Stat Profile pHOx Reference Manual Rev D June 2001

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 : ________________________ Francis C. Manganaro President Nova Biomedical Corporation

3/15/99 Date

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 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 1.2 1.3

1.4

2

Installation ... 1-1 1.1.1 Requirements ... 1-1 Intended Use, Tests Performed, and Clinical Utility ... 1-2 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 About This Reference Manual ... 1-5

Setup... 2-1 2.1 2.2 2.3 2.4 2.5 2.6

2.7 2.8

Installing the Stat Profile pHOx ... 2-1 Power Up Procedure ... 2-1 Using the Keypad and Display ... 2-1 2.3.1 General Keypad Entry ... 2-3 Overview of the Displays (User Interface) ... 2-4 Adapting the Program to Your Clinical Requirements with the Setup Menu ... 2-4 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 QC Setup ... 2-9 2.7.1 QC Lockout ... 2-9 Remote Control ... 2-11

PN 22363 Rev. D 6/2001

TOC-1

Table of Contents 3

Operation... 3-1 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16

3.17

3.18

3.19

4

Operating Procedures... 4-1 4.1 4.2

TOC-2

Display and Door ... 3-3 Keypad ... 3-3 Printer (Optional) ... 3-3 Sampler ... 3-3 Sensor Module ... 3-4 Sensors ... 3-4 Reference Electrode ... 3-4 Barometric Pressure Module ... 3-5 Pinch Valves ... 3-5 Peristaltic Pump ... 3-5 Reagent Pack ... 3-5 Auto-Cartridge QC ... 3-6 Movement Of Fluids ... 3-6 Operational Overview ... 3-7 Ready to Analyze ... 3-7 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 Quality Control ... 3-9 3.17.1 Running QC Samples ... 3-10 3.17.2 Running Linearity Solutions/Proficiency Samples ... 3-10 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 Results Recall ... 3-14

Sample Number Counter ... 4-1 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 PN 22363 Rev. D 6/2001

Nova Stat Profile pHOx Reference Manual

4.3

5

Troubleshooting... 5-1 5.1 5.2 5.3 5.4 5.5

6

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 Display/Cabinet Cleaning ... 4-19

Troubleshooting Procedures ... 5-1 Stat Profile pHOx 2-Point Calibration Sequence ... 5-2 Status Codes ... 5-4 pH Conditioning ... 5-7 Troubleshooting Flow Problems ... 5-7 5.5.1 Operator Flow Test ... 5-7 5.5.2 Flushing the Reference Electrode ... 5-10

Service Menu... 6-1 6.1

6.2 6.3 6.4 6.5 6.6 6.7

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 Analog Input ... 6-3 System Test ... 6-3 Printer Menu ... 6-4 Error Log ... 6-4 Communications Test ... 6-4 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

7.2

A

Appendix... A-1 A.1 A.2

A.3 A.4 A.5 A.5

TOC-4

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 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

Stat Profile pHOx Specifications ... A-1 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 Reference Values ... A-8 Ordering Information ... A-9 Shutdown Procedure ... A-11 Warranty ... A-11

PN 22363 Rev. D 6/2001

Nova Stat Profile pHOx Reference Manual B

Theory... B-1 B.1

B.2

B.3

C

Sensor Calibration ... B-1 B.1.1 Two-Point Calibration ... B-1 B.1.2 One-Point Calibration ... B-1 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 Calculated Values ... B-4 B.3.1 Temperature Correction for Measured Values* ... B-4 B.3.2 Calculated Parameters ... B-5

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 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.

1.1

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

1. Intro.

1

1. Intro.

Stat Profile pHOx Reference Manual 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 ˙ (physiological shunt - requires 2 samples: mixed venous and arterial) Qsp 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

• • • •

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: (PCO2, PO2, and pH)

Whole blood measurement of blood gases is used in the diagnosis and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases.

Oxygen Saturation

Used to assess the oxygenation of hemoglobin and the adequacy of tissue 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 Shunt

The physiologic shunt or AV Shunt calculation relates to the small fraction 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 pathophysiologic 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.

Test Dependencies

1. Intro.

Stat Profile pHOx Reference Manual 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 Measurement 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 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.

1.4

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.

Stat Profile pHOx Reference Manual

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

Stat Profile pHOx Reference Manual 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.

2. Setup

Soft Keys

2-2

2 Setup 2.3.1 General Keypad Entry

Soft Keys Analyze Capillary Number Keys

Green LED Yellow LED

1

2

3

4

5

6

7

8

9

0

Analyze Syringe

Up, Down, Left, Right Keys ENTER

Enter Key Figure 2-1. Stat Profile pHOx Keypad

2-3

2. Setup

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.