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:	[phone]	(in the U.S.A.) or
	[phone]	(outside the U.S.A.)

Technical Assistance

For technical assistance, call Nova Biomedical Technical Services at:

Telephone:	1-800-545-NOVA or
	[phone]
FAX:	[phone]

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 performance. 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

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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

Nova Stat Profile pHOx Reference Manual

		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

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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

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PN 22363 Rev. D 6/2001

Nova Stat Profile pHOx Reference Manual

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.3	B.2.6 SO2 % Concentration ................................................................................		B-4
		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

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Table of Contents

TOC-6

PN 22363 Rev. D 6/2001

1 Introduction

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 (wasteline, 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.

1.1Installation

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.

.Intro .1

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

1. Intro.

Stat Profile pHOx Reference Manual

1.2Intended 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)

•	˙	˙
	Qsp / Qt (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
•	CaO
•	- 2
	CvO2
•	-
	avDO2

•P50

1-2

1 Introduction

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.

.Intro .1

1-3

1. Intro.

Stat Profile pHOx Reference Manual

1.3The 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 L for normal mode and 45 L 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 Measurement of Blood Gases, Electrolytes, and Related Analytes in Whole Blood; Proposed Guideline.

NCCLS Document C32-P. Vol. 13, No. 17.

1.3.2Acceptable 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

1.3.3 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/ L may increase the hematocrit value.

.Intro .1

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 appropriately, 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 maintenance. For example, a high number of cardiopulmonary bypass pump or ECMO (extracorporeal 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.

1.4About 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.

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Stat Profile pHOx Reference Manual

1. Intro.

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2 Setup

2 Setup

This section describes how to setup the Stat Profile pHOx Analyzer.

2.1Installing 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.

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2.2Power 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.

2.3Using 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.

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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.
	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.

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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 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		0												Right Keys
						ENTER

Enter Key

Figure 2-1. Stat Profile pHOx Keypad

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2.4Overview 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).

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.

2.5Adapting the Program to Your Clinical Requirements with the Setup Menu

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

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2.6Setup Options

The Setup Menu has the following setup options:

•Results Configuration Menu

-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

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Stat Profile pHOx Reference Manual

•Communications Menu

-Baud (4800, 9600, 19200)

-Data Bits (7, 8)

-Stop (1,2)

-Parity (None, Even, Odd)

-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

2.6.1Password

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.

5Key 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.

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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
	3.	Scroll down with the arrow keys to the Password option and press Enter. A pop-up
			Setup
		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.

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Stat Profile pHOx Reference Manual

	• 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.
Setup	The patient name will be displayed and printed with the result data if the patient name
	entry feature is ON.
	• Review Accession Number: PDM can return an accession number with the suppressed
2.	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.

2.6.2.3Mandatory 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.

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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 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.

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2.7QC 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 popup 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.

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Stat Profile pHOx Reference Manual

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.

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.

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