NOVA Biomedical 51360 13.56 MHz RFID TAG TRANSMITTER HID User Manual

NOVA Biomedical Corporation 13.56 MHz RFID TAG TRANSMITTER HID

User Manual

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52920
Stat Profile® PRIME™
CCS Analyzer
Instructions for
Use Manual
Nova Prime Quick Start Guide
1 Confirm the analyzer is
Ready for analysis.
Displays Ready, desired
test menu shows no Orange
Icons.
2 Login if necessary. Press the Login
scan your User ID and Password.
icon then enter or
3 Select the Sample Container and the Panel.
4 Prepare the sample for analysis then press
extend the sample probe.
to
5 Position the sample over the
sample probe then press
Aspirate to aspirate the
sample.
6 Enter any additional patient or sample information needed
while the analysis is completed.
7 Review results.
Nova Biomedical Symbol DirectorY
In vitro diagnostic medical device
Batch code
Product fulfills the requirements of Directive
98/79 EC (IVDD)
SN
Serial Number
Caution, consult accompanying documents
Temperature limitation
Consult instructions for use
Upper Limit of Temperature
Use by (last day of the month)
Biological risk
YYYY - MM
Catalog number
Electronic Waste
Manufactured by
Authorized
Representative
EC REP Nova
Biomedical
UK
in the European Community
Control
LASER RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
WAVELENGTH: 650 nm
MAX. OUTPUT: 1.2 mW
EN 60825-1: 2002
LEVEL
Level
Laser Radiation - Do Not
Stare Into Beam
Class II/IEC 825 Laser
Product
Wavelength: 655 nm
Preface
Stat Profile® PRIME™ CCS Instructions for Use Manual
Ordering Information
The Stat Profile® PRIME™ CCS Instructions for Use Manual
can be ordered from Nova Biomedical Order Services.
Write or call:
Nova Biomedical Corporation Telephone:1-800-458-5813
200 Prospect Street
FAX: 1-781-893-6998
Waltham, MA 02454-9141
(in the U.S.A.)
U.S.A.
+1-781-899-0417
(outside the U.S.A.)
Web: www.novabiomedical.com
EC REP
Authorized Representative
Nova Biomedical UK
Telephone:+ 44 1928 704040
Innovation House
Fax:+ 44 1928 796792
Aston Lane South, Runcorn
Cheshire, WA7 3FY, UK
Trademark and Patents
Stat Profile is a registered Trademark of Nova Biomedical
Corporation.
Stat Profile Prime is a Trademark of Nova Biomedical
Corporation.
Copyright
Printed in the U.S.A. Copyright 2013, Nova Biomedical
Corporation, Waltham, MA 02454-9141
Prime CCS Instructions for Use Manual
Preface
Technical Assistance
For technical assistance inside the United States, call Nova
Biomedical Technical Services at:
U.S.A.: 1-800-545-NOVA 1-781-894-0800
FAX: 1-781-894-0585
or
For technical assistance outside the United States, call your
local Nova subsidiary or authorized distributor.
Nova Biomedical Canada Ltd.
17 - 2900 Argentia Road
Mississauga, Ontario L5N 7X9
Canada
Tel: 1-800-263-5999
1 905 567 7700
Nova Biomedical GmbH
Messenhauser Str. 42
Roedermark
Urberach 63322
Germany
Tel: + 49 6074 8448 0
Nova Biomedical France
Parc Technopolis - Bât. Sigma
3 avenue du Canada 1er étage
Les Ulis courtaboeuf
91940
France
Tel: + 33 1 64 86 11 74
Nova Biomedical KK
B-3F Omori Bellport
26 Minami Oi 6-chome
Shinagawa-ku
Tokyo 140-0013
Japan
Tel: + (813) 5471-5461
Nova Biomedical UK
Innovation House
Aston Lane South, Runcorn
Cheshire, WA7 3FY
UK
Tel: + 44 1928 704040
ii
Table of Contents
Introduction
1.1
1.2
1.3
1.4
1.5
1.6
1-1
About This Manual....................................................1-1
Safety........................................................................1-1
Installation and Use..................................................1-4
Requirements...........................................................1-4
Intended Use, Tests Performed, and Clinical Utility..1-5
The Sample..............................................................1-8
1.6.1 Handling Requirements................................. 1-8
1.6.2 Acceptable Anticoagulants............................. 1-9
Getting Started
2-1
2.1 Power Up Procedure................................................2-3
2.2 The Home Screen: Ready .......................................2-4
2.2.1 Header Bar..................................................... 2-4
2.2.2 Selection Area................................................ 2-5
2.2.3 Menu Bar........................................................ 2-6
2.3 Automatic Calibrations..............................................2-7
2.3.1 Manual Calibrations....................................... 2-8
Sample Analysis
3-1
3.1 Analyzing Patient Samples.......................................3-1
3.1.1 Analyzing Syringe Samples........................... 3-1
3.1.2 Utilizing the Luer Station ............................... 3-3
3.1.3 Analyzing Sample: Blood Collection Tube..... 3-6
3.1.4 Analyzing Sample: Capillary Tube................. 3-8
3.2 The Sample Results Display..................................3-10
3.3 Analyzing QC and Proficiency Samples................3-12
3.2.1 Analyzing Internal QC Samples................... 3-12
3.2.2 Analyzing External QC Samples.................. 3-14
3.2.3 Analyzing Proficiency Samples.................... 3-15
Consumable Replacements
4-1
4.1 Scheduled Replacements.........................................4-1
4.2 Calibrator Cartridge & Control Cartridge Changing..4-2
4.2.1 Change Calibrator Cartridge.......................... 4-3
4.2.2 Change Control Cartridge.............................. 4-4
4.3 Change Sensor Card................................................4-4
52920A1 2013-09
toc-1
Prime CCS Instructions for Use Manual
Periodic Replacements
5.1
5.2
5.2
5.3
5.4
5-1
Pump Tubing Replacement......................................5-1
Probe Replacement..................................................5-3
Reference Sensor Replacement..............................5-5
Printer Paper Replacement......................................5-7
Safety Sample Port Replacement............................5-8
Troubleshooting
6-1
6.1 Troubleshooting Procedures.....................................6-1
6.2 Error Log...................................................................6-2
6.3 Operator Flow Test...................................................6-2
6.3.1 Flushing the Reference Sensor..................... 6-2
6.3.1 Flushing the Sensor Cartridge....................... 6-3
6.3.1 Flushing the Sample Probe............................ 6-4
Appendix
A-1
A.1 Specifications.......................................................... A-1
A.1.1 Analytical Specificity.......................................A-3
A.2 Analytical Performance Studies............................... A-5
A.3 Calibrator Cartridge............................................... A-22
A.3.1 Traceability Calibrators, Controls, Standards.. A-22
A.4 Reference Values.................................................. A-23
A.5 Ordering Information.............................................. A-25
A.6 Warranty................................................................ A-26
Principles of Measurement
B-1
B.1 Measured Values..................................................... B-1
B.1.1 Na+, K+, Cl-, and iCa......................................B-1
B.1.3 Partial Pressure of PCO2...............................B-3
B.1.4 Partial Pressure of PO2..................................B-4
B.1.5 Hematocrit......................................................B-4
B.1.6 Glucose..........................................................B-5
B.1.7 Lactate...........................................................B-5
B.2 Calculated Values.................................................... B-6
B.2.1 Temperature Correction for Measured Values.. B-6
B.2.2 Calculated Parameters..................................B-7
toc-2
10
1 Introduction
This manual provides all necessary instructions for the routine
operation and upkeep of all Stat Profile Prime CCS Analyzer.
Please read this manual carefully. It has been prepared to
help you attain optimum performance from your Analyzer.
WARNING: Blood samples and blood products are
potential sources of infectious agents. Handle
all blood products and flow path components
(waste-line, capillary adapter, probe, sensor
card, etc.) with care. Gloves and protective
clothing are recommended. When performing
maintenance and troubleshooting procedures,
also use protective eyewear.
This section introduces the Prime CCS Analyzer and covers
requirements, tests performed, procedural limitations, clinical
utility, and sample handling.
1.1 About This Manual
This manual is for the Stat Profile Prime CCS Analyzer.
Throughout this manual, NOTE: indicates especially important
information, CAUTION: indicates information that is critical to
avoid instrument damage or incorrect results, and WARNING:
indicates possible hazard to the operator.
1.2 Safety
Personnel operating this analyzer must be proficient in the
operating and replacement procedures of the analyzer. The
following safety procedures must be followed.
1-1
1. Intro.
1 Introduction
Prime CCS Instructions for Use Manual
General Safety
1. Read the safety and operating instructions before
operating the analyzer.
2. Retain the safety and operating instructions for
future reference.
3. Observe all warnings on the analyzer and in the
operating instructions.
4. Follow all operating and use instructions.
5. Do not use the analyzer near water, for example
near a sink, etc.
6. Use only with a cart or stand that is recommended
by the manufacturer.
The analyzer and cart combination should be
used with care. Quick stops, excessive force, and
uneven surfaces may cause the analyzer and cart
combination to overturn.
7. Place the analyzer so that its location or position
does not interfere with its proper ventilation.
8. Place the analyzer away from heat sources.
9. Connect the analyzer to a power supply only of
the type described in the operating instructions or
marked on the analyzer.
10. Do not defeat the safety purpose of the polarized
or grounding type plug.
11. Route power cords so that they are not likely to
be walked on or pinched by items placed upon or
against them, paying particular attention to cords at
plugs, power sockets, and at the point where they
exit from the analyzer.
12. The analyzer should be cleaned only as
recommended by the manufacturer.
13. Take care not to let objects or liquids fall into the
analyzer.
14. The analyzer should be serviced by qualified service
personnel.
15. Do not attempt to service the analyzer beyond that
described in the operating instructions. All other
servicing should be referred to qualified service
personnel.
1-2
1 Introduction
Federal Communications Commission (FCC) Notice
This device complies with Part 15 of the FCC Rules:
Operation is subject to the following conditions:
1. This device many not cause harmful interference, and
2. This device must accept any interference received,
Including interference that may cause undesired
operation
Changes and Modifications not expressly approved by
Nova Biomedical Corporation can void your authority to
operate this equipment under Federal Communications
Commissions rules.
Radio Standards Specifications (RSS) Notice
This device complies with Industry Canada licence-exempt
RSS standard(s).
Operation is subject to the following 2 conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including
interference that may cause undesired operation
of the device.
Le présent appareil est conforme aux CNR d'Industrie
Canada applicables aux appareils radio exempts de licence.
L'exploitation est autorisée aux deux conditions suivantes :
1. l'appareil ne doit pas produire de brouillage, et
2. l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.
1-3
1. Intro.
Electrical Safety
1. To reduce the risk of electric shock, do not remove
the cover.
2. There are no user serviceable parts inside the
analyzer.
3. Servicing must be done by qualified service
personnel.
4. To reduce the risk of fire or electric shock, do not
expose the analyzer to water.
5. Use Nova Part Number 52413 external power supply
to power up the analyzer.
6. Ensure that the wall outlet receptacle is properly
wired and earth grounded.
7. DO NOT use a 3-to-2 wire plug adapter.
8. DO NOT use a 2-wire extension cord or a 2-wire
multiple-outlet power strip.
Prime CCS Instructions for Use Manual
Chemical and Biological Safety
1. Observe all precautionary information printed on
the original solution containers.
2. Operate the analyzer in the appropriate environment.
3. Take all necessary precautions when using
pathologic or toxic materials to prevent the
generation of aerosols.
4. Wear appropriate laboratory attire, e.g., safety
glasses, gloves, lab coat, and breathing apparatus,
when working with hazardous materials.
5. Dispose of all waste solutions according to standard
hospital procedures.
1.3 Installation and Use
This section covers the installation requirements and
assembly procedures for the Stat Profile Prime CCS Analyzer.
Prior to use of the analyzer, operators should be familiar with
Chapter 2 Operation and Chapter 3 Operating Procedures.
NOTE:
Under the Warranty, a Nova service representative
will install this equipment for you.
1.4 Requirements
Working Area Requirements (Environmental):
Keep the working area around the system free of dirt,
corrosive fumes, vibration, and excessive temperature
changes.
Electrical Requirements:
• Operating Voltage Range:
• Operating Frequency:
• Power Consumption:
90 - 270 VAC
47 - 63 Hz
Less than 100 Watts
Ambient Operating Temperature:
• 15°C to 30°C (59°F to 86°F)
Operate at Humidity:
• 20 to 85% without condensation
1-4
1 Introduction
Dimensions:
Height:
Width:
Depth:
1. Intro.
Operate at Altitude:
• up to 12,000 feet/3650 meters
15.4 in (39.1 cm)
12.0 in (30.5 cm)
14.4 in (36.2 cm)
Weight:
17.5 lb (8.164 kg) without reagent pack
23 lb (10.45 kg) with full reagent pack
Lifting the Analyzer:
1. One person is needed to lift the analyzer.
CAUTION:Never use the door (open or closed) to assist
you in lifting the analyzer. The door cannot
support the weight of the analyzer.
2. From the front of the analyzer, place your hands
under each side of the analyzer.
3. Lift the analyzer. Remember to bend your knees
and lift with your legs and not your back.
4. Place the analyzer onto a clean and flat surface.
1.5 Intended Use, Tests Performed, and Clinical Utility
Intended Use
The Stat Profile Prime CCS Analyzer System is intended
for in vitro diagnostic use by health care professionals in
clinical laboratory settings for the quantitative determination
of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), and
Lac (Lactate) in heparinized whole blood. It is not intended
for Point of Care use.
Measured Parameters
Stat Profile Prime CCS Analyzer: pH, PCO2, PO2, Hct,
Na+, K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate)
Glucose and Lactate are optional.
1-5
Prime CCS Instructions for Use Manual
Calculated Parameters
From the directly measured results, the calculated results
are shown in Table 1-1 for each analyzer in the Stat Profile
Prime CCS.
Table 1-1. Calculated Parameters
Calculated Parameters
pH, PCO2, PO2 (corrected to patient temperature)
Bicarbonate level (HCO3-)
Total Carbon Dioxide (TCO2)
Base Excess of the blood (BE-b)
Base Excess of extracellular fluid (BE-ecf)
Standard Bicarbonate Concentration (SBC)
Total Carbon Dioxide (TCO2)
Oxygen Content (O2Ct)
Oxygen Capacity (O2Cap)
Alveolar Oxygen (A)
Arterial Alveolar Oxygen Tension Gradient (AaDO2)
Arterial Alveolar Oxygen Tension Ratio (a/A)
Respiratory Index (RI)
P50
PO2/FIO2 ratio
Oxygen Saturation (SO2%)
Hemoglobin (Hbc)
Anion Gap
Normalized Calcium, nCa
1-6
1 Introduction
PCO2, Whole blood measurement of blood gases is used
PO2, in the diagnosis and treatment of life-threatening
pH
acid-base disturbances in critically ill patients with
numerous metabolic and pulmonary diseases.
Na+
Sodium measurement is used in the diagnosis and
treatment of aldosteronism, diabetes insipidus,
adrenal hypertension, Addison’s disease,
dehydration, or diseases involving electrolyte
imbalance.
K+
Potassium Measurement is used to monitor
electrolyte balance in the diagnosis and treatment
of disease conditions characterized by low or high
potassium levels.
Cl-
Chloride measurement is used in the diagnosis and
treatment of electrolyte and metabolic disorders
such as cystic fibrosis and diabetic acidosis.
iCa
Ionized Calcium measurement is used in the
diagnosis and treatment of hypertension, renal
disease, and vitamin D related disorders. Also
useful in the diagnosis and treatment of patients
with increased total protein and/or albumin levels,
as in dehydration.
Glu
Glucose measurement is used in the diagnosis and
treatment of carbohydrate metabolism disturbances
including diabetes mellitus, neonatal hypoglycemia,
and idiopathic hypoglycemia, and of pancreatic islet
cell carcinoma.
Lac
Lactate (lactic acid) measurement is used to evaluate
the acid-base status of patients suspected of having
lactic acidosis.
Ref.
1. Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011.
Tietz Textbook of Clinical Chemistry and Molecular Diagnostics.
5th ed, Philadelphia, PA: W. B. Saunders Co.
1-7
1. Intro.
Clinical Utility1The following list includes the clinical utility
information for each of the analytes measured on the Stat
Profile Prime CCS Analyzer.
Prime CCS Instructions for Use Manual
1.6 The Sample
Sodium or lithium heparin whole blood samples from
syringes, open tubes, small cups, and capillary tubes can be
used on the Stat Profile Prime CCS Analyzer. The minimum
sample size for analysis is 100 µL.
1.6.1
Handling Requirements
Correct sample handling is critical to ensure that the blood gas
values obtained accurately reflect the in vivo state. Ensure
that all samples have been obtained and stored following
consistent, clinically accepted protocols. It is particularly
important to ensure that samples are well mixed before
introduction into the analyzer. Nova Biomedical recommends
that you analyze the sample within 15 minutes for blood
gases. Storing samples on ice is not recommended. Using
iced samples may elevate the PO2 result.1
1.
1-8
Clinical and Laboratory Standards Institute (CLSI),
(March 4) 2009, Blood Gas and pH Analysis and
Related Measurements; Approved Guideline—
Second Edition (C46-A2).
1 Introduction
Acceptable Anticoagulants
•
Sodium and lithium heparins are the acceptable
anticoagulants for use with the analyzer.
•
EDTA, citrate, oxalate, and sodium fluoride ARE
NOT acceptable for use.
•
Depending on the amount of heparin used in the
collection syringe and whether it is filled to capacity
with blood, heparin concentrations of 20 I.U. per mL
to over 100 I.U. per mL may result.
•
Excess sodium heparin may elevate sodium results.
•
Liquid or dry heparin when present in excess may
cause errors. Ensure blood collection devices are
filled per manufacturer instructions.
•
Our experience suggests that lyophilized lithium
heparin giving a final concentration in blood of not
more than 20 I.U. per mL is acceptable.
CAUTION: Stat Profile Prime CCS Analyzer users
should take careful note of these considerations
when establishing reference intervals and
interpreting results.
1-9
1. Intro.
1.6.2
Prime CCS Instructions for Use Manual
1-10
2 Getting Started
2 Getting Started
The Stat Profile Prime CCS Analyzer is pictured below.
2. Started
Figure 2.1 Nova Stat Profile Prime CCS
1.
2.
3.
4.
Touch-screen Display
Printer
Sampler
Door/Front Panel
2-1
Prime CCS Instructions for Use Manual
Figure 2.2 Analytical Compartment
1.
2.
3.
4.
5.
6.
7.
8.
9.
2-2
Waste Line
Reference Line
Pump and Pump Tubing
Calibrator Cartridge Opening
Control Cartridge Opening
Sampler
Air Detector
Sensor Card (under cover)
Reference Sensor (under cover)
2 Getting Started
2.1 Power Up Procedure
After successfully completing the POST, the Home screen
displays with Initializing. During initialization, an internal
diagnostic sequence is run: the Sensor Card life; the calibrator
cartridge fluid level; and the internal QC cartridge fluid level
are checked.
Figure 2.3 Initializing Screen
The Prime CCS performs a prime cycle. After completion,
the screen displays Not Ready.
Figure 2.4 Not Ready Screen
2-3
2. Started
When the analyzer is powered on, it displays the Nova Prime
CCS logo. During this time, an internal Power On Self Test
(POST) is run. Any errors encountered during the POST
will display on the analyzer's screen.
Prime CCS Instructions for Use Manual
2.2 The Home Screen: Ready
Header Bar
Selection
Area
Menu Bar
Figure 2.5 Home Screen: Ready
The screen of the Prime CCS Analyzer is a Touch-screen.
The touch-screen display provides prompts, menus, status
information, sensor status, panel selection, date and time, etc.
2.2.1
Header Bar
The Header Bar is the top section of the display. This is
where Ready or Not Ready, Date and Time, Login, and
Sensor Card, Calibrator Cartridge, and Control Cartridge
status are displayed.
The current Date and Time is displayed.
When a timed operation is in process, the Date
and Time is replaced by a countdown timer.
Login with a Lock icon is displayed in the Header
Bar. Press the Lock and proceed to login with your
Operator ID and password.
Only one person can be logged into the analyzer
at a time. When logged onto the analyzer, an
open lock is shown with the logged in operator
ID displayed under it.
2-4
2 Getting Started
•
The analyzer can also be run with the login featured
turned off.
2.2.2
Selection Area
The Selection Area
is the middle of
the display. Panel
selection, Sample
container selection,
and sensor availability are selected here.
•
Analytes that are displayed in Orange are not
available for analysis. If you press the icon of the
Orange Analyte, a pop-up window with additional
information will display.
•
Analytes that are displayed in Blue are available
and selected for analysis. If you press the icon of
a Blue Analyte, the it turns Grey indicating it is not
selected for analysis.
•
Analytes that are displayed in Grey are available
but not selected for analysis. If you press the icon
of a Grey Analyte, it turns Blue indicating it is not
selected for analysis.
The Container icon allows you to select the type
of container and sample to be analyzed.
The Panel icon allows you to select from a
predefined list of test panels.
2-5
2. Started
The upper right corner of the Home screen (Header
Bar) has the Status Graph which when touched will
display the status of the Sensor Card, calibrator
cartridge, and QC cartridge.
Prime CCS Instructions for Use Manual
2.2.3
Menu Bar
The Menu Bar is the bottom section of the screen. The
Tool Box icon (System Menu screens), Find Results icon,
QC icon (to run QC and QC Menu Screens), and the Start
(Run Test) or Calibrate icon.
The Home icon returns the analyzer to the Home
screen by touching this icon. This icon does not
display on the Home screen.
The Tool Box icon is located at the Menu Bar.
Press this icon to display Screen one of the System
Menus. The up/down arrow key is pressed to
display screen two. From the System Menu, you
can also navigate to the Setup Menu.
The find results icon of the Menu Bar will display
all the patient results stored on the analyzer.
The QC icon will display the QC Menu screen:
Run QC, Setup QC Levels, View QC Data, and
Setup QC Operations.
The Calibrate icon is displayed when all analytes
are not calibrated. Press Calibrate to initiate a
system calibration.
If one or more analytes are calibrated, the Start
icon displays. Press Start to begin an analysis.
These screens may have other navigational icons.
Press the Back icon to return to the previous
screen.
The Page Up and Page Down icons scroll through
the menus that have multiple pages.
2-6
2 Getting Started
2.3 Automatic Calibrations
2-7
2. Started
The Stat Profile Prime CCS analyzer performs a 2-point
calibration on all analytes and air detectors 30 minutes
after being powered on and regularly thereafter to maintain
optimal sensor card and air detector performance. A 1-point
calibration is performed at regular intervals to monitor the
sensor card’s performance between each 2-point calibration.
If a calibration error occurs, an alert is shown to notify
the operator and the test button of the affected analyte is
displayed with an orange background to indicate it is not
available for testing.
Scheduled 2-point calibrations can be delayed once for 10
minutes by pressing the Cancel button. After 10 minutes the
rescheduled calibration will begin and cannot be cancelled.
Prime CCS Instructions for Use Manual
2.3.1
Manual Calibrations
A manually initiated 2-point calibration can be performed
whenever the analyzer displays Ready or Not Ready on
the header bar.
A Not Ready (Not Calibrated) status is displayed after
powering the analyzer on, after replacing some consumable
items or as a result of a system error. When the analyzer
displays Not Ready, samples cannot be run until a 2-point
calibration is performed that successfully calibrates the air
detectors and at least one analyte. To initiate a calibration
from the Not Ready state, press the Calibrate icon
on the Menu Bar.
A Ready status indicates the air detectors and one or more
analytes are calibrated and ready for analysis. To manually
calibrate the analyzer from the Ready state press Toolbox
icon
then press Calibrate
Analytes that display an orange background may be
uncalibrated. Press the icon and select Calibrate
if
displayed to initiate a 2-point calibration.
Figure 2.6 Not Ready Screen and Ready Screen
2-8
3 Sample Analysis
3 Sample Analysis
When Ready is displayed on the Home screen the analyzer
is ready to analyze samples for any analyte not displaying
an Orange test button. The analyzer can measure whole
blood samples from capillary tubes, syringes, test tubes, and
open containers as well as external Quality Control material
from ampules and internal Quality Control material from an
internal QC cartridge
Before running a patient sample verify the analyzer is Ready
to perform an analysis and that all the desired analytes are
available for selection. If necessary, refer to Chapter 2 for
additional information.
3.1.1
Analyzing Syringe Samples
From the Home screen, login if you are prompted to login.
1. Press the Login icon
to log into the analyzer.
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
Figure 3.1 Operator ID Screen and Operator Password Screen
If login is not required or after logging into the analyzer:
1. Select the syringe
drop-down list.
icon from the container
3-1
3. Analysis
3.1 Analyzing Patient Samples
Prime CCS Instructions for Use Manual
2. Select the desired Test Panel from the drop-down list
or select one or more analytes to create a Custom
Panel.
Figure 3.2 Ready Screen: Container and Panel Drop-down List
3. Press Start
icon to begin the analysis.
4. If prompted, enter
all Required
Information
and press Start
once
more to begin the
analysis.
Figure 3.3 Sample Information Screen
5. Prepare the sample for analysis (mix well) then
position the sample
over the probe
and press Aspirate
. The sample
probe will retract
automatically once
sufficient sample
has been aspirated
into the analyzer.
Figure 3.4 Syringe Sample without Luer
3-2
3 Sample Analysis
6. Enter any Required or Optional information while
the analysis is running.
Figure 3.5 Sample Information Screen
3.1.2
Utilizing the Luer Station
The luer station provides a means of attaching a syringe
to the analyzer instead of manually positioning the sample
probe in the sample. When utilizing the leur station Nova
recommends using the Nova Syringe Clot Catcher to ensure
that the sample is positioned correctly for aspiration and to
prevent clots from entering the flowpath. If a clot catcher
is not used, syringes must be filled with sufficient sample
for the probe to travel approximately 1-inch (26 mm) into
the syringe.
From the Home screen:
From the Home screen, login if you are prompted to login.
1. Press the Login icon
to log into the analyzer.
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
3-3
3. Analysis
NOTE: The sample will remain on screen until all Required fields
have been entered.
The analysis can
be cancelled by
pressing the X icon
but results
will not be printed
or transmitted.
Prime CCS Instructions for Use Manual
Figure 3.6 Operator ID Screen and Operator Password Screen
If login is not required or after logging into the analyzer:
1. Select the syringe
icon from the container
drop-down list.
2. Select the desired Test Panel from the drop-down list
or select one or more analytes to create a Custom
Panel.
Figure 3.7 Ready Screen: Container and Panel Drop-down List
3. Prepare the sample for analysis (mix well) then
attach the syringe to the luer station.
3-4
3 Sample Analysis
4. Press Start
icon to begin the
analysis.
Figure 3.8 Syringe Sample with Luer
3. Analysis
5. If prompted, enter
all Required
Information
and press Start
once
more to begin
the analysis.
Figure 3.9 Sample Information Screen
6. Press the Aspirate icon
to aspirate sample
into the analyzer. The sample probe will retract
automatically once sufficient sample has been
aspirated into the analyzer.
7. R e m o v e t h e
syringe from the
luer station.
8. E n t e r
any
R e q u i r e d
or Optional
information while
the analysis is
running.
Figure 3.10 Sample Information Screen
3-5
Prime CCS Instructions for Use Manual
NOTE: The sample will remain on screen until all Required
fields have been entered. The analysis can be cancelled
by pressing the X icon
but results will not be
printed or transmitted.
3.1.3
Analyzing Sample from a Blood Collection Tube
From the Home screen, login if you are prompted to login.
1. Press the Login icon
to log into the analyzer.
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
Figure 3.11 Operator ID Screen and Operator Password Screen
If login is not required or after logging into the analyzer:
1. Select the blood collection tube
icon from
the container drop-down list.
2. Select the desired Test Panel from the drop-down list
or select one or more analytes to create a Custom
Panel.
3-6
3 Sample Analysis
3. Press Start
icon to begin the analysis.
4. If prompted, enter
all Required
Information
and press Start
once
more to begin the
analysis.
Figure 3.13 Sample Information Screen
5. Prepare the sample for analysis (mix well) then
position the sample
over the probe
and press Aspirate
. The sample
probe will retract
automatically once
sufficient sample
has been aspirated
into the analyzer.
Figure 3.14 Blood Tube Sample
3-7
3. Analysis
Figure 3.12 Ready Screen: Container and Panel Drop-down List
Prime CCS Instructions for Use Manual
6. Enter any Required or Optional information while
the analysis is running.
NOTE: The sample will remain on screen until all Required
fields have been
entered.
The
analysis can be
cancelled
by
pressing the X icon
but results
will not be printed
or transmitted.
Figure 3.15 Sample Information Screen
3.1.4
Analyzing Sample from a Capillary Tube
From the Home screen, login if you are prompted to login.
1. Press the Login icon
to log into the analyzer.
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
Figure 3.16 Operator ID Screen and Operator Password Screen
If login is not required or after logging into the analyzer:
1. Select the capillary
drop-down list.
3-8
icon from the container
3 Sample Analysis
2. Select the desired Test Panel from the drop-down list
or select one or more analytes to create a Custom
Panel.
3. Press Start
icon to begin the analysis.
4. If prompted, enter
all Required
Information
and press Start
once
more to begin the
analysis.
Figure 3.18 Sample Information Screen
5. Prepare the sample for analysis (mix well). Then
position the capillary
tube into the capillary
adapter and press
Aspirate
Figure 3.19 Capillary Sample
3-9
3. Analysis
Figure 3.17 Ready Screen: Container and Panel Drop-down List
Prime CCS Instructions for Use Manual
6. When prompted, remove the capillary tube and
press Continue.
7. Enter any Required or Optional information while
the analysis is running.
NOTE: The sample will remain on screen until all Required fields
have been entered.
The analysis can
be cancelled by
pressing the X icon
but results
will not be printed
or transmitted.
Figure 3.20 Sample Information Screen
3.2 The Sample Results Display
Once the sample analysis is complete, results for the selected
and calculated analytes are shown on the following screen
for Blood Results. Each analyte is shown with its measured
value, the unit of measure, and a bar graph that provides a
visual indication of the sample concentration.
The bar graph consists of 3 sections.
The first (left hand) section indicates the sample result is
lower than the entered normal range.
• The segment is displayed with a Orange background
if a sample result is between the low Normal and
low Alert range.
• The segment is displayed with a Red background
when a sample exceeds the low Alert range.
The middle section indicates the sample result is within the
entered normal range.
• The segment is displayed with a Green background
when the sample result is within the entered normal
range
3-10
3 Sample Analysis
The last (right hand) section indicates the sample result is
higher than the entered normal range.
• The segment is displayed with a Orange background
if a sample result is between the high Normal and
high Alert range.
• The segment is displayed with a Red background
when a sample exceeds the high Alert range.
3. Analysis
Figure 3.21 Blood Results Screen
Use the and buttons
to scroll through additional pages of result screens. The
number of pages is shown in the upper left corner of the
display, e.g., 1 of 3.
to print the results on the analyzer’s
Press
thermal printer.
Press
to transmit the results to the
LIS/HIS system.
Press
to return to the Home screen.
3-11
Prime CCS Instructions for Use Manual
3.3 Analyzing QC and Proficiency Samples
Before running a QC sample verify the analyzer is Ready
to perform the analysis and that all the desired analytes are
available for selection. If necessary, refer to Chapter 2 for
additional information.
3.2.1
Analyzing Internal Quality Control Samples
From the Home screen, login if you are prompted to login.
1. Press the Login icon
to log into the analyzer.
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
Figure 3.22 Operator ID Screen and Operator Password Screen
If login is not required or after logging into the analyzer:
1. From the Home Screen, press the QC button
2. Press the Analyze QC button
Figure 3.23 Quality Control Screens
3-12
3 Sample Analysis
3. From the drop-down list select the Internal Control
Level to be analyzed.
4. Enter a QC comment if desired.
5. Press Start to begin the analysis.
6. Once the analysis is complete press Save to keep
the QC results or press Delete to discard the QC
results.
3. Analysis
Option 1
QC Setup
Option 2
QC Setup
Figure 3.24 Quality Control Results Screens
3-13
Prime CCS Instructions for Use Manual
3.2.2
Analyzing External Quality Control Samples
From the Home screen, login if you are prompted to login.
1. Press the Login icon
to log into the analyzer.
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
Figure 3.22 Operator ID Screen and Operator Password Screen
If login is not required or after logging into the analyzer:
1. From the Home Screen, press the QC button
2. Press the Analyze QC button
Figure 3.23 Quality Control Screens
3. From the drop-down list select the External Control
Level to be analyzed.
4. Select the lot number of the External Control to be
analyzed.
5. Enter a QC Comment if desired.
3-14
3 Sample Analysis
Figure 3.24 External Control to Probe
9. Once the analysis is complete press Save to keep
the QC results or press Delete to discard the QC
results.
3.2.3
Analyzing Proficiency Samples
From the Home screen, login if you are prompted to login.
to log into the analyzer.
1. Press the Login icon
2. Enter or scan your Operator ID then press
3. If required, enter or scan your Password then press
Figure 3.25 Operator ID Screen and Operator Password Screen
3-15
3. Analysis
6. Press Start
to begin the analysis.
7. Wait for the Sample Probe to fully extend.
8. Prepare the sample for analysis (mix well) then
position the sample
over the probe
and press Aspirate
. The sample
probe will retract
automatically once
sufficient sample
has been aspirated
into the analyzer.
Prime CCS Instructions for Use Manual
If login is not required or after logging into the analyzer:
1. From the Home Screen, press the QC button
2. Press the Analyze QC button
Figure 3.26 Quality Control Screens
3.
4.
5.
6.
From the drop-down list select the Proficiency.
Press Start
to begin the analysis.
Wait for the Sample Probe to fully extend.
Prepare the sample for analysis (mix well) then
position the sample
over the probe and
press Aspirate
. The sample
probe will retract
automatically once
sufficient sample
has been aspirated
into the analyzer.
Figure 3.27 Proficiency Sample to Probe
7. Once the analysis is complete press Save to keep
the QC results or press Delete to discard the QC
results.
3-16
4 Consumable Replacements
4 Consumable Replacements
The following sections provide detailed information and
directions to operate and to maintain the Stat Profile Prime
CCS Analyzer at peak efficiency. From the Home screen,
press the Tool box icon. From these 2 screens, the following
consumable replacements can be performed:
• Change Sensor Card
• Change Calibrate Cartridge
• Change Control Cartridge
• Replace Pump Tubing
4.1 Scheduled Replacements
It is important to perform preventive care as scheduled.
The Analyzer Log gives suggested schedules based on
number of test. Space is provided for slopes and control results
in the Analyzer
Log. Replacement
procedures are
accessed in the
System Menu.
Figure 4.1 Screen 1 System Menu
4-1
4. Con Repl
WARNING: Blood samples and blood products are
potential sources of infectious agents. Handle
all blood products and flow path components
(waste-line, probe, sensor module, etc.) with
care. Gloves and protective clothing are
recommended. When performing maintenance
and troubleshooting procedures, also use
protective eyewear.
Prime CCS Instructions for Use Manual
Figure 4.2 Screen 2 System Menu
4.2 Calibrator Cartridge and Control Cartridge Changing
The reagent calibrator and/or control cartridge should be
changed when the system indicates the cartridge is empty.
From the Home screen, press the Tool Box icon. Then press
Change Calibrator Cartridge or Change Control Cartridge.
Mix the cartridge thoroughly by gentile inversions. Then follow the
directions on the screen to replace the cartridges and the
capillary adapter.
WARNING: When the calibrator cartridge or control
cartridge is removed, keep your fingers and
hands away from the back of the cartridge
compartment. There are sharp needles that
can cause injury, and the waste needle is also
a biohazard.
NOTE:
4-2
The calibrator or the control cartridge must be
replaced through the Tool Box screens. If you
remove and replace a cartridge (even if it is the
same one) outside these screens, you will not be
able to prime the analyzer, and you will not be
able to calibrate or to analyze samples (Calibrator
Cartridge) or to analyze internal controls (Control
Cartridge). If you have removed and replaced
a cartridge outside these screens, go to the
appropriate screen and press Prime.
4 Consumable Replacements
NOTE:
The capillary adapter comes in the calibrator
cartridge box. It is very important for the proper
operation of the analyzer that the capillary adapter
be changed with every calibrator cartridge change.
4.2.1
Change Calibrator Cartridge
1. Press the Tool Box icon.
2. From the System Menu, press the Change Calibrator
Cartridge and wait for pump to stop.
3. Open the door, remove old cartridge.
4. Slide new cartridge in past the front retaining lip.
5. Change the capillary adaptor: slide off used capillary
adapter and replace with new one that is provided
with Calibrator Cartridge.
6. Close door, press the Calibrate icon.
4-3
4. Con Repl
Figure 4.3 Replacing Calibrator Cartridge and Control Cartridge
Prime CCS Instructions for Use Manual
4.2.2
Change Control Cartridge
1. Press the Tool Box
icon.
2. From the System Menu, press the Change Control
Cartridge and wait for pump to stop.
3. Open the door, remove old cartridge.
4 Slide new cartridge in past the front retaining lip.
5. Close door, press the Calibrate
icon.
4.3 Change Sensor Card
1. Press the Tool Box
icon.
2. From the System Menu, press the Change Sensor
Card and wait for pump to stop.
3. Open the door, remove old cartridge.
4 Open Cartridge door. Insert new cartridge. Close
Cartridge door.
5. Close door, press the Calibrate
icon.
NOTE: Touch Sensor Card by the edges and replace it
the same way back as pictured.
Sensor Card
Hold from
Edges
Figure 4.4 Sensor Card
4-4
5 Periodic Replacements
5 Periodic Replacements
Periodically the pump tubing or probe may may need to be
replaced; the Reference Sensor has run out of use-life; and the
printer needs a new roll of paper. This chapter gives detailed
procedures on replacements of these consumable Items.
5.1 Pump Tubing Replacement
The pump tubing should be replaced at intervals prescribed
in the maintenance log. Replace the tubing that goes around
the pump as follows.
Waste
Line
Reference
Line
Pressure
Plate
Tab of
Tubing
Clip
Holds W
and R
Tubings in
place.
Pump
Tubing
Manifold
Connected
to the
Reference
Sensor
Figure 5.1 Pump Tubing
1. From the Home screen, press the Tool Box
icon.
2. From the System Menu, select Change Pump Tubing
and wait for pump to stop.
3. Open the door and push the White Pressure Plate
release icon to release the Pump Tubing Pressure
Plate.
5-1
5. Periodic
White
Pressure
Plate
Release
Button
Prime CCS Instructions for Use Manual
Figure 5.2 Release Pump Tubing Pressure Plate
3. Disconnect the Waste-line
and Reference-line above
the pump.
4. Disconnect the pump tubing
manifold from the Reference
Sensor.
Figure 5.3 Disconnect Pump Manifold
5. Slide the pump tubing out by holding the tab of the
tubing clip.
6. Discard the used tubing assembly.
7. Stretch the 2 pump tubings around the pump and
slide the tubing clip into the slot under the pump.
8. Connect the W-line to the W-labelled outlet above
the pump.
9. Connect the R-line to the R-labelled outlet above
the pump.
10. Reconnect the W-pump and R-pump manifold to
the top of the Reference Sensor.
11. Close the pressure plate until you hear it click into
place.
12. Place the W and R lines into the hold positions on
the right side of the pump as shown in Figure 4.5.
13. Close the door and press the Calibrate
icon.
5-2
5 Periodic Replacements
5.2 Probe Replacement
If the probe or air detector becomes damaged, replace it.
Use the following procedure when replacing the probe or
the air detector.
1. From the Home screen, press
the Tool Box
icon.
From the System Menu select
Replace Probe and wait for
pump to stop.
2. Remove the capillary adapter
from the front of the probe by
gently pulling.
Figure 5.4 Removing Capillary Adapter
NOTE: Capillary Adapter is usually changed with the
Calibrator Cartridge since a new capillary adapter
comes with the cartridge.
5. Periodic
3. Disconnect the
cable of the air
detector from the
analyzer.
Cable of Air Detector
to Analyzer
Figure 5.5 Disconnect the Cable of the Air Detector
4. D i s c o n n e c t t h e a i r
detector's sample line
from the Reference
Sensor module using the
removal tool attached to
the door.
S-Line with Connection
to Reference Sensor
Figure 5.6 Removing Sample Line from Reference Sensor
5-3
Prime CCS Instructions for Use Manual
5. Pinch together the white probe holder and remove
the probe together with the S-line and air detector
cable and discard.
Pinch
Clamp
S-Line with
Connection to
Reference Sensor
Cable of Air
Detector to
Analyzer
Figure 5.7 Removing Probe, S-line, and Cable of Air Detector
6.
7.
8.
9.
10.
14.
5-4
Place new Probe assembly until it clicks into place.
Replace the capillary adaptor back onto the probe
Reconnect the S-line to the Reference Sensor
Reconnect the Air Detector Cable into the analyzer.
Close the door.
Press the Calibrate
icon.
5 Periodic Replacements
5.2 Reference Sensor Replacement
1. From the Home screen, press the Tool Box
icon.
2. From the System Menu select the Change Reference
Sensor and wait for the pump to stop.
3. Open the door; open Cartridge door.
4 Remove Sensor Card.
NOTE: To change the Reference Sensor the Sensor Card
must be removed first. Only touch Sensor Card by
the edges.
Pump Tubing
Manifold
Sensor Card
Reference
Sensor
5. Periodic
Reference
Sensor Arm
S-Line
Figure 5.8 Reference Sensor
5-5
Prime CCS Instructions for Use Manual
5. Unplug pump tubing manifold from top of sensor.
6. Disconnect the S-line from the bottom of the sensor
using the removal tool attached to the door.
7. Use the Sensor Arm on the left of the sensor to
push the sensor to the right and off.
Slide
Reference
Sensor Off
Figure 5.9 Slide the Reference Sensor Off to the Right
8. Take a new sensor by the arm and slide it back onto
the analyzer from right to left.
9. Plug the pump tubing manifold to the top of the
sensor.
10. Reconnect the S-line to the bottom of the sensor.
11. Replace the Sensor Card. (See Figure 4.4.)
12. Close door, press the Calibrate
icon.
5-6
5 Periodic Replacements
5.3 Printer Paper Replacement
1. Open the printer cover.
2. Remove the depleted roll of paper.
3. Insert a new roll of paper. The loose end of the
paper should feed from the bottom of the roll.
4. Feed paper past the cover. Then close the printer
cover.
5. Periodic
Figure 5.10 Replacing the Printer Paper
5-7
Prime CCS Instructions for Use Manual
5.4 Safety Sample Port Replacement
1.
2.
3.
4.
Open the door.
Slide out the old Safety Sample Port.
Slide in a new Safety Sample Port.
Close the door.
Docking Station
(Safety Sample
Port)
Slides Out
Figure 5.11 Replacing the Safety Sample Port
5-8
6 Troubleshooting
6 Troubleshooting
This section describes the status screens and error codes,
and explains the troubleshooting procedures for the Stat
Profile Prime CCS Analyzer.
WARNING: Blood samples and blood products are potential sources of
infectious agents. Handle all blood products and flow path
components (waste-line, capillary adapter, probe, sensor
cartridge, etc.) with care. Gloves and protective clothing
are recommended. When performing maintenance and
troubleshooting procedures, also use protective eyewear.
6.1 Troubleshooting Procedures
FOR TECHNICAL ASSISTANCE, CALL TOLL FREE:
USA
1-800-545-NOVA
Canada
1-800-263-5999
Other Countries
Contact the local Nova
Biomedical Sales Office or Authorized Nova
Biomedical Distributor
6-1
6. TrShoot.
The recommended troubleshooting procedures use the
most logical and direct steps to resolve the error code. The
solutions are set up in a block format that lists groups of steps
to perform in order to restore operation. The steps are also
organized to prevent unnecessary parts replacement until
the more common causes for an error have been checked.
In the case of multiple error codes, those errors that apply
to flow are at the top of the hierarchy. In most cases, when
you resolve the flow error codes, the other errors will be
resolved as well.
If the recommendations given here do not resolve the
problem, contact Nova Technical Services for troubleshooting
assistance
Prime CCS Instructions for Use Manual
6.2 Error Log
From the Service Menu, select Error Log. The Error Log
screen is displayed with errors displayed in chronological
order. To go to the next or previous error log pages, press
Next Page or Previous Page. To print the error log, select
Printer Menu from the Service Menu.
Table 6.1 lists the analyzer’s error logs and the corrective
action.
Table 6.1 Stat Profile Prime Error Logs
Error
Corrective Action
To Be Determined
6.3 Operator Flow Test
The flow test verifies that fluid can be pulled through the
system from the probe. If water cannot be pulled through
the system, a clog or leak exists. The procedure for the flow
test and sensor cartridge, reference sensor, and sample
probe back flush are as follows.
6.3.1 Flushing the Reference Sensor
1. From the Home screen, press the Tool Box
icon.
2. From the System Menu select the Change Reference
Sensor and wait for the pump to stop.
3. Open the door; open Cartridge door.
4 Remove Sensor Card.
NOTE: To change the Reference Sensor the Sensor Card
must be removed first. Only touch Sensor Card by
the edges.
5. Unplug pump tubing manifold from top of sensor.
6. Disconnect the S-line from the bottom of the sensor
using the removal tool attached to the door.
6-2
Appendix A
7. Use the sensor arm on the left of the sensor to push
the sensor to the right and off.
8. Use a syringe filled with distilled water and a tube
to attach to the S-line port.
9. Push the distilled water through the bottom of the
Reference Sensor.
10. Next attach the tubing of the syringe to the top right
pump tubing port. Push the distilled water through
the top of the Reference Sensor.
11. With the Reference Sensor cleared, take the sensor
by the arm and slide it back onto the analyzer from
right to left.
12. Plug the pump tubing manifold to the top of the
sensor.
13. Reconnect the S-line to the bottom of the sensor.
14. Replace the Sensor Card.
15. Close door, press the Calibrate
icon.
6.3.2 Flushing the Sensor Cartridge
NOTE: Touch Sensor Card by the edges and replace it
the same way back.
6-3
Appendix A
1. Press the Tool Box
icon.
2. From the System Menu, press the Change Sensor
Card and wait for pump to stop.
3. Open the door, remove the Sensor Cartridge.
4. Use the Sensor Cartridge Flushing tool with syringe
to flush the cartridge.
5. Attach the Flushing Tool to the topnport of the
Sensor Cartridge and push distilled water through
the cartridge.
6 With the Sensor Cartridge now cleared, open
cartridge door, insert the cartridge, and close the
cartridge door.
5. Close the Prime door and press the Calibrate
icon.
Prime CCS Instructions for Use Manual
6.3.3 Flushing the Sample Probe
1. From the Home screen, press the Tool Box
icon.
From the System Menu select Replace Probe and wait
for pump to stop.
2. Disconnect the air detector's sample line from the
Reference Sensor module using the removal tool
attached to the door.
3. Use the syringe with attached tubing to flush distilled
water through the S-line and out the Sample Probe.
A small sample cup can be held in front of the
Sample Probe to catch the water.
4. With the Sample Probe now cleared, reconnect the
S-line to the Reference Sensor
5. Close the door.
6. Press the Calibrate
icon.
6-4
Appendix A
A Appendix
Appendix A includes analyzer specifications, performance
data, solutions and reagents, consumable lists, reference
information, and warranty for the Stat Profile Prime CCS
Analyzer.
A.1 Specifications
Measurement Range:
pH
PCO2
PO2
Hct
6.500 - 8.000
3.0 - 200 mmHg
0 - 800 mmHg
0.4 - 26.7 kPa
0.0 - 106.7 kPa
12% - 70%
Na+
80 - 200 mmol/L
K+
1.0 - 20.0 mmol/L
Cl-
50 - 200 mmol/L
iCa
0.10 - 2.70 mmol/L
0.40 - 10.8 mg/dL
Glu
15 - 500 mg/dL
0.8 - 28 mmol/L
Lac
0.3 - 20.0 mmol/L
2.7 - 178.0 mg/dL
Appendix A
A-1
Prime CCS Instructions for Use Manual
Resolution
Calculated Result:
HCO3–
0.1 mmol/L
TCO2
0.1 mmol/L
nCa++
0.10 mmol/L
BE-ecf
0.1 mmol/L
BE-b
0.1 mmol/L
SBC
0.1 mmol/L
O2Ct
0.1 mL/dL
P50
0.1 mmHg
0.1 kPa
0.1 mmHg
0.1 kPa
AaDO2
0.1 mmHg
0.1 kPa
a/A
0.1
PO2/FiO2
0.1 mmHg
With entered FiO2:
Acceptable Samples:
0.1 kPa
Whole Blood (heparinized)
Sample Volume:
Blood Gas and Electrolyte
100 µL
Blood Gas, Electrolyte, Metabolite
100 µL
Capillary
100 µL
Barometer:
A-2
400 - 800 ±1 mmHg, accurate to 1.5%
Appendix A
A.1.1 Analytical Specificity
An interference study was performed according to CLSI
guideline EP7-A2. The study used spiked and diluted
specimens containing potential interfering substances for
pH, PO2, PCO2, Na, K, iCa, Cl, glucose and lactate at
normal physiological levels. Each sample containing the
interfering substance was evaluated against a reference
specimen without the interfering substance. Potential
interfering substances were selected for test based upon a
known potential to interfere with the test methodology. The
following table represents substances that were tested without
demonstrating a clinically significant effect on test results:
Interfering
Substance
Highest
Concentration Tested
Analyte(s)
Tested
Acetaminophen
20.0 mg/dL
Glu, Lac
Acetylsalicylic acid
3.62 mmol/L
Cl, Glu, Lac
Ammonium Chloride
107.0 µmol/L
Na, K, Cl
Ascorbic Acid
50 mg/dL
Cl, Glu, Lac
Na, K, Cl, iCa,
Calcium Chloride
2.0 mmol/L addition
pH, PCO2, PO2,
Na, K
D-Galactose
10.0 mmol/L
Lac
Dopamine
Hydrochloride
5.87 µmol/L
Glu, Lac
EDTA
3.4 umol/L
Glu
Ethanol
0.5%
Glu, Lac
Fluorescein
1.0 mmol/L
PCO2, PO2
Fluoride
105 µmol/L
Glu Lac
Glucose
1,000 mg/dL
Lac
Glycolic Acid
160.0 mg/dL
80.0 mg/dL
Glu
Lac
Appendix A
Benzylkonium Chloride 1.0 mg/dL
A-3
Prime CCS Instructions for Use Manual
A-4
Interfering
Substance
Highest
Concentration Tested
Analyte(s)
Tested
Glucosamine
30.0 µmol/L
Lac
Heparin
100 IU/mL
Glu, Lac
Hydroxyurea
0.8 mg/dL
Lac
Ibuprofen
2,425 µmol/L
Glu, Lac
Intralipid
0.1%
pH, PCO2, PO2, Na,
K, Cl, iCa, Glu, Lac
Lithium Lactate
25.0 mmol/L
Na, K, iCa, Glu
Magnesium Chloride
15.0 mmol/L
Na, Cl, iCa
Maltose
13.0 mmol/L
Glu, Lac
Mannose
10.0 mmol/L
Glu, Lac
Perchlorate
1.0 mmol/L
iCa,
Potassium Chloride
5.0 mmol/L addition
pH, PCO2, PO2, iCa
Potassium
Thiocyanate
2,064 µmol/L
Cl, Glu, Lac
Pyruvate
309 µmol/L
Lac
Sodium Bromide
2.0 mmol/L
Cl
Sodium Chloride
10.0 mmol/L addition
pH, PCO2, PO2, iCa
Sodium Citrate
12.0 mmol/L
Glu, Lac
Sodium Oxalate
500 mg/dL
Glu, Lac
Sodium Salicylate
50.0 mg/dL
Glu, Lac
Urea
40.0 mg/dL
Lac
Uric Acid
1.4 mmol/L
Lac
Xylose
25.0 mg/dL
Glu, Lac
Zinc Chloride
1,300 µg/dL
Na, K, iCa,
Appendix A
The following table represents substances that were tested
that demonstrated a clinically significant effect on test results:
Glucose
Interfering
Substance
Concentration
of interfering
substance
Analyte (Glu)
concentration
Bias mg/dL
D-Galactose
10.0 mmol/L
94 mg/dL
- 10.7 mg/dL
Glucosamine
30 µmol/L
99 mg/dL
- 16.6 mg/dL
Hydroxyurea
0.8 mg/dL
112 mg/dL
- 18.8 mg/dL
Interfering
Substance
Concentration
of interfering
substance
Analyte (Lac)
concentration
Bias mmol/L
Glycolic acid
80 mg/dL
2.7 mmol/L
(+) 3.6 mmol/L
Lactate
A.2 Analytical Performance Studies
Method Comparison Study
Heparinized arterial whole blood discarded specimens
from hospital patients were analyzed in duplicate on the 3
Stat Profile Prime CCS Analyzers and 2 Stat Profile pHOx
Ultra reference analyzers. The number of samples per run
and the total number of runs each day depended upon the
availability of blood specimens on any given test day. Some
A-5
Appendix A
Three Stat Profile Prime CCS analyzers were compared to
2 Stat Profile pHOx Ultra Analyzers in a laboratory setting
by healthcare professionals. The protocol consisted of
within run precision runs, day-to-day precision runs, linearity
validation, and method comparison studies comparing the
performance of the Stat Profile Prime CCS Analyzers to the
Stat Profile pHOx Ultra Analyzers.
Prime CCS Instructions for Use Manual
additional whole blood specimens from consenting donors
were tonometered, spiked, or diluted with saline to cover the
analytical measurement range for all analytes. The number
of data points (N) varies for each parameter due to error,
instrument calibration status, or insufficient sample volume
to complete analysis.
A minimum of 150 whole blood specimens were analyzed
for each parameter in syringe collection devices. The
samples were analyzed on each of the Stat Profile Prime
CCS analyzers and on each of the pHOx Ultra analyzers.
The Stat Profile Prime CCS results for each analyzer were
compared to the average of the 2 results from the pHOx
Ultra comparative method.
A minimum of 100 whole blood specimens were analyzed for
each parameter in capillary collection tubes. Each specimen
was analyzed one time from a capillary container on each
Stat Profile Prime CCS analyzer and then immediately run
as a syringe specimen on the same Stat Profile Prime CCS
analyzer. The capillary test result was compared to the
syringe test result from each test system.
Bias Chart Results
The method comparison bias estimate was analyzed
using CLSI Standard EP09-A2 as a reference document.
The bias plots for each parameter are summarized and
include boundary lines that represent the 95% confidence
interval across the measurement range based upon
each parameter’s between analyzer day-to-day (+/-2SD)
performance specification or CV% (whichever is greater).
Each bias plot represents 3 Stat Profile Prime CCS analyzers
compared to the average result from 2 Stat Profile pHOx Ultra
analyzers. Medically relevant low and high concentrations
are annotated.
A-6
Appendix A
Appendix A
A-7
Prime CCS Instructions for Use Manual
A-8
Appendix A
Appendix A
A-9
Prime CCS Instructions for Use Manual
A-10
Appendix A
Appendix A
A-11
Prime CCS Instructions for Use Manual
Syringe Method Comparison Study Results
vs. Stat Profile pHOx Ultra
Test
total #
# altered specimen
Analyzer
specimens specimens
range
Parameter
pH
PCO2
PO2
Hct
Na
iCa
Cl
Glu
Lac
A-12
Slope Intercept
#1
172
40
6.523 - 7.862 0.9976 0.0099 0.9985
#2
170
38
6.519 - 7.875 0.9977 0.0106 0.9990
#3
168
41
6.520 - 7.953 1.0018 -0.0225 0.9989
#1
179
34
3.4 - 200.0 0.9854 0.9344 0.9977
#2
181
29
3.1 - 192.6 1.0091 0.1547 0.9920
#3
176
32
3.3 - 199.10 1.0019 1.1679 0.9980
#1
177
43
26.9 - 586.3 1.0046 -1.2710 0.9986
#2
167
43
29.5 - 593.2 0.9897 1.4508 0.9988
#3
180
42
31.3 - 587.6 1.0035 0.5961 0.9990
#1
174
22
12 - 70
1.0445 -1.9271 0.9889
#2
170
24
12 - 68
1.0007 -0.6236 0.9871
#3
164
19
13 - 70
1.0207 -0.9936 0.9895
#1
180
30
85.5 - 195.7 1.0189 -2.2841 0.9955
#2
186
29
85.1 - 196.7 1.0109 -2.0438 0.9960
#3
181
31
85.0 - 198.2 1.0278 -3.5873 0.9961
#1
179
26
1.11 - 19.75 1.0163 -0.0371 0.9996
#2
182
25
1.11 - 19.54 1.0138 -0.0619 0.9995
#3
183
25
1.12 - 19.79 1.0272 -0.0769 0.9995
#1
181
25
0.25 - 2.48 0.9880 0.0457 0.9974
#2
180
25
0.25 - 2.42 0.9752 0.0432 0.9958
#3
179
25
0.25 - 2.52 1.0059 0.0345 0.9962
#1
186
39
52.8 - 189.3 1.0003 1.0158 0.9955
#2
183
40
54.1 - 190.6 0.9952 0.6980 0.9787
#3
180
37
51.0 - 179.5 0.9569 4.4537 0.9944
#1
181
22
35 - 432
0.9987 1.1978 0.9960
#2
184
22
39 - 466
1.0005 0.6501 0.9940
#3
185
24
39 - 474
1.0007 -2.6844 0.9892
#1
182
25
0.4 - 17.8
0.9841 0.0937 0.9974
#2
182
26
0.5 - 20.0
1.0463 -0.0577 0.9959
#3
182
26
0.4 - 18.7
1.0101 -0.0342 0.9946
Appendix A
Syringe Method Comparison Study Results
Individual Analyzer Performance Data
Capillary vs. Syringe Comparison
Total #
specimen
Parameter Analyzer
Slope
Intercept
specimens
range
pH
#1
100
6.787 - 7.683
1.0094
-0.0721
pH units
#2
100
6.820 - 7.669
1.0157
-0.1176
0.9986
#3
100
6.806 - 7.668
1.0097
-0.0714
0.9989
0.9988
PCO2
#1
100
17.7 - 111.0
1.0026
-0.4347
0.9989
mmHg
#2
100
19.6 - 103.7
0.9939
-0.1404
0.9981
#3
100
18.0 - 123.2
0.9897
-0.1897
0.9991
PO2
#1
100
25.5 - 435.2
0.9942
2.1791
0.9996
mmHg
#2
100
25.1 - 399.1
1.0082
0.3311
0.9994
#3
100
25.6 - 442.7
0.9944
2.2551
0.9994
#1
100
14 - 69
1.0013
0.0485
0.9963
Hct
#2
100
14 - 66
0.9863
0.6676
0.9960
#3
100
13 - 67
1.0161
-0.4917
0.9950
Na
#1
100
85.0 - 198.1
0.9995
-0.1711
0.9978
mmol/L
#2
100
85.0 - 192.0
1.0016
-0.4681
0.9988
#3
100
85.0 - 194.7
0.9926
0.9061
0.9987
#1
100
2.70 - 19.37
0.9966
0.0934
0.9996
mmol/L
#2
100
2.63 - 19.36
0.9933
0.0872
0.9996
#3
100
2.64 - 19.48
1.0042
0.0375
0.9995
#1
100
0.13 - 2.76
1.0083
-0.0422
0.9873
iCa
mmol/L
100
0.12 - 2.70
0.9936
-0.0069
0.9855
100
0.13 - 2.52
1.0231
-0.0445
0.9818
Cl
#1
100
55.8 - 197.1
0.9897
0.1776
0.9997
mmol/L
#2
100
51.0 - 184.1
0.9921
-0.0870
0.9988
#3
100
54.1 - 199.3
0.9905
0.9342
0.9978
Glu
#1
100
17 - 488
0.9855
-0.4734
0.9998
mg/dL
#2
100
19 - 491
0.9919
-0.5176
0.9998
#3
100
21 - 489
0.9813
0.2346
0.9999
#1
100
1.1 - 18.1
1.0034
0.0120
0.9994
Lac
mmol/L
#2
100
1.2 - 19.9
1.0030
-0.0057
0.9995
#3
100
1.2 - 19.5
0.9911
-0.0010
0.9994
A-13
Appendix A
#2
#3
Prime CCS Instructions for Use Manual
Precision Study Results
Analytical Precision or Repeatability
Three Stat Profile Prime CCS Analyzers were assessed
for within run precision or repeatability within a laboratory
setting. The protocol consisted of within run precision, and
run–to-run precision studies using 3 different quality control
materials.
• Stat Profile Prime Quality Control Level 1
• Stat Profile Prime Quality Control Level 2
• Stat Profile Prime Quality Control Level 3
Within Run Precision Performance
The protocol consisted of 20 replicates per run for each QC
level on each of 3 Stat Profile Prime CCS Analyzers. The
average, SD, CV%, and N for each analyzer for each QC
level and parameter was calculated. The pooled average,
SD, CV%, and N from all 3 analyzers for each QC level and
parameter was calculated.
A-14
Appendix A
Stat Profile Prime Quality Control Level 1
Parameter
n = 20
Analyzer # 1 Analyzer # 2 Analyzer # 3
Pooled
pH
Mean
7.165
7.161
7.167
7.165
pH units
SD
0.001
0.001
0.001
0.003
PCO2
Mean
56.7
56.0
56.3
56.3
mmHg
SD
0.2
0.2
0.1
0.3
CV%
0.4
0.4
0.3
0.6
PO2
Mean
70.1
70.4
70.5
70.3
mmHg
SD
0.3
0.5
0.4
0.4
CV%
0.5
0.8
0.6
0.6
Hct
Mean
38
38
38
38
SD
0.5
0.4
0.3
0.5
Na
Mean
158.1
157.5
158.7
158.1
mmol/L
SD
0.1
0.4
1.4
0.9
CV%
0.1
0.2
0.9
0.6
Mean
5.80
5.84
5.81
5.82
mmol/L
SD
0.00
0.02
0.03
0.03
CV%
0.08
0.31
0.54
0.45
iCa
Mean
1.51
1.52
1.52
1.52
mmol/L
SD
0.01
0.01
0.00
0.01
CV%
0.33
0.36
0.30
0.37
Cl
Mean
131.0
133.3
130.8
131.7
mmol/L
0.1
0.4
0.1
1.2
0.1
0.3
0.1
0.9
Glu
Mean
74
71
74
73
mg/dL
SD
0.0
0.3
0.0
1.5
CV%
0.0
0.4
0.0
2.0
Lac
Mean
0.9
0.8
0.8
0.8
mmol/L
SD
0.0
0.0
0.0
0.1
CV%
2.5
1.1
1.3
A-15
Appendix A
SD
CV%
Prime CCS Instructions for Use Manual
Stat Profile Prime Quality Control Level 2
Parameter
n = 20
Pooled
pH
Mean
7.361
7.360
7.362
7.361
pH units
SD
0.002
0.002
0.002
0.002
PCO2
Mean
41.6
41.3
41.6
41.5
mmHg
SD
0.3
0.3
0.3
0.3
CV%
0.7
0.8
0.7
0.8
PO2
Mean
108.8
109.6
109.6
109.4
mmHg
SD
0.6
1.4
0.3
0.9
CV%
0.5
1.3
0.3
0.9
Hct
Mean
55
55
55
55
SD
0.5
0.3
0.3
0.4
Na
Mean
140.2
140.1
140.0
140.1
mmol/L
SD
0.1
0.2
0.6
0.4
CV%
0.1
0.1
0.5
0.3
Mean
3.84
3.81
3.80
3.82
mmol/L
SD
0.02
0.01
0.02
0.02
CV%
0.43
0.33
0.41
0.53
iCa
Mean
0.97
0.97
0.98
0.97
mmol/L
SD
0.01
0.00
0.01
0.01
CV%
0.92
0.50
0.52
0.68
Cl
Mean
102.3
102.2
101.8
102.1
0.4
mmol/L
A-16
Analyzer # 1 Analyzer # 2 Analyzer # 3
SD
0.5
0.2
0.1
CV%
0.4
0.2
0.1
0.4
Glu
Mean
200
202
198
200
mg/dL
SD
1.1
1.1
0.8
1.9
CV%
0.5
0.5
0.4
0.9
Lac
Mean
2.6
2.6
2.6
2.6
mmol/L
SD
0.0
0.0
0.0
0.0
CV%
0.3
0.3
0.2
0.7
Appendix A
Stat Profile Prime Quality Control Level 3
Parameter
n = 20
Analyzer # 1 Analyzer # 2 Analyzer # 3
Pooled
pH
Mean
7.596
7.597
7.594
7.596
pH units
SD
0.002
0.002
0.002
0.002
PCO2
Mean
23.6
23.7
23.8
23.7
mmHg
SD
0.3
0.3
0.4
0.3
CV%
1.2
1.2
1.5
1.3
PO2
Mean
142.2
138.7
142.3
141.1
mmHg
SD
0.7
0.6
0.3
1.8
CV%
0.5
0.4
0.2
1.3
Hct
Mean
69
68
69
69
SD
0.5
0.5
0.5
0.5
Na
Mean
120.4
120.5
120.2
120.4
mmol/L
SD
0.1
0.3
0.3
0.3
CV%
0.1
0.2
0.3
0.2
Mean
1.88
1.86
1.86
1.86
mmol/L
0.01
0.01
0.00
0.01
0.64
0.46
0.24
0.64
iCa
Mean
0.52
0.52
0.53
0.52
mmol/L
SD
0.00
0.00
0.00
0.00
CV%
0.90
0.43
0.42
0.95
Cl
Mean
84.7
84.6
84.9
84.8
mmol/L
SD
0.5
0.4
0.1
0.4
CV%
0.6
0.4
0.1
0.4
Glu
Mean
320
322
321
321
mg/dL
SD
1.0
0.9
1.0
1.4
CV%
0.3
0.3
0.3
0.4
Lac
Mean
6.4
6.4
6.5
6.4
mmol/L
SD
0.0
0.0
0.0
0.0
CV%
0.3
0.3
0.2
0.371
A-17
Appendix A
SD
CV%
Prime CCS Instructions for Use Manual
Run-to-Run Precision Performance
Estimates of the run to run precision were determined for
each of the Stat Profile Prime CCS analyzers by analyzing
the following solutions in duplicate over a period of 20 days;
2 runs per day for a total of 40 runs.
• Quality Control Material – 3 levels for each parameter
in QC mode.
• Linearity Standards – 5 levels for each parameter
in QC mode.
• Whole Blood – 2 tonometered levels for PCO2 and
PO2 were prepared on each test day and analyzed
in syringe mode.
• Whole Blood – 2 levels for Hematocrit were prepared
on each test day and were analyzed in syringe
mode.
Estimates of the run to run precision were determined for each
level of Quality Control, Linearity Standard, tonometered
blood, and Hematocrit. Statistical analysis for each parameter
include the pooled mean, Sr, ST, CV% (pH excluded), and
N for all analyzers was calculated.
A-18
Appendix A
Run-to-Run Precision Results
pH Precision Data
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
Sample
Pooled
Mean
QC Level 1
7.164
240
0.002
---
0.002
---
QC Level 2
7.362
240
0.000
---
0.001
---
QC Level 3
7.596
240
0.000
---
0.002
---
Linearity Std 1
6.899
240
0.003
---
0.005
---
Linearity Std 2
7.186
240
0.001
---
0.003
---
Linearity Std 3
7.444
240
0.001
---
0.002
---
Linearity Std 4
7.615
240
0.001
---
0.002
---
Linearity Std 5
7.817
240
0.002
---
0.004
---
Sample
Pooled
Mean
(mmHg)
QC Level 1
58.4
240
0.58
1.00
1.33
2.28
QC Level 2
41.9
240
0.06
0.13
0.53
1.26
QC Level 3
23.0
240
0.07
0.29
0.42
1.83
Linearity Std 1
76.6
240
0.46
0.60
2.22
2.90
Linearity Std 2
61.4
240
0.19
0.31
1.32
2.16
Linearity Std 3
41.0
240
0.36
0.88
0.59
1.44
Linearity Std 4
25.3
240
0.06
0.23
0.51
2.02
Linearity Std 5
17.3
240
0.10
0.56
0.83
4.82
Blood Gas ( A )
26.5
240
0.34
1.29
0.93
3.52
Blood Gas ( B )
53.4
240
0.44
0.82
2.03
3.80
Sample
Pooled
Mean
(mmHg)
QC Level 1
70.2
240
0.84
1.19
2.02
2.88
QC Level 2
110.1
240
0.55
0.50
1.16
1.05
QC Level 3
143.8
240
0.39
0.27
1.21
0.84
Linearity Std 1
21.6
240
1.45
6.73
2.68
12.43
Linearity Std 2
60.6
240
1.07
1.77
2.96
4.88
Linearity Std 3
107.2
240
0.98
0.91
2.23
2.08
Linearity Std 4
158.9
240
0.69
0.44
2.41
1.52
Linearity Std 5
453.9
240
3.92
0.86
14.33
3.16
Blood Gas ( A )
111.5
240
1.29
1.16
3.05
2.74
Blood Gas ( B )
61.4
240
0.50
0.81
2.09
3.40
PCO2 Precision Data
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
PO2 Precision Data
A-19
Appendix A
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
Prime CCS Instructions for Use Manual
Hct Precision Data
Sample
Total
Total
Pooled
Within run Within imprecision
Imprecision
Mean (%)
SD (Sr) run % CV SD (St)
%CV
QC Level 1
37.9
240
0.44
1.15
0.81
2.15
QC Level 2
55.0
240
0.20
0.37
0.32
0.58
QC Level 3
68.6
240
0.18
0.26
0.43
0.63
Linearity Std 1
73.4
240
0.30
0.41
0.43
0.59
Linearity Std 2
58.5
240
0.38
0.65
0.44
0.74
Linearity Std 3
55.3
240
0.29
0.52
0.41
0.73
Linearity Std 4
36.4
240
0.34
0.93
0.45
1.24
Linearity Std 5
27.7
240
0.38
1.37
0.48
1.73
Hct ( A )
43.4
240
0.20
0.46
1.12
2.57
Hcy ( B )
60.7
240
0.28
0.47
1.22
2.01
Sample
Pooled
Mean
(mmol/L)
QC Level 1
158.3
240
0.56
0.35
0.68
0.43
QC Level 2
140.1
240
0.12
0.09
0.25
0.18
QC Level 3
120.2
240
0.08
0.07
0.18
0.15
Linearity Std 1
89.7
240
0.45
0.50
0.56
0.62
Linearity Std 2
116.1
240
0.25
0.21
0.52
0.45
Linearity Std 3
132.0
240
0.53
0.40
0.71
0.54
Linearity Std 4
154.5
240
0.40
0.26
0.63
0.41
Linearity Std 5
163.7
240
0.43
0.26
0.80
0.49
Sample
Pooled
Mean
(mmol/L)
QC Level 1
5.81
240
0.020
0.34
0.03
0.48
QC Level 2
3.81
240
0.005
0.14
0.01
0.36
QC Level 3
1.87
240
0.002
0.13
0.02
0.97
Linearity Std 1
11.70
240
0.041
0.35
0.07
0.59
Linearity Std 2
1.91
240
0.006
0.32
0.02
0.92
Linearity Std 3
4.36
240
0.014
0.32
0.02
0.55
Linearity Std 4
6.38
240
0.024
0.38
0.04
0.63
Linearity Std 5
1.60
240
0.006
0.40
0.02
1.23
Na Precision Data
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
K Precision Data
A-20
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
Appendix A
iCa Precision Data
Sample
Pooled
Mean
(mmol/L)
QC Level 1
1.51
240
0.007
0.45
0.02
1.13
QC Level 2
0.97
240
0.002
0.22
0.00
0.43
QC Level 3
0.53
240
0.001
0.23
0.01
1.85
Linearity Std 1
2.81
240
0.031
1.09
0.05
1.78
Linearity Std 2
1.44
240
0.004
0.26
0.01
0.53
Linearity Std 3
1.06
240
0.002
0.21
0.01
0.63
Linearity Std 4
0.51
240
0.001
0.14
0.01
1.31
Linearity Std 5
0.17
240
0.001
0.58
0.01
6.38
Sample
Pooled
Mean
(mmol/L)
QC Level 1
131.5
240
0.57
0.43
2.30
1.75
QC Level 2
103.0
240
0.72
0.70
1.52
1.48
QC Level 3
86.1
240
0.27
0.32
1.38
1.60
Linearity Std 1
73.5
240
0.15
0.21
1.26
1.71
Linearity Std 2
82.6
240
0.10
0.12
0.67
0.82
Linearity Std 3
100.5
240
0.11
0.11
0.67
0.66
Linearity Std 4
124.5
240
0.11
0.09
1.45
1.17
Linearity Std 5
133.5
240
0.13
0.10
2.04
1.53
Sample
Pooled
Mean
(mg/dL)
QC Level 1
71.3
240
1.28
1.79
1.69
2.37
QC Level 2
196.9
240
0.81
0.41
1.33
0.67
QC Level 3
318.6
240
2.32
0.73
3.31
1.04
Linearity Std 1
378.0
240
5.31
1.41
14.89
3.94
Linearity Std 2
67.4
240
0.60
0.88
2.46
3.64
Linearity Std 3
179.7
240
1.64
0.91
3.79
2.11
Linearity Std 4
260.0
240
1.92
0.74
5.50
2.11
Linearity Std 5
n/a
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
Cl Precision Data
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
Glucose Precision Data
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
Appendix A
A-21
Prime CCS Instructions for Use Manual
Lactate Precision Data
Sample
Pooled
Mean
(mmol/L)
QC Level 1
0.79
240
0.022
2.77
0.03
3.58
QC Level 2
2.60
240
0.012
0.47
0.01
0.54
QC Level 3
6.38
240
0.023
0.35
0.06
0.87
Linearity Std 1
13.36
240
0.229
1.71
0.79
5.91
Linearity Std 2
0.67
240
0.013
1.97
0.08
12.71
Linearity Std 3
2.53
240
0.022
0.87
0.07
2.88
Linearity Std 4
6.59
240
0.056
0.85
0.26
3.92
Linearity Std 5
10.51
240
0.086
0.82
0.45
4.26
Total
Total
Within run Within imprecision
Imprecision
SD (Sr) run % CV SD (St)
%CV
A.3 Calibrator Cartridge
The concentrations of the internal standards are printed on
the Calibrator Cartridge. In addition to the calibrators and
solutions, the Calibrator Cartridge has a self-contained
waste bag for safe disposal of waste.
A.3.1
Traceability of Calibrators, Controls, and Standards
Chemistry analytes are traceable to the Standard Reference
Materials of the National Institute of Standards and
Technology (NIST). SO2 is traceable to tonometry.
A-22
Appendix A
A.4 Reference Values
Each laboratory should establish and maintain its own
reference values. The values given here should be used
only as a guide.
______________________________________________________
Table A.1 Reference Values1,2,6
Test
Value
pH
7.35 - 7.45
PCO2
35 - 45 mmHg
HCO3-
21 - 28 mmol/L
Base Excess (Blood)
(-2)-(+3) mmol/L
PO2
83 - 108 mmHg
SO2 (arterial whole blood)
95 - 98%
39 - 49%
35 - 45%
Hemoglobin (Hb)
(Male)
(Female)
13.2 - 17.3 g/dL
11.7 - 15.5 g/dL
______________________________________________________
A-23
Appendix A
Hematocrit (Hct)
(Male)
(Female)
Prime CCS Instructions for Use Manual
Table A.2 Reference Values for Adult Whole Blood
Test
Value
Sodium2
136 - 146 mmol/L
Potassium2
3.5 - 5.1 mmol/L
Chloride2
98 - 106 mmol/L
Glucose2
65 - 95 mg/dL
Lactate4,5
0.7 - 2.5 mmol/L
Calcium3
1.09 - 1.30 mmol/L
______________________________________________________
References:
1.
Statland, Bernard. 1987. Clinical Decisions Levels for Lab Tests,
Medical Economics Books.
2.
Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook
of Clinical Chemistry. Philadelphia, PA: W. B. Saunders Co.
3.
Kost, G.T. 1993. The Significance of Ionized Calcium in Cardiac
and Critical Care. Arch. Pathol. Lab Med. Vol. 117: pp 890-896.
4.
Toffaletti, J., Hammes, M. E., Gray, R., Lineberry, B., and Abrams,
B. 1992. Lactate Measured in Diluted and Undiluted Whole Blood
and Plasma: Comparison of Methods and Effect of Hematocrit.
Clinical Chemistry, Vol. 38, No. 12.
5.
Bernstein, W.K., Aduen, J., Bhatiani, A., Kerzner, R., Davison,
L., Miller, C., and Chernow, B. 1994. Simultaneous Arterial and
Venous Lactate Determinations in Critically Ill Patients. Critical
Care Medicine, Vol. 22.
6.
A-24
Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011. Tietz
Textbook of Clinical Chemistry and Molecular Diagnostics. 5th
ed, Philadelphia, PA: W. B. Saunders Co.
Appendix A
A.5 Ordering Information
Stat Profile Prime CCS Analyzer supplies and parts are
available from Nova Biomedical.
DESCRIPTION..........................................................................Part #
Assembly Probe S Line 100 µL Prime CCS............. 52582
Auto Cartridge Control Prime CCS.......................... 45150
Calibrator Cartridge Prime CCS............................... 52427
Luer Station Packaged (5x) Prime CCS.................. 52669
Prime Calibrator Cartridge CCS 100 Sample.......... 52862
Prime Calibrator Cartridge CCS 200 Sample.......... 53364
Prime Calibrator Cartridge CCS 300 Sample.......... 52863
Prime Calibrator Cartridge CCS 400 Sample.......... 53466
Prime Calibrator Cartridge CCS 500 Sample.......... 53467
Prime Calibrator Cartridge CCS 600 Sample.......... 53468
Prime Calibrator Cartridge CCS Comp 100 Sample.. 52861
Prime Calibrator Cartridge CCS Comp 200 Sample.. 53365
Prime Calibrator Cartridge CCS Comp 300 Sample.. 52427
Prime Calibrator Cartridge CCS Comp 400 Sample.. 53105
Prime Calibrator Cartridge CCS Comp 500 Sample.. 53469
Prime Calibrator Cartridge CCS Comp 600 Sample.. 53470
Prime Pump Harness............................................... 52484
Prime Sensor Card CCS (without Glu/Lac).............. 42032
Prime Sensor Card CCS Comp............................... 42033
Reference Sensor, Prime CCS................................ 42043
Appendix A
A-25
Prime CCS Instructions for Use Manual
A.6 Warranty
Subject to the exclusions and upon the conditions specified below, Nova
Biomedical or the authorized Nova Biomedical distributor warrants that
he will correct free of all charges including labor, either by repair, or at
his election, by replacement, any part of an instrument which fails within
one (1) year after delivery to the customer because of defective material
or workmanship. This warranty does not include normal wear from use
and excludes: (A) Service or parts required for repair to damage caused
by accident, neglect, misuse, altering the Nova equipment, unfavorable
environmental conditions, electric current fluctuations, work performed
by any party other than an authorized Nova representative or any force
of nature; (B) Work which, in the sole and exclusive opinion of Nova,
is impractical to perform because of location, alterations in the Nova
equipment or connection of the Nova equipment to any other device; (C)
Specification changes; (D) Service required to parts in the system contacted
or otherwise affected by expendables or reagents not manufactured by Nova
which cause shortened life, erratic behavior, damage or poor analytical
performance; (E) Service required because of problems, which, in the sole
and exclusive opinion of Nova, have been caused by any unauthorized
third party; or (F) Instrument refurbishing for cosmetic purposes. All parts
replaced under the original warranty will be warranted only until the end of the original
instrument warranty. All requests for warranty replacement must be received by Nova
or their authorized distributor within thirty (30) days after the component failure. Nova
Biomedical reserves the right to change, alter, modify or improve any of its
instruments without any obligation to make corresponding changes to any
instrument previously sold or shipped. All service will be rendered during
Nova’s principal hours of operation. All requests for service outside Nova’s
principal hours of operation will be rendered at the prevailing weekend/
holiday rates after receipt of an authorized purchase order. Contact Nova
for specific information.
The above warranties are invalid if:
1. The date printed on the package label has been exceeded.
2. Non-Nova Biomedical reagents or controls are used, as follows:
Nova Biomedical will not be responsible for any warranties
on parts if these parts are used in conjunction with and are
adversely affected by reagents, controls, or other material not
manufactured by Nova but which contact or affect such parts.
Reagent formulations not manufactured by Nova Biomedical
may contain acids, concentrated salt solutions, and artificial
preservatives that have been shown to cause problems such
as shortened sensor/electrode life, sensor/electrode drift, erratic
analytical results, and inaccurate instrument performance.
THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER
OBLIGATIONS AND LIABILITIES INCLUDING NEGLIGENCE AND ALL
WARRANTIES, OF MERCHANTABILITY OR OTHERWISE, EXPRESSED
OR IMPLIED IN FACT BY LAW AND STATE OUR ENTIRE AND EXCLUSIVE
LIABILITY AND BUYER’S EXCLUSIVE REMEDY FOR ANY CLAIM
OF DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING
OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE,
INSTALLATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO
EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES
WHATSOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES
WILL EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH
THE LIABILITY IS CLAIMED.
A-26
Appendix B
B Principles of Measurement
This section explains the Principles of Measurement for the
Stat Profile Prime CCS Analyzer.
B.1 Measured Values
Measuring Technology: Ten Planar Sensor Technology (Na,
K, Cl, iCa, pH, PCO2, PO2, Glucose, Lactate, Hematocrit)
in a MicroSensor Card
B.1.1
Sodium, Potassium, Chloride, and Ionized Calcium
Calculating Sample Concentration
Equation 1 links the voltage of the cell (Em) to the activity
of the ion. Activity is related to concentration (C) through
the activity coefficient in the relation a = f * C. The activity
coefficient is a function of ionic strength. Thus, Equation 1
can be rewritten in terms of concentration as follows:
Ecell = Eo + S log ao - Er - Ej
Equation 1
Ecell = Eo + S (log(f * C)o) - Er - Ej
Equation 2
Similarly, Equation 2 is rewritten:
(fC)x
E = Ex - Estd = S log _________
(fC)std
Equation 3
B-1
Appendix B
The total ionic strength of whole blood is relatively constant
over the physiological range.1 As a result, the activity
coefficients of sodium, potassium, calcium, and chloride
can be assumed to be constant. The internal standards
are formulated to reflect the same ionic strength as that
of whole blood. Therefore, a given ion’s activity coefficient
can be assumed to be equal in the standard and sample.
The activity coefficient terms in Equation 3 cancel out with
these results:
Prime CCS Instructions for Use Manual
Cx
E = Ex - Estd = S log ____
Cstd
Equation 4
By holding Cstd in Equation 4 constant, E is dependent on
only 1 variable, Cx, the concentration of the ion of interest
in the sample. Equation 5 can be rearranged to isolate this
variable:
Cx = (Cstd) 10(E/S)
Equation 5
The analyzer’s microcomputer uses Equation 5 to calculate
the concentration of sodium, potassium, calcium, and
chloride ions in the sample.
B.1.2
pH Sensor
Definition of pH
The pH of an unknown sample is calculated using the
following equation:
Estd C – Ex
pH Estd C - Ex= pHstd C + –––––––––
Equation 6
Slope
Estd C – Ex
where Slope = ——————————
pHstd C – pHstd D
Equation 7
Principle of pH Measurement
pH is measured using a hydrogen ion selective membrane.
One side of the membrane is in contact with a solution of
constant pH. The other side is in contact with a solution
of unknown pH. A change in potential develops which is
proportional to the pH difference of these solutions.
This change in potential is measured against a reference
electrode of constant potential. The magnitude of the
potential difference is a measure, then of the pH of the
unknown solution.
B-2
Appendix B
B.1.3
Partial Pressure of Carbon Dioxide (PCO2)
Definition of PCO2
The partial pressure (tension) of carbon dioxide in solution
is defined as the partial pressure of carbon dioxide in the
gas phase in equilibrium with the blood.
Principle of PCO2 Measurement
PCO2 is measured with a modified pH sensor. Carbon dioxide
in the unknown solution makes contact with a hydrogen ion
selective membrane CO2 diffuses across the membrane
into a thin layer of bicarbonate buffer in response to partial
pressure difference. This solution then becomes equilibrated
with the external gas pressure of the fluid in contact with
the outer surface of the membrane. CO2 in the solution
becomes hydrated producing carbonic acid which results
in a change in hydrogen ion activity.
CO2 + H20 <=> H2CO3 <=> H+ + [HCO 3 ]
Equation 8
The pH of this internal solution varies with the PCO2 according
to the Henderson-Hasselbalch equation.
pH = pKa + log {HCO3- / PCO2 * a}
The measured potential is related to the logarithm of PCO2
content of the sample after compensation of the measured
potential of the pH sensor.
Appendix B
B-3
Prime CCS Instructions for Use Manual
B.1.4
Partial Pressure of Oxygen (PO2)
Definition of PO2
The partial pressure (tension) of oxygen in solution is
defined as the partial pressure of oxygen in the gas phase
in equilibrium with the blood. PO2 provides an indication of
the availability of oxygen in inspired air.
Principle of PO2 Measurement
PO2 is measured amperometrically by the generation of a
current at the sensor surface. As oxygen diffuses through
a gas permeable membrane, the oxygen molecules are
reduced at the cathode, consuming 4 electrons for every
molecule of oxygen reduced. This flow of electrons is then
measured by the sensor and is directly proportional to the
partial pressure of oxygen.
B.1.5
Hematocrit
Hematocrit is defined as the percentage of red blood cells
to the total blood volume and can be obtained by measuring
electrical resistance of the blood sample. Two standard
solutions are used to calibrate the hematocrit sensor and to
obtain the slope. The analyzer then measures the electrical
resistance of the blood sample to obtain the hematocrit
value. The hematocrit value obtained is corrected for the
concentration of the sodium ion.
B-4
Appendix B
B.1.6
Glucose
Glucose measurement is based on the level of H2O2
produced during the enzymatic reaction between glucose
and oxygen molecules in the presence of the glucose oxidase
enzyme. The reaction is described by the following equation:
Glucose Oxidase Gluconic acid + H O
Glucose + O2 ––--–––––––––––>
2 2
Equation 9
At a constant potential of 0.70 volts, electroactive H2O2 is
oxidized at the surface of the platinum anode as follows:
H2O2 ––––––––> 2H+ + O2 + 2e-
Equation 10
The current generated by the flow of electrons at the
surface of the platinum sensor is proportional to the glucose
concentration of the sample.
B.1.7
Lactate
Lactate measurement is based on the level of H2O2 produced
during the enzymatic reaction between lactate and oxygen
molecules in the presence of the lactate oxidase enzyme.
The reaction is described by the following equation:
Lactate Oxidase Pyruvate acid +
Lactate + O2 –––––––––––––>
H2O2
Equation 11
At a constant potential of 0.70 volts, electroactive H2O2 is
oxidized at the surface of the platinum anode as follows:
Equation 12
The current generated by the flow of electrons at the
surface of the platinum sensor is proportional to the lactate
concentration of the sample.
B-5
Appendix B
H2O2 ––––––––> 2H+ + O2 + 2e-
Prime CCS Instructions for Use Manual
B.2 Calculated Values
The analyzer’s microcomputer uses the measured results to
calculate other clinically relevant parameters. This section
outlines the equations used to calculate these values.
B.2.1
Temperature Correction for Measured Values
The Stat Profile Prime CCS Analyzer allows you to enter
the patient temperature when this differs from 37 °C, as for
example in patients having surgery under hypothermia. The
pH, PCO2, and PO2 sample values, at the patient’s actual
temperature, are then calculated as follows:
pH(corrected) = pH + [- 0.0147 + 0.0065 (7.400 - pH)](T - 37)
Equation 13
PCO2 (corrected) = PCO2 x e (0.04375(T - 37))Equation 14
PO2 (corrected) = PO2 x 10U
U=
([
] )
(5.49
x 1011) Y + 0.071 x (T - 37)
–—————————
(9.72 x 10-9)Y + 2.30
and Y = e[3.88 x ln(PO2)]
B-6
Equation 15
Appendix B
B.2.2
Calculated Parameters
Calculated Bicarbonate Concentration [HCO3-]2
Bicarbonate Concentration (mmol/L) is calculated using the
Henderson-Hasselbalch equation:
[HCO3-]
pH = pK + log –————
α(PCO2 )
Equation 16
where pH and PCO2 are measured.
pK = 6.091
α = 0.0307 = solubility coefficient of CO2 in plasma at 37 °C
Rearranging Equation 16 gives:
Log10 [HCO3-] = pH + log10 PCO2 - 7.604
Equation 17
*The equations are from NCCLS standards2.
Total Carbon Dioxide Content (TCO2)*
TCO2 (mmol/L) includes both dissolved carbon dioxide and
[HCO3-] and is calculated as follows:
TCO2 = [HCO3-] + α(PCO2)
Equation 18
where PCO2 is measured and [HCO3-] is calculated from
Equation 17.
Appendix B
* The equations are from Reference 2.
B-7
Prime CCS Instructions for Use Manual
Hemoglobin (Calculated)
The hemoglobin is calculated based on the following
calculation:
Hemoglobin g/dL = Measured Hematocrit ÷ 3.0 Equation 19
NOTE: The hemoglobin calculation is an estimation
based on a normal mean corpuscular hemoglobin
concentration of 33.3%. The Stat Profile Prime CCS
Analyzer hemoglobin estimation from samples
with Red cell dyscrasia or hemoglobinopathies
may vary significantly from hemoglobin measured
by cyanmethemoglobin method.
Base Excess of Blood (BE-B)*
Base excess of blood is defined as the concentration of
titratable base needed to titrate blood to pH 7.40 at 37 °C
while the PCO2 is held constant at 40 mm Hg. Base excess
of blood is calculated as follows:
BE-B = (1 - 0.014[Hb]) ([HCO3-] - 24 + (1.43[Hb] + 7.7)(pH - 7.4) )
Equation 20
* The equations are from Reference 2.
B-8
Appendix B
Standard Bicarbonate Concentration (SBC)
The Standard Bicarbonate is defined as the bicarbonate
concentration of the plasma of whole blood equilibrated
to a PCO2 of 40 mmHg at a temperature of 37 °C with
the hemoglobin fully saturated with oxygen. Standard
bicarbonate is calculated as follows:
SBC = 24.5 + 0.9Z + Z ( Z - 8 )(0.004 + 0.00025 [Hb])
Equation 21
where Z = [BE-B] - 0.19 [Hb] ((100 - SO2 )/100)
[Hb] = The hemoglobin value which is measured, manually
entered, or is the 14.3 g/dL default value
Base Excess Extracellular Fluid (BE-ECF)*
The Base Excess Extracellular fluid is a corrected form
of the Base Excess Blood in which allowance has been
made for the fact that blood is only approximately 37% of
the extracellular fluid volume. Base excess is calculated
as follows:
BE-ECF = [HCO3-]- 25 + 16.2 (pH - 7.40)
Equation 22
* The equations are from Reference 2.
Appendix B
B-9
Prime CCS Instructions for Use Manual
Oxygen Content (O2Ct)
Oxygen content is defined as the total amount of oxygen
contained in a given volume of whole blood, including
dissolved oxygen and oxygen bound to hemoglobin. It is
expressed in milliliters of oxygen per 100 milliliters of blood
(volume %) as calculated from the oxygen saturation and the
hemoglobin concentration. Four moles of oxygen (22,393
mL/mol at standard temperature and pressure) can combine
with 1 mole of hemoglobin (64,458 g/mol) so that oxygen
capacity is equal to
4 (22393)
_________
64458
= 1.39 mL of O2 per gram of Hb Equation 23
therefore O2Ct = (1.39 [Hb]) (SO2/100) + (0.0031 [PO2])
Equation 24
where 0.0031 is the solubility coefficient of O2.
On the analyzer, hemoglobin can be manually entered,
calculated from the measured hematocrit, or occur as a
default value.
Oxygen Saturation (O2Sat)
Oxygen saturation is defined as the amount of oxyhemoglobin
in blood expressed as a fraction of the total amount of
hemoglobin able to bind oxygen. It is calculated as follows:
[PO2']3 + 150 [PO2']
O2Sat = ––––––––––––––––––––––––
x100 Equation 25
[PO2']3 + 150 [PO2'] + 23400
where [PO2'] = [PO2] x e [2.3026 x (0.48 (pH – 7.4) –
0.0013([HCO3-] – 25))]
NOTE: The equation for calculating oxygen saturation
assumes a normal shape and position of the
patient's oxygen dissociation curve.
B-10
Appendix B
Alveolar Oxygen (A)
Alveolar Oxygen refers to the partial pressure of oxygen in
alveolar gas. It is calculated as follows:
A=
%FIO2
––––– (B.P. - 0.045T2 + 0.84T - 16.5) 100
%FIO2
where
)]
1-(%FIO2/100)
**PCO2 –––––– + –––––––––
100
0.8
Equation 26
T = patient temperature
B.P. = barometric pressure
%FIO2 = fraction inspired oxygen, as a percent
** Temperature corrected gas value
Arterial Alveolar Oxygen Tension Gradient (AaDO2)
The arterial alveolar oxygen tension gradient is a useful
index of gas exchange within the lungs and is defined as:
Aa DO2 = A- **PO2
Equation 27
** Temperature corrected gas value
NOTE: For capillary samples, AaDO2 results have an
asterisk (*). AaDO2 results are dependent on how
the samples are drawn and handled, thus care
must be taken when interpreting these calculated
results.
Appendix B
B-11
Prime CCS Instructions for Use Manual
Arterial Alveolar Oxygen Tension Ratio (a/A)
The arterial alveolar oxygen tension ratio is useful to predict
oxygen tension in alveolar gas and to provide an index of
oxygenation which remains relatively stable when FIO2
changes.
a/A = **PO2/A
Equation 28
** Temperature corrected gas value
Arterial-Mixed Venous O2 Content Difference ( a – –v DO2 )
When the oxygenated blood from the lungs comes into
contact with tissues, it releases oxygen and takes up carbon
dioxide. The quantity of oxygen donated depends on 2 factors:
• The speed of blood flow
• The consumption by tissues
The first factor can be detected from the cardiac output, and
the second depends on the metabolic rate of the patient.
The a – –v DO2 is the measurement of the difference in oxygen
content between the arterial blood and the mixed venous
blood (the amount of oxygen donated to the tissues). This
parameter is not an indication of the basic metabolism or
of the cardiac output. It is an nonspecific indication; even if,
in some cases completely relaxed patients with a constant
metabolic rate, it can be related to the cardiac output.
a – v– DO2 = CaO2 – Cv– O2
Equation 29
B-12
Appendix B
P50 or PO2 (0.5)*
The P50 is defined as the PO2 of a sample at which the
hemoglobin is 50% saturated with oxygen at pH 7.4, 37°C,
and 40 mm Hg PCO2 for SO2% values between 40% and
80%.
P50(uncorrected)=PO2/(SO2%/(100-SO2%))0.37Equation 30
For measured SO2% between 80 and 96.9%, the equation
is as follows:
Where z = tanh(0.5343 * x); x = ln(0.133 * PO2/7); y =
ln(SO2%/(100-SO2%))-1.875
P50(uncorrected)=26.902 * exp(1.121 * (y-x-3.5z)/(1.87 * z2 +
z - 2.87)) Equation 31
The corrected equation is as follows:
log P50(corrected) = log P50(uncorrected) + 0.43 (pH – 7.4) –
0.05 (log PCO2/40) – 0.0131(T – 37)
Equation 32
* The equations are from Reference 4.
Appendix B
B-13
Prime CCS Instructions for Use Manual
Ionized Calcium “Normalized” to pH 7.4
The activity and concentration of ionized calcium in whole
blood is pH dependent. In vitro, a pH increase of 0.1 unit
decreases the ionized calcium level by 4 to 5% (conversely,
a pH decrease has an equal but opposite effect). The sample
of choice for ionized calcium determination is anaerobically
collected whole blood.
If an anaerobic sample is not available, by measuring
the actual pH of the sample at which the ionized calcium
concentration was measured normalized ionized calcium can
be calculated. The normalized ionized calcium represents
what the ionized calcium concentration would have been
if the initial pH was 7.40 (the midpoint of the pH reference
range). The equation used for this calculation is as follows:
log [iCa] 7.4 = log [Ca++]X - 0.24 (7.4 - X)
Equation 33
where X = measured pH of the sample
[iCa]X = ionized calcium concentration in the sample
at the measured pH
[iCa] 7.4 = normalized concentration of ionized calcium
at pH 7.40
The equation assumes a normal concentration of total protein
and may be used for measured values between pH 7.2 and
7.6. Between pH 6.9 and 7.2 and between pH 7.6 and 8.0,
modified forms of the equation are used. Normalized ionized
calcium values for samples with pH outside the range pH
6.9 to pH 8.0 are not displayed.
B-14
Appendix B
Anion Gap
Anion gap is the difference between the sum of the sodium
and potassium concentrations (the cations) and the sum of
the chloride and bicarbonate concentrations (the anions),
as follows:
Anion Gap = (Na + K) - (Cl + [HCO3-})
Equation 34
No anion gap is reported if any of the 4 concentrations are
not reported. Any calculated anion gap less than 0.0 mmol/L
is not reported.
References:
1. Mohan, M.S. and Bates, R.G. 1977. Blood pH,
Gases and Electrolytes. NBS Special Publication,
450. U.S. Government Printing Office.
2. National Committee for Clinical Laboratory
Standards. 1999. Tentative Standard for Definitions
of Quantities and Conventions Related to Blood pH
and Gas Analysis. NCCLS 2:10.
3. Williams, W.J., Beutler, E., Ersley, A.J., and Rundles,
R.W. 1977. Hematology. 2nd ed. McGraw-Hill Co.
4. Burtis, Carl A. and Ashwood, Edward R., ed. 1999.
Tietz Textbook of Clinical Chemistry. Philadelphia,
PA: W. B. Saunders Co.
Appendix B
B-15
Prime CCS Instructions for Use Manual
B-16

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PDF Version                     : 1.6
Linearized                      : Yes
XMP Toolkit                     : Adobe XMP Core 4.0-c321 44.398116, Tue Aug 04 2009 14:24:39
Create Date                     : 2013:08:27 10:56:30-04:00
Metadata Date                   : 2013:09:04 14:56:13-04:00
Modify Date                     : 2013:09:04 14:56:13-04:00
Creator Tool                    : Adobe InDesign CS5.5 (7.5)
Page Image Page Number          : 1, 2
Page Image Format               : JPEG, JPEG
Page Image Width                : 256, 256
Page Image Height               : 256, 256
Page Image                      : (Binary data 9923 bytes, use -b option to extract), (Binary data 2925 bytes, use -b option to extract)
Instance ID                     : uuid:650fd0a7-54ab-4f2e-9563-ff2775c53f50
Document ID                     : adobe:docid:indd:ac18b3c3-16c8-11dd-a802-b4ecef2cf034
Original Document ID            : adobe:docid:indd:ac18b3c3-16c8-11dd-a802-b4ecef2cf034
Rendition Class                 : proof:pdf
Derived From Instance ID        : 5eac3ec2-169f-11dd-a802-b4ecef2cf034
Derived From Document ID        : adobe:docid:indd:55ce3cd3-fbe3-11dc-89a3-9a02108e237e
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User Manual

FCC ID Filing: QYY-51360

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