Nova Stat Profile PHOx - Reference Manual

Reference Manual
EC Declaration of Conformity
Issued by
Nova Biomedical Corporation

200 Prospect Street
Waltham, MA 02454, U.S.A.
Equipment Description: Model - Stat Profile® pHOx® Analyzer

Laboratory Equipment
100 - 120 / 220 - 240 V, 130 W, 50/60 Hz
Protection Class I
Year of Manufacture: See serial number showing date.
Applicable Directives: 73/23/EEC, Low Voltage Directive

Laws for electrical equipment within certain voltage limits
89/336/EEC, EMC Directive

Laws relating to electrical magnetic compatibility
Applicable Standards: EN 61010-1/A2:1995, EN 61010-2-010/A1:1996

Equipment for Measurement, Control and Laboratory use
EN 50081-1:1992
Electromagnetic Compatibility. Generic Emission Standard
EN 50082-1:1992
Electromagnetic Compatibility. Generic Immunity Standard
Type Examination Certificate: GS-mark License Number AL 01 06 20747 011

TUV Product Service, Munich/Germany
Authorized by : ________________________ 3/15/99

Francis C. Manganaro Date
President
Nova Biomedical Corporation
Preface Stat Profile pHOx Reference Manual
Nova Stat Profile® pHOx® Reference Manual
Part Number and Ordering Information
The Stat Profile® pHOx® Reference Manual (PN 22363) can be ordered from Nova Biomedical
Order Services. Write or call:
Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141
U.S.A.
Telephone: 1-800-458-5813
FAX: (781) 893-6998 (in the U.S.A.) or

(781) 899-0417 (outside the U.S.A.)
Technical Assistance
For technical assistance, call Nova Biomedical Technical Services at:
Telephone: 1-800-545-NOVA or
(781) 894-0800
FAX: (781) 894-0585
Trademarks and Patents
Stat Profile® and pHOx® are registered trademarks of Nova Biomedical.

The Stat Profile pHOx Analyzer is covered by the following patents:
U.S. Patent No. 4,686,479, U.S. Patent No. 5,578,194.
Copyright
Printed in the U.S.A. Copyright 2001, Nova Biomedical, Waltham, MA 02454-9141.
i
Preface Stat Profile pHOx Reference Manual
Note: U.S. Legislative Requirements — Nova Analyzers
The new legislative requirements for clinical laboratories have established a new regulatory
environment and have changed the responsibility that Nova Biomedical has regarding the
proper operation and control of Nova analyzers. With the advent of the requirements that the
end user specifically follows all directions for use from the manufacturer, Nova becomes a
partner with the user and becomes responsible for providing instructions that will virtually
guarantee that the analyzer is in control. This requires Nova to provide instructions on
maintenance and control which are virtually foolproof in regards to assuring that an analyzer
is in control.
In addition to asking that all operators perform the maintenance and calibration procedures
described in this manual, we also recommend that only Nova reagents, calibrators, cleaning
agents, and controls be run through the analyzers. These are the only materials that we have fully
characterized and tested. We have neither tested the performance nor determined the long term
effects of products provided by others for use on our instruments. Confirming that an analyzer
is in control by using reagents and controls not certified by Nova Biomedical can not be
guaranteed by Nova, and Nova will not be responsible for the consequences. Users who elect
to use reagents, standards and/or controls from other producers should confirm by the
appropriate testing protocols from those other manufacturers that Nova’s instrumentation is in
control and in compliance with all legislative requirements. This testing verification should
also include a means of troubleshooting when the instrument is not in control, since Nova
Biomedical cannot, in the present environment, provide that service. Since Nova Biomedical
does not know the formulations of the reagents and controls used by other manufacturers,
including the levels of surfactants, preservatives, viscosity adjusters, and other additives that
may be used, there is no way for Nova to be certain that the results obtained on controls or
patient samples will be correct when these products are used. There is also no way to tell
whether there will be long term or short term adverse effects on sensor performance, sensor
life, tubing or flow cell degradation, or on data quality/accuracy or reliability.
Nova Biomedical manufactures totally integrated systems to assure proper analyzer perfor-
mance. We cannot characterize all products that might be used on Nova analyzers, nor can we
control changes that other manufacturers might choose to make to their products. Therefore,
use of these products with a Nova analyzer must be the responsibility of the individual end user
and of that manufacturer rather than Nova.
Under these new legislative requirements, user modification of an in vitro diagnostic device,
is also regulated. Modification of the product includes use of untested products or products
which have not been tested to determine substantial equivalency and safety and effectiveness
in use with Nova analyzers.
Nova Biomedical’s Reference Manuals include the specific information needed for the proper
maintenance, qualification, and operation of Nova Biomedical Analyzers. If the user follows
the directions in those manuals, they should have very few problems. In the case where they
need assistance from Nova Biomedical in troubleshooting their systems, we will stand ready
to assist them in any and all ways necessary.
ii
NCCLS Cross-Reference Stat Profile pHOx Reference Manual
Cross-Reference Table for NCCLS Guideline
NCCLS Guideline Stat Profile pHOx Reference Manual
1. Principle of Test Appendix B: Sections B.2 to B.2.6

2. Specimen required Chapter 1, Sections 1.3, 1.3.1, 1.3.2
3. Reagents, Standards, and Controls Appendix A: Sections A.2 to A.2.3.1
4. Calibration procedures and schedule Chapter 3: Sections 3.16, 3.16.1 to 3.16.4
5. Step-by-Step Directions
Analysis Chapter 3: Sections 3.18, 3.18.1 to 1.18.4
Maintenance Chapter 4
Troubleshooting Chapter 5
6. Calculations Appendix B: Sections B.3 to B.3.2
7. Frequency, Control Tolerance Chapter 3: Sections 3.17, 3.17.1, 1.17.2
8. Expected values Appendix A: Section A.3
9. Linearity limits Appendix A: Section A.1
10. Limitations (interferences) Chapter 1, Sections 1.3.2, 1.3.3, 1.3.4
11. References Chapter 1: Page 1-3; Appendix B: Page B-9
12. Effective Date Table of Contents
13. Distribution Nova pHOx Customers
14. Author Alan J. Mannarino
NOTE: This manual complies with the NCCLS guidelines Vol. 4, Section 2.1. As a user, you
can copy and compile these above sections into one compact NCCLS Nova pHOx Manual or
use the cross-reference to find the appropriate section in the Nova Stat Profile pHOx
Reference Manual.
Nova Stat Profile pHOx Reference Manual
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 Installation ............................................................................................................ 1-1
1.1.1 Requirements ............................................................................................ 1-1
1.2 Intended Use, Tests Performed, and Clinical Utility ............................................ 1-2
1.3 The Sample ........................................................................................................... 1-4
1.3.1 Handling Requirements ............................................................................ 1-4
1.3.2 Acceptable Anticoagulants ....................................................................... 1-4
1.3.3 Interfering Substances .............................................................................. 1-5
1.3.4 Matrix Effects ........................................................................................... 1-5
1.4 About This Reference Manual .............................................................................. 1-5
2 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Installing the Stat Profile pHOx ........................................................................... 2-1
2.2 Power Up Procedure ............................................................................................. 2-1
2.3 Using the Keypad and Display ............................................................................. 2-1
2.3.1 General Keypad Entry .............................................................................. 2-3
2.4 Overview of the Displays (User Interface) ........................................................... 2-4
2.5 Adapting the Program to Your Clinical Requirements with the Setup Menu ....... 2-4
2.6 Setup Options ....................................................................................................... 2-5
2.6.1 Password ................................................................................................... 2-6
2.6.2 Results Configuration Menu ..................................................................... 2-7
2.6.2.1 Remote Review ............................................................................ 2-7
2.6.2.2 Results Suppression ..................................................................... 2-8
2.6.2.3 Mandatory Patient ID .................................................................. 2-8
2.6.3 Operation Configuration Menu ................................................................ 2-9
2.6.4 Communications ....................................................................................... 2-9
2.7 QC Setup .............................................................................................................. 2-9
2.7.1 QC Lockout .............................................................................................. 2-9
2.8 Remote Control .................................................................................................. 2-11
PN 22363 Rev. D 6/2001 TOC-1

Table of Contents
3 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.1 Display and Door .................................................................................................. 3-3
3.2 Keypad .................................................................................................................. 3-3
3.3 Printer (Optional) .................................................................................................. 3-3
3.4 Sampler ................................................................................................................. 3-3
3.5 Sensor Module ...................................................................................................... 3-4
3.6 Sensors .................................................................................................................. 3-4
3.7 Reference Electrode .............................................................................................. 3-4
3.8 Barometric Pressure Module ................................................................................ 3-5
3.9 Pinch Valves .......................................................................................................... 3-5
3.10 Peristaltic Pump .................................................................................................... 3-5
3.11 Reagent Pack ........................................................................................................ 3-5
3.12 Auto-Cartridge QC ............................................................................................... 3-6
3.13 Movement Of Fluids ............................................................................................. 3-6
3.14 Operational Overview ........................................................................................... 3-7
3.15 Ready to Analyze .................................................................................................. 3-7
3.16 Calibrating the Analyzer ....................................................................................... 3-8
3.16.1 Two-Point Calibration (Automatic and Manual) ...................................... 3-8
3.16.2 Manual Calibration ................................................................................... 3-8
3.16.3 SO2/Hb Calibration .................................................................................. 3-8
3.16.4 One-Point Calibration ............................................................................... 3-9
3.17 Quality Control ..................................................................................................... 3-9
3.17.1 Running QC Samples ............................................................................. 3-10
3.17.2 Running Linearity Solutions/Proficiency Samples ................................. 3-10
3.18 Analyzing Samples ............................................................................................. 3-10
3.18.1 Analyzing from a Syringe or an Ampule ................................................. 3-11
3.18.2 Analyzing from a Capillary Tube ........................................................... 3-12
3.18.3 Analyzing in AV Shunt Mode ................................................................. 3-13
3.18.4 Stat Mode ................................................................................................ 3-13
3.19 Results Recall ..................................................................................................... 3-14
4 Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 Sample Number Counter ...................................................................................... 4-1
4.2 Scheduled Maintenance ........................................................................................ 4-1
4.2.1 Reagent Pack and Control Pack Changing ............................................... 4-2
4.2.2 Flowpath/Probe Maintenance ................................................................... 4-3
4.2.3 Standby Mode ........................................................................................... 4-3
4.2.4 pH and Sodium Sensors Replacement ...................................................... 4-3
4.2.5 PCO2 Sensor or Membrane Replacement ................................................ 4-4
4.2.6 PO2 Sensor Polishing and Membrane Replacement ................................. 4-6
4.2.7 Reference Electrode Replacement ............................................................ 4-7
TOC-2 PN 22363 Rev. D 6/2001

4.2.8 SO2 Sensor Maintenance ........................................................................... 4-9

4.2.9 Pump Tubing Replacement ..................................................................... 4-10
4.2.9.1 Waste Line Replacement ........................................................... 4-11
4.2.9.2 Reference Line Replacement ..................................................... 4-12
4.2.10 Sensor Module Conditioning .................................................................. 4-13
4.2.11 Flowpath Cleaning/Deproteinizing ......................................................... 4-13
4.2.12 Printer Paper Replacement ..................................................................... 4-14
4.2.13 Probe and Air Detector Replacement ..................................................... 4-15
4.2.14 Sensor Module Replacement .................................................................. 4-17
4.3 Display/Cabinet Cleaning ................................................................................... 4-19
5 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 Troubleshooting Procedures ................................................................................. 5-1
5.2 Stat Profile pHOx 2-Point Calibration Sequence ................................................. 5-2
5.3 Status Codes ......................................................................................................... 5-4
5.4 pH Conditioning ................................................................................................... 5-7
5.5 Troubleshooting Flow Problems ........................................................................... 5-7
5.5.1 Operator Flow Test ................................................................................... 5-7
5.5.2 Flushing the Reference Electrode ........................................................... 5-10
6 Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 Sensor Subsystem Screens.................................................................................... 6-1
6.1.1 Running a Flow Test and Checking the Rotary Valve Operation ............. 6-1
6.1.2 Checking the Sampler ............................................................................... 6-2
6.1.3 Checking the Pump ................................................................................... 6-2
6.1.4 Checking the Waste Valve......................................................................... 6-2
6.1.5 Checking the Reference Valve .................................................................. 6-2
6.1.6 Checking the SO2 LEDs........................................................................... 6-3
6.1.7 Checking the Air Detectors....................................................................... 6-3
6.2 Analog Input ......................................................................................................... 6-3
6.3 System Test ........................................................................................................... 6-3
6.4 Printer Menu ......................................................................................................... 6-4
6.5 Error Log .............................................................................................................. 6-4
6.6 Communications Test ........................................................................................... 6-4
6.7 RS-232 Serial Ports .............................................................................................. 6-5
6.7.1 CO-Oximeter Interface ............................................................................. 6-6
6.7.2 PDM/Computer Interface ......................................................................... 6-6
6.7.3 Bar Code Scanner Port ............................................................................. 6-6
6.7.4 External Keyboard .................................................................................... 6-6
PN 22363 Rev. D 6/2001 TOC-3

Table of Contents
7 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 High-Level Protocol ............................................................................................. 7-1
7.1.1 Header Record .......................................................................................... 7-2
7.1.2 Patient Information Record ...................................................................... 7-3
7.1.3 Test Order Record ..................................................................................... 7-5
7.1.4 Result Record ........................................................................................... 7-7
7.1.5 Comment Record ...................................................................................... 7-9
7.1.6 Message Terminator Record .................................................................... 7-9
7.1.7 Parameter Names .................................................................................... 7-10
7.2 Examples ............................................................................................................ 7-16
7.2.1 pHOx Only Patient Sample .................................................................... 7-16
7.2.2 pHOx Only QC Sample .......................................................................... 7-17
7.2.3 pHOx ABG Calibration .......................................................................... 7-18
7.2.4 pHOx SO2% Calibration ......................................................................... 7-19
7.2.5 Combined Patient Sample ...................................................................... 7-19
7.2.6 pHOx Only QC Sample .......................................................................... 7-21
A Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.1 Stat Profile pHOx Specifications ......................................................................... A-1
A.2 Reagents and Solutions ........................................................................................ A-5
A.2.1 Reagents and Solutions ............................................................................ A-5
A.2.2 Reagent Pack ........................................................................................... A-6
A.2.3 Verifying the Analyzer's Performance ..................................................... A-6
A.2.3.1 Nova Stat Profile pHOx Controls Levels 1, 2, 3: QC ................ A-7
A.3 Reference Values ................................................................................................. A-8
A.4 Ordering Information ........................................................................................... A-9
A.5 Shutdown Procedure .......................................................................................... A-11
A.5 Warranty ............................................................................................................ A-11
TOC-4 PN 22363 Rev. D 6/2001

B Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
B.1 Sensor Calibration ................................................................................................ B-1
B.1.1 Two-Point Calibration .............................................................................. B-1
B.1.2 One-Point Calibration ............................................................................... B-1
B.2 Parameter Definitions ........................................................................................... B-2
B.2.1 pH Sensor ................................................................................................. B-2
B.2.2 Partial Pressure of Carbon Dioxide (PCO2) ............................................. B-2
B.2.3 Partial Pressure of Oxygen (PO2) ............................................................. B-3
B.2.4 Hematocrit ................................................................................................ B-3
B.2.5 Hemoglobin (Measured) ........................................................................... B-3
B.2.6 SO2 % Concentration ................................................................................ B-4
B.3 Calculated Values .................................................................................................. B-4
B.3.1 Temperature Correction for Measured Values* ........................................ B-4
B.3.2 Calculated Parameters .............................................................................. B-5
C Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
C.1 pHOx Installation ................................................................................................. C-2
C.1.1 Printer Paper Installation .......................................................................... C-2
C.1.2 SO2 Sensor Installation ............................................................................. C-3
C.1.3 Reference Electrode Installation ............................................................... C-3
C.1.4 Pump Tubing Harness Installation ............................................................ C-4
C.1.5 Reference Line (R-line) Installation ......................................................... C-5
C.1.6 Waste Line (W-line) Installation ............................................................... C-6
C.1.7 Sodium and pH Sensor Installation .......................................................... C-6
C.1.8 PO2 and PCO2 Sensor installation ............................................................ C-7
C.1.9 Probe and Air Detector Installation .......................................................... C-8
C.1.10 Reagent Pack Installation ......................................................................... C-9
C.1.11 Auto-Cartridge Quality Control Pack Installation .................................... C-9
C.1.12 Calibration .............................................................................................. C-10
PN 22363 Rev. D 6/2001 TOC-5

Table of Contents
TOC-6 PN 22363 Rev. D 6/2001

1 Introduction
1. Intro.
1 Introduction
This manual provides all necessary instructions for the routine operation and maintenance of
the Stat Profile pHOx Analyzer. Please read this manual carefully. It has been prepared to help
you attain optimum performance from your Stat Profile pHOx Analyzer.
WARNING: Blood samples and blood products are potential sources of hepatitis and
other infectious agents. Handle all blood products and flow path components (waste-
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended.
NOTE: This International Caution Label appears on the rear of the pHOx
! Analyzer and means refer to the manual.
This section introduces the Stat Profile pHOx Analyzer and covers requirements, tests
performed, procedural limitations, clinical utility, and sample handling.
1.1 Installation
This section covers the installation requirements and assembly procedures for the Stat Profile
pHOx Analyzer.
NOTE: Under the Warranty, a Nova service representative will install this
equipment for you.
1.1.1 Requirements
Working Area Requirements:

Keep the working area around the system free of dirt, corrosive fumes, vibration, and excessive
temperature changes. Ambient operating temperature is 15 °C to 30 °C (59°F to 86 °F). Operate
at humidity of 0 to 95% without condensation.
Electrical Requirements:
A grounded, 3-wire receptacle within 5 feet of the system is required for operation. The U.S.
models require a 120 Volt AC line at 50/60 Hz frequency. The analyzer can be operated at
100 - 120; 220 - 240 Volt AC 50/60 Hz.
Fuse requirements:
• 2 Amp Time Delay (SB 2A or T2A) at 100 - 120 Volt AC line.
• 1 Amp Time Delay (T1A) at 220 - 240 Volt AC line.
1-1
Stat Profile pHOx Reference Manual
1. Intro.
1.2 Intended Use, Tests Performed, and Clinical Utility
Intended Use
The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care
professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (SO2%),
hematocrit (Hct), hemoglobin (Hb) in heparinized whole blood.
Measured Parameters
pH, PCO2, PO2, SO2%, Hct, (Na+ required for Hct), Hb, and barometric pressure
Calculated Parameters
From the directly measured results, the calculated results are
• Base Excess of the blood (BE-b)

• Base Excess of extracellular fluid (BE-ecf)
• Bicarbonate level (HCO3-)
• Standard Bicarbonate Concentration (SBC)
• Total Carbon Dioxide (TCO2)
• Oxygen Content (O2Ct)
• Oxygen Saturation (SO2%) - (If measured result not available)
• Alveolar Oxygen (A)
• Arterial Alveolar Oxygen Tension Gradient (AaDO2)
• Arterial Alveolar Oxygen Tension Ratio (a/A)
• Oxygen Capacity (O2Cap)
• Hemoglobin (Hbc) - (If selected or measured result not available)
• P50 (measure single point)
• pH, PCO2, PO2 (corrected to patient temperature)
• ˙ / Qt
Qsp ˙ (physiological shunt - requires 2 samples: mixed venous and arterial)
• Respiratory Index (RI - uses entered %FIO2 or default value of 20.9)
• PO2/FIO2 ratio
With the Nova CO-OXIMETER inputs of Oxygen Capacity of hemoglobin (O2Cap) and
Oxygen Content of hemoglobin (O2Ct), the additional combined CO-Oximeter/Stat Profile
pHOx calculated results are
• CcO2
• CaO2
• Cv-O2
• av-DO2
• P50
1-2
1 Introduction
1. Intro.
Test Dependencies
• If O2Cap from the Nova CO-OXIMETER is available, that value is displayed.
• If O2Ct from the Nova CO-OXIMETER is available, that value is displayed instead
of the calculated O2Ct value.
• If SO2% from the Nova CO-OXIMETER is available, that value is displayed instead
of the SO2% measured by the reflectance method.
• If Hb from the Nova CO-OXIMETER is available, that value is displayed instead of
the Hb measured by the conductivity and photometric methods.
Clinical Utility1
The following list includes the clinical utility information for each of the analytes measured
on the Stat Profile pHOx Analyzer.
Blood Gases: Whole blood measurement of blood gases is used in the diagnosis
(PCO2, PO2, and treatment of life-threatening acid-base disturbances in critically ill
and pH) patients with numerous metabolic and pulmonary diseases.
Oxygen Used to assess the oxygenation of hemoglobin and the adequacy of tissue
Saturation oxygenation in the evaluation of pulmonary function. Also used in the
diagnosis and treatment of cyanosis.
Hematocrit Whole blood measurement of hematocrit is used to estimate that red blood
cells are present in sufficient quantity to carry oxygen and carbon dioxide.
Hemoglobin Oxygen is carried from the lungs throughout the body by hemoglobin present
in red blood cells. Measurement of hemoglobin provides the clinician with
information regarding the evaluation of chronic and acute anemias and also
with information pertaining to the potential oxygen transport capability of the
hemoglobin.
Physiologic The physiologic shunt or AV Shunt calculation relates to the small fraction
Shunt of the cardiac output which goes to the lungs that does not come into contact
with oxygen exchange units (alveoli). In health, this shunt fraction is less than
5%. Increased shunt fraction is seen in cases where there is a pathophysi-
ologic process that reduces the number of functional gas exchange alveoli or
blood is directed away from functional alveoli.
Ref. 1.Tietz, N.W. ed. 1986. Textbook of Clinical Chemistry. W. B. Saunders Co.
1-3
1. Intro.
1.3 The Sample

Sodium or lithium heparin whole blood sample from syringes, open tubes, small cups, and
capillary tubes can be used on the Stat Profile pHOx Analyzer. The sample size is 70 µL for
normal mode and 45 µL for micro mode (blood gases only).
1.3.1 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. National Committee for Clinical Laboratory Standards. Considerations in the Simultaneous Mea-
surement of Blood Gases, Electrolytes, and Related Analytes in Whole Blood; Proposed Guideline.
NCCLS Document C32-P. Vol. 13, No. 17.
1.3.2 Acceptable Anticoagulants
Sodium and lithium heparin are the recommended anticoagulants for use with the Stat Profile
pHOx Analyzer. EDTA, citrate, oxalate, or sodium fluoride are not recommended 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 be
obtained. Liquid heparin when present in excess may cause errors by dilution in pH, PCO2, and
PO2.
Our experience suggests that lyophilized lithium heparin giving a final concentration in blood
of not more than 20 I.U. per mL is acceptable in the critical care laboratory. Stat Profile pHOx
Analyzer users should take careful note of these considerations when establishing reference
intervals and interpreting results.
1-4
Update to PN 22363 Rev. D 3/2002
1 Introduction
1. Intro.
1.3.3 Interfering Substances
SO2% Interferences:
High levels of COHb and MetHb will increase the reported SO2% value.
MetHb values above 15% will interfere with the SO2% value.
10% Intralipid solutions will interfere with the SO2% when the blood concentrations of
Intralipid are >500 mg/dL.
Hemolyzed samples will interfere with the SO2% value.
Hematocrit (Hct) Interference:
White Blood Count (WBC) greater than 50,000 WBC/µL may increase the hematocrit value.
1.3.4 Matrix Effects
Nova instruments are designed for clinical environments to analyze actual patient specimens,
not modified blood samples. Specimens removed from the patient, anticoagulated appropri-
ately, and promptly analyzed are the only type of sample where the measurement results will
be reliable. Matrix effects/interferences can occur when patient specimens are removed from
the body, modified and then measured on a Nova instrument. For example, matrix effects have
been seen on Nova analyzers when attempting to analyze samples collected from cell savers
used in various surgical procedures. Also, evaluation laboratories run specimens from patients
with a wide variety of pathologies and from patients who are being treated with a broad
spectrum of therapeutic and pharmacological agents. Despite extensive clinical trials, it is not
possible to anticipate every possible combination of transfused blood products, crystalloids,
and drugs (or their metabolites) that may be present in a blood sample. As a result, some users
have found that their particular patient mix has necessitated making adjustments to mainte-
nance. For example, a high number of cardiopulmonary bypass pump or ECMO (extracorpo-
real membrane oxygenation) samples result in a need for increased analyzer maintenance. If
you are experiencing excessive downtime, you may need to modify your own maintenance
schedules. Nova’s Clinical Applications Group will assist you in tailoring a maintenance
program to meet these needs.
1.4 About This Reference Manual
This manual is for Stat Profile pHOx 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.
1-5
1. Intro.
1-6
2 Setup
2 Setup
This section describes how to setup the Stat Profile pHOx Analyzer.
2. Setup
2.1 Installing the Stat Profile pHOx
The analyzer is initially installed by a factory authorized representative.
CAUTION: The pHOx analyzer is designed to be left on with adequate fluids

at all times. This is necessary to prevent crystallization of salts in the fluid
lines and cuvette. If it is to be shut down indefinitely, purge all fluid lines
with distilled water and then with air. The purge sequence is selected from
the Operational Menu.
2.2 Power Up Procedure
After power up, the analyzer checks the error condition status of the instrument by the Power
On Self Test (POST). The bicolor LED on the front panel will be a solid yellow if the analyzer
has passed this test.
NOTE: After power up, the analyzer displays the pHOx logo screen. In less
than 1 minute, the Not Ready screen will appear with the LED at solid
yellow. The analyzer will need to be calibrated.
2.3 Using the Keypad and Display
Overview The keypad, display, and status lights are located on the front panel.
Display The display provides prompts, menus, status information, error messages,
patient results, etc. The top line gives the screen's name (i.e., Setup Menu) and
in some screens the date and the time. The second line displays directions for
the screen or additional information about the displayed data. The middle of the
screen is for the menu items that you can select, detailed direction for
procedures, patient information, or electrode statuses. The bottom line defines
the soft keys.
2-1
Soft Keys The 4 soft keys are defined by the labels currently shown on the lower line
of the display. The keys cause system action, such as selection of menus,
initiation of maintenance procedures, and other displays.
Some common soft keys are
Home returns you back to the READY screen.
2. Setup
Next Screen moves you to the next screen in the sequence.

Cancel returns to the previous screen or cancels a sequence.
Status Lights The 2 status lights on the front panel reveal the system status as follows:
Steady Green - All air detectors and one or more channels are calibrated. The
analyzer is ready for analysis or input.
Flashing Green - All air detectors and one or more channels are calibrated, but
the analyzer is busy analyzing, priming, accepting external data, etc. The
analyzer will not allow any analytical or any other sequence to be started until
it becomes not busy.
Steady Yellow - One or more air detectors or all channels are not calibrated.
Flashing Yellow - One or more air detectors or all channels are uncalibrated and
the analyzer is busy.
Status Symbols There are a number of symbols that can appear after the results. The symbols
have the following meanings:
↑ (single up arrow), ↓ (single down arrow) - The result is higher or lower that the
defined reference range for the parameter.
↑↑ (double up arrow), ↓↓ (double down arrow) - The result is higher or lower that
the defined alert range for the parameter.
↑↑↑ (triple up arrow), ↓↓↓ (triple down arrow) - The result is out of the
analyzer's operating range.
X (an A through an analyte prefix) - The channel is uncalibrated.
? (question mark) - Insufficient sample is detected during sample reading.
* (asterisk) - The result is calculated using a default sodium concentration.
— (a line through an analyte prefix) - The channel did not pass QC and QC
lockout is enabled; or the results have been suppressed.
Keypad The keypad allows you to enter information into memory. It consists of 12
number keys (including a decimal point key and a dash key), up (↑), down
(↓), left (←), and right (→) arrow keys, and an ENTER ( ↵ ) key. The arrow
keys move the cursor on the display. Also, the left arrow key can be used as
a backspace when entering numerical information. The ENTER ( ↵ ) key
places data on the display into memory.
Analyze Keys There are 2 keys to initiate an analysis: one key has an icon of a capillary tube
and the other key has an icon of a syringe. To perform an analysis with a
capillary sample, press the capillary key. To perform an analysis with a
syringe sample, press the syringe key. These 2 keys are only active when the
Home screen or the Result screen are displaying.
2-2
2 Setup
2.3.1 General Keypad Entry
Entering numbers:
1. In general, press the arrow keys to select a character entry field or option. Then follow
2. Setup
the screen instructions.
2. For numeric ID entry, press a key to add a character, and the cursor moves to the right.
Up to 20 characters are accepted. If editing an entry, press the left arrow (←) to erase
the last character.
3. After data has been entered correctly, press ENTER ( ↵ ) as a final step to store the
information into memory.
Soft Keys
Analyze Capillary
Number Keys Analyze Syringe

1 2 3
4 5 6
Green LED
7 8 9
Up, Down, Left,
Yellow LED Right Keys
0 ENTER
Enter Key
Figure 2-1. Stat Profile pHOx Keypad
2-3
2.4 Overview of the Displays (User Interface)
The format that allows the operator to change displays, enter data, and perform functions is
generally referred to as the user interface (controlled by software).
2. Setup
Here are some general rules for the user interface:
• To perform any operation, use the screen instructions to guide you.
• To go back to the Ready screen or the menu for a selected section (i.e., QC, Setup,
etc.), press Home.
• To move back to the previous display, press Previous Page (soft key), if applicable.
• Press Cancel (soft key) to terminate the current operation or sequence or to return to
previous display.
• Press Exit (soft key) to return to the previous display.
• Analyzing a sample and performing calculations take precedence over the user
interface. Therefore, you are temporarily locked out of accessing displays that can
interfere with an ongoing sequence or operation.
• A status message indicates an error condition.
2.5 Adapting the Program to Your Clinical Requirements with the Setup Menu
Use the Setup Menu to adapt the analyzer to your requirements.
2-4
2 Setup
2.6 Setup Options
The Setup Menu has the following setup options:

• Results Configuration Menu
2. Setup
- Reference and Alert Limits Setup
pH, PCO2, PO2, SO2%, Hct, Hb
- Electrode Offsets Setup
pH, PCO2, PO2, SO2%, Hct, Hb
- Results Units Setup
Temperature: °C or °F
Blood Gas: mmHg or kPa
pH/H+: pH or H+
Hb: g/dL or mmol/L or g/L
- Results Suppression: Suppress or not suppress
- Remote Review: ON or OFF
- Patient Name: ON or OFF
- Mandatory Patient ID: ON or OFF
• Operation Configuration Menu
- Analysis Configuration
Analysis Transmit Mode Manual/Auto
Transmit Diagnostic Data Off/ON
Analysis Print Mode Manual/Auto
Print Diagnostic Data OFF/ON
CO-Ox Data Merge Accession nbr/Patient ID
Set Analyzer ID Number:
- Calibration Configuration
Set 1 Point Calibration Frequency 30, 45 min.
Set 2 Point Calibration Frequency 2, 4, 6 hr.
Transmit Diagnostic Data OFF/ON
Print Diagnostic Data OFF/ON
Transmit Drift Data OFF/ON
Print Drift Data OFF/ON
- System Configuration
Set Date Format DD/MM/YY, MM/DD/YY, YY/MM/DD
Set Time Mode 24/12 hr. Mode
Date and Time Set
Measured Barometric Pressure 760 mmHg
Corrected Barometric Pressure 0.0 mmHg
Set Default Hb Used in Calculations: 14.3 g/dL
Set Tone Frequency (100-500Hz): 3500 Hz
- Analysis Mode: A or B
- Hb Type: Measured or Calculated
- STAT Mode: ON or OFF
2-5
• Communications Menu
- Baud (4800, 9600, 19200)
- Data Bits (7, 8)
- Stop (1,2)
- Parity (None, Even, Odd)
2. Setup
- External Keyboard: Yes or No

- Co-oximeter attached: Yes or No
• Printer Installed or Not Installed
• Passwords: System or Operator
• Operator Passwords: ON or OFF
• Language: English, Chinese, French, German, Italian, Japanese, and Spanish
2.6.1 Password
The first option you should call up is Set Password: either System or Operator.
The System Password, which safeguards the setup parameters, is required to enter the Setup
Menu. Set up System Passwords as follows:
1. Press Menu on the Ready screen to display the Operational Menu screen.
2. Press Setup to display the Setup Menu screen.
3. A pop-up Password screen appears. Enter the default password, 0. This is the
password until one is officially entered.
4. Scroll down with the arrow keys to the Password option and press Enter. A pop-up
screen appears: select System Password.
5 Key in a password number between 1 and 9999 (up to 4 numeric characters) then
press ENTER.
6. Proceed to the next setup option or return to the Operational Menu.
The Operator Passwords allows you the ability to enable and to enter 200 unique passwords
with privilege levels. When enabled, password entry will be required whenever any of the
home screen soft keys, syringe key, or capillary key are pressed. Entry into any one of the
protected areas depends on the privilege level assigned to the operator of the analyzer.
There are 3 privilege levels: Privilege Level 1 is the most privileged operator and Privilege
level 3 is the default level.
• Privilege Level 1 operators have access to all areas of the analyzer except those
protected by the existing System Password. Level 1 operators do not require PDM
review and may override this feature. Level 1 operators can override QC lockout.
• Privilege Level 2 operators have access to all areas of the analyzer except those
protected by the existing System Password. Level 2 operators will require PDM
review, but may override this feature. Level 2 operators cannot override QC lockout.
• Privilege Level 3 operators have access to analysis only. Level 3 operators will
require PDM review before the results are released. Level 3 operators cannot override
QC lockout.
2-6
2 Setup
Set up Operator Passwords as follows:

1. Press Menu on the Ready screen to display the Operational Menu screen.
2. Press Setup to display the Setup Menu screen.
3. A pop-up Password screen appears. Enter the default password, 0. This is the
password until one is officially entered.
2. Setup
3. Scroll down with the arrow keys to the Password option and press Enter. A pop-up
screen appears: select Operator Password.
4. Key in a password number, up to 4 numeric characters, and press ENTER.
5. To enable Operator Passwords, scroll down to Operator Passwords then press the
Enter key: Off will turn to On.
6. Proceed to the next setup option or return to the Operational Menu.
2.6.2 Results Configuration Menu
The Results Configuration Menu screen allows you to set reference and alert limits (Low and
High) for all analytes; to adjust electrode offsets for slope and intercept for all analytes; to select
units for temperature, pH, blood gas, and hemoglobin; to turn Remote Review On or Off
(operator Password is enabled when On); Mandatory Patient ID (On or Off); Patient Name (On
or Off); Global Suppression (Test Results).
2.6.2.1 Remote Review
The operator passwords are enabled whenever Remote Review is enabled. To enable Remote
Review (password required), go to the Results Configuration screen, select Remote Review,
then press the Enter key to enable (On) - disable is Off.
Features of Remote Review are as follows:

• Send Results Data to PDM for Review: When all results and calculated parameters are
available, the pHOx Analyzer transmits all this data to the PDM. The analysis cycle
is suspended indefinitely until the PDM returns record or the review is bypassed or
cancelled.
• Suppress Results Data: The PDM will return a reviewed data record to the pHOx
Analyzer. The analyzer will suppress test results based on the information received
from PDM.
• Bypass Review: A pHOx operator with password level 1 or level 2 can bypass a remote
review session. When the session is bypassed, the results are saved, displayed, and
printed (if automatic printing is on). A reviewed data record sent by PDM is ignored
if the review session is bypassed.
2-7
• Cancel Review: A pHOx operator can cancel a remote review session. When the session
is cancelled, the results are saved, but the results will not be displayed or printed. A
reviewed data record sent by PDM is ignored if the review session is cancelled.
• Review Patient Name: PDM can return a patient name with the suppressed test results.
The patient name will be displayed and printed with the result data if the patient name
2. Setup
entry feature is ON.

• Review Accession Number: PDM can return an accession number with the suppressed
test results. The accession number will overwrite the existing accession number. The
accession number will be displayed and printed with the result data.
2.6.2.2 Results Suppression
In the Results Configuration screen, test results can be suppressed: will not be displayed,
printed, or transmitted. The suppressed results will only affect analysis results: it will still
calibrate.
Measured tests that depend on the results from a suppressed test will not be displayed. A
dependency error is displayed.
Calculated parameters that depend on suppressed results are not calculated.
Suppress results as follows:
1. In the Results Configuration screen, scroll down to Results Suppression.
2. Press the Enter key to get a pop-up screen of the tests.
3. Scroll to the test that you want to suppress then press the Enter key.
4. Scroll to the next test or exit from screen.
5. On the Home screen, the suppressed test will have a strike through the test;
no results will be reported on this test.
2.6.2.3 Mandatory Patient ID
In the Results Configuration screen, the Mandatory Patient ID is enabled or disabled. If

enabled, the Sample Information screen will prompt for Patient ID before the sample analysis
can continue.
A patient ID can be sent from PDM as part of a remote review session.
A patient ID can also be received from a bar code device or external keyboard through the bar
code port.
2-8
2 Setup
2.6.3 Operation Configuration Menu
The Operation Configuration Menu screen allows you to setup the analysis output options, to
configure calibration frequency, and to set date, time, barometric pressure, analyzer ID
2. Setup
number, and to change the analysis mode (A or B); to select Hb Measured or Calculated; to
select STAT Mode.
2.6.4 Communications
The Communication screen allows you to setup the communication ports: Baud, Stop, Data, and
Parity. Also, the External Keyboard and CO-Oximeter attached (Yes or No) is selected here.
2.7 QC Setup
To access the QC Setup screen, press QC (soft key) on the Ready screen. Then use the down
arrow key to select QC Setup and press the ENTER key to display the QC Setup screen.
For External Controls, enter the Lot Number, the Expiration Date, the Daily Analysis Times
(up to 3 times per control per day), and the Ranges of each control.
For Internal Controls, the Lot Number, the Expiration Date, and the Control Ranges are
automatically read from the control pack when the QC Auto Cartridge is installed. The Daily
Analysis Times (up to 3 times per control per day) must be manually entered.
2.7.1 QC Lockout
QC Lockout can be enabled (ON) in one of 2 modes or disabled (OFF) from the QC Setup
screen (a password protected screen). When QC Lockout is selected from this screen, a pop-
up screen appears. Lockout OFF, Mode A, and Mode B are the choices. When QC Lockout is
ON (Mode A or Mode B) and QC is due, all test that are scheduled for QC will be lock out. A
QC analysis must be done for a locked out test before an analysis can be performed.
Channel Lockout
A channel will be locked out when it does not pass a QC level. The channel appears with a
strike-through it. This channel will not report results unless a password overrides it. When all
channels become locked out, the analyzer displays the Not Ready screen.
NOTE: If the QC Lockout feature is OFF, the analyzer will internally keep
track (Mode A) of the channels that would be locked out if the QC Lockout
feature was ON. If the QC Lockout feature is now turned ON, all those
channels will now become locked out.
2-9
Level Lockout
QC level lockout is enforced for both Mode A and Mode B. If a QC level is not run and QC
Lockout is enabled, all channels in that QC level will become locked out. These channels
remain locked out until the QC analysis cycle of that level is run. A message is displayed on
the Ready/Not Ready screen that a QC analysis is due for a particular level.
2. Setup
NOTE: If the QC Lockout feature is OFF, the analyzer will internally keep
track of all channels in this level that would be locked out if the QC Lockout
feature was ON. If the QC Lockout feature is now turned ON, all those
channels will now become locked out.
QC Lockout is activated by selecting either Mode A or Mode B.

Mode A QC lockout locks or unlocks channels based on the last QC level run. A lockout
channel is displayed with a strike-through the channel name. Results for a locked out channel
are not calculated. If more than one QC level is run for the QC cycle, only the last QC level
that a channel is in determines whether the channel will be locked or unlocked. If 3 levels were
run and the channel passed the first 2 levels but failed the last, the channel will be locked out.
To be unlocked, this channel must pass that last level: passing the first 2 does not count. If the
reverse happened and the channel failed the first 2 levels but passed only the last level, the
channel will not be locked out.
Mode B QC lockout locks or unlocks channels based on the last QC run for all levels. A
lockout channel is displayed with a strike-through the channel name. Results for a locked out
channel are not calculated. If a channel fails any level run in a QC cycle, the channel will be
locked. To be unlocked, the channel must pass all levels that it failed.
QC Lockout OFF
When the QC lockout mode is set to OFF, the analyzer internally tracks the lockout state for
each channel. The tracking uses the Mode A lockout. If QC lockout is enabled by selecting
either Mode A or Mode B, any number of the tracked channel can now become locked out.
QC Lockout is password protected, and a password override (Level 1 operators only) is

provided with a pop-up screen. Analysis can be initiated for all channels in a lockout state, but
results will be displayed with the message "Scheduled QC Not Run" and printed with this error
message.
For Automatic QC mode to perform, turn Automatic QC Analysis ON in the Quality Control
screen.
Messages displayed on the Ready/Not Ready screen detail the reason for the QC lockout. These
message are only displayed if QC lockout is enabled (Mode A or Mode B). The following are
the messages and their meanings.
2-10
2 Setup
Level Lockout Ready/Not Ready Screen Messages

Internal L(n) Not Run Internal L(n) missed a scheduled QC cycle. All channels are locked
out for that level. Results for the locked out channels will not be
reported. Internal QC level (n) must be run to unlock the channels.
External L(n) Not Run External L(n) missed a scheduled QC cycle. All channels are locked
2. Setup
out for that level. Results for the locked out channels will not be
reported. External QC level (n) must be run to unlock the channels.
Mode A Ready/Not Ready Screen Messages

QC Lockout All channels are locked out. Analysis cannot be run without a
password override. Any QC level that is run will unlock the
channels.
Mode B Ready/Not Ready Screen Messages

QC Lockout Internal L(n) Internal L(n) has channels that are locked out. Results for locked out
channels will not be reported. Internal QC level (n) must be run to
unlock the channels.
QC Lockout External L(n) External L(n) has channels that are locked out. Results for locked
out channels will not be reported. External QC level (n) must be run
to unlock the channels.
2.8 Remote Control
Remote control is enabled on the PDM side. See the PDM Manual for information. The
analyzer's system ready status information is sent to the PDM upon each change of status:
barometer, temperature, reagent pack, control pack, minimum calibration, QC test lockout, QC
level lockout, and standby mode state.
The system test status information is sent to the PDM after calibration and QC are completed.
This test status information includes the calibration status and QC lockout status of each test
and the performance status of glucose.
Remote control from the PDM can do the following:
• Initiate a 2-point calibration sequence
• Run an internal QC (any level)
• Turn global suppression on or off
• Enter or delete passwords
• Maintain a maintenance activity record that is sent to the PDM at the completion of
the maintenance. The maintenance status information includes an operator ID, an
activity ID, and the date and time of the maintenance.
2-11
2. Setup
2-12
3 Operation
3 Operation
The Stat Profile pHOx Analyzer is pictured below with its components.
3. Operation
1
1 2 3
4 5
6 2
7 8
9
0
4
6A
DWG #10-101
Figure 3.1 Nova Stat Profile pHOx Components
1. Display
2. Keypad
3. Printer
4. Sampler
5. Door/Front Panel
3-1
11
1
10
2
9
3. Operation
8
4
DWG #10-1017A
5
Figure 3.2 Analytical Compartment
6. Control Pack Opening

1. Waste Line 7. Sampler
2. Reference Line 8. Air Detector
3. Pinch Valve (Reference) 9. Sensor Module With Sensors
4. Pump and Pump Tubing 10. Reference Electrode
5. Reagent Pack Opening 11. Pinch Valve (Waste)
3-2
3 Operation
3.1 Display and Door
The display is a liquid crystal display (LCD). To adjust the display intensity, use the right
(darker) or left (lighter) arrow key while displaying the Ready or Not Ready screen. Prompts,
menus, status information, error messages, patient results, etc. are displayed on the screen. The
default language is English. (Other languages can be selected through the setup menu.)
The door may be opened to access the analytical compartment of the system. There is an inside
latch that is easily released when you pull at the bottom right side of the door.
3. Operation
3.2 Keypad
The primary input device is the keypad. It has the digits (0 thru 9), a decimal point, a dash, an
ENTER key, arrow keys (up, down, left, and right), and analyze keys (syringe and capillary
icons). There are also 4 Soft Keys whose function is determined by the legend displayed just
above it on the LCD display: Print, Exit, Cancel, Menu, etc.
3.3 Printer (Optional)
The internal printer (optional) will be able to print patient results, list the analyzer's setup
information, error log, etc.
3.4 Sampler
The sampler allows for the aspiration of the sample. The sampler has 2 sampling positions:
horizontal for the aspiration of a sample from a capillary tube and inclined for the aspiration
of the sample from a syringe. No special adapters are required to aspirate a sample from a
capillary tube. The capillary or syringe positions are selected by pressing the Black Capillary
key or the White Syringe key.
3-3
3.5 Sensor Module
The sensor module includes the preheater and flow cell. The preheater heats samples and
controls to 37°C. In addition, it contains the hematocrit impedance electrode and 2 air detectors.
The sensor module geometry is an interlaced configuration with the reference electrode at the
top of the sensor module, 3 sensors on the left side, 2 sensors on the right side. In addition to
the Hct sensor located in the preheater, there are 6 sensors: Reference electrode, Na+, PCO2,
SO2 (optic), pH, and PO2. A window in the door allows flow path visibility and is augmented
by a backlight.
3. Operation
3.6 Sensors
The Sensors housed in the sensor module are the core of the Stat Profile pHOx Analyzer. The
methodology used by each sensor are
Electrode Methodology
Na+ Sodium ion-selective electrode

pH Hydrogen ion-selective glass electrode
PCO2 Severinghaus-type electrode
PO2 Polarographic Clark-type electrode
Hct Impedance electrode
Hb Impedance electrode/photometry
SO2 Reflectance photometry (fiber optics)
The sensors clip into the sensor module, and electrical contact is automatically made.
3.7 Reference Electrode
The Reference Electrode is mounted above the sensor module. It is a solid-state Ag/AgCl
electrode and provides the reference voltage for comparison to sample voltages. The exit port
of the flow path is located on this electrode.
3-4
3 Operation
3.8 Barometric Pressure Module
The Barometric Pressure Module, located on a printed circuit board, continuously monitors the
barometric pressure. This barometer can be calibrated against an external barometer, if desired,
through the software.
3.9 Pinch Valves
3. Operation
There are 2 pinch valves: one is used to control the flow of the reference fluid and the other one
is used to control the flow of fluids through the sensor module.
3.10 Peristaltic Pump
The pump is a 6-roller peristaltic pump driven by a stepper motor.
3.11 Reagent Pack
The reagent pack contains 6 flexible bags in a cardboard carton. One of these is a waste bag
to collect the used reagents, controls, and samples. The other 5 bags contain standard reagents:
A, B, C, D, and R. Each bag includes a fitment with a septa.
The exposed bag fitments are arranged in a line along the rear of the pack. The septa are pierced
during insertion of the pack. The lot number and expiration date are printed on the front of the
pack.
The Reagent Management System (RMS) of the reagent pack automatically enters the
calibration values, the lot number, the fluid volumes, and the expiration date to the analyzer's
computer after insertion of the reagent pack.
3-5
3.12 Auto-Cartridge QC
Nova Biomedical's Auto-Cartridge QC is a total automated control system contained within

a single on-board reagent cartridge. This system allows any level of quality control to be run
at any time: either on a programmed schedule or on demand. The Auto-Cartridge QC system
reduces costs by eliminating the time and labor required to manually perform quality control.
Each Nova Auto-Cartridge contains 3 levels of blood gas controls, 2 levels of hematocrit,
SO2%, and hemoglobin controls, plus software that automates running controls and storing
3. Operation
quality control data. When the cartridge is installed, all quality control target ranges, lot code,
and expiration date information is automatically downloaded to the analyzer. The user then
programs the pHOx Analyzer to automatically analyze up to 3 quality control levels, 3 times
per day (a total of 9 analyses per day). If any analyte is outside the target range, it is
automatically reanalyzed. If a control value remains out of range, the user is notified.
All quality control data is automatically stored. Daily and cumulative statistical reports and
Levey-Jennings graphs can be printed at any time. This automation assures that quality control
is always performed accurately and on schedule, thereby guaranteeing regulatory compliance.-
3.13 Movement Of Fluids
To begin an analysis, press the Capillary or Syringe key to move the sampler to either the
capillary or syringe position. Present the sample to the probe and press either Aspirate Normal
or Aspirate Micro (soft keys). The Aspirate Normal soft key allows for the aspiration of 70 µL
of sample, and the Aspirate Micro soft key allows for the aspiration of 45 µL of sample. The
sample is aspirated by the peristaltic pump until the leading edge is detected by either the 45 µL
or 70 µL air detector. After the aspiration is completed, there is an audible beep and a pop-up
display that prompts you to press Analyze after removing the syringe or capillary. The sample
is advanced until the leading edge is properly located in front of the electrodes. Once all
measurements have been completed, the sample is pumped to the waste and the flow path is
washed.
3-6
3 Operation
3.14 Operational Overview
The Stat Profile pHOx Analyzer is a stand-alone, microprocessor-based instrument for

analyzing blood samples. The analyzer measures pH, PCO2, PO2, SO2%, Hct, and Hb in
heparinized blood. The analyzer additionally calculates the parameters listed in Section 1.2.
The software allows the control of the following functions:
• Calibration
• Sample analysis
3. Operation
• Quality Control
• Diagnostic and maintenance functions
• System configurations
• Communication interface with external devices
• Storage and retrieval of patient records
After the analyzer is set up and calibrated, it is ready to begin analyzing samples. Samples can
be aspirated from syringes, capillaries, open tubes, small sample cups, or ampules. After
sample acceptance, patient data can be entered. A limited number of patient records (18) is
stored in a "circular" buffer. Once the buffer is full, each new saved record overwrites the oldest
record.
3.15 Ready to Analyze
When the Ready to Analyze screen is displayed, the analyzer is ready to run samples.
The following information is displayed on the screen:
• All calibrated analytes - Uncalibrated analytes are X'd out.

• Next QC time (if selected in Setup)
• Next Calibration time
• Amount remaining for reagents (A bar graph is displayed for fluid volumes greater
than 10% of the original volume.)
• Soft keys
- Results - Patient
- QC - Run Quality Control Samples
- Calibrate
- Menu (Operational)
3-7
3.16 Calibrating the Analyzer
The analyzer uses a 2-point calibration to measure pH, PCO2, PO2, Hct, Na+ electrode slopes
and to verify electrode performance. This 2-point calibration occurs automatically at regular
intervals, or, if desired, calibration can be manually initiated. The options are listed in the
Calibration screen. If an electrode fails to calibrate for any reason, an appropriate error code
is generated. An operator can cancel a calibration in progress from the keypad to run a stat
analysis. If this is done, the previous calibration slopes are used for the analysis calculations.
3. Operation
3.16.1 Two-Point Calibration (Automatic and Manual)
The analyzer performs an automatic 2-point calibration at 2, 4 or 6 hour intervals (as selected
in Setup). These Auto-Cal intervals can be extended as follows:
Auto-Cal Extension: System Busy when Auto-Cal scheduled to run
If the system is busy when an Auto-Cal is scheduled to run, the request is held in a queue until
the current sequence is completed. The system presents the operator with a pop-up that allows
the delay of a 2-point calibration sequence for an additional 10 minutes. The 2-point calibration
sequence may be delayed indefinitely.
3.16.2 Manual Calibration
Manual calibrations may be initiated to calibrate any uncalibrated electrodes or calibrate the
system after maintenance. Press the soft key for Calibrate on the Home screen. The 2-point
Calibration screen is displayed with options for calibration. Use the arrow keys to go to the
desired option. Then press ENTER.
3.16.3 SO2/Hb Calibration
SO2 and H b must be manually calibrated with 2 external calibrators. To calibrate SO2 and Hb,
press Calibrate on the Home screen. Then go to option 2 and press Enter. Follow the directions
on the screen. You will be asked to enter the assay values for each level of calibrator. These
2 values can be verified on the SO2 Sensor Subsystem screen.
3-8
3 Operation
3.16.4 One-Point Calibration
All analytes are checked for calibration every 30 or 45 minutes if analysis Mode A was selected in
the setup options. This check is done by exposing the electrodes to a known standard and comparing
the new value to the value obtained during the 2-point calibration. A calibration drift error is generated
if the difference exceeds the internally set limits. The flagged sensor will revert to an uncalibrated state.
NOTE: If Mode B is selected, a 1-point calibration does not take place every
30 or 45 minutes, instead the 1-point calibration is automatically performed
3. Operation
with each sample analysis..
3.17 Quality Control
The Quality Control screen is accessed from the Home screen by pressing QC (soft key). Times
for running QC can be set through the QC Setup. This menu also allows access to reports and
manipulation of daily, monthly, cumulative data, and Levy Jennings graphs.
Definitions:
Daily Statistics - All QC samples stored since the last Move Daily Data to Month-to-Date was
performed. Daily data accumulation begins at midnight of the current day.
Monthly Statistics - Cumulative statistics for the last 32 days. Monthly statistics are simply
cumulative statistics.
Cumulative Statistics - A running accumulation of mean, SD (standard deviation), and CV%
(coefficient of variance in percent) for all stored QC samples. Although these statistics are
based on the total number of samples, the n on the screen and on the printout indicates the
number of days. The Cumulative Statistics cannot be reset except by changing to a control with
a new lot number.
NOTE: When the SD approaches zero and is smaller than the display range of
that analyte, the SD result for that analyte is not displayed (blank screen).
When a new Auto-Cartridge QC with a new lot number is installed, the data from the previous
lot number is erased from the memory of the analyzer. Thus, you are unable to run lots in
parallel to validate the new lot to the old by alternating packs on the same unit.
Nova Recommendation: All Nova controls ship with a product insert sheet. This product insert sheet
contains the target value ranges for each level of QC contained in the pack. Nova’s recommen-
dation for conversion to a new lot number is to use the product insert sheet range levels for the
first 30 days or until sufficient data is collected to establish the new target values. After sufficient
data is collected, the established values and ranges can be entered into the analyzer.
Alternate Method: If this method is inadequate, Nova recommends the use of the external
controls run in parallel and overlapping with the on-board product change over. This method
offers continuity in monitoring performance during the change over period, but it does add
cost. The external QC monitoring can be done using the QC program on the analyzer.
3-9
3.17.1 Running QC Samples
From the Home screen, press QC (soft key) to display the Quality Control (QC) screen. Follow
the instructions on the screen.
NOTE: If the mandatory QC mode is selected (i.e., QC times have been
entered) and you choose to delay or not run the QC, a message is displayed
indicating that QC was not run. If the QC lockout mode is selected and a
scheduled QC is not allowed to run, the analyzer becomes Not Ready.
3. Operation
If you power up without QC scheduled and QC Lockout off, the analyzer

will boot up in control.
NOTE: To use the Auto QC mode, set the times for the 3 control levels in the
Setup QC Levels screens, then turn Automatic QC Analysis ON in the
Quality Control (QC) screen.
3.17.2 Running Linearity Solutions/Proficiency Samples
From the Home screen, press QC (soft key) to display the Quality Control (QC) screen. Then
select Proficiency. Follow the instructions on the screen.
NOTE: When a sample is run in this mode, slopes and offsets do not apply.
3.18 Analyzing Samples
Samples can be analyzed from capillaries of various sizes and glass or plastic syringes from
1 cc to 10 cc. Samples are aspirated from a horizontal position for capillary tubes through a
built-in adapter or at a 30° angle from the horizontal for syringes and ampule control samples.
1. Once the Capillary or Syringe button is pressed, the Aspirate screen is displayed.
2. Press one of the soft keys: Aspirate Micro or Aspirate Normal.
3. Then press Aspirate (soft key). The Sample Information screen is displayed.
4. The Sample Information screen is 2 screens. Screen 1 has Accession number, Patient
ID number, Patient Temperature, Combine CO-Ox Data (yes/No), Operator ID, and
Patient Name.
Screen 2 has Sample Type (Arterial, etc.), Puncture Site (Radial Artery, Brachial
Artery, Femoral Artery, Arterial Catheter, or Unspecified), Ventilator Rate/Min,
Tidal Volume, PEEP/CPAP, and Mode of Therapy (Unspecified, CMV, ACV,
SMV, PEEP, CPAP, PSV, PCV).
5. Press View Results (soft key) to display the Results - Measure screen. To view all
results (measured and calculated), continually press Next Page (soft key).
3-10
3 Operation
3.18.1 Analyzing from a Syringe or an Ampule
From the Home screen (Ready for Analysis), press the syringe key (for syringe or ampule
samples) to position the probe. To aspirate the sample, press Aspirate Normal (soft key).
Follow the directions on the screen.
NOTE: To run in micromode, press Aspirate Micro (soft key). The time is
typically longer than normal mode. For other functions, follow the screen
instructions.
3. Operation
Syringe
0-1024A
DWG #1
Figure 3.3 Analyzing from a Syringe
3-11
3.18.2 Analyzing from a Capillary Tube
From the Home screen (Ready for Analysis), press the Capillary key to position the probe. To
aspirate the sample, press Aspirate Normal (soft key). Follow the directions on the screen.
NOTE: To run in micromode, press Aspirate Micro (soft key). The time is
typically longer than normal mode. For other functions, follow the screen
instructions.
3. Operation
Capillary Tube
0-1070A
DWG #1
Figure 3.4 Analyzing from a Capillary Tube
3-12
3 Operation
3.18.3 Analyzing in AV Shunt Mode
The AV Shunt sample analysis combines both the pHOx and the CO-Oximeter results for 2
sample types: mixed venous and arterial. The mixed venous is analyzed first on the pHOx, then
the same sample is analyzed on the CO-Oximeter. Next the arterial is analyzed: first on the
pHOx then on the CO-Oximeter. Follow this procedure with the aid of the pHOx screen
prompts:
1. From the Home screen (Ready for Analysis), press the Syringe key to position the
probe.
3. Operation
2. Press AV Shunt (soft key).
3. Position the mixed venous sample and press Aspirate (soft key).
4. Remove the sample and press Analyze (soft key).
5. Run the same venous mixed sample on the CO-Oximeter.
6. When message, Mixed Venous sample complete, is displayed, analyze the arterial
sample. Position arterial sample and press Aspirate (soft key).
7. After aspiration, remove sample and press Analyze (soft key).
8. Run the same arterial sample on the CO-Oximeter.
9. Press Results (soft key) to get all the results including the combined results.
3.18.4 Stat Mode
Stat Mode is turned ON or OFF in the Operation Configuration Menu screen. When Stat Mode
is ON, the Sample Information screen is not displayed each time an analysis is initiated.
3-13
3.19 Results Recall
Previously analyzed samples can be recalled for viewing only. These records are stored in a
circular buffer. When the buffer becomes full (greater than 18 analyses), the oldest record in
the buffer is overwritten. The record is automatically saved by the analyzer when the analysis
is successfully completed. The results are cataloged by date, time, accession number, and ID
number. These results are accessed through the Ready screen.
NOTE: When connected to a computer and you want to retransmit the
3. Operation
results, follow the results recall steps, then when the results are on the
screen press the decimal (.) key, then the Print (soft Key). The results should
then retransmit.
NOTE: Proficiency results are not stored.
1. From the Ready screen, press Results (soft key).

2. Use the arrow keys to select the desired results. (Or press Latest Results (soft key)
to view the last sample analyzed.)
3. Press ENTER to view the selected results.
4. Follow directions on the screen.
3-14
4 Operating Procedures
The following sections provide detailed information and directions to operate the Stat Profile
pHOx Analyzer at peak efficiency. From the Home screen, press Menu (soft key).
From the Operational Menu screen, the following options can be performed:
• Set Sample Number Counter

• Change the Reagent Pack
• Change the Control Pack
• Flowpath/Probe maintenance: change tubing, sensors, purge, etc.
• Flowpath Cleaning
• Sensor Conditioning
• Standby Mode
4. Op. Proc.
line, probe, sensor module, etc.) with care. Gloves and protective clothing are
recommended.
A Maintenance Log that includes performance records and a maintenance checklist is supplied
with your instrument. Use this log to record data for long-term performance verification and
to document maintenance.
4.1 Sample Number Counter
The screen allows you to check and/or to change the Sample Number Counter, but the Total
Samples Accepted number, the Total Internal QC Samples Accepted number, and the Total
Samples and Internal QC number are read only.
4.2 Scheduled Maintenance
It is important to perform preventive maintenance as scheduled. The Maintenance Log

(PN 22362) gives suggested schedules based on sample volume. Space is provided for
slopes and control results in the Maintenance Log.
4-1
4.2.1 Reagent Pack and Control Pack Changing
The reagent pack and/or control pack should be changed when the system indicates the pack
is empty. From the Operation Menu screen, select Change Reagent Pack or Change Control
Pack and press Enter. Mix the pack thoroughly by inverting several times. Then follow the directions
on the screen to replace the packs and the capillary adapter.
WARNING: When the reagent pack or control pack is removed, keep your
fingers and hands away from the back of the pack compartment. There are
sharp needles that can cause injury, and the waste needle is also a biohazard.
NOTE: The reagent or the control pack must be replaced through the
Operation Menu screens. If you remove and replace a pack (even if it is the
same pack) outside these screens, you will not be able to prime the ana-
4. Op. Proc.
lyzer, and you will not be able to calibrate or to analyze samples (Reagent
Pack) or to analyze internal controls (Control Pack). If you have removed
and replaced a pack outside these screens, go to the appropriate screen and
press Prime (soft key).
NOTE: The capillary

adapter comes in the
reagent pack box. As you
put on the new adapter,
make sure the probe goes
through the center hole of
the adapter.
DWG #10-1003A
Control Pack
Reagent Pack
Figure 4.1 Replacing the Reagent Pack and the Control Pack
4-2
4.2.2 Flowpath/Probe Maintenance

The Flowpath/Probe Maintenance option removes fluid from the flow path, so that tubing,
sensor, or probe changes, or other maintenance can be performed without fluids leaking or
pumping into the analyzer. After all replacements are made, press Continue (soft key) to prime
the flow path. The analyzer will prime and give you the option to calibrate now or later.
4.2.3 Standby Mode

This option allows you to place the analyzer into a standby mode and allows you to reactivate
the analyzer out of the mode at a programmed time and date. The standby mode will use less
reagents and controls because the analyzer will not run its automatic calibration cycles.
Calibration is lost except for SO2 and Hb. Standby mode ends after the set time is elapsed; if
4. Op. Proc.
you turn Standby off; or if you initiate a calibration. The analyzer automatically performs 2
calibrations or a second calibration after Standby mode ends.
The following is the procedure to set the Standby Mode:
1. From the Operational Menu, scroll down to the Standby Mode with the Down
Arrow key.
2. Press ENTER (once if OFF or twice if ON).
3. To set the date, press ENTER again - the date becomes blank.
4. Key in the date that you want the analyzer to come out of Standby Mode.
5. Press ENTER to set (DO NOT press OK).
6. Press any Arrow key to change the time. Then press ENTER - the time becomes blank.
7. Key in the time that you want the analyzer to come out of Standby Mode.
8. Press ENTER to set (DO NOT press OK).
9a. Press OK (soft key) to go into Standby Mode. Another pop-up screen appears to
verify that you want to go into Standby Mode. Press OK (soft key) again. Standby
Mode is now ON.
9b. Press Cancel (soft key) to cancel Standby Mode. The date and time reverts to the
previous settings. The Standby Mode is now OFF.
4.2.4 pH and Sodium Sensors Replacement

1. From the Operation Menu screen, select Flowpath/Probe Maintenance and press
Enter.
2. Open the door and locate the pH or sodium sensor.
3. Remove the sensor from the sensor module by pinching the front and rear of the
sensor clip.
4. Clean the sensor module cuvette with a cotton swab.
5. Insert the new sensor into the sensor module by sliding the sensor body into the
sensor module until the sensor clips into place.
6. Press the Continue key (soft key).
7. A message displays, Priming Flow Path. Please wait until the time bar completes.
8. Recalibrate.
4-3
4.2.5 PCO2 Sensor or Membrane Replacement
The following procedure explains how to replace the PCO2 sensor and membrane.
Enter.
2. Open the door.
3. Locate the PCO2 sensor.
4. Remove the PCO2 sensor by pinching the front and rear of the sensor clip and
sliding it out of the sensor module. Be careful not to touch the electrical contacts.
5. Unscrew the used membrane cap from the sensor body and discard it.
NOTE: If installing a new sensor,
DWG #10-1066A
carefully remove the shipping cap
before installing a new membrane
4. Op. Proc.
cap. Do not touch the electrical

contacts of the sensor.
6. Take a new PCO2 Membrane Cap
(PN 25048) that is prefilled with internal
filling solution. Hold the shipping plug end
of the membrane cap and shake it gently, as
if shaking down a thermometer, to ensure
that the air bubble is at the threaded end of
the membrane cap.
Figure 4.2 Shaking Down Membrane Cap
7. Unscrew the black shipping plug from the cap. Screw the cap onto the sensor.
Discard the black shipping plug. Do not tilt the membrane cap when installing onto
the sensor; the internal filling solution may drip out.
Shipping Plug
123456
See air gap

DWG #10-1068A
DWG #10-1067A
after shaking Sensor

Internal filling solution
Vent Hole
Vent Cover
Figure 4.3 The PCO2 Membrane Cap (With Shipping Plug and Attached to Sensor)
4-4
NOTE: The prefilled PCO2 cap does not require any additional filling
solution. Do not add or remove any Internal Filling Solution. The prefilled
level of solution is all that is needed to operate the analyzer successfully.
Adding or subtracting from the
prefilled level will effect the sensor's
Sensor
performance.
Body
8. Degas the sensor as follows:
DWG #10-1069A
Vent Hole
a. Hold the sensor with the cap down-
ward. With a wrist-snapping motion,
shake the sensor down to move air Vent Cover
bubbles to the back of the sensor.
b. With the sensor tip still downward,
observe the tip for bubbles. If bubbles are present, tap the sensor with a
finger to loosen the bubbles and again shake the sensor down. Repeat if
4. Op. Proc.
necessary.
9. Wipe the sensor body and cap dry. Remove a single vent cover from the blue
backing and place over the vent hole (see Figure 4.4). Press firmly to ensure a good
seal.
Figure 4.4 Vent Cover on Membrane Cap

11. Insert the sensor into the sensor module by sliding the sensor body into the sensor
module until the sensor clips into place.
14. Condition the sensor module.
NOTE: All sensors must be in the sensor module during a Sensor Condition-
ing cycle.
a. Fill a 2 mL sample cup 1/2-full of whole blood.
b. Select Sensor Conditioning from the Operation Menu and press Enter.
c. Immerse the probe in the sample.
d. Press Continue to aspirate the sample. Withdraw the cup after the tone.
e. A message displays, Flow Path conditioning in progress. Please wait until
the time bar completes.
15. Return to the Home screen and calibrate the sensor 2 times.
16. If the sensor does not calibrate due to slope errors, remove air bubbles as follows:
a. Open the door, remove the sensor and shake down the sensor with a wrist-
snapping motion to move air bubbles to the back of the sensor.
b. Reinsert the sensor into the sensor module and close the door.
c. Recalibrate.
4-5
4.2.6 PO2 Sensor Polishing and Membrane Replacement
The following procedure explains how to polish and to replace the PO2 sensor and/or to replace
the membrane cap.
NOTE: The PO2 sensor should be polished during routine membrane
replacement or during troubleshooting characterized by either slope and/or
QC recovery problems.
Enter.
2. Open the door and locate the PO2 sensor.
3. Remove the PO2 Sensor by pinching the front and rear of the sensor clip and sliding
it out of the sensor module.
4. Op. Proc.
4. Unscrew the used PO2 cap from the PO2 body and dispose of it.
5. If polishing the sensor is unnecessary, go to Step 7 to replace the PO2 cap.
6. Polish the sensor as follows:
a. Take a polishing paper from kit PN 21795 and place a couple of drops of
deionized water onto it.
b. Hold the PO2 polishing paper so that the tip of your index finger provides
light pressure against the back of the paper.
c. Gently polish the sensor tip on the paper, move the tip in a circular motion
for about 10 seconds. Discard the polishing paper.
d. Wipe the sensor tip with a lint-free tissue soaked in deionized water.
CAUTION: Never polish the sensor tip on a hard surface such as a bench top.
7. Take a new PO2 Premembraned Cap
(PN 21795) that is prefilled with
internal filling solution, and shake it
DWG #10-1043A
gently to ensure that the solution is pO2 Sensor
away from the threaded end and at
the membrane end. Unscrew and dis-
Shipping Plug
card the shipping plug from the cap.
8. Insert the sensor body straight down See air gap
(vertical position only to ensure no after shaking
loss of internal filling solution) into Internal
the filled cap and screw the cap onto Filling Solution
the sensor body. (See Figure 4.5.)
Figure 4.5 Installing the PO2 Membrane Cap
NOTE: The prefilled PO2 cap does not require any additional filling solu-
tion. Do not add or remove any Internal Filling Solution. The prefilled level
of solution is all that is needed to operate the analyzer successfully. Adding
or subtracting from the prefilled level will effect the sensor's performance.
4-6
9. Degas the sensor as follows:

a. Hold the sensor with the cap downward. With a wrist-snapping motion,
shake the sensor down to move air bubbles to the back of the sensor.
b. With the sensor tip still downward, observe the tip for bubbles. If bubbles
are present, tap the sensor with a finger to loosen the bubbles and again
shake the sensor down. Repeat if necessary.
10. Dry the sensor with a lint-free tissue. Take care not to touch the tip.
12. Insert the sensor into the sensor module by sliding the sensor body into the sensor
module until the sensor clips into place.
13. Close the door and press the Continue key (soft key).
15. Condition the sensor module.
NOTE: All sensors must be in the sensor module during a Sensor Condition-
4. Op. Proc.
ing cycle.
a. Fill a 2 mL sample cup 1/2-full of whole blood.
b. Select Sensor Conditioning from the Operation Menu and press Enter.
c. Immerse the probe in the sample.
d. Press Continue to aspirate the sample. Withdraw the cup after the tone.
e. A message displays, Flow Path conditioning in progress. Please wait until
the time bar completes.
16. Return to the Home screen and calibrate the sensor 2 times.
17. If the sensor does not calibrate due to slope errors, remove air bubbles as follows:
a. Open the door, remove the sensor and shake down the sensor with a wrist-
snapping motion to move air bubbles to the back of the sensor.
b. Reinsert the sensor into the sensor module and close the door.
c. Recalibrate.
4.2.7 Reference Electrode Replacement
Enter.
2. Open the door.
3. Disconnect the W and R-lines from the reference electrode.
4. Pull up the retaining screw.
4-7
Retaining Screw
Reference Electrode
DWG #10-1012A
W
W
R
W-line
R
R-line
Figure 4.6 Disconnecting the Reference Electrode

4. Op. Proc.
5. Lift the used reference electrode up and out of the way of the sensor module.
6. Place the new Reference Electrode (PN 06025) on top of the sensor module, align
the electrode sides with the backplate sides. Ensure that the reference electrode
connector is seated properly on the sensor module interconnect tubing.
W Reference Electrode
R
DWG #10-1011A
Figure 4.7 Placing New Reference Electrode onto Sensor module
7. Push down on the retaining screw.

8. Attach the W/R-lines to the reference electrode and press Continue (soft key).
10. Recalibrate.
4-8
4.2.8 SO2 Sensor Maintenance
Enter.
2. Open the door and locate the SO2 sensor.
3. To remove the sensor, unscrew the lead screw and pull out.
4. Clean the sensor surface with a lint-free tissue that is soaked with 10% Sodium
Hypochlorite Solution (bleach). Rinse with deionized water and blot dry.
6. Reinstall the sensor and tighten the lead screw.
DWG
#10-1
015A
4. Op. Proc.
Figure 4.8 Reinstalling the SO2 Sensor
7. Press Continue (soft key) to prime the flow path.

9. From the Home screen, press Calibrate (soft key).
10. Follow the instructions on the screen.
4-9
4.2.9 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.
Enter.
2. Open the door.
3. Disconnect the R-line and W-line (the ones that go through the pinch valves) from
the pump manifold. 100
7A
G#
10- Half circle
4. Disconnect the R and W-pump tub- DW
ing lines from the labeled outlets

that are below the pump manifold.
5. Slide the top and bottom tube mani-
4. Op. Proc.
folds out
6. Discard the used tubing and mani-
folds.
7. On the new pump tubing, Locate
the half circle on one of the mani-
folds. This is the top manifold.
Figure 4.9 Pump Tubing
8. Slide the top pump tubing manifold

into its slots. The top manifold's half
circle should line up with the half circle
on the slot.
9. Stretch the pump tubing around the
pump and slide the bottom manifold
into its slots.
10. Connect the R-pump tubing line to the
R-labelled outlet below the pump mani-
-10
fold (see Figure 4.10).

10
G#
11. Connect the W-pump tubing line to the R

W
DW
W-labelled outlet below the pump mani-

fold (see Figure 4.10).
Figure 4.10 Connecting the Pump Tubing W and R-lines
12. Reconnect the R-line and W-line (the ones that go through the pinch valves) to the
pump manifold.
14. A message displays, Priming Flow Path. Please wait., and a time bar to completion
also appears.
15. Recalibrate.
4-10
4.2.9.1Waste Line Replacement
The waste line should be replaced at intervals prescribed in the maintenance log. The W-line
connects at the middle of the top pump manifold, travels through the waste pinch valve, and
connects to the top W-labelled outlet on the reference electrode. The W-line can be replaced
by following this procedure.
Enter.
2. Open the door.
3. Disconnect the W-line from the pump manifold, pinch valve, and reference
electrode. Discard the used tubing.
4. Attach the new W-line starting with the pinch valve. At the pinch valve segment
of the W-line (elastic segment), stretch the segment and slide it into the pinch valve.
4. Op. Proc.
5. Connect the line to the W-labelled outlet of the reference electrode and the middle
of the top pump manifold. (See Figure 4.11.)
Pinch valve
segment W
Figure 4.11 Connecting the W-line
also appears.
8. Recalibrate.
4-11
4.2.9.2 Reference Line Replacement
The reference line should be replaced at intervals prescribed in the maintenance log. The R-
line connects at the outside of the bottom pump manifold, travels through the reference pinch
valve, and connects to the bottom R-labelled outlet on the reference electrode. The R-line can
be replaced by following this procedure.
Enter.
2. Open the door.
3. Disconnect the R-line from the pump manifold, pinch valve, and reference
electrode. Discard the used tubing.
4. Attach the new R-line starting with the pinch valve. At the pinch valve segment of
the R-line (elastic segment), stretch the segment and slide it into the pinch valve.
4. Op. Proc.
5. Connect the line to the R-labelled outlet of the reference electrode and the outside
of the bottom pump manifold. (See Figure 4.12.)
Pinch valve
segment
Figure 4.12 Connecting the R-line
also appears.
8. Recalibrate.
4-12
4.2.10 Sensor Module Conditioning
The sensor module is conditioned with whole blood if it is a new sensor module or after
cleaning it. The instrument aspirates blood into the sensor module, holds it for 5 minutes, then
flushes the module. Condition the module as follows:
1. Fill a 2 mL sample cup 1/2-full with whole blood.

2. From the Operational Menu, select Sensor Conditioning and press Enter.
3. Immerse the probe in blood and press Continue.
4. After the tone, remove the cup from the probe, and press Analyze.
5. The message, Sensor Conditioning in Progress. Please wait for completion, is
displayed. To stop the cycle, press Cancel.
6. Recalibrate.
4. Op. Proc.
4.2.11 Flowpath Cleaning/Deproteinizing
Nova recommends the use of Deproteinizing Solution (PN 12704) when routine cleaning is
required. Use, for example, if flow problems persist, if air detectors become uncalibrated, or
if PO2 results are consistently low. To clean the sample preheater, the analyzer aspirates
Deproteinizing Solution, a specially formulated solution, into the sample preheater, where the
solution dissolves protein buildup. The following are more detailed instructions than displayed
on the screen.
NOTE: Terminating a flow path cleaning will trigger a flush sequence
before the Ready For Analysis screen is displayed.
1. From the Operational Menu screen, select Flowpath Cleaning.
2. Wait for the pump to stop. Then remove the sodium sensor and replace it with a
blank.
3. Immerse the probe into an ampule of Deproteinizing Solution. Then press continue.
4. After the tone, remove the probe from the ampule. Then press Analyze.
5. Wait for the flow path cleaning cycle to complete.
6. Select Flowpath/Probe Maintenance.
7. Remove the blank and replace it with the sodium sensor.
8. Recalibrate.
4-13
4.2.12 Printer Paper Replacement
1. Open the printer cover.

2. Open the printer lever. Gently pull the lever to its opposing position and remove
the depleted roll of paper.
3. Remove the paper holder from the used roll of paper and discard the roll.
4. Insert the paper holder into a new roll of paper. The loose end of the paper should
feed from the bottom of the roll.
5. Install the roll of paper with holder into the support collars.
6. Push the paper through the back of the roller. Manually move the roller by using
the knob next to the platen.
4. Op. Proc.
2B
100
10-
G#
DW
Lever
Paper advance knob
Figure 4.13 Replacing the Printer Paper
7. Center the paper and close the printer lever by pushing the lever back to its original
position.
8. Feed paper through cover. Then close the printer cover.
4-14
4.2.13 Probe and Air Detector Replacement
If the probe or air detector becomes damaged, replace it. Use the following procedure when
to replace the probe or the air detector.
1. From the Operation Menu screen, select Flowpath/Probe Maintenance and press Enter.
NOTE: If you are just changing the air detector, skip to Step 4.
2. Press Move Probe (soft key). Open the door.
3. Remove the capillary adapter from the front of the probe by gently pulling.
4. Disconnect the air detector's sample line from the sensor module.
5. Disconnect the 2-prong cable of the air detector from the analyzer.
6. If changing the probe, push the air detector down and pull the air detector with
4. Op. Proc.
probe out of the sampler assembly.
If changing only the air detector, push the air detector down and pull the air detector
out. Replace with new air detector and skip to Step 9. DO NOT remove the probe
if just the air detector is to be changed.
Air detector's
sample line
2-prong cable
DWG #10-1005A
Air detector Capillary

adapter
Figure 4.14 Removing Capillary Adapter
7. Discard the used probe.

8. Place a new probe into the air detector and slide both into the sampler assembly.
4-15
9. Push the air detector up to lock the probe and air detector into the sampler assembly.
4. Op. Proc.
DWG #10-1004A
Probe
Air detector
Figure 4.15 Replacing Probe and Air Detector
10. If changing the probe, do this step; if not skip to next step. Replace the capillary adapter
over the end of the probe. To make the operation easier, push the probe arm back
so that the probe extends (1/2 in or 12 mm) beyond the edge. The probe must go
through the center hole of the adapter to work probably.
11. Reconnect the air detector's sample line to the sensor module.
12. Reconnect the 2-prong cable back into outlet.
also appears.
4-16
4.2.14 Sensor Module Replacement
If the sensor module becomes damaged, replace it. Use the following procedure when you need
to replace it.
1. From the Operation Menu screen, select Flowpath/Probe Maintenance and press Enter.
2. When the cycle is completed, POWER DOWN THE ANALYZER. Open the door.
3. Remove the reference electrode (see Section 4.2.7); the SO2 sensor (see Section
4.2.8); and the air detector's sample line (see Section 4.2.13).
4. Press the tab on the sensors to remove them.
4. Op. Proc.
DWG #10-1023A
Figure 4.16 Removing the Sensors
5. Disconnect the air detector's sample line. Shut Off

6. Push the 2 locking levers to the vertical position. Power Before
Removing
Locking Lever
Sensor Module
1021B
DWG #10-
02 2B
#10-1
Locking Lever
DWG
Figure 4.17 Unlocking and Removing the Sensor Module
4-17
7. Remove the sensor module; pull it straight out.

8. Guide the new sensor module into place so that it fits flat.
9. Push the 2 locking levers to the horizontal position.
10. Replace sensors back into their appropriate place in the sensor module; the sensor
clicks into position.
Locking Lever
4. Op. Proc.
014A
DWG #10-1
013A
#10-1
DWG
Locking Lever
Figure 4.18 Replacing and Locking the Sensor Module
DWG
#10-
1001
A
Figure 4.19 Replacing the Sensors
11. Replace the reference electrode (see Section 4.2.7); the SO2 sensor
(see Section 4.2.8); and the air detector's sample line (see Section 4.2.13).
12. Close the door.
13. Power up the analyzer.
14. Calibrate the analyzer.
4-18
4.3 Display/Cabinet Cleaning
Cleaning the Display: Clean the display screen with a damp (not wet) lint-free cloth.
For a heavy buildup, use a liquid glass cleaner sprayed onto a
lint-free cloth first, never spray directly onto the display. If
available, prepackaged screen wipes can also be used.
Cleaning the Cabinet: Clean the cabinet with a damp (not wet) lint-free cloth. Do not
use aerosol sprays, solvents, or abrasives that might damage the
finish.
4. Op. Proc.
4-19
4. Op. Proc.
4-20
5 Troubleshooting
5 Troubleshooting
This section describes the status screens, error codes, and Service Menu and explains the
troubleshooting procedures for the Stat Profile pHOx Analyzer.
line, capillary adapter, probe, sensor module, etc.) with care. Gloves and protective
clothing are recommended.
5.1 Troubleshooting Procedures
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 which lists groups of steps to perform
in order to restore operation. The steps are also organized to prevent unnecessary parts
replacement, such as sensors and tubing, until the more common causes for an error have been
checked.
5. T. Shoot
In the case of multiple error codes, those errors which 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. It is helpful to have printed or written down the error
codes, flow times, and slope performance numbers.
FOR TECHNICAL ASSISTANCE, CALL TOLL FREE:
1-800-545-NOVA
5-1
5.2 Stat Profile pHOx 2-Point Calibration Sequence
The calibration sequence is outlined in Table 5.1 according to the order in which the various
calibration standards are brought into the system for slope determinations, flow checks, etc.
Table 5.1 Stat Profile pHOx 2-Point Calibration Sequence
Fluid Function
Sequence Start
Std A Standard A readings for AD1, AD2, AD3, AD4, Hct, pH, PCO2, PO2, Na+
Std B Standard B readings for pH and PCO2
Air Air reading for PO2
Std D Standard D reading for AD1, AD2, AD3, AD4, Hct, pH, Na+
Std C Standard C reading for pH
Sensor Slopes are calculated
5. T. Shoot
ADT thresholds are calculated

Initialization
End Calibration
When you troubleshoot flow problems, it is important to view the system as a whole. This
means that you must consider all of the various components that interact in order to transport
fluids throughout the system. These components include the pump, sampler probe, fluid
fountain, rotary valve, pinch valves, and tubing.
The information in this section, along with an understanding of the flow path components and
their functions, will give you the knowledge and tools you will need to resolve most of the
problems you will encounter.
5-2
5 Troubleshooting
Rapid Reference Guide for Resolving Quality Control Problems
pH
Results High • Control Material not at 25°C.
• Check for lowsensor slope (<9.5)
• Condition pH sensor with pH Conditioning Solution
• Check for low fluid pack
Results Low • Condition sensor module with whole blood
• Check for low fluid pack
PO2
Results High • Control Material below 25°C.
• Check for air leak in system
Results Low • Control Material above 25°C.
• Clean probe/preheater
• Run deproteinizing solution
• Check waste line for restrictions
• Change membrane
PCO2
Results High • Control Material below 25°C.
• Check for low slope
• Change membrane
5. T. Shoot
• Change sensor
Results Low • Control Material above 25°C.
• Debubble sensor
• Condition sensor module with whole blood
Combination Problems
Gases low/pH high on controls • Confirm controls temp is not > 25°C
Gases high/pH low on controls • Confirm controls temp is not < 25°C
Gases consistently out • Check barometer
5-3
5.3 Status Codes
Table 5.3 lists the analyzer’s status codes and the corrective action.
Table 5.3 Stat Profile pHOx Status Codes
Status Code Corrective Action
01 pH Slope 1. Recalibrate.
02 pH Instability 2. Condition pH sensor. (See Section 5.4.)
03 pH Overload 3. Replace pH sensor.
04 pH Drift
11 PCO2 Slope 1. Recalibrate.

12 PCO2 Instability 2. Replace PCO2 membrane cap
13 PCO2 Overload (2 times if necessary)
14 PCO2 Drift 3. Replace PCO2 sensor.
5. T. Shoot
15 PCO2 Dependency 1. Recalibrate pH sensor.

2. Condition pH sensor.
3. Replace pH sensor.
21 PO2 Slope 1. Recalibrate.

22 PO2 Instability 2. Replace PO2 membrane cap
23 PO2 Overload (2 times if necessary).
24 PO2 Drift 3. Replace PO2 sensor.
25 PO2 Delta Millivolts 1. Recalibrate.

2. Replace Reagent Cartridge and recalibrate.
31 SO2 Slope 1. Recalibrate.

32 SO2 Instability 2. Clean SO2 sensor.
33 SO2 Overload 3. Replace SO2 sensor.
34 SO2 Drift
35 SO2 Dependency 1. Recalibrate Na+ and Hct sensors.

2. Replace Na+ sensor.
41 Hb Slope 1. Recalibrate Hct, SO2 sensors.
45 Hb Dependency
5-4
5 Troubleshooting
Table 5.3 Stat Profile pHOx Status Codes (Cont.)
For Hematocrit
51 Hct/Det Slope 1. Recalibrate.
52 Hct/Det Instability 2. Clean sensor module.
53 Hct/Det Overload 3. Replace sensor module.
54 Hct/Det Drift
55 Hct/Det Dependency 1. Recalibrate Na+ sensor.

2. Replace Na+ sensor.
If air detector problem, check the Error Log to see which air detector has the problem.
Air detector 1 1. Run Flowpath Cleaning cycle.
2. Recalibrate.
3. Replace air detector
Air detector 2 or 3 1. Clean sensor module.

2. Replace sensor module.
5. T. Shoot
Air detector 4 1. Run Flowpath Cleaning cycle.
2. Recalibrate.
3. Replace reference electrode.
61 Na+ Slope 1. Recalibrate.

62 Na+ Instability 2. Replace Na+ sensor.
63 Na+ Overload
64 Na+ Drift
71 Std A Flow 1. Flush flow path and prime standard.

72 Std B Flow 2. Replace reagent pack.
73 Std C Flow
74 Std D Flow
75 Flowtime
76 Sample Flow
77 Air Flow 1. Check flowpath for proper operation.
78 Back Flow 1. Check waste line flowpath for proper operation.

2. Refer to Operator Flow Test. See Section 5.5.1.
5-5
Table 5.3 Stat Profile pHOx Status Codes (Cont.)
79 Insufficient Sample 1. Verify that you are running the sample in the
correct analysis mode and that you have sufficient
sample volume.
2. Verify a clot has not been aspirated into the flow
path. If yes, flush the flowpath and rerun the
controls.
81 Ctrl 1 Flow 1. Check control pack.

82 Ctrl 2 Flow
83 Ctrl 3 Flow
91 Barometer 1. Call Nova Technical Service.

92. Printer
93. Temperature
5. T. Shoot
94 Communication
95 Hardware
96 Hardware
97 Software
98 Schedule QC
5-6
5 Troubleshooting
5.4 pH Conditioning
Enter.
2. Open the door and locate the pH sensor.
3. Remove the sensor from the sensor module by pinching the front and rear of the
sensor clip.
4 Fill bottom chamber of sensor conditioning holder (PN 09458) with pH condition-
ing solution (PN 23397).
5. Immerse sensor tip in conditioning solution to soak. The pH sensor is conditioned
for 15 minutes.
6. Remove sensor and rinse tip with deionized water.
7. Dry tip with lint-free tissue.
8. Dry flow cell with cotton swab covered with lint-free tissue.
9. Insert the pH sensor into the sensor module by sliding the sensor body into the
sensor module until the sensor clips into place.
12. Recalibrate.
5. T. Shoot
5.5 Troubleshooting Flow Problems
5.5.1 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
module back flush is diagramed on the next 2 pages.
This procedure is also used as a corrective action for Status Code 78 Back Flow.
5-7
Operator Flow Test

From Ready→Service→System Test→Customer Flow Test
1
1. - Lift the tubing out of the Waste solenoid.
- If tubing remains pinched, roll it between fingers to loosen.
1 - Place the sample probe in a cup of water.

Is fluid flow noticed in the waste line tubing?
A. IF YES, call your Nova Service Representative.
B. IF NO, go to Step 2.
2. - Disconnect the Waste (W) from the Reference Electrode.

2
- Place this end of the W tubing into a cup of water.
Is fluid flow seen in the Waste line tubing?
A. IF YES, press “PUMP” to turn off the pump motor.
Go to the next page,
“Sensor Module Back Flush” procedure.
B. IF NO, go to Step 3.
3. - Disconnect the Waste line tubing from the front panel port.
3
- Place this end of the tubing over a gauze to prevent spilling.
- Aspirate water from the same location as in Step 2 above.
Is fluid seen exiting the Waste tubing end you just disconnected?
A. IF YES, go to Step 4.
B. IF NO, Replace the W/R Tubing Harness ( P/N 23023)
4. - Press the “PUMP” key to stop the Pump Motor

4
5. T. Shoot
- Remove the Reagents Cartridge from the unit.

- Install the flush adapter.
- Place the flush adapter tubes into an empty beaker.
- Inject water to the front panel Waste port.
- Water should flow through the adapter waste tube.
(Adapter waste line is last to the right)
* Loss of Reference flow will change the flow rate.
Reference solution will flow at a rate of 1 -2 drops/second
during a pumping cycle.
2 ** If this tubing cannot be flushed call your Nova Service
Representative. If tubing flushes easily, change the Reagents
Cartridge. In a small number of cases the original problem
may have been poor alignment of the Reagents Cartridge.
5-8
5 Troubleshooting
Sensor Module Back Flush Procedure

5 If you are starting from the Operator Flow Test
5.
-Turn the Pump OFF by pressing the “PUMP” key.
7 6 If you are starting from the Ready Screen

6.
- Press Service, System Test and select the Operator Flow Test.
- Turn the pump OFF as in Step 5.
7 Connect a syringe filled with water to the Reference

7.
electrode waste port.
8 Back flush the flow path by injecting the water.

4.
Caution: Place a gauze or towel at the sample probe tip to
receive the obstruction or water.
8 9 If the water easily flushes through the sensor module,

9.
you may have an air leak into the flowpath. This will be
from an interconnect tubing, failed membrane, or poorly
10 seated electrode. Go to Step 15.
10
6. If water does NOT exit the sample probe.
- Lift the Reference electrode off the sensor module.
- Flush the Reference electrode.
11 If it flows freely, confirm that the interconnect tubing is
properly positioned and reinstall the Reference Electrode.
5. T. Shoot
11
7. Disconnect the Air Detector from the bottom of Sensor
Module.
12
8. Inject water into the W port of the Reference Electrode.
Does water flow through the sensor module?
IF YES, go to Step 13.
IF NO, go to Step 14.
13 9. - Connect the syringe to the Sample Probe tip.

13
- Inject water through the Probe
Water should exit the Air Detector (ADT) tubing.
IF NO flow is noted, flush the ADT and probe separately.
IF the water flows easily, the seal between the ADT and
probe may be leaking. Replace the Air Detector.
14 14 (NO from Step 12) The obstruction lies in the flowcell.

While continuing to inject, remove one electrode at a time.
Starting with the bottom electrode. When water starts to
flow either the obstruction flushed into the flowcell or the
electrode just removed was the cause. Re-membrane if
needed. Dry the flowcell before re-inserting the electrode.
15 (From Step 9) Connect the syringe with water to the

sample probe tip. Reconnect the Reference electrode
Waste line. Apply a slight pressure to the syringe. Look
for water entering a flowcell, electrode cap, or leaking
from the interconnect tubing. Replace the membrane, or
tubing as required.
15 If the above does not identify the problem,

please contact your Nova Service Representative.
5-9
5.5.2 Flushing the Reference Electrode
1. Remove the W-line and R-line from the reference electrode.

2. Lift the reference electrode off the sensor module by pulling up on the locking pin
that is on the top of the reference electrode.
3. Connect a syringe (Probe Cleaning Syringe PN 02702) filled with water, that has
a length of tubing attached to it, to the W-port of the reference electrode. While
covering the R-port with your finger, push water through the electrode so that the
water flows out of the flow cell port. Repeat by attaching the syringe to the R-port
and covering the W-port while pushing water through the electrode.
5. T. Shoot
5-10
6 Service
6 Service Menu
To display the Service Menu, press Service (soft key) on the Operational Menu. Then enter
your password. The Service Menu allows access to the following options:
• System Test
• Analog Input - Real time mV
• Sensor Subsystem (Calibration and Analysis data)
• Printer Menu
• Error Log
• Communications tests
• Versions List
6.1 Sensor Subsystem Screens
From the Service Menu, select Sensor Subsystem and press Enter. You can scroll through the
8 sensor screens by pressing Next Screen (soft key). The following are the 8 status screens:
• pH Sensor
• PCO2 Sensor
• PO2 Sensor
• Na Sensor
6. Service
• SO2 LED 1
• SO2 LED 2
• Hct Sensor
• Air Detectors
A printed record for each screen can be obtained by pressing Print (soft key). All the diagnostic
information on the screen is printed (standards, slope, concentrations, etc.).
6.1.1 Running a Flow Test and Checking the Rotary Valve Operation
A flow test can be run on each standard. To run a flow test, display the System Test screen and
select Service Flow Test (soft key), Run Test (soft key). When the test is completed, the Flow
Test Results screen is displayed with the flow results for all standards.
6-1
6.1.2 Checking the Sampler
The sampler can be in any one of several positions: capillary, syringe, air, or home. These
positions can be manually checked by selecting the Sampler option on the System Test screen.
1. Select Sampler with arrow keys.
2. Press Enter.
3. A pop-up window is displayed over the screen. Using the arrow keys, select a
sampler position.
4. After the sampler travels to the selected position, check that the sampler is
positioned correctly.
6.1.3 Checking the Pump
There are 4 pump speeds: slow, medium slow, medium fast, and fast. These speeds can be
manually checked by selected the Pump option on the System Test screen.
1. Select Pump with arrow keys.
2. Press Enter.
3. A pop-up window is displayed over the screen. Select one of the 4 pump speeds
with the arrow keys. Then press Enter to activate the pump.
4. Check that the pump is working and pumping fluid.
5. To stop the pump, repeat steps 1 thru 3 and select the stop option with the arrow
keys, Then press Enter to stop the pump.
6. Service
6.1.4 Checking the Waste Valve
The waste valve can be checked by selected Waste valve with the arrow keys on the System
Test screen. Press Enter to open or close the valve.
6.1.5 Checking the Reference Valve
The reference valve can be checked by selected Ref. valve with the arrow keys on the System
Test screen. Press Enter to open or close the valve.
6-2
6 Service
6.1.6 Checking the SO2 LEDs
The SO2 LEDs can be checked by selected SO2 LEDs with the arrow keys on the System Test
screen. Press Enter to turn the lights on or off.
6.1.7 Checking the Air Detectors
The air detectors can be checked by setting the X-level of the air detector of interest and then
enabling the air oscillator. From the System Test screen, select X-level with the arrow keys then
press Enter. Select the desired air detector then press Enter. Select the air oscillator with the
arrow keys then press Enter to turn the detector on or off.
6.2 Analog Input
From the Service Menu, select the Analog Input option and press Enter. The Analog Input
screen is displayed with the 25 channels and the millivolt readings.
6.3 System Test
6. Service
From the Service Menu, select System Test and press Enter. The System Test screen displays
millivolt readings for all sensors. From the System Test screen, you can check the sampler,
rotary valve, pump, waste valve, reference valve, ADT's and SO2 LED's.
6-3
6.4 Printer Menu
From the Service Menu, select the Printer Menu option and press Enter. The Printer Menu
screen is displayed with 4 options: Printer Enabled, Print System Error Log, Print System
Dump, or Character Set Test.
1. Select an option with the arrow keys.
2. Press Enter.
- Printer Enabled or Disabled, press enter to enable or disable the printer.
- Print System Error Log, press Enter to print the error logs for the analyzer.
- Print System Report, press Enter to print all the setup, calibration, and
analysis data.
- Character Set Test, press Enter to print all characters test pattern of the
printer.
3. Press Exit (soft key) to return to the Service Menu.
6.5 Error Log
From the Service Menu, select the Error Log option and press Enter. The Error Log screen is
displayed with errors displayed in chronological order. To go to the next or previous error log
pages, press the Page Down or Page Up (soft keys). To print the error log, select Printer Menu
from the Service Menu.
6. Service
6.6 Communications Test
From the Service Menu, select the Communications Test option and press Enter. The
Communications Tests screen is displayed with the 2 options: Loopback Tests and Send test
characters.
LoopBack Test
1. Select the Loopback Tests option on the Communications Tests screen.
2. Press Enter to display the Loopback Tests screen.
3. Use the arrow keys to select a port: Bar Code, Computer, and COOX.
4. Install the loopback plug.
5. Press Enter to start the test.
Send Test Characters

1. Select the Send Test Characters option on the Communications Tests screen.
2. Press Enter to display the Send Test Characters screen.
3. Use the arrow keys to select a port: Bar Code, Computer, and COOX.
4. Press Send Characters (soft key) to send the character packet.
6-4
6 Service
6.7 RS-232 Serial Ports
The Stat Profile pHOx Analyzer's communications interface is an asynchronous RS-232C

compatible serial interface. The analyzer can transfer analytical results to an external device (CO-
Oximeter, PDM, computer, etc.). There are 3 serial communication ports and 1 bar code reader
port located at the back of the analyzer. Each port uses a standard DB9P male connector to
connect the analyzer to external devices. Table 6.1 describes the layout of the pHOx's 9-pin
connectors, and Table 6.2 assigns the connections.
Table 6.1 External Device 9-pin Connector
Pin Signal Circuit

Assignment Designation Source Function
1 RCD EXTERNAL Data Carrier Detect

2 RXD EXTERNAL Received data
3 TXD ANALYZER Transmitted data
4 DTR ANALYZER Data Terminal Ready
5 GND - Signal Ground
6 DSR EXTERNAL Data Set Ready
7 RTS ANALYZER Request to Send
8 CTS EXTERNAL Clear to Send
9 RI EXTERNAL Ring Indicator
6. Service
Table 6.2 Serial Port and Device Connections
Serial Port Device
Bar Code Port Bar Code Scanner

COM 1 Nova's use only
COM 2 PDM/Computer
COM 3 CO-Oximeter
The analyzer can transmit or receive data at any one of 3 bauds: 4800, 9600, and 19200. Word
length is fixed at 7 or 8 bits. Configure the ports from the Setup Menu. The following are the
setup options with the defaults in bold:
Baud 4800, 9600, 19200
Stop Bits 1 or 2
Parity None, Odd, Even
Data Bits 7, 8
6-5
6.7.1 CO-Oximeter Interface
The Stat Profile pHOx Analyzer can interface with the Nova CO-OXIMETER via the serial
communications port (COM 3) to receive CO-Ox results.
6.7.2 PDM/Computer Interface
The Stat Profile pHOx Analyzer can interface with the Nova PDM or an external computer via
the serial communications port (COM 2) to transmit patient results. See Section 7.0.
6.7.3 Bar Code Scanner Port
An optional bar code scanner can be connected to the Stat Profile pHOx Analyzer to input
patient data. The patient information can be programmed onto a bar code sticker that is attached
to the patient's sample. Then the patient's information can be easily inputted via the bar code
scanner into the analyzer.
Follow this procedure to set up the bar code scanner.

1. Calibrate the analyzer if it is not calibrated.
2. Plug the bar code scanner into the Bar Code Scanner Port (DB-9P) on the back of
6. Service
the pHOx.
3. Listen for a tone. This indicates that the bar code is ready.
4. Start a sample analysis (syringe only).
5. When the Sample Information screen is displayed, scan in following as needed:
• Accession number
• Patient ID number (English only, alphanumeric)
• Operator ID
• Patient Temperature
6. Continue the analysis.
6.7.4 External Keyboard
Follow the directions of the insert sheet that comes with the keyboard.
6-6
7 Communications
7 Introduction
This document describes how the Nova pHOx transmits data to an external computer. Data
transmission involves a low-level protocol and a high-level protocol. The low-level protocol
is concerned with establishing communication, detecting errors, and sending and receiving
messages. It is not concerned with message content. The high-level protocol is concerned with
message content.
The protocols used are designed to conform to specifications published by the American
Society for Testing and Materials (ASTM). Copies of the specifications can be obtained by
contacting ASTM:
ASTM
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959
USA
phone: 610-832-9585
FAX: 610-832-9555
The low-level protocol used by the Nova pHOx is designed to conform to ASTM E1381-91.
This document is concerned with the high level protocol only.
The following information pertains to pHOx only samples, pHOx only calibration, pHOx Only
QC, and Combined results.
The pHOx also transmits COOX only data. Those records are specified by the COOX ASTM
specification
7.1 High-Level Protocol
7. Comm.
The high-level protocol used by pHOx is designed to conform to ASTM E1394-91.
The tables that follow describe the data records that are sent by pHOx. The column
“ASTM REF” lists the section of the ASTM E1394-91 specification that defines the field. The
column “ASTM NAME” lists the field name that appears in the ASTM specification.
Unless otherwise noted, any field that involves date and time conforms to section 6.6.2 of
ASTM 1394-91. Each record ends with a carriage return.
7-1
7.1.1 Header Record

ASTM REF ASTM NAME pHOx IMPLEMENTATION
7.1.1 Record Type ID Single character: “H”
7.1.2 Delimiter Definition Standard delimiters: |\^&
7.1.3 Message Control ID Not Used
7.1.4 Access Password Not used
7.1.5 Sender Name or ID NOVA^pHOx^vv..vv^dd Where ‘vv..vv’ is the

version of pHOx software, and ‘dd’ is Analyzer
Identification # set by the pHOx operator.
7.1.6 Sender Street Address Not used
7.1.7 Reserved Field Not used
7.1.8 Sender Telephone Number Not used
7.1.9 Characteristics of Sender Not used
7.1.10 Receiver ID Not used
7.1.11 Comment or Special Instruction Not used

7. Comm.
7.1.12 Processing ID Not used
7.1.13 Version No. Version of ASTM Spec., single char.: “1”
7.1.14 Date and Time of Message Date and time at which message was transmit-
ted. (This is not the time of the analysis or
calibration.)
7-2
7 Communications
7.1.2 Patient Information Record

8.1.1 Record Type Single character: “P”
8.1.2 Sequence Number Single character: “1”. (This will always be “1”
because there will be only one patient record per
message.) NOTE: This is NOT the Frame Num-
ber (FN) referred to in ASTM E1381-91.
8.1.3 Practice Assigned Patient ID Not used
8.1.4 Laboratory Assigned Patient ID Patient ID # if available; otherwise, blank. For

patient samples, Patient ID # is available if and
only if it was entered by the pHOx operator. For
QC samples and for calibrations, this will be
blank. NOTE: This is the last field that is used
in this record.
8.1.5 Patient ID No. 3 Not used
8.1.6 Patient Name Last^ First^ Middle
8.1.7 Mother’s Maiden Name Not used
8.1.8 Birthdate Not used
7. Comm.
8.1.9 Patient Sex Not used
8.1.10 Patient Race-Ethnic Origin Not used
8.1.11 Patient Address Not used
8.1.13 Patient Telephone Number Not used
8.1.14 Attending Physician ID Not used
8.1.15 Special Field 1 Not used
7-3
8.1.16 Special Field 2 Not used
8.1.17 Patient Height Not used
8.1.18 Patient Weight Not used
8.1.19 Patient’s Known or Suspected Diagnosis Not used
8.1.20 Patient Active Medications Not used
8.1.21 Patient’s Diet Not used
8.1.22 Practice Field No. 1 Not used
8.1.23 Practice Field No. 2 Not used
8.1.24 Admission and Discharge Dates Not used
8.1.25 Admission Status Not used
8.1.26 Location Not used
8.1.27 Nature of Alternative Diagnostic Code Not used

and Classifiers
8.1.28 Alternative Diagnostic Code Not used

and Classification
7. Comm.
8.1.29 Patient Religion Not used
8.1.30 Marital Status Not used
8.1.31 Isolation Status Not used
8.1.32 Language Not used
8.1.33 Hospital Service Not used
8.1.34 Hospital Institution Not used
8.1.35 Dosage Category Not used
7-4
7 Communications
7.1.3 Test Order Record

9.4.1 Record Type ID Single character: “O”
9.4.2 Sequence Number Single character: “1”. (This will always be “1”
because Ultra will send only one order per
message.) NOTE: This is NOT the Frame Num-
ber (FN) referred to in ASTM E1381-91.
9.4.3 Specimen ID For patient samples, accession # if available;

otherwise, blank. For QC analyses, the ID is
one of the following:
“QC0 Proficiency”
“QC1 Level 1 Internal”
“QC4 Level 1 External”
For calibrations, this field is blank.
9.4.4 Instrument Specimen ID Sample Number from pHOx’s Sample Number

Counter.
7. Comm.
9.4.5 Universal Test ID Not used
9.4.6 Priority Not used
9.4.7 Requested/Ordered Date and Time Not used
9.4.8 Specimen Collection Date and Time Not used
9.4.9 Collection End Time Not used
9.4.10 Collection Volume Not used
9.4.11 Collector ID Not used
7-5
9.4.12 Action Code Not used
9.4.13 Danger Code Not used
9.4.14 Relevant Clinical Information Not used
9.4.15 Date/Time Specimen Received Not used
9.4.16 Specimen Descriptor For patient samples, this will be the sample
type (“Arterial”, “Venous”, “Capillary”, or
“Mixed Venous”). For QC samples, this will
be “Control”. For calibrations, this will be
“Cal”.
9.4.17 Ordering Physician Not used
9.4.18 Physician’s Telephone Number Not used
9.4.19 User Field No. 1 Not used
9.4.20 User Field No. 2 Not used
9.4.21 Laboratory Filed No. 1 Not used
9.4.22 Laboratory Filed No. 2 Not used
9.4.23 Day/Time Results Reported or Not used

Last Modified
7. Comm.
9.4.24 Instrument Charge to Computer System Not used
9.4.25 Instrument Section ID Not used
9.4.26 Report Types ‘F’ - final results (Results do not require remote
review.) ‘P’ - remote review
9.4.28 Location or Ward of Specimen Collection Not used
9.4.29 Nosocomial Infection Flag Not used
7-6
7 Communications
9.4.30 Specimen Service Not used
9.4.31 Specimen Institution Not used
7.1.4 Result Record

10.1.1 Record Type Single character: “R”
10.1.2 Sequence Number Counts the parameters sent for this order; ‘1’ for
the first parameter, ‘2’ for the second, etc.
NOTE: This is NOT the Frame Number (FN)
referred to in ASTM E1381-91.
10.1.3 Universal Test ID Four or five components; the first three are not
used (see sections 6.6.1.1-6.6.1.3 of ASTM
E1394-91). The fourth is a parameter name
assigned by NOVA. The fifth, if present, will be
the parameter type; it will be one of the following:
C - Calculated D - Default E - Entered
M - Measured T - Temperature Corrected
NOTE: Parameter names are listed elsewhere
in this document.
10.1.4 Data or Measurement Value Value of the parameter as an ASCII string.
7. Comm.
10.1.5 Units Abbreviation of units.
10.1.6 Reference Ranges Not used
7-7
10.1.7 Result Abnormal Flags HH - Above High Panic value

H - Above High Reference value
L -Below Low Reference value
LL - Below Low Panic value
> - Above the range of the analyzer
< - Below the range of the analyzer
When calibration data is sent, this field will be
one of the following:
A - (abnormal) channel is not calibrated
N - (normal) channel is calibrated
NOTE: When this field is blank, at least one of
the following is true:
a. A reference range has been set, and the
measurement is within the reference range.
b. A reference range has not been set, but a panic
range has been set, and the measurement is
within the panic range.
c. Neither a reference range nor a panic range
has been set.
d. The sample is a Q.C. sample.
10.1.8 Nature of Abnormality Testing Not used
10.1.9 Result Status ‘F’ - final results (Results do not require remote
review.) ‘P’ - remote review
10.1.10 Date of Change of Instrument Not used

Normative Values or Units
7. Comm.
10.1.11 Operator Identification Operator ID#
10.1.12 Date/Time Test Started Date&time at which the analysis or cal. started.
10.1.13 Date/Time Test Completed Not used
10.1.14 Instrument Identification pHOx Analyzer ID.
7-8
7 Communications
7.1.5 Comment Record
Comment Record(s) will immediately follow a Test Order if and only if there were any errors
during sample analysis. There will be one Comment Record for each error.
11.1.1 Record Type Single character: “C”
11.1.2 Sequence Number Counts the comments sent for this order; ‘1’ for
the first comment, ‘2’ for the second, etc.
11.1.3 Comment Source Single character: “I”
11.1.4 Comment Text An error code followed by descriptive text.

(e.g., “25 Na Unstable”).
11.1.5 Comment Type Single character: “I”
7.1.6 Message Terminator Record

7. Comm.
13.1.1 Record Type Single character: “L”
13.1.2 Sequence Number For this record type this is always “1”.
13.1.3 Termination Code One of the following:

N - normal termination
T - sender aborted
7-9
7.1.7 Parameter Names
The parameter names listed here are used as Manufacturer’s or Local Code (see ASTM E1394-91
sec. 6.6.1.4). They are used to create the Universal Test ID field of the result record (see Result
Record above and see ASTM E1394-91 sec. 10.1.3).
In most cases only a subset of these parameters will be transmitted. For example, during setup
of the pHOx, the operator can disable transmission of any or all of the following:
• Analysis diagnostic data
• Calibration diagnostic data
• Calibration drift data
Parameter Name Units Description
Na+ mmol/L Sodium Concentration
Na+_SM mV Sodium Sample Millivolts
Na+_M1 mV Sodium Millivolts #1
Na+_SL None Sodium Slope
Na+_V2 None Sodium Calibration Std. Value #2

7. Comm.
Hct % Hematocrit Concentration
Hct_SM mV Hematocrit Sample Millivolts
Hct_M1 mV Hematocrit Millivolts #1
Hct_SL None Hematocrit Slope
pH None pH Concentration
7-10
7 Communications
pH_SM mV pH Sample Millivolts
pHTC None pH Conc. Corrected to Patient Temperature
pH_M1 mV pH Millivolts #1
pH_SL None pH Slope
pH_D1 None pH Drift #1
pH_D2 None pH Drift #2
pH_V1 None pH Calibration Std. Value #1
pH_V2 None pH Calibration Std. Value #2
PO2 mmHg, kPa PO2 Concentration
PO2TC mmHg, kPa PO2 Conc. Corrected to Patient Temperature
PO2_SM mV PO2 Sample Millivolts
7. Comm.
PO2_M1 mV PO2 Millivolts #1
PO2_SL None PO2 Slope
PO2_D1 None PO2 Drift #1
PO2_V1 None PO2 Calibration. Gas Value #1
7-11
PCO2 mmHg, kPa PCO2 Concentration
PCO2_SM mV PCO2 Sample Millivolts
PCO2TC mmHg, kPa Corrected PCO2 Concentration
PCO2_M1 mV PCO2 Millivolts #1
PCO2_M2 mV PCO2 Millivolts #2
PCO2_SL None PCO2 Slope
PCO2_D1 None PCO2 Drift #1
PCO2_D2 None PCO2 Drift #2
PCO2_V1 None PCO2 Calibration. Gas Value #1
PCO2_V2 None PCO2 Calibration. Gas Value #2
SO2% None SO2 Percent
S1_SL None SO2 LED #1 Slope
S2_SL None SO2 LED #2 Slope
S1_SM mV SO2 LED #1 Sample Millivolts

7. Comm.
S2_SM mV SO2 LED #2 Sample Millivolts
S1_M1 mV SO2 LED #1 millivolts #1
7-12
7 Communications
FIO2 % Percent Fraction Inspired Oxygen
BP mmHg Barometric Pressure
TempM deg C, deg F Measurement Temperature
TempP deg C, deg F Patient Temperature
Hb g/dL Hemoglobin
Hb_SL None Hemoglobin Slope
BE-ecf mmol/L Base Excess, Extra-Cellular Fluid
BE-b mmol/L Base Excess, Blood
SBC mmol/L Standard Bicarbonate
HCO3- mmol/L Bicarbonate Ion Concentration
TCO2 mmol/L Total CO2
O2Ct Vol/100mL, mL/dL, mL/L Oxygen Content
7. Comm.
A mmHg,kPa Alveolar Air PO2
a/A None Alveolar Ratio
AaDO2 mmHg,kPa Alveolar Arterial Oxygen Gradient
P50 mmHg PO2 @ 50% SO2
O2CAP Vol/100mL, mL/dL, mL/L Oxygen Capacity
RI None Respiratory Index
THb g/dL, g/L, mmol/L Total Hemoglobin
7-13
O2Hb % or None Oxyhemoglobin
COHb %or None Carboxyhemoglobin
MetHb %or None Methemoglobin
HHb %or None Reduced Hemoglobin
FO2Hb % or None Fractional Hemoglobin
PO2/FIO2 mmHg, kPa
CcO2 mL/dL capillary oxygen concentration
CvO2 mL/dL venous oxygen concentration
CaO2 mL/dL arterial oxygen concentration
AvDO2 mmHg, kPa arterial-mixed venous oxygen gradient
Qsp/Qt None physiologic shunt
MTHB g/dL Measured tHb for a pHOx Calibration
TTHB g/dL Target tHb for a pHOx Calibration
DTHB g/dL tHb drift for a pHOx Calibration
puncture_site None Entered by user
ventilator_rate/min None Entered by user

7. Comm.
tidal_volume None Entered by user
peep_cpap None Entered by user
mode_of_therapy None Entered by user
The following are for CO-Ox diagnostics only and will not normally be transmitted:
NumScans_X None
SHb_X None
Turbid_X None
7-14
7 Communications
Abs1_X None
Abs2_X None
Abs3_X None
Abs4_X None
Abs5_X None
Abs6_X None
Abs7_X None
Abs8_X None
WL1_X None
WL2_X None
WL3_X None
WL4_X None
WL5_X None
WL6_X None
WL7_X None
WL8_X None
7. Comm.
tHbCal_X None
MO2HB_X % or None
TO2HB_X % or None
DO2HB_X % or None
MHHB_X % or None
THHB_X % or None
DHHB_X % or None
7-15
7.2 Examples
The following examples do not include any special characters such as ENQ and STX. Also,
each line ends before the checksum.
7.2.1 pHOx Only Patient Sample
1H|\ ^&|||NOVA^pHOxî04.07^82||||||||1|20010611125800
2P|1||123456789012345||MannarinoÂlan^J.
3O|1|123456789012345|4||||||||||||Arterial||||||||||F
4C|1|I|55 Hct/Air Det Dependenc|I
5R|1|^^^pH^M|7.484|||||F||123456789012|20010611125600||82
6R|2|^^^PCO2^M|4.9|mmHg||||F||123456789012|20010611125600||82
7R|3|^^^PO2^M|192.2|mmHg||||F||123456789012|20010611125600||82
0R|4|^^^Hb^M^D|14.9|g/dL||||F||123456789012|20010611125600||82
1R|5|^^^Hct^M^D|45|%||||F||123456789012|20010611125600||82
2R|6|^^^SO2%^M^D|99.8|||||F||123456789012|20010611125600||82
3R|7|^^^pHTC^T|7.484|||||F||123456789012|20010611125600||82
4R|8|^^^PCO2TC^T|4.9|mmHg||||F||123456789012|20010611125600||82
5R|9|^^^PO2TC^T|192.2|mmHg||||F||123456789012|20010611125600||82
6R|10|^^^HCO3-^C|3.7|mmol/L||||F||123456789012|20010611125600||82
7R|11|^^^BE-b^C^D|-14.2|mmol/L||||F||123456789012|20010611125600||82
0R|12|^^^BE-ecf^C|-19.9|mmol/L||||F||123456789012|20010611125600||82
1R|13|^^^TCO2^C|3.8|mmol/L||||F||123456789012|20010611125600||82
2R|14|^^^SBC^C^D|13.9|mmol/L||||F||123456789012|20010611125600||82
3R|15|^^Â^C|146.8|mmHg||||F||123456789012|20010611125600||82
4R|16|^^â/A^C|1.3|||||F||123456789012|20010611125600||82
5R|17|^^Ô2Ct^C^D|21.2|mL/dL||||F||123456789012|20010611125600||82
6R|18|^^Ô2CAP^C^D|20.7|mL/dL||||F||123456789012|20010611125600||82
7. Comm.
7R|19|^^^TempP^D|37.0|deg C||||F||123456789012|20010611125600||82
0R|20|^^^BP^M|760.8|mmHg||||F||123456789012|20010611125600||82
1R|21|^^^TempM^M|37.0|deg C||||F||123456789012|20010611125600||82
2R|22|^^^FIO2^D|20.9|%||||F||123456789012|20010611125600||82
3R|23|^^^tidal_volumeÊ|0.2|||||F||123456789012|20010611125600||82
4R|24|^^^peep_cpapÊ|15.0|||||F||123456789012|20010611125600||82
5R|25|^^^pH_SM^M|106.85|||||F||123456789012|20010611125600||82
6R|26|^^^PCO2_SM^M|71.33|||||F||123456789012|20010611125600||82
7R|27|^^^PO2_SM^M|-125.66|||||F||123456789012|20010611125600||82
0R|28|^^^Hct_SM^M|928.30|||||F||123456789012|20010611125600||82
1R|29|^^^pH_M1^M|108.89|||||F||123456789012|20010611125600||82
2R|30|^^^PCO2_M1^M|107.41|||||F||123456789012|20010611125600||82
3R|31|^^^PO2_M1^M|-120.28|||||F||123456789012|20010611125600||82
4R|32|^^^Hct_M1^M|2212.11|||||F||123456789012|20010611125600||82
7-16
7 Communications
5R|33|^^^pH_SL^M|10.57|||||F||123456789012|20010611125600||82
6R|34|^^^PCO2_SL^M|9.45|||||F||123456789012|20010611125600||82
7R|35|^^^PO2_SL^M|-7.18|||||F||123456789012|20010611125600||82
0R|36|^^^Hb_SL^M|10.00|||||F||123456789012|20010611125600||82
1R|37|^^^Hct_SL^M|28.64|||||F||123456789012|20010611125600||82
2R|38|^^^S1_SM^M|513.28|||||F||123456789012|20010611125600||82
3R|39|^^^S2_SM^M|583.67|||||F||123456789012|20010611125600||82
4R|40|^^^S1_M1^M|56.57|||||F||123456789012|20010611125600||82
5R|41|^^^S2_M1^M|175.09|||||F||123456789012|20010611125600||82
6R|42|^^^S1_SL^M|8.87|||||F||123456789012|20010611125600||82
7R|43|^^^S2_SL^M|10.03|||||F||123456789012|20010611125600||82
0R|44|^^^puncture_siteÊ|Brachial Artery|||||F||123456789012|20010611125600||82
1R|45|^^^mode_of_therapyÊ|ACV|||||F||123456789012|20010611125600||82
2R|46|^^^ventilator_rateÊ|50|||||F||123456789012|20010611125600||82
3L|1|N
7.2.2 pHOx Only QC Sample

1H|\^&|||NOVA^pHOxÎ00.53^123||||||||1|19980827180000
2P|1||123456
3O|1|QC4 Level 1 External|0||||||||||||Control||||||||||F
4C|1|I|35 SO2% Dependency|I
5C|2|I|45 Hb Dependency|I
6R|1|^^^H+^M|70.479|nmol/L||||F||1|19980827175800||123
7R|2|^^^PCO2^M|59.8|mmHg||||F||1|19980827175800||123
0R|3|^^^PO2^M|62.3|mmHg||||F||1|19980827175800||123
1R|4|^^^Hb^M||g/dL||||F||1|19980827175800||123
2R|5|^^^Hct^M||%||<||F||1|19980827175800||123
3R|6|^^^SO2%^M||||||F||1|19980827175800||123
7. Comm.
4R|7|^^^Na+^M||mmol/L||||F||1|19980827175800||123
5R|8|^^^pH_SM^M|43.290|||||F||1|19980827175800||123
6R|9|^^^PCO2_SM^M|102.995|||||F||1|19980827175800||123
7R|10|^^^PO2_SM^M|-42.850|||||F||1|19980827175800||123
0R|11|^^^Hct_SM^M|2243.885|||||F||1|19980827175800||123
1R|12|^^^Na+_SM^M||||||F||1|19980827175800||123
2R|13|^^^pH_M1^M|28.478|||||F||1|19980827175800||123
3R|14|^^^PCO2_M1^M|88.510|||||F||1|19980827175800||123
4R|15|^^^PO2_M1^M|-115.677|||||F||1|19980827175800||123
5R|16|^^^Hct_M1^M|1897.903|||||F||1|19980827175800||123
6R|17|^^^Na+_M1^M|66.348|||||F||1|19980827175800||123
7R|18|^^^pH_SL^M|10.584|||||F||1|19980827175800||123
0R|19|^^^PCO2_SL^M|10.389|||||F||1|19980827175800||123
1R|20|^^^PO2_SL^M|-6.731|||||F||1|19980827175800||123
7-17
2R|21|^^^Hb_SL^M|10.000|||||F||1|19980827175800||123
3R|22|^^^Hct_SL^M|24.293|||||F||1|19980827175800||123
4R|23|^^^Na+_SL^M|8.863|||||F||1|19980827175800||123
5R|24|^^^S1_SM^M|201.127|||||F||1|19980827175800||123
6R|25|^^^S2_SM^M|170.187|||||F||1|19980827175800||123
7R|26|^^^S1_M1^M|200.144|||||F||1|19980827175800||123
0R|27|^^^S2_M1^M|169.418|||||F||1|19980827175800||123
1R|28|^^^S1_SL^M|0.770|||||F||1|19980827175800||123
2R|29|^^^S2_SL^M|1.104|||||F||1|19980827175800||123
3L|1|N
7.2.3 pHOx ABG Calibration

1H|\^&|||NOVA^pHOxÎ00.53^123||||||||1|19980827172200
2P|1||
3O|1||||||||||||||Cal||||||||||F
4R|1|^^^pH_M1^M|28.478|||N||F|||19980827172200||123
5R|2|^^^pH_M2^M|25.114|||N||F|||19980827172200||123
6R|3|^^^pH_M3^M|29.803|||N||F|||19980827172200||123
7R|4|^^^pH_M4^M|63.084|||N||F|||19980827172200||123
0R|5|^^^PCO2_M1^M|88.510|||N||F|||19980827172200||123
1R|6|^^^PCO2_M2^M|101.932|||N||F|||19980827172200||123
2R|7|^^^PO2_M1^M|-115.677|||N||F|||19980827172200||123
3R|8|^^^PO2_M2^M||||N||F|||19980827172200||123
4R|9|^^^PO2_M3^M|-100.099|||N||F|||19980827172200||123
5R|10|^^^Hct_M1^M|1897.903|||N||F|||19980827172200||123
6R|11|^^^Hct_M2^M||||N||F|||19980827172200||123
7R|12|^^^Hct_M4^M|877.612|||N||F|||19980827172200||123
0R|13|^^^Na+_M1^M|64.789|||N||F|||19980827172200||123
7. Comm.
1R|14|^^^Na+_M2^M||||N||F|||19980827172200||123
2R|15|^^^Na+_M4^M|49.057|||N||F|||19980827172200||123
3R|16|^^^pH_SL^M|10.584|||N||F|||19980827172200||123
4R|17|^^^PCO2_SL^M|10.389|||N||F|||19980827172200||123
5R|18|^^^PO2_SL^M|-6.731|||N||F|||19980827172200||123
6R|19|^^^Hb_SL^M|0.000|||A||F|||19980827172200||123
7R|20|^^^Hct_SL^M|24.293|||N||F|||19980827172200||123
0R|21|^^^Na+_SL^M|8.863|||N||F|||19980827172200||123
1L|1|N
7-18
7 Communications
7.2.4 pHOx SO2% Calibration

1H|\^&|||NOVA^pHOxÎ00.53^123||||||||1|19980827173400
2P|1||
3O|1||||||||||||||Cal||||||||||F
4R|1|^^^S1_M1^M|319.258|||N||F|||19980827173400||123
5R|2|^^^S2_M1^M|305.213|||N||F|||19980827173400||123
6R|3|^^^S1_M2^M|665.084|||N||F|||19980827173400||123
7R|4|^^^S2_M2^M|275.745|||N||F|||19980827173400||123
0R|5|^^^S1_M3^M|-13.953|||N||F|||19980827173400||123
1R|6|^^^S2_M3^M|-16.503|||N||F|||19980827173400||123
2R|7|^^^S1_M4^M|200.954|||N||F|||19980827173400||123
3R|8|^^^S2_M4^M|170.514|||N||F|||19980827173400||123
4R|9|^^^S1_SL^M|0.770|||N||F|||19980827173400||123
5R|10|^^^S2_SL^M|1.104|||N||F|||19980827173400||123
6L|1|N
7.2.5 Combined Patient Sample
1H|\ ^&|||NOVA^pHOxî04.07^6||||||||1|20011107100100
2P|1||123456789012345||
3O|1|1234567890|106||||||||||||Arterial||||||||||F
4C|1|I|55 Hct/Air Det Dependenc|I
5R|1|^^^pH^M|7.616|||||F||123456789012|20011107095800||6
6R|2|^^^PCO2^M|22.5|mmHg||||F||123456789012|20011107095800||6
7R|3|^^^PO2^M|147.0|mmHg||||F||123456789012|20011107095800||6
0R|4|^^^Hb^M||g/dL||||F||123456789012|20011107095800||6
1R|5|^^^Hct^M^D|43|%||||F||123456789012|20011107095800||6
7. Comm.
2R|6|^^^SO2%^M||||||F||123456789012|20011107095800||6
3R|7|^^^pHTC^T|7.616|||||F||123456789012|20011107095800||6
4R|8|^^^PCO2TC^T|22.5|mmHg||||F||123456789012|20011107095800||6
5R|9|^^^PO2TC^T|147.0|mmHg||||F||123456789012|20011107095800||6
6R|10|^^^HCO3-^C|23.1|mmol/L||||F||123456789012|20011107095800||6
7R|11|^^^BE-b^C|?4.0|mmol/L||||F||123456789012|20011107095800||6
0R|12|^^^BE-ecf^C|1.6|mmol/L||||F||123456789012|20011107095800||6
1R|13|^^^TCO2^C|23.8|mmol/L||||F||123456789012|20011107095800||6
2R|14|^^^SBC^C|?31.8|mmol/L||||F||123456789012|20011107095800||6
3R|15|^^Â^C|124.4|mmHg||||F||123456789012|20011107095800||6
4R|16|^^â/A^C|1.2|||||F||123456789012|20011107095800||6
5R|17|^^Ô2Ct^C|?48.1|mL/dL||||F||123456789012|20011107095800||6
6R|18|^^Ô2CAP^C|?18.3|mL/dL||||F||123456789012|20011107095800||6
7R|19|^^^CcO2^C|?0.1|mL/dL||||F||123456789012|20011107095800||6
7-19
0R|20|^^^CaO2^C|?-7.0|mL/dL||||F||123456789012|20011107095800||6
1R|21|^^^THb^M|?13.2|g/dL||||F||123456789012|20011107095800||21
2R|22|^^^HHb^M|?25.0|%||||F||123456789012|20011107095800||21
3R|23|^^Ô2Hb^M|?-40.6|%||||F||123456789012|20011107095800||21
4R|24|^^^SO2%^M|?259.9|||||F||123456789012|20011107095800||21
5R|25|^^^COHb^M|?99.5|%||||F||123456789012|20011107095800||21
6R|26|^^^MetHb^M|?16.1|%||||F||123456789012|20011107095800||21
7R|27|^^Ô2Ct^M||mL/dL||<||F||123456789012|20011107095800||21
0R|28|^^Ô2CAP^M||mL/dL||<||F||123456789012|20011107095800||21
1R|29|^^^TempP^D|37.0|deg C||||F||123456789012|20011107095800||6
2R|30|^^^BP^M|755.1|mmHg||||F||123456789012|20011107095800||6
3R|31|^^^TempM^M|37.0|deg C||||F||123456789012|20011107095800||6
4R|32|^^^FIO2^D|20.9|%||||F||123456789012|20011107095800||6
5R|33|^^^tidal_volumeÊ|20.0|||||F||123456789012|20011107095800||6
6R|34|^^^peep_cpapÊ|50.0|||||F||123456789012|20011107095800||6
7R|35|^^^pH_SM^M|84.22|||||F||123456789012|20011107095800||6
0R|36|^^^PCO2_SM^M|118.21|||||F||123456789012|20011107095800||6
1R|37|^^^PO2_SM^M|-88.61|||||F||123456789012|20011107095800||6
2R|38|^^^Hct_SM^M|880.69|||||F||123456789012|20011107095800||6
3R|39|^^^pH_M1^M|93.97|||||F||123456789012|20011107095800||6
4R|40|^^^PCO2_M1^M|124.37|||||F||123456789012|20011107095800||6
5R|41|^^^PO2_M1^M|-104.21|||||F||123456789012|20011107095800||6
6R|42|^^^Hct_M1^M|1926.86|||||F||123456789012|20011107095800||6
7R|43|^^^pH_SL^M|10.50|||||F||123456789012|20011107095800||6
0R|44|^^^PCO2_SL^M|10.18|||||F||123456789012|20011107095800||6
1R|45|^^^PO2_SL^M|-6.27|||||F||123456789012|20011107095800||6
2R|46|^^^Hb_SL^M|10.00|||||F||123456789012|20011107095800||6
3R|47|^^^Hct_SL^M|24.16|||||F||123456789012|20011107095800||6
4R|48|^^^S1_SM^M|275.06|||||F||123456789012|20011107095800||6
5R|49|^^^S2_SM^M|521.26|||||F||123456789012|20011107095800||6
7. Comm.
6R|50|^^^S1_M1^M|60.38|||||F||123456789012|20011107095800||6
7R|51|^^^S2_M1^M|281.84|||||F||123456789012|20011107095800||6
0R|52|^^^S1_SL^M|9.24|||||F||123456789012|20011107095800||6
1R|53|^^^S2_SL^M|10.03|||||F||123456789012|20011107095800||6
2R|54|^^^puncture_siteÊ|Femoral Artery|||||F||123456789012|20011107095800||6
3R|55|^^^mode_of_therapyÊ|CPAP|||||F||123456789012|20011107095800||6
4R|56|^^^ventilator_rateÊ|.2|||||F||123456789012|20011107095800||6
5L|1|N
7-20
7 Communications
7.2.6 pHOx Only QC Sample
1H|\^&|||NOVA^pHOxÎ00.53^123||||||||1|19980827180000
2P|1||123456
3O|1|QC4 Level 1 External|0||||||||||||Control||||||||||F
4C|1|I|35 SO2% Dependency|I
5C|2|I|45 Hb Dependency|I
6R|1|^^^H+^M|70.479|nmol/L||||F||1|19980827175800||123
7R|2|^^^PCO2^M|59.8|mmHg||||F||1|19980827175800||123
0R|3|^^^PO2^M|62.3|mmHg||||F||1|19980827175800||123
1R|4|^^^Hb^M||g/dL||||F||1|19980827175800||123
2R|5|^^^Hct^M||%||<||F||1|19980827175800||123
3R|6|^^^SO2%^M||||||F||1|19980827175800||123
4R|7|^^^Na+^M||mmol/L||||F||1|19980827175800||123
5R|8|^^^pH_SM^M|43.290|||||F||1|19980827175800||123
6R|9|^^^PCO2_SM^M|102.995|||||F||1|19980827175800||123
7R|10|^^^PO2_SM^M|-42.850|||||F||1|19980827175800||123
0R|11|^^^Hct_SM^M|2243.885|||||F||1|19980827175800||123
1R|12|^^^Na+_SM^M||||||F||1|19980827175800||123
2R|13|^^^pH_M1^M|28.478|||||F||1|19980827175800||123
3R|14|^^^PCO2_M1^M|88.510|||||F||1|19980827175800||123
4R|15|^^^PO2_M1^M|-115.677|||||F||1|19980827175800||123
5R|16|^^^Hct_M1^M|1897.903|||||F||1|19980827175800||123
6R|17|^^^Na+_M1^M|66.348|||||F||1|19980827175800||123
7R|18|^^^pH_SL^M|10.584|||||F||1|19980827175800||123
0R|19|^^^PCO2_SL^M|10.389|||||F||1|19980827175800||123
1R|20|^^^PO2_SL^M|-6.731|||||F||1|19980827175800||123
2R|21|^^^Hb_SL^M|10.000|||||F||1|19980827175800||123
3R|22|^^^Hct_SL^M|24.293|||||F||1|19980827175800||123
4R|23|^^^Na+_SL^M|8.863|||||F||1|19980827175800||123
7. Comm.
5R|24|^^^S1_SM^M|201.127|||||F||1|19980827175800||123
6R|25|^^^S2_SM^M|170.187|||||F||1|19980827175800||123
7R|26|^^^S1_M1^M|200.144|||||F||1|19980827175800||123
0R|27|^^^S2_M1^M|169.418|||||F||1|19980827175800||123
1R|28|^^^S1_SL^M|0.770|||||F||1|19980827175800||123
2R|29|^^^S2_SL^M|1.104|||||F||1|19980827175800||123
3L|1|N
7-21
7. Comm.
7-22
Appendix A
A Appendix
Appendix A includes analyzer specifications, solutions and reagents, consumable lists,
reference information, and warranty for the Stat Profile pHOx Analyzer.
A.1 Stat Profile pHOx Specifications*
Measurement Range:pH 6.500 - 8.000 H+ 316.23 - 10.00 nmol/L

PCO2 3.0 - 200 mmHg 0.4 - 26.7 kPa
PO2 0 - 800 mmHg 0.0 - 106.7 kPa
SO2 30.0 - 100 % 0.0 - 1.00
Hct 12% - 70%
Hb 4.0 - 24.0 g/dL 40.0 - 240 g/L 2.5-14.9 mmol/L
BarP 400.0 - 800.0 mmHg 53.3 - 106.7 kPa 15.7- 31.5 inHg
Calculated Result Resolution: HCO3 0.1 mmol/L

TCO2 0.1 mmol/L
Beecf 0.1 mmol/L
Beb 0.1 mmol/L
SBC 0.1 mmol/L
O2Ct 0.1 mL/dL
P50 0.1 mmHg 0.1 kPa
With entered FiO2: A 0.1 mmHg 0.1 kPa
A-aDO2 0.1 mmHg 0.1 kPa
NOTE: If the
a/A 0.1
calculated result of
PO2/FiO2 0.1 mmHg 0.1 kPa
AaDO2 is less than
With CO-OX inputs: MetHb 0.1 % 0.001
or equal to zero, the
COHb 0.1 % 0.001
test and its result will
HHb 0.1 % 0.001
not be displayed.
O2Hb 0.1 % 0.001
O2Cap 0.1 mL/dL 0.01 mL/L
Appendix A
O2Ct 0.1 mL/dL 0.01 mL/L

Combined: CcO2 0.1 mL/dL
CaO2 0.1 mL/dL
CvO2 0.1 mL/dL
a-vDO2 0.1 mmHg 0.1 kPa
P50 0.1 mmHg 0.1 kPa
*Specifications are subject to change
A-1
Acceptable Samples: Whole Blood (heparinized)
Measuring Technology: Ion Selective Electrodes (Na+, pH, PCO2)

Amperometry (PO2)
Conductivity (Hematocrit/Hemoglobin)
Reflectance Photometry (Oxygen Saturation/Hemoglobin)
Analysis Rate: Stat Analysis Time Throughput Time

45 seconds 60 seconds
Sample Volume: 45 microliters whole blood micro sample for blood gases
70 microliters whole blood sample size for full panel
Barometer: 400 - 800 ±1 mmHg, accurate to 1.5 mmHg
Slope Limits: pH 9.1 - 11.6

PO2 -15.0 - (-1.6)
PCO2 7.9 - 12.6
Hct 12.0 - 50.0
Na+ 8.3 - 12.0
SO2 6.9 - 18.2
Slope and Offset Limits: Slope Offset

pH N/A lower -0.1
upper 0.1
PCO2 lower 0.80 lower -10.0
upper 1.20 upper 10.0
PO2 lower 0.90 lower -20.0
Appendix A

SO2 lower 0.90 N/A
upper 1.1
Hct lower 0.80 lower -10.0
Hb lower 0.9 lower -2.0
upper 1.1 upper 2.0
*Specifications are subject to change.
A-2
Appendix A
Analytical Specifications for Imprecision

Analyte Within-run Day-to-Day
Precision Precision
n=20 n=20
Whichever is Greater Whichever is Greater
CV% SD CV% SD
pH 0.005 0.013
PCO2 3.0 1.0 (mmHg) 5.0 2.0 (mmHg)
PO2 3.0 1.5 (mmHg) 5.0 3.0 (mmHg)
Hct 1.0 Hct% 1.0 Hct%
Hb 2.5% 0.3 g/dL
SO2 1.0 SO2% 1.5 SO2%
Stat Profile pHOx vs Ultra E Method Comparison
Analyte Mode Number of Correlation Range Reference

Samples N Coefficient R Instrument
pH Blood 52 0.997 6.88 - 7.44 STAT Ultra E

PCO2 Blood 56 0.998 28 - 112 mmHg STAT Ultra E
PO2 Blood 56 0.999 18 - 414 mmHg STAT Ultra E
Hct Blood 50 0.986 16% - 68% STAT Ultra E
Hb Blood 40 0.995 6 - 21 g/dL STAT Ultra E
SO2 Blood 50 0.998 32.6% - 99.0% STAT Ultra E
Appendix A
A-3
Electrical Compliance: Meets IEC 1010, UL, and CSA standards
Temperature Thermostatting: 37 °C ± 0.1 °C
Dimensions: Height: 15.0 in (38.1 cm)

Width: 12.0 in (30.5 cm)
Depth: 15.0 in (38.1 cm)
Weight: 18 lb (8.19 kg) without reagent pack

23 lb (10.45 kg) with full reagent pack
Power: 100-120; 220-240 VAC, 50/60 Hz, 130W
Environmental: Indoor use at temperature between 15°C and 30°C (59°F and
86°C); altitude up to 2000 meters; Relative Humidity of 0-85%
(noncondensing)
Lifting the Analyzer: 1. One person is needed to lift the analyzer.

CAUTION: Never use the control panel or doors (open or closed) to assist
you in lifting the analyzer. They 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.
Appendix A
A-4
Appendix A
A.2 Reagents and Solutions

This section covers the reagents and solutions required for proper operation and maintenance
of the Stat Profile pHOx Analyzer.
A.2.1 Reagents and Solutions
Reagents and solutions are as follows:

1. Reagent Pack: PN 20807
2. pH Electrode Conditioning Solution: PN 23397
3. Preheater Cleaning Agent: PN 11802
4. Nova Stat Profile pHOx SO2 Calibrators PN 22771:

• External Calibrator Level 1 - SO2
• External Calibrator Level 2 - SO2
5. Nova Stat Profile pHOx Controls:

• Level 1 - Acidosis, with low pH, high PCO2, low PO2, low SO2, & low
normal Hct & Hb: PN 22760
• Level 2 - Normal, with normal pH, PCO2, and PO2: PN 22761
• Level 3 - Alkalosis, with high pH, low PCO2, high PO2, SO2, and normal
high Hct & Hb: PN 22762
• Multi Pack: PN 22763
6. Auto-cartridge QC (Internal): PN 23930, PN 23931, PN 23932, PN 23933
Nova will not be responsible for any of its warranties on sensors, electrodes, tubing, probes,
or other 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.
Some reagent formulations not manufactured by Nova contain acids, concentrated salt
solutions, and artificial preservatives which have been shown to cause problems such as
Appendix A
shortened sensor/electrode life, sensor/electrode membrane damage, sensor/electrode drift,

erratic analytical results, and unacceptable instrument performance.
NOTE: Refer to the Nova Stat Profile Control insert for storage requirements
for these controls. Store all other Nova Stat Profile reagents, standards,
and solutions at 15 to 30° C.
A-5
A.2.2 Reagent Pack
The concentrations of the internal standards* are printed on the reagent pack. In addition to the
reagents and solutions, the reagent pack has a self-contained waste bag for safe disposal of waste.
A.2.3 Verifying the Analyzer's Performance
Nova Biomedical recommends that each laboratory performs the following minimum QC
procedures on each analyzer:
• Stat Profile pHOx Blood Gas/SO2/Hct/Hb Controls Levels 1, 2, 3

- During each 8 hours of testing, analyze one level of Stat Profile pHOx
Control.
- Analyze all 3 levels during each day of operation.
CAUTION: The sensor performance of the analyzer may be affected by use of

controls other than Nova Stat Profile pHOx Controls. Contact Nova Bio-
medical for additional information.
Appendix A
A-6
Appendix A
A.2.3.1 Nova Stat Profile pHOx Controls Levels 1, 2, 3: Quality Control
The pHOx Analyzer can perform internal or external Quality Control. The internal controls are
analyzed at the programed times inputted into the QC Setup. The control levels 1, 2, and 3 are
contained in the Control Pack. The in control results are printed only if the Analysis Print Mode
is ON. If a result is out of range (not in control), up or down arrows will print next to the result,
and the Exceed Limits screen is displayed.
To run internal controls manually proceed as follows:

1. From the Ready screen, press QC (soft key)
2. Select Analyze QC with the arrow keys then press Enter
3. Press Next Control (soft key) until QC Select Internal L1 screen is displayed: this
is Internal Control Level 1.
4. Press Analyze (soft key): QC Results Internal 1 screen is displayed. There are 2
results screens. Press Next Page (soft key) to view second screen.
5. To print the results of QC Level 1, press Print (soft key).
6. Repeat steps 1 - 5 to run internal QC Level 2 and again to run internal QC Level 3.
To run external controls, use the Nova Stat Profile pHOx Controls formulated as Levels 1, 2,
and 3:
Level 1 - Acidosis, with low pH, high PCO2, low PO2, low SO2, & low normal Hct & Hb
Level 2 - Normal, with normal pH, PCO2, and PO2
Level 3 - Alkalosis, with high pH, low PCO2, high PO2, SO2, and normal high Hct & Hb
The ampules must be at 25° C for at least 24 hours before opening.

CAUTION: The sensor performance of the analyzer may be affected by use of
controls other than Nova Stat Profile pHOx Controls.
Analyze the Nova Stat Profile pHOx Controls Levels 1, 2, 3, as follows:
Appendix A
1. Before opening, shake the ampule for about 10 seconds.
2. Protect the fingers with tissue or gloves. Snap open the ampule.
CAUTION: Analyze the liquid within 30 SECONDS of opening to prevent
contamination with room air and alteration of stated values.
3. Press QC, select level, present the control, press Continue (soft key) to initiate
aspiration, and press Analyze (soft key) to present sample to sensors.
4. Compare the results with those listed in the assay data sheet included with the
controls.
A-7
A.3 Reference Values
Each laboratory should establish and maintain its own reference values. The values given here
should be used only as a guide.
____________________________________________________________________________________
Table D.1 Reference Values1,2
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%
Hematocrit (Hct)
(Male) 39 - 49%
(Female) 35 - 45%
Hemoglobin (Hb)
(Male) 13.2 - 17.3 g/dL
(Female) 11.7 - 15.5 g/dL
____________________________________________________________________________________
References:
1. Statland, Bernard. 1987. Clinical Decisions Levels for Lab Tests, Medical Eco-
Appendix A
nomics Books.
2. Tietz, Norbert W., ed. 1994. Textbook of Clinical Chemistry, W.B. Saunders Co.,
Philadelphia, Penn.
A-8
Appendix A
A.4 Ordering Information
Supplies and parts for the Stat Profile pHOx Analyzer are available from Nova Biomedical.
DESCRIPTION Part #
Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22362

Reference Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22363
Air Detector (Sample) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21513
Bar Code Scanner (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23591
Blank Sensor (Electrode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22507
Clot Removal Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18431
Electrode Conditioning Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 09458
Keyboard Kit (External) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33963
Linearity Solution Set G, L1 (Hematocrit/Hemoglobin) . . . . . . . . . . . . . . 24877
Linearity Solution Set G, L2 (Hematocrit/Hemoglobin) . . . . . . . . . . . . . . 24878
Line Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01498
PCO2 Sensor and Washer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21524
PCO2 Membrane Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25048
pH Sensor Conditioning Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23397
pH Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21522
PO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21521
PO2 Membrane Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21795
Preheater Deproteinizing Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12704
Printer Paper (5 Rolls) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23298
Probe Cleaning Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 02702
Reference Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21520
Reference Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21497
Sample Probe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21519
Sensor Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21494
Shaft for Paper Roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22816
SO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21512
Sodium Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21523
Appendix A
A-9
Ordering Information (cont’d)
DESCRIPTION Part #
Stat Profile pHOx Auto-Cartridge QC Econo . . . . . . . . . . . . . . . . . . . . . . 23930

Stat Profile pHOx 1 Auto-Cartridge QC . . . . . . . . . . . . . . . . . . . . . . . . . . 23931
Stat Profile pHOx Control Multipack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22763
Stat Profile pHOx Reagent Pack A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23935
Stat Profile pHOx Reagent Pack B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23937
Stat Profile pHOx Reagent Pack C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23936
Stat Profile pHOx Reagent Pack D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23934
Stat Profile pHOx SO2 Calibrators Level 1 and 2 . . . . . . . . . . . . . . . . . . . 22771
Waste Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21926
W/R Pump Tube assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23023
Appendix A
A-10
Appendix A
A.5 Shutdown Procedure
If the analyzer is to be turned off for more than 24 hours, flush the tubing harness first with
distilled water then with air. Use the Flush Fixture (PN 24327) to perform this procedure.
NOTE: If the analyzer is to be shutdown for more than 1 week, remove the
sensors and rinse and dry the flow cell.
1. Remove the Reagent Pack from the analyzer.
2. Install the Flush Fixture into the analyzer in the same way as the Reagent Pack.
3. Place the W-line of the fixture into an empty container.
4. Place the other tubing ends into a beaker of distilled water.
5. From the Ready/Not Ready screen, press Menu (soft key).
6. Select Flowpath Maintenance and press Enter.
7. Press Purge (soft key).
8. When the cycle ends, take all the tubings out of the distilled water. Leave the
W-line in its container.
9. Repeat the purge with air.
10. When this cycle is completed, remove the flush fixture.
11. Relax the pump tubing by removing one of the mounting blocks from its bracket.
12. The pHOx Analyzer is now ready to be powered off for extended time.
A.5 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 per-
formed by any party other than an authorized Nova representative or any force of nature; (B)
Appendix A
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,
A-11
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 following exceptions apply:

1. The sodium sensor is warranted for one (1) month and the pH, PCO2, PO2, and
reference electrodes are warranted for six (6) months from the date of installation,
provided they are stored at room temperature and placed into service prior to the
use before date on the packaging. In the event that a sensor/electrode does not meet
that use life, then Nova Biomedical will replace that sensor/electrode at no charge
under this warranty. This warranty is invalid under the conditions specified after
item 3.
2. Consumable items, including the reagent pack, calibration gases, replaceable
membranes, tubing and tubing harnesses, electrolyte solutions, external standards,
and septum assemblies are warranted to be free of defects at time of installation.
The item must be placed into service prior to the expiration date printed on the
packaging. All defects must be promptly reported to Nova Biomedical in writing.
This warranty is invalid under the conditions specified after item 3.
3. Freight is paid by the customer.
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 sensors/electrodes,
tubing, probes, septa, or other 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 manufac-
tured by Nova Biomedical may contain acids, concentrated salt solutions, and
artificial preservatives that have been shown to cause problems such as shortened
sensor/electrode and septa life, sensor/electrode membrane damage, sensor/elec-
trode drift, erratic analytical results, and inaccurate instrument performance.
Appendix A
THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER OBLIGATIONS AND

LIABILITIES INCLUDING NEGLIGENCE AND ALL WARRANTIES, OF MERCHANT-
ABILITY 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 FURNISH-
ING OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE, INSTALLA-
TION OR OPERATION. NOVA BIOMEDICAL WILL IN NO EVENT BE LIABLE FOR
ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHATSOEVER, AND OUR LI-
ABILITY UNDER NO CIRCUMSTANCES WILL EXCEED THE CONTRACT PRICE
FOR THE GOODS FOR WHICH THE LIABILITY IS CLAIMED.
A-12
Appendix B Theory
B Theory
This section explains instrument theory of the Stat Profile pHOx Analyzer.
B.1 Sensor Calibration
B.1.1 Two-Point Calibration
The analyzer uses a 2-point calibration to set sensor slope and verify sensor performance. The
reagent pack and the external calibrators (ampules) contain the standards which are used for
this purpose. Calibration can be initiated manually by pressing CALIBRATE and is also
initiated automatically by the system at intervals of 2, 4, or 6 hours depending on user setup.
The External Two Standard Hb, SO2% Calibration sequence is not initiated automatically.
B.1.2 One-Point Calibration
Sensor drift is the slow variation in sensor response over time. The determination of the activity
for an unknown sample is dependent on both the sensor potential generated by the unknown
and that generated by the standard. The analyzer uses a 1-point calibration to monitor and
minimize the effect of the sensor drift on the analytical results. If analyzer is in Mode A, a 1-
point calibration occurs at 30 minute intervals and is independent of the sample cycle. If
analyzer is in Mode B, the 1-point calibration occurs with every analysis.
A drift error code is displayed when sensor drift is beyond the drift limits
B. Theory
B-1
B.2 Parameter Definitions
B.2.1 pH Sensor
Definition of pH
The pH of an unknown sample is calculated using the following equation:
E Std C − E x
pH x = pH std C + Equation 1
Slope
E std − Ex
C
where Slope = Equation 2
pH std C − pH std D
Principle of pH Measurement
pH is measured using a hydrogen ion selective glass membrane. One side of the glass 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.2.2 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.
B. Theory
Principle of PCO2 Measurement

PCO2 is measured with a modified pH sensor. Carbon dioxide in the unknown solution makes
contact with a gas permeable membrane mounted on a combination measuring/reference
electrode. CO2 diffuses across the membrane into a thin layer of electrolyte solution in response
to partial pressure difference. This solution then becomes equilibrated with the external gas
pressure. CO2 in the solution becomes hydrated producing carbonic acid which results in a
change in hydrogen ion activity.
CO 2 + H 2 O ⇔ H 2 CO3 ⇔ H + + HCO3− [ ] Equation 3
B-2
Appendix B Theory
The electrolyte solution behind the membrane is in contact with a glass hydrogen ion selective
sensor. The change in hydrogen ion activity in the electrolyte solution produces a potential
which is measured against the internal filling solution. This change in potential is measured
against the constant potential of the reference electrode half cell and is logarithmically related
to the PCO2 of the unknown sample.
B.2.3 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.2.4 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. Next, the hematocrit
value obtained is corrected for the concentration of the sodium ion.
B.2.5 Hemoglobin (Measured)

B. Theory
Hemoglobin is measured by combining a conductivity measurement and a photometric

measurement. The combination provides a measure of the hemoglobin concentration. It is
refined by the SO2 measurement that adjusts the hemoglobin concentration for the effects of
red cell morphology changes with saturation and for the concomitant effects on the relationship
between the sample conductivity and the packed volume of red cells in the blood sample.
B-3
B.2.6 SO2 % Concentration
Definition of SO2
Oxygen saturation, SO2%, represents the percent of hemoglobin bound to oxygen, expressed
as a fraction of the amount of hemoglobin capable of binding to oxygen (oxyhemoglobin plus
deoxyhemoglobin). As the level of SO2% changes within a blood sample, the color of the whole
blood changes.
Principle of SO2 Measurement

On the Stat Profile pHOx analyzer, a reflectance photometry system is used to measure the
color of the whole blood to determine the level of oxygen saturation. Using a multiple branch
bundle of optical fibers, the whole blood sample is illuminated by multiple wavelengths of
light. A portion of each wavelength of light is reflected onto one of the optical fiber bundles
and in turn onto a photo detector. By relating the signal observed to those of known standards,
the color of the blood sample is measured, and the level of oxygen saturation is determined.
B.3 Calculated Values
The analyzer’s microcomputer uses the measured results to calculate other clinically valuable
parameters. This section outlines the equations used to calculate these values.
B.3.1 Temperature Correction for Measured Values*
The Stat Profile Ultra 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 4

B. Theory
PCO2 ( corrected ) = PCO2 × e (0.04375(T − 37)) Equation 5
PO2( corrected ) = PO2 × 10 U Equation 6

( )
  5.49 × 10 −11 Y + 0.071 


× (T − 37) and Y = e 3.88 × ln( PO )
where U =  
( −9
)
  9.72 × 10 Y + 2.30 


[ 2 ]
*The equations are from NCCLS standards2.
B-4
Appendix B Theory
B.3.2 Calculated Parameters
Calculated Bicarbonate Concentration [HCO3-]*

Bicarbonate Concentration (mmol/L) is calculated using the Henderson-Hasselbalch equation:
[HCO3-]
pH = pK + log ________ Equation 7
α(PCO2 )
where pH and PCO2 are measured.
pK = 6.091
α = 0.0307 = solubility coefficient of CO2 in plasma at 37 °C
Rearranging Equation 7 gives:
Log10 [HCO3-] = pH + log10 PCO2 - 7.604 Equation 8
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 9
where PCO2 is measured and [HCO3-] is calculated from Equation 8.
Hemoglobin (Calculated)
B. Theory
The hemoglobin is calculated based on the following calculation:
Hemoglobin g/dL = Measured Hematocrit ÷ 3.0 Equation 10

NOTE: The hemoglobin calculation is an estimation based on a normal mean
corpuscular hemoglobin concentration of 33.3%. The Stat Profile pHOx
hemoglobin estimation from samples with Red cell dyscrasia or hemoglo-
binopathies may vary significantly from hemoglobin measured by cyan-
methemoglobin method.
B-5
Base Excess of Blood (BE-B: sometimes called In Vitro Base Excess)*

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 11
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 12
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 13
Oxygen Content (O2Ct)

B. Theory
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)
_________ = 1.39 mL of O2 per gram of Hb Equation 14
64458
B-6
Appendix B Theory
O 2 Ct = (1.39 [Hb])  2  + (0.0031 [ PO 2 ])

SO
therefore  100  Equation 15
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 = × 100 Equation 16
[ PO2' ]3 + 150 [ PO2' ] + 23400
where
[ PO2' ] [ ( (
= [ PO2 ] × e 2.3026 × 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.
Alveolar Oxygen (A)

Alveolar Oxygen refers to the partial pressure of oxygen in alveolar gas. It is calculated as
follows:
  1 − %FIO2  
%FIO2  %FIO2  100  
A= (B.P. − 0.045T 2 + 0.84T − 16.5)−* *PCO 2  +
100  
 100 

0.8 


Equation 17
B. Theory
where T = patient temperature

B.P. = barometric pressure
%FIO2 = fraction inspired oxygen, as a percent
B-7
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 18
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 19
** Temperature corrected gas value
Arterial-Mixed Venous O2 Content Difference ( a − v DO 2 )

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 DO 2 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 nor 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 DO 2 = CaO 2 - C v O 2 Equation 20
B. Theory
B-8
Appendix B Theory
˙ ˙ )
Physiologic Shunt (AV Shunt) Calculation ( Qsp/Qt
The estimation of shunt flow can be performed when both mixed venous and arterial blood
samples are sent and they are analyzed on the pHOx interfaced to a Nova CO-Oximeter. The
selection of syringe sample type analysis and the AV Shunt key is required. The instruments
require analysis of the mixed venous sample first followed by the arterial sample on both the
Stat Profile pHOx and Nova CO-Oximeter.
˙ / Qt
The Physiologic Shunt Calculation ( Qsp ˙ ) requires the calculation of the End Capillary
Oxygen Content (Cc'O2), Arterial Oxygen Content ( CaO2 ) and Mixed Venous Oxygen
Content ( CvO2 ):
Qsp ˙ = Cc′O2 − CaO2 × 100

˙ / Qt Equation 21
Cc′O2 − CvO2
Where: Cc′O2 = 1.39 × Hb × 1.0

CaO2 = 1.39 × Hb × SaO2 [from arterial sample]
CvO2 = 1.39 × Hb × SvO2 [from mixed venous ample]
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%.
 SO2  Equation 22
log P50 ( uncorrected ) = log PO2 − 0.37 log  
 100 − SO2 
log P50 ( corrected ) = log P50 ( uncorrected )

 PCO2 
+ 0.43(2.3)( pH − 7.4) − 0.05  log  − 0.031(2.3)(T − 37) Equation 23
 40 
B. Theory
* The equations are from Reference 4.
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. 1982. 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. Tietz, Norbert W., ed. 1986. Textbook of Clinical Chemistry. W.B. Saunders Co. Philadelphia, Penn.
B-9
B. Theory
B-10
Appendix C
C Appendix
Appendix C includes all the information needed to install the pHOx Analyzer.
Reference Electrode Sensors
Air Detector
W-Line
R-Line
Pump and Tubing

SO2 Sensor
DWG #10-1003A
Appendix C
Auto-Cartridge
Reagent Pack (Control Pack)
Figure C.1 pHOx Analyzer
C-1
C.1 pHOx Installation
1. Remove pHOx from box.

2. Install PCMCIA card in the slot on the bottom left corner of the back of the pHOx.
3. Verify the fuses are installed. (The fuse compartment is next to the power entry
module on the back of the pHOx.)
4. Install the power cord into the power entry module on the back of the pHOx.
C.1.1 Printer Paper Installation
1. Open the printer cover.

2. Open the printer lever. Gently pull the lever to its opposing position.
3. Remove the paper holder.
4. Insert the paper holder into a new roll of paper. The loose end of the paper should
feed from the bottom of the roll.
5. Install the roll of paper with holder into the support collars.
6. Push the paper through the back of the roller. Manually move the roller by using
the knob next to the platen.
7. Center the paper and close the printer lever by pushing the lever back to its original
position.
8. Feed paper through cover. Then close the printer cover.
Appendix C
B
002
10-1
G#
DW
Lever
Paper advance knob
Figure C.2 Installing the Printer Paper
C-2
Appendix C
C.1.2 SO2 Sensor Installation
1. Open the analytical compartment door (front of pHOx). Verify the Sensor module
is installed.
2. Verify the SO2 sensor is installed.
3. If not, remove the SO2 sensor from its packaging.
4. Install the sensor by sliding it into the SO2 position in the sensor module.
5. Tighten the lead screw.
DW G
#10-
1015
A
Figure C.3 Installing the SO2 Sensor
C.1.3 Reference Electrode Installation

W
1. Remove the reference electrode Reference
from its packaging. Electrode R
2. Place the new Reference Electrode
on top of the sensor module; align
the electrode sides with the
backplate sides. Ensure the refer-
ence electrode connector is seated
Appendix C
properly on the sensor module

interconnect tubing.
3. Push down on the retaining screw.
DWG #10-1011A
Figure C.4 Installing the Reference Electrode onto Sensor module
C-3
C.1.4 Pump Tubing Harness Installation
1. Remove the pump tubing from its packaging. Locate the half circle on
one of the manifolds. This is the top manifold.
2. Slide the top pump tubing manifold into its slots. The top manifold’s half
circle should line up with the half circle on the slot.
3. Stretch the pump tubing around the pump and slide the bottom manifold into its
slots.
7A
100
10-
G#
DW
-10
10
G#
R
W
DW
Figure C.5 Installing the Pump Tubing
Appendix C
C-4
Appendix C
C.1.5 Reference Line (R-line) Installation
1. Remove the R-line from its packaging.

2. Attach the R-line starting with the pinch valve. (Stretch the elastic segment of the
R-line and slide it into the pinch valve.)
3. Connect the top end of the R-line to the R-labeled outlet of the reference electrode.
4. Connect the bottom end to the outside port of the bottom pump manifold.
Figure C.6 Installing the R-line
Appendix C
C-5
C.1.6 Waste Line (W-line) Installation
1. Remove the W-line from its packaging.

2. Attach the W-line starting with the pinch valve. (Stretch the elastic segment of the
W-line and slide it into the pinch valve.)
3. Connect the top end of the W-line to the W-labeled outlet of the reference electrode.
4. Connect the bottom end to the inside port of the top pump manifold. (See Figure
C.1 for tubing location.)
Figure C.7 Installing the W-line
C.1.7 Sodium and pH Sensor Installation
1. Remove the Sodiun and pH sensors from there packaging.

2. Degas the Na+ sensor.
Hold the Na+ sensor with the cap downward. With a wrist-snapping
Appendix C
a.
motion, shake the sensor down to move air bubbles to the back of the sensor.
b. With the sensor tip still facing downward, observe the tip for bubbles. If
bubbles are present, tap the sensor with a finger to loosen the bubbles and
again shake the sensor down.
3. Insert the new Na+ and pH sensors into the sensor module; slide the sensor body
into the sensor module until the sensor clips into place. (Sodium is top left; pH is
top right; see Figure C.8.)
C-6
Appendix C
DWG
#10-1
001A
Figure C.8 Installing the Sensors
C.1.8 PO2 and PCO2 Sensor installation
1. Remove the PO2 / PCO2 sensor from its packaging.

2. Unscrew the protective PO2 / PCO2 cap from the PO2 / PCO2 body and dispose of it.
3. Take PO2 / PCO2 Premembraned Cap that is prefilled with internal filling solution.
Shake it gently to ensure that the solution is away from the threaded end and at the
membrane end. Unscrew and discard the shipping plug from the cap.
4. Insert the sensor body straight down (vertical position only to ensure no loss of
internal filling solution) into the filled cap and screw the cap onto the sensor body.
NOTE: The prefilled PO2 / PCO2 cap does not require any additional filling
solution. Do not add or remove any Internal Filling Solution. The prefilled
level of solution is all that is needed to operate the analyzer successfully.
Adding or subtracting from the prefilled level will effect the biosensor’s
performance. Appendix C
5. Degas the PO2 / PCO2 sensor.
a. Hold the sensor with the cap downward. With a wrist-snapping motion,
shake the sensor down to move air bubbles to the back of the sensor.
b. With the sensor tip still downward, observe the tip for bubbles. If bubbles
are present, tap the sensor with a finger to loosen the bubbles and again
shake the sensor down. Repeat if necessary.
6. Dry the sensor with a lint-free tissue. Take care not to touch the tip.
7. Insert the new PO2 / PCO2 sensor into the sensor module; slide the sensor body
into the sensor module until the sensor clips into place. (PO2 is bottom right; PCO2
is bottom left; see Figure C.8.)
C-7
C.1.9 Probe and Air Detector Installation
1. Verify the air detector, probe, and capillary adapter are installed properly. If not
installed, power on the pHOx and continue this procedure.
Enter.
3. Press Move Probe (soft key). Open the door.
4. Remove the probe and air detector from their packaging.
5. Place the probe into the air detector and slide both into the sampler assembly.
6. Push the air detector up to lock it in place.
7. Connect the air detector’s sample line to the sensor module
8. Install the 2-prong cable of the air detector to the analyzer.
9. Remove the capillary adapter from the reagent pack and gently push it on to the
sampler assembly.
10. Press Move probe to move sampler assembly down.
11. Press Cancel. Then press Cancel again to return to the Home screen.
DWG #10-1004A
Appendix C
Probe
Air detector
Figure C.9 Installing the Probe and the Air Detector
C-8
Appendix C
C.1.10 Reagent Pack Installation
1. Mix the reagent pack by inverting 10 times

2. Open the pHOx door.
3. Insert the pack into the left compartment.
4. Push pack inward (see Figure C.1). Ensure it is seating inside the lip of the analyzer.
5. Power on the pHOx. (Switch is near the power cord.)
6. Validating and Prime reagent pack
a. Press Menu from the Ready (Home) screen
b. Arrow down to select Change reagent pack. Press Enter.
c. Press Prime.
d. After Priming, a pop-up screen appears to question. Do you want to
calibrate? --- Press Yes to Calibrate.
C.1.11 Auto-Cartridge Quality Control Pack Installation
Setup of the controls is necessary to collect data. If the Lot Number of the new control pack is
different, all the previous data for the previous Lot Number will be erased. Remember to print out this
data before you change an Auto-Cartridge Control Pack with a different Lot Number.
NOTE: The analyzer will prompt you with a pop-up screen if the lot number
is different, giving you a Warning that all data will be deleted.
The Control Pack should be changed when the system indicates the pack has expired or is
empty. Install the Control Pack as follows:
1. Mix the reagent pack by inverting 10 times
2. Open the pHOx door.
3. Insert the pack into the right compartment.
4. Push pack inward (see Figure C.1). Ensure it is seating inside the lip of the analyzer.
5. From the Operational Menu screen, select Change Pack and press Enter.
6. From the pop-up screen, select Change Control Pack and press Enter.
7. Follow the directions on the screen to install the pack.
Appendix C
8. The control ranges are automatically read from the control pack during the Change
Control Pack procedure.
WARNING: When the control pack is removed, keep your fingers and hands
away from the back of the pack compartment. There are sharp needles that
can cause injury.
NOTE: The control pack must be replaced through the Change Control Pack option. If
you remove and replace a pack (even if it is the same pack) outside these
screens, you will not be able to prime the analyzer.
C-9
C.1.12 Calibration
After calibrating the pH, PCO2, PO2, Hct, and Na+ sensors, calibrate the SO2 and Hb using the
external standards.
1. Press Calibrate from the Ready (Home) screen.
2. Arrow down to External two Standard Hb, SO2% calibration.
3. Press Enter.
4. Enter in the Assay value for Std #1. Press enter.
5. Mix Calibrator #1 by inversion.
6. Open ampule and position the extended probe into the calibrator so that the
tip is well covered.
7. Press Continue. When the system signals by an audible alarm, remove the
ampule.
8. Press Analyze.
9. Repeat the procedure for Calibrator #2. Enter in the assay value.
10. Mix Calibrator #2 by inversion.
11. Open ampule and position the extended probe into the calibrator so that the
tip is well covered.
12. Press Continue. When the system signals by an audible alarm, remove the
ampule.
13. Press Analyze.
14. Set up Analyzer to meet the facilities needs.
15. Set up Quality Controls
16. Run quality controls as appropriate for lab/hospital.
Appendix C
C-10
A Cancel review 2-8

Capillary tube analyzing 3-12
Acceptable samples A-2 Carbon dioxide content (TCO2) B-5
Accession number, review 2-8 Channel lockout 2-9
Adapting to your requirements 2-4 Checking the air detectors 6-3
Air detector replacement 4-15 Checking the pump 6-2
Air detectors, checking 6-3 Checking the reference valve 6-2
Alveolar oxygen (A) B-7 Checking the sampler 6-2
Ampule analyzing 3-11 Checking the SO2 LEDs 6-3
Analog input 6-3 Checking the waste valve 6-2
Analysis configuration 2-5 Cleaning flowpath 4-13
Analysis mode 2-5 Cleaning the cabinet 4-19
Analysis rate A-2 Cleaning the Display 4-19
Analytical compartment 3-2 Clinical utility 1-3
Analyze keys 2-2 CO-Oximeter interface 6-6
Analyzer, lifting or moving A-4 Combined calculated results 1-2
Analyzing - capillary tube 3-12 Communications 2-9
Analyzing - syringe or ampule 3-11 Communications menu 2-6
Analyzing in AV Shunt Mode 3-13 Communications test 6-4
Analyzing samples 3-10 Computer interface 6-6
Anticoagulants 1-4 Conditioning sensor module 4-13
Arterial alveolar oxygen tension gradient (AaDO2) B-8 Configuration, analysis 2-5
Arterial alveolar oxygen tension ratio B-8 Configuration, calibration 2-5
Auto-Cartridge QC 3-6 Configuration, system 2-5
AV Shunt B-9, 1-3 Control pack changing 4-2
AV Shunt Mode 3-13 Controls A-5
B D
Bar code scanner 6-6 Data bits 2-6, 6-5
Barometer A-2 Definition of PCO2 B-2
Barometric pressure module 3-5 Definition of pH B-2
Base excess extracellular fluid (BE-ECF) B-6 Definition of PO2 B-3
Baud 2-6, 6-5 Dependencies, test 1-3
Bicarbonate concentration B-5 Deproteinizing probe 4-13
Blood gases 1-3 Deproteinizing sensor module 4-13
Bypass review 2-7 Dimensions A-4
Display 2-1, 3-3
C Display cleaning 4-19
Cabinet cleaning 4-19 Displays 2-4
Calculated parameters B-5, 1-2 Door 3-3
Calculated resolution A-1
Calculated results, combined 1-2
E
Calculated values B-4 Effects, matrix 1-5
Calibration B-1, C-10, 3-8 Electrical compliance A-4
Calibration 1-Point B-1 Electrical requirements 1-1
Calibration, 1-Point 3-9 Electrode methodology 3-4
Calibration 2-Point B-1 Electrode offsets setup 2-5
Calibration, 2-point 3-8 Electrode, reference 3-4
Calibration configuration 2-5 Electrodes 3-4
Calibration, Hb 3-8 Electrolyte resolution 2-5
Calibration, manual 3-8 Environmental A-4
Calibration sequence 5-2 Error log 6-4
Calibration, SO2 3-8 External keyboard 2-6, 6-6
i-1
Index
F Lockout, channel 2-9

Lockout, level 2-10
Flow test 5-7, 6-1 Lockout, QC 2-9
Flowpath cleaning 4-13 LoopBack test 6-4
Flowpath maintenance 4-3
Fluids, movement 3-6 M
Flushing reference electrode 5-10
Fuse requirements 1-1 Mandatory patient ID 2-5, 2-8
Manual calibration 3-8
H Matrix effects 1-5
Measured parameters 1-2
Handling requirements 1-4 Measurement range A-1
Hb calibration 3-8 Measuring technology A-2
Hb type 2-5 Method comparison A-3
Hematocrit B-3, 1-3 Mode A QC lockout 2-10
Hematocrit interference 1-5 Mode, analysis 2-5
Hemoglobin B-3, B-5, 1-3 Mode B QC lockout 2-10
Module, barometric pressure 3-5
I Module, sensor 3-4
Installation C-2, 1-1 Movement Of fluids 3-6
Air detector C-8
Auto-Cartridge QC Pack C-9
O
PCO2 Sensor C-7 O2 content difference B-8
pH Sensor C-6 O2Sat B-7
PO2 Sensor C-7 Offsets setup 2-5
Printer paper C-2 One-Point calibration 3-9
Probe C-8 One-point calibration B-1
Pump tubing harness C-4 Operating procedures 4-1
Reagent pack C-9 Operation 3-1
Reference electrode C-3 Operation configuration menu 2-5, 2-9
Reference line (R-line) C-5 Operational overview 3-7
SO2 Sensor C-3 Operator flow test 5-7
Sodium Sensor C-6 Operator passwords 2-6
Waste line (W-line) C-6 Ordering information A-9
Installing 2-1 Oxygen content (O2Ct) B-6
Intended use 1-2 Oxygen saturation B-7, 1-3
Interference, hematocrit 1-5
Interfering substances 1-5 P
Introduction 1-1
P50 B-9
K Parameter definitions B-2
Parameters, calculated 1-2
Keyboard, external 2-6, 6-6 Parameters, measured 1-2
Keypad 2-2, 3-3 Parity 2-6, 6-5
Keypad entry 2-3 Partial pressure of carbon dioxide (PCO2) B-2
Partial pressure of oxygen (PO2) B-3
L Parts A-9
Language 2-6 Password 2-6
Level lockout 2-10 Password protected 2-10
Lifting the analyzer A-4 Password, system 2-6
Lights, status 2-2 Passwords, operator 2-6
Limits setup 2-5 Passwords, system 2-6
Linearity solutions 3-10 Patient ID 2-5
i-2
Patient ID, mandatory 2-8 QC procedures A-6

Patient name 2-5 QC samples, running 3-10
Patient name, review 2-8 QC setup 2-9
PCO2 1-3 Quality Control A-7, 3-9
PCO2, definition of B-2
PCO2 measurement, principle of B-2 R
PCO2 sensor 4-4 Range, measurement A-1
PCO2 sensor replacement 4-4 Ready to analyze 3-7
PDM interface 6-6 Reagent pack A-6, 3-5
Peristaltic pump 3-5 Reagent pack changing 4-2
pH 1-3 Reagents A-5
pH conditioning 5-7 Recall, results 3-14
pH, definition of B-2 Reference electrode 3-4
pH sensor B-2 Reference electrode flushing 5-10
pH sensor replacement 4-3 Reference electrode replacement 4-7
pHOx components 3-1 Reference line replacement 4-12
Physiologic shunt 1-3 Reference values A-8
Physiologic shunt calculation B-9 Reference valve checking 6-2
Pinch valve 3-5 Remote control 2-11
PO2 1-3 Remote review 2-5, 2-7
PO2, definition of B-3 Requirements 1-1
PO2 measurement, principle of B-3 Results configuration menu 2-5, 2-7
PO2 sensor 4-6 Results data, send 2-7
PO2 sensor polishing 4-6 Results data, suppress 2-7
PO2 sensor replacement 4-6 Results recall 3-14
Power A-4 Results, retransmit 3-14
Power up procedure 2-1 Results suppression 2-8
Precision A-3 Retransmit the results 3-14
preheater 3-4 Review accession number 2-8
Principle of PCO2 measurement B-2 Review patient name 2-8
Principle of PO2 measurement B-3 Rotary valve operation 6-1
Printer 2-6, 3-3 RS-232 serial ports 6-5
Printer paper replacement 4-14 Running QC samples 3-10
Printer test 6-4
Privilege Level 1 2-6 S
Privilege Level 2 2-6
Privilege Level 3 2-6 Sample 1-4
Probe maintenance 4-3 Sample number counter 4-1
Probe replacement 4-15 Sample volume A-2
Proficiency samples 3-10 Sampler 3-3
Pump checking 6-2 Sampler, checking 6-2
Pump, peristaltic 3-5 Scheduled maintenance 4-1
Pump tubing replacement 4-10 Screen messages, level lockout 2-11
Screen messages, Mode A 2-11
Q Screen messages, Mode B 2-11
Send results data 2-7
QC, Auto-Cartridge 3-6 Sensor calibration B-1
QC lockout 2-9 Sensor module 3-4
QC lockout, Mode A 2-10 Sensor module conditioning 4-13
QC lockout, Mode B 2-10 Sensor module replacement 4-17
QC Lockout OFF 2-10 Sensor subsystem screens 6-1
QC Lockout, password protected 2-10 Serial ports, RS-232 6-5
i-3
Index
Service menu 6-1 System configuration 2-5

Setup 2-1 System password 2-6
Setup options 2-5 System passwords 2-6
Shunt calculation, physiologic B-9 System test 6-3
Shunt, Physiologic 1-3
Shutdown procedure A-11 T
Slope limits A-2 Temperature A-4
SO2% concentration B-4 Temperature correction for measured values B-4
SO2 calibration 3-8 Test characters 6-4
SO2 LEDs checking 6-3 Test dependencies 1-3
SO2 maintenance 4-9 Theory B-1
Sodium sensor replacement 4-3 Troubleshooting 5-1
Soft keys 2-2 Two-point calibration B-1, 3-8
Solutions A-5
Specifications A-1 U
Standard bicarbonate concentration (SBC) B-6
Standby mode 4-3 Units setup 2-5
Stat mode 3-13
Status codes 5-4, 5-5, 5-6
V
Status lights 2-2 Valves, pinch 3-5
Status symbols 2-2 Verifying performance A-6
Stop 2-6
Stop bits 6-5 W
Substances, interfering 1-5
Supplies A-9 Warranty A-11
Suppress results data 2-7 Waste line replacement 4-11
Suppression, results 2-8 Waste valve checking 6-2
Symbols, status 2-2 Weight A-4
Syringe analyzing 3-11 Working area requirements 1-1
i-4
Stat Profile pHOx
WARRANTY REGISTRATION CARD
CUSTOMER COPY
(to be retained by customer)
Unit sold by: Analyzer Serial No.

Delivery Date
Distributor
Address
City State Zip
THIS IS YOUR WARRANTY

TO PROTECT YOURSELF - MAIL IN FACTORY COPY
RETAIN THIS COPY IN YOUR FILES
Cut and detach before mailing
WARRANTY REGISTRATION CARD Stat Profile pHOx
FACTORY COPY
(to be sent to Waltham, Massachusetts) Analyzer Serial No.
Delivery Date
Operator name
Laboratory
Company or institution
Address Telephone No. ( )
City State Zip
Distributor purchased from:
Distributor Location: City State Zip
Installed by: Date
(Customer Signature)
NOVA BIOMEDICAL
CUSTOMER’S WARRANTY
STAT PROFILE pHOx ELECTROLYTE ANALYZER
Subject to the exclusions and upon the conditions specified below, Nova Biomedical The following exceptions apply:
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 1. The sodium electrode is warranted for one (1) month pH, PCO2, PO2, and
part of an instrument which fails within one (1) year after delivery to the customer reference electrodes are warranted for six (6) months from the date of installation,
because of defective material or workmanship. This warranty does not include provided they are stored at room temperature and placed into service prior to the
normal wear from use and excludes: (A) Service or parts required for repair to use before date on the packaging. In the event that an electrode does not meet that
damage caused by accident, neglect, breakage, misuse, altering the Nova equipment, use life, then Nova Biomedical will replace that electrode at no charge under this
warranty. This warranty is invalid under the conditions specified after item 3.
unfavorable environmental conditions, electric current fluctuations, work per-
2. Consumable items, including the reagent pack, calibration gases, replaceable
formed by any party other than an authorized Nova representative, or any force of membranes, tubing and tubing harnesses, electrolyte solutions, external standards,
nature; (B) Work which, in the sole and exclusive opinion of Nova, is impractical and septum assemblies are warranted to be free of defects at time of installation. The
to perform because of location, alterations in the Nova equipment or connection of item must be placed into service prior to the expiration date printed on the
the Nova equipment to any other device; (C) Specification changes; (D) Service packaging. All defects must be promptly reported to Nova Biomedical in writing.
required to parts in the system contacted or otherwise affected by expendables or This warranty is invalid under the conditions specified after item 3.
reagents not manufactured by Nova which cause shortened life, erratic behavior, 3. Freight is paid by the customer.
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 The above warranties are invalid if:
unauthorized third party; or (F) Instrument refurbishing for cosmetic purposes. All 1. The date printed on the package label has been exceeded.
parts replaced under the original warranty will be warranted only until the end of the original 2. Non-Nova Biomedical reagents or controls are used, as follows:
instrument warranty. All requests for warranty replacement must be received by Nova or their Nova Biomedical will not be responsible for any warranties on electrodes,
authorized distributor within thirty (30) days after the component failure. Nova Biomedical tubing, probes, septa, or other parts if these parts are used in conjunction with and
reserves the right to change, alter, modify or improve any of its instruments without are adversely affected by reagents, controls, or other material not manufactured
any obligation to make corresponding changes to any instrument previously sold or by Nova but which contact or affect such parts. Reagent formulations not
manufactured by Nova Biomedical may contain acids, concentrated salt solu-
shipped. All service will be rendered during Nova’s principal hours of operation. All
tions, and artificial preservatives that have been shown to cause problems such as
requests for service outside Nova’s principal hours of operation will be rendered at shortened electrode and septa life, electrode membrane damage, electrode drift,
the prevailing weekend/holiday rates after receipt of an authorized purchase order. erratic analytical results, and inaccurate instrument performance.
Contact Nova for specific information.
THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER OBLIGA-
TIONS AND LIABILITIES INCLUDING NEGLIGENCE AND ALL WARRAN-
TIES, 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.
IN ORDER FOR THE WARRANTY TO BE EFFECTIVE, THE WARRANTY
CARD MUST BE SENT TO NOVA BIOMEDICAL, 200 PROSPECT STREET,
WALTHAM, MA 02454-9141, USA.
INSTRUCTIONS
NO POSTAGE 1. FILL OUT COMPLETELY.
NECESSARY IF
MAILED IN THE 2. In order for the Warranty to be effec-
UNITED STATES
tive, the warranty cards must be signed
and dated as of the date of delivery and
sent to NOVA BIOMEDICAL,
WALTHAM, MASSACHUSETTS.
BUSINESS REPLY MAIL
FIRST CLASS PERMIT NO. 47966 WALTHAM, MA
3. Retain one card for your files.
POSTAGE WILL BE PAID BY ADDRESSEE
Nova Biomedical
NOVA Biomedical
200 PROSPECT STREET
PO BOX 9141
WALTHAM, MA 02254-9825
02454-9141
1. Intro.
1.3 The Sample

Sodium or lithium heparin whole blood sample from syringes, open tubes, small cups, and
capillary tubes can be used on the Stat Profile pHOx Analyzer. The sample size is 70 µL for
normal mode and 40 µL for micro mode (blood gases only).
1.3.1 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. National Committee for Clinical Laboratory Standards. Considerations in the Simultaneous Mea-
surement of Blood Gases, Electrolytes, and Related Analytes in Whole Blood; Proposed Guideline.
NCCLS Document C32-P. Vol. 13, No. 17.
1.3.2 Acceptable Anticoagulants
Sodium and lithium heparin are the recommended anticoagulants for use with the Stat Profile
pHOx Analyzer. EDTA, citrate, oxalate, or sodium fluoride are not recommended 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 be
obtained. Liquid heparin when present in excess may cause errors by dilution in pH, PCO2, and
PO2.
Our experience suggests that lyophilized lithium heparin giving a final concentration in blood
of not more than 20 I.U. per mL is acceptable in the critical care laboratory. Stat Profile pHOx
Analyzer users should take careful note of these considerations when establishing reference
intervals and interpreting results.
1-4
3.12 Auto-Cartridge QC
Nova Biomedical's Auto-Cartridge QC is a total automated control system contained within

a single on-board reagent cartridge. This system allows any level of quality control to be run
at any time: either on a programmed schedule or on demand. The Auto-Cartridge QC system
reduces costs by eliminating the time and labor required to manually perform quality control.
Each Nova Auto-Cartridge contains 3 levels of blood gas controls, 2 levels of hematocrit,
SO2%, and hemoglobin controls, plus software that automates running controls and storing
3. Operation
quality control data. When the cartridge is installed, all quality control target ranges, lot code,
and expiration date information is automatically downloaded to the analyzer. The user then
programs the pHOx Analyzer to automatically analyze up to 3 quality control levels, 3 times
per day (a total of 9 analyses per day). If any analyte is outside the target range, it is
automatically reanalyzed. If a control value remains out of range, the user is notified.
All quality control data is automatically stored. Daily and cumulative statistical reports and
Levey-Jennings graphs can be printed at any time. This automation assures that quality control
is always performed accurately and on schedule, thereby guaranteeing regulatory compliance.-
3.13 Movement Of Fluids
To begin an analysis, press the Capillary or Syringe key to move the sampler to either the
capillary or syringe position. Present the sample to the probe and press either Aspirate Normal
or Aspirate Micro (soft keys). The Aspirate Normal soft key allows for the aspiration of 70 µL
of sample, and the Aspirate Micro soft key allows for the aspiration of 40 µL of sample. The
sample is aspirated by the peristaltic pump until the leading edge is detected by either the 40
µL or 70 µL air detector. After the aspiration is completed, there is an audible beep and a pop-
up display that prompts you to press Analyze after removing the syringe or capillary. The
sample is advanced until the leading edge is properly located in front of the electrodes. Once
all measurements have been completed, the sample is pumped to the waste and the flow path
is washed.
3-6
Acceptable Samples: Whole Blood (heparinized)
Measuring Technology: Ion Selective Electrodes (Na+, pH, PCO2)

Amperometry (PO2)
Conductivity (Hematocrit/Hemoglobin)
Reflectance Photometry (Oxygen Saturation/Hemoglobin)
Analysis Rate: Stat Analysis Time Throughput Time

45 seconds 60 seconds
Sample Volume: 40 microliters whole blood micro sample for blood gases
70 microliters whole blood sample size for full panel
Barometer: 400 - 800 ±1 mmHg, accurate to 1.5 mmHg
Slope Limits: pH 9.1 - 11.6

PO2 -15.0 - (-1.6)
PCO2 7.9 - 12.6
Hct 12.0 - 50.0
Na+ 8.3 - 12.0
SO2 6.9 - 18.2
Slope and Offset Limits: Slope Offset

pH N/A lower -0.1
upper 0.1
PCO2 lower 0.80 lower -10.0
PO2 lower 0.90 lower -20.0
Appendix A

SO2 lower 0.90 N/A
upper 1.1
Hct lower 0.80 lower -10.0
Hb lower 0.9 lower -2.0
upper 1.1 upper 2.0
A-2

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Reference Manual

Nova Biomedical Corporation

Equipment Description: Model - Stat Profile® pHOx® Analyzer

Year of Manufacture: See serial number showing date.

Applicable Directives: 73/23/EEC, Low Voltage Directive

89/336/EEC, EMC Directive

Applicable Standards: EN 61010-1/A2:1995, EN 61010-2-010/A1:1996

Type Examination Certificate: GS-mark License Number AL 01 06 20747 011

Authorized by : ________________________ 3/15/99

Nova Stat Profile® pHOx® Reference Manual

Part Number and Ordering Information

FAX: (781) 893-6998 (in the U.S.A.) or

For technical assistance, call Nova Biomedical Technical Services at:

FAX: (781) 894-0585

Trademarks and Patents

Stat Profile® and pHOx® are registered trademarks of Nova Biomedical.

Printed in the U.S.A. Copyright 2001, Nova Biomedical, Waltham, MA 02454-9141.

Note: U.S. Legislative Requirements — Nova Analyzers

Cross-Reference Table for NCCLS Guideline

NCCLS Guideline Stat Profile pHOx Reference Manual

1. Principle of Test Appendix B: Sections B.2 to B.2.6

PN 22363 Rev. D 6/2001 TOC-1

4 Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . 4-1

TOC-2 PN 22363 Rev. D 6/2001

4.2.8 SO2 Sensor Maintenance ........................................................................... 4-9

6 Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

PN 22363 Rev. D 6/2001 TOC-3

TOC-4 PN 22363 Rev. D 6/2001

PN 22363 Rev. D 6/2001 TOC-5

TOC-6 PN 22363 Rev. D 6/2001

Working Area Requirements:

1.2 Intended Use, Tests Performed, and Clinical Utility

• Base Excess of the blood (BE-b)

1.3 The Sample

1.3.1 Handling Requirements

1.3.2 Acceptable Anticoagulants

1.3.4 Matrix Effects

1.4 About This Reference Manual

This manual is for Stat Profile pHOx Analyzer.

The analyzer is initially installed by a factory authorized representative.

CAUTION: The pHOx analyzer is designed to be left on with adequate fluids

2.2 Power Up Procedure

2.3 Using the Keypad and Display

Next Screen moves you to the next screen in the sequence.

2.3.1 General Keypad Entry

Number Keys Analyze Syringe

Figure 2-1. Stat Profile pHOx Keypad

2.4 Overview of the Displays (User Interface)

Here are some general rules for the user interface:

• To perform any operation, use the screen instructions to guide you.

• Press Exit (soft key) to return to the previous display.

• A status message indicates an error condition.

Use the Setup Menu to adapt the analyzer to your requirements.

2.6 Setup Options

The Setup Menu has the following setup options:

- External Keyboard: Yes or No

Set up Operator Passwords as follows:

2.6.2 Results Configuration Menu

2.6.2.1 Remote Review

Features of Remote Review are as follows: