxxxxx
Birthdate xxx xx xxxx
Age xxx
Sex x
Physician ID xxxxxxxxxxxx
Location xxx
SYRINGE SAMPLE
BLOOD GAS 37°C
xxx.xx
pCO2
xxx.xx
pO2
Corrected 38.5°C
xxx.xx mmHg
xxx.xx mmHg
ACID/BASE 37°C
pH
xx.xxx
xxx.xx
HCO3-act
HCO3-std
xxx.xx
xxx.xx
ctCO2
BE(B)
xxx.xx
BE(ecf)
xxx.xx
Corrected 38.5°C
xxx.xx
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
Sample Data
Sample Type
Temperature
Corrected Values
.....................................................................................
CO-oximetry
ctHb
xxx.xx
Hct
xxx.xx
xxx.xx
sO2
FO2Hb
xxx.xx
FCOHb
xxx.xx
FMetHb
xxx.xx
FHHb
xxx.xx
OXYGEN STATUS 37°C
g/dL
%
%
%
%
%
%
Corrected 38.5°C
..............................
850
840
..............................
................................................................................................
........................................................................................................
.................................
PATIENT SAMPLE REPORT
SYSTEM xxx-xxxx
SYSTEM xxx-xxxx
Sequence no xxxxx
Acc no xxxxx
Source xxxxxxxx
These results
appear when an
CO-ox 845, 855, or 865
is interfaced.
. . . . .ctO
. . . .2.(a)
. . . . . . . . . . . . . .xxx.xx
. . . . . . . . . . . . . . . . . . . . . . . . . . .mL/dL
..................................
xxx.xx
mL/dL
BO2
pO2
xxx.xx
xxx.xx mmHg
....................
.................................
p50
xxxx.x
pO2 (A-a) (T)
pO2 (a/A) (T)
RI (T)
xxx.xx
xxx.xx
xxx.xx
ELECTROLYTES AND METABOLITES
Na+
xxx.xx
K+
xxx.xx
Cl
xxxxxx
++
Ca
xx.xxx
Ca++(7.4)
xx.xxx
AnGap
xxx.xx
Glucose
xxxxxx
Lactate
xx.xx
ENTERED
Temp
FIO2
ctHb
Flow
Resp Rate
p50
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
mmHg
mmHg
%
%
Temperature
Corrected Values
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
mmol/L
°C
%
g/dL
L/min
b/min
mmHg
Entered Values
Roll Printer Report D provides a four-column layout of parameters. Figure F-4
shows an example of Roll Printer Report D.
PATIENT SAMPLE REPORT
SYSTEM xxx-xxxx
Patient Data
840
Patient ID xxxxxxxxxxx
Birthdate xxx xx xxxx
Age xxx
Sex x
Physician ID xxxxxxxxxxxx
Location xxx
SYRINGE SAMPLE
ACID/BASE 37°C
pH
xxx.xx
xxx.xx
pCO2
xxx.xx
pO2
HCO3-act
xxx.xx
xxx.xx
HCO3-std
xxx.xx
ctCO2
BE(B)
xxx.xx
BE(ecf)
xxx.xx
Sample Data
Sample Type
Corrected 38.5°C
xxx.xx
xxx.xx
xxx.xx
Temperature
Corrected Values
xxx.xx
xxx.xx
xxx.xx
xxx.xx
OXYGEN STATUS
pO2(A-a)(T)
pO2(a/A)(T)
RI(T)
38.5°C
xxx.xx
xxx.xx
xxx.xx
xxx.xx
FCOHb
xxx.xx
CO-ox
FMetHb
xxx.xx
FHHb
xxx.xx
......................................................
.......
...................................
pO2
. . . p50
. . . . . . . . . . . . . . . . . . . .xxxx.x
................................
sO2
xxx.xx
FO2Hb
xxx.xx
...............
ctHb
Hct
ctO2(a)
BO2
......
. . .OXYGEN
. . . . . . . . . STATUS
. . . . . . . . . . 37°C
.............
.............
These results
appear when an
845, 855, or 865
is interfaced.
Temperature
Corrected Values
.......
ELECTROLYTES AND METABOLITES
Na+
xxx.xx
Glucose
xxxxxx
K+
xxx.xx
. . .Lactate
. . . . . . . . . . . . . . . . . . . . .xx.xx
.........
++
++
Ca
xxx.xx
Ca (7.4)
xxx.xx
Cl
xxx.xx
AnGap
xxx.xx
.......
850
.................................................................
860
.................................................................................
..................................................................................
.................................
Sequence No xxxxx
Acc No xxxxx
Source xxxxxxxx
Apr 12 1994
13:02
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxx/xxxxxxx
......................................................................................
..................................
ENTERED
Temp
ctHb
p50
xxx.xx
xxx.xx
xxxxxx
FIO2
Flow
Resp Rate
xxx.xx
xx.xxx
xx.xx
Entered Values
Roll Printer Report E is similar to Report C, except that it includes the pH value
with the blood gas values. Figure F-5 shows a sample of Roll Printer Report E.
PATIENT SAMPLE REPORT
SYSTEM xxx-xxxx
Sequence no xxxxx
Acc no xxxxx
Source xxxxxxxx
APR 12 1994
13:02
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxx
Patient ID xxxxxxxxxxx
Birthdate xxx xx xxxx
Age xxx
Sex x
Physician ID xxxxxxxxxxxx
Location xxx
SYRINGE SAMPLE
BLOOD GAS 37°C
pH
xx.xxx
pCO2
xxx.xx
pO2
xxx.xx
Corrected 38.5°C
xxx.xx nmol/L
xxx.xx mmHg
xxx.xx mmHg
ACID/BASE 37°C
HCO3-act
xxx.xx
HCO3-std
xxx.xx
ctCO2
xxx.xx
BE(B)
xxx.xx
xxx.xx
. . . . . . . BE(ecf)
Corrected 38.5°C
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
Patient Data
...........................
Sample Type
Temperature
Corrected Values
. . . . .CO-OXIMETRY
................................................................................
ctHb
Hct
sO2
FO2Hb
FCOHb
FMetHb
FHHb
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
..............................
850
840
..............................
860
..................................................................................................
.......................................................................................................
.................................
Sample Data
g/dL
%
%
%
%
%
%
These results
appear when an
CO-ox 845, 855, or 865
is interfaced.
OXYGEN STATUS 37°C
Corrected 38.5°C
ctO2(a)
xxx.xx
mL/dL
. . . . .BO
..2
. . . . . . . . . . . . . . . . .xxx.xx
. . . . . . . . . . . . . . . . . . . . . . . . . . .mL/dL
..................................
pO2
xxx.xx
xxx.xx mmHg
p50
xxxx.x
mmHg
pO2(A-a)(T)
xxx.xx mmHg
pO2(a/A)(T)
xxx.xx %
Temperature
RI(T)
xxx.xx %
Corrected Values
ELECTROLYTE AND METABOLITES
Na+
xxx.xx
K+
xxx.xx
Ca++
xx.xxx
Ca++(7.4)
xx.xxx
Clxxxxxx
xxx.xx
. . . . . . . . . . . . . . . . . . . . AnGap
Glucose
xxxxxx
xx.xx
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lactate
ENTERED
Temp
ctHb
FIO2
Flow
Resp Rate
p50
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
mmol/L
°C
g/dL
%
L/min
b/min
mmHg
Entered Values
This section contains examples of the patient sample reports that you can print on a
line printer. The examples include all possible parameters, patient sample data
fields, temperature corrected values, entered values, and CO-oximeter values for
800 systems. The examples include the following reports:
Line Printer Report A
Line Printer Report B
Line Printer Report C
Refer to Defining the Printer Report Format in Section 5 for information about
how to select the line printer report you want to print.
Line Printer Report A is the default line printer report. It includes the CO-oximeter
values with the oxygen status values. Figure F-6 shows an example of Line Printer
Report A.
Patient and
Sample Data
.......................
840
.......
APR 12 1994
13:02
Hospital Name
Hospital Address Line 1
Hospital Address Line 2
City, State Zip
Patient ID xxxxxxxxxxx
Physician ID xxxxxxxxxxx
Location xxx
Birthdate xxx xx xxxx
Age xxx
Sex x
System
System
Seq no
Acc no
Source
ACID/BASE 37°C
pH
xx.xxx
xxx.xx
pCO2
xxx.xx
pO2
xxx.xx
HCO3-act
xxx.xx
HCO3-std
xxx.xx
ctCO2
BE(B)
xxx.xx
BE(ecf)
xxx.xx
Units
mmHg
mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
xxx-xxxx
xxx-xxxx
xxxxx
xxxxx
xxxxx
Reference
(x.xxxx (xxx.xx (xxxx.x -
Range
x.xxxx)
xxx.xx)
xxxx.x)
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxxx
Corrected 38.5°C
xxx.xx
xxx.xx
xxx.xx
Temperature
Corrected
Values
OXYGEN STATUS 37°C
ctHb
xxx.xx
mmol/L (xxx.xx - xxx.xx)
Hct
xxx.xx
%
............................
xxx.xx
mL/dL
(xxx.xx - xxx.xx)
ctO2(a)
mL/dL
(xxx.xx - xxx.xx)
BO . . . . . . . . . . . . . . . . .xxx.xx
.......2
............................................................
xxx.xx
mmHg
(xxx.xx - xxxx.x)
pO2
p50
xxx.xx
mmHg
(xxx.xx - xxx.xx)
....................................................................................
CO-ox
xxx.xx
%
(xxx.xx - xxx.xx)
sO2
xxx.xx
%
(xxx.xx - xxx.xx)
FO2Hb
FCOHb
xxx.xx
%
(xxx.xx - xxx.xx)
............................
FMetHb
xxx.xx
%
(xxx.xx - xxx.xx)
FHHb
xxx.xx
%
(xxx.xx - xxx.xx)
....................
............
..............
850
............
....................................................................................
................
860
....................................................................................................
........................................................................................................
.................................
PATIENT SAMPLE REPORT
These results
appear when
an 845, 855,
or 865 is
interfaced.
....................................................................................
OXYGEN STATUS
pO2(A-a)(T)
pO2(a/A)(T)
RI(T)
....................
.................................
38.5°C
xxx.xx
xxx.xx
xxx.xx
mmHg
%
%
ELECTROLYTES AND METABOLITES
Na+
xxx.xx
mmol/L
K+
xxx.xx
mmol/L
Ca++
xxx.xx
mmol/L
Ca++(7.4)
xxx.xx
mmol/L
Clxxx.xx
mmol/L
AnGap
xxx.xx
mmol/L
Glucose
xxxxxx
mg/dL
Lactate
xx.xx
mmol/L
ENTERED
Temp
CtHb
FIO2
Flow
Resp Rate
p50
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
°C
mmol/L
%
L/min
b/min
mmHg
(xxx.xx - xxx.xx)
(xxx.xx - xxx.xx)
(xxx.xx - xxx.xx)
Temperature
Corrected
Values
(xxx.xx - xxxx.x)
(xxx.xx - xxxx.x)
(xxx.xx - xxxx.x)
(xxx.xx - xxxx.x)
(xxxxxx - xxxxxx)
( xx.xx - xx.xx )
Entered
Values
Line Printer Report B lists blood gas and CO-oximetry values separately.
Figure F-7 shows an example of Line Printer Report B.
Patient and
Sample Data
Patient ID xxxxxxxxxxx
Physician ID xxxxxxxxxxx
Location xxx
Birthdate xxx xx xxxx
Age xxx
Sex x
System xxx-xxxx
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxxx
Seq no xxxxx
Acc xxxxx
Source xxxx
Units
mmHg
mmHg
Reference Range
Corrected 38.5°C
(xxx.xx - xxx.xx) xxx.xx
(xxx.xx - xxx.xx) xxx.xx
ACID/BASE 37°C
pH
xx.xxx
xxx.xx
HCO3-act
xxx.xx
HCO3-std
BE(B)
xxx.xx
BE(ecf)
xxx.xx
.......
Units
Reference Range
Corrected 38.5°C
(xx.xxx - xx.xxx) xxx.xx
...........................
840
Temperature
Corrected
Values
mmol/L
mmol/L
mmol/L
mmol/L
. . . .CO-OXIMETRY
............................................................................................................
ctHb
Hct
sO2
FO2Hb
FCOHb
FMetHb
FHHb
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
g/dL
%
%
%
%
%
%
(xxx.xx - xxxx.x)
(xxx.xx
(xxx.xx
(xxx.xx
(xxx.xx
(xxx.xx
-
xxxx.x)
xxxx.x)
xxxx.x)
xxxx.x)
xxxx.x)
.................................
..................................
........................................................................................................
............................................................................................................
860
APR 12 1994
12:02
Hospital Name
Hospital Address Line 1
Hospital Address Line 2
City, State Zip
BLOOD GAS 37°C
xxx.xx
pCO2
pO2
xxx.xx
.................................
850
PATIENT SAMPLE REPORT
CO-ox
OXYGEN STATUS 37°C
OXYGEN STATUS 38.5°C
xxx.xx
mL/dL
(xxx.xx - xxx.xx)
ctO2(a)
BO
xxx.xx
mL/dL
(xxx.xx - xxx.xx)
. . . . . . .2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
xxx.xx
mmHg
(xxx.xx - xxx.xx) xxx.xx
pO2
p50
xxxx.x
mmHg
mmHg
xxx.xx
pO2(A-a)(T)
pO2(a/A)(T)
%
xxx.xx
RI(T)
%
xxx.xx
....................
.................................
ELECTROLYTES and METABOLITES
Na+
xxx.xx
mmol/L
K+
xxx.xx
mmol/L
++
Ca
xxx.xx
mmol/L
++
Ca
(7.4)
xxx.xx
mmol/L
Cl
xxx.xx
mmol/L
AnGap
xxx.xx
mmol/L
Glucose
xxxxxx
mg/dL
Lactate
xx.xx
mmol/L
ENTERED
Temp
ctHb
FIO2
Flow
Resp Rate
p50
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
°C
g/dL
%
L/min
b/min
mmHg
(xxx.xx
(xxx.xx
(xxx.xx
(xxx.xx
(xxx.xx
-
xxx.xx)
xxx.xx)
xxx.xx)
xxx.xx)
xxx.xx)
These results
appear when
an 845, 855,
or 865 is
interfaced.
Temperature
Corrected
Values
(xxxxxx - xxxxxx)
( xx.xx - xx.xx )
Entered
Values
Line Printer Report C is similar to Report B, except that it includes the pH value
with the blood gas values. Figure F-8 shows an example of Line Printer Report C.
Patient and
Sample Data
............................
APR 12 1994
12:02
Hospital Name
Hospital Address Line 1
Hospital Address Line 2
City, State Zip
Patient ID xxxxxxxxxxx
Physician ID xxxxxxxxxxx
Location xxx
Birthdate xxx xx xxxx
Age xxx
Sex x
System xxx-xxxx
BLOOD GAS 37°C
pH
xx.xxx
xx.xxx
pCO2
xxx.xx
pO2
ACID/BASE 37°C
xxx.xx
HCO3-act
xxx.xx
HCO3-std
BE(B)
xxx.xx
BE(ecf)
xxx.xx
......
CO-oximetry
ctHb
Hct
sO2
FO2Hb
FCOHb
FMetHb
FHHb
Seq no xxxxx
Acc no xxxxx
Source x-xxx
Units
mmHg
mmHg
Reference
(x.xxxx (x.xxxx (xxx.xx -
Range
x.xxxx)
x.xxxx)
xxx.xx)
Analysis Date xxx xx xxxx
Analysis Time xx:xx
Draw Date xxx xx xxxx
Draw Time xx:xx
Operator ID xxxxxxxxxxx
Corrected 38.5°C
xxx.xx
xxx.xx
xxx.xx
Temperature
Corrected
Values
Units
Reference Range
mmol/L
mmol/L
mmol/L
mmol/L
................................................................................................................
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
xxx.xx
................................
850
840
.................................
860
.........................................................................................................
...............................................................................................................
.................................
PATIENT SAMPLE REPORT
g/dL
%
%
%
%
%
%
CO-ox
OXYGEN STATUS 37°C
OXYGEN STATUS 38.5°C
xxx.xx
mL/dL
ctO2(a)
xxx.xx
mL/dL
BO2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
xxx.xx
mmHg
(xxx.xx - xxx.xx) xxx.xx
pO2
p50
xxx.xx
mmHg
mmHg
xxx.xx
pO2(A-a)(T)
%
xxx.xx
pO2(a/A)(T)
RI(T)
%
xxx.xx
ELECTROLYTES and METABOLITES
Na+
xxx.xx
mmol/L
K+
xxx.xx
mmol/L
++
Ca
xxx.xx
mmol/L
++
Ca (7.4)
xxx.xx
mmol/L
Clxxx.xx
mmol/L
AnGap
xxx.xx
mmol/L
...................
Glucose
xxxxxx
mg/dL
Lactate
xx.xx
mmol/L
.................................
ENTERED
Temp
ctHb
FIO2
Flow
Resp Rate
P50
xxx.xx
xxx.xx
xxx.xx
xx.xxx
xx.xx
xxxxxx
°C
g/dL
%
L/min
b/min
mmHg
(xxx.xx - xxx.xx)
(xxx.xx - xxx.xx)
(xxx.xx - xxx.xx)
(xxx.xx - xxx.xx)
These results
appear when
an 845, 855,
or 865 is
interfaced.
Temperature
Corrected
Values
(xxxxxxx - xxxxxx)
( xx.xx - xx.xx )
Entered
Values
This section contains an example of the patient sample report you can generate
from the 800 series compatible ticket printer.
The ticket printer report displays only 45 lines of data. You can define the data that
appears on the report by selecting the parameters and data entry fields in Setup. Do
not use the optional hospital header lines and delete some parameters in Setup to
limit the report length to 45 lines.
NOTE: If you do not complete a field on the Patient Information Screen, the field
does not appear on the ticket printer.
Refer to Defining the Printer Report Format in Section 5 for information about
how to select the ticket printer report. Refer to Defining the Patient Information
Form and Selecting Parameters for Analysis in Section 5 for more information
about turning off data entry fields.
Figure F-9 shows an example of a ticket printer report that contains all parameters,
patient sample data fields, CO-oximeter values, and entered parameters in the
correct order of appearance. This example displays more than 45 lines of data.
PATIENT SAMPLE REPORT
Hospital Header Line 1
Hospital Header Line 2
Hospital Header Line 3
Hospital Header Line 4
Displays hospital
name and address.
SYSTEM xxx-xxxx
Sequence no xxxxx
Source xxxxxxxx
Analysis Time
Draw Time
Operator ID
Patient ID
Location
Physician ID
Birthdate
Patient Data
860
........................
.......
ACID/BASE 37°C
pH
xxxxx
xxxxx
pCO2
xxxxx
pO2
xxxxx
HCO3-act
xxxxx
HCO3-std
xxxxx
ctCO2
BE(B)
xxxxx
BE(ecf)
xxxxx
CORRECTED 38.5°C
xxxxx
xxxxx mmHg
xxxxx mmHg
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
Sample Data
Temperature
Corrected Values
OXYGEN STATUS 37°C
CORRECTED 38.5°C
ctHb
xxxxx
mmol/L
Hct
xxxxx
%
xxxxx
mL/dL
ctO2(a)
xxxxx
%
BO2
p50
xxxxx
%
xxxxx
mL/dL
sO2
CO-ox
xxxxx
%
FO2Hb
FCOHb
xxxxx
%
FMetHb
xxxxx
%
. . . . .FHHb
. . . . . . . . . . . . . . . . . . . xxxxx
. . . . . . . . . . . . . . . . . . . .%. . . . . . . . . . . . . . . . . . . . . . . . . .
xxxxx mmHg
pO2(A-a)(T)
xxxxx %
pO2(a/A)(T)
RI(T)
xxxxx %
......................................................................
.............................
850
840
xxx xx xxxx xx:xx
xxx xx xxxx xx:xx
xxxxxxxxxxx
xxxxxxxxxxx Sex x
xxx
xxxxxxxxxxxx
xxx xx xxxx Age xx
.............................
............................................................................................
.................................................................................................
..................................
Acc no xxxxx
....................
..................................
These results
appear when an
845, 855, or 865
is interfaced.
ELECTROLYTES AND METABOLITES
Na+
xxxxx
mmol/L
K+
xxxxx
mmol/L
++
Ca
xxxxx
mmol/L
++
Ca (7.4)
xxxxx
mmol/L
Clxxxxx
mmol/L
AnGap
xxxxx
mmol/L
Glucose
xxxxxx
mg/dL
Lactate
xx.xx
mmol/L
ENTERED
Temp
ctHb
Qt
FIO2
Flow
Resp Rate
p50
xxxxx
xxxxx
°C
mmol/L
xxxxx
xxxxx
xxxx
xxxxxx
%
L/min
b/min
mmHg
Entered Values
The 800 system provides a setup option, Defining Correlation Coefficients, that
you can use to adjust the slope and intercept values to correlate results from an 800
system with results from another analyzer or methodology.
Before changing these values, you must simultaneously analyze a range of samples
on the 800 system and on a reference analyzer. A properly conducted regression
analysis will provide the appropriate correction equation slope and offset values.
NOTE: Changing the correlation coefficients affects the recovery of calibration
verification materials and proficiency survey materials when analyzed as patient
samples. Consult your proficiency survey administrator for detailed instructions on
reporting adjusted results.
Use the following procedure to determine the slope and offset values for the
correction equation.
1. Access the Correlation Coefficients screen from the Menu screen:
a. Select 5 Operating Setup, and press Enter.
b. Select 8 Correlation, and press Enter.
The Correlation Coefficients screen appears.
2. Ensure that the slope values are set to 1.000 and the offset value is set to 0.00
for each analyte that will be correlated to the reference methodology.
3. Press Exit Menu to return to the Ready screen.
4. Use a large sample population (minimum of 100 samples spanning the entire
analytical and reporting range) to obtain a random distribution of sample
values.
Failure to include a significant number of results at the extremes of
the concentration ranges will compromise the quality of the correlation.
5. Analyze each of the samples concurrently on both the 800 system and the
reference analyzer. Do not allow more than 3 minutes between paired
analyses. The data collection should take place over several days to allow the
inclusion of normal analytical variability for both methods. It is recommended
that samples be run in duplicate on both the 800 system and the reference
analyzer
6. Remove any statistical outliers beyond ±3SD.
7. Perform a linear regression analysis of the duplicate pairs of results
a. The regression should be performed by a computer capable of calculating
the regression by the Deming method. The debiased slope and offset
provided by this method is the recommended process for method
comparison.
b. Compute the correction equation by setting the 800 system as the X
(independent variable) and the reference analyzer as the Y (dependent
variable).
The calculation provides the equation y = mx +b where m is the slope and b is
the offset.
The calculation must be made in the manner described. The
calculation of a correction equation is the mathematical inverse of
the traditional correlation equation. Failure to calculate the regression
as described will cause the results to move further from the reference analyzer.
A less acceptable alternative is to perform the linear regression on a calculator
or computer that cannot use the Deming method. Set the 800 system as the X
variable and the reference analyzer as the Y variable.
8. Enter the slope and offset correlation values for the 800 system. Refer to
Defining Correlation Coefficients in Section 5.
Your 800 system should be installed by an authorized Bayer Diagnostics
representative. Use the following procedure to install your 800 system yourself
only if you are located in a region where Bayer Diagnostics Field Service
Representatives do not perform installation. For detailed information about the
software, refer to Learning About the System in Section 1 and Operating the
System in Section 2.
Select a location for your system. Place the 800 system in a location that is not
exposed to direct sunlight. Refer to Table H-1 for the system specifications.
! ambient operating
temperature
15 – 32°C
ambient operating
relative humidity
5 – 85%, non-condensing
power rating
400VA (maximum)
voltage requirements
100V/120V (85V to 132V)
50/60Hz
220V/240V (170V to 264V)
50/60Hz
ambient operating
barometric pressure
400 – 825 mmHg (53.0 – 110.0 kPa)
system dimensions
height
width
depth
weight
50.8 cm (20 inches)
55.9 cm (22 inches)
50.8 cm (20 inches)
29.5 kg (65 lbs)
Materials required:
Phillips screwdriver
CAUTION: Do not remove the glucose or lactate biosensors from their packages
during room temperature equilibration.
1. Remove the glucose and lactate biosensors from the refrigerator and allow
them to equilibrate at room temperature (18 – 25°C) for at least 1 hour
before use.
2. Inspect the packing case and report any damage to the shipper. Notify your
Bayer Diagnostics representative at installation.
3. Cut the shipping straps and open the packing case.
4. Remove the installation tray and set it aside.
5. Carefully lift the packing case up and off of the system. If you anticipate
relocating your system, do not discard the packing case.
6. Place the system on a level work surface, with the rear panel accessible.
7. Remove any tape and protective packing material from the system.
8. Unpack the installation tray and check the contents against the printed list
included in the box.
9. Open the system:
a. Turn the fasteners one-half turn to the left with a Phillips screwdriver.
b. Lift the top of the system up and secure the hinges.
10. Inspect PC boards and cables:
a. Remove the card cage cover.
b. Ensure that the PC boards are seated properly.
c. Ensure that all of the cables are connected.
11. Close the system:
a. Release the hinges.
b. Turn the fasteners one-half turn to the right with a Phillips screwdriver.
12. Install the optional bar code scanner:
a. Remove the bar code scanner from the shipping carton.
b. Connect the bar code scanner to the bar code scanner port on the rear panel
as shown in Figure H-1.
'$
-+,$ )
"!&$%& !"
# "($
#$ #""
$ &$
"($
% "
!&$
$ " !!$
"$&
&)"$ "$&
$ "$& $ "$&
*"$ "$&
$ "$& $ "$& 13. Rotate the system so that the right side panel faces you.
14. Install the fuses as required for your system
! your system has no voltage bobbin,
it uses a universal power supply
suitable for 100V to 240V
gently pry open the fuse compartment door
using a small, flat–blade screwdriver and
continue with step e.
your system has a voltage bobbin
continue with step a.
a. Take the voltage bobbin from the customizing box and the fuse kit from the
installation kit.
b. Gently pry the fuse compartment door open using a small, flat-blade
screwdriver.
c. Select the operating voltage.
Rotate the voltage bobbin so that the correct voltage faces you.
d. Install the voltage bobbin as shown in Figure H-2.
120 VAC
100 VAC
Voltage Bobbin
Fuse Compartment
Door Notch
Voltage Selection
Bobbin Window
Fuse Compartment Door
Power Input
Air Filter Cover
e. Check the system fuses.
f. Pull one of the fuse holders out of the fuse compartment, as shown in
Figure H-3.
Voltage Selection
Bobbin
Fuse Holder
Fuse Compartment
Fuse compartment
door in open position.
Fuse
Refer to the table below to identify the correct fuses for the voltage you use.
100/120V
4A Slo Blo
5 x 20 mm
220/240V
2A Slo Blo
5 x 20 mm
g. Install the fuses as shown in Figure H-3.
h. Slide the fuse holder(s) back into the fuse compartment. Make sure that the
arrow on the end of the holder points to your right, as indicated by the
arrows printed inside the compartment.
i. Close the fuse compartment door .
Do not connect the power cord to the AC wall outlet.
15. Insert the power cord into the power input connector on the right side panel.
16. Rotate the system so that the front panel faces you.
17. Adjust the Display assembly:
a. Remove the packing material from the hinges.
b. Lift the display assembly up.
18. Remove the front cover of the system.
19. Install the calibration gas tanks as shown in Figure H-4 and Table H-2:
a. Remove the gas connector cover.
b. Unpack the calibration gas kit from its packing case.
c. Place the gas tanks (cal gas and slope gas) into their final positions and
secure them.
d. Peel the white plastic protective wrapping from the valve assembly of each
tank.
e. Install the gas tank seals on the regulators.
&#+)* $% % $ &%!#
$ &%!# ""
!
#(
$ '
&$% %
!
!
!( $
' &%%
' %
!( !$
$ f. Attach the gas regulators to the gas tanks with the regulator nipple
engaging the opening in the tank valve.
g. Attach and tighten the yoke screws firmly.
h. Attach and tighten the tubing adapter fittings into each needle valve. Ensure
that the needle valve is fully open.
Second Stage
Pressure Gauge
Main Tank
Pressure Gauge
Needle Valve
Adjustment Knob
Gas Tank
i. Connect one end of a length of black tubing to the regulator fitting on the
slope gas tank (10% CO2).
j. Connect the tubing attached to the slope gas tank to the slope connector on
the reagent manifold.
k. Connect one end of a length of black tubing to the regulator fitting on the
cal gas tank (5% CO2, 12% O2).
l. Connect the tubing attached to the cal gas tank to the cal connector on the
reagent manifold.
m. Direct the tubing in the tubing guide under the system either to the left, to
the right, or behind the system.
n. To prevent restrictions in the tubing and uneven gas flow, secure the slope
and cal gas tubing so that the tubing does not cross under the system.
o. Reinstall the gas connector cover.
20. Initiate gas flow:
a. Ensure that the tanks are connected correctly. The slope gas tank contains
10% CO2 with the balance N2. The cal gas tank contains 5% CO2 and 12%
O2 with the balance N2.
b. Slowly open each main tank valve using the wrench from the calibration
gas kit until the regulator pressure gauge indicator stops rising
(approximately 3/4 of a turn; average psi is 2200).
c. Open the valve one more turn.
d. Listen for any gas leakage. Check by using soapy water and look for
bubbles.
e. Verify that each regulator outlet gauge indicates 3 – 5 psi.
21. Install the reagents:
Do not tighten or remove the bottle cap or attempt to mix the contents
of one bottle with another. The bottle caps are adjusted to ensure proper
reagent flow.
a. Remove the plugs from the reagent bottle caps.
b. Record the installation date in the space provided on the reagent labels.
c. Slide the bottles into position in the reagent compartment. The reagents
must be placed as follows from left to right on the reagent manifold:
22. Prepare the waste bottle:
a. Remove the waste bottle.
b. Remove the protective packaging from the waste detector.
c. Replace the waste bottle and ensure it is seated properly.
23. Prepare the reference sensor:
a. Partially fill the internal reference electrode compartment with 4M KCl
solution, and tap to remove bubbles.
b. Continue to fill the internal reference sensor compartment until the 4M KCl
fill solution flows into the reservoir.
c. Use the hex tool to remove the internal reference electrode from its
container. Insert the internal reference electrode into the reference electrode
compartment. Screw it into place using the hex tool. Do not cross thread
the internal sensor into the compartment. Tap the sensor to remove bubbles.
d. Remove the reservoir cap with the hex tool.
e. Fill the reservoir to the fill line with 4M KCl fill solution.
f. Put the reservoir cap back into position. Hand tighten the reservoir cap.
Do not overtighten. Overtightening can deform the gasket and cause
leakage.
g. Wipe any excess KCl solution from the exterior of the reference sensor
with a lint-free tissue.
h. Tap the sensor with your knuckle to remove bubbles.
24. Install the reference sensor:
a. Open the measurement module door by pushing up on the latches located
on the lower corners to release the door, and then lifting the door up.
b. Push the spring-loaded latch to the right.
c. Verify that the O-rings are in place on both sides of the sensor.
d. Verify that the O-ring is in place on the left side of the spring-loaded latch.
e. Align the top of the reference sensor with the sensor contact.
f. Snap the body of the sensor down into place.
g. Ensure that the sensor O-rings are in place.
25. Fill the Cl– sensor:
a. Grasp the tab on the blank sensor. Pull it up and out of the measurement
module.
b. Remove the Cl– sensor from its package.
c. Unscrew the internal electrode and carefully set it aside on a lint-free
tissue.
d. Rinse the sensor body with 3 drops of the Na+, K+, Cl–, Ca++ fill solution
and empty.
e. Slowly add the fill solution until the sensor is almost full.
f. Screw the internal electrode into place.
g. Tap the sensor with your knuckle to remove bubbles.
h. Wipe the sensor with a dry lint-free tissue.
i. Ensure that the O-ring is in place on the left side of the sensor.
j. Align the top of the sensor with the sensor contact.
k. Snap the body of the sensor down into place.
26. Connect the power cord to the AC wall outlet.
The system begins a power-up sequence. Wait for the Not Ready screen to
appear.
27. Verify that the sensors are almost full of fill solution. If any sensor is not filled
correctly, follow the procedure Filling the Measurement Sensors in Section 3,
using the appropriate fill solution.
The Na+ sensor should be full. The pH, K+, Cl–, and Ca++ sensors
should be almost full.
28. Verify that each O-ring is correctly positioned.
29. Press down the tab on the spring-loaded latch to release it.
30. Verify that the sensors are installed in the following order:
31. Close the measurement module door.
32. Install the reagent pump tubing:
a. Disconnect the right side of the tubing from right positions 1 and 2.
b. Remove the tubing cuff from the right side of the platen.
c. Place the tubing over the top of the roller cage.
d. Hold the right tubing cuff, turn the roller cage clockwise, and work the new
tubing between the platen and roller cage. Do not stretch the tubing.
It is normal for the pump tubing to fit tightly.
e. Place the right tubing cuff under the right side of the platen.
f. Connect the right end of the large tubing to position 1.
g. Connect the right end of the small tubing to position 2.
33. Install the sample pump and waste pump tubing:
a. Disconnect the right side of the sample pump tubing.
b. Place the tubing over the top of the roller cage.
c. Hold the right tubing cuff, rotate the roller cage clockwise, and gently work
the new tubing between the platen and roller cage. Do not stretch the
tubing.
It is normal for the pump tubing to fit tightly.
d.
e.
f.
g.
Place the right tubing cuff under the right side of the platen.
Connect the right tubing to the manifold at position 4.
Repeat steps a through d for the waste pump tubing.
Connect the right tubing to the manifold at position 5.
34. Install the printer paper:
a. Lift the printer cover up.
b. Place the paper roll in the cavity with the paper unrolling from
the bottom.
c. Lift the printer lever up.
d. Push the paper under the platen until it comes out of the other side in front.
e. Pull the paper from under the platen and push it through the slot in the
printer cover.
f. Push the printer lever down.
35. Close the printer cover:
a. Pull up the paper spool.
b. Insert the paper into the paper slot on the spool and turn three or four
rotations. Press Paper Advance if there is not enough paper.
c. Push down the spool.
36. Access the Menu screen and set up your system.
Refer to System Administration in Section 5 for more information about setting
up the system.
37. Initiate a prime sequence from the Menu screen to remove bubbles from the
reagent lines:
a. Select 2 Maintenance and press Enter.
b. Select 3 Prime and press Enter.
c. Select All and press Enter.
d. Press Done.
e. Watch the movement of wash solution to verify that the wash reagent flows
through the system during the wash sequence that automatically follows the
prime sequence.
38. Verify the gas flow rates for cal gas and slope gas:
a. Access the Valves Test from the Menu screen.
b. Select Cal Gas and press Start Test.
c. Insert an aspiration adapter into the sample port.
d. Immerse the open end of the aspiration adapter into a small container of
reagent water.
e. Press Start Test.
f. Verify that a steady stream of bubbles flows into the water.
g. Press Stop Test.
h. Verify that the bubbles stop flowing.
i. Repeat steps b through h for slope gas.
j. Remove the aspiration adapter.
k. Press Exit Test.
39. Access the Temperature test from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 2 Temperature and press Enter.
c. Check the screen to verify that the sample temperature is 37.00 ± 0.15°C.
If the temperature is outside of the range, verify that the power has
been on for at least 30 minutes.
40. Access the Barometer screen from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 8 Barometer and press Enter.
The Barometer Calibration screen appears.
41. Compare the displayed atmospheric pressure to the laboratory’s barometer
reading.
the displayed atmospheric
pressure is correct
press Done. The Ready screen appears.
the displayed atmospheric
pressure is incorrect
a. Type the correct atmospheric pressure, and press
Enter.
b. Press Done to save the new atmospheric pressure
and return to the Ready screen.
c. Perform a gas two-point calibration.
42. Condition the sensors.
Refer to Conditioning the Sensors in Section 3.
CAUTION: Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
43. Install the glucose and lactate biosensors:
a. Remove test/blank sensors (TB4).
b. Remove the lactate and glucose biosensors from the foil package.
c. Align the contacts on the biosensors with the contacts in the measurement
module.
d. Snap the body of the biosensors down into place. The contacts must be
flush with the sensors.
e. Press the tab on the spring-loaded latch down to release the latch.
44. Verify that the sensors are installed in the following order:
45. Perform three two-point calibrations to start hydrating the glucose and lactate
biosensors as soon as possible.
46. Allow the glucose and lactate biosensors to equilibrate for at least 30 minutes.
47. Verify that the system temperature is within the acceptable range.
48. Verify sensor performance by completing two successful two-point
calibrations.
The Ready screen appears when the calibration finishes.
49. Analyze QC material and verify acceptable results.
50. Replace the front cover.
%! BIOHAZARD: Refer to Appendix A for recommended precautions when working
with biohazardous materials.
The 800 series CO-oximeter (CO-ox) module must be installed by an authorized
Bayer Diagnostics Representative. Unauthorized use of these procedures can void
the warranty or service contract.
For detailed information about the software, refer to Learning About the System in
Section 1 and Operating the System in Section 2 of the operator’s manual.
Select a location for the new system configuration where it is not exposed to direct
sunlight. Refer to Table H-3 for system specifications.
%#$" "
ambient operating
temperature
15 – 32°C
ambient operating relative
humidity
5 – 85%, non-condensing
power rating
400VA (maximum)
power requirements from
the 800 base model:
100V (±) 10% 50/60 Hz
120V –15 to +10% 50/60 Hz
220V (±) 10% 50/60 Hz
240V (±) 10% 50/60 Hz
ambient operating
barometric pressure
400 – 825 mmHg (53.0 – 110.0 kPa)
system dimensions
height 30.3 cm (11.94 inches)
when installed 47.8 cm (18.81 inches)
width 17.35 cm (6.83 inches)
when installed 70.3 cm (27.66 inches)
depth 50.8 cm(20.0 inches)
weight 7.9 kg (17.5 lbs)
when installed 36.5 kg (82 lbs)
flat-blade screwdriver #2 [15.24 cm (6 inches) minimum shank length]
Phillips screwdriver #2 [15.24 cm (6 inches) minimum shank length]
pliers
1. Inspect the packing case and report any damage to the shipper.
2. Prepare a level work surface for the 800 CO-ox module.
3. Open the box:
Cut the tape along the edge of the top flap.
Open the flaps.
4. Remove the product inserts:
Unpacking Instructions
Ship Damage Instructions
Contact Bayer Diagnostics Representative Insert
5. Remove the printer cover and the 800 instrument rear label. Set them aside.
The new printer cover replaces the printer cover on the base model. The 800
instrument rear label is placed over the model number information on the 800
base model.
Do not cut the black straps surrounding the module. The straps assist
in lifting the module out of the packing case.
6. Use the black straps to carefully lift the CO-ox module from the packing case
and to place the module upright on the work surface.
7. Cut the black straps.
8. Carefully remove the foam end caps from the module.
9. Remove the plastic bag surrounding the module.
10. Remove any tape used to secure parts during shipment.
If you are installing the CO-ox module to an operational 800 series system,
perform the following procedure to shut down the system.
1. Shut down the system from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 3 Shutdown and press Enter.
The Shutdown screen appears.
2. Press Yes.
A message appears on the screen and on the roll printer, directing you to wait
before you disconnect the power.
Do not unplug the system until the following message appears on
the screen:
...synching disks... done
This is an operating system message indicating that the system has
successfully completed the shutdown procedures. Unplugging the system
before this message appears can damage the system.
3. When you see the operating system message, disconnect the power cord from
the power supply.
This procedure refers to right and left as you look at the rear of system.
1. Disconnect the power cord from the 800 base model.
Note the port location of each cable to ensure cables are reconnected
correctly.
2. Disconnect the cables from the ports at the rear of the 800 base model. Refer
to Figure H-5.
'$-+, $ ! %
% "
!&$
$ " !!$
"$&
&("$ "$&
$ "$& $ "$&
*"$ "$&
$ "$& $ "$& 3. Open the 800 base model, secure the spring locks, access and remove the right
side panel by loosening the captive screws mounted on the interior floor of the
chassis. Do not remove the screws. Retain the side panel.
Slide the base model to the edge of the work surface to access the
front plug.
4. Remove the two plugs mounted to the right side wall of the base model
hydraulic wall:
a. Push on the plug stems that protrude from the interior of the hydraulic wall.
b. Remove the plugs and retain.
$#$! & -") "' 1. Lift the hydraulic wall of the CO-ox module to access the power cable.
2. From inside the CO-ox chassis push the connector end of the cable through the
slot and gently pull the cable through.
This procedure refers to right and left as you are looking at the rear of system.
NOTE: Placing a piece of paper under the CO-ox module will allow for easier
movement on the work surface.
1. Move the CO-ox module close to the right side of the 800 base model.
2. Ensure that the CO-ox module hydraulic wall is open and slide the hydraulic
wall into position.
3. Install the CO-ox power cable:
a. Insert the CO-ox module power cable through the access hole in the side of
the 800 base model.
b. Gently pull the cable through the access hole while pushing the CO-ox
module as close to the 800 base model as possible.
c. Connect the CO-ox module power cable to J38 on the 800 base model
Backplane board.
4. Install the side panel from the base model to the CO-ox module.
5. Close the 800 base model, but do not tighten the locking screws.
6. Lift the side of the 800 base model up slightly to ensure that the lip of the
CO-ox module is seated in the groove located under the chassis shelf of the
800 base model.
Ensure that the two bosses on the CO-ox module are seated in the two
receptacles of the base model and that the screws are aligned with the bosses.
Do not tighten the screws.
7. Move the CO-ox module hydraulic wall laterally along its hinge pin until the
sides of both units touch.
The two alignment bosses on the left side of the CO-ox module
hydraulic wall must be seated properly in the hydraulic wall receptacles of the
800 base model.
Do not crimp or pinch tubing between the hydraulic walls.
8. Secure the hydraulic walls together:
Install the top rear screw first. You may need to remove the filter if it
prevents access to the top (upper rear) through hole. Be careful not to cut the
optics cable when securing the bottom (lower front) screw.
a. Ensure that the rear walls of both chassis are properly aligned.
b. Ensure that the captive screws are not engaged in the threaded portion of
the CO-ox hydraulic wall.
c. Insert a screwdriver into the access holes on the CO-ox module hydraulic
wall and tighten the screws to secure the hydraulic walls together.
9. Open the hydraulic walls and lock the counterbalance hinges.
10. Tighten the two screws in the alignment bosses on the CO-ox module chassis
to the chassis receptacles of the 800 base model.
11. Install the two plugs retained from the 800 base model to the right side wall.
Ensure that the new adhesive dots are in place.
12. Install the communications cable connectors between the CO-ox module and
the 800 base model to the CO-ox communications ports shown in Figure H-5.
Tighten the connector screws.
13. Ensure that the CO-ox module PC boards are firmly seated.
14. Ensure the the lamp is aligned correctly in the keyway and firmly seated in the
housing retainer.
15. Apply the new instrument label over the existing instrument label.
1. Access the preheater on the measurement module and disconnect the sample
tubing.
2. Remove the sample connector:
a. Remove the screw, located in the front of the preheater block, that attaches
the sample tee adaptor and retain.
b. Remove the sample tee adaptor.
Ensure that the gasket around the tube is in place and does not slip off the
end of the tube.
Overtightening the screw can damage the sample tee adaptor.
3. Invert the position of the sample connector and reinstall it to the preheater on
the 800 base model so that two sample tubes are facing toward you.
4. Reinstall the sample tubing:
an old style manifold
a. Remove the left manifold cap and place the CO-ox
module sample tubing on the manifold so that it is
flush against the flat.
b. Replace the manifold cap being careful not to pinch
the sample tubing.
a new style manifold
push the sample tubing into the recessed slot on top of
the manifold.
NOTE: Ensure that the waste tubing is positioned through the hole on the CO-ox
module fluid detector.
5. Connect the waste tubing to the 800 base model manifold.
6. Connect the sample tubing to the sample connector.
! " This procedure refers to right and left as you look at the front of system.
1. Remove the printer paper.
2. Remove the old printer cover:
a. Lift the cover and slide it to the right until the cover flange clears the pivot
pin.
b. When the left side of the cover is free of the pivot pin, pull the cover to the
left to remove it from the printer.
3. Install the new printer cover:
a. Slide the left tab over the pin on the spindle arm bracket while pushing the
cover all the way to the left.
b. Bend the tab on the cover or pivot it to allow the tab to slide over the pivot
pin.
! 1. Locate the groove on the left side of the base model front cover.
2. Using pliers, grasp the tubing tab inside the grooved area. Move and flex the
tubing tab to weaken the joint until the tab breaks free from the cover.
3. Close the system:
a. Tighten both locking screws on the base unit.
b. Tighten the one locking screw on the CO-ox module.
# This procedure is used by Bayer Diagnostics Service Representatives to change the
system information that the 800 system uses to present information on the screen
and in printed reports.
NOTE: A service password is required to access this setup function.
1. Reconnect all cables to the ports as shown in Figure H-5.
2. Plug the power cord into the AC power receptacle.
At startup, the system proceeds through a series of initial tests and then
displays Initializing in the banner. Any errors incurred during initialization are
posted to the status log.
3. Access the Service Setup screen from the Menu screen:
a. Select Service Setup and press Enter.
b. Select 4 System ID and press Enter.
4. Type the service password and press OK.
5. Select the system configuration(s) that you want and press Enter.
6. Enter the CO-ox module serial number and press Enter
7. Press Done.
8. You can define another setup function or press Exit Menu to return to the
Ready screen.
9. Access the Menu screen and set up your system.
Refer to System Administration in Section 5 for more information about setting
up the system.
10. Initiate a two-point calibration from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 2 Two-point and press Enter.
c. Verify acceptable drift.
11. Initiate a tHb slope from the Menu screen:
a. Select 1 Calibration and press Enter.
b. Select 9 tHb Slope and press Enter.
c. Verify acceptable drift.
12. Analyze QC material and verify acceptable results.
No special handling or preparation is required to relocate your system to another
area in your laboratory. To store your 800 system for an extended period of time or
to ship it to another location, perform the following procedures, or contact your
Bayer Diagnostics Service Representative for assistance.
Materials required:
10% solution of household bleach
sterile water
reagent water
lint-free tissue and swabs
aspiration adapter
test/blank sodium or pH sensor (TB2)
glucose test/blank sensor (TB4)
lactate test/blank sensor (TB4)
reference test/blank sensor (TB5)
valve wrench
BIOHAZARD: Refer to Appendix A for recommended precautions when working
with biohazardous materials.
CAUTION: Exposure to bleach damages the glucose and lactate biosensor
CAUTION: Do not remove or return the sensors to the measurement module
membranes. Replace the glucose and lactate biosensors with the test/blank (TB4)
sensor before cleaning the sample path.
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
1. Take the appropriate action.
840 or 850
Go to step 2.
860
a. Remove the glucose and lactate biosensors.
b. Install the test/blank sensors.
c. Go to step 2.
2. Deproteinize the sample path:
a. Prepare the deproteinizer as directed on the package.
b. Select 2 Maintenance and press Enter.
c. Select 1 Deproteinize and press Enter.
d. Invert the deproteinizer several times to mix.
e. Insert an aspiration adapter into the sample port and insert the other end
into the deproteinizer.
f. Press Analyze.
g. Remove the adaptor when prompted.
h. Wait 5 minutes for the deproteinizing cycle to finish.
Prolonged exposure to the 10% bleach solution damages the
reference sensor membrane. You must replace the reference sensor with a
test/blank ref sensor (TB5) while you complete the cleaning procedure. Do not
substitute a new reference sensor.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
3. Replace the reference sensor with a test/blank ref sensor (TB5):
a. Remove the reference sensor from the measurement module and set it
aside.
b. Install a test/blank ref sensor (TB5) in the measurement module.
4. Access the Condition screen from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 2 Condition and press Enter.
Wear safety glasses, gloves, and a laboratory coat when
handling the reagents.
5. To clean the sample pathway:
a. Insert an aspiration adapter into the sample port and immerse the aspiration
adapter in the 10% bleach solution.
b. Press Analyze.
c. Remove the aspiration adapter when prompted.
d. Wait 5 minutes for cleaning to finish.
Press Cancel if you want to stop cleaning.
e. Press No. The Menu screen appears.
6. Perform two additional wash sequences.
Do not remove or return the sensors to the measurement module
without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.
7. Replace the reference sensor:
a. Remove the test/blank ref sensor (TB5) in the measurement module and set
it aside.
b. Install the reference sensor in the measurement module.
1. Remove all the reagent bottles from the system and perform a prime sequence.
2. Access the Prime screen from the Menu screen:
a. Select 2 Maintenance and press Enter.
b. Select 3 Prime and press Enter.
3. Select All Reagents and press Enter.
4. Press Done.
5. Press Menu to return to the Menu screen.
6. Press No.
7. Access Fluidics Functions from the Menu screen:
a. Select 3 Troubleshooting and press Enter.
b. Select 1 Fluidics System and press Enter.
c. Select 1 Fluidics Functions and press Enter.
8. Select C1/C2 and press Enter.
9. Press Start Test.
10. Press Exit Test.
11. Empty, rinse, and fill the four reagent bottles with reagent water.
12. Install the reagent bottles containing reagent water in place on the system.
13. Perform a Prime sequence as described in steps 2 through 6.
14. Perform an C1/C2 Fluidics Function Test as described sequence 7 through 10.
15. Remove the reagent bottles.
16. Air dry the pathways:
a. Repeat steps 2 through 6 without the reagent bottles in place.
b. Repeat steps 7 through 10 without the reagent bottles in place.
1. Stop the system from the Menu screen:
a. Select and press .
b. Select and press .
2. Grasp the sample door and pull it to the right as shown in Figure H-6.
3. Grasp the tab on the retainer ring and firmly pull the tab toward you to rotate
the ring.
Mount
O-ring
Drip Tray
Retainer Ring
Sample Door
Sample Port
4. Grasp the sample port and drip tray and pull it to the right to remove it.
The sample port and the drip tray are one piece.
Wear safety glasses, gloves, and a laboratory coat when
handling the reagents.
5. Clean any deposits on the sample port, the drip tray, and the mount with a
lint-free swab moistened with a 10% solution of household bleach.
6. Rinse the sample port, the drip tray, and the mount with reagent water.
Ensure that the three O-rings are in place.
7. Reinstall the sample port, matching the tab on the sample port to the notch in
the retainer ring.
8. Push the tab on the retainer ring away from you until it locks in place.
9. Reinstall the sample door, ensuring that it snaps in place.
10. Press .
11. Press .
12. Press to return to the Ready screen.
Wear safety glasses, gloves, and a laboratory coat when handling
the reagents.
1. Using a 10% solution of household bleach, wipe all exterior surfaces
including:
the sample entry components and the drip tray
the waste area
NOTE: Do not insert swabs into the sample port or spray anything into the
measurement module.
2. Rinse the exterior surfaces with reagent water.
3. Clean spills around any of the roller cages, if required:
a. Remove the roller cage as described in Replacing a Roller Cage in
Section 3.
b. Clean the roller cage and the roller cage shaft with a 10% solution of
household bleach.
c. Rinse with reagent water and dry thoroughly.
d. Reinstall the roller cage.
4. Empty and discard the waste bottle. Clean waste outlets and waste outlet cover
as described in Emptying the Waste Bottle in Section 3.
5. Remove the printer paper. Refer to Replacing the Printer Paper in Section 3.
6. Tape the printer cover in place.
1. Shut down the system from the Menu screen:
a. Select 7 System Utilities and press Enter.
b. Select 3 Shutdown and press Enter.
c. Press Yes.
The Shutdown screen appears.
Do not unplug the system until the following message appears on
the screen:
...synching disks... done
This is an operating system message, indicating that the system has
successfully completed the shutdown procedures. Unplugging the system
before this message appears can damage the system.
2. When you see the operating system message, you can disconnect the power
cord from the power supply.
Compressed gas tanks require cautious handling. To prevent
damage and possible personal injury, refer to Replacing the Gas Tanks in Section
3, for more detailed precautions.
1. Remove the gas tanks, as shown in Table H-4:
)'(% # " $#!
" $#! !&
" %
$"## & "
% $##
% #
& "
" a. Using a valve wrench, close each gas tank by turning the valve stem
clockwise.
b. Disconnect the gas regulators from the gas tanks by unscrewing the yoke
screws.
c. Verify that the gas tank seals are in place on the regulators.
d. Remove the gas tanks to a well ventilated, open area.
e. Position each valve outlet so that it is facing down, away from loose
objects.
Avoid contact with the gas stream. Gas under pressure can cause
bodily injury and property damage.
f. Using the wrench, release the contents of the gas tanks by turning the valve
stems counterclockwise.
g. When each gas tank is completely vented and the pressure is zero, label the
container Empty, and dispose of the tanks according to your laboratory
protocol.
Bayer Diagnostics recommends that you remove the valve stems before
disposal.
2. Pack the 800 system in the original shipping carton. If the original carton is no
longer available, contact your Service Representative for a replacement
shipping carton.
The measurement technology used for the 800 critical blood analytes systems is
based on electrochemical, biochemical and optical phenomena. Electrochemistry
involves the measurement of current or voltage occurring in an electrochemical
cell. The cell consists of two or more electrodes that interact with a chemical in
solution and are connected to an electrical system.
Electrodes used for measurement in the 800 systems are called sensors. Sensors are
responsible for direct measurement of a specific substance of interest in a sample.
They must have the following characteristics: a molecular or ion-specific
recognition mechanism, a transducer mechanism, and a signal processor system.
The molecular recognition mechanism gives a sensor its identity. Each sensor is
designed to selectively measure the activity of a specific substance. Although
many elements in a sample may interact with a sensor, the sensor is highly
selective for one substance over others. The common recognition mechanism used
in many 800 sensors is a membrane designed to be selective for a specific
substance.
The transducer mechanism converts the potential generated by the molecular
recognition mechanism to an electrical signal. In the 800 systems, this is
accomplished through potentiometry or amperometry. Potentiometry is the
technology that measures the difference in potential (voltage) between two
electrodes (the molecular recognition mechanism) in a solution without applied
current. Amperometry is a technique that involves applying voltage to the
electrode and then measuring the current generated.
The signal processing system conditions the electronic signal from the sensor,
through electronic smoothing and noise filtering. Then it converts the electronic
signals into a concentration expressed in recognizable units of measurement.
Potentiometry measures the voltage or potential generated between two electrodes
in an electrochemical cell when no external current is applied; the cell is in a state
of equilibrium. The electrochemical cell consists of two electrodes (a measuring or
indicator electrode and a reference electrode), an electrolyte solution (sample
solution), and a measuring device such as a voltmeter. The electrochemical cell is
capable of measuring the concentration or activity of a substance in a solution.
Refer to Figure I-1.
Voltmeter
Measuring Electrode
Reference Electrode
Liquid Junction
Sample Solution
Each electrode, which acts as a half-cell with a half-cell potential, contains an inner
reference element immersed in an internal electrolyte solution. The measuring
electrode is designed to respond to changes in the concentration of the specific
analyte being measured in the sample solution. It develops a half-cell potential that
is directly related to the concentration or activity of the specific analyte. The
reference electrode provides a steady, unchanging potential to the cell. Both
electrodes are connected to the measuring device. With the current in the cell at
zero, the potential developed by the electrochemical cell is determined by
calculating the difference in potential between the measuring electrode and the
reference electrode.
Ecell = Emeas – (Eref + Elj)
where
Ecell
=
electrochemical cell potential
Emeas =
measuring electrode half-cell potential
Eref
=
reference electrode 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 two liquids. This difference in rates results in a charge
separation that gives rise to the liquid junction potential. Although the potential
formed is small, it must be considered when measuring cell potential.9
System sensors are designed to measure a specific substance in a sample. To better
understand the ability of a sensor to measure specific substances, consider
ion-selective electrode (ISE) technology. Many of the sensors, like the pH sensor,
are designed with this technology. For the purpose of measuring a variety of
analytes in solution, sensors must have the ability to measure specific analytes in
solution. This ability is known as the recognition mechanism. An ISE contains a
specially designed membrane that provides sensor selectivity. Selectivity is the
ability of the sensor to interact with a specific ion in solution. The membrane
separates an inner, reference element, which is immersed in a fixed electrolyte
solution, from the sample.
During analysis, a membrane potential develops as a result of the interaction of the
analyte (ion) at the membrane. The membrane potential is related to the amount of
substance being measured in the sample. The half-cell potential in the sensor
consists of the inner reference element potential plus the membrane potential.
Voltmeter
A fixed electrolyte
solution surrounds
the inner element.
ISE Inner Reference
Element
Ion-selective
Membrane
Potassium Chloride
Solution
Inner element of
the reference electrode.
Liquid junction potential
develops here.
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 = reference electrode half-cell potential
Eref elmt = potential of the ISE inner reference element
Ememb = potential of the ISE membrane
Elj = liquid junction potential
In this equation, the reference electrode potential and the potential of ISE inner
reference element are constant; the liquid junction potential can be controlled.
Therefore, the potential remaining is the potential generated at the membrane. The
membrane potential corresponds to the ion activity and is related directly to the
concentration of the ion in solution. The cell potential is expressed quantitatively by
the Nernst equation.9
Ecell = K + (2.3 RT/ZF) log ai
where
Ecell = electrochemical cell potential
K = a constant from various sources such as the liquid junction
R = gas constant
T = absolute temperature
Z = ionic charge
F = Faraday’s constant
ai = activity of the ion in the sample
This equation states that the cell potential is logarithmically related to the activity
of the analyte in the sample.
The potential that the sensor actually measures is the activity of the analyte in
solution. In clinical chemistry, it is typical that the results be expressed in the
concentration of total substance rather that the activity of the substance. For this
reason, the measured results must be expressed in units of concentration.
The activity equals the numerical value of the concentration of the ion (mol/L)
times the activity coefficient. The activity coefficient is a measure of the degree
with which the ion interacts with other ions in solution. The activity coefficient is
dimensionless and depends on the ionic strength of the solution.
I = 1/2 ∑ m * z2
where
I = ionic strength of the solution
z = the charge number of the ions in solution
m = concentration of the ion (mol/L)
The activity coefficient generally decreases with increasing ionic strength.10
Using an established convention, the activity of ions that are measured by sensors
can be expressed in terms of concentration. This convention contains the
assumption that the normal ionic strength of blood plasma water is 160 mmol/kg.11
Because ionic strength is the primary variable affecting the activity coefficient of
ionic species in solution, controlling the ionic strength of calibrating solutions to
160 mmol/kg sets the activity coefficients of ionic species in the calibrating
solutions equal to those of blood plasma water at sample ionic strengths close to
normal. Both calibrations and the expression of measured quantities may then be
made in units of concentration instead of activity.12
The reference sensor for the 800 systems works with certain measuring sensors in
the measurement module to create an electrochemical cell. It provides a fixed
potential, which is independent of analyte activity. The system compares the fixed
potential of the reference sensor to the measured potential from the following
sensors:
pH
840, 850, 860
Na+
850, 860
K+
850, 860
Cl–
850, 860
Ca++
850, 860
The reference sensor contains a silver (Ag) wire, coated with a layer of silver
chloride (AgCl) and an ion permeable polymer, surrounded by a saturated
potassium chloride (KCl) solution. By ensuring that the concentration of Cl–
remains unchanged in the solution, the reference sensor maintains a constant
electrical potential. A potassium chloride (KCl) block is in the reference sensor
solution chamber to ensure a saturation solution of KCl at 37°C. Refer to
Figure I-3.
Solution Chamber
Silver/Silver
Chloride Wire
Saturated Potassium
Chloride Solution
Sample Path
A permeable cellulose membrane separates the KCl solution from the sample and
provides the ionic conduction between the KCl solution and the sample. The
membrane completes the conductive path to the sample from the fixed half-cell
potential that is required for the measurement.
The Ag wire conducts the half-cell potential of the reference sensor to the
measurement device where it is compared to the potential of the measuring sensor.
The potential difference measured reflects the concentration of analyte in the
sample. Although the reference sensor provides a constant potential from sample to
sample, the potential difference measured between sensors varies with each
sample.
Amperometry is an electrochemical technique used to determine the amount of a
specific substance in solution by applying a fixed voltage between two electrodes
in an electrochemical cell, and then measuring the current generated as a result of a
reaction which produces or consumes electrons (oxidation or reduction,
respectively).
The electrochemical cell contains two electrodes: the anode, which is positively
charged and the cathode, which is negatively charged. The measuring electrode,
which is frequently composed of platinum(Pt) or another noble metal, can be either
the anode or the cathode. Each electrode is attached to an external voltage source
as shown in Figure I-4.
Electrical current
is measured by
ammeter.
Ammeter
Applied
Voltage
Positively charged
electrode acts as
an anode.
Negatively charged
electrode acts as a
cathode.
Test Solution
As the sample comes in contact with the two electrodes, a known voltage is applied
between the anode and the cathode. The analyte to be measured is either an
oxidizable or reducible species. If the analyte is an oxidizable species, it will
diffuse to the anode where it is oxidized. If the analyte is a reducible species, it will
diffuse to the cathode, where it is reduced. In either case, the electrochemical
reaction produces a current flow between the anode and cathode that can be
measured by a device, such as a milli/micro ammeter. The current measured is
directly proportional to the concentration of substance (oxidizable or reducible)
present in the sample solution.
The 800 series systems analyze blood samples for pH, pO2, and pCO2.
The notation of pH expresses the hydrogen ion activity in a solution as the negative
logarithm of the hydrogen ion concentration. The hydrogen ion is actually the
determinant of the acidity of blood or plasma. Normal cellular metabolism requires
an exacting environment where hydrogen ion concentration must be maintained
within narrow limits. Hydrogen ion activity reflects the acid-base balance within
blood. Acids are substances that donate hydrogen ions; bases are substances that
remove hydrogen ions from solution. The lungs, kidneys and blood bases all work
to maintain the acid-base status within the strict limits for normal cell functioning.
Expressed in concentration units, hydrogen ion concentrations are very small
numbers that are cumbersome to use. (For example the common “neutral” pH of
7.00 is 0.0000001 mol/L.) In 1909 Sorenson13 converted the numbers
mathematically to simplify their use and described the notation pH
pH = –log 10 cH+
where (H+) is the molar concentration of hydrogen ions.
Using this formula, a hydrogen ion concentration of 1 x 10–7 mol/L has a pH value
of 7. Because pH is the negative logarithm, it’s value is inversely proportional to
the actual hydrogen ion concentration in a sample. Therefore, as the hydrogen ion
concentration decreases, the pH value increases and visa versa.
The normal pH range of human blood is 7.35 – 7.45.
The Henderson-Hasselbalch equation describes how pH expresses the interaction
of acid and base in blood.
where K is the dissociation constant, which describes the ability to release
hydrogen ions.
Since K, and thus pK, is a constant, this equation can be used to demonstrate that
pH is proportional to the acid-base concentrations
in blood.
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. An acid-base
disorder resulting initially from ventilatory dysfunction is called a primary
respiratory acidosis or alkalosis, while a disorder due to renal or gastrointestinal
inadequacy is referred to as metabolic acidosis or alkalosis. Using acceptable
therapeutic ranges, a pH less than 7.3 indicates acidosis, and a pH greater than 7.5
indicates alkalosis.14
The pH sensor, which is based on ISE technology, is a half-cell that forms a
complete electrochemical cell when combined with the external reference sensor. It
contains a silver/silver chloride wire surrounded by a buffer solution. A glass
membrane that is highly sensitive and specific for hydrogen ions separates the
sample from the solution.
Buffer Solution
Silver/Silver Chloride
Wire
Sample Path
As the sample comes in contact with the membrane of the pH sensor, a membrane
potential develops due to the exchange of hydrogen ions in the membrane. The
silver/silver chloride inner conductor transmits the potential to a voltmeter where it
is compared to the constant potential of the reference sensor. The final measured
potential reflects the hydrogen ion concentration of the sample and is used to
report the pH value of the sample.
Carbon dioxide (CO2) is produced during normal cell metabolism and is released
into the blood stream where it is transported to the kidneys and lungs for excretion.
CO2 is transported through the blood as bicarbonate (HCO3–), dissolved CO2, and
carbonic acid (H2CO3). CO2 exists in a dynamic state in the blood as seen in the
following equation:
CO2 + H2O H2CO3 HCO3–+ H+
The levels of HCO3–, H2CO3, and dissolved CO2 play a major role in maintaining
the pH in blood. This relationship is best described through the
Henderson-Hasselbalch equation:
Substituting HCO3– as the base and dissolved CO2 and H2CO3 as the acid, the
equation reads as follows:
Taking the equation further, pH is seen as being proportional to the acid-base
relationship:
Although other acids and bases are present in the blood, the H2CO3/HCO3–
relationship is sensitive and dynamic and typically reflects other acid-base
changes.
When the measurement of the partial pressure of carbon dioxide (pCO2) in the
blood is combined with the measured pH, the values can be incorporated into the
Henderson-Hasselbalch equation to determine HCO3– in addition to the ctCO2.
Since 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.
The measurement of pCO2 is essential in determining ventilatory status. Because
the lungs are primarily responsible for controlling pCO2 levels, changes in pCO2
reflect respiratory status. For example, an increase in CO2 indicates decreased
ventilation as CO2 is retained, and a decrease in CO2 indicates increased
ventilation (hyperventilation) as CO2 is expired from the lungs.
Together, pH and pCO2 provide a more definitive diagnostic tool in assessing
respiratory function. An increase in the pCO2 value and a decrease in pH indicates
respiratory acidosis—a condition in which CO2 is retained by the lungs. A
decrease in the pCO2 value and an increase in pH indicates respiratory
alkalosis—a condition in which the lungs are expiring too much CO2 relative to the
amount produced.
The pCO2 sensor is based upon the electrode described by Severinghaus and
Bradley.15 It is a complete electrochemical cell that consists of a measuring
electrode and an internal reference electrode. The measuring electrode, which is a
pH electrode, is surrounded by a chloride bicarbonate solution. A membrane
permeable to gaseous CO2 separates this solution from the sample. The internal
reference electrode, which contains a silver/silver chloride electrode surrounded by
the chloride-bicarbonate solution, provides a fixed potential.
Internal Reference
Electrode Contact
Measuring Electrode
Contact
Sample Path
As the sample comes in contact with the membrane, CO2 diffuses into
the chloride-bicarbonate solution, which causes a change in the hydrogen ion
activity.
CO2 + H2O HCO3– + H+
The internal pH electrode detects the change in hydrogen concentration occurring
in the chloride bicarbonate solution and generates a half-cell potential. This
potential, when compared to the fixed potential of the reference electrode, results
in a measurement that reflects pH change in the chloride bicarbonate solution. The
change in pH is related to the log of the partial pressure of CO2.
Oxygen (O2) is essential for cell and tissue metabolism in the body. The
cardiopulmonary system is responsible for transporting oxygen to the cells.
Oxygen transport involves four major steps: convection and diffusion from the air
into the pulmonary circulation, combination of O2 from the lungs with hemoglobin
in red blood cells, transportation of the O2 through the arteries to the cell, and
finally the release into the tissues and utilization of O2 at the cellular level.
Since it is not possible to measure intra-cellular oxygen tension (pO2), arterial pO2
has become a standard for clinical evaluation of arterial oxygenation status.
Measurement of pO2(A), which indicates the oxygen tension in arterial blood,
reflects the pressure or driving force for moving oxygen from one location to the
next due to pressure differential; it is not a measurement of the O2 content, but it
provides a measurement tool to evaluate the pulmonary gas exchange efficiency
from an arterial blood sample.
Complete laboratory evaluation of oxygenation often requires much more than
simple blood gas measurements. Assessment of ventilatory system and acid-base
status is essential to properly interpret clinical significance of arterial oxygenation
status. However, many patients can be evaluated and treated successfully using
blood gases alone if clinical observations and patient history are taken into
account.16
The measurement of pO2 is significant in evaluating the degree of hypoxemia (a
deficiency of O2 in arterial blood) present in a patient. The laboratory reference
value for pO2 is usually 95 mmHg (12.7 kPa) for a healthy young adult living near
sea level. However, as with pCO2 and pH, a wider range of values may occur
before any therapeutic action is indicated. Generally a pO2 of 80 mmHg (10.7 kPa)
signals therapeutically significant hypoxemia. Above this value there is very little
change in oxygen saturation or oxygen content with changes in oxygen tension, but
below it changes in saturation can occur rapidly. Exceptions to this limit are
newborns, who have an acceptable range of 40 – 70 mmHg (95.3 – 9.3 kPa) and
adults over 50 years old, who have a normal deterioration of lung function that
causes a decrease in expected pO2 values of about 1 mmHg (0.13 kPa) per year.14
The pO2 sensor is based upon the electrode described by Clark.17 It is a complete
electrochemical cell that incorporates amperometric technology. The sensor
consists of a platinum (Pt) cathode, and silver (Ag) anode, an electrolyte solution,
and a gas permeable membrane.
Anode Contact
Cathode Contact
Sample Path
A constant voltage, 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.
O2 + 2H2O + 4e– 4OH–
The circuit is completed at the anode, when the Ag is oxidized.
4Ag 4Ag+ + 4e–
The amount of reduced oxygen is directly proportional to the number of electrons
gained at the cathode. Therefore, by measuring the change in current (electron
flow) between the anode and the cathode, the amount of oxygen in the electrolyte
solution is determined.16
The 850 and 860 systems analyze blood samples for sodium (Na+), potassium
(K+), chloride (Cl–), and calcium (Ca++) in addition to pH and the blood gases.
These systems report two additional parameters, the anion gap and a value for
calcium adjusted to pH of 7.40. Refer to the section Other Reported Parameters,
page I-25, for a discussion of these parameters.
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 I-8 identifies components of the electrolyte sensors. The illustration shows
two sensors. One represents the K+, the Cl–, and the Ca++ sensors, which have
similar components. The other represents the Na+ sensor.
Electrolyte Solution
Electrolyte
Solution
Silver/Silver Chloride
Wire
Silver/Silver Chloride
Wire
Sample Path
Sample Path
Potassium, Chloride, and
Calcium Sensor
Sodium Sensor
The recognition mechanism in the ISE is the membrane. Each sensor has a
membrane selective for the specific substance that it measures. To understand this
concept more clearly, take the case of the potassium sensor. The potassium sensor
membrane is designed as a charge separator. As shown in Figure I-9, the
positively-charged potassium ions selectively interact with the membrane when the
sample interfaces with the membrane. The negatively-charged chloride ions do not
interact with the membrane. The charge separation causes the membrane potential
that is measured by the electrochemical cell.
Internal Electrolyte
Solution
Electrode
K+
Na+
Cl-
K+
Cl-
K+
Cl-
ClNa+
Cl-
K+
Cl-
K+
Cl-
K+
ClNa+
K+
K+
Cl-
K+
Cl-
K+
Cl-
K+
K+
Membrane
Electrolyte
Solution
Na+
Cl-
K+
Cl-
Cl-
Randomly
Oriented Ions
Sodium (Na+) is the most abundant cation in the extracellular space in the body. It
is the major determinant of extracellular osmotic regulation and plays a central role
in determining body fluid volume. The kidneys are the primary regulator of
sodium and consequently water volume; only minimal amounts of sodium are lost
through the skin and other insensible sites. Two regulatory hormones, aldosterone
and the antidiuretic hormone (ADH), affect kidney function and hence sodium
balance. Aldosterone stimulates the kidneys to reabsorb sodium; ADH stimulates
the kidneys to reabsorb water. Maintaining sodium homeostasis is essential in
order to regulate body fluids, maintain electrical potential in muscle cells, and
control cellular membrane permeability.
Clinically, plasma sodium levels are significant in diagnosing and treating
conditions related to sodium imbalance, such as gastroenteritis, vomiting, diarrhea,
Addison’s disease, and acute renal failure.
The sodium sensor is a half-cell that combines with the external reference sensor to
form a complete electrochemical cell. The sensor contains a silver/silver chloride
wire surrounded by an electrolyte solution that has a fixed concentration of sodium
and chloride ions. The membrane, a specially formulated glass capillary that is
highly selective for sodium ions over other clinically encountered cations,
separates the electrolyte solution from the sample.
As the sample comes in contact with the membrane of the sensor, a potential
develops due to the exchange of sodium ions in the membrane. The potential
developing across the membrane is compared to the constant potential of the
external reference sensor. The final measured potential is proportional to the
sodium ion concentration in the sample. The potential developed by the
electrochemical cell varies with the ion activity in each sample.
Potassium (K+) is the major intracellular cation. It plays an important role in
maintaining cell membrane potential in neuromuscular tissue. The normal level
within cells is 150 mmol/L, while the normal extracellular potassium level is only
4 mmol/L. A depletion of extracellular potassium causes an increase in the
transmembrane electrical potential gradient, which impedes the impulse formation
and propagation involved in muscle contraction.
Most potassium is excreted by the kidney, which is the major regulator of
potassium output in the body. Actually, the kidney is better at conserving sodium
and excreting potassium so in cases where potassium intake stops, the kidney
requires time to adjust and stop excreting potassium. Two hormones, insulin and
aldosterone can affect the extracellular level of potassium. Both insulin and
aldosterone influence intercellular uptake of potassium, while aldosterone causes
increased potassium excretion through the kidney.
Because the serum level of potassium is so small, minor changes can have
significant consequences. Therefore, monitoring potassium levels is important
especially in patients who are undergoing surgery, or who are experiencing cardiac
arrhythmias or acute renal failure, and who are being treated with diuretics.
Additionally, regulating serum potassium is significant in cardiac patients who are
receiving digitalis therapy since hypokalemia can increase cardiac sensitivity to
digoxin.18
The potassium sensor is a half-cell that combines with the external reference
sensor to form a complete electrochemical cell. The sensor contains a silver/silver
chloride wire surrounded by an electrolyte solution that has a fixed concentration
of potassium ions. The membrane, which consists of the ionophore valinomycin
immobilized in a plasticized PVC (polyvinyl chloride) matrix, separates the
electrolyte solution from the sample. Valinomycin is a neutral ion carrier that is
highly selective for potassium ions over other clinically encountered cations.
As the sample comes in contact with the membrane of the potassium sensor, a
membrane potential is created by the interaction of potassium ions with the
membrane. The potential developing in the potassium sensor is compared to the
constant potential of the external reference sensor. The final measured potential is
directly proportional to the potassium ion concentration in the sample. The
potential developed by the electrochemical cell varies with the ion activity in each
sample.
Chloride (Cl–) is the major extracellular anion in the body. It plays a large role in
maintaining electrical neutrality and normal osmolality, and it participates in the
regulation of acid-base balance. The kidneys are the main regulator of chloride in
the body. Serum levels of chloride usually correspond to increases and decreases of
sodium. Clinically, the serum chloride level alone is rather meaningless. A change
in chloride level does not reveal much about a patient’s condition; it must be
viewed as part of the overall fluid and electrolyte status.
Hypochloremia is usually seen in states of hyponatremia. However in pyloric
stenosis, chloride levels are usually proportionally lower than sodium levels.
Hyperchloremia is seen in cases of excessive administration of chloride and in
renal failure. Additionally, because the chloride level remains fairly constant, it is
valuable in the calculation of the anion gap.
The chloride sensor is a half-cell that combines with the external reference sensor
to form a complete electrochemical cell capable of measuring chloride
concentration in a sample. The sensor contains a silver/silver chloride wire
surrounded by an electrolyte solution that has a fixed concentration of chloride
ions. The membrane is a derivitized quaternary ammonium compound that is
immobilized in a polymer matrix. It acts as an ion exchanger with a high selectivity
for chloride ions over other ions present in the sample, and separates the electrolyte
solution from the sample.
As the sample comes in contact with the membrane of the chloride sensor, chloride
ion exchange occurring at the membrane, creates a membrane potential. The
potential that develops in the chloride sensor is compared to the constant potential
of the external reference sensor. The final measured potential is directly
proportional to the chloride ion concentration in the sample. The potential
developed by the electrochemical cell varies with the ion activity in the sample.
Ionized calcium (Ca++) is the physiologically active form of calcium, which
comprises approximately 45% of the total calcium in plasma. It is essential for the
contractility of smooth vascular muscle, and, it plays a vital part in cardiovascular
function. It is also important in muscle function, nerve function, and bone
formation, and it is a cofactor in many cellular hormone and enzyme reactions.
The action of the parathyroid hormone (PTH)—1,25 dihydroxyvitamin D
(1,25D)—and calcitonin closely controls the concentration of calcium in
extracellular fluid, and regulates the transport of calcium across the gastrointestinal
tract, kidney, and bone. Calcium is one of the most tightly controlled analytes in
the body with fluctuations of less than 5% occurring about the mean during a
24-hour period.19
Clinically, hypocalcemia can result from a deficiency of PTH or 1,25 D, which can
be caused by malabsorption of vitamin D, hypoparathyroidism, or chronic renal
failure. Hypercalcemia, which occurs more frequently than hypocalcemia, is
commonly caused by primary hyperparathyroidism and malignant disease. The
elevated calcium resulting from both of these conditions can produce abnormal
cardiovascular rhythms.
In critical care situations, especially where large amounts of blood are being
transferred, ionized calcium levels should be monitored closely. Transfused blood
typically contains citrate as an anticoagulant that can bind ionized calcium and
affect its level in the blood. Although total calcium levels may increase, ionized
calcium may decrease and lead to cardiac and neuromuscular malfunction.
When measuring ionized calcium, pH should also be measured. Because hydrogen
ions compete with calcium for calcium binding sites, a change in sample pH can
have a direct effect on calcium levels. For example, a change in pH of 0.1 can
cause a change in calcium of 0.2 mg/dL, which exceeds the span of the normal
range. Its effects, if not taken into account, are clearly significant.20
The calcium sensor is a half-cell that combines with the external reference sensor
to form a complete electrochemical cell capable of measuring calcium levels in a
blood sample. The sensor contains a silver and silver chloride wire surrounded by
an electrolyte solution that has a fixed concentration of calcium ions. A membrane,
consisting of an ionophore imbedded in a polyvinyl chloride membrane, separates
the electrolyte solution from the sample. The ionophore is a compound that is
highly selective for calcium ions over other ions.
When the sample comes in contact with the membrane of the measuring sensor, a
membrane potential develops as calcium ions interact with the membrane. This
membrane potential is compared to the constant potential of the external reference
sensor. The final measured potential is proportional to the calcium ion
concentration in the sample. The potential developed by the electrochemical cell
varies with the ion activity in each sample.
The 860 system analyzes blood samples for glucose and lactate in addition to pH,
blood gases, and electrolytes.
Glucose is the fundamental molecule in carbohydrate metabolism. Carbohydrates,
which provide a major food supply and energy source for the body, are broken
down into simple sugars such as glucose. Glucose is then absorbed through the
intestine, passes through the liver, and eventually enters the vascular system where
it reaches the cell level to be used as fuel.
A number of factors influence the level of blood glucose. Dietary intake has a
direct effect of glucose concentration. Blood levels of glucose will fluctuate
depending on nutritional condition and the time of day when a sample is taken.
Insulin, a hormone produced by specialized cells in the pancreas, plays an
important role in regulating the blood level of glucose. By promoting glycogenesis
(conversion of glucose to glycogen) and by increasing the permeability of cells to
glucose, insulin can decrease blood glucose levels.
Determining the blood glucose level is helpful in diagnosing many metabolic
diseases. Hyperglycemia is usually equated with diabetes mellitus where the
pancreas fails to supply sufficient insulin to control glucose levels. However, other
conditions such as Cushing’s disease, hyperthyroidism, pancreatitis, and diuretic
therapy can also cause an increase in glucose levels. Hypoglycemia is most
frequently caused by over administration of insulin. Other causes of low blood
glucose levels include Addison’s disease, hypopituitarism, and severe liver disease.
Lactate acid is an intermediary product of the anaerobic metabolism of glucose.
Glycolysis is the term commonly used to describe the conversion of glucose to
lactic acid. Under normal circumstances, glycolysis occurs during muscle
contraction where the rate of metabolism outpaces the oxygen supply in the cells.
During strenuous exercise, the level of lactic acid increases significantly and
passes to the blood where it is transported to and metabolized by the liver. In
normal aerobic conditions the lactic acid is readily oxidized in the cell to pyruvic
acid, which is eventually degraded to CO2 and H2O.
The concentration of lactate in the blood is affected by the rate of production, the
rate of metabolism, and the availability of oxygen at the cell level.
Determining the blood lactate level is helpful in assessing the supply of oxygen at
the tissue level. Increased oxygen deprivation causes the normal oxidation of
pyruvic acid to lactate and can cause severe acidosis called lactic acidosis. This
condition is characterized by increased lactate levels and increased lactate:pyruvic
ratio in the blood due to the lack of cellular oxidative process. Additionally,
increased lactate levels are seen in hypoxia with hypoxemia as seen in shock,
cardiac decompensation, and pulmonary insufficiency. Finally, because the liver
plays a significant role in lactate metabolism, decreased liver perfusion will result
in increased lactate levels.
The glucose and lactate biosensors are complete electrochemical cells that
incorporate amperometric technology to measure glucose or lactate concentration
in samples. The biosensors consist of four electrodes.* The measuring electrode
contains platinum and glucose oxidase or lactate oxidase in a binder, while the
reference electrode is composed of Ag/AgCl. Two other electrodes are also
present. The counter electrode is a Pt (platinum) conductor that ensures a constant
applied potential. Another measuring electrode, without the enzyme, determines
interfering substances in the sample. The potential from interfering substances is
removed from the total differential measurement. A microporous cover membrane
separates the electrodes from the sample.
Interference Measuring
Electrode
Reference Electrode
Glucose Measuring
Electrode
Counter Electrode
Sample Path
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
C 6H 12O 6 H 2O O 2
(glucose)
GOX
C 6H 12O 7 H 2O 2
(gluconic acid)
where GOX is the glucose oxidase.
The polarizing voltage is sufficient to cause oxidation of the hydrogen peroxide to
oxygen.
H 2O 2 2H O 2 2e –
* Platinized activated carbon electrode technology license from Cambridge Life Sciences plc. under U.S.
Patent Nos. 4,970,145 and 5,160,418 and foreign counterparts.
The loss of electrons in the oxidation of H2O2 creates a current flow that is directly
proportional to the lactate concentration in the sample.
In the lactate sensor, lactic acid from the sample interacts with the lactate oxidase
on the surface of the measuring electrode to form pyruvic acid and hydrogen
peroxide
C 3H 6O 3 H 2O O 2
LOD
C 3H 4O 3 H 2O 2
(lactic acid) (pyruvic acid)
where LOD is the lactate oxidase.
The polarizing voltage is sufficient to cause oxidation of the hydrogen peroxide to
oxygen.
H 2O 2 2H O 2 2e –
The loss of electrons in the oxidation of H2O2 creates a current flow that is directly
proportional to the lactate concentration in the sample.
Hemoglobin analysis yields important information necessary to assess the function
of the oxygen transport system. The need for hemoglobin determinations has led to
the development of a number of methods to determine the concentration of total
hemoglobin, hemoglobin derivatives, and dyshemoglobins in whole blood. The
presence of dyshemoglobins and toxins changes the oxygen binding capacity of
hemoglobin and therefore its ability to transport oxygen.33
Hemoglobin is a tetrameric protein consisting of two pairs of polypeptide chains,
each chain having a heme group containing one atom of iron. Each molecule of
hemoglobin can bind up to four molecules of oxygen, one at each heme group.
Hemoglobin has a key role in the transport of oxygen from the lungs to the tissues
and the transport of carbon dioxide from the tissues to the lungs.
Hemoglobin’s ability to bind and release oxygen depends on several factors:37 pH,
pCO2, pO2, 2, 3–diphosphoglycerate concentration, temperature.
The presence of dyshemoglobins (that is, hemoglobins not available for reversible
binding with oxygen), such as carboxyhemoglobin, methemoglobin, and
sulfhemoglobin, as well as abnormal concentrations of hemoglobin variants, such
as fetal hemoglobin, may also affect the normal oxygen transport mechanism.38
Hyperlipemia can result in artificially increased methemoglobin
values.42, 43 High bilirubin concentrations can falsely increase oxyhemoglobin
values. Hyperlipemia and administration of fat emulsions can increase total
hemoglobin values. Samples frozen with liquid nitrogen can have decreased total
hemoglobin levels.43 Samples from patients receiving blood substitutes yield
unreliable results for oxygen content blood due to the different oxygen solubility of
the blood substitutes.
Total hemoglobin (tHb) is the total of all measured hemoglobin fractions.38 Total
hemoglobin determination is important in the assessment of oxygen transport and
in the evaluation of anemia. The total hemoglobin reference range for a normal
adult population is 12.0 to 18.0 g/dL.
Total hemoglobin in the CO-ox module is determined using the following
equation:
tHb = FO Hb + FHHb + FMetHb + FCOHb
Oxyhemoglobin (O Hb) is the fraction of hemoglobin that is reversibly bound to
oxygen.38 The oxyhemoglobin reference range for arterial blood for a normal
population is 94.0 to 97.0%.
The percent of oxyhemoglobin is determined using the following equation:
cO 2Hb
FO 2Hb ctHb 100
Deoxyhemoglobin (HHb) refers to the hemoglobin capable of binding oxygen.
Deoxyhemoglobin is sometimes referred to as reduced hemoglobin.38 The
deoxyhemoglobin reference range for arterial blood for a normal population is 0.0
to 5.0%.
The percent of deoxyhemoglobin is determined using the following equation:
cHHb
FHHb ctHb 100
Methemoglobin (MetHb), which is sometimes known as hemoglobin Hi, is
hemoglobin whose iron is oxidized to its ferric state (FE(111) and is unable to bind
oxygen. High methemoglobin concentrations, a condition called
methemoglobinemia, can produce hypoxia and cyanosis. Methemoglobinemia can
be the result of hereditary conditions or of exposure to toxic substances such as
nitrates, nitrites, aniline dyes and their derivatives and topical anesthetics such as
benzocaine.39,41 Infants and other individuals with significant fetal hemoglobin
concentrations show increased susceptibility to methemoglobinemia because fetal
hemoglobin converts to methemoglobin more readily than adult hemoglobin.27,40
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 100
ctHb
Carboxyhemoglobin (COHb) is hemoglobin covalently bound to carbon monoxide.
Hemoglobin has over 200 times greater affinity for carbon monoxide than for
oxygen. Hemoglobin bound to carbon monoxide is unavailable for oxygen
transport, and high levels of carboxyhemoglobin result in hypoxia and cyanosis,
which can be fatal.
The carboxyhemoglobin reference range for a normal population is 0.0 to 1.5%.
While the amount of carboxyhemoglobin in the blood of healthy nonsmokers is
very small (between 0.1% and 0.4%), smoking, air pollution, and occupational
exposure to carbon monoxide affect COHb levels.39
The percent of carboxyhemoglobin is determined using the following equation:
cOHb
FCOHb ctHb 100
Sulfhemoglobin (SulfHb) is a stable compound of hemoglobin and sulfur.
Sulfhemoglobin has an extremely low affinity for oxygen and may often be
accompanied by methemoglobinemia. The presence of sulfhemoglobin affects
oxyhemoglobin values and other quantities if its absorbance spectrum is not
accounted for.39 The sulfhemoglobin reference range for a normal population is 0.0
to 2.2%.
The CO-oximeter (CO-ox) module detects and indicates concentrations of
sulfhemoglobin greater than 1.5%.
Hemoglobin derivatives have characteristic absorbance spectra; that is, 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 at a specific wavelength is equal to
the product of the path length, concentration of the fraction or substance, and the
molar absorptivity or the extinction coefficient for that substance, as shown in the
following equation:
A x ε 1C 1 2C 2
...
nC n
where Ax is the absorbance at a specific wavelength, ε is the major extinction
coefficient for that fraction or substance at a specific wavelength, and C is the
concentration of the substance.
These equations are based on the work of VanAssendelft33,34 and Benesch,
Benesch, and Yung.35
The 800 systems CO-oximeter (CO-ox) module measures the light of whole blood
at several wavelengths. Based on this, the CO-ox module measures and reports
total hemoglobin and other related quantities. The CO-ox module also detects the
presence of interfering substances such as bilirubin, cyanmethemoglobin, turbidity,
and dyes.
The CO-ox module is connected to the base model, which supplies power to the
module. The CO-ox module contains measuring, fluidic, and electronic
components. It uses the sample entry port, reagents, and waste components of the
base model.
The measurement system for the CO-ox module detects and quantitates the
analytes present in the sample. The measurement system has the following
components:
the lamp
the illumination optics (lenses and filters)
the fiber optic coupler
the sample chamber
the polychromator—which consists of coupling lenses, entrance slot, collimating
mirror, grating camera mirror, and the diode array
Light from the lamp passes through the lenses, a series of filters, and the fiber optic
coupler to the sample chamber. The light is coupled from the sample chamber, by a
second pair of lenses, to the polychromator. In the polychromator, light is
collimated by the first mirror and is diverted to the grating which separates the
light into a continuous spectrum of wavelengths. The spectrum of light is focused
by the second mirror to the diode array where the intensities at several wavelengths
are measured.
The sample chamber is located between the fiber optics and the polychromator.
After passing through the hemolyzer, the sample flows through tubing into the
sample chamber, where the sample is warmed to 37°C and then measured. The
sample chamber also acts a fluid detector, sensing when sufficient sample reaches
the chamber for measurement.
This section describes the specific reported parameters generated by the 800
system. The parameters are all based on NCCLS/IFCC recommendations unless
otherwise noted.
The bicarbonate ion (HCO3–) is the major buffer substance present in the body, and
plays a major role in maintaining the pH level in blood. It is present in large
amounts in the blood as a result of the dynamic state of CO2 in the blood. CO2 is
transported through the blood as bicarbonate (HCO3–), dissolved CO2, and
carbonic acid (H2CO3). The following equation describes the dynamic state of
CO2 in blood:
CO2 + H2O H2CO3 HCO3– + H+
The majority of CO2 is transported as HCO3–. Its role as a base is seen through the
Henderson-Hasselbalch equation:
pH pK log
base
acid
Substituting HCO3– as the base and dissolved CO2 and H2CO3 (which equals
0.0307 pCO2) as the acid, the equation reads as follows:
pH = pK + log
[HCO3–]
0.0307 pCO2
where pK, which is the dissociation constant describing the ability to release
hydrogen ions, equals 6.105 for normal plasma, and 0.0307 is a combination of
CO2 solubility in plasma and a factor for converting mmHg to mmol/L.
The equation can be further developed to show pH as proportional to the acid-base
relationship:
pH HCO 3 –
H 2CO 3
The equation clearly demonstrates the HCO3– H relationship. As HCO3–
increases the pH increases, and as HCO3– decreases the pH decreases.21
The kidneys are the major controller of the bicarbonate ion. Bicarbonate levels are
clinically significant in helping to determine the non-respiratory, renal (metabolic)
component in acid-base disorders.
Changes in HCO3– levels along with pH values can help determine whether
acidosis and alkalosis disorders are metabolic in origin. In metabolic acidosis,
HCO3– levels decrease causing an increase in H+ which leads to a decrease in pH.
Conversely, in metabolic alkalosis, HCO3– levels increase, causing a decrease in
H+, which leads to an increase in pH.
There are two versions of bicarbonate, the actual value and the standard value. The
800 system lets you select the bicarbonate equations to apply to patient results. You
can select the equation for actual bicarbonate, standard bicarbonate, or both.
Solving the Henderson-Hasselbalch equation for bicarbonate ion concentration
results in the following equation, which is based on the National Committee for
Clinical Laboratory Standards (NCCLS) recommendations,32 for actual
bicarbonate:
log cHCO3– = pH + log (pCO2 × 0.0307) – 6.105
The equation described by VanSlyke and Cullin23 is used for calculating standard
bicarbonate:
[HCO3–] = 24.5 + 0.9A + (A – 2.9)2 (2.65 + 0.31ctHb)/1000
where
A = BE(B) – 0.2 [ctHb] [100 – O2SAT]/100
The ctHb value can be entered during sample analysis or it can be a value defined
in setup.
Base excess is an empirical expression that approximates the amount of acid or
base required to titrate one liter of blood back to a normal pH of 7.40. The base
excess in blood with a pH of 7.40, a pCO2 of 40 mmHg (5.33 kPa), a total
hemoglobin of 15.0g/dL and a temperature of 37.0°C is zero. Base excess is useful
in the management of patients with acid-base disorders as it permits the estimation
of the number of equivalents of sodium bicarbonate or ammonium chloride
required to correct the patient’s pH to normal.
There are two versions of base excess, the base excess of extracellular fluid
[BE(ecf)] and the base excess of blood [BE(B)]. In the setup options, you can
select the version you want to use for displayed results, and you can select one or
both for printing on all patient reports.
The calculations for both versions of base excess are derived from the following
relationships, which are based on the NCCLS recommendations.22
The base excess of extracellular fluid, formerly known as in vivo base excess,
reflects only the nonrespiratory component of pH disturbances.
BE(ecf) = cHCO3– – 24.8 + 16.2 (pH – 7.40)
The base excess of blood, formerly known as in vitro base excess, is calculated
from the following equation.
BE(B) = (1 – 0.014 × ctHb) [(cHCO3– – 24.8) + (1.43 × ctHb + 7.7)(pH – 7.40)]
The ctHb value can be entered during sample analysis or can be a value defined in
setup.
Oxygen saturation is a ratio, expressed as a percentage of the volume of oxygen
carried to the maximum volume that can be carried by the hemoglobin. Knowledge
of oxygen saturation, when combined with knowledge of oxygen content, is useful
for evaluating the amount of oxygen actually available for the tissues and can be
used to determine the effectiveness of oxygen therapy.
Oxygen saturation can be directly measured or it can be estimated using the
relationship described by Kelman24 and Thomas25:
O2SAT =
N4 – 15N3 + 2045N2 + 2000N
N4 – 15N3 + 2400N2 – 31,100N + (2.4 × 106)
× 100
where N = pO2 × 10 [0.48(pH–7.4) – 0.0013 BE(B)] and BE(B) is calculated assuming 100%
oxygen saturation.
Since oxygen saturation also depends upon the level of carbon monoxide and 2,3
diphosphoglycerate (2,3 DPG) in the blood, the calculated value for oxygen
saturation may not be equal to the measured value in patients with abnormal levels
of 2,3 DPG or carbon monoxide. The equation does not account for these
variations, therefore, the oxygen saturation that is reported should only be used as
an estimate of the actual oxygen saturation.
NOTE: Clinically significant errors can result from incorporation of an estimated
value for oxygen saturation in further calculations, such as oxygen content and
shunt fraction (Qsp/Qt), or by assuming that the value obtained is equivalent to
fractional oxyhemoglobin.26
Hemoglobin oxygen saturation (sO ) is a ratio of the amount of hemoglobin bound
to oxygen to the total amount of hemoglobin able to bind oxygen.38 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. The hemoglobin
oxygen saturation reference range for arterial blood for a normal population is 92.0
to 98.5%.
Hemoglobin oxygen saturation, expressed as a percent, is determined using the
following equation:
O 2Hb
sO 2 O 2Hb HHb x 100
Oxygen content is the concentration of the total oxygen carried by the blood,
including oxygen bound to hemoglobin as well as oxygen dissolved in plasma and
in the fluid within red cells.
Clinically, dissolved oxygen is unimportant for most situations. However, at very
low levels of hemoglobin or in patients receiving hyperbaric oxygen therapy,
dissolved oxygen may be a very significant contributor to oxygen content and thus
to oxygen transport.
Oxygen content is determined, using NCCLS recommendations,26 from the
following relationship:
ctO2 = FO2Hb × 1.xx × ctHb + 0.00314 × pO2
where ctHb is expressed in g/dL.
If FO2Hb is unavailable, oxygen content is derived from estimated oxygen
saturation (O2SAT) according to the following equation:
O2CT = O2SAT × 1.39 × ctHb + .00314 × pO2
If ctHb is not measured or entered,O2CT is not displayed or printed.
NOTE: Clinically significant errors can result from incorporation of an estimated
value for oxygen saturation in further calculations, such as oxygen content and
shunt fraction (Qsp/Qt), or by assuming that the value obtained (O2SAT) is
equivalent to fractional oxyhemoglobin.26
The oxygen content of hemoglobin, ctO2(Hb), is the volume of oxygen actually
bound to hemoglobin.38 The oxygen content of hemoglobin, with hemoglobin
oxygen saturation 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. The oxygen content reference
range for arterial blood for a normal population is 15.0 to 23.0 mL/dL.
The oxygen content of hemoglobin for a sample analyzed only for CO-ox
parameters on an 800 system is determined using the following equation:
ctO2 (Hb) = 1.xx × FO2Hb × ctHb
where 1.xx represents the oxygen binding factor of hemoglobin and is a value in
the range of 1.30 to 1.40 as specified in the CO-ox module setup.
The oxygen content of a sample analyzed for blood gas and CO-ox parameters on
an 800 system is determined using the following equation:
ctO2 (B) = 1.xx × FO2Hb × ctHb + 0.00314 × pO2
where the additional equation component represents the dissolved oxygen (0.00314
is the solubility coefficient).
The oxygen capacity of hemoglobin (BO2 or O2CAP) is the maximum amount of
oxygen that the hemoglobin in a given quantity of blood can carry. This value
represents the potential of hemoglobin to bind to oxygen and includes all the
oxygen that can be bound to the available hemoglobin.38 The oxygen capacity of
hemoglobin, with hemoglobin oxygen saturation and oxygen content, 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.
The oxygen capacity reference range for arterial blood for a normal population is
17.6 to 23.6 mL/dL.
The oxygen capacity of hemoglobin is determined using the following equation:
O 2CAP 1.xx
FO 2Hb FHHb
x ctHb
100
where 1.xx represents the oxygen binding factor of hemoglobin and is a value in
the range of 1.30 to 1.40 specified in the CO-ox module setup
Half saturation of hemoglobin by oxygen (p50) indicates the partial pressure of
oxygen when oxygen has saturated 50% of the available hemoglobin. The p50
value indicates the position of the oxygen-hemoglobin dissociation curve.27 Unless
a CO-oximeter is connected to the 800 system, p50 is an entered value only.
low p50 shifts the curve to the left and indicates increased oxygen-hemoglobin
affinity
high p50 shifts the curve to the right and indicates decreased oxygen-hemoglobin
affinity
The p50 value is useful in indicating the presence of abnormal hemoglobin that
affects the oxygen transport mechanism, and as an indirect measure of the 2,3 DPG
concentration. It can also indicate changes in pH, pCO2, and temperature.26,27
The p50 value is reported for sO2 values between 20% and 90% and is determined
using the following equation:
p50 26.6 (pO 2 1 pO 2S
where pO2 = measured pO2 corrected to 37°C and pH 7.4, and pO2S = pO2
corresponding to measured sO2 calculated as follows:31
sO i 7
K [(pO 2S – 27.5)(pO S 27.5)]i
i 0
K
K
K
K
K
K
K
K
51.87074
129.8325
6.82836
8
–223.7881
–27.953
258.5009
21.84175
–119.2322
Total carbon dioxide (ctCO2), in combination with pH and pCO2, is useful in
distinguishing between metabolic and respiratory acid-base disorders.
Carbon dioxide exists in several forms in blood plasma, but only two forms,
dissolved CO2 and HCO3–, are quantitatively significant. Based on NCCLS
recommendations,22 the following equation is used:
ctCO2 = cHCO3– + (0.0307 × pCO2)
Hematocrit (Hct) is the ratio of the volume of packed red blood cells to the volume
of whole blood.53 Hematocrit, with other parameters such as total hemoglobin, is
useful in the evaluation of anemia. The hematocrit reference range for a normal
population is 35.0 to 53.0 g/dL.
The estimated hematocrit value is determined using the following equation:
Hct = ctHb x 2.941
where 2.941 is a factor calculated by dividing 100 g/dL by a normal MCHC (mean
corpuscular hemoglobin concentration) of 34%.
Estimated hematocrits should not be used as the sole consideration in the diagnosis
of hematological disorders.
All measurements and calculations are based upon a standard temperature of
37.0°C. During sample analysis, you can enter the actual patient temperature value,
which enables the system to provide temperature corrected results. The following
equations, based on NCCLS recommendations,22 are used:
pH correction Gas exchange indices are a quick way to estimate the relationship between
pulmonary dysfunction and the hypoxia, and to quantitatively determine the degree
of pulmonary shunting. The primary benefit of using gas exchange indices, is that
they are easy to derive at the bedside. However, they do not have a high level of
correlation with the actual measurement of arterial and mixed venous blood and
should be used with discretion. A more reliable method is the Qs/Qt shunt fraction,
which is based on measurements of pO2 and oxygen content.
The gas exchange indices are provided with the 800 system for convenience. Final
judgment of their use is in the hands of the physician.
All gas exchange indices require an arterial sample and use measured values at
patient temperature.
Alveolar oxygen tension, referred to as pO2(A) or pAO2, is the partial pressure of
oxygen in alveolar gas. It is a primary component in the detection of gas exchange
indices. The following equation16,28 is used to estimate pO2(A).
where
R = gas exchange ratio
R
The 800 system does not report alveolar oxygen tension, but uses the pO2(A) value
to calculate the alveolar-arterial oxygen tension difference and the arterial-alveolar
oxygen tension ratio.
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 equation16,28 is used:
pO2(A–a)(T) = pO2(A)(T) – pO2(a)(T)
where pO2(A)(T) is the temperature corrected oxygen tension of alveolar gas and
pO2(a)(T) is the temperature corrected oxygen tension of arterial blood.
The arterial-alveolar oxygen tension ratio, pO2(a/A), which is also referred to as
the a/A ratio, provides an index of oxygenation that remains relatively stable when
FIO2 changes. It is useful in predicting oxygen tension in alveolar gas. The
following equation29 is used:
pO2(a/A)(T) =
pO2 (a)(T)
pO2(A)(T)
where pO2(a)(T) is the temperature corrected oxygen tension of arterial blood and
pO2(A)(T) is the temperature corrected oxygen tension of alveolar gas.
The respiratory index (RI) is the ratio of the alveolar-arterial blood oxygen
pressure difference to arterial pO2. RI, another a means of assessing the extent of
pulmonary shunting, can be used instead of the alveolar-arterial oxygen tension
difference [pO2(A–a)]. Because RI is a ratio and not an absolute value, it does not
present the inherent problems that are seen with the pO2(A–a) value. The
following equation16 is used:
RI(T) = pO2(A–a)(T) / pO2(a)(T)
where pO2(A–a)(T) is the temperature corrected alveolar-arterial oxygen tension
difference and pO2(a)(T) is the temperature corrected oxygen tension of arterial
blood.
Ionized calcium values are dependent upon sample pH. The calcium value adjusted
to pH of 7.40 reflects the true ionized calcium concentration of blood normalized
to pH 7.40. Calcium is corrected according to the following equation.30
adjusted Ca++ = Ca++ measured × 10 –0.178 [required pH –measured pH]
Calcium value is adjusted only when pH, at 37°, is between 7.2 and 7.7, since no
reliable, published, clinical data is available outside that range.
The anion gap (AnGap) is an approximation of the difference between unmeasured
cations and unmeasured anions. Historically, several formulas have been used to
mathematically approximate the balance of these unmeasured ions.
An anion gap result is of twofold value in a clinical laboratory. Primarily, abnormal
anion gap results indicate electrolyte imbalance or other conditions where
electroneutrality is disrupted, such as seen with diabetes, toxin ingestion, lactic
acidosis, or dehydration. Secondly, the anion gap result is useful for quality
assurance of laboratory results. If an increased or decreased anion gap result is
calculated from a non-diseased individual this indicates the possibility to one or
more erroneous electrolyte results.
The 800 system calculates the anion gap based on the following analytes:
AnGap = (Na+ + K+) – (Cl– + HCO3–act)
The bicarbonate (HCO3–) in the above formula is also derived using the
Henderson-Hasselbalch equation for determining bicarbonate calculations.
When mixed venous blood gases from the pulmonary artery are combined with
arterial blood gas measurements, the results frequently clarify the cardiopulmonary
status and assist in determining appropriate therapeutic procedures to be initiated.
This section describes the parameters associated with a-v studies.
The oxygen content of arterial blood (ctO2(a)) is a determination of the total
oxygen carried by the arterial 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 NCCLS
recommendations45 as follows:
ctO2(a) = (1.39 × ctHb × FO2Hb) + (0.00314 × pO2)
where 1.39 is the system default value for the oxygen binding factor.
The oxygen content of venous blood (ctO2(v)) is a determination of the total
oxygen carried by the venous 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 venous blood, based on NCCLS
recommendations45 as follows:
ctO2(v) = (1.39 × ctHb × FO2Hb) + (0.00314 × pO2)
where 1.39 is the system default value for the oxygen binding factor.
The arterial-venous oxygen content difference (ctO2(a-v)) refers to the oxygen
difference between arterial and venous blood. It is a determination of the amount
of oxygen released to the tissues per volume of blood. 46
When this result is obtained using a mixed venous sample, it is useful as an
indicator of changes in cardiac output and helps to assess the cardiac and metabolic
factors affecting arterial oxygenation. 47
The system determines the arterial-venous oxygen content difference as follows:
ctO2(a–v) = ctO2(a) – ctO2(v)
The a-v extraction index (ctO2([a-v]/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. 50 The value is most properly determined using arterial blood and
mixed venous blood.
The system determines the a-v extraction index as follows:
ctO 2([a–v]a) ctO 2(a–v)
ctO 2(a)
The oxygen consumption rate (VO2), which is also referred to as “oxygen uptake”,
is a determination of the volume of oxygen consumed by the body per minute. 48
The system determines the oxygen consumption rate as follows:
VO2 = ctO2(a–v) × Qt × 10
Oxygen delivery (DO2), which is also referred to as “oxygen transport”, refers to
the volume of oxygen per minute that is transported to the tissues. 49
The system determines oxygen delivery as follows:
DO2 = ctO2(a) × Qt × 10
The physiologic shunt [Qsp/Qt(T)] is that portion of the cardiac output entering the
left side of the heart that does not perfectly respire with the alveoli. The shunt
calculation represents the best available means of delineating the extent to which
the pulmonary system contributes to hypoximia. 50
The system determines the physiologic shunt using the following equation:32
Qst/Qt(T) =
ctO2(c)-ctO2(a)
ctO2(c)-ctO2(v)
where ctO2(c) = [1.39 x ctHb x (1 - FCOHb - FMetHb)] + (0.00314 x A);
A = [(FIO2/100) x (pAtm - pH2O)] - {pCO2 x [1.25 - (0.25 x FIO2/100)]};
ctO2(v) is for a mixed venous sample;
1.39 is the system default value for the oxygen binding factor.
Pulmonary artery blood gases are not always readily available, but there may still
be a need to determine changes in the physiologic shunt. The best alternative
method for reflecting changes in the physiologic shunt is the estimated shunt
[Qsp/Qt(est,T)] value, which is applicable to most hypoxemic patients with
cardiovascular stability. 51
The system determines the estimated shunt using the following equation:
Qst/Qt(est,T)=
ctO2(c)–ctO2(a)
[ctO2(a-v) entered]+ctO2(c)–ctO2(a)
where ctO2(c) = [1.39 x ctHb x (1 - FCOHb - FMetHb)] + (0.00314 x A);
A = [(FIO2/100) x (pAtm - pH2O)] - {pCO2 x [1.25 - (0.25 x FIO2/100)]};
1.39 is the system default value for the oxygen binding factor;
[ctO2(a-v) entered] uses 3.5 mL/dL, which is the system default value for the
arterial-venous oxygen content difference.
As with all diagnostic tests, each laboratory should establish its own reference
ranges for the diagnostic evaluation of patient results. Bayer Diagnostics
recommends that the reference ranges listed below be used to evaluate patient
results.
pH
7.350 – 7.450*
pCO2
35.0 – 45.0 mmHg*
4.7 – 6.0 kPa
pO2
75.0 – 100.0 mmHg
10.0 – 13.3 kPa
Na+
135.0 – 148.0 mmol/L*
K+
3.50 – 5.30 mmol/L*
Ca++
1.13 – 1.32 mmol/L
Cl–
Glucose
Lactate
98 – 106 mmol/L*
66.8 – 93.2 mg/dL
3.7 – 5.2 mmol/L
0.5 – 2.0 mmol/L*
* Tietz NW ed. Fundamentals of clinical chemistry. 3rd ed. Philadelphia: WB Saunders, 1987; 864-891.
Weisberg HF. Acid-Base pathophysiology in the neonate and infant. Annals of Clinical and Laboratory
Science 1982; 12(4)249.
Lentner C ed. Geigy scientific tables. Vol 3, 8th ed. Basel: Ciba-Geigy Ltd., 1984; 82-83.
Sabata V, Stubbe P, Wolf H. Energy metabolism in the premature fetus. Biology Neonate. 1971;
19:299.
Appendix J provides Maintenance Checklist charts for you to record maintenance
activities performed on the 800 system.
Make photocopies of these charts as necessary and record your maintenance
activities according to the maintenance protocol of your laboratory.
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Technical
Bulletin
from Bayer Business Group Diagnostics.
Reagent Water
Quality
Table 1 lists the NCCLS specifications for the three types of reagent water. Use
this information to determine the water quality in your laboratory. Refer to the
NCCLS guidelines for common laboratory uses of Type I, Type II, and Type III
reagent water.
Introduction
Table 1. Reagent Water Specifications
Water quality is an important consideration in the laboratory because it can
significantly affect the outcome of
laboratory procedures and the measurement of patient samples.
This bulletin provides an overview of
reagent water quality guidelines as
specified by the National Committee
for Clinical Laboratory Standards
(NCCLS).1 Use these guidelines to
evaluate the reagent water quality in
your laboratory and to determine the
best method for obtaining the water
quality you need.
Good laboratory practices suggest that
you establish a protocol that supports
the manufacturer’s requirements for the
instrument to:
Specification
Type I
Type II
Type III
Maximum bacterial content
colony forming units per
mL (CFU/mL) *
10 (preferably bacteria
free)
1000
not applicable
pH
not applicable
not applicable
5.0 – 8.0
Minimum resistivity
(megohm/centimeter at
25°C) †
10 (inline measurement
by sensor or resistor)
1.0
0.1
Maximum silicate (mg/L) ‡
0.05
0.1
1.0
Particulate matter (µm) §
smaller than 0.22 µm
(water is passed through
a 0.22 µm filter)
not applicable
not applicable
Organic compounds **
pretreat with activated
carbon
not applicable
not applicable
* Bacterial content: The number of colony forming units in water. Bacterial content is a water contaminant you measure to determine water quality.
† Resistivity: The ability of water to resist electrical conduction due to the ion content. Resistivity is the
standard test measurement for determining water quality. The higher the resistivity, the lower the ion
content and the better the water quality.
• ensure optimum performance of
automated laboratory instruments
‡ Silicates: Compounds you remove to produce Type I reagent water.
• eliminate water quality as a source of
problems when troubleshooting
** Organic compounds: Compounds you remove to produce Type I reagent water.
• help you to meet requirements for
state and federal laboratory
certification
What is Reagent Water?
Reagent water is laboratory water that
meets specifications for clinical
laboratory use.2,3
The NCCLS has defined three grades
of reagent water:
§ Particulate matter: Undissolved (insoluble) substances larger than 0.22 µm are removed by the filter.
Purifying Water
As with all diagnostic testing procedures, good laboratory practices suggest that
you establish a protocol that supports the manufacturer’s requirements for
selecting the appropriate type of reagent water. You can then produce reagent
water in your laboratory by setting up and maintaining a water purification system
which uses the purification methods described in Table 2.
Table 2 describes some of the typical laboratory water purification methods.
Table 2. Water Purification Methods
Method
Description
Distillation
Changes water from liquid to vapor and leaves behind
impurities such as particulates and bacteria
Deionization
Uses synthetic resins to remove ionized impurities by ion exchange
Reverse Osmosis
Forces water under pressure through a semipermeable membrane
to remove dissolved solids and organic impurities
Adsorption
Uses activated carbon, clays, silicates or metal oxides to remove
organic impurities
Filtration
Forces water through a semipermeable membrane to remove
insoluble matter, emulsified solids, pyrogens, and microorganisms
• Type I, the highest grade
• Type II, the intermediate grade
• Type III, the lowest grade
The quality of the reagent water you
produce depends on the quality of the
water you start with (source water),
and the performance of your water
purification system.
Figure 1. Water Purification System
To produce the type of water you
require, you may need a purification
system that uses a combination of
methods. For example, if you want to
produce Type I water, you need a
system that uses adsorption to remove
organic impurities, ionization to
remove ionized impurities, and
filtration to remove particulates.
Figure 1 is an illustration of a water
purification system that combines
adsorption, deionization, and filtration
to produce Type I water.
Maintaining Water Quality
You can ensure that the reagent water
supply in your laboratory consistently
meets NCCLS guidelines by:
• storing reagent water properly
• testing for resistivity and
contamination
• maintaining your water purification
system
Establishing procedures for
maintaining reagent water quality is
also required for laboratory inspection
and accreditation by the College of
American Pathologists (CAP).4
Storing Reagent Water
Type I reagent water cannot be stored.
Use it immediately after you produce it
because it degrades quickly and no
longer meets Type I reagent water
specifications. Additionally, you cannot
purchase Type I reagent water because
its purity is not reliable.
Store Type II and Type III reagent
water in glass or polyethylene bottles.
Use it as soon as possible after preparation to reduce the risk of contamination
by microorganisms.
Testing Reagent Water
To monitor water quality and detect
problems with your water purification
system, test reagent water regularly for
resistivity and bacterial contamination.
You may also want to send reagent
water out of the laboratory periodically
for independent evaluation. Record
your test results and any corrective
action.
Refer to the NCCLS specifications for
information about recommended water
testing methods.1
Maintaining your Purification
System
Efficient operation and regularly scheduled maintenance of your water purification system is the key to optimizing
the performance of the system and
consistently obtaining reagent quality
water. Preventative maintenance
reduces the chance of the purification
system introducing additional contaminants into source water and ensures
that reagent water retains its purity
when it is introduced into the laboratory instrument.
The following are suggested guidelines
for maintaining water purification
systems to ensure smooth operation
and prevent system problems.
For Customized Water Systems . . .
• Change filters on carbon or
membrane filter systems as required
• Use a recirculating pump to optimize
performance and reduce
contamination
• Filter the source water before
treatment in reverse osmosis systems,
and recirculate deionizers in closed
loops to extend resin life
For Distillation Systems . . .
• Check the water vessels regularly for
the presence of a slippery film
• Clean and disinfect the vessels as
required with an agent that rinses
well, such as H2O2
• Clean the boiler regularly to remove
deposits
• Test routinely for contamination
For complete information about
operation and maintenance requirements for your water purification
system, refer to the manufacturer’s
specifications.
Problems Caused by Water
Using water that does not meet
NCCLS guidelines can cause problems
with clinical laboratory systems. Some
common problems include:
• contamination of system components
• inaccurate patient and calibration
results
• out-of range quality control results
• deterioration of lyophilized quality
control material
• color changes and poor stability and
performance of reagents
These problems can be caused by
failure to use the appropriate type of
reagent water, bacterial contamination,
and inadequate maintenance of the
water purification system.
Refer to the troubleshooting section in
your system manual for more detailed
information about problems caused by
water that does not meet reagent water
specifications.
References
1. National Committee for Clinical
Laboratory Standards. Preparation
and testing of reagent water in the
clinical laboratory. 2nd ed.
Villanova (PA): NCCLS; 1991
Aug. 37 p. (NCCLS Document
C3-A2).
2. Tietz, Norbert W. Fundamentals of
clinical chemistry, 3rd ed.
Philadelphia: W.B. Saunders
Company; 1987. 1010 p.
3. Kaplan, Lawrence A. Pesce,
Amadeo J. Clinical Chemistry;
theory, analysis, and correlation,
2nd edition. St. Louis: C.V. Mosby
Company; 1989. 1212 p.
4. College of American Pathologists,
Laboratory General Inspection
Checklist Section 1, Quality of
water, p. 8. Northfield, IL.1989.
Manufactured by:
Bayer Corporation
East Walpole, MA 02032-1597 USA
Bayer Argentina S.A.
Division Diagnósticos
Buenos Aires, Argentina
Bayer Australia Limited
Diagnostics Business Group
Scoresby, Victoria 3179, Australia
Bayer Austria GesmbH
GB Diagnostika
A-1164 Wien, Austria
Bayer Diagnostics
1050 Bruxelles, Belgium
Bayer S.A. Diagnostics
São Paulo SP, Brazil
Bayer Diagnostics
92807 Puteaux Cedex, France
Bayer Vital GmbH & Co. KG
Geschäftsbereich Diagnostika
D-35463 Fernwald, Germany
Bayer Hellas AG
BG Diagnostics
151 25 Athens, Greece
Bayer Diagnostics Limited
Hong Kong
Bayer Diagnostics India Limited
Gujarat, India
Bayer S.P.A.
Divisione Diagnostici
20151 Milan, Italy
Bayer Inc.
Toronto, Ontario
Canada M9W1G6 ETOBI
Bayer OY
FIN 02270 Espoo, Finland
107060 Rev. C 10/99
Bayer B.V.
Division Diagnostics
3641 RT Mijdrecht
The Netherlands
Bayer As
N-1483 Skytta, Norway
Bayer Sp. z o.o.
02-326 Warsaw, Poland
Bayer Diagnostics Lda.
2795 Carnaxide, Portugal
Bayer Puerto Rico Inc.
Diagnostics Division
Carolina, Puerto Rico
Bayer (Pty) Ltd.
Isando
South Africa
Bayer S.A.
Bogotá, D.C. – 6, Columbia
Bayer A/S
DK-2800 Lyngby, Denmark
Bayer de México, S.A. de C.V.
Division Diagnósticos
Delegagción Benito Juárez
México, D.F.C.P. 03100
Química Farmacéutica Bayer, S.A.
08029 Barcelona, Spain
Bayer Diagnostics Korea Ltd.
Seoul, Korea
Bayer AB
S-402 24 Göteborg, Sweden
Bayer (Schweiz) AG
Geschäftsbereich Diagnostika
8045 Zuerich, Switzerland
Bayer Taiwan Co., Ltd.
Diagnostics Division
Taipei, Taiwan, R.O.C.
Bayer Plc
Diagnostics Division
Newbury, RG14 1JA
United Kingdom
Bayer Corporation
Diagnostics Division
Tarrytown, NY 10591-5097 USA
..
Accept
The F-key that lets you store QC results in a QC file and
update the statistics in the QC file.
accession number
A number, not assigned by the 800 system, used to
identify a sample. The number is usually assigned by
the hospital or laboratory to cross reference the analysis
for billing purposes.
action range
A range of values with upper and lower limits that the
800 system uses to evaluate patient sample results. Any
sample results that are beyond these limits are flagged
on reports and require immediate action by the operator.
air filter
The component that protects internal parts of the system
from excessive dirt build-up. Inspecting the air filter is a
regular maintenance task.
Analyte
Performance
Verification
A process developed by Bayer Diagnostics that lets you
verify performance specifications for new test systems
or methods before you report patient results.
Analyze
The key that begins sample analysis.
Analyze mode
The normal operating state in which you can analyze
patient and QC samples and perform calibrations.
arrow keys
Left, right, up, and down keys that allow you move the
cursor through menus, from field to field, and through
an option list to select an option.
atmospheric
pressure
Barometric pressure.
Auto Accept QC
The QC setup option that lets you automatically accept
QC results into a QC file and updates the statistics in
the file.
Auto Clean
An automatic system function that initiates a cleaning
cycle once every 24 hours to clean the system with a
cleaning solution.
Auto ID
The QC setup option that automatically identifies a QC
sample and assigns it to a QC file at the endof analysis.
Auto Move
The system setup option that automatically moves a
capillary sample into position for analysis.
Auto Repeat
The calibration setup option that automatically repeats a
calibration up to two times when drift limits are
exceeded.
Auto Send
The system setup option that automatically sends patient
or QC sample results to a laboratory information system
(LIS) or data management system.
Backup
The Disk Utilities menu option that copies all the
system files to diskettes for storage. Use backup to
prevent loss of data in case of a hard disk failure.
Bar Code Scanner
The Troubleshooting menu option that lets you perform
a bar code scanner test, which tests the ability of the bar
code scanner to read a test pattern.
bar code scanner
An optical device that enters patient ID and accession
numbers, quality control, and reagent information into
the system by scanning bar code labels.
Barometer
The Calibration menu option that lets you enter the true
atmospheric (barometric) pressure to calibrate the
internal atmospheric pressure sensor.
base model
The part of the 800 series system that includes the
measurement module, fluidic components, and reagents.
For example, the base model for an 865 is an 860.
biosensor
A device that utilizes an active biomolecule, such as an
enzyme, to measure analyte levels in a sample. The
glucose and lactate sensors are biosensors.
calibration
The process of testing and adjusting the electronic
signal from a sensor. The 800 systems automatically
perform one-point calibrations and two-point
calibrations at regular intervals for each measured
parameter.
calibration drift
The degree of deviation from the last calibration for the
selected parameter.
Calibration Setup
The Operating Setup menu option that lets you define
drift limits, enter calibration gas values, and set
calibration frequency and auto repeat options.
Cancel
The F-key that discontinues an activity. For example, if
you press Cancel during a calibration, the system stops
calibrating, initiates a wash, and displays the Ready
screen.
Change Sample
Type
The F-key that lets you select a sample type for the next
sample you analyze.
check box
A box next to each option in a list of options that
indicates whether the option is chosen. If the option is
chosen, the box is filled in. If the option is not chosen,
the box appears empty. You can select more than one
option from a list of options with check boxes.
Clear Entry
The F-key that deletes a character or the entire entry
from a field. Pressing the Clear Entry key once deletes a
single character. Pressing the Clear Entry key twice in
quick succession deletes the entire entry. The cursor
returns to the beginning of the field to allow you to
enter new data.
Communications
The System Setup menu option that lets you define
parameters for connecting external devices to the 800
system. Also a Troubleshooting menu option that lets
you to perform the External Loopback test.
Condition
The Maintenance menu option that performs the
conditioning maintenance procedure, which cleans
deposits off of the glass pH and Na+ sensors.
conditioner
A solution used during the conditioning procedure that
cleans and conditions the sensors.
CO-oximeter
(CO-ox)
A device that spectrophotometrically measures the
absorption of whole blood at several wavelengths to
determine the concentration of hemoglobin and its
derivatives in whole blood.
CO-ox zero
A sequence, during a one- or two-point calibration, that
calibrates the CO-ox optical system by establishing the
value of a colorless fluid (7.3/CO-ox Zero reagent). No
value is reported on the screen.
Correlation
The Operating Setup menu option that lets you specify
correlation coefficients (slope and offset values) so that
the results from the system match the results of a
reference analyzer in your laboratory.
cursor
A visual device that indicates the active area of the
screen. For example, when the cursor moves to a field,
the field is enclosed by a box, or if a box already exists,
the border becomes darker. You move the cursor by
pressing an arrow key or the Enter key.
CVM
Calibration Verification Material. A material formulated
to verify the calibration of blood gas, electrolyte, and
total hemoglobin systems throughout the reportable
range.
Data Recall
The menu option that lets you access stored data, such
as patient, quality control, and calibration data, and
workload statistics.
D code
A diagnostic code, which appears in the status area of
the screen, that you use as a reference when
troubleshooting. An example of a D code is
D3 Slope Error.
default values
Values assigned by Bayer Diagnostics during
manufacturing. You can change default values through
setup menus.
Deproteinize
The Maintenance menu option that lets you clean the
sample path to remove protein deposits.
deproteinizer
A cleaning solution that removes protein deposits from
the sample path.
Discard
The F-key that lets you store QC data in a discard data
file and does not update the statistics.
discard data file
A temporary storage file for discarded QC results. The
system does not place discarded QC data into an active
file or update the statistics. You can retrieve the
discarded data using the Data Recall function if the data
was accidentally discarded. Also called File 14.
diskette
A 3.5-inch (90 mm) disk to which you can copy data
files from the hard disk.
diskette drive
The opening located behind the screen into which you
insert diskettes.
Disk Utilities
The System Utilities menu option that lets you perform
disk utilities functions, including Backup, Archive,
View Archive, Restore, and Install.
Done
The F-key you press when you have finished selecting
options and have entered data in a form. When you
press Done, the system accepts the changes.
drift limits
The values used to determine excessive drift during a
calibration. You enter acceptable drift limits for each
parameter through the Calibration Setup menu.
endpoint
The final measurement value obtained from a sensor.
Enter
The key you press when you have finished typing
information into a field or a when you have made a
selection from a list or menu.
External Loopback
The Communications menu option that performs an
external communications loopback test. This test
verifies the internal communications through the serial
ports and external cables.
File 13
A storage file containing QC data that
Bayer Diagnostics field service engineers use during
troubleshooting. You can delete the contents of the file,
but you cannot access the file data.
File 14
A temporary storage file for discarded QC results. The
system does not place data into an active QC file or
update the statistics. You can recall the data in this file
using the Data Recall function if it was accidentally
discarded.
fixed time
calibrations
A method of determining intervals between calibrations
in which you determine the maximum time between
one-point and two-point calibrations. You determine
fixed time calibration through the Calibration Setup
menu.
F-keys
The five function keys (F1 through F5) located below
the screen that are associated with the labels displayed
on the bottom line of the screen. The key functions can
change as you move from screen to screen.
flag
A symbol that appears on some screens and printed
reports that indicates that the system detects an
unexpected result or measurement. For example, the
single up arrow (↑) on a patient report indicates that the
sample result is above the reference range or that the
calibration result is above the high drift limit.
flexible time
calibrations
A method of determining calibration intervals. The
system uses an algorithm to determine the time between
calibrations based on sensor status and previous
calibration results (calibration drift).
Fluid Detector
The Fluidics System menu option that lets you test fluid
detectors 1, 1A, and 2 with air, clear liquid, or opaque
liquid (blood) and test fluid detectors 3 and 4 with air or
clear liquid.
fluid detector
A sensor that detects fluid in the sample path. There are
five fluid detectors: 1, 1A, 2, 3, and 4.
Fluidics System
The Troubleshooting menu option that lets you test the
fluidic system.
fluidic system
The subsystem responsible for the movement of fluids
in the 800 system, including tubing, pumps, fluid
detectors, waste system, solenoid valves, and reagents.
frame
The boxed area on a screen that displays information
and messages, such as message boxes, fields, and option
lists.
Global QC Settings
The QC Setup menu option that turns Auto ID
(automatic identification) and Auto Accept QC on or
off.
hard disk
A device that stores the system programs and data files
required for system operation.
Help
The key that lets you view additional information about
the current Analyze mode screen or an index of topics
about the Menu mode. You can also use Help during
troubleshooting.
hemolyzer
A chamber in the CO-ox sample path that uses
ultrasonic sound vibrations to rupture red blood cells.
highlight bar
The area of the screen that appears in reverse video to
indicate the selected choice in a scroll list or menu.
HIS
Hospital information system. A computer system that is
used for data management throughout the hospital.
Home
The key that returns the system to the Ready screen
when the system is ready for analysis.
initialize
The function performed during system installation or
startup that prepares data files for accepting the data
you enter in the 800 system.
Install
The Disk Utilities menu option that transfers system
software and upgrades from the installation disk to the
hard disk.
instruction line
An area on the screen that contains one line of
directions for moving through or working with the
current screen.
keyboard
A device that provides a set of alphanumeric and other
keys that you use to enter information into the system.
keypad
The area of the system that contains the F-keys, arrow
keys, numeric keys, and other keys through which you
interact with the system.
Levey-Jennings
chart
A visual representation of measured QC values used to
detect results that fall outside of the established control
limits and to observe trends or shifts in control values.
LIS
Laboratory information system. A computer system that
is used for data management in one or more
laboratories.
Maintenance
The Menu screen option that accesses maintenance
functions, such as Deproteinize, Condition, and Prime.
Measurement
The Troubleshooting menu option that tests electrical
sensor output.
Measurement
module
The area of the system that measures the analytes in a
sample. It consists of the sensors, preheater,
measurement block, and sample ground/temperature
sensor.
Menu mode
The system operating state that lets you perform all
system functions other than sample analysis. Menu
mode accesses the Calibration, Troubleshooting,
Maintenance, Data Recall, Operating Setup, System
Setup, System Utilities, and Service Setup menus.
Menu screen
The screen that appears when you are in Menu mode.
From this screen, you can access all system functions
other than sample analysis.
message box
A box that displays information that requires you to
perform an action or select an option by pressing an
F-key. The message box remains on the screen until you
respond.
Microsample
A sample that has a total volume less than required for a
standard capillary/syringe analysis. When measuring a
microsample, the system measures pO2 and pCO2 and
then advances the sample to measure the remaining
parameters.
numeric keys
The keys on the keypad that you use to type numbers.
offset
The value obtained through linear regression analysis
that represents the variance that is constant between the
data points in one set of data and any of the data points
in another set of data. An offset of 0.0 indicates no
variation.
Operating Setup
The Menu screen option that lets you define QC setup,
reference and action ranges, patient data entry, report
formats, measurement units, parameter names, printing
options, calibration setup, printing options, and
correlation coefficients.
option button
A diamond symbol that appears next to an option in an
option list. When an option button is filled in, that
option is selected. You can select only one option in an
option list.
option list
A list of two or more options in a frame that you select
by highlighting the required option. An option list can
contain check boxes, option buttons, or a scroll list.
panel
A set of parameters, such as pO2, pCO2, and pH, that
are measured by an 800 system. You can select a panel
for the system through the System Setup menu. The
default panel is All Parameters.
Paper Advance
The key that advances the paper in the roll printer.
Paper Spool
The key that tightens the printer paper on the spool.
Parameter Names
The Operating Setup menu option that lets you select
the chemical symbols to identify parameters.
Parameters
The System Setup menu option that lets you turn on and
off individual parameters for sample analysis.
password
A set of characters (up to eight) that lets you access
certain system functions. An 800 system has two
passwords: a system password that lets you operate the
system and a menu password that lets you use
designated menus. You can define separate passwords
for accessing the system and for accessing menu
options. You define passwords through the System
Setup menu.
patient sample
Blood or a volume of expired gas collected from a
patient. The system uses the sample to analyze specific
parameters and displays the results.
pATM
Atmospheric (barometric) pressure.
PC board
Printed circuit board. A component that performs
specific electronic functions within the system.
pH only
The Sample Type menu option that lets you analyze
samples that require only a pH measurement. This
feature is available only on 840 systems.
platen
The component in a pump that, in conjunction with the
roller cage, applies pressure to the tubing to move
liquids through the system with a pumping action. The
pumping action seals the tubing to prevent a vacuum
from reaching the measurement module.
power supply
The component that accepts the voltage from the power
input, converts it from AC to DC, and directs it through
the system.
Prime
The Maintenance menu option that pumps reagents
through the system to remove bubbles from the reagent
tubing.
Print
The F-key that lets you print a report.
printer
The component of the system that generates printed
reports. The 800 system has a built-in roll printer. You
can also connect the ticket printer or a parallel printer to
the 800 system.
Printing Options
The Operating Setup menu option that lets you select a
report type, turn on automatic printing, enter the number
of copies to be printed, and select a printer.
Purge
A function that moves solutions through the
measurement module, thereby automatically
maintaining the characteristics of the sensors when there
has been no wash, sample, or calibration operation for a
period of time.
QC
Quality control.
QC sample
A unit of material that lets you perform quality control
analysis.
QC Setup
The Operating Setup menu option that lets you create or
edit QC files.
quality control
Quality control (QC) analysis is an 800 system function
that lets you evaluate the performance of the system and
make sure that results of patient sample analysis are
accurate and reliable.
Ready screen
The system default screen. You use the Ready screen to
analyze all types of samples. You can access the Ready
screen (if the system is ready for analysis) from other
screens by pressing the Home key.
reagent
A substance that the system uses because of its chemical
or biological activity to detect or measure the analytes
present in a patient sample, to analyze a QC sample, to
calibrate the system, or to wash system tubing.
reagent fitting
The component of the reagent manifold that attaches to
the reagent bottles and lets the reagents enter the
system.
reagent manifold
The component of the system that contains solenoid
valves and tubing that direct the movement of reagents
and gases through the system.
reagent water
Water purified for clinical laboratory use as described
by the National Committee for Clinical Laboratory
Standards.
Recall Data
The Menu screen option that lets you access data stored
in the system. You can use this menu option to view,
edit, and print reports of stored data.
reference limit
The value that determines whether a patient sample or
calibration result is outside the expected range.
reference range
A range of values with upper and lower limits that the
system uses to evaluate patient sample results. The
reference range represents the range within which
results are expected to fall.
reference sensor
The sensor that works with the pH, Na+, Cl–, and Ca++
sensors to create an electrochemical cell. The system
compares the fixed potential of the reference sensor to
potential generated by the sample at the membrane of a
measuring sensor to measure an analyte in the sample.
Reject
The F-key that lets you store QC results in a QC file,
but not update the statistics in the QC file.
Report Formats
The Operating Setup menu option that lets you define
screen reports and select a format for printer reports.
Reporting
Resolution
A system option that determines whether results for
certain parameters appear in high resolution (more
significant digits) or low resolution (fewer significant
digits). For example, the high resolution option for pH
is 0.001 and the low resolution option is 0.01.
required fields
Patient data entry fields in which you must enter a
value. For example, if the Patient Temp field is a
required field, you must enter a patient temperature in
the field before you can access the next screen. You
define required fields in Setup.
Restore
The Disk Utilities menu option that copies backed up
patient, quality control, CVM, calibration, maintenance,
diagnostic, and setup files from diskettes to the hard
disk. Restoring data replaces the corresponding data on
the hard disk.
roller cage
The component of a pump that rotates and, in
conjunction with the platen, causes liquids to move
through the system via a pumping action.
Roll Printer
The Troubleshooting menu option that performs a roll
printer test. This test generates all characters that the
system prints in all positions on the roll printer.
RS-232
A communication standard that defines hardware
requirements used for serial ports to connect printers
and other devices to the system.
sample connector
The component that splits the sample path to allow a
sample to go to both the measurement module and the
CO-ox module.
sample door
The component that that lets you introduce a patient or
QC sample into the system. It also determines the
sample type and the volume.
Sample Entry
The Fluidics System menu option that lets you perform
sample door tests.
sample ground/
temperature sensor
The sensor that detects the sample temperature and
provides a sample ground for stable sensor readings.
sample port
The area where samples are introduced into the system.
The sample port is designed to accept a variety of
sample collection devices.
sample source
The origin of a patient sample: arterial, venous, mixed
venous, or expired gas.
Sample Type
The option list on the Ready screen that lets you select
the sample type: syringe/capillary (default sample type),
quality control (QC), pH only, or microsample.
scroll list
A list of options in a frame. You use arrow keys to
move through the list and select an option.
Security Options
The System Setup Menu option that lets you define
passwords for the system and for Menu mode.
sensor
A device designed to detect a particular analyte in a
sample. The pH and the pCO2 sensors are examples.
sensor status
indicator
The area on the screen that indicates the current status
of each sensor in the system.
septum
The membrane on the reagent bottle through which the
fitting on the reagent manifold passes.
sequence number
A unique number assigned by the system to every
sample analysis, QC analysis, and calibration.
Shutdown
The System Utilities menu option that lets you shut
down the system before performing service.
slope
The value obtained through linear regression analysis
that represents the relationship between two sets of data.
A slope of 1.0 indicates identical data sets.
slope drift
The difference between the results for the current slope
and the theoretical value for a calibration.
solenoid valve
The component associated with opening and closing the
path within the fluidic system to control the passage of
fluids and gases.
Standby
The System Utilities menu option that lets you place the
system into an inactive mode when you are not
analyzing samples. The system does not perform
automatic calibrations while in standby.
status area
The top portion of the screen that displays the status
name, system messages, sensor status indicators, and
date and time.
Status Event Log
The Data Recall menu option that lets you view
diagnostic codes and system messages and print the
Status Event Log report. Also a report that lists the last
72 hours of status messages, D codes, and samples for
which required data entry is incomplete.
Stop System
The Maintenance menu option that lets you disable
sample analysis and automatic calibration functions so
that you can perform maintenance activities.
System ID
The Service Setup menu option that lets a Service
Representative identify the system model and enter the
system ID and installation date.
system message
A message that appears in the status area of the screen
that describes the status of certain system operations.
System Options
The System Setup menu option that lets you define
system options. The options include Reporting
Resolution, Beeper Volume, Auto Move Capillary
Sample, and Roll Printer.
System Setup
The Menu screen option that lets you define system
functions. You can define the date and time, enable and
disable parameters, define panels, define
communication parameters, and define system options.
System Utilities
The Menu screen option that lets you access file and
system management functions, including Standby, Disk
Utilities, and Shutdown.
Target limit
The values that determine the limits above and below
the target mean for QC sample analysis.
Temp/pAtm
The Troubleshooting menu option that lets you perform
a temperature test and a barometer test.
Troubleshooting
The Menu screen option that lets you access diagnostic
tests.
Units/Values
The Operating Setup menu option that lets you select
measurement units that the system uses to display
primary, entered, and calculated parameters.
user interface
The components of the 800 system, including the
screen, keypad, and printer that let you direct system
activities.
Valves
The Fluidics System menu option that lets you perform
automatic and manual valve tests.
View Status
The F-key that displays a status log that lists the last 72
hours of diagnostic messages and samples for which
required data entry is incomplete. The View Status
F-key only appears if the status log contains messages.
Wash
A Maintenance menu option that lets you perform a
wash.
waste cap
The component that seals the waste bottle.
waste components
The components that collect the waste reagents and
samples from the system and then clean and prepare the
system for the next activity. They consist of a waste
bottle, waste detector probes, a waste cap, a pump, and
tubing.
waste detector
The component beneath the waste bottle that detects the
presence of the waste bottle and detects the amount of
liquid in the bottle to prevent waste overflow.
work area
The area on the screen that displays the screen elements
that pertain to the function you are performing. The
contents of the work area varies with the function. For
example, during sample analysis, the system displays a
data entry form you use to enter patient demographic
data, and when analysis is finished, it displays results.
Workload Stats
The Data Recall menu option that lets you display
month-to-date and year-to-date workload statistics,
including the current number of patient samples, quality
control samples, and calibrations stored by the system.
It also displays the total cycle count, which is the total
number of wash and purge sequences the system has
performed since installation.
..
?, 2-31, 2-32, 4-99, 4-116
?=If Blood, Question Data, 4-7 to 4-9
#, 2-31, 2-32, 4-98, 4-118
––––––↑, 2-30, 2-32, 4-95, 4-98
––––––↓, 2-30, 2-32, 4-95, 4-98
*, 2-30, 2-32, 4-97
******, 2-30, 2-32
**Empty**, 2-30, 2-32, 2-40, 4-95, 4-98,
4-116, 4-118, E-8, I-36
↑, 2-30, 2-32, 4-95, 4-98
↓, 2-30, 2-32, 4-95, 4-98
↑↑, 2-30, 2-32, 4-95, 4-98
↓↓, 2-30, 2-32, 4-95, 4-98
__ Not Sent message, 2-33, 4-9
__ Sent message, 2-34, 4-9
1-pt Cal Pending in __ Min message, 4-6
1-pt Metabolite Cal Due in __ Min message, 4-6
1-pt Metabolite Cal Due message, 4-6
2-pt Cal Pending in __ Min message, 4-6
6.838 Buffer
active ingredients, 1-39
handling and preparing, 1-43
intended use, 1-41
removing (illustration), 3-22
replacing, 3-22
storing, 1-42
7.3/CO-ox Zero Buffer
active ingredients, 1-39
handling and preparing, 1-43
intended use, 1-41
removing (illustration), 3-20
replacing, 3-20 to 3-21
storing, 1-42
270 CO-oximeter
combining results with 800 system results, 2-22 to
2-29
configuring an 800 system for, 5-62
connecting to an 800 system, D-2 to D-3
a–v extraction index, I-36
a–v studies, I-35
analyzing, 2-24
requirements for analysis, 2-24
rules to determine results, 2-24
Additional Messages message, 4-6
air filter
removing (illustration), 3-32
replacing, 3-32
replacing CO-ox, 3-33
alveolar oxygen tension, I-32
alveolar–arterial oxygen tension difference, I-33
Analyze key, 1-24
Analyze mode, 1-28
anion gap, I-34
anticoagulants, 1-36
effect on measurements, 1-33
archiving QC results. See disk utilities
arrow keys, 1-24
arterial blood samples, 1-34
arterial oxygen content, I-35
arterial–alveolar oxygen tension ratio, I-33
arterial–venous oxygen content difference, I-35
measurement values, 5-15
aspiration, 2-3
aspiration adapter, 2-18, 2-40
atmospheric pressure. See barometric pressure
auto accept QC, turning on or off, 5-54
Auto Clean Pending in __ Min message, 4-6
auto ID, turning on or off, 5-53
auto move capillary sample, turning on or off, 5-37
auto send, turning on or off
patient results, 5-38
QC results, 5-55
autoclean, changing the time, 5-33
backing up system data. See disk utilities
backing up trace log data. See disk utilities
Backup screen, 5-73
bar code scanner
connecting to an 800 system, D-4
troubleshooting, 4-109
bar code scanner test, 4-56, 4-77
bar code scanner test pattern (illustration), 4-77
barometer, checking, 3-10
barometric pressure, acceptable range, 2-59
base excess, I-27
beeper, adjusting volume, 5-36
beeps, meaning of, 1-31
bicarbonate ion, I-25
biohazards, 2-3
meaning of warning, xviii
protecting yourself from, A-1
waste disposal, 1-38
bubbles
detecting before measurement, 2-3
detecting during measurement, 2-4
effect on results, 2-4
Bubbles Detected in Sample, 4-114
Bubbles Detected In Sample message, 2-32, 4-6
Busy Icon, meaning of, 1-31
Cal G/L reagent
active ingredients, 1-40
handling and preparing, 1-43 to 1-45
intended use, 1-41 to 1-43
removing (illustration), 3-20
replacing, 3-20 to 3-22
storing, 1-42
Cal Gas, 1-44
composition, 3-92
Cal Intervals screen, 5-61
calcium, sensor, I-18
calcium, ionized, measuring, I-17
Calibrate key, 1-26
calibrating
interrupting metabolite, 2-60
reporting results with drift, 5-40
calibration data
printing, 2-62, 2-63
recalling, 2-61 to 2-66
transmitting, 2-62, 2-63
Calibration Data Search Log screen, 2-62
Calibration Data Search Result screen, 2-63
Calibration Drift Limits screen, 5-58
Calibration Gas Values screen, 5-59
calibration gases, 1-44
calibration values, 5-59
defining values, 5-58
handling precautions, 1-44
Calibration Menu, 2-56
Calibration Overdue message, 4-6
Calibration Type Form screen, 2-55
calibrations, 1-45
automatic, 1-45, 5-60
fixed time, 1-45
flexible time, 1-46
barometer, 1-47, 2-59
drift limits, 1-48, 5-57
valid entry ranges, 5-57
frequency, 5-60
glucose biosensor, 1-46
interrupting, 2-60
manually initiated, 1-47
one-point, 1-45, 1-64 to 1-74
options, 5-57 to 5-61
reagent pump, 4-57
recalling data, 1-49
repeating, 1-48
reporting results with drift, 1-48
results, 1-48
selecting
from the Analyze mode, 2-55
from the Menu mode, 2-56
tHb slope, 1-47, 2-57
two-point, 1-45, 1-68 to 1-74
Cancel key, 1-26, 5-5
canceling sample analysis, 2-7, 2-14, 2-19, 2-42
capillary blood samples, 1-35
capillary seal, 2-8, 2-11, 2-15
inspecting, 3-21
replacing, 3-100
replacing (illustration), 3-101
capillary tubes, using, 1-36, 2-3
carboxyhemoglobin (FCOHb), measurement
principles, I-23
CAUTION, meaning of, xviii
Change parameters, custom panel, 2-29 to 2-31
Change Parameters key, 1-26
Change Parameters screen, 2-29
Change Sample Type key, 1-26
Change Sample Type screen, 2-12
changing parameters, 2-14
changing sample type, 2-11, 2-15, 2-20, 2-40
Chiron Diagnostics addresses and communication
numbers, B-1
chloride
measuring, I-16
sensor, I-17
cleaning solutions
active ingredients, 1-40
changing, 3-19
handling and preparing, 1-43
intended use, 1-41
removing (illustration), 3-19
storing, 1-42
Clear Entry key, 5-4
CO–ox Sample Chamber Temp Error, 4-114
CO–ox Sample Temp Out of Range, 4-114
components of system, 1-15 to 1-22
Conditioner
active ingredients, 1-40
handling and preparing, 1-43
intended use, 1-41
storing, 1-42
conditioning the sensors, 3-14
CO-ox cover, close before analyzing sample, 2-6
CO-ox Cover is Open message, 4-6
CO-ox Cover Open During Meas message, 2-33, 4-6
CO-ox Cover Open During Zero message, 4-6
CO-ox measurement, insufficient sample volume, 2-8
CO-ox module
integration time (zero calibration), 4-55, 4-75
overview, 1-17, I-24
replacing
air filter, 3-33
air filter (illustration), 3-33
lamp, 3-103 to 3-105
lamp (illustration), 3-104 to 3-105
sample tubing, 3-37
sample tubing (illustration), 3-37
CO-ox optics test, 4-55, 4-75
CO-ox Optics Test screen, 4-75
CO-ox sample chamber, temperature range (error),
4-113, 4-114
CO-ox Sample Chamber Temp Error message, 2-33,
4-7
CO-ox sample path
disconnecting, 4-92
illustration, 4-87
reconnecting, 4-93
removing obstructions, 4-87 to 4-91
CO-ox Sample Temp Out of Range message, 2-33, 4-7
CO-oximeter Slope
active ingredients, 1-40
handling and preparing, 1-43
intended use, 1-41
copying files
See also disk utilities
file format, 5-81 to 5-83
correlation adjustment, G-1 to G-2
Correlation Adjustment message, 4-7
correlation coefficients
defining, 5-42
ranges, 5-42
values, 5-42
Correlation Coefficients screen, 5-43
custom panel, selecting as default, 5-12
D codes
overview, 4-11
Status Event Log, 4-5
D2 Excessive Drift: Glu, 4-15 to 4-54
D2 Excessive Drift: Lac, 4-15
D2 Excessive Drift: pH, Na+, Ca++, Cl–, 4-13 to 4-54
D2 Excessive Drift: pO2, pCO2, 4-12 to 4-54
D2 Excessive Drift: tHb, 4-16
D3 Slope Error: Glu, 4-19 to 4-54
D3 Slope Error: Lac, 4-19
D3 Slope Error: pH, Na+, K+, Ca++, Cl–, 4-18 to 4-54
D3 Slope Error: pO2, pCO2, 4-17 to 4-54
D3 Slope Error: tHb, 4-20
D4 Offset Error: Glu, 4-23 to 4-54
D4 Offset Error: Lac, 4-23
D4 Offset Error: pH, Na+, K+, Ca++, Cl–, 4-22 to 4-54
D4 Offset Error: pO2, pCO2, 4-21 to 4-54
D5 No Endpoint: Glu, 4-26 to 4-54
D5 No Endpoint: Lac, 4-26 to 4-54
D5 No Endpoint: pH, Na+, K+, Ca++, Cl–, 4-25 to 4-54
D5 No Endpoint: pO2, pCO2, 4-24 to 4-54
D12 Sample Door Position Error, 4-27
D13 No Sample Detected at FD1, 4-28 to 4-54
D14 No Sample Detected at FD2, 4-29 to 4-54
D19 Fluid Detector Error: FD1, FD1A, FD2, 4-30 to
4-54
D19 Fluid Detector Error: FD3, FD4, 4-31
D19 Fluid Detector Error: FD5, 4-32
D21 Processing Error: 1, 3, 4-33
D22 Barometric Pressure Error, 4-34
D23 Rgt Manifold: No 7.3 Buffer, 6.8 Buffer,
Wash/Zero, C1/C2, Cal Glu/Lac, 4-35 to 4-54
D24 Meas Module: No 7.3 Buffer, 6.8 Buffer,
Wash/Zero, Cal Glu/Lac, 4-36 to 4-54
D29 Insufficient Wash Flow, 4-37 to 4-54
D33 Probe Position Error, 4-38
D35 Electronics Error: [1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
12, 13], 4-39
D38 Temperature Error: [1, 2, 3, 4, 5, 6, 7, 8, 9, 10,
11], 4-40
D50 Glu Sensor Error, 4-41 to 4-54
D51 Lactate Sensor Error, 4-42 to 4-54
D60 Port Error: [1, 2, 3, 4, 5], 4-43
D70 Optics Error: [2, 3, 4, 7, 9], 4-44 to 4-54
D71 No Sample Detected at FD5, 4-45 to 4-54
D72 No COox Sample Detected, 4-46 to 4-54
D75 Lamp Failure, 4-47 to 4-54
D76 COox Electronics Error: [1, 2, 3, 4, 5, 6, 7, 8, 9,
10, 11, 12], 4-48
D77 COox Temperature Error, 4-51
D78 COox Module: No [7.3/COox Zero, Wash/Glu
Zero], 4-52
D79 COox Insufficient Wash Flow, 4-54
Data Entry Format screen, 5-8
Data Entry Incomplete message, 2-33, 4-7
data files
copying, 5-79 to 5-80
disk utilities functions, 5-67
managing, 5-67 to 5-82
data management system
configuring an 800 system for, 5-62
connecting to an 800 system, D-4
date and time
changing, 5-31 to 5-32
selecting a format, 5-31
Date and Time Setup screen, 5-31
default passwords
menu options, 5-30
operator, 5-28
supervisor, 5-26, 5-27, 5-29, 5-30
defining passwords
menu options, 5-29 to 5-30
operator, 5-27 to 5-29
supervisor, 5-29 to 5-30
deoxyhemoglobin (FHHb), measurement principles,
I-22
Deproteinizer
active ingredients, 1-40
handling and preparing, 1-43
intended use, 1-41
storing, 1-42
deproteinizing, 3-13
Device Connected to Port __ message, 4-7
Device Selection screen, 5-63
diagnostic tests, overview, 4-55
disconnecting CO-ox sample path, 4-92
disk utilities
archiving QC data, 5-68 to 5-69
backing up system data, 5-72 to 5-74
backing up trace log data, 5-72 to 5-74
copying files, 5-79 to 5-80
restoring system data, 5-74
viewing archived QC data, 5-70 to 5-72
diskette, format to use, 5-67
Do Not Send key, 1-26
Done key, 5-4
electronic components, 1-21 to 1-22
troubleshooting, 4-110
Enter key, 1-24, 5-5
estimated shunt, I-37
determining the value, 2-5
Excessive Bubbles in CO–ox Sample, 4-115
Excessive Bubbles in CO–ox Zero, 4-115
Excessive Bubbles in CO-ox Sample message, 2-33,
4-7
Excessive Bubbles in CO-ox Zero message, 4-7
Excessive Bubbles in tHb Slope, 4-115
Excessive Bubbles in tHb Slope message, 4-7
*Excessive Scatter in co–ox Meas, 4-115
Excessive Scatter in CO-ox Meas message, 4-7
Exit Menus key, 5-5
exiting standby, 5-84
expired gas samples, 1-35
exterior
cleaning, 3-8
front base model (illustrations), 1-9, 1-10
front with CO-ox (illustrations), 1-11
rear with CO-ox (illustration), 1-13
side (illustration), 1-12
external devices
configuring an 800 system for, 5-62 to 5-65
connecting to an 800 system, D-1
external loopback test, 4-55, 4-75 to 4-76
External Loopback Test screen, 4-76
fetal hemoglobin, I-23
File (file number) Outdated QC message, 4-7
file format for copied files, 5-81 to 5-83
fluid detector test, 4-55, 4-66 to 4-67
Fluid Detector Test screen, 4-66
fluidic components, overview, 1-18 to 1-21
fluidics function test, 4-55, 4-56
Fluidics Functions Test screen, 4-56
fuses
installing (illustration), H-4
replacing, 3-105 to 3-108
gas exchange indices, I-32
gas flow rate test, 4-55, 4-64
gas tanks
checking pressure, 3-16
installing the regulator (illustration), H-6
operating pressure, 3-16
regulator (illustration), 3-16, H-7
removing, H-26
replacing, 3-90 to 3-94
valve assembly and regulator (illustration), 3-92
gas tubing
illustration, 3-94
removing, 3-94 to 3-95
Global QC Settings screen, 5-53
glucose and lactate biosensors, measurement
principles, lactate biosensor, I-20
glucose biosensor, interfering substances, E-28 to E-30
Help key, 1-24
Help program, 1-32
hematocrit, I-31
hemolyzer
anvil, 3-30
cleaning, 3-30
disassembling (illustration), 3-30
hepatitis B virus (HBV), A-1
hex tool (illustration), 3-73
Home key, 1-24, 5-5
household bleach. See sodium hypochlorite
human immunodeficiency virus (HIV), A-1
If Blood, Question Data, 4-7 to 4-9, 4-116
installation
800 system, H-1 to H-28
system specifications (table), H-1
tools required, H-14
Insufficient CO–ox Sample, 4-117
Insufficient CO-ox Sample message, 2-33, 4-8
Insufficient Sample, 4-118
Insufficient Sample message, 2-33, 4-8
Interfering Substance Detected message, 2-33
Interfering Substance tHb message, 4-8
Interfering Substance: Glu, 4-118
Interfering Substance: Glu message, 4-8
Interfering Substance: Lac, 4-118
Interfering Substance: Lac message, 4-8 to 4-151
Interfering Substance: tHb, 4-118
Interfering Substance: tHb message, 2-33
Interfering Substances, Lactate, E-33
ion-selective electrode (illustration), I-3
keyboard, optional, 1-25
keypad
F-keys, 1-26
illustration, 1-14
system keys, 1-24
Lactate Biosensor, interfering substances, E-31 to E-33
lamp
replacing CO-ox, 3-103
replacing measurement module, 3-102
languages, selecting, 5-32
limitations on blood gas analysis, 1-33
line printer
configuring an 800 system for, 5-62
connecting to an 800 system, D-5
examples of printed reports, F-7
LIS
canceling an assay order, 2-4
communication parameters, 5-64
configuring an 800 system for, 5-62
connecting to an 800 system, D-6
patient sample assay order, 2-4
QC sample assay order, 2-4
sending sample results to, 2-4
turning auto send (patient results) on or off, 5-38
turning auto send (QC results) on or off, 5-55
location for 800 system, H-1
maintenance
analyzing High G/L, 3-12 to 3-14
checklist charts, J-1
scheduling tasks, 5-33 to 5-34
Maintenance Log screen, 3-7 to 3-44
Maintenance Schedule screen, 3-5 to 3-44
Maintenance Setup screen, 5-34 to 5-35
Material Safety Data Sheets, 1-40
Meas Module Temperature Error, 4-119
Meas Module Temperature Error message, 4-8
Meas Module Temperature Warning, 4-119
Meas Module Temperature Warning message, 4-8
measured parameters, listed by system, 1-5
measurement module
840, 844, and 845 systems (illustration), 1-16
850, 854, and 855 systems (illustration), 1-16
860, 864, and 865 systems (illustration), 1-17
components, 1-15
opening door (illustration), 3-18
overview, 1-15 to 1-17
removing obstructions, 4-82 to 4-86
replacing lamp, 3-102 to 3-103
replacing lamp (illustration), 3-102
replacing tubing, 3-34 to 3-36
840 and 845 systems (illustration), 3-35
850 and 855 systems (illustration), 3-36
860 and 865 systems (illustration). See 850
system (illustration)
temperature range (error), 4-113, 4-119
temperature range (warning), 4-112, 4-119
Measurement Module Door Open message, 4-8
Measurement Module Temp Error message, 2-33
Measurement Module Temp Warning message, 2-33
measurement test, 4-55, 4-70 to 4-74
printing stored signals, 4-70
testing a sensor circuit without a sensor, 4-72
measuring hemoglobin, CO-ox module, I-24
menu codes, 1-31
Menu key, 5-4
menu map, 1-30
Menu mode, 1-29 to 1-30
menu options password
default, 5-30
defining, 5-29 to 5-30
metabolite calibration, slope, 1-45
metabolite recal, 5-60, 5-61
methemoglobin (FMetHb), measurement principles,
I-23
mixed venous blood samples, 1-34
More Results key, 1-26
Next Screen key, 5-4
NIST traceable
calibration gases, 1-44
reagents, 1-41
temperature, 3-10, 4-69
No Paper In Printer message, 4-8
No Sample Device Detected, 4-120
No Sample Device Detected message, 4-9
No Waste Bottle Detected message, 4-9
numeric keys, 1-24
O2 binding measurement values, 5-15
operating principles, I-1 to I-38
a–v studies, I-35
amperometry, I-6
entered parameters, p50, I-30
measuring electrolytes, I-13 to I-38
chloride, I-16
ionized calcium, I-17
potassium, I-15
sodium, I-15
measuring metabolites, I-18 to I-38
glucose, I-18
lactate, I-19
measuring pCO2, I-9
measuring pH, I-8
measuring pO2, I-11
other reported parameters, I-25
potentiometry, I-1 to I-38
operator password, default, 5-28
operator passwords, defining, 5-27 to 5-29
Operator Passwords Screen, 5-28
other reported parameters, listed by system, 1-5
Out of Range message, 4-9
oxygen capacity (hemoglobin), I-30
oxygen consumption rate, I-36
oxygen content (hemoglobin), I-29
oxygen content, estimated, I-28
oxygen delivery, I-36
oxygen saturation (hemoglobin), I-28
oxygen saturation, estimated, I-27
oxyhemoglobin (FO2Hb), measurement principles,
I-22
p50, I-30
p50 measurement values, 5-15
paper spool, turning on or off, 5-25
paper-advance key, 1-24
paper-spool key, 1-25
parameter name options, 5-16
Parameter Names screen, 5-17
parameter names, selecting, 5-16
parameter panels
custom, 5-9
default, 5-10
options, 5-10
selecting, 2-29, 5-10
parameter units
default and optional, 5-13
reporting ranges, E-3 to E-9
selecting, 5-13
significant digits, 5-39
parameter values, defining, 5-15
parameters analyzed, selecting, 5-12
Parameters screen, 5-13
password protection, selecting, 5-26 to 5-27
Password Protection screen, 5-26
passwords
default. See default passwords
defining. See defining passwords
entering, 2-5
menu options, 2-5
system, 2-5
Patient Data Search Criteria screen, 2-35, 5-80
Patient Data Search Log (screen), 2-36
Patient Data Search Result screen, 2-37
Patient Information form, 2-27
defining, 5-6 to 5-8
fields, 5-6
screen, 2-27
patient sample analysis
canceling, 2-4
capillary samples, 2-8 to 2-29
inserting (illustration), 2-8
moving automatically, 5-37
moving manually, 2-9
sample volume requirements, 2-8
combining results with 270 CO-oximeter results,
2-22 to 2-29
CO-ox only, sample volume requirements, 2-14
CO-ox only samples, 2-14 to 2-29
expired gas samples, 2-20 to 2-29
inserting (illustration), 2-20
sample volume requirements, 2-20
microsamples, 2-11 to 2-29
sample volume requirements, 2-11
overview, 2-3 to 2-5
pH samples, 2-15 to 2-29
moving manually, 2-15
sample volume requirements, 2-15
Ready state, 2-3
syringe samples, 2-6 to 2-7
inserting (illustration), 2-6
insufficient sample, 2-7
sample volume requirements, 2-6
sequence, 1-59 to 1-74
vacuum tube samples, 2-18 to 2-29
inserting with aspiration adapter (illustration),
2-18
insufficient sample, 2-19
moving manually, 2-19
sample volume requirements, 2-18
patient sample data
copying files, 5-79 to 5-80
editing, 2-38 to 2-44
entering, 2-27 to 2-29
printing, 2-39
recalling, 2-35 to 2-38
transmitting, 2-39
patient sample results, 2-30
reports
example, 2-31
symbols, 2-30
screen, 2-30
transmitting to an LIS, HIS, or data management
system, 5-38
troubleshooting, 4-97
patient temperature correction, I-32
pCO2
measuring, I-9
sensor, I-11
performance
840 data, E-11 to E-16
850 data, E-17 to E-27
860 data, E-28 to E-45
limitations, E-10
pH
calcium adjustment, I-34
measuring, I-8
sensor, I-9
pO2
measuring, I-11
sensor, I-12
Port Selection screen, 5-62
ports
connecting external devices, D-1
illustration, 1-13
ports form (illustration), 5-64
potassium
measuring, I-15
sensor, I-16
power failure, recovering from, 5-85
precision, 2-3
Previous Screen key, 1-26, 5-5
priming the system, 3-62
printed reports
examples, F-1 to F-12
printing options, 5-20
printer report format, defining, 5-22
Printer Report screen, 5-22
Printing Options screen, 5-21, 5-24, 5-25
printing options, selecting, 5-20
Probe Detected Obstruction message, 4-9
pump flow rate test, 4-55, 4-57
Pump Flow Rate Test screen, 4-57
pump functions test, 4-55, 4-58 to 4-62
Pump Functions Test screen, 4-59
pumps
calibrate, 4-57
illustration, 1-19
replacing tubing, 3-39 to 3-43
CO-ox pump (illustration), 3-41
reagent pump (illustration), 3-42
sample and waste pump (illustration), 3-40
roller cages
cleaning, 3-51 to 3-53
removing (illustration), 3-52, 3-97
replacing, 3-96 to 3-97
troubleshooting, 4-112
QC Data Search Log (screen), 2-46
QC Data Search Result screen, 2-47
QC file information, 5-45
QC File Information form, screen, 2-43
QC File Information form (screen), 2-43
QC File Setup (Ranges) screen, 5-47
QC File Setup screen, 5-46
QC files, 1-52
creating new QC files, 5-46
editing file setup information, 5-49
identifying automatically, 1-53
printing QC setup report, 5-56
selecting automatic QC file assignment, 5-53
setting up, 5-45
QC results
accepting automatically, 1-53, 5-54
archiving, 1-55, 5-68
editing, 2-48
entering into a QC file, 2-43 to 2-44
Levey-Jennings charts, 1-54
viewing and printing, 2-52 to 2-66
recalling, 1-54, 2-45 to 2-66
results outside of limits, 2-42
transmitting automatically, 1-54, 2-49
transmitting to an LIS, HIS, or data management
system, 5-55
troubleshooting, 4-94
viewing archived data, 5-70 to 5-72
QC sample report
example, 2-49
printing, 2-49
QC Sample Search Criteria screen, 2-45
QC samples
analyzing, 2-40
inserting with aspiration adapter (illustration), 2-41
specifying a panel, 2-40
QC setup report
illustration, 5-56
printing, 5-56
QC statistical summary report
example, 2-51
printing, 2-51
QC statistical summary reports, automatic printing of,
5-33
QC statistical summary reports, 1-55
Qt, entering for a–v studies, 2-24
quality control (QC), 1-50
analyte performance verification, 1-56
calibration verification, 1-56
how often to run, 1-51
materials, 1-50
options, 5-45 to 5-56
statistics, 1-51 to 1-52
reagent delivery components, illustration, 1-19
reagent fittings
cleaning, 3-53 to 3-54
removing, 3-53
reagent manifold, cleaning, H-23
reagent manifold vent filter, replacing, 3-44
reagent pump calibration, 4-57
reagents
active ingredients, 1-39
checking levels, 3-9
handling and preparing, 1-43
intended use, 1-41
removing bottles, 3-65
replacing bottles, 3-65
storing, 1-42
troubleshooting, 4-100 to 4-107
rear panel (illustration), H-16
reconnecting CO-ox sample path, 4-93
reference and action ranges
default values, 5-18
defining, 5-17
Reference and Action Ranges screen, 5-19
reference electrode (illustration), I-3
reference methods, E-9
references, C-1 to C-4
relocation, 800 system, H-20 to H-28
removing obstructions
capillary seal (illustration), 4-80
clearing a sensor (illustration), 4-82
CO-ox sample path, 4-87 to 4-91
measurement module, 4-82 to 4-86
pH, Na+, reference, or sample ground/temp sensor
(illustration), 4-83
preheater (illustration), 4-85
sample entry components, 4-79 to 4-81
sample port (illustration), 4-81
sample tubing (illustration), 4-79
spring-loaded latch (illustration), 4-86
Report Results with Cal Drift message, 4-9
Reset Default Values key, 5-5
respiratory index, I-33
restoring saved data. See disk utilities
roll printer
cleaning, 3-56
examples of printed reports, F-1 to F-6
illustration, 1-9
paper
checking, 3-10
installing (illustration), 3-67, 3-68
replacing, 3-66 to 3-68
troubleshooting, 4-111
turning on or off, 5-24
roll printer test, 4-56, 4-76
sample chamber
cleaning, 3-26 to 3-29
removing (illustration), 3-27
replacing. See cleaning
sample chamber gasket (illustration), 3-27
sample connector (illustration), 4-92
sample count, 5-5
sample devices, 1-35
identifying, 2-3
sample entry components
illustration, 1-18
removing obstructions, 4-79
sample entry test, 4-55, 4-67 to 4-69
Sample Entry Test screen, 4-68
sample path
checking temperature, 3-10
cleaning with bleach, 3-59 to 3-61
cleaning with cleaning solution, 3-62
cleaning with glutaraldehyde, 3-57
deproteinizing, 3-13
sample port
cleaning, 3-55 to 3-56
removing (illustration), 3-55
replacing, 3-98
sample probe
replacing, 3-99 to 3-100
replacing (illustration), 3-100
troubleshooting, 4-111
sample requirements
sources, 1-34
storage and handling, 1-36 to 1-37
storing on ice, 1-37
Sample Temperature Out of Range, 4-120
Sample Temperature Out of Range message, 2-34, 4-9
sample tubing
base model, 3-99
removing (illustration), 3-24
replacing, 3-23 to 3-26
replacing CO-ox, 3-37
rotating (illustration), 3-24
saving system data, 5-72
screen
check box, 1-27
cursor, 1-27
elements, 1-27
frame, 1-27
highlight bar, 1-27
illustration, 1-9, 1-23
message box, 1-27
option button, 1-27
scroll list, 1-27
sensor icons, 1-27, 1-28
text field, 1-27
timing bar, 1-27
Select Custom Panels screen, 5-9 to 5-19
Select Default Panel screen, 5-12 to 5-19
Select Parameters, 2-29 to 2-76
Send key, 1-26
sensors
checking for bubbles (illustration), reference sensor,
3-48
cleaning
reference sensor, 3-47 to 3-48
sample ground/temperature sensor, 3-49 to 3-50
sample ground/temperature sensor (illustration),
3-49
conditioning, 3-14
filling
checking solution levels, 3-17 to 3-19
electrode compartment of reference sensor
(illustration), 3-72
fill solutions, 3-81
KCl reservoir on reference sensor (illustration),
3-80
measurement sensors, 3-80 to 3-83
reference sensor, 3-69 to 3-70
measurement principles
calcium sensor, I-18
chloride sensor, I-17
glucose and lactate biosensors, I-20
lactate, I-19
pCO2 sensor, I-11
pH sensor, I-9
pO2 sensor, I-12
potassium sensor, I-16
reference sensor, I-5
sodium sensor, I-15
measurement sensors, installation order, 3-88
position in measurement module, 3-85
reinstalling
glucose and lactate biosensor, 3-88
measurement, 3-89 to 3-90
reference sensor, 3-89 to 3-90
removing
bubbles from reference sensor, 3-47
glucose and lactate biosensors, 3-87 to 3-89
measurement sensors (illustration), 3-81
measurement sensors internal electrode
(illustration), 3-82
reference sensor (illustration), 3-47, 3-69
reference sensor internal electrode (illustration),
3-78
reservoir cap from reference sensor (illustration),
3-70
sample ground/temperature sensor (illustration),
3-49
replacing
glucose and lactate biosensors, 3-86 to 3-89
measurement sensors, 3-83 to 3-86
reference sensor, 3-71 to 3-74
reference sensor cassette, 3-74 to 3-76
reference sensor internal reference electrode, 3-77
to 3-80
sample ground/temperature sensor, 3-83 to 3-86
sample ground/temperature sensor, installation
position, 3-88
troubleshooting, 4-107
sequences, 1-58 to 1-74
one-point calibration, 1-64 to 1-74
syringe sample, 1-59 to 1-74
two-point calibration, 1-68 to 1-74
wash, 1-62 to 1-74
service
setup information, 5-66
under warranty, B-4 to B-7
service telephone number, 5-5
Set Passwords Screen, 5-30
security setup
menu options password, 5-29 to 5-30
password protection, 5-26 to 5-27
operator passwords. See defining passwords
supervisor password, 5-29 to 5-30
setting up the system
beeper volume, 5-36
capillary sample movement, 5-37
correlation coefficients, defining, 5-42
date and time, 5-31 to 5-32
keys used, 5-4
menu options password, 5-29 to 5-30
overview, 5-3 to 5-19
paper spool, 5-25
parameter names, 5-16
parameter panels, 5-10
parameter resolution, 5-39
parameter units, 5-13
parameter values, 5-15
parameters analyzed, 5-12
password protection, 5-26 to 5-27
operator passwords, 5-27 to 5-29
Patient Information form, 5-6 to 5-8
printer report format, 5-22
printing options, 5-20 to 5-21
reference and action ranges, 5-17
reporting results with calibration drift, 5-40
roll printer, 5-24
setup report, printing, 5-44
supevisor password, 5-29 to 5-30
system information, 5-5
transmission of patient results to an LIS, HIS, or
data management system, 5-38
setup report, printing, 5-44
shutting the system down, H-15
site requirements, H-1
Size of patient sample database, 5-35
Slope Gas, 1-44
composition, 3-92
sodium
measuring, I-15
sensor, I-15
sodium hypochlorite, 3-8
software
Analyze mode, 1-28
F-keys, 1-26
installing, 5-76 to 5-79
Main Menu, 1-29
menu codes, 1-31
menu map, 1-30
Menu mode, 1-29
screen elements, 1-27
system keys, 1-24
specifications, system (table), H-1
standby, placing the system in, 5-83
Status Event Log, 4-5
Status Event Log Report (illustration), 4-5
stopping the system, 3-63
SulfHb > 1.5% message, 4-9
sulfhemoglobin (SulfHb), measurement principles,
I-23
supervisor password
default, 5-26, 5-27, 5-29, 5-30
defining, 5-29 to 5-30
supplies, list with part numbers and descriptions, B-8
syringes, using, 1-35, 2-3
system fuses, replacing (illustration), 3-106
System Information screen, 5-6
system information, viewing, 5-5
system keys, 1-24
system messages, 4-5, 4-6 to 4-10
troubleshooting, 4-114
System Options screen, 5-33, 5-35, 5-36, 5-37 to 5-39,
5-40 to 5-43
system specifications, E-2
system specifications (table), H-1
temperature/ pAtm test, 4-55, 4-69
tHb
See also CO–ox module
measurement principles, I-22
tHb measurement values, 5-15
tHb slope
analyze mode, 2-57
menu mode, 2-57
tHb Slope Calibration Due message, 4-9
tHb Slope Calibration screen, 2-57
ticket printer
configuring an 800 system for, 5-62
connecting to an 800 system, D-3
examples of printed reports, F-11
total carbon dioxide, I-31
trace log, 5-72 to 5-74
troubleshooting
bar code scanner, 4-109
bar codes, 4-109
cloudiness or particulate matter in fluids, 4-106
electronic problems, 4-110
fluid leaks, 4-101
gas problems, 4-107
insufficient fluid flow, 4-102 to 4-105
patient sample results, 4-97
pumps, 4-112
quality control results, 4-94
roll printer, 4-111
sample probe, 4-111
sensors, 4-107
system messages, 4-114
temperature (thermal) control, 4-112
tubercle bacillus, A-1
two-point calibration report (example), 2-64
Unexpected Device Detected message, 4-9
Units and Values form (screen), 5-16
Units and Values screen, 5-14
user interface, 1-23 to 1-32
vacuum tubes, using, 1-36
Valve Test screen, 4-63
valves test, 4-55, 4-62
venous blood samples, 1-34
venous oxygen content, I-35
voltage bobbin (illustration), H-4
WARNING, meaning of, xviii
warranty, B-4 to B-7
Wash G/L Zero
active ingredients, 1-39
handling and preparing, 1-43
intended use, 1-41 to 1-152
removing (illustration), 3-22
replacing, 3-22 to 3-24
storing, 1-42 to 1-44
wash sequence, 1-62 to 1-74
washing the system, 3-62
Waste Full message, 4-9
waste bottle
checking, 3-10
discarding, 3-46
emptying, 3-45 to 3-46
removing (illustration), 3-45
waste components, illustration, 1-20
waste disposal, 1-38
Waste Is Almost Full message, 4-9
waste outlet cover, removing (illustration), 3-46
workload statistics
report (illustration), 3-64
reviewing and printing, 3-64