Stat Profile pHOx Training Manual Rev B July 2001

Table of Contents

Stat Profile pHOx Training Manual

QUICK REFERENCE Key Facts (pHOx) ... QR-1 Maintenance Planner ... QR-2 Resolving Results Problems ... QR-3 Key Facts (BioProfile pHOx)... QR-4

Preface Stat Profile pHOx Customer Training Programs ... i Learning Objectives ... ii

1

System Identification ... 1-1

1.1 1.2

System Overview ... 1-1 Flow Overview ... 1-3 1.2.1 Reagents ... 1-3 Flow Components ... 1-3 1.3.1 Reagent Pack ... 1-3 1.3.2 Reagent Harness ... 1-4 1.3.3 Pinch Valves... 1-4 1.3.4 Peristaltic Pump ... 1-4 1.3.5 Sampler Assembly - Sample Probe ... 1-4 1.3.6 Sensor Module ... 1-5 1.3.7 Sensors ... 1-5 1.3.8 Reference Electrode ... 1-6 1.3.9 Sensor Blanks ... 1-6 1.3.10 Interconnect Tubing ... 1-6 1.3.11 Barometric Pressure Module ... 1-6 1.3.12 Pump Tubing ... 1-7

1.3

2 Running an Analysis ... 2-1 2.1 2.2

2.3 2.4 2.5 2.6

Is the Instrument Ready for Analysis? ... 2-1 2.1.1 Home Screen ... 2-1 Patient Samples - Acceptable Samples/Sample Handling ... 2-1 2.2.1 Acceptable Samples ... 2-1 2.2.2 Acceptable Anticoagulants ... 2-2 2.2.3 Syringe Handling Tips ... 2-2 2.2.4 Capillary Handling Tips ... 2-3 2.2.5 Sample is Presented and Analysis Occurs ... 2-3 Sample Information ... 2-4 Results Screen and Printout ... 2-4 Running an Analysis Exercise ... 2-4 Standby Mode ... 2-4

PN 24302 Rev. B 7/2001

TOC-1

Table of Contents

Stat Profile pHOx Training Manual 3

Operational Status ... 3-1

3.1 3.2 3.3

Home Screen - Ready for Analysis ... 3-1 Questionable Results ... 3-1 System Status Screen ... 3-1

4

Calibrating the Analyzer ... 4-1

4.1 4.2 4.3

Full 2-Point Calibration - all except Hb and SO2 ... 4-1 Calibration Timing ... 4-1 Other Types of Calibration ... 4-2 4.3.1 SO2 and Hb Calibration ... 4-2 4.3.2 Single Point Calibration for Non-Gas Sensors ... 4-2

5

Using and Handling Controls ... 5-1

5.1

Controls ... 5-1 5.1.1 Stat Profile pHOx Controls ... 5-1 Handling Controls ... 5-1 5.2.1 Storage Temperature ... 5-1 5.2.2 Stability of Opened Ampules ... 5-2 5.2.3 Altitude and Barometric Pressure Effects ... 5-2 When to Use ... 5-2 Using the Stat Profile pHOx's On-Board QC Features ... 5-2 5.4.1 The QC Soft key ... 5-3 5.4.2 Automatic QC Analysis (Internal) ... 5-3 5.4.3 Manual QC Analysis (External)... 5-3 QC Data ... 5-7 5.5.1 View Today's Data ... 5-7 5.5.2 View Daily Statistics ... 5-7 5.5.3 View Monthly Statistics ... 5-8 5.5.4 Printing Levey-Jennings Charts ... 5-9

5.2

5.3 5.4

5.5

TOC-2

6

Replacing Reagents and Paper ... 6-1

6.1 6.2 6.3 6.4 6.5

When to Replace ... 6-1 How to Replace ... 6-1 Replacing the Reagent Pack ... 6-1 Replacing the Control Pack ... 6-1 Replacing the Printer Paper ... 6-1

7

Troubleshooting ... 7-1

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8

Sensor Screens ... 7-1 System Test ... 7-1 Error Log ... 7-2 Flow Related Problems ... 7-2 Sensor Problems ... 7-3 Results Related Problems ... 7-3 Miscellaneous Problems - Operational ... 7-3 Call Nova... 7-3

PN 24302 Rev. B 7/2001

Table of Contents

Stat Profile pHOx Training Manual

8

Flow Test and Flushing ... 8-1

8.1

8.2 8.3

Manual Flow Test Lab ... 8-1 8.1.1 Water (Flow) Test ... 8-4 8.1.2 Pump Test ... 8-5 8.1.3 Flushing Sensor Module, Air Detector, and Probe ... 8-7 8.1.4 Flushing the Reference Electrode ... 8-8 Flushing the Entire Flow Path ... 8-9 Reference Solution Test ... 8-12

9

Maintenance ... 9-1

9.1

Logging Maintenance ... 9-1 9.1.1 Maintenance Log Sheets ... 9-1

10

Routine Maintenance ... 10-1

10.1 10.2

Overview ... 10-1 General Maintenance Procedures... 10-1 10.2.1 Suggested Daily Start-up Procedure ... 10-2 10.2.2 Flowpath Cleaning/Deproteinizing ... 10-2 10.2.3 Flow Cell Conditioning ... 10-5

11

Maintaining Sensors ... 11-1

11.1

Overview ... 11-1

12

Periodic Maintenance ... 12-1

12.1

12.2

Replacement of Pump Tubing, R-Line, and W-Line ... 12-1 12.1.1 Pump Tubing Replacement ... 12-2 12.1.2 Waste Line Replacement ... 12-3 12.1.3 Reference Line Replacement ... 12-4 Probe and Air Detector Replacement ... 12-5

13

Setup ... 13-1

13.1

Adapting the Analyzer to Meet Your Requirements ... 13-1 13.1.1 Data Input Display Options ... 13-1 13.1.2 General Operating Options ... 13-2 Inputting Selections ... 13-2 Setup Menu Checklist ... 13-3 13.3.1 Results Configuration Menu Checklist ... 13-4 13.3.1.1 Reference & Alert Limits Setup Checklist 13-5 13.3.1.2 Electrode Offsets Setup Checklist ... 13-6 13.3.1.3 Results Units Setup Checklist ... 13-7 13.3.1.4 Results Suppression Checklist... 13-8 13.3.1.5 Remote Review... 13-9 13.3.1.6 Patient Name ... 13-9 13.3.1.7 Mandatory Patient ID ... 13-9

13.2 13.3

PN 24302 Rev. B 7/2001

TOC-3

Table of Contents

Stat Profile pHOx Training Manual 13.3.2 Operation Configuration Checklist ... 13-10 13.3.2.1 Analysis Configuration Checklist ... 13-11 13.3.2.2 Calibration Configuration Checklist ... 13-12 13.3.2.3 System Configuration Checklist ... 13-13 13.3.2.4 Analysis Mode Checklist ... 13-15 13.3.2.5 Hb Type Checklist ... 13-15 13.3.2.6 Stat Mode ... 13-15 13.3.3 Communication Menu Checklist ... 13-16 13.3.4 Printer Checklist ... 13-17 13.3.5 System Password Checklist ... 13-18 13.3.6 Operator Password Checklist ... 13-18 13.3.7 Language Checklist ... 13-19

14

QC Setup ... 14-1

14.1

QC Setup Checklist ... 14-1 14.1.1 Control Lot Checklist ... 14-3 14.1.2 Expiration Date Checklist ... 14-3 14.1.3 Daily Analysis Time Checklist ... 14-4 14.1.4 QC Lockout Checklist ... 14-5 14.1.5 Set Ranges Checklist ... 14-5

15

Troubleshooting Lab ... 15-1

15.1

Troubleshooting Exercises ... 15-1 Problem #1 ... 15-2 Problem #2 ... 15-2 Problem #3 ... 15-3 Problem #4 ... 15-3 Problem #5 ... 15-4 Problem #6 ... 15-4

16

Examination/Evaluation ... 16-1

16.1

Certificate and C.E.U. Credits ... 16-1 Training Examination... 16-3 Training Evaluation ... 16-7

A

Appendix ... A-1

A.1

Technical Assistance ... A-1 A.1.1 Telephone Technical Support (Hot Line) ... A-1 A.1.2 Field Service Support ... A-2 Ordering Parts ... A-3 A.2.1 Recommended Spare Parts... A-3 Warranty Replacements ... A-4 Emergency (After Hours) Parts Shipments... A-4 Reaching your Nova Sales Representative ... A-4

A.2 A.3 A.4 A.5

TOC-4

PN 24302 Rev. B 7/2001

Quick Reference

Stat Profile pHOx Training Manual

Key Facts (pHOx and pHOx Basic) NOTE: The pHOx Basic Analyzer measures only pH, PCO2, and PO2. Sample Volume:

45 microliters whole blood (Micro sample) 70 microliters whole blood (Normal sample)

Slope Limits: pH PCO2 PO2 SO2 Na+ Hct Measurement Range: pH PCO2 PO2 SO2 Hb Hct

9.1 - 11.6 7.9 - 12.6 (-15.0) - ( -1.6) 6.9 - 18.2 8.8 - 11.5 12.0 - 50.0

6.50 - 8.00 3.0 - 200 0 - 800 0.0 - 100 4.0 - 24.0 12 - 70

pH units mmHg mmHg % g/dL %

H+ 316.23 - 10.00 nmol/L 0.4 - 26.7 kPa 0.0 - 106.7 kPa 0.0 - 1.0 40.0 - 240.0 g/L 2.5 - 14.9 mmol/L

Dependency Rule and Information: Hct Requires Na+ calibrated for calibration/results. PCO2 Requires pH calibrated for results. (pH is checked on standards to assure bicarb is correct.) SO2 Requires Hct and PO2 calibrated for results (uses calculated SO2 if measured SO2 is not available). Hgb Requires Hct and SO2 for reporting. Priority: 1. If linked with the CO-Ox, then CO-Ox Hgb is reported. 2. If no CO-Ox or measured result, calculated result from Hct reading (Hct/3) is reported. 3. If no CO-Ox, no measured, and no Hct, analyzer reports Default Value (Hgb). P50 Measured reported only with PO2 between 30 and 75 mmHg. P50c is reported when PO2 is outside above limits. Also P50 requires calibrated SO2% and Hgb/Hct for reporting. Qsp Qt Requires 2 separate blood samples for determination: mixed venous and arterial. RI Utilizes input or default FIO2% for calculation. Calculated Results Requires calibrated and proper results by measured tests used in calculation. Suppression (Hgb) Only Hgb can be suppressed. Your option is to turn Hgb from measured to calculated (one or the other will always appear). Option is done in the Setup Menu.

Update to PN 24302 Rev. B 3/2002

QR-1

Quick Reference

Stat Profile pHOx Training Manual

Maintenance Planner NOTE: For the BioProfile pHOx, SO2 is not applicable.

Weekly

Monthly

Reposition Tubing in Pinch Valves Record Slopes

Calibrate SO2

Clean SO2 Sensor and Cuvette

Quarterly

Replace Pump Tubing Replace W-line Replace R-line

As Needed Deproteinize Probe/Sensor Module

Replace Probe

Replace Reagent Pack

Replace PO2 Cap

Condition pH Sensor

Replace Control Pack

Replace PCO2 Cap

Replace Sensors

Replace Printer Paper

QR-2

Quick Reference

Stat Profile pHOx Training Manual

Resolving Results Problems Flow problems are often accompanied by sensor related problems. Do not change sensors or membranes until flow problems have been resolved first.

NOTE: For the BioProfile pHOx, use protein solution instead of whole blood; blood gases are just gases; SO2 is not applicable. Blood Gases PO2/PCO2

SO2

Results High

Verify controls are at room temperature

or Low

Check for low slope

Results High or Low

Recalibrate, clean cuvette and sensor, inspect or replace washer

Change membrane

pH

Change sensor

Results High

Verify controls are at room temperature

Debubble sensor

or Low

Check for low sensor slope (<9.5)

Condition sensor module w/whole blood

Condition w/pH Conditioning Solution

Calibrate

Condition sensor module w/whole blood

Check for air leak in system

Verify reference solution delivery

Clean probe and preheater

Change pH sensor

Check waste line for restrictions

Change reference electrode

QR-3

Quick Reference

Stat Profile pHOx Training Manual

Key Facts (BioProfile pHOx) Sample Volume:

300 microliters sample size for full panel

Slope Limits: pH PCO2 PO2 Measurement Range: pH PCO2 PO2 BarP

9.1 - 11.6 7.9 - 12.6 (-15.0) - (-1.6)

5.00 - 8.00 pH units 3.0 - 200 mmHg 0 - 800 mmHg 400.0 - 800.0 mmHg

0.4 - 26.7 kPa 0.0 - 106.7 kPa 53.3 - 106.7 kPa

15.7 - 31.5 inHg

Dependency Rule and Information: PCO2 Requires pH calibrated for results. (pH is checked on standards to assure bicarb is correct.) Calculated Results Requires calibrated and proper results by measured tests used in calculation.

QR-4

Preface

Stat Profile pHOx Training Manual

Stat Profile® pHOx® Customer Training Programs

NOTES:

Stat Profile® and pHOx® are registered trademarks of Nova Biomedical. Training on the Stat Profile pHOx Analyzer is intended to be carried out by a Nova training specialist utilizing this training guide, the reference manual shipped with the analyzer, training aids, and supplemental hands-on exercises as appropriate. Training has been designed to be carried out in several stages corresponding to the operator’s involvement level. When carried out at your location, the time you make available per training session will determine how much material can be covered. Basic operator training requires approximately 1-2 hours, based on analyzer features and the participants' prior experience. Key or principal operator training requires an additional 2 hours of training. See the following page for topics generally covered.

For additional information on training programs and materials, contact the Nova customer training department at:

(800) 545-NOVA ext. 571

i

Preface NOTES:

Stat Profile pHOx Training Manual Learning Objectives Basic Operator Training is designed to provide a new (first line) operator with skills to: • Perform analyses of patient and QC samples • Locate and use selected software screens and functions • Identify major components • Perform routine maintenance procedures • Identify error conditions • Carry out simple corrective procedures • Use the reference manual or the Nova Hot Line as necessary Key Operator Training adds those skills and information to: • Perform all routine maintenance procedures • Locate and utilize all necessary software screens and functions • Identify performance trends and patterns • Introduction to Nova support service • Customize maintenance schedules • Apply advanced troubleshooting techniques to resolve fluidic, calibration, and results-related problems • Identify pre-analytical and other sources of sample handling error • Use troubleshooting guides to resolve results-related problems • Train additional operators in the workplace Management Options will be discussed with the medical and/or technical director. They include the following: • •

• •

ii

Adapting the analyzer to the facility’s needs (setup options) Guidelines for analyzer performance verification (See Getting Your Nova Analyzer On Line, PN 17361.) - Linearity - Precision - Correlation QA Program options CLIA compliance

1 System Identification 1

System Identification

1.1

System Overview •

• • • •

•

Stat Profile pHOx Training Manual NOTES:

The display is a backlit liquid crystal display (LCD) for menus and messages. Menus allow use of operating options and features. The keypad is the primary input device. The internal printer prints patient results, QC, setup information, error log, etc. The analytical compartment is where all calibration reagents enter and the sensor measurements take place. Reagents enter from the reagent pack. Waste materials (samples and reagents) are expelled into the reagent pack waste bottle. Sensors and air detectors are automatically calibrated periodically to insure accuracy.

1-1

1 System Identification

Stat Profile pHOx Training Manual

NOTES:

11

1

10

2 9

3

8

4

DWG #10-1017A

7

5

6

Figure 1.1 Analytical Compartment

1. 2. 3. 4. 5. 6.

1-2

Waste Line Reference Line Pinch Valve (Reference) Pump and Pump Tubing Reagent Pack Opening Control Pack Opening

7. Sampler 8. Air Detector 9. Sensor Module with Sensors 10. Reference Electrode 11. Pinch Valve (Waste)

1 System Identification

Stat Profile pHOx Training Manual

1.2 Flow Overview 1.2.1 Reagents Reagents are drawn from the reagent pack, through the reagent harness, through the rotary valve, to the fluid fountain by way of the sample tubing, where they are aspirated by the sample probe. The sample probe can aspirate different reagents depending upon the position of the rotary valve. Aspirated fluids are drawn through the probe, the air detector, the sensor module with sensors, reference electrode, around the pump and out through the waste line to the waste container in the reagent pack.

NOTES:

Instructor shows all these parts as they are described.

1.3 Flow Components 1.3.1 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 polyethylene fitment with a septa seal. The waste bag has a hydrophobic air vent. Septa 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 at 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.

Instructor points out that the reagent pack can be inserted and removed a few times.

1-3

1 System Identification

Stat Profile pHOx Training Manual

NOTES:

1.3.2 Reagent Harness The Reagent Harness transports reagents from the reagent pack to the rotary valve. It is replaced as part of annual maintenance by Nova Service.

1.3.3 Pinch Valves 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 flow cell.

1.3.4 Peristaltic Pump The pump is a 6-roller peristaltic pump driven by a stepper motor.

1.3.5 Sampler Assembly - Sample Probe 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. A capillary adapter automatically moves to the end of the probe when the Capillary Analyze key is pressed. 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.

1-4

1 System Identification

Stat Profile pHOx Training Manual NOTES:

1.3.6 Sensor Module The sensor module includes the preheater and flow cell. The preheater preheats samples and controls to 37°C. In addition, it contains the hematocrit impedance sensor 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.

1.3.7 Sensors The Sensors housed in the sensor module are the core of the Stat Profile pHOx Analyzer. The methodology used by each sensor are Sensor

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 an electrical contact is automatically made.

1-5

1 System Identification

Stat Profile pHOx Training Manual

NOTES:

1.3.8 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.

1.3.9 Sensor Blanks (PN 22507) Sensor Blanks (see Figure 1.2) are used in place of sensors that are not present on the analyzer or that are removed for certain maintenance and troubleshooting procedures. Periodically (as needed) remove blanks and clean the flow cell and tip of the blank with a cotton-tipped applicator that is moistened with bleach.

DWG #7-0-0 39A

Figure 1.2 Sensor Blank

1.3.10 Interconnect Tubing (PN 07161) Interconnect Tubing is installed between the reference electrode and the sensor module. Required for the proper sealing of these components.

1.3.11 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.

1-6

1 System Identification

Stat Profile pHOx Training Manual NOTES:

1.3.12 Pump Tubing The pump tubing has 2 manifolds (a top and bottom) and reference and waste tubing, labelled R and W. The top manifold can be identified by the half circle (right-sided). The R and W-pump tubing are connected to the corresponding labeled outlets below the pump.

DW

G#

10-1

007

A

Figure 1.3 Pump Manifolds and Tubing

1-7

1 System Identification NOTES:

1-8

Stat Profile pHOx Training Manual

2 Running an Analysis

Stat Profile pHOx Training Manual

2 Running an Analysis 2.1

NOTES:

Is the Instrument Ready for Analysis?

2.1.1 Home Screen Check the Home screen for Ready to analyze. The screen displays all analytes with the uncalibrated ones x'd out. Also, the next QC and Calibration times are displayed. A bar graph for the amount of reagents and controls shows the approximate percent remaining.

2.2

Patient Samples - Acceptable Samples/Sample Handling

2.2.1 Acceptable Samples The acceptable sample is heparinized whole blood. 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.

Update to PN 24302 Rev. B 3/2002

For whole blood analysis only. No serum or plasma unless operator has validated the system for that purpose. No urine, CSF, cardioplegia solution, or other body fluids.

2-1